Assignment : answer real world case 7.1 and 7.2 questions; at least one
Page per case ; cite textbook
Please see chapter readings from textbook below
Real World Case 7.1
Remember, databases are used for a variety of reasons and contain large amounts of secondary data. One significant issue that healthcare professionals face is ensuring the data are kept safe and secure. The digitization of healthcare data has created many benefits, but it has also created challenges. A research report from IntSights, “Chronic (Cyber) Pain: Exposed and Misconfigured Databases in the Healthcare Industry,” reveals how hackers are obtaining personally identified information from exposed databases. It is not only old or outdated databases that get breached, some newly established platforms are vulnerable due to misconfiguration or open access. The researchers found that hackers were able to access sensitive data in databases through such simple methods as Google searches (Landi 2018).
Most cybercriminals usually attack for money, but since hospitals don’t hold currency, these attackers target the industry for one of three reasons:
1. State-sponsored APTs Targeting Critical Infrastructure: An attempt to infiltrate a network to test tools and techniques to set the stage for larger, future hacks, or to obtain information on a specific individual’s medical condition.
2. Attackers Seeking Personal Data: Attackers seek personal data to use in multiple ways such as sell electronic protected health information, blackmail individuals, or use it as a basis for future fraud like phishing or scam calls.
3. Attackers Taking Control of Medical Devices for Ransom: Attackers target medial IT equipment to spread malware that exploits specific vulnerabilities and demands a ransom to release the infected devices (Ainhoren 2018).
Many healthcare organizations are working diligently to protect themselves from cyber-attacks and threats. It is important to constantly evaluate for gaps in the IT infrastructure and implement strategies such as assessing what needs to be secured, mastering identity and mobile device management, testing and re-testing tools, detecting and continuously monitoring threats, and training employees (Davis 2017).
While secondary data such as databases makes it a powerful tool for data collection, it is important for healthcare professionals to be aware of the threats and challenges presented which include privacy, security, data quality, and more.
Real World Case Questions 7.1
1. Where can you find information about healthcare database threats?
2. Investigate healthcare data breaches for the past year. Identify the main causes of database breaches.
Real World Case 7.2
As mentioned before, many databases are maintained at the state and national level for public use. The National Youth Tobacco Survey (NYTS) serves this purpose and others. The NYTS is used to help provide researchers with information to explore in detail. It also is used as part of a public initiative (Healthy People 2020) for surveillance of trends of adolescent tobacco use (CDC 2019b). Evidence of current topics of secondary data (in other words, databases) is all around us.
A recent report from CDC’s 2018 NYTS indicates that the use of electronic cigarettes (e-cigarettes) is on the rise. The use of e-cigarettes spiked almost 80 percent among high school students and 50 percent among middle school students in the past year. The recent increase is largely due to the popularity of one e-cigarette brand, which looks like a USB flash drive (Boyles 2018).
Vaping, the act of inhaling the vapors of e-cigarettes, by US teenagers has reached epidemic levels, threatening to hook a new generation of young people on nicotine. “We have never seen use of any substance by America’s young people rise this rapidly,” HHS Secretary Alex Azar explains. Vaping is ingrained in the high school culture with kids using e-cigarettes in school bathrooms and even during class. Kids don’t realize many e-cigarettes contain nicotine. Among younger students, candy-flavored e-cigarettes are the most popular, while fruit-flavored products are popular with older students (Finnegan 2018).
Numerous efforts are underway to prevent and reduce tobacco use among young people. The NYTS was designed to provide national data on long-term, intermediate, and short-term indicators to serve as a baseline for data comparison toward meeting the Healthy People 2020 goal of reducing tobacco use among youth (CDC 2018d).
