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Michigan Department of Health and Human Services
MDHHS Division of Immunizations
Michigan Care Improvement Registry/MCIR
Ongoing Data Quality Improvement Plan
Version 2015
Ongoing Data Quality Improvement Plan Version 2015 ii Michigan Care Improvement Registry/MCIR
Table of Contents
1. Introduction ...................................................................................................................... 3
2. Assumptions/Constraints/Risks ......................................................................................... 4 2.1 Assumptions .......................................................................................................................4 2.2 Constraints..........................................................................................................................4 2.3 Risks ...................................................................................................................................4
3. Data Quality Principles ....................................................................................................... 5
4. Organization Roles and Responsibilities ............................................................................. 8
5. Data Quality Tools ........................................................................................................... 19
6. Routine MCIR Data Quality Processess ............................................................................. 20
7. Data Quality Processes and Schedules ............................................................................. 31
8. ACRONYMS ..................................................................................................................... 37
9. Referenced Documents .................................................................................................... 38
12. Record of Changes ......................................................................................................... 38
Ongoing Data Quality Improvement Plan Version 2015 3 Michigan Care Improvement Registry/MCIR
1. Introduction
There are many advantages to maintaining immunization data in a statewide Immunization
Information System (IIS) such as the Michigan Care Improvement Registry (MCIR). MCIR
allows authorized organizations to print immunization histories without pulling medical charts; it
allows automated forecast of “immunizations due” based on the child’s age, history, and
recommendations put forth by the Advisory Committee on Immunization Practices (ACIP)
through the ACIP schedule. The MCIR; makes immunization histories transportable if the
patient seeks care elsewhere; and makes it possible for medical practices, counties and the
State of Michigan to assess immunization coverage and generate recall notices at all of these
levels. The IIS can also be used for surveillance activities.
However, all these benefits depend on the quality of the information in the MCIR. The
information in MCIR should be a true reflection of all of the immunizations a patient has
received. For MCIR to be a robust and useful immunization information system, stakeholders
must be able to have confidence in the data it contains.
The accuracy of immunization records is a decisive factor in improving the health of patients.
Both public health decision-making and healthcare clinic operations rely on the accuracy of the
MCIR. Inaccurate immunization records may result in increased morbidity and mortality. It is the
responsibility of the MCIR program and the stakeholders to ensure the reliability of data stored
in the registry. Data are entered into the MCIR from a variety of external sources; it is especially
critical to establish standards for validating incoming data at the data entry point. Accurate,
complete, and timely data in MCIR promotes participation among healthcare providers, health
plans, schools and others. Higher participation in the registry results in complete immunization
records for patients. Benefits of higher data quality include:
Increased provider trust
Increased use of the data
Improvements in clinical decisions
Improved patient health
Improved public health
Ongoing Data Quality Improvement Plan Version 2015 4 Michigan Care Improvement Registry/MCIR
Poor data quality could result in a loss of confidence in MCIR and could create an incomplete
picture of a patient's immunizations, and possible erroneous forecast recommendations.
Incomplete and inaccurate data could impact provider participation in the MCIR. Program and
public policy decisions could be impacted by inaccurate summary data as organizations move
towards increased electronic data sharing capabilities. It is critical that all users and
stakeholders in the system adopt a consistent approach to data quality.
2. Assumptions/Constraints/Risks
2.1 Assumptions
MCIR is designed to:
1. Create or support effective interventions such as clinical decision support, reminder and
recall activities.
2. Generate and evaluate public health responses to outbreaks of vaccine-preventable
disease.
3. Facilitate vaccine management, vaccine ordering and accountability.
4. Determine a person’s vaccination status for decisions made by clinicians, and schools.
5. Aid in surveillance and investigations of vaccination rates, missed vaccination
opportunities, invalid dose administration, and disparities in vaccination coverage.
2.2 Constraints
The support of the state immunization program, all users and stakeholders of the system is
required to support the MCIR design criteria listed above.
2.3 Risks
The advancement of electronic health records (EHRs), MCIR and the interoperability between
the systems has and will continue to decrease the use of the general MCIR user interface for
direct vaccine submission and patient query. Fewer users will view data submissions at the time
of entry, which could increase duplicate patient and vaccine record submissions.
Ongoing Data Quality Improvement Plan Version 2015 5 Michigan Care Improvement Registry/MCIR
3. Data Quality Principles
Table 1: Data Quality Principles
Principle Condition Examples
Consistency The conditions (criteria) for validating data items should be the same regardless of how the data items have been reported to MCIR.
Regardless of a data item’s source and the method of data reporting (e.g., direct user entry or via HL7 reporting), the data item should go through the same set of data validation checks.
Rejected data
When information is rejected by MCIR, the following actions should occur:
Electronic import logs errors and notifies submitters
HL7 users can generate an Electronic Submission Summary Report (ESSR)
User Interface (UI) displays an error message, offering user opportunity for error correction
The MCIR Electronic Submission Summary Report and Doses Administered Report, along with available inventory reports, assist the end user in finding, correcting and resubmitting data errors.
UI users receive edit checks verifying information on the screen, before data submission.
Internal consistency
Characteristics of the vaccination history should not contradict one another. This includes reported data as well as existing MCIR data.
This principle is a basis for all crosscheck validations.
This principle covers cross-validations between characteristics of multiple vaccination events that comprise immunization history, as well as cross-validations between characteristics of individual vaccination events.
Vaccination history includes demographics, and information on all recorded vaccination events.
