Alternate Data Submission Users Guide

Transcription

1 Alternate Data Submission Users Guide AHRQ Common Formats for Event Reporting Community Pharmacy Version 1.0

2 Change Log Version Author Date Revision 1.0 PSOPPC 12/2016 Initial Version 1.1 PSOPPC 04/2018 Revised for Alternate Data Submission via website For AHRQ Common Formats for Event Reporting - Community Pharmacy Version 1.0 Page 2 of 21

3 Table of Contents 1. PSOPPC Data Submission Overview Background Intended Audience 1.3 File Format and Submission Methods Supported Submission Methods PSOPPC Website Submission SFTP Submission and File Name Definition SFTP File Naming Example Validation Mandatory Prerequisites File Structure and Examples XML Format Submissions XML Schema Definition and File Samples High-Level XML Structure Question and Answer XML Structure XML File Examples Header Section XML Example CommunityPharmacy Event Section AdditionalInfo to Provide for Answer Code A66 and A Providing Multiple Answers for One Question Submission of the Unknown Answer Value DSV Format Submissions DSV File Samples DSV File Structure DSV File Examples Header Section Example CommunityPharmacy Event Section Example Additional Answer Information to Provide for A66 or A Providing Multiple Answers for One Question Submission of Unknown Answer Values Appendix Reference For AHRQ Common Formats for Event Reporting - Community Pharmacy Version 1.0 Page 3 of 21

4 List of Tables Table 1. File Name Format... 7 Table 2. Additional Answer Information Table 3. Header Section Data Elements Table 4. Medication-specific Data Elements (Questions) Table 5. General Error Code and Message Examples List of Figures Figure 1. High-Level XML Structure Example... 9 Figure 2. Question and Answer XML Structure Example Figure 3. Header Section XML File Example Figure 4. CommunityPharmacy Event Section XML File Example Figure 5. AdditionalInfo for DE1112 with Answer Code A66 XML File Example Figure 6. Multiple Answers for One Question XML File Example Figure 7. Submission of the Unknown Answer Value XML File Example Figure 8. DSV File Structure Example Figure 9. Header Section DSV File Example Figure 10. CommunityPharmacy Event Section DSV File Example Figure 11. Additional Answer Information for DE1112 with Answer Code A Figure 12. Multiple Answers for One Question DSV File Example Figure 13. Submission of Unknown Answer Values DSV File Example For AHRQ Common Formats for Event Reporting - Community Pharmacy Version 1.0 Page 4 of 21

5 1. PSOPPC Data Submission Overview 1.1 Background The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), and its regulations (the Patient Safety Rule) authorized the creation of Patient Safety Organizations (PSOs), which collect, aggregate, and analyze information regarding the quality and safety of healthcare. PSOs voluntarily contribute non-identifiable data on patient safety concerns. The Agency for Healthcare Research and Quality (AHRQ) established the PSO Privacy Protection Center (PSOPPC) to assist PSOs and others with meeting the statutory requirement when submitting data. AHRQ also created the Common Formats to help providers uniformly report data. The PSOPPC has been receiving and processing data in AHRQ Common Formats since AHRQ requires Common Formats data to be submitted in Extensible Markup Language (XML) format, which abides by the Health Level Seven (HL7) Clinical Document Architecture (CDA), Release 2.0 standard. The Alternate Data Submission process was developed to provide PSOs with flexibility when submitting data. This process enables the submission of Common Formats data in basic XML (i.e. non-cda format) or delimiter-separated values (DSV) format. The XML or DSV files should only contain Common Formats data. Once the data is received by the PSOPPC, the Alternate Data Submission process will convert the data into the required CDA XML format and continue load it into PSOPPC system. The Alternate Data Submission process also provides the opportunity for organizations, such as hospitals, to easily create and send submission-ready XML or DSV formatted files directly to their designated PSO. This enables the organization to produce acceptable formatted data in less time than the traditional CDA XML files, helping to expedite the overall process. 1.2 Intended Audience This document is for personnel responsible for submitting Common Formats data to the PSOPPC. Readers should be familiar with the following AHRQ Common Formats for Event Reporting - Community Pharmacy Version 1.0 (CFER-CP V1.0) documents and guides: Implementation Guide, Resource Workbook, and Data Dictionary, which are available on the PSOPPC website. 1.3 File Format and Submission Methods Supported The PSOPPC supports two data file formats for the Alternate Data Submission option: Extensible Markup Language (XML) Delimiter-Separated Values (DSV) You can submit alternate format files in one of two ways: Secure File Transfer Protocol (SFTP) or via the PSOPPC website. Here are some points for each: For AHRQ Common Formats for Event Reporting - Community Pharmacy Version 1.0 Page 5 of 21

