Commonwealth of PA- Department of Health / Bureau of Information Technology
Bureau of Family Health

AppendixH

Newborn Screening and Follow-up

Use Cases

Project #: / 6100025874
Date submitted: / October04, 2013
Document version: / V1.1

Table of Contents

1Purpose of the Document

2Acronyms

3Actors

4USE CASES

4.1USE CASE UC001 “Create a Newborn Record”

4.2USE CASE UC002 “Enter Initial Metabolic Screening Results”

4.3USE CASE UC003 “Enter Initial Hearing Screening Results”

4.4USE CASE UC004 “Search for a Newborn”

4.5USE CASE UC005 “Perform a Search”

4.6USE CASE UC006 “Add RFP Test Results”

4.7USE CASE UC007 “Merge Records”

4.8USE CASE UC008 “View Audit Trail”

4.9USE CASE UC009 “Respond to an Alert/Reminder”

4.10USE CASE UC010 “Generate and Print Manual Letters”

4.11USE CASE UC011 “Validate and Print Letters”

4.12USE CASE UC012 “View/Reprint a Letter”

4.13USE CASE UC013 “Generate Canned Reports”

4.14USE CASE UC014 “Run Ad Hoc Reports”

4.15USE CASE UC015 “Update Existing Newborn Record”

4.16USE CASE UC016 “Enter Referral”

4.17USE CASE UC017 “Enter Contact Notes”

4.18USE CASE UC018 “Enter Diagnosis”

4.19USE CASE UC019 “Close Case”

4.20USE CASE UC020 “Re-open Closed Case”

4.21USE CASE UC021 “Perform Library Maintenance”

4.22USE CASE UC022 “Add/Edit Letter Template”

4.23USE CASE UC023 “Add/Edit Alerts”

4.24USE CASE UC024 “Add/Edit Reminders”

4.25USE CASE UC025 “Add/Edit a Condition”

4.26USE CASE UC026 “Add/Edit Canned Contact Notes”

4.27USE CASE UC027 “Add/Edit Canned Reports”

4.28USE CASE UC028 “Register to Become a New User”

4.29USE CASE UC029 “Manage User Accounts”

4.30USE CASE UC030 “Send/Receive E-mail”

4.31USE CASE UC031 “Send/Receive Fax”

4.32USE CASE UC032 “Send Mass Communication”

4.33USE CASE UC033 “Submit Report”

4.34USE CASE UC034 “Login”

6100025874 Newborn Screening and Follow-up / Page 1 of 57 / Use Cases
Commonwealth of PA- Department of Health / Bureau of Information Technology
Bureau of Family Health

1Purpose of the Document

This document provides use cases for evaluating Software-as-a-Service (SaaS) vendors and their Commercial-Off-The-Shelf (COTS) product for use by the Newborn Screening and Follow-Up (NBSF) program. The use cases included here are functions the Pennsylvania Department of Health (PA DOH) will want to see demonstrated by the potential vendors to assure that the proposed solution will meet the business and system requirements of the NBSF program.

For requirements details, refer to the _NBSF_Requirements_Document.

2Acronyms

The following table providesthe acronyms along with their definitions that are used throughout this document.

Acronym / Definition
AKA / Also Known As
Audio / Audiologist
BFH / Bureau of Family Health
BIT / Bureau of Information Technology
CCHD/CHD / Critical Congenital Heart Defect
CHN / Community Health Nurse
COTS / Commercial-Off-The-Shelf
DOB / Date of Birth
EHDI / Early Hearing Detection and Intervention
EHR / Electronic Health Records
EI / Early Intervention
ENT / Ear Nose and Throat Specialist
FP / Filter Paper
FPN / Filter Paper Number
FTP / File Transfer Protocol
HSD / Hearing Screening Device
HL7 / Health Level Seven, Inc., a non-profit organization that establishes healthcare standards for the exchange of EHR
ID / Identifier
IHEARR / Infant Hearing Education Assessment, Reporting and Referral Act (Act 89 of 2001)
NBSF / Newborn Screening and Follow-Up
NPI / National Provider Identifier
NSG / Division of Newborn Screening and Genetics
PA / Commonwealth of Pennsylvania
PA DOH / Pennsylvania Department of Health
PC / Pediatric Cardiologist
PCP / Primary Care Provider
PEG / PerkinElmer Genetics, Inc.
PKU / Phenylketonuria
Pre-Pos/Pre-Positive / Presumptive Positive
QC / Quality Control
RFP / Repeat Filter Paper
SaaS / Software-as-a-Service
TC / Treatment Center
UMASS / University of Massachusetts New England Newborn Screening Program
WNL / Within Normal Limits

3Actors

The term “actor” is used to describe any entity that interacts with the system. An actor can be a person, a group of people, an agency, or another automated system. Another way to think of an actor is a role in the system.

