Specimen Gate Screening Center

Transcription

1 P R O D U C T N O T E Total Process Management Specimen Gate Screening Center Screening Center focuses on the activities associated with patient demographics, patient reports, and the overall management of newborn screening programs. Thus, Screening Center offers the ability to enter and track patient and contact information, create and maintain business rules governing the content of patient reports as well as how and when the patient reports are to be created, and statistical information to monitor the performance of the program. Because the Specimen Gate database is shared across applications (see Specimen Gate Database on page 6 for more information), Screening Center may be used to monitor overall program performance including data collected from Laboratory, PatientCare, and ereports.

2 Business Rules And Workflow Screening Center includes basic business rules and workflow practices based on input from a wide variety of newborn screening programs around the world. Generation of Patient Reports Several conditions must be satisfied before a patient report may be created: All tests must be complete (i.e. there are no outstanding test requests) Lab results must be electronically signed (optional) Data Entry must be complete (all required demographics have been entered and any validation processes have been satisfactorily completed) Figure 1. Example of a Result Code Tree (Initial Screen). Any exceptions have been addressed (see Exceptions on page 5 for more information) Screening Center stores an electronic image (.pdf) of each Patient Report created Delivery of Patient Reports Screening Center can deliver electronic Patient Reports via Fax, ereports, or xchange (electronic data import and export such as HL7). Users also have the option of printing Patient Reports to send via mail. Specimen Gate will automatically create cases in PatientCare to track Positive (Elevated or Decreased) and Unsatisfactory specimens and allow users to document follow up activities. In addition, Screening Center provides a number of default validation rules for use at Data Entry (e.g. Birth Date cannot be in the future). Result Codes Specimen Gate software uses Result Codes and Result Code Trees to define a specific stage in the screening process. The figures below demonstrate a simplified version of the process used to determine whether or not a sample contains an elevated level of GALT (Galactose-1-Phosphate Uridyl-1- Transferase). In Figure 1, Result Codes RC1 and RC3 will be used to run repeat tests. The path for each repeat test is shown in Figure 2. Figure 2. Example of a Result Code Tree (Repeat Screen). Used together, the Result Code Trees shown in Figures 1 and 2 mimic a typical screening process and derive a specific Result Code to mark each possible outcome. These Result Codes are then used to drive the formulation of the Patient Report that is used to communicate results interpretations to health care professionals. Based on the information in Figures 1 and 2 above, negative (Within Expected Range) results will be reported for Result Codes RC2 and RC4 and positive (Elevated or Decreased) results will be reported for Result Codes RC5 and RC6. The positive Patient Reports will contain information and follow up recommendations specific to each individual Result Code. Searches, Reports, And Statistics Screening Center s search capabilities are designed to simplify searching, viewing, and working with data. For instance: The SmartSearch Bar is located at the top of the screen and allows users to quickly search for patients or Contacts. To search, users simply enter key data such as patient name, sample id, or doctor s name. 2