6 SFTP Supports automation Best for larger datasets Requires special file naming convention Requires SFTP account setup PSOPPC website Requires manual data submission Preferable for smaller datasets (less than 20 MB) and quick testing No special file naming convention No SFTP account setup required 2. Submission Methods 2.1 PSOPPC Website Submission When alternate data format files are submitted via the PSOPPC website, they must adhere to these rules: Common Formats version must be selected on the web page One file must be selected on the web page File name extensions should be either CSV (delimiter-separated values), XML, or ZIP, case insensitive Zip files can contain either XML files or CSV files, they cannot contain both types File size submitted cannot be larger than 80 MB File name cannot contain any spaces nor the following characters: \ / : & *? < > File name must be less than 45 characters in length 2.2 SFTP Submission and File Name Definition Submissions via the SFTP method need to follow a specific file naming convention. Incoming patient safety concerns data should be compressed into a zip file, containing data in either XML or DSV format. Characters in the zip file name are case sensitive and must follow the naming convention defined in Table 1: DataFormatName-SubmissionType-CommonFormatsVersionName- PSONumber-SubmissionDate-BatchSequence-DocumentVersionNumber.zip For AHRQ Common Formats for Event Reporting - Community Pharmacy Version 1.0 Page 6 of 21

7 Table 1 provides detailed information for each of the seven sections of the file name. Table 1. File Name Format Name Description Valid Value and Format Data Format Name Specify submission data is in XML format or DSV format XML DSV Submission Type Specify submission is Test (T) or Production (P). Test T submissions can be deleted later by user from PSOPPC P website; Production submission cannot be deleted. Common Formats Version Name AHRQ Common Formats for Event Reporting version. This must be an exact match. CP_1_0 PSO Number AHRQ assigned PSO Number, e.g., P1234. Pxxxx When vendors submit for a PSO, this identifier should specify the PSO Number, not the Vendor Number. Submission Date Specify submission date in numeric format: YYYYMMDD YYYYMMDD Batch Sequence Batch Level Document Version Number A unique number to distinguish submission batches for a submission date. An integer that is incremented to identify updates to a previously submitted file (the first version being 1; the second being 2, etc.). When the PSO does not provide a document version number in the XML or DSV file, this batch level document version number will be used to generate the CDA XML file. 0 is used as not applicable. From 1 to or SFTP File Naming Example XML-P-CP_1_0-P zip The first three characters of the file name indicate that the submission data is in XML format. The P represents a Production submission, and CP_1_0 signifies the submission is for CFER-CP V1.0. P0000 represents the AHRQ-assigned PSO ID of the PSO submitting the batch. Following the PSO ID is the submission date. After submission date, the batch sequence number is shown. In this example the batch file is the 12 th batch that the PSO has submitted on that particular day. 0 indicates the Batch Level Document Version Number is not applicable. DSV-T-CP_1_0-P zip The first three characters of the file name indicate that the submission is in DSV format. The T represents a Test submission, and CP_1_0 signifies the submission file is for CFER-CP V1.0. P0000 represents the AHRQ-assigned PSO ID number of the PSO submitting the batch. Following the PSO ID is the submission date. After submission date, the batch sequence number is shown. In this example, the 1 indicates this is the first batch the PSO has submitted on that particular day. The Batch Level Document Version Number is set to 2, indicating the PSO wants to use 2 as the Document Version Number (docversion) in the files in this batch. For AHRQ Common Formats for Event Reporting - Community Pharmacy Version 1.0 Page 7 of 21

