Secondary Records and Healthcare Databases

chapter 14
Secondary Records and Healthcare
Marcia Y. Sharp, EdD, RHIA
Learning Objectives
● Distinguish between primary and secondary data and
between patient-identifiable and aggregate data
● Identify the internal and external users of secondary data
● Compare the facility-specific indexes commonly found
in hospitals
● Describe the registries used in hospitals according to purpose, methods of case definition and case finding, data
collection methods, reporting and follow up, and pertinent laws and regulations affecting registry operations
● Define the terms pertinent to each type of secondary
record or database
● Discuss agencies for approval and education and certification for cancer, immunization, trauma, birth defects,
diabetes, implant, transplant, and immunization registries
● Distinguish among healthcare databases in terms of
purpose and content
● Compare manual and automated methods of data
collection and vendor systems with facility-specific
● Assess data quality issues in secondary records
● Recognize appropriate methods for ensuring data
security and the confidentiality of secondary records
● Discuss some of the other issues related to the
collection and maintenance of secondary data such as
transparency, ownership, and deidentification
● Identify the role of the health information management
professional in creating and maintaining secondary
Key Terms
Computer virus
Data confidentiality
Data dictionary
Data security
Demographic information
Disease index
Disease registry
Facility-based registry
Abbreviated Injury Scale (AIS)
Accession number
Accession registry
Activities of daily living (ADLs)
Agency for Healthcare Research and Quality (AHRQ)
Aggregate data
Autodialing system
Case definition
Case finding
Clinical trial
Collaborative Stage Data Set
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368 Chapter 14
Food and Drug Administration (FDA)
Health services research
Healthcare Cost and Utilization Project (HCUP)
Healthcare Integrity and Protection Data Bank
Injury Severity Score (ISS)
Interrater reliability
Master population/patient index (MPI)
Medical Literature, Analysis, and Retrieval System Online
Medicare Provider Analysis and Review (MEDPAR)
National Center for Health Statistics (NCHS)
National Health Care Survey
National Practitioner Data Bank (NPDB)
National Vaccine Advisory Committee (NVAC)
Operation index
Patient-identifiable data
Physician index
Population-based registry
Primary data source
Public health
Secondary data source
Staging system
Traumatic injury
Unified Medical Language System (UMLS)
Vital statistics
As a rich source of data about an individual patient, the health
record fulfills the uses of patient care and reimbursement for
individual encounters. However, it is not easy to see trends in
a population of patients by looking at individual records. For
this purpose, data must be extracted from individual records
and entered into specialized databases that support analysis across individual records. These data may be used in a
facility-specific or population-based registry for research and
improvement in patient care. In addition, they may be reported
to the state and become part of state- and federal-level databases that are used to set health policy and improve healthcare.
The health information management (HIM) professional can play a variety of roles in managing secondary
records and databases. He or she plays a key role in helping to set up databases. This task includes determining the
content of the database or registry and ensuring compliance
with the laws, regulations, and accrediting standards that
affect the content and use of the registry or database. All
data elements included in the database or registry must be
defined in a data dictionary. In this role, the HIM professional may oversee the completeness and accuracy of the
data abstracted for inclusion in the database or registry.
This chapter explains the difference between primary and
secondary data sources and their uses. It also offers an indepth look at various types of secondary databases, including indexes and registries, and their functions. Finally, the
chapter discusses how secondary databases are processed
and maintained.
Primary versus Secondary Data
Sources and Databases
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. Data taken from the primary health
record and entered into registries and databases are considered a secondary data source.
Data also are categorized as either patient-identifiable
data or aggregate data. The health record consists entirely
of patient-identifiable data. In other words, every fact
recorded in the 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, and maintained in
an identifiable form. Registries are an example of patientidentifiable data on groups of patients.
More often, however, secondary data are considered
aggregate data. Aggregate data include data on groups of
people or patients without identifying any particular 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
Secondary data sources consist of facility-specific indexes;
registries, either facility or population based; and other
healthcare databases. Healthcare organizations maintain
those indexes, registries, and databases that are relevant to
their specific operations. States as well as the federal government also maintain databases to assess the health and wellness of their populations.
Secondary data sources provide information that is not
easily available by looking at individual health records.
For example, if the HIM director doing a research study
wanted to find the health records of 25 patients who
had the principal diagnosis of myocardial infarction,
he or she would have to look at numerous individual
records to locate the number needed. This would be a
time-consuming and laborious project. With a diagnosis
index, the task would involve simply looking at the list of
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Secondary Records and Healthcare Databases 369
diagnoses in numerical order and selecting those with the
appropriate diagnosis code for myocardial infarction for
inclusion in the study.
Data extracted from health records and entered into
disease-oriented databases can, for example, help researchers
determine the effectiveness of alternate treatment methods.
They also can quickly demonstrate survival rates at different
stages of disease.
Internal users of secondary data are individuals located
within the healthcare facility. 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 in patient care, long-range planning, budgeting, and benchmarking with other facilities.
External users of patient data are individuals and institutions outside the facility. Examples of external users are state
data banks and federal agencies. States have laws that mandate cases of patients with diseases such as tuberculosis and
AIDS be reported to the state department of health. Moreover, the federal government collects data from the states on
vital events such as births and deaths.
The secondary data provided to external users is generally aggregate data and not patient-identifiable data. Thus,
these data can be used as needed without risking breaches of
Check Your Understanding 14.1
Instructions: Answer the following questions on a separate piece
of paper.
1. What is the difference between a primary data source and a
secondary data source?
2. What is the difference between patient-identifiable data and
aggregate data?
3. Why are secondary data sources developed?
4. What are the differences between internal users and external
users of secondary data sources?
Facility-Specific Indexes
The secondary data sources that have been in existence the
longest are the indexes that have been developed within
facilities to meet their individual needs. An index is simply
a report from a database that enables health records to be
located by diagnosis, procedure, or physician. Prior to extensive computerization in healthcare, these indexes were kept
on cards with handwritten data. They now are usually computerized reports available from data included in databases
routinely maintained in the healthcare facility. Most acutecare facilities maintain indexes described in the following
Master Population/Patient Index
The master population/patient index (MPI), which is
sometimes called the master person index, contains patientidentifiable data such as name, address, date of birth, dates
of hospitalizations or encounters, name of attending physician, and health record number. Because health records are
filed numerically in most facilities, the MPI is an important
source of patient health record numbers. These numbers
enable the facility to quickly retrieve health information for
specific patients.
Hospitals with a unit numbering system also depend on
the MPI to determine whether a patient has been seen in the
facility before and, therefore, has an existing medical record
number. Having this information in the MPI avoids issuance
of duplicate record numbers. Most of the information in
the MPI is entered into the facility database at the time of the
admission, preadmission, or registration process.
Disease and Operation Indexes
In an acute care setting, the disease index is a listing in diagnosis code number order for patients discharged from the
facility during a particular time period. Each patient’s diagnoses are converted from a verbal description to a numerical
code, usually using a coding system such as the International
Classification of Diseases (ICD). In most cases, patient diagnosis codes are entered into the facility health information
system as part of the discharge processing of the patient health
record. The index always includes the patient’s health record
number as well as the diagnosis codes so that records can be
retrieved by diagnosis. Because each patient is listed with the
health record number, the disease index is considered patientidentifiable data. The disease index also may include other
information such as the attending physician’s name or the date
of discharge. In nonacute settings, the disease index might be
generated to reflect patients currently receiving services in the
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 ICD or Current Procedural Terminology
(CPT) codes. 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.
In many cases, facilities no longer have an actual listing
for the diagnosis and operation indexes. Instead, they query
the health information system utilizing the ICD code for the
condition or operation needed.
Physician Index
The physician index is a listing of cases in order 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
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370 Chapter 14
index enables users to retrieve information about a particular physician, including the number of cases seen during a
particular time period. As with the disease and operation
indexes, facilities generally query the health information system (HIS) to obtain physician data.