Real world case questions 7.2
1. Research NYTS, covered in real-world case 7.2, and identify the impact that registries have had on consumer and population health. Students can access information on the registry at: https://www.cdc.gov/tobacco/data_statistics/surveys/nyts/index.htm
2. Investigate activities in your area that are focused on reducing and preventing teen tobacco use. What did you find interesting about the programs? What value does a registry like this provide?
https://msdh.ms.gov/msdhsite/_static/43,0,94,756.html ; https://msdh.ms.gov/msdhsite/_static/resources/7856.pdf
HITT 1301 CHAPTER 7
Health Information Management Technology,
An Applied Approach
Nanette Sayles, Leslie Gordon
Copyright ©2020 by the American Health Information Management Association. All rights reserved.
Except as permitted under the Copyright Act of 1976, no part of this publication may be reproduced,
stored in a retrieval system, or transmitted, in any form or by any means, electronic, photocopying,
recording, or otherwise, without the prior written permission of AHIMA, 233 North Michigan Avenue,
21st Floor, Chicago, Illinois 60601-5809 (http://www.ahima.org/reprint).
AHIMA Product No.: AB103118
As a rich source of data about an individual patient, the health record’s primary purpose is in patient care and reimbursement for individual encounters. (Chapter 3, Health Information Functions, Purpose, and Users, discusses the purpose of the health record in more detail). It is difficult to see trends in a population of patients by looking at individual health records. For this purpose, data must be extracted from individual health records and entered into databases. These data may be used in a facility-specific or population-based registry for research and improvement of patient care (explained later in this chapter). Data may be reported to the state and become part of state- and federal-level databases used to set health policy and improve healthcare. With the electronic health record (EHR), it is possible for data to be collected once in the EHR and used many times (secondary records) for a variety of purposes as outlined in this chapter.
The health information management (HIM) professional can play a variety of roles in managing secondary data and databases. The HIM professional plays a key role in database setup. The HIM professional’s role includes determining the content of the database and ensuring compliance with the laws, regulations, and accreditation standards that affect its content and use. All data elements included in the database or registry must be defined in a data dictionary. A data dictionary is a descriptive list of names, definitions, and attributes of data elements to be collected in an information system or database (AHIMA 2014a). For more on the data dictionary, see chapter 6, Data Management. The HIM professional serves as a data steward to oversee the completeness and accuracy of the data abstracted for inclusion in the database or registry. “Data stewardship is a responsibility guided by principles and practices to ensure the knowledgeable and appropriate use of data derived from individuals’ personal health information” (NCVHS 2009, 1). Data stewardship and the role of the data steward are also discussed in chapter 6.
This chapter explains the difference between primary and secondary data and its users. It offers an in-depth look at the types of secondary databases, including indexes and registries, and their functions. Finally, this chapter discusses how secondary databases are processed and maintained.
Differences between Primary and Secondary Data Sources
The health record is considered a primary data source because it contains information about a patient that has been documented by the professionals who provided care or services to that patient. A primary data source is an original data source where the data are documented or collected by the provider of care. Data derived from the primary health record, such as an index or a database, are considered secondary data sources. These data are known as secondary data.
Data are categorized as either patient-identifiable data or aggregate data. With patient-identifiable data, the patient is identified within the data either by name, address, date of birth, or social security number or other government issued identification. The health record consists entirely of patient-identifiable data. In other words, every fact in the health record relates to a particular patient identified by name. Secondary data also may be patient identifiable. In some instances, data are entered into a database along with information such as the patient’s name maintained in an identifiable form. Registries are an example of patient-identifiable data in a secondary data source.
Data are patient-identifiable if the identity of the patient is linked via address, age, or another identifier. For example, if an individual can be identified by using a combination of elements such as date of birth, zip code, gender, marital status, and phone number, this would be considered patient-identifiable data.
More often, however, secondary data are considered aggregate data. Aggregate data include data on groups of people or patients without identifying any patient individually. Examples of aggregate data are statistics on the average length of stay (ALOS) for patients discharged within a particular diagnosis-related group (DRG).