3 Six standard searches are provided with Screening Center: Patients/Specimens allows users to search for Patients or Specimens Patients by Contact allows users to search for Patients associated with a given contact Contacts allows users to search for information related to healthcare professionals and institutions Results allows users to search for specific results, result codes, and determinations Reports allows users to search for Patient Reports that have already been created/delivered Report Batches allows users to search for batches of Patient Reports Users have the ability to personalize the standard searches to their individual needs by modifying the criteria used to execute each of the standard searches. Search results are context-sensitive. That is, Screening Center may enable additional features based upon the type of search being executed. For instance, after searching for a Contact, users with appropriate security permissions have the ability to edit the Contact; users searching for Patients will have the ability to view the Patient Report, view the Patient Summary, or open the Data Entry Screen. Furthermore, users have the ability to export the search results directly to Microsoft Excel. After a search is run, the search results are displayed in a grid for users to review. Screening Center allows users to manipulate the grid by changing the order of the columns (e.g. move the Sample ID to the first column), sorting the results based on a certain column (e.g. sort results by patient s last name in alphabetic or reverse alphabetic order), or add/remove data from the results grid. And, as with the searches, users may personalize the layout of the search results by saving their changes. The results of searches may also be combined with a report template for viewing within Screening Center or exporting to hardcopy/paper reports,.pdf files, and Microsoft Excel. Screening Center leverages the data obtained from searches with report templates created in SQL Server s Reporting Services to offer a wide range of Reports and Statistics. Screening Center provides three standard Statistical Reports: the Dashboard shows a breakdown of the different stages in the screening process (e.g. data entry complete, tests complete, report generated) and the number of specimens at each stage Laboratory Throughput is a histogram that displays the specimens currently being processed based upon the number of hours that the specimen has been in the laboratory Clerk Performance shows details regarding the number of specimens entered by each person in Data Entry Additional statistical reports may be created based on any data residing within the Specimen Gate database (or other data sources accessible from the reporting server). Please work with your local PerkinElmer Software Services representative for more information. Data Entry Users can enter patient, hospital, doctor and specimen information through the Data Entry module. This includes information such as: Name of the patient, patient s mother, hospital, and physician Birth date and weight Feed type Specimen collection date By default, Screening Center offers a standard set of data entry fields commonly found on bloodcards used throughout the world. In addition, the Data Entry screen may be configured to reflect the layout of a specific blood collection card. Validation rules may be configured to enforce certain policies. For example, users can be forced to enter a sample collection date that is greater than or equal to the patient s birth date. Screening Center s Data Entry module also offers a number of features designed to simplify the processes involved in data entry: A scanned image of the bloodcard may be used as the background of the Data Entry screen. This helps to ensure that the layout of the screen matches the layout of the bloodcard and gives users a visual reference to the data being entered (this is helpful in situations where multiple cards are being used). Screening Center may be configured to display different Data Entry screens based on different criteria (typically the accession number). Thus, Screening Center can easily handle situations where a laboratory is changing from one bloodcard layout to another or the laboratory treats several groups of specimens differently (e.g. different screening panel, different cutoffs). 3

4 Tabbed Data Entry Screening Center s Data Entry module displays bloodcards in individual tabs and allows multiple tabs to be open at the same time. Together with the SmartSearch feature, Tabbed Data Entry allows users to perform Data Entry on individual specimens as well as the ability to quickly search for a patient and view the patient s demographics in another tab without changing screens or losing any work. Contacts Screening Center allows users to maintain a library of information about the people and facilities (referred to as Contacts ) involved with newborn screening. Generally, the contact information includes items such as: Name of the person or facility Full street address (city, state, and zip code) Telephone number and fax number Screening Center also offers a wide range of options regarding reporting. Each of these options is configured at the contact level, allowing laboratories full control over how the reports are generated and delivered to each Contact. For instance: All Contacts have a default language setting. Thus, reports may be created for one Contact in English while another Contact s reports are created in Spanish. Screening Center will automatically generate patient reports for each contact using the default language setting. One or more delivery methods (print, fax, ereports, HL7) may be configured for each contact. Patient Reports Patient Reports are a very specific form of report and are used to report screening results for all specimens with an Accepted status in the Laboratory software. The general format of the Patient Report is as follows: Header Section (Customer-specific logo and contact information) Patient and Specimen Information Section Display of patient information from the demographics portion of the bloodcard. Results Section Disorders will be grouped together and displayed by the name of the group (e.g. Amino Acid Disorders or Fatty Acid Oxidation Disorders) For each group, results will be displayed according to result status Groups with negative results will be displayed with a message stating All Within Expected Range Groups with positive results will display: The result of the primary analyte The result of one or more secondary analytes Secondary analytes or other elevated/decreased analytes not related to the Positive disorder will not be displayed Analytes are displayed only once within each disorder group Comments Section One standard comment for each abnormal disorder dis played. By default, comments are limited to 256 characters. Footer Section Page and date information Static section to list all core disorders and primary analytes for each group. Sorting Initial sort by positive and negative specimens Secondary sort by contact Tertiary sort by baby last name Patient Summary Screening Center also provides a Patient Summary to display key patient data and links to additional information such as notes and patient reports. The Patient Summary is the central gathering point for all relevant patient demographics, specimens, reports, and notes. The information available includes: Patient information such as Name, Date of Birth, Gender, and Address Specimen information such as Accession Number/Barcode, Collection Date/Time, Weight, Gestational Age, and Transfused Date Results for each specimen including Concentrations, Result Codes, and Result Status 4