Check Your Understanding 14.2
Instructions: Answer the following questions on a separate piece
of paper.
1. How do HIM departments use facility-specific indexes?
2. What is the purpose of the master population/patient index?
What types of information does it include?
3. What is the purpose of disease and operation indexes? What
types of information do they include?
4. What is the purpose of the physician index? What types of
information does it include?
Disease registries are collections of secondary data related
to patients with a specific diagnosis, condition, or procedure.
Registries are different from indexes in that they contain
more extensive data. Index reports can usually be produced
using data from the facility’s existing databases. Registries
often require more extensive data from the patient record.
Each registry must define the cases that are to be included
in it. This process is called case definition. In a trauma registry, for example, the case definition might be all patients
admitted with a diagnosis falling into ICD code numbers 800
through 959, the trauma diagnosis codes.
After the cases to be included have been determined
through the case definition process described earlier, the
next step in data acquisition is usually case finding. Case
finding includes the methods used to identify the patients
who have been seen and treated in the facility for the particular disease or condition of interest to the registry.
After cases have been identified, extensive information
is abstracted from the paper-based patient record into the
registry database or fed from other databases and entered
into the registry database.
The sole purpose of some registries is to collect data
from the patient health record and to make them available
to 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
might include rate and duration of survival and quality-oflife issues over time.
Cancer Registries
Cancer registries have a long history in healthcare. According to the National Cancer Registrars Association (NCRA),
the first hospital registry was founded in 1926, at Yale-New
Haven Hospital. It has long been recognized that aggregate
clinical information is needed to improve the diagnosis and
treatment of cancer. Cancer registries were developed as an
organized method to collect these data. The registry may be
a facility-based registry (located within a facility such as a
hospital or clinic) or a population-based registry (gathering
information from more than one facility within a geographic
area such as a state or region).
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.
In population-based registries, 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
● Demographic information about each case of cancer
● Information on the industrial or occupational history
of the individuals with the cancers (to the extent such
information is available from the same record)
● Administrative information, including date of diagnosis and source of information
● Pathological data characterizing the cancer, including site, stage of neoplasm, incidence, and type of
Case Definition and Case Finding in
the Cancer Registry
As defined previously, case definition is the process of
deciding what cases should be entered in the registry. In a
cancer registry, for example, all cancer cases except certain
skin cancers might meet the definition for the cases to be
included. Skin cancers such as basal cell carcinomas might
be excluded because they do not metastasize and do not
require the follow-up necessary for other cancers included
in the registry. Data on benign and borderline brain or central nervous system tumors also must be collected by the
National Program of Cancer Registries (CDC 2008a).
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 identify
cases of patients with cancer for inclusion in the registry. Another case-finding method is to use the facilityspecific disease indexes or the health information system
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
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Secondary Records and Healthcare Databases 371
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 population-based registry has
a responsibility to ensure that all cases of cancer in the target
area have been identified and reported to the central registry.
Data Collection for the Cancer Registry
Data collection methods vary between facility-based registries and population-based registries. When a case is first
entered in the registry, an accession number is assigned.
This number consists of the first digits of the year the
patient was first seen at the facility, with the remaining digits
assigned sequentially throughout the year. The first case in
2012, for example, might be 12-0001. The accession number may be assigned manually or by the automated cancer
database used by the organization. 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 monitor that all cases have been
entered into the registry.
In a facility-based registry, data are initially obtained
by reviewing and collecting them from the patient’s health
record. In addition to demographic information (such as
name, health record number, address), patient data in a cancer registry include
● 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. Historically, several different staging systems have been used. The American
Joint Committee on Cancer (AJCC) has worked, through its
Collaborative Stage Task Force, with other organizations
with staging systems to develop a standardized data set, the
Collaborative Stage Data Set, which uses computer algorithms to describe how far a cancer has spread (AJCC 2008).
After the initial information is collected at the patient’s
first encounter, information in the registry is updated periodically through the follow-up process discussed in the following section.
Frequently, the population-based registry only collects
information when the patient is diagnosed. Sometimes, however, it receives follow-up information from its reporting
entities. These entities usually submit the information to the
central registry electronically.
Reporting and Follow-up for Cancer
Registry Data
Formal reporting of cancer registry data is done through an
annual report. 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 facility as well as in research. Data on survival
rates by site of cancer and methods of treatment, for example, would be helpful in researching the most effective treatment for a type of cancer.
Another activity of the cancer registry is patient followup. On an annual basis, the registry attempts to obtain information about each patient in the registry, including whether
he or she is 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
facility’s patient health records may be checked for return
hospitalizations or visits for treatment. The patient’s physician also 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 address
and telephone number of the patient and other contacts. 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 and
online telephone books. The information obtained through
follow-up is important to allow the registry to develop statistics on survival rates for particular cancers and different
treatment methodologies.
Population-based registries do not always include followup information on the patients in their databases. They may,
however, receive the information from the reporting entities
such as hospitals, physician offices, and other organizations
providing follow-up care.
Standards and Approval Agencies
for Cancer Registries
Several organizations have developed standards or approval
processes for cancer programs. (See table 14.1.) The
American College of Surgeons (ACS) Commission on Cancer
has an approval process for cancer programs. One of the
Table 14.1. Standard-setting or approval agencies for
cancer registries
Agency Type of Registry
American College of Surgeons (ACS) Facility based
North American Association of
Central Cancer Registries (NAACCR)
Population based
Centers for Disease Control and
Population based
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372 Chapter 14
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 2008a). 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.
The 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 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 onthe-job training and professional workshops and seminars.
The NCRA has worked with colleges to develop formal educational programs for cancer registrars either through a certificate or an associate’s degree program. A cancer registrar
may become certified as a certified cancer 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 2008).
Trauma Registries
Trauma registries maintain databases on patients with
severe traumatic injuries. A traumatic injury is a wound
or another injury caused by an external physical force such
as an automobile accident, a shooting, a stabbing, or a fall.
Examples of such injuries would include fractures, burns,
and lacerations. Information collected by the trauma registry may be used for performance improvement and research
in the area of trauma care. Trauma registries are usually
facility based but may, in some cases, include data for a
region or state.
Case Definition and Case Finding
for Trauma Registries
The case definition for the trauma registry varies from registry to registry. To find cases with trauma diagnoses, the
trauma registrar may query the HIS system looking for cases
with codes in the trauma section of ICD. 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 but usually include
● 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 accident or in transport from the
accident site to the hospital)
● Status of the patient at the time of admission
● Patient’s course in the hospital
● ICD diagnosis and procedure codes
● Abbreviated Injury Scale (AIS)
● Injury Severity Score (ISS)
The Abbreviated Injury Scale (AIS) reflects the nature
of the injury and the severity (threat to life) by 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 the three most
severe injuries of the patient ( 2008).
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, a large database of aggregate data on
trauma cases (ACS 2008b). An example of the use of such
population data is the number of head injuries from motorcycle
accidents in a state to encourage passage of a helmet law.
Trauma registries may or may not do follow-up of the
patients entered in the registry. When follow-up is done,
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 Agencies for Approval
of Trauma Registries
The American College of Surgeons certifies levels I, II, III, and
IV trauma centers. 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 2008b).
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Secondary Records and Healthcare Databases 373
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
accomplished through workshops and on-the-job training.
The American Trauma Society (ATS), for example, provides
core and advanced workshops for trauma registrars. It also
provides a certification examination for trauma registrars
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, they provide information
on the incidence of birth defects to study causes and prevention of birth defects, to monitor trends in birth defects to
improve medical care for children with birth defects, and to
target interventions for preventable birth defects such as folic
acid to prevent neural tube defects.
In some cases, registries have been developed after
specific events have put a spotlight on birth defects. After
the initial Persian Gulf War, for example, some feared an
increased incidence of birth defects among the children
of Gulf War veterans. The Department of Defense subsequently started a birth defects registry to collect data on the
children of these veterans to determine whether any pattern
could be detected.