Purposes and Users of Secondary Data Sources
There are four major purposes for collecting secondary data. They are the following:
1. Quality, performance, and patient safety. Healthcare organizations, for example, collect core measure information from the health record for the Centers for Medicare and Medicaid Services (CMS) to evaluate the quality of care within the healthcare organization.
2. Research. Data taken from health records and entered into databases help researchers determine the effectiveness of alternate treatment methods. An example of this type of secondary data use is a disease database that cross-references an index of human diseases, medications, signs, abnormal findings, and more (Diseases Database 2019). Another example is the secondary data collected from the Patient-Centered Outcomes Research Institute (PCORI) used to help patients, families, and clinicians make better healthcare choices (PCORI 2019).
3. Population health. Population health is an “interdisciplinary, customized approach that allows health departments to connect practice to policy for change to happen locally” (CDC 2019a). For example, states require information be reported to them on certain diseases so the extent of the disease can be determined, and steps taken to prevent the spread of that disease.
4. Administrative. In credentialing physicians, healthcare organizations are required to access a national database for information on previous malpractice or other adverse decisions against a physician. This information is used to evaluate the qualifications, skills, and performance history of a physician.
In healthcare, the health record is a source for various types of data and serves many purposes. The various users of healthcare data are discussed in the following sections.
Internal users of secondary data are individuals located within the healthcare organization. For example, internal users include medical staff and administrative and management staff. Secondary data enable these users to identify patterns and trends that are helpful to inpatient care, long-range planning, budgeting, and benchmarking with other healthcare organizations.
External users of patient data are individuals and institutions outside the healthcare organization. Examples of external users are state data banks (discussed later in this chapter) and federal agencies. States have laws mandating that cases of patients with diseases such as tuberculosis, sexually transmitted diseases, and other communicable diseases be reported to the state department. The federal government collects data from the states on vital events such as births and deaths.
The secondary data provided to external users are generally aggregate data, not patient-identifiable data. Thus, these data can be used as needed without risking breaches of confidentiality.
Types of Secondary Data Sources
Secondary data sources consist of facility-specific indexes; registries, either facility or population based; or other healthcare databases.
The most long-standing secondary data sources are those developed within healthcare organizations to meet their individual needs. These indexes enable health records to be located by diagnosis, procedure, or physician. Prior to extensive computerization in healthcare, these indexes were kept on cards. Today, most indexes are maintained as computerized reports based on data from databases routinely developed in the healthcare organization.
Disease and Operation Indexes
The disease index is a listing in diagnosis code number order of patients discharged from the healthcare organization during a specific time period. Each patient’s diagnoses are converted from a verbal description to a numerical code, usually using the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM). The patient’s diagnosis codes are entered into the healthcare organization’s health information system as part of the discharge processing of the patient’s health record. The index always includes the patient’s health record number as well as the diagnosis codes so health records can be retrieved by diagnosis. Because each patient is listed with the health record number, which may be linked to the patient’s name and other information, the disease index is considered patient-identifiable data. The disease index also may include information such as the date of discharge and the attending physician’s name.
The operation index is similar to the disease index except that it is arranged in numerical order by the patient’s procedure code(s) using International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD-10-PCS) or Current Procedural Terminology (CPT) codes. For specifics on ICD-10-PCS and CPT, refer to chapter 15, Revenue Management and Reimbursement. The other information listed in the operation index is generally the same as that listed in the disease index except that the surgeon may be listed in addition to, or instead of, the attending physician. For additional information on coding systems, see chapter 5, Clinical Terminologies, Classifications, and Code Systems.
The physician index is a listing of cases organized by physician name or physician identification number. It also includes the patient’s health record number and may include other information, such as date of discharge. The physician index enables users to retrieve information about a particular physician, including the number of cases seen during a specific time period.