Actor / Description
Submitter / Midwives, Birthing Centers (BC), and Hospitals submit bloodspot specimens on filter papers to the lab and/or hearing screening results to the NBSF program.
Community Health Nurse (CHN) / DOH staff responsible for following up and tracking of newborns that do not pass their screening. Determines whether appropriate assessment and evaluation is completed in a timely fashion and that infants receive the prescribed treatment and intervention.
Laboratory (Lab) / Laboratories contracted by the state to receive the blood spot specimens on filter papers and conduct the metabolic testing. They send the newborn demographics and screening test results to the NBSF system as well as requests for repeat tests for unacceptable or inconclusive screening tests.
Treatment Center (TC) / A center under contract with DOH to provide expert consultation, diagnosis and treatment for newborns with a presumptive abnormal test result.
Primary Care Provider (PCP) / Directs and coordinates the follow-up evaluation and referral process; refers the newborn to TC, medical specialist, or appropriate agencies for treatment for early intervention services.
Specialist / Audiologist (Audio), Pediatric Cardiologist (PC), Ear Nose & Throat Specialist (ENT), Immunologist, Endocrinologist, and Early Intervention (EI) responsible for reporting diagnosis and treatment.
Program Administrator / Program Administrator will serve as the non-technical liaison between the NBSF Program and the SaaS vendor’s System Administrator.
Program Manager / Manages the CHN staff and oversees the metabolic screening and hearing screening programs.
System Administrator / SaaS Vendorstaff responsible for the NBSF System maintenance; makes additions, changes, and corrections in the system as necessary.
DOH Bureau of Information Technology (BIT) / Serves as the technical liaison between NBSF and the SaaS vendor. 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
Clerical / Mails letters generated by the system.
System / NBSF system stores the newborn screening data and generates letters, reminders, and alerts automatically based on the established business rules. Closes completed cases.
Potential User / Potential user is any user that has applied for access to the NBSF system.
Hearing Screening Device (HSD) / Device used for screening newborns for hearing loss. Send the hearing screening results directly to the NBSF program.

4USE CASES

4.1USE CASE UC001 “Create aNewborn Record”

Version / Description / Changed By / Date
1.1 / NBSF / 10/07/13
Reference: / UC001
Priority / 1.01
Name: / “Create aNewborn Record”
Overview: / When the lab receives a specimen from a submitterit enters the demographic information from the filter paper into their information system. If it is the first specimen received so far for the baby, the lab system creates a new record for the newborn and assigns it a unique identifier. As the test results are released, they are added to the newborn’s record in the lab system. The lab sends this newborn data to the NBSF system.
The newborn’s demographic information and the test results are sent to the NBSF system as separate pieces of information. The NBSF system creates a unique record for each newborn screened. In most cases the demographic information is received prior to the test results, which triggers the creation of a new record in the NBSF system. In case the test results are available before the demographic information is received from the lab, the user (other than the NBSF system) creates a new record.
Goal: / To allow user to create a new record for the newborn in the system.
Preconditions: / No record already exists for the newborn in the NBSF system.
Trigger: / Lab receives a filter paper with a blood spot sample from a submitter.
Actors: / Lab, CHN
Basic Flow:
  1. Lab receives a filter paper for testing.
  2. Lab conducts a search to assure the newborn does not already exist in the lab system and finds no existing record.
  3. Lab enters the demographic information from the filter paper into the lab system.
  4. Lab sends the information to the NBSF system via HL7.
  5. The NBSF system searches for a matching record to assure the newborn record does not already exist (UC004).
  6. The NBSF system creates a new record and assigns a unique identifier to the newborn.
  7. Newborn record is populated with data from lab.

Conclusion: / A newborn record is created and populated in the system.
Post Condition: / Newborn’s record is available for screening results, follow-up, diagnosis entry, treatment entry, and reporting.
Requirements References: / BR001, BR002, BR003, BR004, BR008, BR009, BR010, BR011, BR013, BR014, BR015, BR016, BR024, BR027, BR028, BR033, BR037, BR041, BR042, BR062, BR063
CR001, CR003, IN005, IN006, IN016, IN019, IN021, IN025, IN076, IN082, IT012, IT018, IT022, IT023, IT033, SP008, SP009, SP010
Alternate Flows:
Hearing Screening First
  1. Newborn is screened for hearing loss.
  2. Test results are sent to the NBSF program.
  3. CHN receives the hearing screening test results.
  4. The CHN searches for the newborn’s record (UC004).
  5. The system search does not find the newborn’s record.
  6. The CHN creates a newborn record.
  7. The NBSF system assigns a unique identifier to the newborn.
  8. The CHN populates the hearing screening results in the newborn’s record.
Born Out-of-State
  1. CHN receives information for a baby born outside of PA.
  2. CHN searches in the NBSF system to assure the newborn record does not already exist (UC004).
  3. The CHN creates a new newborn record.
  4. The NBSF system assigns a unique identifier to the newborn.
  5. The CHN populates newborn record with data.

