BRD - PA



Appendix DNewborn Screening and Follow-upRequirements DocumentProject #:6100025874Date submitted:September 30, 2013Table of Contents TOC \o "1-3" \h \z \u 1Intentionally Left Blank PAGEREF _Toc375302779 \h 32Intentionally Left Blank PAGEREF _Toc375302780 \h 43Purpose of the Document PAGEREF _Toc375302781 \h 54Acronyms PAGEREF _Toc375302782 \h 65Executive Summary PAGEREF _Toc375302783 \h 86Introduction PAGEREF _Toc375302784 \h 96.1Project Overview PAGEREF _Toc375302785 \h 96.2References/Inputs PAGEREF _Toc375302786 \h 107Business Model PAGEREF _Toc375302787 \h 117.1Organizational Profile PAGEREF _Toc375302788 \h 147.2High-level As-Is Process Flow PAGEREF _Toc375302789 \h 157.3High-level To-Be Process Flow PAGEREF _Toc375302790 \h 337.4Process Mapping PAGEREF _Toc375302791 \h 438Requirements Definition PAGEREF _Toc375302792 \h 458.1Overview PAGEREF _Toc375302793 \h 458.2Approach PAGEREF _Toc375302794 \h 458.3Detailed Requirements PAGEREF _Toc375302795 \h 459Addendum PAGEREF _Toc375302796 \h 469.1Sample Filter Paper PAGEREF _Toc375302797 \h 46Intentionally Left BlankIntentionally Left BlankPurpose of the DocumentThe purpose of the Requirements Document (RD) is to lay the foundation for the design and development of a technical solution. The RD describes the high-level business process, outlines the business needs that will be fulfilled by the successful completion of the project, and identifies actual technical or system requirements for the solution.The foundation for a successful project is built upon the quality and thoroughness of requirements gathering. The RD establishes key requirements, objectives, and goals that drive all other subsequent lifecycle phases. It describes the business problem to be solved in terms of verifiable and traceable characteristics and constraints. In addition to key program level requirements, the RD captures operational concepts and program level interfaces. This document should be referenced continuously during the project lifecycle phases to ensure that the deliverables from the project meet the approved requirements.Acronyms The following table provides the acronyms along with their definitions that are used throughout this document.AcronymDefinition3MCC3-Methylcrontonyl-CA Carboxylase DeficiencyAKAAlso Known AsASAArgininosuccinic AcidemiaAudioAudiologistBABusiness AnalystBFHBureau of Family HealthBIOTBiotinidase DeficiencyBITBureau of Information Technology BKTBeta-Ketothiolase DeficiencyCAHCongenital Adrenal HyperplasiaCbl A,BMethylmalonic AcidemiaCEOChief Executive OfficerCFCystic FibrosisCHDCongenital Heart DefectCHNCommunity Health NurseCITCitrullinemiaCORECore System COTSCommercial-Off-The-ShelfCUDCarnitine Uptake DefectDOADepartment of AgingDOBDate of BirthEHDIEarly Hearing Detection and InterventionEHRElectronic Health RecordsEIEarly InterventionENTEar Nose and Throat SpecialisteSP?e-Screener Plus?FPFilter PaperFPNFilter Paper NumberFTPFile Transfer ProtocolGA IGlutaric Acidemia Type 1/Glutaryl-CoA Dehydrogenase Deficiency Type 1GALGalactosemiaHb S/CHb S/C DiseaseHb S/ThHb S/Beta-ThalassemiaHCYHomocystinuriaHL7Health Level Seven, Inc., a non-profit organization that establishes healthcare standards for the exchange of EHRHMG 3-Hydroxy 3-Methylglutaryl-CoA Dehydrogenase Deficiency Type 1HRSAHealth Resources and Services AdministrationHyperalHyperalimentationIAWIn Accordance WithIDIdentifierIHEARRInfant Hearing Education Assessment, Reporting and Referral Act (Act 89 of 2001)IRTImmuno-Reactive TrypsinogenITBInformation Technology BulletinIVAIsovaleric Acidemia/Isovalery-CoA Dehydrogenase DeficiencyLCHADLong-Chain L-3-OH Acyl-CoA Dehydrogenase DeficiencyMAMedical AssistanceMCADMedium-Chain Acyl-CoA Carboxylase DeficiencyMCDMultiple Carboxylase Deficiency (MCD)MOUMemorandum of UnderstandingMSUDMaple Syrup Urine DiseaseMUTMethylmalonic Acidemia (Mutase Deficiency)NBSFNewborn Screening and Follow-Up NPINational Provider IdentifierNSGDivision of Newborn Screening and GeneticsPACommonwealth of PennsylvaniaPA DOHPennsylvania Department of HealthPACEPharmaceutical Assistance Contract for the ElderlyPCPediatric CardiologistPCPPrimary Care ProviderPEGPerkinElmer Genetics, Inc.PHIProtected Health InformationPHPAPublic Health Program AdministratorPKUPhenylketonuriaPLAParticipating Laboratory AgreementPMOProject Management OfficePPVPositive Predictive ValuePre-Pos/Pre-PositivePresumptive PositivePROPPropionic Acidemia/Propionyl-CoA Carboxylase Deficiency QCQuality ControlRDRequirements DocumentRFPRepeat Filter PaperRFQRequest for QuoteSaaSSoftware-as-a-ServiceSCIDSevere Combined ImmunodeficiencyTCTreatment CenterTFPTrifunctional Protein DeficiencyTYR 1Tyrosinemia TypeUMASSUniversity of Massachusetts New England Newborn Screening ProgramVLCADVery Long-Chain Acyl-CoA Dehydrogenase DeficiencyWNLWithin Normal LimitsExecutive SummaryAs a result of the limitations of the current Newborn Screening and Follow-Up (NBSF) information systems and planned Bureau of Family Health (BFH) Division of Newborn Screening and Genetics (NSG) expansions in the near future, Pennsylvania Department of Health (DOH) has to implement a new enterprise solution to address the information processing needs of NSG. While it would be nice to have a system that would address all current and future needs of NSG, it is imperative to replace the current outdated and fragile metabolic and hearing systems immediately without waiting for some of the new programs to be established. This effort involves acquisition and implementation of a Commercial Off-The-Shelf (COTS) Software-as-a-Service (SaaS) solution. The initiative will result in a new enterprise-wide information management system replacing the current two systems used by NSG for the hearing and metabolic NBSF program.During the requirements gathering phase of this effort, the project team performed analysis of both of the existing systems. The project team conducted interviews with NBSF Managers, Community Health Nurses (CHN), Public Health Program Managers and clerical staff who use these systems on a daily basis to achieve a thorough understanding of the As-Is business processes. The project team held job shadow sessions with several of the CHNs to grasp a deeper understanding of both the information systems being used and the current processes. After gathering information from the system analysis, CHN interviews and job shadows, As-Is process flows and narratives were created. Some of the issues with the current system are: limited search capabilities, inaccurate linking of repeat filter papers (RFP), and incapability to generate necessary reports.When As-Is documentation was completed, requirements workshops were held with NBSF Managers, DOH Business Analysts (BA), and Bureau of Information Technology (BIT) Application Developers to develop high-level To-Be process flows. A gap analysis was performed on these As-Is and To-Be process flows. They were analyzed and used to create the business and system requirements presented later in this document.The most significant impact to the business processes will be the activities performed by external stakeholders and the reduced number of follow-up activities necessary for the DOH CHNs. The To-Be system and processes will strive to minimize sending and receiving faxes and telephonic communication between laboratories, treatment centers (TC), and the DOH. The laboratories and TCs will perform data entry and status updates directly into the system. The new process flows encourage reducing the amount of printed paper by using internal system communications or electronic mail.With greater capabilities and increased functionality of a new system, DOH will be able to rely on the system for reporting purposes, generating multiple levels of reports to be used for decision making, budgeting, trending, statistics, state and federal reporting, and quality assurance of the laboratories, TCs, and other system users.IntroductionProject OverviewDOH BIT currently maintains a dated and unstable .Net web application that supports the Newborn Screening and Follow-Up (NBSF) program’s newborn metabolic screening area. NBSF’s newborn hearing screening area is supported by an out-sourced system, fully hosted and managed by the vendor.With the termination of the vendor contract quickly approaching and the instability of the system being used by metabolic, NSG would like to procure a new, comprehensive, flexible, integrated, web-based enterprise solution for newborn hearing and metabolic screening, short and long-term follow-up. The original data systems were limited to departmental users. To facilitate seamless exchange of information among various professionals working with newborns, DOH requires the new system to be capable of assigning unlimited users to both internal DOH staff and external users. These external users will be medical professionals from hospitals, laboratories, birthing centers, treatment centers, primary care providers (PCPs), mid-wives, and specialists that are involved with a newborn’s screening and follow-up activities. Each individual will be assigned access levels based on the care and case management needs they provide.DOH BIT and NSG have agreed to undertake a project to procure and implement a new SaaS enterprise solution for the NBSF program. The new system will be a web-based solution with the capability to track both hearing and metabolic follow-up activities performed by external users. DOH will have to monitor the completion of these activities and generate reports. DOH will have to generate reports for trend tracking, funding purposes, statistics, and federal reporting. The new solution will be evaluated on its capability to support the potential needs of other NSG programs expected to be implemented in the near future also.The following timeline depicts the high-level schedule for the projectJanFebMarAprMayJunJulAugSepOctNovDecJanFebMarAprInitiationRequirements Gathering & AnalysisRFQ DevelopmentRFQ SolicitationCOTS EvaluationsProcurement20132014.References/InputsThe following documents were used to assist BAs in the development of the business and system requirements for the project. These documents are located on the NBSF SharePoint Site.Newborn Screening Provider Manual, July 20090111 Visio Hearing Process Flows0111 Visio Metabolic Process FlowsOverview of eSP? Functionality of the State of PennsylvaniaPA Lab Import FilesParticipating Laboratory Agreement (PLA) Conditions to Provide Newborn Screening Laboratory ServicesVisio Metabolic Process, April 20, 2012Metabolic Revised Requirements, June 27, 2012Metabolic Narrative, July 20, 2012Business ModelBFH/NSG’s NBSF is the program area responsible for the monitoring and follow-up activities for newborn screening, both metabolic conditions and hearing loss. The NBSF metabolic program oversees the testing of newborn blood spot specimens by contracted newborn screening laboratories and ensures follow-up services are completed on all abnormal test results for metabolic conditions as required by the Newborn Child Testing Act, 35 P.S. §621, et. seq. and the regulations under 28 Pa. Code §28.1, et.seq.The Infant Hearing Education Assessment, Reporting and Referral (IHEARR) Act (Act 89 of 2001) and the Pennsylvania Early Hearing Detection and Intervention (EHDI) program drive the DOH NBSF hearing program. The EHDI program seeks to assure that all newborns are screened for hearing within their first 30 days of life, evaluated within the first three months of life, and provided with Early Intervention (EI) services within six months of birth.For metabolic conditions, the regulations require the program to provide for screening tests of newborn children for the following conditions:Phenylketonuria (PKU)Maple Syrup Urine Disease (MSUD)Sickle-cell Disease (hemoglobinopathies)Galactosemia (GAL)Congenital Adrenal Hyperplasia (CAH)Primary Congenital HypothyroidismAct 36 of 2008 amends the Newborn Child Testing Act and enables the DOH, effective July 1, 2009, to establish a program for follow-up services for the 22 additional genetic and metabolic conditions listed below. The reporting of the newborn screening results to the NBSF program for follow-up is required for these conditions:Isovaleric acidemia/Isovalery-CoA Dehydrogenase Deficiency (IVA)Glutaric Acidemia Type I/Glutaryl-CoA Dehydrogenase deficiency Type I (GA I)3-Hydroxy 3-Methylglutaryl-CoA Lyase Deficiency (HMG)Multiple Carboxylase Deficiency (MCD)Methylmalonic Acidemia (Mutase Deficiency) (MUT)Methylmalonic Acidemia (Cbl A,B)3-Methylcrontonyl-CoA Carboxylase Deficiency (3MCC)Propionic Acidemia/Propionyl-CoA Carboxylase Deficiency (PROP)Beta-Ketothiolase Deficiency (BKT)Medium Chain Acyl-CoA Dehydrogenase Deficiency (MCAD)Very Long-Chain Acyl-CoA Dehydrogenase Deficiency (VLCAD)Long-Chain L-3-OH acyl-CoA Dehydrogenase Deficiency (LCHAD)Trifunctional Protein Deficiency (TFP)Carnitine Uptake Defect (CUD)Homocystinuria (HCY)Tyrosinemia type I (TYR I)Argininosuccinic Acidemia (ASA)Citrullinemia (CIT)Hb S/Beta-Thalassemia (Hb S/Th)Hb S/C Disease (Hb S/C)Biotinidase Deficiency (BIOT)Cystic Fibrosis (CF)The NBSF program is responsible for monitoring the follow-up activities and services for all abnormal (presumptive positive, inconclusive, and unacceptable) metabolic screening results. They follow each affected newborn through to their connection to services for confirmatory testing, diagnosis and treatment. In order to follow-up thoroughly on all of the newborns identified through newborn screening in PA (approximately 6,000 metabolic cases each year out of approximately 150,000 births), the program has developed a detailed set of processes and procedures presented later in this section.Effective March 1, 2013, Congenital Heart Disease (CHD) was added to the list of diseases for which follow-up services relating to case management, referrals, confirmatory testing and assessments in section 3(a) (2) of the Newborn Child Testing Act are required. Hospitals, birthing centers, midwives and other legally responsible parties are advised to develop policies and procedures for reporting CHD screening, referral and diagnosis activities to DOH. They are encouraged to screen all newborns for CHD prior to discharge from a birthing facility and submit CHD information to the DOH by completing the Excel forms posted on the DOH web-site. Screening and reporting for Severe Combined Immunodeficiency (SCID) began in July 2013 at these hospitals and birthing centers.The Commonwealth currently contracts with PerkinElmer Genetics, Inc. (PEG) and the University of Massachusetts New England Newborn Screening Program (UMASS) laboratories to complete the laboratory testing of the filter papers submitted by hospitals, birthing facilities, and midwives. Each hospital, birthing facility and midwife holds a contract with one of these laboratories to perform the testing on submitted filter papers. PEG processes a significantly higher number of filter papers for the Commonwealth than UMASS. The laboratories use different testing methodologies and follow different processes when transmitting information and results to the NBSF program. It is possible for the newborn to have filter paper specimens processed by both laboratories if the newborn is transferred after birth or is seen at a treatment center shortly after birth for a RFP.The information communicated by the laboratories to the NBSF program includes the demographics provided on the filter paper, including information about the submitter, the birth facility, the newborn, and the mother as well as the laboratory information. It is a legal requirement that the original information reported on the filter paper must be maintained; however, the NBSF program must keep the follow-up activity information associated with the newborn’s case up-to-date.In accordance with the Newborn Child Testing Act, the laboratories execute screening tests which may indicate the presence of one or more of the conditions identified in the act. The test results are provided at varying levels of detail based on the testing and the conditions. For some conditions, a panel is executed and within that panel a number of analytes are tested. For example, the amino acid panel tests for a number of analytes and depending on the results, different conditions might be possible. This also applies to acylcarnitine. On the other hand Biotinidase Deficiency has one test associated with it; therefore, in this case the test is both a panel and an analyte. All filter papers received by the laboratories are transmitted to the NBSF program. Normal results must be available to the program to respond to requests from PCPs and through legal