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 birth 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 liveborn or stillborn babies with discernible 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
● Demographics
● Codes for diagnoses
● Birth weight
● Status at birth, including liveborn, stillborn, aborted
● Autopsy
● Cytogenetics results
● Whether the infant was a single or 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
Diabetes registries collect data about patients with diabetes for the purpose of assistance in managing care as
well as for research. Patients whose diabetes is not kept
under good control frequently have numerous complications. The diabetes registry can keep up with whether the
patient has been seen by a physician in an effort to prevent
Case Definition and Case Finding
for Diabetes Registries
There are two types of diabetes mellitus: insulin-dependent
diabetes (type I) and non-insulin-dependent diabetes
(type II). 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
the reviews of the following types of information:
● ICD 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 maintained by physician offices and clinics because
they are the main location for diabetes care. Thus, the data
about the patient to be entered into the registry are available at these sites rather than at the hospital. Patient health
records of diabetes patients in the physician practice may
be identified through ICD code numbers for diabetes, billing data for diabetes-related services, medication lists for
patients on diabetic medications, or identification of patients
as the physician sees them.
Health plans also are interested in optimal care for their
enrollees because diabetes can have serious complications
when not managed correctly. They may provide information to the office or clinic on diabetic enrollees in the
health plan.
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374 Chapter 14
Data Collection for Diabetes Registries
In addition to demographic information about the cases,
other data collected may include laboratory values such as
HbA1c. This test is used to determine the patient’s blood
glucose level 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 may be developed from the diabetes
registry. For facility-based registries, one report may 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 be of patients who
have not been tested within a year or who 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 may be used to
investigate risk factors for diabetes.
Follow-up is aimed primarily at ensuring that the diabetic
is seen by the physician at appropriate intervals to prevent
Implant Registries
An implant is a material or substance inserted in 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
In the recent past, the safety of implants has been questioned in a number of highly publicized cases. In some cases,
implant registries have been developed in response to such
events. 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 that all patients with the implant 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 and then amended through the Medical Device
Amendments of 1992. These acts required facilities 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. Implant registries can help in complying with the
legal requirement for reporting for the sample of facilities
required to report.
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 such as
cochlear, saline breast, 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 information on the following (FDA 2008):
● User facility report number
● Name and address of the device manufacturer
● Device brand name and common name
● Product model, catalog, and serial and lot number
● Brief description of the event reported to the manufacturer or the FDA
Thus, these data items also should be included in the
implant registry to facilitate reporting.
Reporting and Follow-up for
Implant Registries
Data from the implant registry may be used to report to the
FDA and the manufacturer when devices cause death or serious illness or injury. Follow-up is important to track the performance of the implant. When patients are tracked through
the registry, they can be easily notified of product failures,
recalls, or upgrades.
Transplant Registries
Transplant registries may have varied purposes. Some organ
transplant registries maintain databases of patients who need
organs. When an organ becomes available, an equitable way
then may be used to allocate the organ to the patient with the
highest priority. 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. Posttransplant
information also is kept on organ recipients and donors.
Because transplant registries are used 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
Data collected in the transplant registry also may be used
for research, policy analysis, and quality control projects.
Case Definition and Case Finding for
Transplant Registries
Physicians identify patients needing transplants. Information
about the patient is provided to the registry. When an organ
becomes available, information about it is matched with
potential donors. For donor registries, donors are solicited
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Secondary Records and Healthcare Databases 375
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. Pretransplant data about the recipient include
● Demographics
● Patient’s diagnosis
● Patient’s status codes regarding medical urgency
● Patient’s functional status
● Whether the patient is on life support
● Previous transplantations
● Histocompatibility—“a state of immunologic similarity (or identity) that permits successful homograft
transplantation” (Stedman’s Online Dictionary)
Information on donors varies according to whether the
donor is living. For organs harvested from patients who have
died, information is collected on
● Cause and circumstances of the death
● Organ procurement and consent process
● Medications the donor was taking
● Other donor history
For a living donor, information includes
● Relationship of the donor to the recipient (if any)
● Clinical information
● Information on organ recovery
● Histocompatibility
Reporting and Follow-up for
Transplant Registries
Reporting includes information on donors and recipients as
well as survival rates, length of time on the waiting list for an
organ, and death rates. Follow-up information is collected for
recipients as well as living donors. For living donors, the information collected might include complications of the procedure
and length of stay (LOS) in the hospital. Follow-up information
about recipients includes information on status at the time of
follow-up (for example, living, dead, lost to follow-up), functional status, graft status, and treatment, such as immunosuppressive drugs. Follow-up is carried out at intervals throughout
the first year after the transplant and then annually after that.
Immunization Registries
Children are supposed to receive a large number of immunizations during the first six years of life. These immunizations
are so important that the federal government has set several objectives related to immunizations in Healthy People
2010, a set of health goals for the nation (HHS 2000). These
include increasing the proportion of children and adolescents
who are fully immunized (Objective 14-24) and increasing
the proportion of children in population-based immunization
registries (Objective 14-26).
Immunization registries usually have the purpose of
increasing the number of infants and children who receive
proper immunizations at the proper intervals. To accomplish
this goal, they collect information within a particular geographic area about children and their immunization status.
They also help by maintaining a central source of information for a particular child’s immunization history, even
when the child has received immunizations from a variety of
providers. This central location for immunization data also
relieves parents of the responsibility of maintaining immunization records for their own children.
Case Definition and Case Finding for
Immunization Registries
All children in the population area served by the registry
should be included in the registry. Some registries limit their
inclusion of patients to those seen at public clinics, excluding those seen exclusively by private practitioners. Although
children are usually targeted in immunization registries,
some registries do include information on adults for influenza and pneumonia vaccines.
Children are often entered in the registry at birth. Registry
personnel may review birth and death certificates and adoption records to determine what children to include and what
children to exclude because they died after birth. In some
cases, children are entered electronically through a connection with an electronic birth record system. Accuracy and
completeness of the data in the registry are dependent on the
thoroughness of the submitters in reporting immunizations.
Data Collection for Immunization
The National Immunization Program at the CDC has worked
with the National Vaccine Advisory Committee (NVAC)
to develop a set of core immunization data elements to be
included in all immunization registries. The data elements
are divided into required and optional. The required data elements include (CDC 2008b)
● Patient’s name (first, middle, and last)
● Patient’s birth date
● Patient’s sex
● Patient’s birth state and country
● Mother’s name (first, middle, last, and maiden)
● Vaccine type
● Vaccine manufacturer
● Vaccination date
● Vaccine lot number
Other optional items may be included, as needed, by the
individual registry.
Reporting and Follow-up for
Immunization Registries
Because the purpose of the immunization registry is to
increase the number of children who receive immunizations
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376 Chapter 14
in a timely manner, reporting should emphasize immunization rates, especially changes in rates in target areas. Immunization registries also can provide automatic reporting of
children’s immunization to schools to check the immunization status of their students.
Follow-up is directed toward reminding parents that it is
time for immunizations as well as seeing whether the parents do not bring the child in for the immunization after
a reminder. Reminders may include a letter or postcard or
telephone calls. Autodialing systems may be used to call
parents and deliver a prerecorded reminder. Moreover,
registries must decide how frequently to follow up with
parents who do not bring their children for immunization.
Maintaining up-to-date addresses and telephone numbers is
an important factor in providing follow-up. Registries may
allow parents to opt out of the registry if they prefer not to
be reminded.