Exception Flows:
Record Already Exists
  1. Lab receives a filter paper for testing.
  2. Lab searches for the newborn’s record in their system and finds an existing record.
  3. Lab determines which filter paper is the initial filter paper.
  4. Lab enters/updates the demographic information from the filter paper into the lab system.
  5. Lab sends the information to the NBSF system via HL7.
  6. The NBSF system searches for a matching record to assure the newborn record does not already exist and finds a matching existing record (UC004).
  7. The existing newborn record is updatedwith data from the lab (UC002 if initial FP) (UC006 if RFP).

Questions:
  • Will the system be able to handle imports from multiple labs?
  • How will the system report the status and exceptions from the lab imports?
  • Can we define weighted criteria for matching records when importing data into the system? This criterion is essential and must be clearly defined to ensure that only one record is created for each newborn screened.

The user wants to create a newborn record so that the newborn’s test results can be tracked and followed up on appropriately.

4.2USE CASE UC002 “Enter Initial Metabolic Screening Results”

Version / Description / Changed By / Date
1 / NBSF / 9/17/13
Reference: / UC002
Priority: / 1.02
Name: / “Enter Initial Metabolic Screening Results”
Overview: / There are three types of newborn screening done in PA: the heel prick for several metabolic and genetic conditions, the hearing test and pulse oximetry for critical congenital heart defect (CCHD). For the heel prick test, a healthcare provider, usually a nurse or licensed midwife, takes a few drops of blood from a baby’s heel, typically 24-48 hours after birth. The blood spots are collected on a special filter paper card and shipped to the contracted laboratory for analysis. The lab performs the blood spot testing and sends the test resultsto the NBSF system. If out-of-range test results are received the system begins to process alerts, letters, follow-up and referrals in addition to tracking diagnosis and treatment.
Goal: / To allow the user to enter the initial metabolic screening results.
Preconditions: /
  • Filter paper is received by the lab.
  • Initial newborn record has already been created in the system.
  • At least one test is completed.

Trigger: / Testing of blood spots from FP is completed or partially completed by the lab.
Actors: / Lab
Basic Flow:
  1. Lab completes at least one test on the blood spot from the FP.
  2. Lab enters test results into the lab system.
  3. Lab sendsthe test results to NBSF system via HL7.
  4. NBSF system finds the newborn’s record in the system (UC004).
  5. Newborn record is populated with the metabolic screening test results.

Conclusion: / A newborn’ record in the NBSF system is populated with metabolic screening results.
Post Condition: / Newborn’s initial metabolic screening test results are available in the NBSF system for follow-up, referral, diagnosis entry, treatment entry, and reporting.
Requirements References: / BR001, BR002, BR003, BR005, BR006, BR008, BR009, BR010, BR011, BR013, BR017, BR027, BR028, BR034, BR035, BR037, BR038, BR041, BR042, BR048, BR051, BR053, BR057, BR062, BR063
CR003, IN001, IN006, IN011, IN013, IN014, IN015, IN025, IN031, IN038, IN043, IN070, IN072, IN086, IN087, IT004, IT012, IT022, IT033, SP008, SP009, SP010
Alternate Flows:
  1. Lab completes at least one test on the blood spot from the FP.
  2. Lab enters test results into the lab system.
  3. Lab sendsthe test results to the NBSF system via HL7.
  4. NBSF system does not find the newborn’s record in the system (UC004).
  5. NBSF system creates a newborn record (UC001).
  6. Newborn record is populated with the metabolic screening test results.

Exception Flows:
Questions:
  • Searching and identifying the correct newborn record is a very important step when recording the data in the system. What capabilities does the system have to match and link the test results to the correct newborn record?

The lab wants to enter the initial metabolic screening results so that the newborn’s record is available for follow-up, referral, diagnosis entry, and reporting.

4.3USE CASE UC003 “Enter Initial Hearing Screening Results”

Version / Description / Changed By / Date
1 / NBSF / 9/12/13
Reference: / UC003
Priority: / 1.03
Name: / “Enter Initial Hearing Screening Results”
Overview: / 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.
Goal: / To allow user to enter hearing screening results.
Preconditions: / The user has conducted the hearing screening on a newborn.
Trigger: / Hearing screening results are sent to the NBSF program.
Actors: / CHN, Hospital, BC, Midwife, Audio, ENT, EI, HSD
Basic Flow:
  1. Newborn is screened for hearing loss.
  2. Test results are sent to the NBSF program.
  3. CHN receives hearing screening test results.
  4. The CHN searches in the system to find the newborn’s record (UC004).
  5. If needed, the CHN creates a new record (UC001).
  6. CHN populates newborn record with data.