requisitions. The NBSF program documents potential false negative results when results were reported as within normal limits (WNL) and the NBSF program later receives information from a treatment center or physician indicating that the newborn is being treated for a condition. There are instances where newborns come to the Commonwealth from another state and the program area has to perform metabolic or hearing screening follow-up. In these instances, the laboratory’s test results may not be available or cannot be entered into the system manually.For hearing screening, the IHEARR Act regulation requires that newborns receive their initial hearing screening prior to being discharged from the hospital. Newborns that fail the initial screening are required to have a follow-up re-screen either at the hospital as an outpatient or at an audiologist’s office.The NBSF program is responsible for monitoring the follow-up activities for newborns who fail screenings to ensure that they receive appropriate follow-up and services. The program follows each impacted newborn through their re-screens, evaluations and confirmatory screens until their connection to services.The current metabolic screening system used by the DOH is dated and lacks the technical capabilities to provide NBSF program with dependable automated procedures. Due to the inconsistencies with the current system, the Community Health Nurses (CHN’s) do not trust the reports provided by the system and currently track findings in various spreadsheets. The system automatically generates letters, but the letters print with inaccurate information, frequently forcing the nurses or clerical staff to correct them manually. The NBSF program management hopes the procurement of a new system will alleviate the lack of confidence that the nurses currently feel toward the systems being used today and ensure a more efficient workflow for both internal and external anizational ProfileTitleNumber of PositionsDivision/BureauDutiesBureau Director1BFHSecures spending authority and resources for the project. Acts as liaison to sponsors. Provides overall direction and guidance to the project.1BITDivision Director1NSGActs as liaison to sponsors. Reviews deliverables and provides feedback. Helps resolve issues and policy decisions. Defines project scope, goals, and objectives. Makes high-level strategy, plan, and budget decisions. Resolves risks, issues, and change requests.1BIT1PMOProgram Managers1NSGManages the DOH Nursing staff. Oversees the metabolic screening and hearing screening programs.1NSGApplications Developer Administrator1BITManages the project team and provides assistance in defining the RFQ Solicitation Process.Senior Applications Developer1BITCommunicates with the laboratories and program areas.Applications Developer1BITAssists in communicating with laboratory when CHN is having problems with the munity Health Nurses7NSGActs as Subject matter experts that participated in interviews to document the As-Is and To-Be process flows for the current NBSF program systems. Performs follow-up for metabolic and hearing conditions until infants are linked to a treatment center. Primary end users.Program Administrator4NSGProvide reports that the system currently doesn’t produce.Clerical2NSGAssists with CHD data collection and report submissions.High-level As-Is Process FlowThese high-level business process flows depict the business functions for the NBSF program. Please note that the narratives for the business functions appear after the process flowcharts. The Hearing flow information appears first followed by the Metabolic flow information.DOH BIT imports an infant’s demographic information into the hearing screening system. This information is received from the laboratory that performed the metabolic newborn screening.The NBSF program receives the abnormal hearing results via fax. The CHN begins searching for the newborn in the system using different combinations of the information provided. After several failed searches the CHN will contact the hospital for more detailed information on how to locate the newborn. When the infant’s record is found, the CHN verifies the infant’s data in the system with the forms they received and manually enters the PCP reported on the faxed report. The CHN will enter the hearing results and create contact notes.It is important to note that the parents may refuse the newborn’s initial hearing screening. If it is communicated to NSG that the parents refused the initial screening, the CHN documents this fact and updates the contact notes accordingly, and closes the newborn’s case. Parents have the right to refuse the hearing screening and/or testing at any time. If this occurs at any time during the process, the CHN updates the case notes and closes the case.If this is a new case, the CHN validates and processes letters to be mailed to the mother and the PCP indicating the need for a re-screen. The clerical staff prepares the letters for mailing and mails them. The CHN “tickles” the case to be reviewed again in 30 days if re-screen results are not received. If the nurse determines that a newborn passed the re-screen, the nurse updates the notes as such and closes the case. Indication of a failed re-screen requires follow-up from the CHN via fax or telephone to the PCP and parents.During this follow-up, if contact is made and the CHN is informed that the infant is deceased, the information is added to the notes in the system and the case is closed. If contact is made but a diagnosis is not yet received, the CHN updates