Standards and Agencies for Approval
of Immunization Registries
The CDC, through its National Immunization Program,
provides funding for some population-based immunization
registries. The CDC has identified 12 minimum functional
standards for population-based immunization registries
(CDC 2008b), including the following:
● Electronically store data on all NVAC-approved core
data elements
● Establish a registry record within six weeks of birth for
each newborn child born in the catchment area
● Enable access to and retrieval of immunization information in the registry at the time of the encounter
● Receive and process immunization information within
one month of vaccine administration
● Protect the confidentiality of healthcare information
● Ensure the security of healthcare information
● Exchange immunization records using Health Level
Seven (HL7) standards
● Automatically determine the routine childhood
immunization(s) needed, in compliance with current Advisory Committee on Immunization Practices
(ACIP) recommendations, when an individual presents
for a scheduled immunization
● Automatically identify individuals due or late for an
immunization(s) to enable the production of reminder
or recall notifications
● Automatically produce immunization coverage reports
by providers, age groups, and geographic areas
● Produce official immunization records
● Promote the accuracy and completeness of registry
The CDC provides funding for population-based immunization registries.
Other Registries
Registries may be developed for any type of disease or condition. Examples of other types of registries that are commonly kept include HIV/AIDS and cardiac registries.
In 2007 the state of Nebraska initiated a partnership
within the state called the Nebraska Registry Partnership
(NRP) to introduce, sustain, and gradually expand a registry
for chronic disease management for cardiovascular diseases
and diabetes care improvement for patients seen in rural
health clinics.
In addition, the American Gastroenterological Association (AGA) sponsors the AGA Registry. The AGA Registry is
the only gastroenterology registry sponsored by the Centers
for Medicare and Medicaid Services (CMS), enabling practices to directly submit data for the CMS Physician Quality
Reporting System (AGA 2011). It is a national outcomesdriven registry that allows clinicians to monitor and improve
patient care while generating data to compare the efficacy of
A new registry used to track cases of sudden unexpected
infant deaths (SUIDs) is being piloted in five states (Georgia,
Colorado, Michigan, New Jersey, and New Mexico) over a
three-year period, and it represents a collaboration between
the Centers for Disease Control and Prevention and the
National Center for Child Death Review. The SUID Registry, now in the third year (2012), aims to improve knowledge
of factors surrounding SUID events, create prevention strategies and interventions, and ultimately reduce SUIDs and
injury-related infant deaths (Shapiro-Mendoza et al. 2012).
Registries may be developed for administrative purposes also. The National Provider Identifier (NPI) Registry
is an example of an administrative registry. The NPI Registry enables users to search for a provider’s national plan
and provider enumeration system information, including the
national provider identification number. The NPI number is a
10-digit unique identification number assigned to healthcare
providers in the United States. There is no charge to use the
registry, and it is updated daily. Data collected for healthcare
administrative purposes are discussed in the next subsection.
Check Your Understanding 14.3
Instructions: Answer the following questions on a separate piece
of paper.
1. What is a registry? What is the purpose of a registry?
2. How is case definition different from case finding?
3. What is the difference between a facility-based registry and
a population-based registry?
Answer questions 4 through 10 for each of the following registries:
cancer, trauma, birth defects, diabetes, implant, transplant, and
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Secondary Records and Healthcare Databases 377
4. What methods are used for case definition and case finding?
5. What methods of data collection are used?
6. What methods of reporting are used?
7. What methods of follow-up are used?
8. What standards are applicable, and what agencies approve or
accredit the registry?
9. What education is required for registrars?
10. What certification is available for registrars? What
agency/organization provides certification? What are the
certification requirements?
Healthcare Databases
Databases may be developed for a variety of purposes.
The federal government, for example, has developed a
wide variety of databases to enable it to carry out surveillance, improvement, and prevention duties. Health information managers may provide information for these databases
through data abstraction or from data reported by a facility
to state and local entities. They also may use these data to do
research or work with other researchers on issues related to
reimbursement and health status.
There are concerns about collecting healthcare data in an
environment without clear guidance about ownership of secondary data, unauthorized reuse of data, and spotty confidentiality and security regulations. Patients have concerns that
secondary data collected about them may adversely affect
their employment or ability to obtain health insurance. It is
much more difficult for patients to determine what information about them is maintained in secondary databases than
it is to view their primary health records. Although facilities
utilize secondary data under the “healthcare operations” section of the Health Insurance Portability and Accountability
Act (HIPAA), patients must be made aware of this practice
through the Notification of Privacy Practices. Also, not all secondary data are protected under HIPAA.
National and State Administrative
Some databases are established for administrative rather
than disease-oriented reasons. Data banks are developed,
for example, for claims data submitted on Medicare claims.
Other administrative databases assist in the credentialing
and privileging of health practitioners.
Medicare Provider Analysis
and Review File
The Medicare Provider Analysis and Review (MEDPAR)
file is made up of acute-care hospital and skilled nursing
facility (SNF) claims data for all Medicare claims. It consists
of the following types of data:
● Demographic data on the patient
● Data on the provider
● Information on Medicare coverage for the claim
● Total charges
● Charges broken down by specific types of services,
such as operating room, physical therapy, and pharmacy charges
● ICD-9-CM diagnosis and procedure codes
● DRGs
The MEDPAR file is frequently used for research on topics such as charges for particular types of care and analysis
by DRG. The limitation of the MEDPAR data for research
purposes is that it only contains data about Medicare patients.
National Practitioner Data Bank
The National Practitioner Data Bank (NPDB) was mandated under the Health Care Quality Improvement Act of
1986 to provide a database of medical malpractice payments;
adverse licensure actions including revocations, suspensions,
reprimands, censures, probations, and surrenders of licenses
for quality-of-care purposes only; and certain professional
review actions (such as denial of medical staff privileges)
taken by healthcare entities such as hospitals against physicians, dentists, and other healthcare providers (NPDB 2006).
The NPDB was developed to address the lack of information
on malpractice decisions, denial of medical staff privileges, or
loss of medical license. Because these data were not widely
available, physicians could move to another state or another
facility and begin practicing again with the current state or
facility unaware of the previous actions against the physician.
Information in the NPDB is provided through a required
reporting mechanism. Entities making malpractice payments, including insurance companies, boards of medical
examiners, and entities such as hospitals and professional
societies, must report to the NPDB. The information to be
reported includes information on the practitioner, the reporting entity, and the judgment or settlement. Information on
physicians must be reported. A recent change to the law now
requires entities such as private accrediting organizations
and peer review organizations to report adverse actions to the
data bank. In addition, adverse licensure and other actions
against any healthcare entity must be reported, not just physicians and dentists. Monetary penalties may be assessed for
failure to report.
The law requires healthcare facilities to query the NPDB
as part of the credentialing process when a physician initially applies for medical staff privileges and every two years
Healthcare Integrity and Protection
Data Bank
Part of HIPAA of 1996 mandated the collection of information on healthcare fraud and abuse because there was
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378 Chapter 14
no central place to obtain this information. As a result, the
national Healthcare Integrity and Protection Data Bank
(HIPDB) was developed. The types of items that must be
reported to the data bank include reportable final adverse
actions such as (HHS 2008)
● Federal or state licensing and certification actions,
including revocations, reprimands, censures, probations, suspensions, and any other loss of license, or
the right to apply for or renew a license, whether by
voluntary surrender, nonrenewability, or otherwise
● Exclusions from participation in federal or state healthcare programs
● Any other adjudicated actions or decisions defined in
the HIPDB regulations
There may be some overlap with the National Practitioner
Data Bank, so a single report is made and then sorted to the
appropriate data bank. Information to be reported includes
information on the healthcare provider, supplier, or practitioner that is the subject of the final adverse action, the nature
of the act, and a description of the actions on which the decision was based. Only federal and state government agencies
and health plans are required to report, and access to the
data bank is limited to these organizations and to practitioners, providers, and suppliers, who may only query about
State Administrative Data Banks
States also frequently have health-related administrative
databases. Many states, for example, collect either Uniform
Hospital Discharge Data Set (UHDDS) or UB-04 data on
patients discharged from hospitals located within their area.
The Statewide Planning and Research Cooperative System
(SPARCS) in New York is an example of this type of administrative database. It combines UB-04 data with data required
by the state of New York.