Disease registries are collections of secondary data related to patients with a specific diagnosis, condition, or procedure. Examples of disease registries may include, but are not limited to, Alzheimer’s Prevention Registry, Colon Cancer Family Registry, National and State Cancer Registries, and Rare Disease Registry. Registries are different from indexes because they contain more extensive data. Index reports are usually produced using data from the healthcare organization’s existing databases. Registries often require more extensive entry of data from the health record. Each registry must define the cases that are to be included; this process is called case definition. In a trauma registry, for example, the case definition might be all patients admitted with a diagnosis that includes the ICD-10-CM trauma diagnosis codes.
After the cases to be included have been determined, the next step is usually case finding. Case finding is a method used to identify the patients who have been seen or treated in the healthcare organization for the specific disease or condition of interest to the registry. After cases have been identified, extensive information is abstracted from the patients’ health records into the registry database or extracted from other databases and automatically entered into the registry database.
The sole purpose of some registries is to collect data from health records and make them available for users. Other registries take further steps to enter additional information in the registry database, such as routine follow-up of patients at specified intervals. Follow-up information might include rate and duration of survival and quality of life over time. General terminology associated with registries is defined in figure 7.1 and a list of major registries is displayed in table 7.1.
Figure 7.1 Terminology associated with registries
Table 7.1 Major registries
Cancer registry Tracks the incidence (new cases) of cancer
Trauma registry Tracks patients with traumatic injuries from the initial trauma treatment to death
Birth defects registry Collects information on newborns with birth defects
Diabetes registry Collects cases of patients with diabetes to assist in managing care as well as for research
Implant registry Tracks the performance of implants including complications, deaths, and defects resulting from implants, as well as implant longevity
Transplant registry Maintains databases of cases of patients who need organ transplants
Immunization registry Collects information within a particular geographic area on children and their immunization status and maintains a central source of information for a particular child’s immunization history, even when the child has received immunizations from a variety of providers
According to the National Cancer Registrars Association (NCRA), the first hospital cancer registry was founded in 1926 at Yale–New Haven Hospital (NCRA 2018a). It has long been recognized that information is needed to improve the diagnosis and treatment of cancer. Cancer registries were developed as an organized method to collect these data. The data may be facility based (for example, within a hospital or clinic) or population based (for example, from more than one healthcare organization within a state or region).
Facility-based registries include cases from a particular type of healthcare organization such as a hospital or clinic. The data from facility-based registries are used to provide information for the improved understanding of cancer, including its causes and methods of diagnosis and treatment. The data collected also may provide comparisons in survival rates and quality of life for patients with different treatments and at different stages of cancer at the time of diagnosis. Population-based registries include information from more than one healthcare organization in a specific geographical area such as a state or region. In population-based registries, the emphasis is on identifying trends and changes in the incidence (new cases) of cancer within the area covered by the registry.
The Cancer Registries Amendment Act of 1992 provided funding for a national program of cancer registries with population-based registries in each state. According to the law, these registries were mandated to collect data such as the following:
· Demographic data about each case of cancer; demographic data describing the individual, including the patient’s name, age, gender, race, ethnicity, and birthplace
· Information on the industrial or occupational history of the individuals with the cancers (to the extent such information is available from the same health record)
· Administrative information, including date of diagnosis and source of information
· Pathological data characterizing the cancer, including site, stage of the neoplasm (specifies the amount of metastasis, if any), incidence, and type of treatment (Public Law 102-515 1992)
Case Definition and Case Finding in Cancer Registries As defined previously, case definition is the process of deciding which cases should be entered in the registry. For example, in a cancer registry all cancer cases except skin cancer might meet the definition for the cases to be included. Information on malignant neoplasms, data on benign and borderline brain or central nervous system tumors must be collected by the National Program of Cancer Registries (CDC 2018a).
In the facility-based cancer registry, the first step is case finding. One way to find cases is through the discharge process in the HIM department. During the discharge procedure, coders or discharge analysts can easily earmark cases of patients with cancer for inclusion in the registry. Another case-finding method is using the facility-specific disease indexes to identify patients with diagnoses of cancer. Additional methods may include reviews of pathology reports and lists of patients receiving radiation therapy or other cancer treatments to determine cases that have not been found by other methods.