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Principle Condition Examples
Accuracy
The data recorded in MCIR should match exactly what happens in a clinical encounter, whether or not it is clinically appropriate.
MCIR staff periodically audit a random sample of incoming data to verify that it matches clinical records.
Submitters should periodically audit a random sample of data to verify that it is correctly documented in MCIR.
Appropriate vaccination The vaccinations reported by a provider should be appropriate for the population served at the clinic.
MCIR Doses Administered Report (DAR)
Vital Records Vital Records is the definitive source for:
Date of Birth
Date of Death
Adoption
Validation of correct demographic information
Management of duplicate EBC records
It is possible that an incorrect birth date or death date is transmitted from vital records, but those are rare occasions.
Currently, approximately 90% of birth dates come from the electronic birth certificate records.
End users may flag a person as deceased.
A feed from vital records also provides an electronic file of official death records to MCIR.
Adoption records are managed at the regional level.
Validation priority The importance of validating a data item is related to the data item’s significance in clinical decision-making, public health assessments, and research.
Critical high priority data items are:
Vaccine Type
Vaccination Encounter Date
Eligibility
Lot number
Manufacturer
Date of Birth
Zip Codes
ACIP recommendations principle:
Deviations from ACIP recommendations and U.S. licensure may indicate data
If a date of birth is modified on a MCIR record, it could result in some vaccine encounter dates being
Ongoing Data Quality Improvement Plan Version 2015 7 Michigan Care Improvement Registry/MCIR
Principle Condition Examples
quality problems
MCIR does not accept immunization data prior to patient DOB
documented before the date of birth.
Timeliness Michigan Department of Health and Human Services requires immunization data to be entered into MCIR within 72 hours of administration for children less than 20 years of age.
To be useful for clinical decision support and health policymaking, immunization data should appear in the MCIR soon after the clinical event occurs.
Completeness The information submitted to MCIR must contain the minimum/mandatory set of data items in order to be accepted by MCIR.
Required data fields and the minimum/mandatory data sets for necessary MCIR function and operation
Relevant data is optional and of value in improving MCIR function. The goal is to capture all relevant data on patients and their vaccination events.
Supremacy of medical records
Patient medical records are of greater reliability in collecting immunization data than patient billing records (CPT codes). MCIR has not accepted billing data since 2003.
MCIR accepts vaccine (clinical) data
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4. Organizational Roles and Responsibilities
Table 2: Organizational Roles and Responsibilities
Organization Role Quality Responsibility
Immunization Provider To provide accurate patient level and vaccine data to MCIR within 72 hours of administration.
Ensure that the data recorded in MCIR should match exactly what happens in a clinical encounter, whether or not it is clinically appropriate
Generate required data quality reports on a weekly basis allowing data quality errors to be corrected in MCIR
Conduct reminder and or recall mailings and update patient addresses from returned reminder or recall mail notifications
Health Plan To increase immunization coverage level of members.
Assure participating provider meet Healthcare Effectiveness Data and Information Set (HEDIS) measure and comply with ACIP
Document address changes on members and flag possible duplicate records in MCIR
Conduct reminder and or recall mailings and update patient addresses from returned reminder or recall mail notifications
Ongoing Data Quality Improvement Plan Version 2015 9 Michigan Care Improvement Registry/MCIR
Organization Role Quality Responsibility
Health System To provide accurate patient level and vaccine information to MCIR within 72 hours of vaccine administration
Ensure that the data recorded in MCIR matches exactly what happens in a clinical encounter; whether or not it is clinically appropriate
Generate required data quality reports on a weekly basis and fix errors related to data quality in a reasonable amount of time
Assess clinic-level compliance and coverage rates, and ensure clinical-level compliance with the 72 hour mandate
Schools and Childcares To ensure accurate immunization coverage levels by school building and to maintain compliance with local health department (LHD) reporting requirements
End users add immunization data to students’ records, as necessary
School/Childcare data and immunizing provider data are separated in MCIR
School/Childcare data is not viewable to immunizing providers
Local health departments are able to verify school/childcare data, after which it become accessible (viewable) to immunizing providers
Report duplicate student vaccination records, and request required data corrections to student records
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Organization Role Quality Responsibility
Local Health Departments (LHDs)
To provide accurate patient level and vaccine data to MCIR within 72 hours of administration. Assure immunizations are given appropriately and timely in their jurisdiction
To oversee the Vaccine for Children’s Program at the local level
Ensure that the data recorded in MCIR matches exactly what happens in a clinical encounter; whether or not it is clinically appropriate
Enter all historical information on a patient to assist with increasing immunization coverage levels in the jurisdiction
Routinely monitor the quality of data being submitted and make the necessary corrections in MCIR within a reasonable amount of time
Conduct reminder and or recall mailings and update patient addresses from returned reminder or recall mail notifications
Recommend data quality strategies to immunization providers in their jurisdiction
Health Information Exchanges (HIE)
To transport accurate patient level data to MCIR
Assure that the required fields in the message header are populated and formatted correctly
Accountable Care Organizations
To increase the immunization coverage level of members
Assure participating providers meet HEDIS measures and comply with ACIP recommendations for immunizations
Document change of addresses on members and flag duplicate patients in MCIR
Conduct reminder and or recall mailings and update patient addresses from returned reminder or recall mail notifications
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Organization Role Quality Responsibility
Electronic Health Record (EHR) Vendor
