Health Information Chapter 9

Where is the health record’s primary purpose?
•Patient care
•Reimbursement for individual encounters

It is not easy to see trends in a population of patients by just looking at what? How is it best to recognize trends?
•Individual records
•Data must be extracted from individual records and entered into databases

Definition of database
An organized collection of data, text, references, or pictures in a standardized format, typically stored in a computer system for multiple applications.

How may this patient data be used?
•May be used in a facility-specific or population-based registry for research and improvement of patient care.
•They may be reported to the state and become part of state- and federal-level databases used to set health policy and improve healthcare.

What is possible with the electronic health record?
It is possible for data to be collected once in the EHR and used many times for a variety of purposes.

What roles can the HIM professional play in managing secondary records and databases?
Key role is in setting up databases

What is included in database set up?
•Determining the content of the database and
•Ensuring compliance with the laws, regulations, and accreditation standards that affect its content and use

Where must all data elements included in the database or registry be defined?
In a data dictionary

How may the HIM professional serve as a data steward?
To oversee the completeness and accuracy of the data abstracted for inclusion in the database or registry

Data stewardship:
The responsibilities and accountabilities associated with managing, collecting, viewing, storing, sharing, disclosing, or otherwise making use of personal health information

Case study using patient data to demonstrate an existing problem.
A hospital with a level I trauma center was required to provide care to all major trauma cases in service area regardless of ability to pay. State was unwilling to pay for the care; hospital was losing money. The hospital admin asked the trauma registrar to gather data on patients from state X. The trauma registrar easily identified the patients / zip code / type and severity of injuries. Business office was able to calculate the cost to the hospital for their care. The administrator then presented this information to state X’s legislature to obtain the money to pay for the care the trauma center provided to the state’s indigent patients.

Who requires certified trauma centers to maintain a trauma registry?
The American College of Surgeons

Difference between primary and secondary sources: The health record i considered a:
Primary data source

Primary data source
A record developed by healthcare professionals in the process of providing patient care

Why is The health record considered a primary data source?
Bc it contains information about a patient that has been documented by the professionals who provided care or services to that patient.

Secondary data source
Data taken from the primary health record and entered into registries and databases are considered a secondary data source.

How are data also categorized other than primary and secondary?
Patient Specific/Identified data
Patient identifiable data
Aggregate data

Patient specific data
Personal information that can be linked to a specific patient, such as age, gender, date of birth, and address

How is the patient identified in patient-identified data? What does the health record consist of?
•The patient is identified within the data
•he health record consists entirely of patient-identified data
•In other words, every fact recorded in the record relates to a particular patient identified by name.

What other kind of data can be patient identified?
•Secondary data

What are an example of patient-identified data on groups of patients?
•In some instances, data are entered into a database along with information such as the patient’s name maintained in an identified form
•Registries are an example of patient-identified data on groups of patients

When are data patient-identifiable?
•Data are patient-identifiable if the identity of the patient can be derived or inferred from the data, with or without the assistance of computers and artificial intelligence

What is an example of data that are patient-identifiable?
For example, if an individual can be identified by using a combination of elements such as date of birth, zip code, gender, marital status, and phone number, this would be considered patient-identifiable data.

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).

What are four major purposes for collecting secondary data?
1. Quality, performance, and patient safety
2. Research
3. Population Health Reporting
4. Administration

1. Quality, performance, and patient safety
Healthcare facilities, for ex. collect core measures information from the health record for the Centers for Medicare and Medicaid Services to evaluate the quality of care within the facility.

2. The second area of secondary data use is research.
Data taken from health records and entered into disease-oriented databases can help researchers determine the effectiveness of alternate treatment methods. They also can quickly demonstrate survival rates at different stages of diseases

3. The third major use is for population health.
States, for example, require that information be reported to them on certain diseases so that the extent of the disease can be determined and measures to prevent its spread can be initiated.

4. The final use of secondary data is for administration.
In credentialing physicians, for example, facilities are required to access a national database for information on previous malpractice or other adverse decisions against a physician

Who are the internal users of secondary data?
Individuals located within the healthcare facility.
For example: internal users include medical staff and administrative and management staff.

What does secondary data enable for users?
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.

Who are external users of patient data?
Individuals and institutions outside the facility.

Who are examples of external users?
•State data banks and federal agencies.
•States have laws that cases of patients w/ diseases such as tb and AIDS must be reported to the state dept of health.
•Fed govt collects data from the states on vital events such as births and deaths.

What kind of data is the secondary data provided to external users, and how can this data be used?
The secondary data provided to external users are generally aggregate data and not patient-identifiable data. Thus, these data can be used as needed without risking breaches of confidentiality.

Check your understanding 9.1:
1. Bob Smith is a 56-year-old white male. This is an example of what type of data?
A. Patient-specific

Check your understanding 9.1:
2. Which of the following is an example of how an internal user utilizes secondary data?
D. Benchmarking with other facilities

Check your understanding 9.1:
3. Secondary data is used for multiple reasons including:
A. Assisting researchers in determining effectiveness of treatments

Check your understanding 9.1:
Instructions: Indicate whether the following statements are true or false (T or F).
4. _T___ A registry or database is a secondary data source.
5. __F__ A patient health record contains aggregate data.
6. _T___ Secondary data provide information that is not easily collected from individual health records.
7. __T__ Administrative and management staff members are internal users of secondary data.
8. _F___ Medical staff members are external users of secondary data.

What do secondary data sources consist of?
Facility-specific indexes; registries, either facility or population based; or other healthcare databases.

Index:
An organized (usually alphabetical) list of specific data that serves to guide, indicate, or otherwise facilitate reference to the data

What are the most long-standing secondary data sources?
Those that have been developed within facilities to meet their individual needs.

What do the long-standing data source indexes enable?
These indexes enable health records to be located by diagnosis, procedure, or physician.

What were the source indexes kept on prior to extensive computerization in healthcare? How are they maintained today?
Prior to extensive computerization in healthcare, these indexes were kept on cards. Today, most indexes are maintained as computerized reports based on data from databases routinely developed in the healthcare facility.

The master population index (MPI), is sometimes called:
The master person index

What does the MPI contain?
Patient-identifiable data such as name, address, date of birth, dates of hospitalizations or encounters, name of attending physician, and health record number.

Why is the MPI an important source of patient health record numbers?
•Because paper-based health records are filed numerically in most facilities.
•These numbers enable the facility to quickly retrieve health information for specific patients.