Population-based registries usually depend on hospitals, physician offices, radiation facilities, ambulatory surgery centers (ASCs), and pathology laboratories to identify and report cases to the central registry. The administrators of a population-based registry have a responsibility to ensure all cases of cancer have been identified and reported to the central registry.
Data Collection for Cancer Registries Data collection methods vary between facility-based and population-based registries. When a case is first entered in the registry, it is assigned an accession number, a number unique to the patient. This number consists of the first digits of the year the patient was first seen at the healthcare organization, and the remaining digits are assigned sequentially throughout the year. For example, the first case in the year might be 21-0001. The 21 indicates that the person was seen in the year 2021. An accession registry is a list of cases in a cancer registry in the order in which they were entered. An accession registry of all cases can be kept manually or provided as a report by the database software. This listing of patients in accession number order provides a way to ensure all the cases have been entered into the registry.
In a facility-based registry, data are initially reviewed and collected from the patient’s health record. In addition to demographic information, data in the registry about the patient include the following:
· Type and site of the cancer
· Diagnostic methodologies
· Treatment methodologies
· Stage at the time of diagnosis
The stage provides information on the size and extent of spread of the tumor throughout the body. There are currently several staging systems. The American Joint Committee on Cancer (AJCC) has worked through its Collaborative Stage Task Force with other organizations with staging systems to develop a new standardized staging system—the Collaborative Stage Data Set. This staging system uses computer algorithms to describe how far a cancer has spread (Collaborative Stage Data Collection System 2019). After the initial information is collected at the patient’s first encounter, data in the registry are updated periodically through the follow-up process, which is discussed in the section that follows.
Frequently, the population-based registry only collects information when the patient is diagnosed. Sometimes, however, it receives follow-up information from its local, state, or national entities. These entities usually submit information to the central registry electronically.
Reporting and Follow-up for Cancer Registries Formal reporting of cancer registry data is done annually. The annual report includes aggregate data on the number of cases in the past year by site and type of cancer. It also may include information on patients by gender, age, and ethnic group. Often a particular site or type of cancer is featured with more in-depth data provided.
Other reports are provided as needed. Data from the cancer registry are frequently used in the quality assessment process for a healthcare organization as well as in research. Data on survival rates by site of cancer and methods of treatment, for instance, would be helpful in researching the most effective treatment for a type of cancer.
Another activity of the cancer registry is patient follow-up. On an annual basis, the registry attempts to obtain information about each patient in the registry, including whether they are still alive, status of the cancer, and treatment received during the period. Various methods are used to obtain this information. For a facility-based registry, the healthcare organization’s patient health records may be checked for return hospitalizations or visits for treatment. Additionally, the patient’s physician may be contacted to determine whether the patient is still living and to obtain information about the cancer.
When patient status cannot be determined through these methods, an attempt may be made to contact the patient directly using information in the registry such as the patient’s address and telephone number. In addition, contact information from the patient’s health record may be used to request information from the patient’s relatives. Other methods used include reading newspaper obituaries for deaths and using the Internet to locate patients through sites such as the Social Security Death Index. The information obtained through follow-up is important and allows the registry to develop statistics on survival rates for specific cancers and different treatment methodologies.
Population-based registries do not always include follow-up information on the patients in their databases. However, those who follow up usually receive the information from the reporting entities such as hospitals, physician offices, and other healthcare organizations providing follow-up care.
Standards and Approval Processes for Cancer Registries Several organizations have developed standards or approval processes for cancer programs. The American College of Surgeons (ACS) Commission on Cancer has an approval process for cancer programs. One of the requirements of this process is the existence of a cancer registry as part of the program. The ACS standards are published in the Cancer Program Standards (ACS 2019a). When the ACS surveys the cancer program, part of the survey process is a review of cancer registry activities.