8 3. Validation 3.1 Mandatory Prerequisites Submitting PSOs or Vendors must complete the following steps before they can take advantage of the Alternate Data Submission service: 1. PSOs and Vendors must have registered and be listed as an active organization on the PSOPPC Website 2. PSOs must have a fully executed Data Use Agreement (DUA) with ActioNet, Inc. in its capacity as the PSOPPC. Vendors can only submit data for PSOs holding a fully executed DUA 3. PSOs and/or Vendors must hold at least one active Level 3 user account 4. (For SFTP only) PSOs and/or Vendors must complete the PSOPPC SFTP System Interconnection Agreement and have a valid SFTP account setup 5. Vendors must be authorized by the PSO to submit data on their behalf. PSOs must submit their Vendor Authorizations to the PSOPPC Help Desk at support@psoppc.org or at (866) File Structure and Examples When submitting patient safety concerns data in XML or DSV format, PSOs only need to provide Common Formats defined questions and their associated answers. The PSOPPC will handle the complexity to convert this data into compliant CDA XML in accordance with AHRQ requirements. 4.1 XML Format Submissions XML Schema Definition and File Samples XML Schema Definition (XSD) is used to describe the file structure and elements for the XML format. The XSD file defines all of the data elements that can be included in the XML file, each element s data type, valid input value and if it is required or not. Submit a request to the PSOPPC Help Desk at support@psoppc.org or call (866) to retrieve the following technical information: Alternate Data Submission Schema XSD file for CFER-CP V1.0 XML-formatted sample files for CFER-CP V1.0 Incidents, Near Misses, and Unsafe Conditions High-Level XML Structure The list below describes each component of the high-level XML structure. PatientSafetyData The root of the document. It contains docversion, and two sections: Header and CommunityPharmacy. o Header Section that contains all administrative-level questions. For AHRQ Common Formats for Event Reporting - Community Pharmacy Version 1.0 Page 8 of 21

9 o CommunityPharmacy Section containing the following two elements: eventlevelquestions Questions occurring at the event level. medications Questions specific to each medication should be grouped under the medications element. This element can contain up to 4 specific medications. o docversion The number that represents the version of an event file, which assists in identifying an updated version of a previously submitted file. If provided in the file, it must be a positive integer that shall be incremented for subsequent versions. If not provided, the batch level event document version will be used to generate the CDA XML file. If not provided in either the file level or batch level, the file will be rejected. Figure 1. High-Level XML Structure Example <PatientSafetyData xmlns=" <docversion>1</docversion> <Header> <question code="de1" /> </Header> <CommunityPharmacy> <eventlevelquestions> <question code="de270" /> </eventlevelquestions> <medications> <medication> <question code="de280" /> </medication> <medication> <question code="de280" /> </medication> </medications> </CommunityPharmacy> </PatientSafetyData> For AHRQ Common Formats for Event Reporting - Community Pharmacy Version 1.0 Page 9 of 21

10 4.1.3 Question and Answer XML Structure Figure 2 shows the question and answer information needed to build an XML-formatted file. Figure 2. Question and Answer XML Structure Example <question code="dataelementid"> <value>answer1 </value> <additionalinfo>more answer info here</additionalinfo> <value>answer2</value> Each question corresponds to a Data Element ID defined in the Data Elements worksheet of the Resource Workbook. A question code tag is required for each question, e.g. <question code= DE1 />. A question can have one or more answers according to the definition of the question in the Data Element worksheet within the Multiple Answer Values Allowed for each Data Element column of the Resource Workbook. An answer value is required, which can contain an answer code or other text data. A value tag is mandatory for each answer, e.g. <value>a15</value>. Answer values are defined in the Answers worksheet of the Resource Workbook. If an answer to a question is unknown, the value should be provided as UNK. To verify if UNK is an acceptable answer for a question, reference the Resources Workbook, select the Data Elements worksheet, and go to the Applicable NullFlavor column. The additionalinfo tag can be used with an answer value to provide additional answer information for a question. Additional answer information can only be used for answer codes A66, and A1215. See Table 2 below for full descriptions about each answer code: Table 2. Additional Answer Information Answer Code Answer Description Answer Additional Info A66 A1215 Other: Please specify Other substance: please specify Enter free text for Other: Please specify answer (2000 character limit) Enter free text for Other substance: please specify answer (2000 character limit) For AHRQ Common Formats for Event Reporting - Community Pharmacy Version 1.0 Page 10 of 21