To develop electronic medical records (EMR) that meet healthcare organization requirements, and federal requirements for required documentation support for immunization services
Develop and support HL7 interface requirements according to MCIR specifications for their customer’s specifications
Michigan Department of Health and Human Services (MDHHS) Division of Immunizations
Division Director
To provide oversight of the State of Michigan Immunization Program
Provide oversight of MCIR data quality policies
MDHHS Division of Immunizations
MCIR Coordinator
To provide oversight of the Michigan Care Improvement Registry program
Promote, develop and monitor MCIR data quality policies
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Organization Role Quality Responsibility
MDHHS Division of Immunizations
MCIR Regional Coordinators
To monitor, recruit and train immunization providers, health plans and health systems. To generate and create Business Objects (“ad hoc”) reports on behalf of MCIR users To develop and update regional forms and training materials, as necessary To monitor data submission and immunization rates for the region To assure all regional users are updated on MCIR system changes and procedural changes To develop strategies to increase private provider enrollment and participation in MCIR To maintain listing of providers and users trained for the region To operate and manage regional help desk activities. To monitor data quality , including the performance of patient and vaccine level de-duplicate measures
Perform patient and vaccine level record de-duplications
Monitor electronic data submission
Work with LHDs to establish an internal process to assure persons who have died within their county are appropriately flagged in the IIS
Refer EBC and NICU data quality issues to PHBPP for required follow-up
Train providers on submitting HL7 messages and generating the MCIR ESSR report
Process MCIR Petition for Modification requests
Generate routine reports to monitor and identify MCIR data quality issues:
72 hour submission (accreditation) report
Active site listing report
Profile Reports
Inventory Control Reports
First time HL7 submitters production
First time HL7 submitters onboarding
Weekly HL7 message count
Sites with no weekly HL7 activity
Offer data quality assurance (DQA) best practice strategies to providers
Refer DQA issues to appropriate stakeholders [LHDs, Assessment, Feedback, Incentives and eXchange (AFIX), Peer Education Program and/or State MCIR Program]
Provide tier 1 helpdesk support to regional MCIR end users
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Organization Role Quality Responsibility
MDHHS Division of Immunizations
Vaccines for Children (VFC) program
To provide access to vaccines (recommended by the Advisory Committee on Immunization Practices) to children whose parents or guardians may not be otherwise able to afford them, helping to ensure that all children have a better chance of receiving recommended vaccinations on schedule. Vaccines available through the VFC Program
Monitor data quality assurance for provider adherence to eligibility requirements, vaccine ordering and inventories
Referrals to MCIR staff for data quality reviews and training
Referrals to LHD’s for inventory management issues
MDHHS Division of Immunizations
Assessment, Feedback, Incentives and eXchange (AFIX) program
To raise immunization coverage levels, reduce missed opportunities to vaccinate, and improve standards of practice at the provider level through quality improvement processes
Assist with monitoring data quality at the clinic level
Refer providers to MCIR regional staff for data quality improvement training
MDHHS Division of Immunizations
Perinatal Hepatitis B Prevention Program (PHBPP)*
*Established in 1991
To prevent hepatitis B transmission from pregnant women to their infants, household and sexual contacts. To coordinate the sharing of preventative perinatal hepatitis B transmission information between primary care providers, hospitals, laboratories, the state and local health departments
Monitoring Hepatitis B vaccine compliance in birthing hospitals, including NICUs
Identifying duplicate patient records
Correct information identified as missing or requiring correction in the MCIR Electronic Birth Certificate (EBC) record
Monitor and perform necessary follow-up on Hospital Worksheet’s Unknown Hep B immunization and Unknown Immune Globulin (IG) data
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Organization Role Quality Responsibility
MDHHS Division of Immunizations
Immunization Nurse Educators (INEs)
To provide free immunization education*, performed by INEs from both the Michigan Department of Health and Human Services and LHDs, to Michigan provider offices statewide *The educational modules are developed and maintained by a core group of MDHHS-based nurses. Registered LHD nurses meeting the established qualifications and requirements, and completing the INE orientation are approved to teach these immunization educational programs within their LHD jurisdiction(s).
To educate and promote data quality improvement strategies to immunization providers.
Identify data quality issues and refer provider offices to MCIR Regional Staff for data quality improvement training.
MDHHS Office of Public Health Preparedness (OPHP)
To protect the health of Michigan citizens before, during and after an emergency through the integration of public health and medical preparedness initiatives and by leveraging diverse partnerships To maintain a dual role in both preparedness planning and in emergency response activities encompassing all hazards, including natural and man-made disasters, acts of bioterrorism, infectious disease outbreaks and other emergencies that impact the health of the public
Monitoring data quality assurance for vaccine/antiviral ordering and distribution.
MDHHS Division of Immunizations
Epidemiologists
To conduct ad-hoc queries, for the MDHHS Division of Immunizations, used to identify pockets of need, and trends in vaccination coverage
To develop queries and identify data quality issues in the MCIR database.
To provide recommendations to the Division of Immunizations for business rules or best practices to increase the quality of data in MCIR.
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Organization Role Quality Responsibility
MDHHS Division of Immunizations
Adolescent program
To monitor adolescent coverage rates for the State of Michigan To develop campaigns to increase adolescent immunization rates
Promotion of MCIR to adolescent service providers
Promote use of Patient Status, complete immunization records documented in MCIR.
Promote MCIR Reminder/Recall activities.
MDHHS Division of Immunizations
Technical Team
To provide technical infrastructure and related support To develop IIS enhancements and newly identified functionality
To conduct testing of the MCIR web application, as needed
To coordinate and monitor Health Plan data loads for HEDIS reporting.