The North American Association of Central Cancer Registries (NAACCR) has a certification program for state population-based registries. Certification is based on the quality of data collected and reported by the state registry. NAACCR has developed standards for data quality and format and works with other cancer organizations to align their various standards sets.
The Centers for Disease Control and Prevention (CDC) also has national standards regarding the completeness, timeliness, and quality of cancer registry data from state registries through the National Program of Cancer Registries (NPCR). The NPCR was developed as a result of the Cancer Registries Amendment Act of 1992. The CDC collects data from the NPCR state registries.
Education and Certification for Cancer Registrars Traditionally, cancer registrars have been trained through on-the-job training and professional workshops and seminars. The National Cancer Registrars Association (NCRA) has worked with colleges to develop formal educational programs for cancer registrars. A cancer registrar may become credentialed as a certified tumor registrar (CTR) by passing an examination provided by the National Board for Certification of Registrars (NBCR). Eligibility requirements for the certification examination include a combination of experience and education (NCRA 2018b).
Trauma registries maintain databases on patients with severe traumatic injuries. A traumatic injury is a wound or other injury caused by an external physical force such as a motor vehicle crash, a gunshot wound, a stabbing, or a fall. Information in the trauma registry may be used for performance improvement and research in the area of trauma care. Trauma registries may be facility based or may include data for a region or state.
Case Definition and Case Finding for Trauma Registries The case definition for the trauma registry varies but frequently involves inclusion of cases with diagnoses from the trauma diagnosis codes in the ICD-10-CM. To find cases with trauma diagnoses, the trauma registrar can access the disease indexes looking for cases with codes from this section of ICD-10-CM. In addition, the registrar may look at deaths in services with frequent trauma diagnoses—such as trauma, neurosurgery, orthopedics, and plastic surgery—to find additional cases.
Data Collection for Trauma Registries After the cases have been identified, information is abstracted from the health records of the injured patients and entered into the trauma registry database. The data elements collected in the abstracting process vary from registry to registry. Abstracting can be either the process of extracting information from a document to create a brief summary of a patient’s illness, treatment, and outcome, or extracting elements of data from a source document or database and entering them into an automated system. Data elements in the abstracting process include the following:
· Demographic information on the patient
· Information on the injury
· Care the patient received before hospitalization (such as care at another transferring hospital or care from an emergency medical technician who provided care at the scene of the crash or in transport from the crash site to the hospital)
· Status of the patient at the time of admission
· Patient’s course in the hospital
· Diagnosis and procedure codes
· Abbreviated Injury Scale
· Injury Severity Score
The Abbreviated Injury Scale (AIS) reflects the nature of the injury and its threat to life by each body system. It may be assigned manually by the registrar or generated as part of the database from data entered by the registrar. The Injury Severity Score (ISS) is an overall severity measurement calculated from the AIS scores for patients with multiple injuries (Agency for Clinical Innovation 2019).
Reporting and Follow-up for Trauma Registries Reporting varies among trauma registries. An annual report is often developed to show the activity of the trauma registry. Other reports may be generated as part of the performance improvement process, such as self-extubation (patients removing their own tubes) and delays in abdominal surgery or patient complications. Some hospitals report data to the National Trauma Data Bank (ACS 2019b).
Trauma registries may or may not follow up on the patients entered in the registry. When a follow-up is done, the emphasis is frequently on the patient’s quality of life after a period of time. Unlike cancer, where physician follow-up is crucial to detect recurrence, many traumatic injuries do not require continued patient care over time. Thus, follow-up is often not given the emphasis it receives in cancer registries.
Standards and Approval Process for Trauma Registries The ACS certifies levels I, II, III, IV, and V trauma centers. As part of its requirements, the ACS states that the level I trauma center must have a trauma registry (ACS 2019c). As part of its certification requirements, the ACS states that the level I trauma center, the type of center receiving the most serious cases and providing the highest level of trauma service, must have a trauma registry (ACS 2019c). See table 7.2 for a description of each trauma center level.
