USCDI Export for the Public

The Karnofsky Performance Status (KPS) is a tool used to measure a patient's functional status. It can be used to compare the effectiveness of different therapies and to help assess the prognosis of certain patients, such as those with certain cancers. The KPS score ranges from 0 to 100 in intervals of 10. Higher scores are associated with better functional status, with 100 representing no symptoms or evidence of disease, and 0 representing death.

LOINC, SNOMED-CT, and FHIR see: https://search.loinc.org/searchLOINC/search.zul?query=functional+status http://hl7.org/fhir/us/mcode/ https://browser.ihtsdotools.org/?perspective=full&conceptId1=273472005&edition=MAIN/2020-07-31&release=&languages=en

In the past year whether patient has been able to unable to find affordable or pay for childcare. (LOINC) LA30127-7 Synonyms: (ICD-10-CM) Z59.68 (Unable to pay for child care)

LOINC 93031-3 In the past year, have you or any family members you live with been unable to get any of the following when it was really needed?

In the past year whether patient has been unable to afford or access medicine or or any health care (medical, dental, mental health, vision) services. (LOINC) LA30128-5 LA15832-1 (Very hard), 2; LA14745-6 (Hard), 3; LA22683-9 (Somewhat)" Synonyms: (SNOMEDCT) 423593006 Inadequate healthcare resources (ICD-10-CM) Z59.63 (Unable to pay for medical care) Z59.61 (Unable to pay for prescriptions)

LOINC 93031-3 In the past year, have you or any family members you live with been unable to get any of the following when it was really needed?

In the past year whether patient has been unable to afford or access a phone. (LOINC) LA30129-3 LA13918-0 (With little difficulty), 3; LA13920-6 (with some difficulty), 2; LA13919-8 (With much difficulty) Synonyms: (SNOMEDCT) 5501000175107 Lack of telephone in home environment (ICD-10-CM) Z59.65 (Unable to pay for phone)

LOINC 93031-3 In the past year, have you or any family members you live with been unable to get any of the following when it was really needed?

Inability to pay for, threat of shutoff and lack of access to utilities. (LOINC) LA30124-4 : Synonyms: (ICD-10-CM) Z59.1 Inadequate housing (lack of heat, restriction of space, technical home defects, unsatisfactory surroundings) Z59.62 (Unable to pay for utilities)

LOINC 93031-3 In the past year, have you or any family members you live with been unable to get any of the following when it was really needed?

The AJCC Cancer Staging System describes the severity of an individual's cancer based on the magnitude of the original (primary) tumor as well as on the extent cancer has spread in the body. Understanding the stage of the cancer helps doctors to develop a prognosis and design a treatment plan for individual patients. The AJCC Cancer Staging System classifies cancers by the size and extent of the primary tumor (T), involvement of regional lymph nodes (N), and the presence or absence of distant metastases (M), supplemented in recent years by evidence-based prognostic and predictive factors. There is a T,N,M staging algorithm for cancers of virtually every anatomic site and histology, with the primary exception of pediatric cancers. The three categories—T, N, and M—and the prognostic factors collectively describe, with rare exceptions, the extent of tumor, including local spread, regional nodal involvement, and distant metastasis. It is important to stress that each component (T, N, and M) is referred to as a Category. The term stage is used when T, N, and M and cancer site–specific required prognostic factors are combined. The Criteria for T, N, and M are defined separately for cancers in different anatomic locations and/or for different histologic types.

SNOMED CT has content related to the AJCC T category under the hierarchy of 385356007 'Tumor stage finding' but it is outdated and inaccurate. SNOMED CT codes do not always make a distinction between clinical and pathological classifications (e.g. cT1 and pT1) and are represented by the same SNOMED CT code 23351008 'T1 category'). SNOMED CT does not have complete T,N,M staging terminology and is an incomplete data set. Most importantly, the SNOMED structure is not a good fit for the AJCC data elements that can change as new editions/versions of the AJCC Cancer Staging System are published. However, the AJCC is planning on submitting the data elements to the National Library of Medicine’s Value Set Authority Center (VSAC), in parallel to the submission to USCDI. The AJCC feels that VSAC would be an appropriate centralized repository for AJCC data elements. This would facilitate EHR systems' use of the data elements that the AJCC develops and maintains.