the notes and re-tickles the case for another follow-up attempt with parents and PCP in another 30 days. When a CHN is unable to reach the PCP and/or the parents for three consecutive months, either lost contact or refusal is noted in the system (depending on specific circumstances) and the case is closed.When contact is made and a diagnosis of normal hearing is received the CHN enters the diagnosis into the system and the case is closed. When a diagnosis of other than normal hearing is determined, the CHN enters the details into the system and establishes whether or not the infant has been connected to EI services or an Ear, Nose, and Throat (ENT) specialist (otorhinolaryngologlist) for ongoing medical treatment. If the parents were not provided with the EHDI information, the nurse assists them with getting the information. After the nurse knows the family has been provided all of the necessary information, the notes are updated and the case is closed.Presently, PEG and the UMASS laboratories electronically transfer all newborn demographic and screening data to the NBSF program twice each day, Monday through Friday. When submitting data to DOH, UMASS provides the newborn’s name, identifier (ID), filter paper number (FPN), and the filter paper screening results. PEG provides the newborn’s name, ID, FPN, screening results, and contact information. Both laboratories save their data in multiple flat files (.txt files) and place them on a secured File Transfer Protocol (FTP) server, once in the morning and once in the afternoon. Twice a day, BIT runs a script that retrieves the files from the FTP server and saves them on a BIT file server. An automatic batch job reads the files, performs preliminary data validation and imports the data into the system database. A log file is generated listing all errors and failures.The laboratory assigns each newborn screened a unique ID that is used to link the infant’s initial and RFPs in their system. Occasionally, a newborn is issued two newborn IDs when the initial filter paper is processed by one laboratory and the RFP is processed by another. Since submitters (i.e., hospitals, birthing centers, and midwives) only contract with one laboratory, if a baby is transferred to a different location after birth, the possibility exists that the RFP is submitted to a different laboratory. As a result, the baby is assigned two newborn IDs, one at each laboratory. BIT monitors and reviews batch log files daily. They follow up with the laboratories to resolve any errors, and perform data edits as needed. For example, if the newborn ID is missing for a record or flagged as duplicate in the log file, BIT contacts the laboratory to resolve the issue and corrects the record in the system. If the date of birth is left blank, BIT enters the generic date of 01/01/1900. If the submitter code is missing, BIT contacts the laboratory to identify the submitter code, creates a new submitter record, and updates the newborn’s record with the submitter code. When the laboratories do not provide sufficient feedback, this creates inconsistent data in the system.The screening result codes that are provided by the laboratories trigger both system-generated reminders and letters for the CHNs at specific pre-configured times, to aid them in performing NBSF.The laboratories fax abnormal results to the NBSF program that serve as the trigger for a CHN to begin the follow-up process immediately. Laboratories notify the submitter of the filter paper and at times, the newborn’s PCP, upon receiving abnormal results. The follow-up process for each type of abnormal result is depicted in this section. The high-level processes are specific to the type of result outcome (i.e., inconclusive, unacceptable, or presumptive positive) and the panel. A screening result may include more than one outcome and the CHN needs to interpret this result to identify the correct processes to execute. When clerical receives a laboratory fax containing an abnormal screening result, they print a copy of the fax and hand-carry it to the NBSF program for processing. A CHN reviews the fax to see the outcome and determine which process to follow. The nurse searches for the newborn’s record using a variety of search parameters initially, including but not limited to, the FPN, last name, mother’s name, birthdate etc. At first, only the newborn’s demographic information may be found in the system depending on the time the result is received in relation to the download/import of laboratory data by BIT.The process flows for unacceptable and inconclusive screening results are more complex than others because their goal is to ensure that timely follow-up testing is completed to determine whether an infant may or may not have a specific condition. An unacceptable test result is possible at the filter paper level (i.e., the entire specimen is unacceptable), or it could be at the panel or analyte level. In both instances, the laboratories typically provide a reason for the unacceptable result. If an unacceptable specimen is received and the results for any test completed are presumptive positive, the overall record is treated as presumptive positive until the RFP is received or the newborn is seen at a TC. If an unacceptable result is received for an RFP, the CHN defers to the first filter paper and continues to follow the protocol for the first filter paper.It is not as urgent to follow up on an unacceptable result as it is to follow up on an inconclusive result. For example, an unacceptable result requires that a CHN