What other kinds of institutions depend on the MPI to determine if a patient has been seen there before and has an existing health record number?
•Hospitals with unit numbering systems depend on MPI to determine whether a patient has been seen in the facility before and has an existing health record number
•Having this information in the MPI avoids the duplication of record numbers

Where is most of the information in the MPI entered? When is it entered?
Most of the information in the MPI is entered into the facility database at the time of admission/preadmission or registration

Disease index:
A list of diseases and conditions of patients sequenced according to the code numbers of the classification system in use

The disease index
•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 the International Classification of Diseases
•The patient’s diagnosis codes are entered into the facility’s health information system as part of the discharge processing of the patient’s health record

What does the disease index always include?
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, which may be linked back to the patient’s name, the disease index is considered patient-identifiable data

What else may the disease index also include?
The disease index also may include information such as the attending physician’s name and the date of discharge.

Operation index:
A list of the operations and surgical procedures performed in a healthcare facility that is sequenced according to the code numbers of the classification system in use

The operation index is similar to the disease index, except:
That the operation index is arranged in numerical order by the patient’s procedure code(s) using International Classification of Diseases or Current Procedural Terminology (CPT) codes.

The other information listed in the operation index is generally the same as what’s listed in the disease index, except?
Except the surgeon may be listed in addition to, or instead of, the attending physician.

Physician index:
A list of patients and their physicians that is usually arranged according to the physician code numbers assigned by the healthcare facility.

The physician index is a listing of cases in order by physician name or physician identification number. What else does it include?
It also includes the patient’s health record number and may include other information, such as date of discharge.

What does the physician index enable users to do?
The physician index enables users to retrieve information about a particular physician, including the number of cases seen during a particular time period.

Disease registry:
A centralized collection of data used to improve the quality of care and measure the effectiveness of a particular aspect of healthcare delivery

Case definition:
A method of determining criteria for cases that should be included in a registry

Case finding:
A method of identifying patients who have been seen and/or treated in a healthcare facility for the particular disease or condition of interest to the registry.

What do disease registries collections of?
Disease registries are collections of secondary data related to patients with a specific diagnosis, condition, or procedure.

How are registries different from indexes?
•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 entry of data from the patient record

Each registry must define the cases that are to be included in it, what is this process called?
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 the International Classification of Diseases trauma diagnosis codes.

After the cases to be included have been determined, what is the next step in data acquisition?
Case finding

What is case finding?
Case finding is a method used to identify the patients who have been seen and/or treated in the facility for the particular disease or condition of interest to the registry.

What happens after cases have been identified?
After cases have been identified, extensive information is abstracted from the patients’ paper-based health records into the registry database or extracted from other databases and automatically entered into the registry database.

What is the sole purpose of some registries?
To collect data from health records and to make them available for users.

Other registries take further steps to enter additional information in the registry database, such as:
•Routine follow-up of patients at specified intervals.
•Follow-up information might include rate and duration of survival and quality of life over time.

Cancer registries
•Cancer registries have a long history in healthcare
•According to the National Cancer Registrars Association (NCRA), the first hospital cancer registry was founded in 1926 at Yale-New Haven Hospital

What were cancer registries developed as?
•It has long been recognized that information is needed to improve the diagnosis and treatment of cancer
•Cancer registries were developed as an organized method to collect these data
•The data may be facility based (for example, within a hospital or clinic) or population based (for example, from more than one facility within a state or region)

Facility-based registry:
A registry that includes only cases from a particular type of healthcare facility, such as a hospital or clinic

What is the data from facility-based registries used to provide?
The data from facility-based registries are used to provide information for the improved understanding of cancer, including its causes and methods of diagnosis treatment.

What may the data collected also provide comparisons for?
•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, what is emphasis placed on?
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.

Population-based statistics:
Statistics based on a defined population rather than on a sample drawn from the same population

Incidence:
The number of new cases of a specific disease

Stage of the neoplasm:
A classification of malignancies (cancers) according to the anatomic extent of the tumor, such as primary neoplasm, regional lymph nodes, and metastases

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 the neoplasm, incidence, and type of treatment

Case definition and the cancer registry:
•As defined previously, case definition is the process of deciding which cases should be entered in the registry
•In the cancer registry, all cancer cases except skin cancer might meet the definition for the cases to be included
•In addition to information on malignant neoplasms, data on benign and borderline brain/central nervous system tumors must be collected by the National Program of Cancer Registries (CDC n.d.)

What is the first step in the facility-based cancer registry?
The first step is case finding.

What is one way to find cases in “case finding”? What happens during this process?
•One way to find cases is through the discharge process in the HIM department
•During the discharge procedure, coders and/or discharge analysts can easily earmark cases of patients with cancer for inclusion in the registry

What are additional case-finding methods?
•Another case-finding method is to use the facility-specific disease indexes to identify patients with diagnoses of cancer
•Additional methods may include reviews of pathology reports and lists of patients receiving radiation therapy or other cancer treatments to determine cases that have not been found by other methods

Population-based registries
•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 have been identified and reported to the central registry.

Accession number:
A number assigned to each case as it is entered in a cancer registry

Accession registry:
A list of cases in a cancer registry in the order in which they were entered

How do 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, and the remaining digits are assigned sequentially throughout the year
•The first case in the year, for example, might be 10-0001. The accession number may be assigned manually or by the automated cancer database used by the organization

How is an accession registry kept? What does this listing provide?
•An accession registry of all cases can be kept manually or provided as a report by the database software
•This listing of patients in accession number order provides a way to ensure that all cases have been entered into the registry.

How are data initially obtained in a facility-based 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, and address), data in the registry about the patient include:
•Type and site of the cancer
•Diagnostic methodologies
•Treatment methodologies
•Stage at the time of diagnosis

Demographic information:
Information used to identify an individual, such as name, address, gender, age, and other information linked to a specific person

What does the “stage” at time of diagnosis provide?
•The stage provides information on the size and extent of spread of the tumor throughout the body.
•There are currently several staging systems.

Which agency has worked through its collaborative stage task force with other organizations to develop a new standardized staging system? What is this system called?
The American Joint Committee on Cancer (AJCC) has worked through its Collaborative Stage Task Force with other organizations with staging systems to develop a new standardized staging system, the Collaborative Stage Data Set.

The Collaborative Stage Data Set
•A new standardized staging system
•This system uses computer algorithms to describe how far a cancer has spread (AJCC 2009)
•After the initial information is collected at the patient’s first encounter, information in the registry is updated periodically through the follow-up process.