National, State, and County
Public Health Databases
Public health is the area of healthcare dealing with the health
of populations in geographic areas such as states or counties. Publicly reported healthcare data vary from quality and
patient safety measurement data to patient satisfaction results.
The aggregated data range from a local to national perspective, such as state-specific public health conditions to national
morbidity and mortality statistics. In addition, consumers are
becoming more actively involved in their healthcare. Publicly
reported data may be presented for consumer use through various star ratings on different quality measures via organizations
such as the Leapfrog Group, HealthGrades, or Hospital Compare. One of the duties of public health agencies is the surveillance of health status within their jurisdiction.
Databases developed by public health departments provide information on the incidence and prevalence of diseases,
possible high-risk populations, survival statistics, and trends
over time. Data for these databases may be collected using a
variety of methods including interviews, physical examination
of individuals, and review of health records. At the national
level, the National Center for Health Statistics (NCHS) has
responsibility for these databases.
National Health Care Survey
One of the major national public health surveys is the
National Health Care Survey. To a large extent, it relies on
data from patient health records. It consists of a number of
databases, including
● National Hospital Discharge Survey
● National Ambulatory Medical Care Survey
● National Survey of Ambulatory Surgery
● National Nursing Home Survey
● National Home and Hospice Care Survey
Table 14.2 lists the component databases of the National
Health Care Survey, along with their corresponding data
Data in the National Hospital Discharge Survey are
abstracted manually from a sample of acute-care hospitals
or from discharged inpatient records or are obtained from
state or other discharge databases. Items collected follow
UHDDS, including demographic data, admission and discharge dates, and final diagnoses and procedures.
The National Ambulatory Medical Care Survey includes
data collected by a sample of office-based physicians and
their staffs from the records of patients seen in a one-week
reporting period. Data included are demographic data, the
patient’s reason for visit, the diagnoses, diagnostic and
screening services, therapeutic and preventive services,
ambulatory surgical procedures, and medications and injections, in addition to information on the visit disposition and
time spent with the physician.
Data for the National Survey of Ambulatory Surgery
are collected on a representative sample of hospital-based
and freestanding ambulatory surgery centers. Data include
patient demographic characteristics; source of payment;
information on anesthesia given; the diagnoses; and the
surgical and nonsurgical procedures on patient visits to
hospital-based and freestanding ambulatory surgery centers.
The survey consists of a mailed survey about the facility and
abstracts of patient data.
The National Nursing Home Survey provides data on the
facility, current residents, and discharged residents. Information is gathered through an interview process. The administrator or designee provides information about the facility.
For information on the residents, the nursing staff member
most familiar with the resident’s care is interviewed. The
staff member uses the resident’s health record for reference
in the interview. Data collected on the facility include information on ownership, size, certification status, admissions,
services, full-time equivalent employees, and basic charges.
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Secondary Records and Healthcare Databases 379
Both the current and discharged resident interviews provide
demographic information on the resident as well as LOS,
diagnoses, level of care received, activities of daily living
(ADLs), and charges.
For the National Home and Hospice Care Survey, data are
collected on the home health or hospice agency as well as
on its current and discharged patients. Data include referral
and length of service, diagnoses, number of visits, patient
charges, health status, reason for discharge, and types of
services provided. Facility data are obtained through an
interview with the administrator or designee. Patient information is obtained from the caregiver most familiar with the
patient’s care. The caregiver may use the patient’s health
record in answering the interview questions.
Because of the bioterrorism scares in recent years,
the CDC is developing the National Electronic Disease
Surveillance System (NEDSS), which serves as a major part
of the Public Health Information Network (PHIN). It will
provide a national surveillance system by connecting the
CDC with local and state public health partners. This integrated system will allow the CDC to monitor trends from
disease reporting at the local and state level to look for possible bioterrorism incidents.
The National Center for Health Statistics, Centers for
Disease Control announced plans to conduct a new survey beginning in 2013, the National Hospital Care Survey
(NHCS). This survey combines the National Hospital Discharge Survey (NHDS) and the National Hospital Ambulatory Medical Care Survey (NHAMCS). The newly formed
initiative aims to request data on the utilization of healthcare
provided in emergency departments, outpatient departments,
and ambulatory surgery centers, thus integrating the NHDS
Table 14.2. Components of the National Health Care Survey
Type of
Setting Content Data Source
Method of
Data Collection
National Hospital
Discharge Survey
Note: this survey
ended in 2010. See
note 1 below
Uniform Hospital
Discharge Data Set
Discharged patient
National Ambulatory
Medical Care Survey
Data on the patient
and the visit
State discharge
Office-based physician
National Survey of
Ambulatory Surgery
and freestanding
surgery centers
Data on the facility
and patients
Facility response to
survey and patient
Survey and
National Nursing
Home Survey
Nursing home Data on the facility
and current and
discharged residents
Nurse caregiver
National Home and
Hospice Care Survey
Home health
and hospice
Facility data and
patient data
National Electronic
Disease Surveillance
System (NEDSS)
Public health
Local and state public
health departments
National Hospital Care
Survey (NHCS)
Note: Will replace
NHDS beginning
2013. See note 2 below
surgery centers
Uniform Hospital
Discharge Data
Set and data on the
patient and the visit
Discharged patient
The National Hospital Discharge Survey (NHDS) was conducted annually from 1965 to 2010. The NHDS is
being transitioned to the National Hospital Care Survey, and data collection began in 2011 with inpatient data
from 500 hospitals. Other care areas will be added in 2013.
Data collection began in 2011 with inpatient data from 500 hospitals. Expansion will occur in 2013.
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380 Chapter 14
and NHAMCS into NHCS. NHCS will replace NHDS and
NHAMCS but continue to provide nationally representative data on utilization of hospital care and general purpose
healthcare statistics on inpatient care as well as care delivered in emergency departments, outpatient departments, and
ambulatory surgery centers.
Other national public health databases include the National
Health Interview Survey, which is used to monitor the health
status of the population of the United States, and the National
Immunization Survey, which collects data on the immunization status of children between the ages of 19 months and 35
months living in the United States.
State and local public health departments also develop
databases as needed to perform their duties of health surveillance, disease prevention, and research. An example of
a state database is the infectious and notifiable disease database. Each state has a list of diseases that must be reported
to the state, such as AIDS, measles, and syphilis, so that
containment and prevention measures may be taken to avoid
large outbreaks. As mentioned before, these state and local
reporting systems will be connected with the CDC through
NEDSS to evaluate trends in disease outbreaks. Statewide
databases and registries also may collect extensive information on particular diseases and conditions such as birth
defects, immunization, and cancer.
Vital Statistics
Vital statistics include data on births, deaths, fetal deaths,
marriages, and divorces. Responsibility for the collection of
vital statistics rests with the states. The states share information with NCHS. The actual collection of the information
is carried out at the local level. For example, birth certificates are completed at the facility where the birth occurred.
They are then sent to the state. The state serves as the official repository for the certificates and provides vital statistics information to NCHS. From the vital statistics collected,
states and the national government develop a variety of databases and statistics about vital events in the state or country.
One vital statistics database at the national level is the
Linked Birth and Infant Death Data Set. In this database,
the information from birth certificates is compared to death
certificates for infants who die under one year of age. This
database provides data to conduct analyses for patterns of
infant death. Other national programs that use vital statistics
data include the National Mortality Followback Survey, the
National Survey of Family Growth, and the National Death
Index (CDC 2008c). In some of these databases, such as the
National Mortality Followback Survey, additional information is collected on deaths originally identified through the
vital statistics system.
Similar databases using vital statistics data as a basis are
found at the state level. Birth defects registries, for example,
frequently use vital records data with information on the
birth defect as part of their data collection process.