Type of the event itself in relation to the subject

adverse events are mapped to MedDRA terminology

Information on the possible cause of the event

adverse events are mapped to MedDRA terminology

Medical orders guide what medical interventions providers will perform for a patient. A portable medical order is a type of medical order. Portable medical orders are not authored by patients. They are authored by practitioners in the context of an electronic medical record system. The medical orders are provided to the patient in the form of a document so the orders can travel with the patient and be exchanged with other care providers who do not have access to the EMR where the orders originated. Medical orders regarding life-sustaining treatments are established by a practitioner regarding treatments that restore, sustain or prolong a patient’s life. These types of medical orders are intended to be consistent with the patient’s instructions and wishes. Orders to perform or not perform specific types of life-sustaining treatments are documented by physicians as medical orders within the EMR system used by the organization providing medical interventions or the practitioner’s EMR. When medical orders regarding life-sustaining treatment are produced in a portable format, they are portable medical orders for life-sustaining treatment. Currently, there is no national standard for the expected content in a portable medical order for life-sustaining treatments, as the content can vary by State and EMR system. All doctors, emergency medical professionals, and other healthcare professionals, must follow these medical orders as the patient moves from one location to another (hospital, care facility, home, etc.), unless a treating physician examines the patient, reviews the medical order for life-sustaining treatment, and through conversation with the patient detects the need for a replacement order or as a result of their own clinical judgement creates a replacement order. In an emergency situation, characterized by a life-threatening health crisis, if the patient is unable to speak for themselves, life-sustaining treatments and procedures that are legally required of medical and emergency personnel can be overridden by a valid portable medical order. Depending on the state, a portable medical order may go by any of the following names: • MOLST (Medical Orders for Life-Sustaining Treatment) • POLST (Physician Orders for Life-Sustaining Treatment) • MOST (Medical Orders for Scope of Treatment) • POST (Physician Orders for Scope of Treatment) • TPOPP (Transportable Physician Orders for Patient Preferences) • Out-of-hospital Do Not Resuscitate (DNR) Orders The above forms have historically been paper-based and siloed in EMRs that might contain a scanned image, or a clinical note that details the decisions documented in the portable medical order. Emergency and treating care teams do not have mechanisms for establishing that the copy they are provided is the most current version and that another, more recent portable medical order doesn’t exist that would contradict the order they are reviewing. These uploaded copies of the portable medical order for life-sustaining treatment are considered to be just as valid as the original paper medical order that was provided by a physician to the patient for whom it was written. The currently supported digital interchange format for portable medical orders is a pdf document, as there are not standard interoperable data elements. The pdf document can be represented as a C-CDA Unstructured Document or a FHIR DocumentReference to enable key administrative information to be processed.

Portable Medical Orders for Life Sustaining Treatment The currently supported digital interchange format for portable POLST orders is a pdf document. The pdf document can be represented as a C-CDA Unstructured Document or a FHIR DocumentReference to enable key administrative information to be processed. There is no standard guidance about the expected content in a portable medical order for life sustaining treatments. The content varies by state and by EMR system. Portable Medical Orders for Life Sustaining treatment are a type of Medical Order. Data Element Code Definition Portable medical order form 93037-0 LOINC urn:oid:2.16.840.1.113883.6.1 Physician Order for Scope of Treatment which encompasses Physician Orders for Life-Sustaining Treatment (POLST) or Medical Orders for Life-Sustaining Treatment (MOLST). MOLST Observation In the context of a Patient Summary or Encounter Summary authored by a clinician or assembled by clinician’s EMR system, observations verifying a patient’s advance directive information and medical orders for life sustaining treatments using established standards for recording this type of information documented by providers. If a person has a medical order or physician order for life sustaining treatment (MOLST or POLST). This observation does not indicate what orders are included in the MOLST or POLST. It indicates if a MOLST or POLST exists. If a MOLST or POLST exists, the template includes a reference structure that can be used to point to the MOLST or POLST document. The vocabulary and structure needed to express this observation is provided in the HL7 CDA® R2 Implementation Guide: Personal Advance Care Plan (PACP) Document, Release 1 - US Realm STU Release 2 August 2020 Volume 2 – Templates. This observation can be used to document a patient authored statement about portable medical orders for life sustaining treatments or physician authored statements about there being portable medical orders for life sustaining treatments. Note that a physician’s own medical orders placed for life sustaining treatments are documented as medical orders placed within the physician’s own EMR.

The Distince Identification code (aka Donation Identification Number (DIN)) is applicable to devices that are also regulated as HCT/Ps and is a number that is assigned to each donation. This number/code is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeling, distribution and use to be determined. Taken from FDA Data Elements Reference Table - see https://www.fda.gov/media/88408/download

Please see FDA UDI regulation and FDA Data Elements Reference Table - see https://www.fda.gov/media/88408/download. Please see FDA Formats by Accredited Issuing Agency that shows the structured of each of the parts of the UDI as a complete standard - https://www.fda.gov/media/96648/download UDI-DI and all AccessGUDID data elements are listed in NCI Thesaurus. See https://www.nlm.nih.gov/research/umls/sourcereleasedocs/current/NCI_FDA/index.html#:~:text=%20The%20NCI%20Thesaurus%20includes%20the%20following%20FDA,Global%20Unique%20Device%20Identification%20Database%20%28GUDID%29%20More%20

The date by which the label of a device states the device must or should be used. Taken from FDA Data Elements Reference Table - see https://www.fda.gov/media/88408/download

Please see FDA UDI regulation and FDA Data Elements Reference Table - see https://www.fda.gov/media/88408/download. Please see FDA Formats by Accredited Issuing Agency that shows the structured of each of the parts of the UDI as a complete standard - https://www.fda.gov/media/96648/download UDI-DI and all AccessGUDID data elements are listed in NCI Thesaurus. See https://www.nlm.nih.gov/research/umls/sourcereleasedocs/current/NCI_FDA/index.html#:~:text=%20The%20NCI%20Thesaurus%20includes%20the%20following%20FDA,Global%20Unique%20Device%20Identification%20Database%20%28GUDID%29%20More%20

The custodian is the organization that is in charge of maintaining and is entrusted with the care of the document.