When does the population-based registry collect information?
•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 information to the central registry electronically

What is formal reporting of cancer registry data done through? What does this report include?
•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

In what are data from the cancer registry frequently used?
Data from the cancer registry are frequently used in the quality assessment process for a facility as well as in research

What data would be helpful in researching the most effective treatment for a type of cancer?
•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.

What is another activity of the cancer registry? What information does the registry attempt to obtain annually?
•Patient follow-up
•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

What methods are used to obtain information for the patient cancer registry?
•For a facility-based registry, the facility’s patient health records may be checked for return hospitalizations or visits for treatment
•Additionally, the patient’s physician may be contacted to determine whether the patient is still living and to obtain information about the cancer

When the main methods of obtaining patient status for the cancer registry don’t work, what is attempted?
•An attempt may be made to contact the patient directly using information in the registry such as the patient’s address and telephone number
•In addition, contact information from the patient’s health record may be used to request information from the patient’s relatives

What other methods are used to obtain status information for the patient registry?
•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

What kinds of registries do not always include follow-up information on patients?
•Population-based registries do not always include follow-up information on the patients in their databases
•Those who do follow up usually receive the information from the reporting entities such as hospitals, physician offices, and other organizations providing follow-up care

American College of Surgeons Commission on Cancer:
The organization that approves cancer-related programs, including cancer registries and trauma centers

Several organizations have developed standards or approval processes for cancer programs, what are they? What are the requirements?
•The American College of Surgeons (ACS) Commission on Cancer has an approval process for cancer programs
•One of the requirements of this process is the existence of a cancer registry as part of the program

Where are the ACS standards published?
•The ACS standards are published in the Cancer Program Standards (ACS COC 2009)
•When the ACS surveys the cancer program, part of the survey process is a review of cancer registry activities

North American Association of Central Cancer Registries (NAACCR):
A national organization that certifies state, population-based cancer registries

What is the North American Association of Central Cancer Registries (NAACCR) certification program? What is certification based on?
•The North American Association of Central Cancer Registries (NAACCR) has a certification program for state population-based registries. •Certification is based on the quality of data collected and reported by the state registry
•NAACCR has developed standards for data quality and format and works with other cancer organizations to align their various standards sets

What are the CDC’s national standards?
•The Centers for Disease Control and Prevention (CDC) also has national standards regarding the completeness, timeliness, and quality of cancer registry data from state registries through the National Program of Cancer Registries (NPCR). •NPCR was developed as a result of the Cancer Registries Amendment Act of 1992
•The CDC collects data from the NPCR state registries

What have cancer registrars traditionally been trained through?
•On-the-job training and professional workshops and seminars
•The National Cancer Registrars Association (NCRA) has worked with colleges to develop formal educational programs for cancer registrars

How may a cancer registrar become credentialed?
•A cancer registrar may become credentialed 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 2009)

Traumatic injury:
A wound or injury included in a trauma registry

What do trauma registries maintain?
•Trauma registries maintain databases on patients with severe traumatic injuries
•A traumatic injury is a wound or other injury caused by an external physical force such as an automobile accident, a shooting, a stabbing, or a fall
•Information collected by the trauma registry may be used for performance improvement and research in the area of trauma care
•Trauma registries may be facility based or may include data for a region or state.

The case definition for the trauma registry varies, but frequently involves what?
The case definition for the trauma registry varies from registry to registry but frequently involves inclusion of cases with diagnoses from the trauma diagnosis codes from the International Classification of Diseases.

How does the trauma registrar find cases with trauma diagnoses?
•To find cases with trauma diagnoses, the trauma registrar can access the disease indexes looking for cases with codes from this section of International Classification of Diseases
•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

Abstracting:
1. The process of extracting information from a document to create a brief summary of a patient’s illness, treatment, and outcome. 2. The process of extracting elements of data from a source document or database and entering them into an automated system.

What happens after trauma 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 and/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
•Diagnosis and procedure codes
•Abbreviated Injury Scale (AIS)
•Injury Severity Score (ISS)

Abbreviated Injury Scale (AIS):
A set of numbers used in a trauma registry to indicate the nature and severity of injuries by body system

Injury Severity Score (ISS):
An overall severity measurement maintained in the trauma registry and calculated from the abbreviated injury scores for the three most severe injuries of each patient

How does the abbreviated injury scale (AIS) work? How is it calculated?
•The AIS reflects the nature of the injury and the threat to life of the injury 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 ISS is an overall severity measurement calculated from the AIS scores for patients with multiple injuries (Trauma.org 2009)

Reporting among trauma registries:
•Reporting varies among trauma registries
•An annual report is often developed to show the activity of the trauma registry
•Other reports may be generated as part of the performance improvement process, such as self-extubation (patients removing their own tubes) and delays in abdominal surgery or patient complications
•Some hospitals report data to the National Trauma Data Bank (ACS Trauma Programs 2009).

Trauma registry follow-up; is it given the emphasis it receives in cancer registries?
•Trauma registries may or may not do follow-up on 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 Approval Process for Trauma Registries:
•The ACS verifies levels I, II, III, and IV trauma centers
•As part of its requirements, the ACS states that the level I trauma center must have a trauma registry (ACS 2009)

Education and Certification of Trauma Registrars; how are registrars registered, who may they be?
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.

How is training done for trauma registrars?
•Training for trauma registrars is 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 who meet their education and experience requirements through its Registrar Certification Board
•Certified trauma registrars have earned the credential CSTR (certified specialist in trauma registry)

What do birth defect registries collect?
•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, what registries have been developed after specific events to spotlight?
•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: what kind of criteria is used to determine which cases to include in the registry?
•Birth defects registries use a variety of criteria to determine which cases to include in the registry
•Some registries limit cases to those with defects found within the first year of life
•Others include those children with a major defect that occurred in the first year of life and was discovered within the first five years of life
•Still other registries include only children who were live born or stillborn babies with discernible birth defects

How are cases detected?
•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:
•Demographic information
•Codes for diagnoses
•Birth weight
•Status at birth, including live born, stillborn, aborted
•Autopsy
•Cytogenetics results
•Whether the infant was a single birth or one in a multiple birth
•Mother’s use of alcohol, tobacco, or illicit drugs
•Father’s use of drugs and alcohol
•Family history of birth defects

What do diabetes registries include cases of?
•Diabetes registries include cases of patients with diabetes for the purpose of assistance in managing care as well as for research
•Patients whose diabetes is not kept under good control frequently have numerous complications

What can the diabetes registry keep up with?
•The diabetes registry can keep up with whether the patient has been seen by a physician in an effort to prevent complications

What are the two types of diabetes? What are diabetes registries sometimes limited by?
•There are two types of diabetes mellitus: type 1 and type 2 diabetes. •Registries sometimes limit their cases by type of diabetes
•In some instances, there may be further definition by age
•Some diabetes registries, for example, only include children with diabetes

What does case finding include?
Case finding includes the review of health records of patients with diabetes

Other case-finding methods include review of the following types of information:
Diagnostic codes
Billing data
Medication lists
Physician identification
Health plans

Where are facility-based diabetes registries found? Why is it found here?
•Although facility-based registries for cancer and trauma are usually hospital based, facility-based diabetes registries are often found in physician offices or clinics
•Office or clinic is the main location for diabetes care
•Thus, data about the patient to be entered into the registry are available at these sites rather than at the hospital.