Tier 3 state-level MCIR help desk support for the Michigan Public health Institute (MPHI).
Quality assurance related to provider onboarding.
MDHHS Division of Vital Records
To compile and store records of:
Michigan births, deaths, adoptions and marriages filed as early as 1867
Michigan divorces filed as early as 1897
To provide the MCIR with complete and accurate electronic birth records
To provide timely and accurate death record information to MCIR.
MDHHS Division of Lifecourse Epidemiology & Genomics
Newborn Screening (NBS) program
To identify babies with rare but serious disorders who require early treatment*, as identify by Michigan law
*All babies are tested in order to find the small numbers who have a rare medical condition.
To flag duplicate patient records in MCIR
MDHHS Division of Lifecourse Epidemiology & Genomics
Early Hearing Detection And Intervention (EHDI) program
To assist in identifying infants with hearing loss To follow the identified infants to enrollment of early intervention services To work in collaboration with hospitals, clinics, parents, and audiologists
To flag duplicate patient records in MCIR
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Organization Role Quality Responsibility
MDHHS Early Periodic Screening Diagnosis and Treatment (EPSDT)
To offer early and periodic screening, diagnosis, and treatment (EPSDT) services to Medicaid eligible beneficiaries younger than 21 years of age, as required by Federal regulations
To flag duplicate patient records in MCIR.
MDHHS Center for Medicaid and Medicare Services (CMS)
To support shared services that are utilized by the MCIR program, e.g. the Master Patient Index, MPI, and the Data warehouse
To share known duplicate patient records found in the MPI with MCIR
To share Medicaid Patient ID’s with MCIR on a monthly basis
Michigan Department of Technology, Management and Budget
To manage all Information Technology (IT) services within state government
To provide database management services and disaster recovery services for the Division of Immunizations
MDHHS Division of Women Infant and Children (WIC)
WIC program
To provide supplemental foods, health care referrals, and nutrition education* to low-income pregnant, breastfeeding, and non-breastfeeding postpartum women, and infants and children up to age five who are found to be at nutritional risk
*funded through federal grants to the WIC Special Supplemental Nutrition program
To flag duplicate patient records in MCIR.
To share WIC ID’s and clients addresses with MCIR on a monthly basis
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Organization Role Quality Responsibility
Michigan Public Health Institute (MPHI)
To provide technical and programmatic assistance to MDHHS Division of Immunization to successfully develop, deploy, and support statewide use of the MCIR
To provide testing and approval for electronic file submission, according to MDHHS-approved policy & procedure. To update the MCIR Vaccine Code List and to identify system bugs and enter them into bug tracking software.
To maintain a second-tier helpdesk for technical support of the MCIR web application. To maintain a first-tier helpdesk for technical support of school and childcare usage of the MCIR.
To conduct testing of the MCIR web application as needed.
Provide tier 2 state-level helpdesk support to MCIR end users (i.e., providers) statewide
Provide quality assurance service on new functionality programmed into MCIR.
Center for Disease Control and Preventions (CDC)
National Center for Immunization and Respiratory Diseases (NCIRD) Immunization Information Systems Support Branch (IISSB)
To maximize protection against vaccine-preventable diseases by leading the advancement of IIS, including the capture of accurate data on which to make informed immunization decisions.
To facilitate the development, implementation, and acceptance of IIS, whereby immunization providers will have access the data required to make informed clinical decisions
To develop national standards to ensure the quality of data in an IIS
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Organization Role Quality Responsibility
American Immunization Registry Association (AIRA)
To promote the development and implementation of IIS as an integral tool in the prevention and control of vaccine preventable diseases, through collaborative interaction of the nation’s IIS
Develop performance measures for IIS data quality compliance and best practices to achieve the recommended standards developed by CDC
University of Michigan
Child Health Evaluation and Research (CHEAR) Unit
To conducts projects, which involve both primary data collection and secondary data analysis, and utilizes both quantitative and qualitative research methods where appropriate
To provide data quality analysis and recommendations for improved MCIR data, through a contract with the MDHHS Division of Immunizations
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5. Data Quality Tools
Table 3: Data Quality Tools
Quality Tool Description
MCIR Data Quality Tool Handles data from different providers
differently depending on data quality issues encountered in the past and what kind of data is expected.
Reviews an entire batch of HL7 messages for problems.
Applies added vaccination specific rules and knowledge to a single message
Monitors and reports back to submitters and MCIR staff the status of imports on a submitter level.
Business Objects Business Objects software allows MCIR staff to develop ad hoc reports from the MCIR database. Several data quality reports are generated on a routine basis, including: Accreditation Report, County Cleanup Report, Active Site Listing, Electronic Submissions By Provider By County, and Monthly Shot Crosstab Report.
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6. Routine MCIR Data Quality Processess
Table 4: Routine MCIR Data Quality Processes
Quality Process Tools & Techniques
Patient De-Duplication MCIR Regional Staff are responsible for merging duplicate patient records on a daily basis. MCIR staff review each record in the duplicate patient list. They verify that the duplicate records are valid duplicates. If indicators are insufficient to allow for an accurate determination, they contact the current provider for supporting information. If the provider is unable to substantiate information for completion of the merge, a responsible party may be contacted. Vaccine administrations are reviewed to determine if the merging of the patient records may affect the vaccine inventory in MCIR. A determination must be made regarding whether patient records can be consolidated (merged) or should be designated as “Not Duplicates.”