11 4.1.4 XML File Examples Header Section XML Example The Header Section is only one of two required sections for CFER-CP V1.0. Table 3 provides all data elements required for the Header Section. For further information on data elements please refer to the Data Elements worksheet in the Resources Workbook. Table 3. Header Section Data Elements Data Element ID DE1 DE3 DE4 DE2 DE1103 DE1106 Description Provider ID Report type PSO OID Event ID Report date Sex For AHRQ Common Formats for Event Reporting - Community Pharmacy Version 1.0 Page 11 of 21

12 Figure 3 provides an example of the Header Section of an XML-formatted file including all of the required questions codes (data elements) and answer values. <Header> <question code="de1"> <value>123456</value> <question code="de2"> <value>providerid</value> <question code="de4"> <value>p0000</value> <question code="de3"> <value>a3</value> <question code="de1103"> <value> </value> <question code="de1106"> <value>m</value> </Header> Figure 3. Header Section XML File Example For AHRQ Common Formats for Event Reporting - Community Pharmacy Version 1.0 Page 12 of 21

13 CommunityPharmacy Event Section The CommunityPharmacy event section is the only event section for CFER-CP V1.0 and consists of two elements, eventlevelquestions and medications. Each patient safety concern event can report a maximum of four medications. Information collected for each medication are called medication-specific data elements, and are listed in Table 4. Data elements that are NOT listed in Table 4 are event-level questions and should be grouped under the eventlevelquestions element. Table 4. Medication-specific Data Elements (Questions) Data Element ID DE280 DE306 DE321 DE322 DE324 DE327 DE330 DE333 DE336 DE1148 DE1151 DE1154 DE1157 Description Generic name Expiration date of substance Identification of the brand name RXCUI brand name Identification of the manufacturer Identification of the strength or concentration Dosage form of product Medication/substance prescribed Medication/substance given NDC Code RXCUI Semantic Clinical Drug (SCD) Quantity dispensed Direction for use; (narrative) Figure 4 shows how to structure questions and answers for the eventlevelquestions, and medications elements. For AHRQ Common Formats for Event Reporting - Community Pharmacy Version 1.0 Page 13 of 21

14 Figure 4. CommunityPharmacy Event Section XML File Example <CommunityPharmacy> <eventlevelquestions> <question code="de270"> <value>a1198</value> <question code="de284"> <value>a1219</value> </eventlevelquestions> <medications> <medication> <question code="de280"> <value>ciprofloxacin</value> <question code="de321"> <value>cipro</value> </medication> <medication> <question code="de1154"> <value>200 ml</value> <question code="de1157"> <value>unk</value> </medication> For AHRQ Common Formats for Event Reporting - Community Pharmacy Version 1.0 Page 14 of 21

15 </medications> </CommunityPharmacy> AdditionalInfo to Provide for Answer Code A66 and A1215 Additional answer information is collected for answer codes A66 and A1215. Figure 5 provides an XML file example on how to provide AdditionalInfo for DE1112 (Description of wrong drug) with answer code A66. Figure 5. AdditionalInfo for DE1112 with Answer Code A66 XML File Example <question code="de1112"> <value>a66</value> <additionalinfo>wrong drug description</additionalinfo> Providing Multiple Answers for One Question CFER-CP V1.0 permits the submission of multiple answers for one question (data element). To identify the specific data elements that accept multiple answers, refer to the Resources Workbook, select the Data Elements worksheet, and locate the Multiple Answer Values Allowed for each Data Element column. Figure 6 describes how to structure an XML file when submitting multiple answers values for one question, DE291 (Incorrect action(s) involving a substance). <question code="de291"> <value>a1272</value> <value>a1293</value> Figure 6. Multiple Answers for One Question XML File Example Submission of the Unknown Answer Value Based on CFER-CP V1.0 specifications, some data elements allow for the submission of UNK (Unknown) as an answer value. Refer to the Resources Workbook, select the Data Elements worksheet, and go to the Applicable NullFlavor column to identify which data elements allow the UNK answer value. Figure 7 shows how to submit UNK for data element DE1157 (Direction for use). For AHRQ Common Formats for Event Reporting - Community Pharmacy Version 1.0 Page 15 of 21