Table 7.2 Trauma center levels and definitions
Trauma center level Description
Level I Able to provide total care for every aspect of injury from prevention through rehabilitation
Level II Able to initiate definitive care for all injured patients
Level III Able to provide prompt assessment, resuscitation, surgery intensive care and stabilization of injured patients, and emergency operations
Level IV Able to provide advanced trauma life support (ATLS) prior to transfer of patients to a higher-level trauma center; provides evaluation, stabilization, and diagnostic capabilities for injured patients
Level V Able to provide initial evaluation, stabilization, and diagnostic capabilities, and prepares patients for transfer to higher levels of care
Source: ATS 2018.
Education and Certification of Trauma Registrars Trauma registrars may be registered health information technicians (RHITs), registered health information administrators (RHIAs), registered nurses (RNs), licensed practical nurses (LPNs), emergency medical technicians (EMTs), or other health professionals. Training for trauma registrars is through workshops and on-the-job training. The American Trauma Society (ATS) provides core and advanced workshops for trauma registrars and a certification examination for trauma registrars who meet its education and experience requirements through its Registrar Certification Board. Certified trauma registrars have earned the certified specialist in trauma registry (CSTR) credential.
Birth Defects Registries
Birth defects registries collect information on newborns with birth defects. Often population based, these registries serve a variety of purposes. For example, birth defects registries provide information on the incidence of birth defects to study causes and prevention; monitor trends in birth defects; improve medical care for children with birth defects; and target interventions for preventable birth defects.
Case Definition and Case Finding for Birth Defects Registries Birth defects registries use a variety of criteria to determine which cases to include in the registry. Some registries limit cases to those with defects found within the first year of life. Others include those children with a major defect that occurred in the first year of life and was discovered within the first five years of life. Still other registries include only children who were live born or stillborn babies with obvious birth defects.
Cases may be detected in a variety of ways, including review of disease indexes, labor and delivery logs, pathology and autopsy reports, ultrasound reports, and cytogenetic reports. In addition to information from hospitals and physicians, cases may be identified from rehabilitation centers and children’s hospitals and from vital records such as birth, death, and fetal death certificates.
Data Collection for Birth Defects Registries A variety of information is abstracted for the birth defects registry, including the following:
· Demographic information
· Codes for diagnoses
· Birth weight
· Status at birth, including live born, stillborn, aborted
· Cytogenetics results
· Whether the infant was a single birth or one in a multiple birth
· Mother’s use of alcohol, tobacco, or illicit drugs
· Father’s use of drugs and alcohol
· Family history of birth defects
Diabetes registries include cases of patients with diabetes for the purpose of assistance in managing care as well as for research. Patients whose diabetes is not kept under control frequently have numerous complications. The diabetes registry can keep up with whether the patient has been seen by a physician to prevent complications.
Case Definition and Case Finding for Diabetes Registries There are two types of diabetes mellitus: type 1 and type 2 diabetes. Registries sometimes limit their cases by type of diabetes. In some instances, there may be further definition by age. Some diabetes registries, for example, only include children with diabetes.
Case finding includes the review of health records of patients with diabetes. Other case-finding methods include review of the following:
· Diagnostic codes
· Billing data
· Medication lists
· Physician identification
· Health plans
Although facility-based registries for cancer and trauma are usually hospital based, facility-based diabetes registries are often found in physician offices or clinics. The office or clinic is the main location for diabetes care. Thus, data about the patient to be entered into the registry are available at these sites rather than at the hospital. The health records of diabetes patients treated in physician practices may be identified through diagnosis code numbers for diabetes, billing data for diabetes-related services, medication lists for patients on diabetic medications, or identification of patients as the physician treats them.
Health plans are interested in optimal care for their enrollees because diabetes can have serious complications when not managed correctly. The plans can provide information to the office or clinic on enrollees who are diabetics.