5 Contact information such as Contact ID, Contact Type, and Address Notes applied to the specimen including the person who created the note, the date the note was created, and the contents of the note (or a link to the attachment) Reports created for each specimen including the date the report was created, who the report was created by, and a link to the report Linking Screening Center allows users to link two or more specimens to the same patient. When specimens are linked, Screening Center associates the patient information for one or more specimens with the patient information of another. Typically, the patient information for each specimen is linked with the patient information from the most recent sample based on the assumption that the most recent patient information should be reported. For instance, assume the following specimens are to be linked: Specimen 1 is received on January 1, 2011 from patient Jane Doe Specimen 2 is received on January 15, 2011 from patient Jane Doe Specimen 3 is received on January 31, 2011 from patient Jane Smith Following the most recent linking philosophy, Screening Center would associate the name Jane Smith with all three specimens listed above. Users have the option of initiating either an automatic or a manual linking process. In the case of automatic linking, Screening Center will scan the Specimen Gate database at defined intervals and identify specimens that are potential candidates to be linked. If the patient information for each sample meets a set of established criteria, each sample is linked to the most recent patient information. If a manual linking operation is requested, Screening Center will identify potential candidates to be linked, but require the user to make the final decision regarding which samples will be linked together. The criteria used to identify candidates to be linked usually include the patient s name, medical record number, mother s name, and Contact information. In an automatic linking scenario, specimen information must match a specified number of criteria to (often 3 out of 4 or 4 out of 5) before a match is identified and the samples are linked. In manual linking, the criteria are used only to identify and present a list of potential candidates to the user. Exceptions Screening Center may be configured to enforce certain rules or processes. Specimens that violate these rules are stored as Exceptions and must be approved by Supervisors before the patient report may be generated. For instance, instead of preventing users from entering feed and collection dates prior to a patient s birth date, Screening Center can be configured to allow users to enter incorrect dates but mark, or flag, these entries as Exceptions. A Supervisor must review and approve all Exceptions before a patient report may be generated. Result Code Editor Users with appropriate security permissions may change the attributes of a given specimen using the Result Code Editor. For instance, users can: Add or request a test Modify the test phase for a given specimen (e.g. change from Initial to Repeat) Change the result code associated with a given result History History presents an overview of changes made to patient information, specimen information, and contact information. The information is displayed as it existed prior to modification, with the current record and all prior records shown for comparison (including the date and user that made the change). Differences between the current record and each of the previous records are highlighted for reference. Notes Screening Center allows users to enter additional information about a patient, specimen, determination, or a case. This information can be viewed, entered, and modified in various places throughout the application. All notes created in Screening Center are available in the Patient Summary. Multi-Language Capabilities Screening Center is available in English and Spanish, with support for additional languages expected in the future. Screening Center s language capabilities allow: User-specific language settings (i.e. two users on the same PC may display the application in different languages) Contact-specific language settings (see Contacts on page 4 for more information) 5