How may the health records of diabetes patients treated in physician practices be identified?
The health records of diabetes patients treated in physician practices may be identified through
•Diagnosis code numbers for diabetes, •Billing data for diabetes-related services, Medication lists for patients on diabetic medications, or
•Identification of patients as the physician sees them

Why are health plans also are interested in optimal care for their diabetic enrollees?
•Health plans also are interested in optimal care for their enrollees because diabetes can have serious complications when not managed correctly
•The plans can provide information to the office or clinic on enrollees who are diabetics

Data Collection for Diabetes Registries: other than demographic information about the cases, what else is collected? What is this used to determine?
•Other data collected may include laboratory values such as HBA1c
•This test is used to determine the patient’s blood glucose for a period of approximately 60 days prior to the time of the test. •Moreover, facility registries may track patient visits to follow up with patients who have not been seen in the past year

A variety of reports can be developed from the diabetes registry, what reports may be used for facility-based registries?
•For facility-based registries, one report might keep up with laboratory monitoring of the patient’s diabetes to allow intensive intervention with patients whose diabetes is not well controlled
•Another report might concern patients who have not been tested within a year or have not had a primary care provider visit within a year

What do population-based diabetes registries provide reporting on? What else might registry data be used for? What is follow-up aimed at ensuring?
•Population-based diabetes registries might provide reporting on the incidence of diabetes for the geographic area covered by the registry
•Registry data also might be used to investigate risk factors for diabetes.
•Follow-up is aimed primarily at ensuring that the diabetic is seen by the physician at appropriate intervals to prevent complications

Food and Drug Administration (FDA):
The federal agency responsible for controlling the sale and use of pharmaceuticals, biological products, medical devices, food, cosmetics, and products that emit radiation, including the licensing of medications for human use

Implant registries: what are considered implants?
•An implant is a material or substance inserted into the body, such as breast implants, heart valves, and pacemakers

What have implant registries been developed for?
•Implant registries have been developed for the purpose of tracking the performance of implants, including complications, deaths, and defects resulting from implants, as well as implant longevity

Why have implant registries been developed?
•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 cases about the safety of implants arise, what has been difficult to ensure? what has been enacted as a result?
•When such cases arise, it has often been difficult to ensure that all patients with the implants have been notified of safety questions
•A number of federal laws have been enacted to regulate medical devices, including implants

What were devices first covered under?
•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

What did the Food, Drug, and Cosmetic Act and the Safe Medical Devices Act of 1990 require? How can implant registries help in compliance?
•These acts required a sample of 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

What do implant registries sometimes include?
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

Demographic data on patients receiving implants are included in the registry. The FDA requires that all reportable events involving medical devices include the following information (FDA 2009):
•Name and address of the device manufacturer
•Device brand name and common name
•Product model, catalog, serial, and lot numbers
•Brief description of the event reported to the manufacturer and/or the FDA
•Where the report was submitted (for example, to the FDA, manufacturer, or distributor)
•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:
•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, they can be easily notified of product failures, recalls, or upgrades

Transplant Registries: purpose
•Transplant registries may have varied purposes
•Some organ transplant registries maintain databases of patients who need organs
•When an organ becomes available, a fair way then may be used to allocate the organ to the patient with the highest priority

In what other cases is the registry used?
•The purpose of the registry is to provide a database of potential donors for transplants using live donors, such as bone marrow transplants
•Post-transplant information also is kept on organ recipients and donors

Why are transplant registries national or international in scope?
Because transplant registries are used to try to match donor organs with recipients, they are often national or even international in scope

What are examples of national transplant registries?
•UNet of the United Network for Organ Sharing (UNOS)
•Registry of the National Marrow Donor Program (NMDP)

Data collected may also be used for?
Data collected in the transplant registry also may be used for research, policy analysis, and quality control

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 through community information efforts similar to those carried out by blood banks to encourage blood donations

Data Collection for Transplant Registries. The type of information collected varies according to the type of registry. Pre-transplant data about the recipient include:
•Demographic data
•Patient’s diagnosis
•Patient’s status codes regarding medical urgency
•Patient’s functional status
•Whether the patient is on life support
•Previous transplantations
•Histocompatibility (compatibility of donor and recipient tissues)

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: what information does reporting include?
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

Who is follow-up transplant information collected for? What might the information include for living donors?
•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 in the hospital

What does follow-up on recipients include? How is it carried out?
•Follow-up on 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
•These include increasing the proportion of children and adolescents that are fully immunized (objective 14-24) and increasing the proportion of children in population-based immunization registries (objective 14-26)

What is the purpose of immunization registries? How is this goal accomplished?
•Immunization registries usually have the purpose of increasing the number of infants and children who receive the required immunizations at the proper intervals
•To accomplish this goal, registries collect information within a particular geographic area on children and their immunization status

How else do immunization registries help?
•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 children

Case Definition and Case Finding for Immunization Registries: who is served by the registry? Who should be included?
•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

In addition to children in immunization registries, some also include information on?
Although children are usually targeted in immunization registries, some registries do include information on adults for influenza and pneumonia vaccines

When are children entered into the registry? How may personnel determine which children to exclude from the registry because they died after birth?
•Children are often entered in the registry at birth
•Registry personnel may review birth and death certificates and adoption records to determine which children to include and which children to exclude because they died after birth
•In some cases, children are entered electronically through a connection with an electronic birth record system.