Clinical Trials Databases
A clinical trial is a research project in which new treatments and tests are investigated to determine whether they
are safe and effective. The trial proceeds according to a
protocol, which is the list of rules and procedures to be
followed. Clinical trials databases have been developed to
allow physicians and patients to find clinical trials. A patient
with cancer or AIDS, for example, might be interested in
participating in a clinical trial but not know how to locate
one applicable to his or her type of disease. Clinical trials
databases provide the data to enable patients and practitioners to determine what clinical trials are available and applicable to the patient.
The Food and Drug Administration Modernization Act
of 1997 mandated that a clinical trials database be developed. The National Library of Medicine has developed the
database, called, which is available on
the Internet for use by both patients and practitioners (NLM
2008). Information in the database includes the following:
● Abstracts of clinical study protocols
● Summary of the purpose of the study
● Recruiting status
● Criteria for patient participation
● Location of the trial and specific contact information
● Additional information (may help a patient decide
whether to consider a particular trial)
● Research study design
● Phase of the trial
● Disease or condition and drug or therapy under study
Each data element has been defined. For example, the
brief summary gives an overview of the treatments being
studied and types of patients to be included. The location
of the trial tells where the trial is being carried out so that
patients can select trials in convenient locations. Recruitment
status indicates whether subjects are currently being entered
in the trial or will be in the future or whether the trial is
closed to new subjects. Eligibility criteria include information on the type of condition to be studied, in some cases the
stage of the disease, and what other treatments are allowed
during the trial or must have been completed before entering the trial. Age is also a frequent eligibility criterion. Study
types include diagnostic, genetic, monitoring, natural history,
prevention, screening, supportive care, training, and treatment (McCray and Ide 2000, 316). Study design includes the
research design being followed.
A clinical trial consists of four study phases. Phase I studies research the safety of the treatment in a small group of
people. In phase II studies, emphasis is on determining the
treatment’s effectiveness and further investigating safety.
Phase III studies look at effectiveness and side effects and
make comparisons to other available treatments in larger
populations. Phase IV studies look at the treatment after it
has entered the market.
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Secondary Records and Healthcare Databases 381
Some clinical trials databases concentrate on a particular
disease. The Department of Health and Human Services, for
example, has developed the AIDS Clinical Trials Information Service (ACTIS). The National Cancer Institute sponsors the Physician Data Query (PDQ), a database for cancer
clinical trials. These databases contain information similar
to Although has been
set up for use by both patients and health practitioners, some
databases are more oriented to practitioners. Clinical trials
are discussed in chapter 21.
Health Services Research Databases
Health services research is research concerning healthcare
delivery systems, including organization and delivery and care
effectiveness and efficiency. Within the federal government,
the organization most involved in health services research is
the Agency for Healthcare Research and Quality (AHRQ).
AHRQ looks at issues related to the efficiency and effectiveness of the healthcare delivery system, disease protocols, and
guidelines for improved disease outcomes. AHRQ also provides access to different types of data that are primarily used
for quality and utilization management purposes.
A major initiative for AHRQ has been the Healthcare
Cost and Utilization Project (HCUP). HCUP uses data
collected at the state level from either claims data from the
UB-04 or discharge-abstracted data, including UHDDS items
reported by individual hospitals and, in some cases, by freestanding ambulatory care centers. Which data are reported
depends on the individual state. Data may be reported by the
facilities to a state agency or to the state hospital association,
depending on state regulations. The data are then reported
from the state to AHRQ, where they become part of the
HCUP databases.
HCUP consists of the following set of databases:
● Nationwide Inpatient Sample (NIS) consists of
inpatient discharge data from a sample of hospitals in
35 states throughout the United States
● State Inpatient Database (SID) includes data collected
by states on hospital discharges
● State Ambulatory Surgery Databases (SASD) include
information from a sample of states on hospitalaffiliated ASCs and, from some states, data from
freestanding surgery centers
● State Emergency Department Databases include data
from hospital-affiliated emergency departments (EDs)
● Abstracts for visits that do not result in a hospitalization
● Kids Inpatient Database (KID) is made up of inpatient
discharge data on children younger than 19 years old
These databases are unique because they include data
on inpatients whose care is paid for by all types of payers
including Medicare, Medicaid, and private insurance as well
as by self-paying and uninsured patients. Data elements
include demographic information, information on diagnoses
and procedures, admission and discharge status, payment
sources, total charges, LOS, and information on the hospital
or freestanding ambulatory surgery center. Researchers may
use these databases to look at issues such as those related to
the costs of treating particular diseases, the extent to which
treatments are used, and differences in outcomes and cost for
alternative treatments.
National Library of Medicine
The National Library of Medicine produces two databases
of special interest to the HIM professional: MEDLINE and
Medical Literature, Analysis,
and Retrieval System Online
Medical Literature, Analysis, and Retrieval System Online
(MEDLINE) is the best-known database from the National
Library of Medicine. It includes bibliographic listings for publications in the areas of medicine, dentistry, nursing, pharmacy,
allied health, and veterinary medicine. HIM professionals use
MEDLINE to locate articles on HIM issues as well as articles
on medical topics necessary to carry out quality improvement
and medical research activities.
Unified Medical Language System
The Unified Medical Language System (UMLS) provides
a way to integrate biomedical concepts from a variety of
sources to show their relationships. This process allows
links to be made between different information systems
for purposes such as the electronic health record. UMLS
is of particular interest to the HIM professional because
medical classifications such as ICD-9-CM, CPT, and the
Healthcare Common Procedure Coding System (HCPCS)
are among the items included. UMLS is covered extensively in chapter 15.
Health Information Exchange
Health information exchange (HIE) initiatives have been
developed in an effort to move toward a longitudinal patient
record with complete information about the patient available
at any point of care. The data from an HIE are patient specific rather than aggregate and are used primarily for patient
care. Some researchers have looked at the amount of data
available through the health information exchanges as a possible source of data to aggregate for research. Since HIE is
a fairly new concept, it is important that HIEs take the time
to develop policies and procedures covering the use of data
collected for patient care for other purposes. Special attention needs to be paid to whether patients included in the HIE
need to provide individual consent to be included when the
data are aggregated for research or other purposes. Aggregated data can be deidentified to add another layer of protection for the patient’s identity. A full discussion of HIE is
included in chapter 9.
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382 Chapter 14
Data for Performance Measurement
The Joint Commission, CMS, and some health plans are
requiring healthcare facilities to collect data on core performance measures. These measures are “quantitative tools
used to assess the clinical, financial, and utilization aspects
of a healthcare provider’s outcomes of processes” (AHIMA
2010). As such, they are secondary data. Facilities must determine how to collect these measures and how to aggregate the
data for reporting purposes. Such measures may be used in
the future as a basis for pay for performance. It is, therefore,
extremely important that the data accurately reflect the quality
of care provided in the facility.
Check Your Understanding 14.4
Instructions: Answer the following questions on a separate piece
of paper.
1. What information is included in the Medicare Provider
Analysis and Review file?
2. What limitations are encountered when using MEDPAR data
in research?
3. Why was the National Practitioner Data Bank developed? What
law requires its use? Why was the Healthcare Integrity and
Protection Data Bank developed? What law requires its use?
4. What types of information must be reported to the National
Practitioner Data Bank and the Healthcare Integrity and
Protection Data Bank? Do the two data banks overlap in any
5. How do healthcare organizations use the National
Practitioner Data Bank? Who may use the HIPDB?
6. How can the health information manager contribute to public
health databases?
7. Which of the five National Health Care Survey databases use
data from health records?
8. What is a clinical trial? Why are clinical trials databases
developed? Which law mandated development of a national
clinical trials database?
9. What is the source of data for the Healthcare Cost and
Utilization Project?
10. Why is UMLS of interest to HIM professionals?
11. Why have health information exchange efforts been
12. What type of data is included in HIEs?
Processing and Maintenance
of Secondary Databases
Several issues surround the processing and maintenance of
secondary databases. HIM professionals are often involved
in decisions concerning these issues.