6 Scanning Screening Center users may purchase the Scanning module to allow the software to capture electronic images of paper documents. The scanning module is designed to interact with industry standard hardware and software and is intended to simplify the work involved with managing the documents commonly involved in newborn screening. The Scanning module will: Capture an electronic image of a paper document Translate computer-generated information such as a barcode or accession number from the scanned document into a unique identification number (users can generate labels containing a barcode or accession number and apply the label to any documents without this information) Link an electronic image of the scanned document to an existing specimen record (images are stored using the specimen id in the filename). Prompt the user to accept the scan/linking operation. As part of this process, the Scanning Module will alert users to any errors or discrepancies. Allow Screening Center users to view electronic images. Screening Center users may also make electronic images viewable by ereports users. The Scanning module may be configured to recognize different types of documents including demographics cards and letters. In addition, multiple documents can be grouped together using one barcode. Thus, once the Scanning module has been configured properly: Users can load the scanner with demographic slips, press Scan, and perform other activities while the Scanning module imports the electronic images. Users can scan multiple documents and link them to one specimen by grouping all of the documents to be scanned into a batch Different batches of documents may be linked to different specimens. In this case, the first document in each batch must contain a barcode. Then, the Scanning module will automatically scan the documents in order, linking all documents in each batch to the barcode from the first document. Requirements The Scanning Module is designed for use with EMC Captiva QuickScan Pro version 4.6 (Pricing Level 2) and recommended for use with Panasonic KV-S2026C and KV-S2046C scanners. Additional scanners may be compatible and are subject to user testing and validation. Compatibility with ISIS (Image and Scanner Interface Specification) and EMC Captiva QuickScan Pro Version 4.6 or greater are required. For more information regarding additional scanners and pricing levels, please refer to The Scanning Module must be installed on a PC that is connected to the scanner. In addition, the Scanning Module must have read/write access to the Specimen Gate fileshare. The scanner software (EMC Captiva QuickScan Pro) governs the recognized barcode formats and supported image types. Industry standard barcode (such as Code 128 and Data Matrix) and image (e.g..gif,.jpg,.tiff) formats are supported. Note: The Scanning Module is not intended to recognize handwritten information. Although the technology exists, Optical Character Recognition (OCR) on its own does not provide enough accuracy to import handwritten information. For more information, please contact your local PerkinElmer representative. Specimen Gate Database Application-specific configuration information and all data collected by Specimen Gate (e.g. specimen information, test results, and patient information) are stored in a series of databases collectively known as the Specimen Gate Database. All of the Specimen Gate software applications Specimen Gate Laboratory, Screening Center, PatientCare, and ereports require the Specimen Gate database for proper operation. The Specimen Gate Database is a Microsoft SQL Server database. Security Specimen Gate Laboratory, Screening Center, and PatientCare require users to be able to authenticate to the Specimen Gate database server using domain authentication (mixed mode). Specimen Gate utilizes integrated security for user authentication by validating that the Windows user name is setup as a Specimen Gate user. Specimen Gate can restrict access to applications and components based on the Windows user name. 6

7 Screening Center Supervisor Review Create/Print Patient Reports (PDF, hardcopy) ereports Laboratory Enter Patient Demographics Results Editor Release abnormals/ normals ready Screening for reporting Center PatientCare TIME Link records Send abnormals to follow-up Screening Center About Specimen Gate In continuous development since 1994, PerkinElmer s Specimen Gate software is a suite of configurable applications designed specifically to provide a Total Process Management Solution for your newborn screening laboratory. There are four Specimen Gate applications: Laboratory Screening Center PatientCare ereports PerkinElmer is the world s number one provider of software systems to screening laboratories. Our global team of more than 50 professionals draws upon over 300 years of combined experience developing, installing, and supporting software designed exclusively for the Newborn and Prenatal screening markets. Specimen Gate software is developed using Agile (Scrum) development techniques according to the FDA s Good Manufacturing Practices (GMP) guidelines in an ISO certified and FDA inspected facility. Our credentials for development and manufacturing site Quality System compliance are: ISO 9001 since 1992 ISO since 2003/CMDCAS since 2003 OHSAS since 2008 Specimen Gate software is designed to simplify the data collection and workflow processes involved with receiving specimens, screening for abnormalities, managing patient information, generating specimen reports, and following up abnormal and unsatisfactory specimens. Installed in more than 75 laboratories in over 20 countries worldwide, Specimen Gate software is used to screen more than 7 million specimens each year. 7

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