sends an initial follow-up letter 16 days from the infant’s date of birth. With most types of inconclusive screening results, CHNs have to send initial letters within 24 hours of receipt of the abnormal laboratory results. CHNs continue to “paper tickle” and follow up on these cases through the receipt of multiple RFPs until a conclusive result is received that indicates the next steps to be taken by the NBSF program. The “paper tickle” times are addressed in the process flows.Several types of inconclusive results that trigger variations in the process and follow-up protocol are depicted in the process flows. These are based on specific panels: congenital adrenal hyperplasia (CAH), galactosemia (GAL), and cystic fibrosis (CF), and if the newborn is on hyperalimentation. Each of these types of inconclusive results, as well as unacceptable results, has its own rules regarding the follow-up activities that have to be completed and when these specific activities have to occur. Most follow-up activities for unacceptable and inconclusive results require that CHNs process letters to be sent to the parents, the PCP, and the submitter of the filter paper to the laboratory, or any combination of these three. One important item to note, letters are NEVER sent to the parents when the newborn’s weight is less than 1500g. In consideration of the families in these situations, the timing of the letters is delayed in order to ensure the newborn’s survival. Appropriate letters are sent only to the mother of these babies when either or both of the following conditions are met:The baby is discharged.The baby’s weight is greater than 1500g.Currently, system-generated letters print each day at 11:00 a.m. The assigned nurse retrieves the letters and reviews the notes of the case to determine if the letter should be sent. If so, the CHN prints the most recent laboratory results and passes the results and the letter to clerical staff to prepare for mailing. If the letter does not have to be sent, the nurse discards it in the shred bin. Electronic copies of these letters are retained with the record exactly as printed, except for those that are generated manually.Some letters are not system-generated. For these letters, templates are maintained on a shared drive. This allows the CHNs to tailor the letters more accurately. All letters are tailored to the specific results (e.g., unacceptable letters for unacceptable results and inconclusive letters for inconclusive results). Inconclusive result letters for CAH, GAL, CF, and hyperalimentation that are sent to PCPs or submitters are specific to the outcome. Letters to the parents tend to be written in more generic language instead of the specifics of the condition(s). These pre-defined letters may be either regular letters or urgent notice letters, depending on the situation. Letters to the PCP may be addressed to a specific physician or to an entire physician’s practice.Other follow-up activities in which the CHNs may participate, as the process flows describe, involve: Initiating/receiving phone calls with the laboratory, the submitter, PCP, or parentsSending e-mail and faxes back and forth with these entitiesEnsuring they fulfill their responsibilities to complete their steps in the processViewing and removing reminders from the systemChecking for RFPsReviewing and updating notesThe assigned follow-up CHN is responsible for reviewing the letters prepared for mailing by the clerical staff. The CHN checks in the system one final time for an update from the laboratory or for an RFP before releasing the letters to be mailed. This same CHN processes undeliverable mail by contacting PCPs, parents, etc. for updated contact information before closing a case because of lost contact.Throughout the newborn screening follow-up process, the CHNs record contact notes at every action taken. These contact notes in conjunction with the laboratory notes tell the story of what has taken place with this newborn’s metabolic screening from beginning to end.When RFPs are received by the laboratories and processed, it is the laboratories’ responsibility to provide the information that links the RFP to the initial filter paper. Occasionally, the laboratory completing the repeat testing is different than the laboratory that completed the initial screening, and they are unaware of the initial filter paper. At these times, BIT may be able to link filter papers, but in these situations the CHNs have only the ability to use demographic information to recognize the RFP as such, and enter contact notes indicating the two should be linked.When an RFP is within normal limits (WNL), the case is closed and no further action is necessary from the CHNs. When an RFP is abnormal, the nurses are alerted by the fax from the laboratory which triggers a new set of follow-up activities per the process flow. If an RFP is inconclusive for the same test result as the initial filter paper, the newborn is treated as presumptive positive, and that protocol is followed. However, with consecutive inconclusive results for tyrosine and methionine, more than two RFPs may be necessary. In this situation, the successive inconclusive results are not treated as a presumptive positive result with respect to the follow-up process, until further testing is completed.In some cases, the follow up-activities are unsuccessful and the repeat testing is never completed. For these instances, the nurses close the case so that the follow-up activities are no longer created and tracked and the case can be reported as a