Manual versus Automated Methods
of Data Collection
Although registries and databases are almost universally computerized, data collection is commonly done manually. The
most frequent method is abstracting. Abstracting is the process
of reviewing the patient health record and entering the required
data elements into the database. In some cases, the abstracting
may initially be done on an abstract form. The data then would
be entered into the database from the form. In many cases, it is
done directly from the primary patient health record into a data
collection screen in the computerized database system.
Not all data collection is done manually. In some cases,
data can be downloaded directly from other electronic systems.
Birth defects registries, for example, often download information on births and birth defects from the vital records system.
In some cases, providers such as hospitals and physicians send
information in electronic format to the registry or database.
The National Discharge Survey from the National Center for
Health Statistics uses information in electronic format from
state databases. As the electronic health record (EHR) develops
further, less and less data will need to be manually abstracted
since it will be available electronically through the EHR.
Vendor Systems versus Facility-Specific
Each registry must determine what information technology
solution best meets its needs. In some cases that will be a
vendor-created product specifically for registries. In other
cases, the registry system may be part of an overall facility
health information system. It is important that either type of
product is able to incorporate demographic and other pertinent information from the facility health information system.
In this way, time is saved and data integrity between the registry information and the health information system is maintained. If registries utilize registry applications as part of a
facility-wide health information system, it is important that
the registry manager be included in the decision of which
health information system to purchase for the facility as well
as in pertinent training and implementation decisions.
Data Quality Issues
Indexes, registries, and databases are only helpful when the
data they contain are accurate. Decisions concerning new
treatment methods, healthcare policy, and physician credentialing and privileging are made based on these databases.
Incorrect data will likely result in serious errors in decision
making. Several factors must be addressed when assessing
data quality, including data validity, reliability, completeness, and timeliness.
Validity of the Data
Validity refers to the accuracy of the data. For example, in a
cancer registry, the stage of the neoplasm must be recorded
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Secondary Records and Healthcare Databases 383
accurately because statistical information on survival rates
by stage is commonly reported.
Several methods may be used to ensure validity. One
method is to incorporate edits in the database. An edit is a
check on the accuracy of the data, such as setting data types.
When a particular data element, such as admission date, is set
up with a data type of date, the computer will not allow other
types of data, such as name, to be entered in that field. Other
edits may use comparisons between fields to ensure accuracy. For example, an edit might check to see that all patients
with the diagnosis of prostate cancer are listed as males in the
Reliability of the Data
Another factor to be considered in looking at data quality is reliability. Reliability refers to the consistency of the
data. For example, all patients in a trauma registry with the
same level, severity, and site of injury should have the same
Abbreviated Injury Scale. Reliability is frequently checked
by having more than one person abstract data for the same
case. The results are then compared to identify any discrepancies. This is called an interrater reliability method of
checking. Several different people may be used to do the
checking. In the cancer registry, physician members of the
cancer committee are called on to check the reliability of
the data.
The use of uniform terminology is an important way to
improve data reliability. This has been evident in case definition for registries. The criteria for including a patient in a
registry must have a clear definition. Definitions for terms
such as race, for example, must include the categories to be
used in determining race. When uniform terms are not used,
the data will not be consistent. Also, it will be impossible
to make comparisons between systems when uniform terms
have not been used for all data. A data dictionary in which
all data elements are defined helps ensure that uniform data
definitions are being followed. An example would be the
term discharge time. Discharge time could be the time the
physician writes the discharge order, the time the information about the discharge is entered into the admission, discharge, transfer (ADT) system, or the time the patient leaves
the floor. The data dictionary could define it as the time the
information is entered in the ADT system, and then everyone
recording discharge time would be using the same time reference for that data element.
Completeness of the Data
Completeness is another factor to be considered in data quality. Missing data may prevent the database from being useful
for research or clinical decision making. To avoid missing
data, some databases will not allow the user to move to the
next field without making an entry in the current one, especially for fields considered crucial. Looking at a variety of
sources in case finding is a way to avoid omitting patients who
should be included in a registry.
Timeliness of the Data
Another concept important in data quality is timeliness. Data
must be available within a time frame helpful to the user.
Factors that influence decisions may change over time, so it
is important that the data reflect up-to-date information.
Data Security and Confidentiality Issues
Data security usually refers to the tools, including technological safeguards, used to ensure confidentiality of personal
health information. Data confidentiality usually refers to an
individual’s right to information privacy and is accomplished
through well-managed administrative privacy policies and
practices and technology tools.
HIPAA-Covered Entities
When looking at data security and confidentiality issues,
it is important to consider the HIPAA regulations for privacy and security. For HIPAA-covered entities, the data
collection done by registries is considered part of “healthcare operations.” The patient does not, therefore, have
to sign an authorization for release of protected health
information (PHI) to be included in the registry. Reporting
of notifiable diseases to the state comes under “required
reporting” and does not require patient authorization for
release (Handling Cancer Registry Requests 2003, 7).
Release of information to requestors other than the state
will depend on the requestor. Data may be released to
internal users, such as physicians for research, without the
patient’s consent as well because research also comes under
healthcare operations. External users, such as the American
College of Surgeons, collect aggregate data from facilities,
so individual patient authorization is not required. Information about patients that may be included in registries or
other secondary data sources and reported to outside entities must be included in the facility’s Notice of Privacy
Practices given to each patient on his or her initial encounter. Through this mechanism, patients are made aware that
data about them may be reported to outside entities.
HIPAA security regulations also apply to data in registries
and indexes. These regulations require policies in the areas
of administrative, technical, and physical security, which are
discussed here. (See chapter 12 for further discussion of privacy, security, and confidentiality.)
Entities Not Covered by HIPAA
Not all registries and databases are covered under HIPAA
if they do not bill for patient care services. Central registries
would be an example of a registry that is not covered under
HIPAA. In such cases, the general norms for data security and
confidentiality should be followed.
Data Security
Registries and secondary databases must ensure the security of the information that they maintain. A number of
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384 Chapter 14
methods such as passwords and role-based access may be
used to ensure that only authorized people have access
to patient data in the facility’s computer system. Loss of
data is another important consideration in data security
that could severely affect registries and secondary data
sources. Although data sometimes are lost as a result of
unauthorized access, more often they are lost in more
routine ways such as computer malfunction or computer
viruses that can cause data to be erased or lost.
Physical security of the system is a consideration that is
required under the HIPAA security regulations. Computer
terminals must be kept in areas that are not physically accessible to unauthorized people. Reports and printouts from the
system should not be left where they can be seen. When they
are no longer needed, they should be destroyed.
Technical security under HIPAA involves issues such as
whether sensitive data need to be encrypted. Encryption
is a method of scrambling data so that they cannot be read
without first being decoded. An AIDS registry, for example,
might want to use an encryption method to protect patientidentifiable information since AIDS data are considered
Data Privacy and Confidentiality
Maintaining the privacy and confidentiality of health data is a
traditional role of HIM professionals. When looking at methods to protect secondary records, patient-specific information
requires more control than secondary databases that include
only aggregate data because individual patients cannot be
identified in aggregate data. Policies on who may access the
data provide the basic protection for confidentiality.
The type of data maintained also may affect policies on
confidentiality. For many of the government databases discussed previously, the information is aggregate and the data
are readily available to any interested users. For example,
public health data are frequently published in many formats,
including printed reports, Internet access, and direct computer access.
As is true of all employees working with patient data,
employees working with data in indexes, registries, and databases should receive training on confidentiality. Further, they
should be required to sign a yearly statement indicating that
they have received the training and understand the implications of failure to maintain confidentiality of the data.
In some cases, users of secondary data will need to remove
identifying data so that data can be used without violating
the patient’s privacy. This process is called deidentification.
The HIPAA privacy regulations indicate two ways to accomplish the deidentification:
● The covered entity can strip off certain elements to
ensure that the patient’s information is truly deidentified (45 CFR 164)
● The covered entity can have an expert apply generally
accepted statistical and scientific principles and methods to minimize the risk that the information might be
used to identify an individual (Brodnik et al. 2009)
Whichever method is utilized, it is important that a data
set released as deidentified contain no information that
would enable patients to be individually identified.