Vaccine De-Duplication
Onboarding
Death Records The Medicaid Data Warehouse submits a death record file to MCIR on a monthly basis. (birth through 18 years of age)
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Quality Process Tools & Techniques
Record Modifications 1. MCIR end users may modify or delete
errors in the MCIR record if the data was added to the system by their office. The change does not require the submission of a Petition for Modification to the Regional Office. The ability for end user data correction pertains to immunization data only, not patient demographics, e.g., name, DOB, etc.
2. All other data entry edits not mentioned above must be submitted through sending a Petition for Modification form to the Regional office. Appropriate documentation may be required for requested modifications to MCIR shot data. Sites requesting name changes are NOT required to submit additional documentation (the office staff should have verified the name with the responsible party by following internal office policies).
3. If the requested change is determined to be valid, the Petition for Modification will be processed within 7 days of receipt.
4. Regional staff will determine the modification actions necessary for the following: modifying demographics, merging duplicate patient and/or vaccine records, deleting invalid doses, and adjusting inventory.
Patient Searches Users must search twice for a record before creating a new patient record in MCIR. Users may call regional office before adding a patient born after 1-1-94.
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Table 5: MCIR Data Quality Business Rules
Business Rule Action Comment
A patient should not have more than:*
50 vaccinations recorded in MCIR before age 5
35 vaccinations recorded in MCIR before 2 years of age
70 vaccinations recorded in MCIR regardless of age.
The MCIR State and Regional staff may query the MCIR using Business Objects on a yearly basis to determine If any MCIR records exceed this Business Rule. This report needs to be developed.
If this condition does exist from incoming data, the source should be notified and the patient record should be reviewed and modified to reflect accurate immunization information from the patient record.
*Requires IIS Design & Development of the business rule [included in Table 6]
Vaccination encounter date must not be before patient date of birth. Data items:
Vaccination Encounter Date
Date of Birth
Electronic import: Reject the patient and all related vaccination event submissions (new/incoming) User interface: Reject the vaccination event
MCIR reviews each vaccination event in the record being validated; MCIR will reject the information if any encounter date precedes date of birth. Possible interpretations:
Vaccination encounter date is incorrect
Patient date of birth is incorrect
Patient date of birth and vaccination encounter date are incorrect
Patient identification is incorrect (e.g., could be a sibling)
Vaccination encounter date should not be after the patient date of death. Data items:
Vaccination Encounter Date
Patient Date of Death
Electronic import: Reject the patient and all related vaccination event submissions (new/incoming) User interface: Reject the vaccination event
Implementation Example: Check:
If vaccination encounter date is after date of death
If date of death is after vaccination encounter
MCIR reviews each vaccination event in the record being validated; reject if any encounter date is later than the date of death.
Possible interpretations:
Date of death is recorded
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Business Rule Action Comment
incorrectly or patient is not actually deceased
Vaccination encounter date is incorrect
Error in software used to report encounter to MCIR
Two distinct patients are reported (one who received the vaccination and one who is deceased)
Vaccination encounter date must be less than or equal to (before or the same as) the Report submission date.
Reject the vaccination event submission
The create date in MCIR should be the same as the date of the vaccine encounter or recorded in MCIR after the date of administration.
The minimum/mandatory set of data items for a Vital Records submission includes:
Patient Date of Birth
Patient First Name
Patient Last Name
Gender
Mothers Maiden Name
Mothers First and Last Name
Mothers Address
Birth Facility Name and Location
Reject the Patient's record (complete rejection of submitted information).
MCIR does not accept birth records with the word “Baby” in the first name field or records containing Baby Boy or Baby Girl in the first name field.
The minimum/mandatory set of data items for the Provider EHRs must include:
Provider Organization Name/ID
Patient Name, First
Patient Name, Last
Patient Date of Birth
Patient Address
Vaccine Encounter Date
Vaccine Type
Vaccine Eligibility
Vaccine Lot Number
Vaccine Manufacturer
Responsible Party Last Name
If the demographic data items are incomplete (patient can't be identified): Reject the Patient's record (complete rejection of submitted information) • If the demographic data items are complete (patient can be identified): Reject those vaccination events that are incomplete (partial rejection of submitted
MCIR will not accept a patient record unless all of the required fields are submitted from an EHR
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Business Rule Action Comment
Responsible Party First Name
VFC-eligible children should have the manufacturer and lot number reported with vaccination event. Data items:
Vaccination Encounter Date
VFC Eligibility
Vaccine Manufacturer
Vaccine Lot Number
Reject the vaccination event submission This applies to administered immunizations only.
This information is required for inventory management and vaccine accountability.
The percentage of vaccination event submissions from Vital Records with hepatitis B birth doses should be within an expected threshold level. Data items:
Vaccine Type
Submitter Type
If threshold is deviated by 10%, then immediately follow up with vital records department.
The Perinatal Hepatitis B program measures all birth doses by vital records and hospital submission on a quarterly basis. MDHHS generates an annual report measuring how many MI birth records are added to the IIS, based on the number of births reported by Vital Records.
Vaccination encounter date should not be on the patient's date of birth unless it is on the list of vaccines recommended on the date of birth, e.g. Hepatitis B. Data items:
Vaccination Encounter Date
Patient Date of Birth
Vaccine Type
Electronic import: Accept
and flag for investigation
User Interface: Accept (after issuing a warning)
When this error is discovered, MCIR staff may ask the provider office to:
Review patient chart
Ask office to contact patient to validate date of birth
Possible interpretations:
Clinical error
The current date accidentally typed in the encounter date field
Other typographical error
For administered vaccinations, report submission date should be within 72 hours of vaccination encounter date for all patients under the age of 20.