closed case. Additionally, if CHNs identify that an infant is expired, the CHN updates the notes and closes the case.Presumptive positive results are time-critical and have to be addressed as soon as possible to ensure the best possible outcome for the newborn. The laboratory initiates this process with both a fax and a phone call. The presumptive positive workflow is straightforward and aims to identify a diagnosis for the newborn as soon as possible and ensures the baby’s connection to a TC. The NBSF program handles filter papers where the immuno-reactive trypsinogen (IRT) includes one mutation as a presumptive positive result for cystic fibrosis.When a newborn is presumptive positive or the determination is made to handle a case as presumptive positive, the nurses’ work with the newborn’s physician to refer the newborn to an appropriate treatment center. There are metabolic, CF, and sickle cell TCs which have contracts with Pennsylvania, and additional endocrine, TCs, and specialists, but they are not all located within the state.Once a baby is referred to a TC, the nurses continue to follow up with that TC until a diagnosis is made. The system generates and prints a diagnosis packet when the result is imported into the system. The CHN faxes this packet of information to the TC. The TC, using this diagnosis sheet, documents and confirms the diagnosis, the specific treatment, and the dates. A newborn may have more than one diagnosis, which will include the condition, and sometimes a sub-category level of detail. For instance, biotinidase deficiency might be profound or partial deficiency. The diagnosis may not be one of the 28 conditions identified in the Newborn Screening Act. Abnormal results on the newborn screen do not identify the condition definitively, but all abnormal results are followed, thus, certain results may end in a diagnosis for conditions not included in those conditions the NBSF program is required to follow.One particular type of condition identified by the newborn screening process is Phenylketonuria (PKU). Newborns with PKU have to remain on metabolic formula for their entire lives. The NBSF Public Health Program Administrator (PHPA) tracks these individuals because DOH pays for the metabolic formula for those patients who do not have insurance to cover the cost or who receive medical assistance (MA). DOH pays for the formula for males up to the age of 22, and females until they are beyond child-bearing years, if they intend to have a baby. DOH has a Memorandum of Understanding (MOU) with the Department of Aging (DOA) to administer the metabolic formula program through their Pharmaceutical Assistance Contract for the Elderly (PACE) program.Once identified by a TC, the PHPA informs the clerical staff to send the individual an application. Once the completed application is received and the requested pharmacy is confirmed, clerical staff enters patient information into the Core system, which determines the patient’s eligibility for the program based on the federal poverty guidelines set-up in the system. Income is entered as “$0” for these individuals so that Core does not reject the application. Clerical staff processes the application and uploads the patient record to the Magellan secure website, operated by DOA. Clerical staff tracks patient information in a spreadsheet, because Core does not maintain pharmacy information. The reimbursement for the formula is processed through Core.The clerical staff sends the patient a renewal application approximately six weeks prior to the eligibility end date. If the renewal application is not completed and returned two weeks prior to the eligibility end date, the PHPA notifies the TC who works with the patient to complete and return the renewal application so their eligibility is not impacted.When cases are closed for lost contact or no RFP received after the last tickle period, they are passed to a specific CHN who tracks these cases on a spreadsheet and periodically performs a follow-up check for a RFP. This process is performed for a few reasons: Validation of the established follow-up timeframes (i.e., to identify if the tickle periods need to be extended prior to closing these cases)Verification that the laboratory notified the NBSF program of any RFPsReporting purposes and statistics (both internal and federal)An additional manual process exists when unacceptable filter papers are received. The CHN processing laboratories for the day receives an Unacceptable Report from both the laboratories. As the CHN processes each one according to the unacceptable protocol, they hand-write (PEG) or highlight (UMASS) the birth facility and the unacceptable code/reason for each specimen. This information is passed to the PHPA for tracking on a separate spreadsheet.Most of the CHNs maintain some sort of tracking spreadsheet of their own on their desktop to track specific information.High-level To-Be Process FlowThese high-level To-Be business process flows depict the desired functionality for a new web-based SaaS solution for the NBSF program of the BFH. The greatest change to these To-Be process maps is not necessarily in the flow of data. The most significant changes to the processes will impact the external stakeholders who will be more involved with the system, reducing the involvement of the CHN.These proposed processes strive to minimize sending and receiving faxes and telephonic communication between laboratories, TC, and the DOH. The laboratories and TCs will perform their own data entry and status updates, or they will