Data Collection for Diabetes Registries In addition to demographic information about the cases, other data collected may include laboratory values such as glycated hemoglobin, also known as HbA1c. This test is used to determine the patient’s blood glucose for a period of approximately 60 days prior to the time of the test. Moreover, facility registries may track patient visits to follow up with patients who have not been seen in the past year.
Reporting and Follow-up for Diabetes Registries A variety of reports can be developed from the diabetes registry. For facility-based registries, one report might keep up with laboratory monitoring of the patient’s diabetes to allow intensive intervention with patients whose diabetes is not well controlled. Another report might concern patients who have not been tested within a year or have not had a primary care provider visit within a year.
Population-based diabetes registries might provide reporting on the incidence of diabetes for the geographic area covered by the registry. Registry data also might be used to investigate risk factors for diabetes.
Follow-up is aimed primarily at ensuring that the patient with diabetes is seen by the physician at appropriate intervals to prevent complications.
An implant is a material or substance inserted into the body, such as breast implants, heart valves, and pacemakers. Implant registries have been developed for the purpose of tracking the performance of implants including complications, deaths, and defects resulting from implants, as well as implant longevity. In the recent past, the safety of implants has been questioned. For example, there have been questions about the safety of silicone breast implants and temporomandibular joint implants. When such cases arise, it has often been difficult to ensure all the patients with the implants have been notified of safety concerns. A number of federal laws have been enacted to regulate medical devices, including implants. These devices were first covered under Section 15 of the Food, Drug, and Cosmetic Act. The Safe Medical Devices Act of 1990 was passed (GPO 1990). It was amended through the Medical Device Amendments of 1992 (GPO 1992). These acts required a sample of healthcare organizations to report deaths and severe complications thought to be due to a device to the manufacturer and the Food and Drug Administration (FDA) through its MedWatch reporting system. The MedWatch reporting system alerts health professionals and the public of safety alerts and medical device recalls (FDA 2018). Implant registries may help ensure compliance with legal reporting requirements for device-related deaths and complications.
Case Definition and Case Finding for Implant Registries Implant registries sometimes include all types of implants but often are restricted to a specific type of implant. Examples of specific types of implants may be cochlear, silicone, or temporomandibular joint.
Data Collection for Implant Registries Demographic data on patients receiving implants are included in the registry. The FDA requires that all reportable events involving medical devices include the following information: “User facility report number; name and address of the device manufacturer; device brand name and common name; product model, catalog, serial, and lot numbers; brief description of the event reported to the manufacturer or the FDA; where the report was submitted (for example, to the FDA, manufacturer, or distributor)” (FDA 2018).
Thus, these data items should be included in the implant registry to facilitate reporting.
Transplant registries may have varied purposes. Some organ transplant registries maintain databases of patients who need organs. When an organ becomes available, allocation of the organ to the patient is based on a prioritization method. In other cases, the purpose of the registry is to provide a database of potential donors for transplants using live donors, such as bone marrow transplants. Post-transplant information also is kept on organ recipients and donors.
Because transplant registries are used to try to match donor organs with recipients, they are often national or even international in scope. Examples of national registries include the UNet of the United Network for Organ Sharing (UNOS) and the registry of the National Marrow Donor Program (NMDP).
Data collected in the transplant registry may be used for research, policy analysis, and quality control.
Case Definition and Case Finding for Transplant Registries A physician will identify patients needing transplants. Information about the patient is provided to the registry. When an organ becomes available, the patient’s information is matched with potential donors. For donor registries, donors are solicited through community information efforts similar to those carried out by blood banks to encourage blood donations.
Data Collection for Transplant Registries The type of information collected varies according to the type of registry. Pre-transplant data about the recipient include the following:
· Demographic data
· Patient’s diagnosis
· Patient’s status codes regarding medical urgency
· Patient’s functional status
· Whether the patient is on life support
· Previous transplantations