Transparency refers to the degree to which patients
included in secondary data sets are aware of their inclusion.
In its report Toward a National Framework for the Secondary Use of Health Data, the American Medical Informatics
Association (2006) has recommended that full disclosure be
the policy for all secondary uses of data.
Trends in the Collection of Secondary Data
The most significant trend in collecting secondary data is
the increased use of automated data entry. Registries and
databases are more commonly using data already available
in electronic form rather than manually abstracting all data.
As the EHR becomes more common, separate databases for
various diseases and conditions such as cancer, diabetes, and
trauma will become unnecessary. The patient health record
itself will be a database that can be queried for information
currently obtained from specialized registries.
Since not all data can currently be entered through automated means, other facilities are using existing technologies
such as point-of-care data collection at the patient’s bedside
using wireless technology (Eisenhower et al. 2005). Finally,
secondary data collection is becoming more common and
more secondary data are being collected about patients.
Because of this fact, national stakeholders such as the
American Medical Informatics Association and the National
Center for Vital and Health Statistics are becoming more
involved in setting national policy related to secondary data.
One of the issues of concern is the ownership of secondary
data. As stated in an AHIMA practice brief, “‘Who can do
what to which data and under which circumstances’ is really
the central question that must be asked in determining the
rights and responsibilities of each stakeholder” (BurringtonBrown and Hjort 2007). Stakeholders include patients,
health facilities, HIE organizations, vendors, governmental
agencies, employers, and researchers. There is currently no
clear-cut guidance on the sometimes conflicting rights and
responsibilities of each stakeholder of the data. Additional
issues include transparency, deidentification, and data privacy and confidentiality, which were previously discussed.
As more secondary data are collected, the role of the HIM
professional remains that of data steward. According to the
American Medical Informatics Association, data stewardship “encompasses the responsibilities and accountabilities
associated with managing, collecting, viewing, storing, sharing, disclosing, or otherwise making use of personal health
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Secondary Records and Healthcare Databases 385
information” (NCVHS 2007). These are traditional roles for
the HIM professional in relationship to primary data. It will
be necessary for these roles to be expanded to encompass
secondary data.
Check Your Understanding 14.5
Instructions: Answer the following questions on a separate piece
of paper.
1. What factors must be considered when determining the
quality of data?
2. Which errors in registries and other secondary databases can
cause serious problems?
3. What methods and systems can be used to ensure the quality
of secondary healthcare data?
4. What is the difference between security and confidentiality?
5. What methods might be used to control access to a health
information system?
6. What types of data should be encrypted?
7. What methods can be used to ensure data confidentiality?
8. What trends are evident in the collection of secondary data?
9. Which types of registries and secondary data sources would
be covered by HIPAA privacy and security regulations?
10. How are patients notified that data about them may be included
in registries and databases and released to outside entities?
11. What is deidentification, and what are two ways under
HIPAA that deidentification may be accomplished?
Health records contain extensive information about individual
patients but are difficult to use when attempting to perceive
trends in care or quality. For that reason, secondary records
were developed. One type of secondary record is the index.
An index is a report from a database that provides information
on patients and supports retrieval by diagnosis, procedure, or
physician. Health information management departments routinely produce indexes.
Disease registries are developed when extensive information is needed about specific diagnoses, procedures, or conditions. They are commonly used for research and to improve
patient care and health status. From the database created
through the data collection process, reports can be developed
to answer questions regarding patient care or issues such
as rates of immunization and birth defects. In some cases,
patient follow-up is done to assess survival rates and quality
of life after a disease or an accident.
HIM professionals perform a variety of roles in relation to
registries. In some cases, they work on setting up the registry.
Moreover, they may work in data collection and management of registry functions. HIM professionals are well suited
to such positions because of their background and education
in management, health record content, regulatory and legal
compliance, and medical science and terminology.
Today, organizations and institutions of all types commonly maintain databases pertaining to healthcare. At the
federal level, some administrative databases provide data and
information for decisions regarding claims and practitioner
credentialing. Other databases focus on the public health
area, using data collected at the local level and shared with
states and the federal government. These databases assist in
government surveillance of health status in the United States.
Some databases, such as the clinical trials database, are mandated by law and help patients and providers locate clinical
trials regardless of source or location.
Registries and databases raise a number of managerial
issues. Data collection is often time-consuming, so some
databases now use automated entry methods. In addition,
decisions must be made between vendor and facility-specific
products. Finally, the quality of the data is an important issue
because the decisions made based on data in registries and
databases depend on the data’s validity, reliability, accuracy,
and timeliness.
Another important issue related to registries and databases is data security. Facilities must adopt methods that will
ensure controlled access to data as well as prevent the loss of
data. Confidentiality is always of concern to the HIM professional, and steps must be taken to protect it.
In the future, separate registries and databases may become
less common with the advent of the computer-based patient
record. Essentially a large database, the electronic health
record can be queried directly rather than having to first
abstract data from the primary record into a secondary record.
American College of Surgeons. 2008a. Commission on Cancer.
American College of Surgeons. 2008b. Trauma programs.
American Gastroenterological Association. 2011. AGA digestive
health outcomes registry.
American Health Information Management Association. 2010.
Pocket Glossary of Health Information Management and
Technology, 2nd ed. Chicago: AHIMA.
American Joint Committee on Cancer. 2008. http://www
American Medical Informatics Association. 2006. Toward a
National Framework for the Secondary Use of Health Data.
Bethesda, MD: American Medical Informatics Association.
Copyright @ 2013. AHIMA Press. All rights reserved. May not be reproduced in any form without permission from the publisher, except fair uses permitted under U.S. or applicable copyright law.
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386 Chapter 14
Brodnik, M., et al. 2009. Fundamentals of Law for Health Informatics and Information Management. Chicago: AHIMA.
Burrington-Brown, J., and B. Hjort. 2007. Health data access, use
and control. Journal of AHIMA 78(5): 63–66.
Centers for Disease Control and Prevention. 2008a. National
Program of Cancer Registries.
Centers for Disease Control and Prevention. 2008b. National immunization program.
Centers for Disease Control and Prevention. 2008c. National Center for Health Statistics.
Department of Health and Human Services. 2000. Healthy people
2010: Tracking healthy people 2010.
Department of Health and Human Services. 2008. Fact sheet on the
Healthcare Protection and Integrity Data Bank.
Eisenhower, C., et al. 2005. Data abstraction unplugged: Taking
trauma registry to the point of care with wireless technology.
Journal of AHIMA 76(7): 42–45.
Food and Drug Administration. 2008.
Handling cancer registry requests for information. 2003. In
Confidence 11(8):7.
McCray, A., and N.C. Ide. 2000. Design and implementation of a
national clinical trials registry. Journal of the American Medical
Informatics Association 7(3):313–323.
National Committee on Vital and Health Statistics. 2007. Report
to the Secretary of the U.S. Department of Health and Human
Services on Enhanced Protection for Uses of Health Data: A
stewardship framework for “Secondary Uses” of Electronically
Collected and Transmitted Health Data.
National Library of Medicine. 2008.
National Practitioner Data Bank. 2006 (Mar. 21). National
Practitioner Data Bank for Adverse Information on Physicians and
Other Health Care Practitioners: Reporting on adverse and negative
actions. Federal Register 71 FR 14135.
Shapiro-Mendoza, C.K., et al. 2012. http://pediatrics.
Stedman’s Medical Dictionary Online. 2008. http://www.stedmans.
com/section.cfm/45. 2008.
45 CFR 164: Health Insurance Portability and Accountability
security regulations. 2007.
Copyright @ 2013. AHIMA Press. All rights reserved. May not be reproduced in any form without permission from the publisher, except fair uses permitted under U.S. or applicable copyright law.
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