use HL7 messaging to accomplish this task. DOH will contact the laboratories or TCs only when notified that the appropriate follow-up actions for abnormal screening results have not been taken. DOH will no longer have to contact submitters directly. The new process flows encourage the use of internal system or electronic mail communications to reduce the need to print numerous faxes and additional paperwork. Current manual processes will be automated and current system workarounds will be eliminated to increase efficiency in operations.DOH will rely heavily on the reporting capabilities and functionality of the new system. NBSF program will need the capability to generate multiple levels of reports to use for decision making, trending, statistics, state and federal reporting, and quality assurance of the laboratories, TCs, and other system users.Since the new system will be a SaaS, BIT’s role in maintaining the system will be reduced considerably. Their role will be one of quality assurance from a system perspective. They will receive management reports, error logs, data extracts, and a data dictionary. BIT will serve as the technical liaison between the NBSF program and the SaaS vendor.In 2013, DOH began tracking the newborn screening for two new conditions: CHD and SCID. The follow-up process for SCID is to follow the result of the screening, either inconclusive or presumptive positive. Currently, birthing organizations report on newborns screening positive for CHD along with their referral information to a pediatric cardiologist (PC). The PC forwards diagnoses information to DOH; there are no follow-up activities performed by the DOH NSG.More specific processes will be defined once a COTS SaaS solution is procured and its functionality is evaluated and tested thoroughly.Process MappingThe primary goal of the new enterprise solution will be to provide a common platform for various newborn screening professionals to seamlessly exchange information over the Web. It will provide role based access to a number of internal and external users (see Figure 1), allowing each user group to enter and view their information in the system. Figure 1. Newborn Screening Users Direct data entry by the laboratories, hospitals, treatment centers, birthing centers and other specialized healthcare professionals will help eliminate some of the data quality issues in the current system and will enable the CHNs to focus on their role and responsibilities. The system will generate electronic alerts and reminders to keep tasks on track and allow the users to indicate in the system when they have completed their task. This will also reduce the numerous faxes and telephonic communications between the users for status updates and ensure timely diagnosis and treatment for newborns needing urgent medical attention. Considering the introduction of enhanced automation features, some of the NBSF business processes have been redefined to keep them aligned with the business goals and the proposed functionality of the new system.The new system will be implemented as a SaaS solution. The business application and the associated data will be centrally hosted and maintained by the SaaS vendor, lowering the initial setup cost and the overall IT support cost. BIT will take on the quality assurance role instead of being responsible for lab data imports and regular system maintenance. Since the newborn data will be accessible and may be updated by multiple user groups, the system will provide adequate security checks to ensure authorized access to confidential data. It will also include data validation and business rules to maintain data accuracy and integrity at all times. Incoming data will be verified by the system and the records that do not pass the rules, will need to be suspended until they are manually reviewed, corrected, and/or completed appropriately. The system will provide the capability to generate automatic and on-demand letters, faxes, and emails. Canned and ad-hoc reports will be available for various levels of stakeholder groups to assist them in status reviews, decision making, trending, quality assurance, federal reporting, and taking timely actions when needed. Figure 2 below provides an overview of some of the inputs and outputs of the system. Figure 2. Newborn Screening System Inputs and Outputs Requirements DefinitionOverviewThis section outlines the approach used to elicit the business and system requirements. It includes the tools used to capture the requirements, with traceability to the goals, mandates, and business processes.ApproachThe approach used to gather the requirements was the review of all existing documentation, review of the current systems and interviews with the NBSF staff (See Sec. 7.2, Sessions Schedule and Attendance). Once the current processes were better understood and documented, the project team conducted a series of workshops to define the To-Be processes to aid them in documenting the business and system requirements that are detailed in the Requirements Trace Matrix in the next section.Detailed RequirementsThe project team used the DOH Project Management Office (PMO) Requirements Tool template to document the business requirements, system requirements, and traceability. Please note in the attached workbook there is a worksheet for each of these topics. The requirements category, sub-category, ID, priority, and source for each system requirement is indicated in the tool.AddendumSample Filter Paper ................
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