16 Figure 7. Submission of the Unknown Answer Value XML File Example <question code="de1157"> <value>unk</value> 4.2 DSV Format Submissions DSV-formatted files are defined with a fixed number of columns, with each column representing a specific field, and each row representing the information associated with to each question code (data element). This simple DSV file structure is defined in a way that is easy to understand, and flexible enough to accommodate all data elements required for different AHRQ Common Formats DSV File Samples Submit requests to the PSOPPC Help Desk at support@psoppc.org or call (866) to receive complete DSV-formatted sample files for CFER-CP V1.0 Incidents, Near Misses, and Unsafe Conditions DSV File Structure DSV Format: The DSV file format is defined to contain 7 columns: 1. Record ID 5. Answer Value 2. Document Version 6. Answer Additional Info 3. Section Name 7. Question Group ID 4. Question Code Figure 8 shows how to apply the file format defined in the above 7 columns to each data element row for the Header and CommunityPharmacy sections. For AHRQ Common Formats for Event Reporting - Community Pharmacy Version 1.0 Page 16 of 21

17 Header DE4 P Header DE1 eventid Header DE2 prividerid Header DE3 A Header DE Header DE1106 M CommunityPharmacy DE270 A CommunityPharmacy DE284 A CommunityPharmacy DE1109 A DSV File Detail Description: Figure 8. DSV File Structure Example The Vertical Bar character is chosen as the delimiter between the fields to reduce the risk of interference with characters in the data. Record ID This is a mandatory field. Ideally, this field should contain the user s unique system generated Report ID, and each ID identifies a specific patient safety concerns report from the user s system. Each row in the DSV file with the same Record ID will be considered as data for the same patient safety data report. Once the DSV file is converted to a CDA XML file, the CDA XML file name will contain this ID, which can be used to link the DSV file to the CDA XML file. Doc Version The number that represents the version of an event file, which assists in identifying an updated version of a previously submitted file. If provided in the file, it must be a positive integer that shall be incremented for subsequent versions. If not provided, the batch level event document version will be used to generate the CDA XML file. If not provided in either the file level or batch level, the file will be rejected. Section Name Patient safety data is grouped into sections, and each section contains a group of questions and answers. The Section Name is case sensitive, and it must be an exact match as defined below: o Header o CommunityPharmacy Question Code (Data Element) This field is required. It should contain an AHRQ defined CFER-CP V1.0 data element, such as DE4 or DE1112. Refer to the Data Elements worksheet of the Resources Workbook for all data elements specifications. Answer Value This field is required. It should contain either a valid answer code or text answers, such as A66. If the answer to the question is Unknown, the value should be provided with UNK. Please refer to the Resources Workbook for the valid answer data set and null flavors allowance for each question. Answer Additional Info This field is used to provide additional answer information for answers A66, and A1215. Please reference Table 2. Additional Answer Information for the full descriptions of each answer. For AHRQ Common Formats for Event Reporting - Community Pharmacy Version 1.0 Page 17 of 21

18 Question Group ID This field is used to group related questions together within a Section. Please note: do not leave this field blank, it must be populated with a value (a default value can be 1 ). The Question Group ID can be any characters or numbers, but it must have the same value for all the questions belonging to the same group. When multiple medications are involved, a Question Group ID must be used to group-related questions for the CommunityPharmacy event section. Multiple Answers Some questions permit multiple answer values. Each additional answer value must be provided on a separate row, and all other columns (i.e., Record ID, Section Name, Question Code, etc.) should remain the same DSV File Examples Header Section Example The below example (Figure 9) shows all questions and answers needed to be reported in the Header section. There is no additional information needed for any of the questions and answers here, so that field is left blank Header DE4 P Header DE1 providerid Header DE2 eventid Header DE3 A Header DE Header DE1106 M 1 Figure 9. Header Section DSV File Example CommunityPharmacy Event Section Example In this example, Question Group ID 1 represents all event-level questions, Question Group ID 2 identifies all first medication questions, and Question Group ID 3 represents all second medication questions. The highlighted Question Group IDs indicate the start of each new group. For AHRQ Common Formats for Event Reporting - Community Pharmacy Version 1.0 Page 18 of 21