Accept and flag for investigation
MCIR regions generate a 72-hour ad-hoc report and contact provider offices for training and develop a corrective action plan.
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Business Rule Action Comment
Data Items:
MCIR create date
Vaccine encounter date
Trade Name, Manufacturer, CVX Code, CPT Code and Vaccine Type should not contradict one another.
Reject the vaccination event submission.
MCIR will reject the electronic submission of vaccine type if it includes the wrong vaccine manufacturer.
The same patient should not receive the same antigen more than once in single day. Data Items:
Vaccination encounter date
Vaccine Type (in order to derive the antigen)
MCIR allows:
Rabies RIG for wound management and Rabies Vaccine on the same day
Two .25ml doses of Influenza on the same day
Two .50ml doses of Hep A on the same day
Two .50ml doses of Hep B on the same day
Possible interpretations to this rule:
Invalid dose or incomplete immunization
Two separate pediatric doses on the same date to an adult
Poor clinical practice
Vaccination Encounter Date should not be after the lot number expiration date. Data items:
Vaccination Encounter Date
Lot Number Expiration Date
Electronic Import: Accept and flag for investigation.
User Interface: Accept (after issuing a warning)
MCIR allows the end user to submit an administered vaccine with an expired lot number.
Administered vaccinations should have specific Vaccine Types, e.g., Hib PRP-OMP; Unspecified vaccine types, e.g., Hib, NOS, are less desirable. Data items:
Administered/Historical Indicator
Accept – during production
Investigate - during onboarding.
MCIR accepts unspecified vaccine types only for historical doses.
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Business Rule Action Comment
Vaccine Type
The volume of reporting from the Vital Records feed should be within an expected threshold level (to be determined by each IIS). Data item:
Report Submission Date
Michigan has 113,000 births a year. 96% of birth records should be entered into MCIR via the vital records feed.
If the rate of reporting significantly deviates from the threshold, the State MCIR Coordinator will follow up with the Division of Vital Records.
The percentage of rejected vaccination event submissions in a report should be within an expected threshold level.
During the onboarding process if more than 10% of the vaccination event submissions are rejected for errors, initiate an investigation.
MCIR regional staff will begin to review a random sample of DQA reports on a yearly basis to check for 10% or more error rejection rate. The regional staff will work with the provider office on a corrective action plan to eliminate existing data quality errors in the future.
A patient should not have more than 6 DTaP vaccinations by age 7. * Data Items:
Date of Birth
Vaccination Encounter Date
Vaccine Type
Accept – during production
Investigate - during onboarding.
MCIR should have this query as an ad-hoc report and be generated on a quarterly basis. *Requires IIS Design & Development of the business rule [included in Table 6]
A patient should not have more than 10 vaccinations per visit.* Data Item:
Vaccination encounter date
Accept and flag for investigation
MCIR should have this query as an ad-hoc report and generate this report on a quarterly basis? *Requires IIS Design & Development of the business rule [included in Table 6]
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Table 6: MCIR Vaccine De-duplication Business Rules
Business Rule Description Action Taken
Allow two .50ml doses of Hep B on the same day
Accept one additional record only. Flag as potential duplicate
Allow two .50ml doses of Hep A on the same day
Accept one additional record only. Flag as potential duplicate
Allow two .25ml doses of Influenza on the same day
Accept one additional record only. Flag as potential duplicate
Allow a single Rabies RIG for wound management, per day
Accept dose of RIG or Rabies vaccine if an existing dose already recorded for that day is NOT recorded as a RIG or Rabies Vaccine
Allow a single Rabies Vaccine, per day Accept dose of RIG or Rabies vaccine if an existing dose already recorded for that day is NOT recorded as a RIG or Rabies Vaccine
Allow Rabies Vaccine (not RIG) on successive days <5 day interval. Same vaccine product is required for all subsequent doses or record will be rejected as a duplicate.
Allow additional doses of Rabies Vaccine to be reported within a 4 consecutive day window
Allow Tdap on same day as Td, DT
Allow the reporting of a Tdap vaccine the same day as a Td, DT
Allow Tdap within 5 days, if prior dose was a Td or DT
Allow Tdap to be reported on same day or <4 days since last Td, DT (non Pertussis containing vaccine)
Allow Hep B or HBIG if birth dose reported by Hospital and existing dose reported by Electronic Birth Certificate*.
*Data reported by Hospital EHR provides a more complete vaccination record than EBC interface.
Based on investigation, the regional MCIR office will determine:1) whether to replace EBC dose with Hep B dose data entered into the IIS, via a variety of external sources; and 2) to perform the required adjustment manually or through the vaccine deduplication queue
Accept HL7 interface record if previously reported via HL7 by the same provider site and having change in eligibility or other clinical information.
Accept record and flag as potential duplicate.
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Business Rule Description Action Taken
Accept potential duplicate if lot# provided and existing record has no lot
Accept record and flag as potential duplicate
Reject potential duplicate if vaccine, manufacturer is the same and better lot information is not available.
Reject record
Reject potential duplicate if vaccine is the same and better lot information is not available
Reject record
Reject potential duplicate if record does not have better clinical information to offer.
Reject record
Table 7: MCIR Data Integrity Standards
Data Item Range/Codes Comments
CPT Code Should be chosen from the standard table of CPT (billing) codes
Prefer CVX codes
Patient Name Should not contain invalid name characters such as []{}0123456789~!@#$%^&*\, as well invalid names, e.g., "baby."