National Vaccine Advisory Committee (NVAC):
A national advisory group that supports the director of the National Vaccine Program

Data Collection for Immunization Registries; The National Immunization Program at the CDC has worked with the National Vaccine Advisory Committee (NVAC) to develop:
A core set of immunization data elements to be included in all immunization registries. These data elements include (CDC 2009a):
•Patient name (first, middle, and last)
•Patient birth date
•Patient sex
•Patient race
•Patient ethnicity
•Patient birth order
•Patient birth state/country
•Mother’s name (first, middle, last, and maiden)
•Vaccine type
•Vaccine manufacturer
•Vaccination date
•Vaccine lot number
•Other items may be included as needed by the individual registry

Autodialing system:
A method used to automatically call and remind patients of upcoming appointments

Reporting and Follow-up for Immunization Registries: because the purpose of the immunization registry is to increase the number of children who receive immunizations in a timely manner, what should reporting emphasize?
•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

What is follow-up directed toward? What may reminders include?
•Follow-up is directed toward reminding parents that it is time for immunizations as well as seeing whether parents fail to 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

What else may registries decide on? What is an important factor in providing this follow-up?
•Moreover, registries must decide how frequently to follow up with parents who do not bring their children in 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 Approval Processes for Immunization Registries. The CDC, through its National Immunization Program, provides funding for:
Some population-based immunization registries

The CDC, through its National Immunization Program has identified 12 minimum functional standards for immunization registries (CDC 2009a), including:
•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 ACIP (Advisory Committee on Immunization Practices) recommendations, when an individual presents for a scheduled immunization
•Automatically identify individuals due/late for immunization(s) to enable the production of reminder/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 data

Provides funding for population-based immunization registries
The CDC

Other Registries may be developed for? What are other commonly kept types of registries?
•Registries may be developed for any type of disease or condition
•Other commonly kept types of registries are HIV/AIDS and cardiac registries

In addition, registries may be developed for administrative purposes. What is an example of an administrative registry?
•The National Provider Registry is an example of an administrative registry
•Data collected for healthcare administrative purposes are discussed in the next subsection

Healthcare Databases: what are some reasons they would be developed?
•The federal government has developed a variety of databases to enable it to carry out surveillance, improvement, and prevention duties
•HIM 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

National and State Administrative Databases: What are databases 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.

What is the Medicare Provider Analysis and Review File made up of?
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.

What types of data make up the medicare provider analysis and review (MEDPAR) File?
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 type of service, such as operating room, physical therapy, and pharmacy charges
•International Classification of Diseases diagnosis and procedure codes
•MS-DRGs

What is the MEDPAR file frequently used for?
The MEDPAR file is frequently used for research on topics such as charges for particular types of care and DRGs.

What is the limitation of the MEDPAR data for research purposes?
The limitation of the MEDPAR data for research purposes is that the file contains only Medicare patients

National Practitioner Data Bank (NPDB):
•Data bank established by the federal government through the 1986 Health Care Quality Improvement Act
•Contains information on professional review actions taken against physicians and other licensed healthcare practitioners, which healthcare organizations are required to check as part of the credentialing process

What Act was the National Practitioner Data Bank (NPDB) mandated under? What was it created to provide?
•The Health Care Quality Improvement Act of 1986
•It was developed to provide a database of medical malpractice payments, adverse licensure actions, 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 as well as private accrediting organizations and peer review organizations (NPDB 2010).

What was the NPDB developed to alleviate?
It was developed to alleviate lack of information about:
•Malpractice decisions
•Denial of medical staff privileges, or
•Loss of medical license

What was a result of physician data not be widely available (before the NPDB was developed)?
Because these data were not widely available, physicians who lost their license to practice in one state or facility could move to another state or another facility and begin practicing again with the current state and/or facility unaware of previous actions against the physician

How is information in the NPDB provided?
•Information in the NPDB is provided through a required reporting mechanism.

Which entities must report to the NPDB?
Entities making malpractice payments, including insurance companies, boards of medical examiners, and entities such as hospitals and professional societies, must report to the NPDB

What kind of information must be reported to the NPDB? What penalty is there for not reporting?
•Information about the practitioner
•The reporting entity, and
•The judgment or settlement
•Information about physicians and other healthcare providers must be provided (National Practitioner Data Bank Final Rule 2010)
•Monetary penalties may be assessed for failure to report

The law requires healthcare facilities to query the NPDB as part of what process?
Credentialing process when a physician initially applies for medical staff privileges and every two years thereafter

Part of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) mandated:
The collection of information on healthcare fraud and abuse because there was no central place to obtain this information.

What was developed as a result of HIPPA mandating the collection healthcare fraud and abuse?
The national Healthcare Integrity and Protection Data Bank (HIPDB) was developed

Healthcare Integrity and Protection Data Bank:
A database maintained by the federal government to provide information on fraud-and-abuse findings against U.S. healthcare providers

The types of items that must be reported to the data bank include reportable final adverse actions such as (HHS 2009):
•Federal or state licensing and certification actions, including revocation, reprimands, censures, probations, suspensions, and any other loss of license, or the right to apply for or renew a license, whether by voluntary surrender, non-renewability, or otherwise
•Exclusions from participation in federal or state healthcare programs
•Any other adjudicated actions or decisions defined in the HIPDB regulations

What happens when there is overlap with the NPDB and HIPDB?
A single report is made and then sorted to the appropriate data bank

What does information reported by HIPDB include? Who is required to report? What is access limited to?
Information about 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
•Access to the data bank is limited to these organizations and to practitioners, providers, and suppliers who may only query about themselves.

States also frequently have health-related administrative databases. For example:
•Many states collect either UHDDS or UB-04/837 Institutional 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-04/837 Institutional data with data required by the state of New York

National, State, and County Public Health Databases: What is the area of healthcare dealing with the health of populations in states and counties? What is one of the duties of its agencies?
•Public health is the area of healthcare dealing with the health of populations in geographic areas such as states or counties
•One of the duties of public health agencies is surveillance of the health status of the population within their jurisdiction

What do the 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

How are data for the public health department databases collected? Who may have input in these databases?
Data for the databases may be collected using a variety of methods, including •Interviews
•Physical examinations of individuals, and •Reviews of health records
•The HIM manager may have input in these databases through data provided from health record

Who has responsibility for the pulic health department databases?
At the national level, the National Center for Health Statistics has responsibility for these databases

National Healthcare Survey
•One of the major national public health surveys
•To a large extent relies on data from patients’ health records