19 Figure 10. CommunityPharmacy Event Section DSV File Example CommunityPharmacy DE270 A CommunityPharmacy DE284 A CommunityPharmacy DE1109 A CommunityPharmacy DE CommunityPharmacy DE CommunityPharmacy DE44 A CommunityPharmacy DE55 A CommunityPharmacy DE15 Description of the event CommunityPharmacy DE291 A CommunityPharmacy DE291 A CommunityPharmacy DE1112 A CommunityPharmacy DE303 A CommunityPharmacy DE315 A CommunityPharmacy DE1160 A CommunityPharmacy DE1166 A CommunityPharmacy DE280 Ciprofloxacin CommunityPharmacy DE321 Cipro CommunityPharmacy DE324 Pfizer CommunityPharmacy DE327 2 mg/ml CommunityPharmacy DE330 IV solution CommunityPharmacy DE CommunityPharmacy DE CommunityPharmacy DE ml CommunityPharmacy DE1157 UNK CommunityPharmacy DE333 A CommunityPharmacy DE336 A CommunityPharmacy DE280 second drug CommunityPharmacy DE321 second drug brand CommunityPharmacy DE324 Johnson & Johnson CommunityPharmacy DE327 5mg/pill CommunityPharmacy DE330 pill CommunityPharmacy DE CommunityPharmacy DE CommunityPharmacy DE CommunityPharmacy DE1157 UNK CommunityPharmacy DE333 A CommunityPharmacy DE336 A15 3 All medication-specific questions are listed above in Table 4. They should be grouped together with same Question Group ID for each medicine. A maximum of four medications can be reported in a single event. Questions in the CommunityPharmacy event section that are NOT listed in For AHRQ Common Formats for Event Reporting - Community Pharmacy Version 1.0 Page 19 of 21

20 Table 4 are event-level questions, and should be grouped together with the same Question Group ID Additional Answer Information to Provide for A66 or A1215 Figure 11 displays how to format a DSV file when providing additional answer information for DE1112 (Description of wrong drug) with answer code A66. Figure 11. Additional Answer Information for DE1112 with Answer Code A CommunityPharmacy DE1112 A66 Wrong drug description Providing Multiple Answers for One Question In Figure 12, Question DE291 (Incorrect action(s) involving a substance) has two answers. Each answer value is provided on a separate row, and all other column fields remain the same. To identify which questions allow multiple answers, please reference to the Data Element worksheet of the Resources Workbook, the Multiple Answer Values Allowed for each Data Element column. Figure 12. Multiple Answers for One Question DSV File Example CommunityPharmacy DE291 A CommunityPharmacy DE291 A Submission of Unknown Answer Values Certain data elements allow for the submission of UNK (Unknown) as a NullFlavor value. This example shows how to structure DSV files when providing the applicable NullFlavor value UNK. Determine all data elements that allow UNK by referencing the Data Elements worksheet in the Resources Workbook, and navigating to the Applicable NullFlavor column. Figure 13. Submission of Unknown Answer Values DSV File Example CommunityPharmacy DE1157 UNK 2 For AHRQ Common Formats for Event Reporting - Community Pharmacy Version 1.0 Page 20 of 21

21 Appendix Appendix A Error Message List Table 5 includes general error code and message examples for both XML and DSV formats. Table 5. General Error Code and Message Examples Error Code CDA-1100 CDA-1102 CDA-1105 CDA-1107 CDA-1202 CDA-1204 CDA-1301 CDA-1307 CDA-1400 CDA-1401 CDA-1405 Error Message XML is not valid according to schema. PSO OID is not valid. Question Code: DE4 Section: Header Report type is not valid. Question Code: DE3 Section: Header Document version is not valid. It must be provided at batch level or file level. It must be an integer greater than 0. Multiple questions groups provided. Section, Header, only supports one question group. Same section is repeated. Only one is allowed. Section: Header Question is not supported. Question Code: DE111. Section: CommunityPharmacy Question cannot be repeated. Question Code: DE3 Section: Header Answer is not provided for the question. Question Code: DE4 Section: Header Answer is not valid for the question. Question Code: DE1112 Section: CommunityPharmacy Multiple answers are provided for the question. The question supports only one answer. Question Code: DE4 Section: Header For more information on error codes, please contact the PSOPPC Help Desk at support@psoppc.org or call (866) Reference AHRQ Common Formats: PSOPPC: AHRQ PSO Program website: Extensible Markup Language: XML Path Language (XPath): HL7 OID Registry main page: For AHRQ Common Formats for Event Reporting - Community Pharmacy Version 1.0 Page 21 of 21