Prefer legal names instead of aliases
Patient Date of Birth
Dates should represent valid calendar dates.
Patient Date of Death
Dates should represent valid calendar dates.
A user may document a patient as deceased via HL7 or through the user interface.
Patient Gender
Male, Female, Unknown
Mothers Maiden Name
Should not contain invalid name characters such as []{}0123456789~!@#$%^&*\
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Data Item Range/Codes Comments
Vaccine Encounter Date
Dates should represent valid calendar dates.
Vaccination Event Site
Should be chosen from the standard table of vaccination sites and routes.
http://www.mcir.org/forms/MCIR_HL7_Spec_Guide_with_MNF_CVX%20attach.pdf
http://www.mcir.org/forms/MCIR_Provider_Transfer_
Specs.pdf
Vaccination Route
Should be chosen from the standard table of vaccination sites and routes.
http://www.mcir.org/forms/MCIR_HL7_Spec_Guide_with_MNF_CVX%20attach.pdf
http://www.mcir.org/forms/MCIR_Provider_Transfer_Specs.pdf
Vaccination Event– Dosage
Includes 1) value and 2) unit of measurement; both have to be captured or known (e.g., presumed to be in mL) Value has to be a positive unit of measurement, e.g., mL.
Value should be numeric. Value should not be negative. If value is zero; the presumption is that field was not filled.
Vaccine – Type
Should be chosen from the standard table of vaccine codes.
See CVX or CPT codes.
http://www.mcir.org/forms/All_Vaccine_codes.pdf
Vaccine – Lot Number
Typically, an alpha-numeric field.
Vaccine – Lot Number Expiration Date
Dates should represent valid calendar dates.
Vaccine – Manufacturer
Should be chosen from the standard table of
http://www.mcir.org/forms/All_Vaccine_codes.pdf
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Data Item Range/Codes Comments
MVX codes.
State/Province
If country code is specified as 'US' (or not indicated and assumed to be 'US'), state code should be drawn from the USPS state codes list. This list should also include the Federal District (DC), insular areas, Freely Associated States, and Armed Forces codes.
State/Province designations for other country codes must be valid.
http://www.mcir.org/forms/MCIR_HL7_Spec_Guide_with_MNF_CVX%20attach.pdf
http://www.mcir.org/forms/MCIR_Provider_Transfer_Specs.pdf
ZIP Codes For addresses with a US country code (or a blank US country code that is assumed to be US): ZIP codes may be either 5 or 9 digits and with a dash appearing after the first 5 digits.
.
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7. Data Quality Processes and Schedules
Table 8: Scheduled Data Quality Processes
Process Schedule Responsibility Tool(s)
Patient deduplication algorithms
Daily MDHHS Division of Immunizations
Automated report
Vaccine deduplication algorithms
Daily MDHHS Division of Immunizations
Automated report
72 hour submission report monitoring
Quarterly MDHHS Division of Immunizations
MDHHS Division of Immunizations, MCIR Regional Coordinators
MCIR end user/ Immunizing Provider
MDHHS: Accreditation Report (Business Objects)
MCIR Regions: Accreditation Report (Business Objects)
Immunizing Provider: EXT Transfer Report
Vital records monitoring Quarterly
Annually
Quarterly-PHBPP
Annually-MDHHS Division of Immunizations
PHBPP: Quarterly Hep B Hospital measurement reports
MDHHS: Immunization Information Systems Annual Report (IISAR)
Duplicate patient records Daily MDHHS Division of Immunizations
MDHHS Division of Immunizations, MCIR Regional Coordinators
Regional patient deduplication queue
Duplicate vaccine entries in a record
Daily MDHHS Division of Immunizations, MCIR Regional Coordinators
Regional vaccine deduplication queue
Business Objects reports
Monitoring of provider DQA reports
Ongoing pre-production
MDHHS Division of Immunizations, MCIR Regional Coordinators
MPHI
MCIR Regions: Vaccine Deduplication Business Objects reports
MPHI: IIS DQA Tool, ESSR report
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Process Schedule Responsibility Tool(s)
Immunization Provider review of ESSR report and correct data quality errors listed report
Daily MPHI
MDHHS Division of Immunizations, MCIR Regional Coordinators
MCIR end user/ Immunizing Provider
MPHI: IIS DQA Tool Report
MCIR Regions & Providers: MCIR ESSR report
Review and modify ongoing data quality policies
Annual Review MDHHS Division of Immunizations
MDHHS Division of Immunizations, MCIR Regional Coordinators
MDHHS Division of Immunizations, MCIR Data Quality Workgroup members
MDHHS Division of Immunizations: Review of current policies
MDHHS Division of Immunizations, MCIR Regional Coordinators: Review of current procedures as they relate to current MDHHS Division of Immunization policies
Death record imports Monthly MDHHS Division of Immunizations
Manual monthly process from Medicaid Warehouse to IIS
Vital Record imports Daily MDHHS Division of Immunizations, Tech Team
Automated report
Batch assessment (updating forecast on all records in the database)
Daily MDHHS Division of Immunizations, Tech Team
Automated report
Weekly HL7 message count
Weekly MDHHS Division of Immunizations, Tech Team
Automated report
Sites having no weekly HL7 activity
Weekly MDHHS Division of Immunizations, Tech Team
Automated report
First time HL7 submitters production
Weekly MDHHS Division of Immunizations, Tech Team
Automated report
First time HL7 submitters Weekly MDHHS Division of Immunizations, Tech
Automated report
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Process Schedule Responsibility Tool(s)
onboarding Team
Meaningful Use Regional TRACKER Status Report
Weekly MDHHS Division of Immunizations, Tech Team
Automated report
Table 9: Newly Identified Data Quality Procedures and Reports to be Implemented
Process Schedule Responsibility Tool(s) Required
Appropriate Vaccinations by Age –
A patient should not have more than:*
50 vaccinations recorded in MCIR before age 5
35 vaccinations recorded in MCIR before 2 years of age
70 vaccinations recorded in MCIR regardless of age.