The National Healthcare Survey consists of a number of parts, including:
•The National Hospital Discharge Survey
•The National Ambulatory Medical Care Survey
•The National Survey of Ambulatory Surgery
•The National Nursing Home Survey
•The National Home and Hospice Care Survey

How are data in the National Hospital Discharge Survey abstracted?
•Either abstracted manually from a sample of acute care discharged inpatient records or
•Obtained from state or other discharge databases

Items collected for the National Hospital Discharge Survey follow what data set?
•Items collected follow the Uniform Hospital Discharge Data Set (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 health records of patients seen in a one-week reporting period
•Data included are:
-Demographic data
-The patients’ reasons for visit
-The diagnoses
-Diagnostic/screening services
-Therapeutic and preventive services,
-Ambulatory surgical procedures, and
-Medications/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 included in a sample of hospital-based and freestanding ambulatory surgery centers for the National Ambulatory Surgery include:
Data include
•Patient demographic characteristics •Source of payment
•Information on anesthesia given
•The diagnoses
•The surgical and nonsurgical procedures on patient visits of hospital-based and freestanding ambulatory surgery centers

The National Survey of Ambulatory Surgery consists of?
The survey consists of a mailed survey about the facility and abstracts of patient data.

The National Nursing Home Survey provides:
•Data on each facility, current residents, and discharged residents
•Information is gathered through an interview process

Who provides information about the facility for the nursing home survey?
The administrator or designee provides information about the facility being surveyed.

Who is interviewed for information on nursing home residents? What information is used?
•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 during the interview.

Data collected on the facility for the National Nursing Home Survey include:
Information on ownership, size, certification status, admissions, services, full-time equivalent employees, and basic charges.

What provides demographic information for the National Nursing Home Survey?
Interviews about both current and discharged residents provide demographic information on the resident as well as length of stay, diagnoses, level of care received, activities of daily living (ADL), and charges.

Activities of daily living (ADL):
The basic activities of self-care, including grooming, bathing, ambulating, toileting, and eating

For the National Home and Hospice Care Survey, data are collected on:
The home health or hospice agency as well as on their current and discharged patients.

Data included in the National Home and Hospice Care Survey include:
Referral and length of service
Diagnoses
Number of visits
Patient charges
Health status
Reason for discharge, and
Types of services provided.

How is facility data for home and hospice care provided?
•Facility data are provided 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.

What has the CDC developed due to the bioterrorism scares in recent years?
The CDC has developed the National Electronic Disease Surveillance System (NEDSS) that serves as a major part of the Public Health Information Network (PHIN)

What does the National Electronic Disease Surveillance System (NEDSS) provide?
•This system provides a national surveillance system by connecting the CDC with local and state public health partners
•It allows the CDC to monitor trends from disease reporting at the local and state levels to look for possible bioterrorism incidents

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
•Table 9.1 summarizes the national databases

Database: National Ambulatory Medical Care Survey
Setting: Office-based physician practice
Content: Data on the patient and visit
Data Source: State discharge databases and Office-based physician records
Method of collection: Abstract

Database: National Nursing Home Survey
Setting: Nursing home
Content: Data on the facility, current and discharged residents
Data Source: Administrator and Nurse caregiver
Method of collection: Interview

Database: National Hospital Ambulatory Medical Care Survey
Setting: Hospital ER dept, outpatient clinics
Content: Data on patient, visit and method of payment
Data Source: ER dept and outpatient clinic records
Method of collection: Abstract

Database: National Home and Hospice Care Survey
Setting: Home health, hospice
Content: Facility and patient data
Data Source: Administrator, caregiver
Method of collection: Interview

Database: National Electronic Disease Surveillance System (NEDSS)
Setting: Public health departments
Content: Possible bioterrorism incidents
Data Source: Local and state public health departments
Method of collection: Electronic surveillance

State and local public health departments also develop databases, as needed, to perform what?
Their duties of health surveillance, disease prevention, and research

An example of state databases is:
Infectious/notifiable disease databases

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 can be taken to avoid large outbreaks of these diseases.

As mentioned above, state and local reporting systems connect with the CDC through:
•NEDSS to evaluate trends in disease outbreaks.
•There also may be statewide databases/registries that collect extensive information on particular diseases and conditions such as birth defects, immunizations, and cancer

Vital statistics
Data related to births, deaths, marriages, and fetal deaths

What do vital statistics include data on? Who has responsibility for the collection of 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 the National Center for Health Statistics (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 and then are sent to the state

What does the state serve as for vital statistics? What is developed from this collection?
•The state serves as the official repository for the certificate and provides vital statistics information to the NCHS
•From the vital statistics collected, states and the national government develop a variety of databases.

Linked Birth and Infant Death Data Set
•A vital statistics database at the national level is the
•In this database, the information from birth certificates is compared to death certificates for infants under one year of age who die
•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 2009b)

What additional information is collected in In some of these databases, such as the National Maternal and Infant Health Survey and 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 trial
•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

What do clinical trials databases provide data to enable?
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, which is available on the Internet for use by both patients and practitioners at www.clinicaltrials.gov

Information in the clinical trials database includes:
Abstracts of study protocols
•Brief 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 in the clinical trials database has been defined, for example:
•Brief summary gives an overview of the treatments being studied and types of patients to be included
•Recruiting 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

Criteria for patient participation in clinical trials includes:
•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 be completed before entering the trial
•Age is a frequent eligibility criterion (Clinicaltrials.gov 2009)
•Study design includes the research design being followed

A clinical trial consists of four phases:
1. Phase I studies research the safety of the treatment in a small group of people. 2. In phase II studies, emphasis is on determining the treatment’s effectiveness and further investigating safety
3. Phase III studies look at effectiveness and side effects and make comparisons to other available treatments in larger populations
4. Phase IV studies look at the treatment after it has entered the market

Some clinical trials databases concentrate on a particular disease. The Department of Health and Human Services, for example:
•Has developed ACTIS, the AIDS Clinical Trials Information Service
•The National Cancer Institute sponsors PDQ (Physician Data Query), a database for cancer clinical trials. These databases contain information similar to Clinicaltrials.gov
•Although Clinicaltrials.gov has been set up for use by both patients and health practitioners, some databases are more oriented toward practitioners

Health services research:
Research conducted on the subject of healthcare delivery that examines organizational structures and systems as well as the effectiveness and efficiency of healthcare services

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

What is a major initiative for AHRQ?
•The Healthcare Cost and Utilization Project (HCUP)

The Healthcare Cost and Utilization Project (HCUP):
•Uses data collected at the state level from either claims data or discharge-abstracted data, including the UHDDS items reported by individual hospitals and, in some cases, by freestanding ambulatory care centers

Which data are reported to HCUP depends on what?
•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 then are reported from the state to AHRQ, where they become part of the HCUP databases.