Conclusion: / A newborn record is populated with the hearing screening results.
Post Condition: / Newborn’s initial hearing screening test results are available in the system for follow-up, referral, diagnosis entry, treatment entry, and reporting.
Requirements References: / BR002, BR003, BR006, BR008, BR010, BR018, BR024, BR029, BR030, BR034, BR037, BR041, BR042, BR062
CR003, EX002, IN002, IN031, IN046, IN047 IN048, IN049, IN050, IN051, IN052, IN053, IN054, IN055, IN056, IN057, IN058, IN059, IN060, IN061, IN062, IN068, IN069, IN071, IN074, IT012, IT022, IT028, SP008, SP009, SP010
Alternate Flows:
Hearing Screening Test Results from HSD
  1. Newborn is screened for hearing loss.
  2. Test results are sentdirectly to the NBSF system from the HSD.
  3. The system searches for the newborn’s record (UC004).
  4. If needed, the system creates a newborn record (UC001).
  5. The systempopulates the hearing screening resultsin the newborn’s record.

Exception Flows:
Questions:

The user wants to report the results of a newborn hearing screening so that the newborn’s test results can be tracked and followed up on appropriately.

4.4USE CASE UC004 “Search for a Newborn”

Version / Description / Changed By / Date
1 / NBSF / 9/18/13
Reference: / UC004
Priority: / 2.01
Name: / “Search for a Newborn”
Overview: / The ability for a user to quickly and accurately search for a newborn in the system is an important feature of the system. Searching for a newborn’s record can be a complicated process with only partial identifying information available at hand. For instance, most of the time the baby’s first name is not listed on the filter paper. In such cases,cross-referencing data elements such as unique ID, FPN, DOB, newborn’s last name, and mother’s name can narrow the search results and insure that the correct record is found.
Goal: / To allow the user to search for a newborn record in the system.
Preconditions: / Newborn record exists in the system.
Trigger: / A user has to find a newborn’s record.
Actors: / All users
Basic Flow:
  1. User navigates to search.
  2. User enters newborn’s informationin the search criteria.
  3. If the initial query does not produce results, user performs a Soundex or an advanced search by entering any or all of the known information: unique ID, FPN, DOB, mother’s name, AKA, etc.
  4. System displays the search results.
  5. User selects a newborn record.
  6. System displaysthe newborn record details.

Conclusion: / The correct newborn record is found.
Post Condition: / Newborn record is available for viewing and appropriate follow-up, referral, diagnosis, treatment, or reporting.
Requirements References: / BR002, BR003, BR013, BR021, BR022, BR041, BR042, BR050, BR062
IN017, IN018, OU008, OU026, OU092, OU093, SP008, SP009, SP010
Alternate Flows:
  1. User navigates to search.
  2. User enters newborn’s informationin the search criteria.
  3. If the initial query does not produce results, user performs a Soundex or an advanced search by entering any or all of the known information: unique ID, FPN, DOB, mother’s name, AKA, etc.
  4. No matching records are found.
  5. The system displays no record found.

Exception Flows:
Questions:

The user wants to find a newborn record in the system so that the user can read report on, or add to the record.

4.5USE CASE UC005 “Perform a Search”

Version / Description / Changed By / Date
1.1 / NBSF / 10/07/13
Reference: / UC005
Priority: / 2.02
Name: / “Perform a Search”
Overview: / The system should allow users to search for a record in the system using search criteria. If the search returns multiple results, the system should allow the user to sort the results and/or refine the search parameters, as needed.
Goal: / To allow the user to search for a record.
Preconditions: / User has access to the information for which they are searching.
Trigger: / The user has to find a record in the system.
Actors: / All users
Basic Flow:
  1. User navigates to search.
  2. User enters the search parameter(s).
  3. System conducts the search.
  4. System displays the search results.
  5. If the search returns more than one record, the user sorts the results based on any of the columns listed on the search results.
  6. User selects the correct record.
  7. System displays the record details.

Conclusion: / The recordis found in the system.
Post Condition: / System displays the results of the search.
Requirements References: / BR003, BR021, BR022, BR025, BR031, BR034, BR041, BR042, BR050, BR062
IN017, IN091, IT005, IT013, OU008, OU009, OU013, OU092, OU093, SP008, SP009, SP010
Alternate Flows:
  1. User navigates to search.
  2. User enters the search parameter(s).
  3. System conducts the search.
  4. No records match the search criteria.
  5. System displays no recordfound.

Exception Flows:
Questions:
  • Can search results be displayed in groups of selectable quantities (10, 25, 50, 100, etc.)?

The user wants to conduct a search so that he/she can find a recordin the system.