Annually MDHHS Division of Immunizations, MCIR Regional Coordinators
IIS design and development of business rules Business Processes defined Business Objects
A patient should not have more than 6 DTaP vaccinations by age 7.* Data Items:
Date of Birth
Vaccination Encounter Date
Vaccine Type
Quarterly MDHHS Division of Immunizations, MCIR Regional Coordinators
IIS design and development of business rules Business Processes defined Business Objects
A patient should not have more than 10 vaccinations per visit. Data Item:
Vaccination encounter date
Quarterly MDHHS Division of Immunizations, MCIR Regional Coordinators
IIS design and development of business rules Business Processes defined Business Objects
Algorithms to prevent documentation of
Daily MDHHS Division of Immunizations, Tech
MCIR Algorithm
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Process Schedule Responsibility Tool(s) Required
administered vaccines on DOB, excluding ACIP recommended “birth” doses
Team
Algorithms to prevent documentation of administered vaccines post Date of Death
All vaccine encounters
MDHHS Division of Immunizations, Tech Team
MCIR Algorithm
Algorithms to prevent documentation of duplicate vaccination type administered on same day
All vaccine encounters
MDHHS Division of Immunizations, Tech Team
MCIR Algorithm
Algorithms to prevent documentation of vaccines administered post the vaccine’s expiration date
All vaccine encounters for VIM users
MDHHS Division of Immunizations, Tech Team
MCIR Algorithm
Algorithms to prevent documentation of Unspecified and/or NOS vaccines unless documented as Historical doses
All vaccine encounters
MDHHS Division of Immunizations, Tech Team
MCIR Algorithm
Compliance of Submission policy for Vital Records birth certification information, i.e., EBC creation
Daily MDHHS-Immunization Division
MDHHS Division of Immunizations, Tech Team
MCIR Regional Coordinator Procedure
Allow electronic transfer of death record data, without vaccination data attached*
Ongoing Any immunizing provider using HL7 messaging
Transfer specs
HL7 guide
*Requires Admission, Discharge Transfer (ADT) Messaging
Canned IIS report of all immunization added to a person’s record: by HL7 message per a specified time
As required MDHHS Division of Immunizations
IIS capacity/function
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Process Schedule Responsibility Tool(s) Required
frame including: patient’s first
and last name, DOB, MCIR ID, Vaccine Admin Date, Vaccine Type, Lot # and Manufacturer
Onboarding approval process
Go Live will occur within 30 days of approval
MPHI
MDHHS Division of Immunizations, MCIR Regional Coordinators
MPHI and Regional Coordinators:
Onboarding Procedure
ESSR report
IIS queue for Potential Patient deduplication, merging and approved IIS visibility
Routinely MDHHS Division of Immunizations, MCIR Regional Coordinators
IIS Potential Patient Deduplication Queue -business rules and functional specifications TBD
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8. ACRONYMS
Table 10: ACRONYMS
Acronym Literal Translation
ACIP Advisory Committee on Immunizations
ADT Admission, Discharge Transfer Messaging
AFIX Assessment Feedback Incentives and eXchange program
AIRA American Immunization Registry Association
CHEAR Child Health Evaluation and Research Unit, University of Michigan
CDC Centers for Disease Control and Prevention
CMS Center for Medicaid and Medicare Services
DQA Data Quality Assurance
EBC Electronic Birth Certificate
EHDI Early Hearing Detection And Intervention program
EHR Electronic Health Record
EMR Electronic Medical Record
EPSDT Early Periodic Screening Diagnosis and Treatment program
HIE Health Information Exchange
HEDIS Healthcare Effectiveness Data and Information Set
IIS Immunization Information System
IISAR Immunization Information System Annual Report
IISSB Immunization Information System Support Branch, CDC
INE(s) Immunization Nurse Educator(s)
IT Information Technology
LHD(s) Local Health Department(s)
MCIR Michigan Care Improvement Registry
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Acronym Literal Translation
MDHHS Michigan Department of Health and Human Services
MIROW Modeling Immunization Registry Operations Workgroup, AIRA
MPHI Michigan Public Health Institute
NBS Newborn Screening program
NCIRD National Centers for Immunization and Respiratory Diseases, CDC
OPHP Office of Public Health Preparedness
PHBPP Perinatal Hepatitis B Prevention program
QA Quality Assurance
UI User Interface
VFC Vaccines For Children program
WIC Women Infant and Children program
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9. Referenced Documents
Table 11: Referenced Documents
Document Name Document Number and/or URL Issuance Date
MIROW Data Quality Assurance in Immunization Information Systems: Incoming Data
02/11/2008
MCIR HL7 Guide Michigan Care Improvement Registry HL7 2.5.1 Specification for Vaccination Messages
6/14/2008
10. Record of Changes
Table 12: Record of Changes
Version
Number Date Author/Owner Description of Change
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