HCUP consists of a set of databases, including:
•The Nationwide Inpatient Sample (NIS), which consists of inpatient discharge data from a sample of hospitals in 35 states throughout the United States
•The State Inpatient Database (SID), which includes data collected by states on hospital discharges
•The State Ambulatory Surgery Database (SASD), which includes information from a sample of states on hospital-affiliated ASCs and, from some states, data from freestanding surgery centers
•State Emergency Department Databases include data from hospital-affiliation emergency departments (EDs)
•Abstracts for visits that do not result in a hospitalization
•The Kids Inpatient Database (KID) is made up of inpatient discharge data on children younger than 19 years old

Why are HCUP databases unique?
•Because they include data on inpatients whose care is paid for by all types of payers, including Medicare, Medicaid, private insurance, 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.

What may researchers use HCUP databases to look at?
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.

The National Library of Medicine (NLM) produces two databases of special interest to the HIM manager:
MEDLINE and UMLS

Medical Literature, Analysis, and Retrieval System Online (MEDLINE)
•One of two databases produced by the NLM
•Is the best-known database from the NLM. It includes bibliographic listings for publications in the areas of medicine, dentistry, nursing, pharmacy, allied health, and veterinary medicine
•HIM managers use MEDLINE to locate articles on HIM issues as well as articles on medical topics necessary to carry out quality improvements and medical research activities

The Unified Medical Language System (UMLS)
•One of two databases produced by the NLM
•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 electronic health record systems
•UMLS is of particular interest to the HIM manager because medical vocabularies such as the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM), Current Procedural Terminology (CPT), and the Healthcare Common Procedure Coding System (HCPCS) are among the items included

Why have health information exchange (HIE) initiatives been developed? What is this data used for?
•In an effort to move toward a longitudinal patient record with complete information about the patient available at the point of care
•This is patient-specific rather than aggregate data and is 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

What is important 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 is aggregated for research and other purposes
•Aggregated data can be deidentified to add another layer of protection for the patient’s identity

The Joint Commission, the Centers for Medicare and Medicaid Services, and some health plans require healthcare facilities to:
•Collect data on core performance measures
•These measures are secondary data because they are taken from patient medical records
•Facilities must determine how to collect these measures and how to aggregate the data for reporting purposes

Whether a facility reports core performance measures will be used as a basis for?
•Whether a facility reports such measures will be used as a basis for pay for performance systems
•It is, therefore, extremely important that the data accurately reflect the quality of care provided by the facility

Check Your Understanding 9.2:
1. Which of the following indexes is an important source of patient health record numbers?
B. Master patient index

Check Your Understanding 9.2:
2. After the types of cases to be included in a registry have been determined, what is the next step in data acquisition?
D. Case finding

Check Your Understanding 9.2:
3. What number is assigned to a case when it is first entered in a cancer registry?
A. Accession number

Check Your Understanding 9.2:
4. What are the patient data such as name, age, address, and so on called?
A. Demographic data

Check Your Understanding 9.2:
5. What type of registry maintains a database on patients injured by an external physical force?
C. Trauma registry

Check Your Understanding 9.2:
6. In addition to collecting patient data, what activities do many types of registries engage in?
D. Reporting and follow-up

Check Your Understanding 9.2:
7. Why is the MEDPAR File limited in terms of being used for research purposes?
B. It only contains Medicare patients.

Check Your Understanding 9.2:
8. Which of the following acts mandated establishment of the National Practitioner Data Bank?
A. Health Care Quality Improvement Act of 1986

Check Your Understanding 9.2:
9. I started work today on a clinical trial. I need to familiarize myself with the rules and procedures to be followed. This information is called the:
A. Protocol

Check Your Understanding 9.2:
10. An advantage of HCUP is that it:
C. Contains data on all payer types

Several issues surround the processing and maintenance of secondary databases:
HIM managers are often involved in decisions concerning these issues.
1. Manual versus Automated Methods of Data Collection
2. Vendor Systems versus Facility-Specific Systems
3. Data Stewardship issues associated with secondary data use
4. Data quality 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 be done initially 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.

Manual versus Automated Methods of Data Collection: 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 they will be available electronically through the EHR.

Vendor Systems versus Facility-Specific Systems: Each facility must determine what information technology solution best meets its needs
•A vendor system is an information system developed by an outside company and sold to a variety of organizations
•A facility-specific system is an information system developed within the facility for its own use
•It may be part of the facility health information system
•It is important that either type of product is able to incorporate demographic and other pertinent information from the facility HIS system
•In this way, time is saved and data integrity between the registry information and the HIS system is maintained

Data Stewardship issues associated with secondary data use:
With the increased availability of secondary data in electronic format, 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.

Data Stewardship issues associated with secondary data use: patient concerns
•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. •Such concerns have led to increasing emphasis on data stewardship

According to the National Center for Vital and Health Statistics, data Stewardship is:
“… a responsibility, guided by principles and practices, to ensure the knowledgeable and appropriate use of data derived from individuals’ personal health information
• These uses include (but are not limited to) data collection, viewing, storage, exchange, aggregation, and analysis” (NCVHS 2009)
•Data stewardship encompasses the concepts of data quality, security, confidentiality, and uniformity. Issues involve the rights of stakeholders to access, use, and control the data maintained about their care

Many of these data stewardship issues have been the domain of:
•Health information managers since the profession began
•It is important for HIM professionals to migrate these skills from the paper to the electronic environment to maintain their leadership in this area

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 based on these databases. Incorrect data will likely result in serious errors in decision making

An important tenet in quality of secondary data is the quality of the primary data source:
•The patient health record often contains inconsistencies and errors that can lead to data quality issues in secondary data sources
•It is important that facilities and providers pursue clinical documentation improvement to ensure the quality of the primary data source necessary for quality secondary data

Data quality issues; Several factors must be addressed when assessing data quality. These include data accuracy, consistency, completeness, and timeliness:
1. Accuracy of the Data
2. Consistency of the Data
3. Comprehensiveness of the Data
4. Timeliness of the Data
5. Data Security
6. Data confidentiality:
•HIPAA-Covered Entities
•Entities not covered by HIPAA
7. Data definitions and standards
8. Rights of Stakeholders to Rights of Access, Use, and Control
9. Data Exchange and Interoperability

Data quality issue 1. Accuracy of the data:
•Data accuracy, also referred to as data validity means that data are correct
•For example, in a cancer registry, the stage of the neoplasm must be recorded 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
•If 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 database

Data quality issue 2. Consistency of the Data:
•Sometimes referred to as data reliability. •For example, all patients in a trauma registry with the same level, severity, and site of injury should have the same score on the 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 a cancer registry, for example, physician members of the cancer committee may be called on to check the reliability of the data

Interrater reliability
A measure of a research instrument’s consistency in data collection when used by different abstractors

Data quality issue 3. Comprehensiveness of the Data
•Also referred to as completeness
•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 findings is a way to avoid missing patients who should be included in a registry.

Data quality issue 4. Timeliness of the Data
•Another concept important in data quality is timeliness
•Data timeliness means that healthcare data should be up-to-date
•Data must also 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 quality issue 5. Data Security
•Registries and secondary databases must ensure the security of the information that they maintain
•Data security usually refers to efforts to control access to health information. •HIPAA security regulations apply to data in some registries and other secondary data sources
•Only data maintained by healthcare facilities that bill for patient care services must follow the HIPAA security regulations
•These regulations require policies in the areas of administrative, technical, and physical security

Data quality issue 5. Data Security: methods to ensure authorized access to to patient data in the facility’s computer system
•One common method is the use of passwords. Other methods may involve biometric identification systems that use retinal scans or fingerprints
•Tokens such as identification badges also may be used
•Moreover, the facility may establish levels of access to the computer system. •In this case, each user would be allowed access to only certain parts of the system. •Only those parts of the system to which the users have access appear on the screen. In addition, a record of all transactions in the system, called an audit trail, is maintained and reviewed for instances of unauthorized access.

Data quality issue 5. Data Security: Loss of data
•Although data sometimes are lost as a result of unauthorized access, more often they are lost in more routine ways
•For example, a computer malfunction can cause data to be erased or lost. •Backing up the data on electronic media such as tapes or disks is commonly done to avoid such losses
•The backup must be done frequently, and the backup media must be kept away from the site where the main system is kept
•If the backup were kept on-site, it would be vulnerable to the same destruction affecting the main system from sources such as fire and flood.

Data quality issue 5. Data Security: Physical security of the system is another consideration.
•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

Data quality issue 5. Data Security: Computer viruses and other malware
•These are computer programs that attack systems and reproduce themselves
•They may alter or destroy data
•Facilities must use antivirus software to combat viruses
•Moreover, they must keep the antivirus software up-to-date because new viruses appear regularly

Data quality issue 5. Data Security: Sensitive data encryption
•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 patient-identifiable information.

Data quality issue 6. Data confidentiality:
Data confidentiality usually refers to efforts to guarantee the privacy of personal health information
•HIPAA-Covered Entities
•Entities not covered by HIPAA

Data quality issue 6. Data confidentiality: HIPAA-Covered Entities; When looking at confidentiality issues, it is important to consider the HIPAA regulations for privacy.
•For HIPAA covered entities, the data collection done by registries is considered part of “healthcare operations.”
•Therefore, the patient does not 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 also comes under “healthcare operations” and does not require patient authorization for release (In Confidence 2003)
•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 patients on their initial encounters. •Through this mechanism, patients are made aware that data about them may be reported to outside entities.

Data quality issue 6. Data confidentiality: Entities not covered by HIPAA
•Not all registries and databases are covered under HIPAA if the organization maintaining them does not bill for patient care services
•Central registries would be an example of registries that are not covered under HIPAA. In such cases, the general norms for data confidentiality should be followed

Data quality issue 7. Data definitions and standards
•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
•If uniform terms are not used, the data will not be consistent
•Also, it will be impossible to make comparisons between systems if 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

Data quality issue 8. Rights of Stakeholders to Rights of Access, Use, and Control
•In the past, a great deal of emphasis has been placed on who owned the data—both primary and secondary
•With the primary data source—the patient health record—the consensus was that the facility owned the patient record while the patient controlled its use
•This consensus has broken down, however, with extensive use of data from the primary data source in secondary data banks that were unknown to patients, much less under their control.
•Emphasis has switched to the rights of stakeholders regarding access, use, and control of both primary and secondary data

Data quality issue 8. Rights of Stakeholders to Rights of Access, Use, and Control; what is a stakeholder? Who are they in healthcare?
•A stakeholder is someone who is affected by an issue
•In the field of health data, the main stakeholders are patients and providers. •In looking back at the four main purposes of collecting secondary data, it is evident that researchers and governments are also stakeholders in this arena

Data quality issue 8. Rights of Stakeholders to Rights of Access, Use, and Control; Transparency
•Patients must be informed that they do not have exclusive ownership of their information but have the right to know what is collected about them and what uses are made of the data
•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

Data quality issue 8. Rights of Stakeholders to Rights of Access, Use, and Control; Role of providers
•Providers must be aware that patients have rights regarding their patient records to access what is collected about them as well as to amend or correct erroneous information
•Patients have a limited right to determine who has access to their primary data
•This right is limited by laws and regulations allowing access to data by governments, researchers, and other legitimate users of the data

Data quality issue 9. Data Exchange and Interoperability
•With the introduction of health information exchange, patient information may be used for patient care by a variety of healthcare providers over disparate healthcare facilities
•Patients may or may not be aware that their information is available for access
•It is important for patients to have an opportunity to know that their data may be involved in data exchange and to have the opportunity to “opt in” or “opt out” of such an exchange

Check your understanding 9.3:
1. Using uniform terminology is a way to improve:
D. Data reliability

Check your understanding 9.3:
2. Which of the following is a true statement about data stewardship?
C. HIM professionals have worked with many data stewardship issues for years

Check your understanding 9.3:
3. A threat to data security is:
B. Malware

Check your understanding 9.3:
4. What is used to check the quality of data entered into an information system?
A. Edits

Check your understanding 9.3:
5. Data security refers to:
B. Controlling access

Check your understanding 9.3: True or false?
6._F___ Now that registries and databases are almost universally computerized, data collection is no longer done manually.
7.__T__ One advantage to a vendor system is that purchasers can find out about the system’s performance from other users.
8.__F__ With regard to data quality, validity refers to the consistency of the data.
9.__F__ The record of transactions in a computer system is called the audit security.
10.__T__ Among the HIM professional’s traditional roles is that of maintaining the confidentiality of health data

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