The date on which a device is manufactured. Taken from FDA Data Elements Reference Table - see https://www.fda.gov/media/88408/download

Please see FDA UDI regulation and FDA Data Elements Reference Table - see https://www.fda.gov/media/88408/download. Please see FDA Formats by Accredited Issuing Agency that shows the structured of each of the parts of the UDI as a complete standard - https://www.fda.gov/media/96648/download UDI-DI and all AccessGUDID data elements are listed in NCI Thesaurus. See https://www.nlm.nih.gov/research/umls/sourcereleasedocs/current/NCI_FDA/index.html#:~:text=%20The%20NCI%20Thesaurus%20includes%20the%20following%20FDA,Global%20Unique%20Device%20Identification%20Database%20%28GUDID%29%20More%20

The number assigned to one or more device(s) that consists of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. Taken from FDA Data Elements Reference Table - see https://www.fda.gov/media/88408/download

Please see FDA UDI regulation and FDA Data Elements Reference Table - see https://www.fda.gov/media/88408/download. Please see FDA Formats by Accredited Issuing Agency that shows the structured of each of the parts of the UDI as a complete standard - https://www.fda.gov/media/96648/download UDI-DI and all AccessGUDID data elements are listed in NCI Thesaurus. See https://www.nlm.nih.gov/research/umls/sourcereleasedocs/current/NCI_FDA/index.html#:~:text=%20The%20NCI%20Thesaurus%20includes%20the%20following%20FDA,Global%20Unique%20Device%20Identification%20Database%20%28GUDID%29%20More%20

For both Clinical (cM) and Pathological (pM) the M Category is defined as the absence or presence of distant metastases in sites and/or organs outside the local tumor area and regional nodes as defined for each cancer site. For some cancer sites, the location and volume or burden of distant metastases are included. Distant Metastasis (M) Categories: The distant metastasis category specifies whether distant metastasis is present. M0 No evidence of distant metastasis M1 Distant metastasis

SNOMED CT has content related to the AJCC T category under the hierarchy of 385356007 'Tumor stage finding' but it is outdated and inaccurate. SNOMED CT codes do not always make a distinction between clinical and pathological classifications (e.g. cT1 and pT1) and are represented by the same SNOMED CT code 23351008 'T1 category'). SNOMED CT does not have complete T,N,M staging terminology and is an incomplete data set. Most importantly, the SNOMED structure is not a good fit for the AJCC data elements that can change as new editions/versions of the AJCC Cancer Staging System are published. However, the AJCC is planning on submitting the data elements to the National Library of Medicine’s Value Set Authority Center (VSAC), in parallel to the submission to USCDI. The AJCC feels that VSAC would be an appropriate centralized repository for AJCC data elements. This would facilitate EHR systems' use of the data elements that the AJCC develops and maintains.

The number that allows for the identification of a device, indicating its position within a series.Taken from FDA Data Elements Reference Table - see https://www.fda.gov/media/88408/download

Please see FDA UDI regulation and FDA Data Elements Reference Table - see https://www.fda.gov/media/88408/download. Please see FDA Formats by Accredited Issuing Agency that shows the structured of each of the parts of the UDI as a complete standard - https://www.fda.gov/media/96648/download UDI-DI and all AccessGUDID data elements are listed in NCI Thesaurus. See https://www.nlm.nih.gov/research/umls/sourcereleasedocs/current/NCI_FDA/index.html#:~:text=%20The%20NCI%20Thesaurus%20includes%20the%20following%20FDA,Global%20Unique%20Device%20Identification%20Database%20%28GUDID%29%20More%20

Cancer patients with similar prognoses are grouped by using prognostic stage group tables. Clinical and pathological stage groups are defined for each case as appropriate. These disease-specific groups are composed of the following categories: • cT, cN, and cM or pM • pT, pN, and cM or pM • factors for both groups, if applicable Rules for assigning prognostic stage groups: Prognostic stage groups are based on combinations of T, N, M, and relevant prognostic factors and usually define groups of patients with similar outcomes to help define prognosis and appropriate treatment, as well as to enable comparisons of similar groups of patients between institutions and over time.

SNOMED CT has content related to the AJCC T category under the hierarchy of 385356007 'Tumor stage finding' but it is outdated and inaccurate. SNOMED CT codes do not always make a distinction between clinical and pathological classifications (e.g. cT1 and pT1) and are represented by the same SNOMED CT code 23351008 'T1 category'). SNOMED CT does not have complete T,N,M staging terminology and is an incomplete data set. Most importantly, the SNOMED structure is not a good fit for the AJCC data elements that can change as new editions/versions of the AJCC Cancer Staging System are published. However, the AJCC is planning on submitting the data elements to the National Library of Medicine’s Value Set Authority Center (VSAC), in parallel to the submission to USCDI. The AJCC feels that VSAC would be an appropriate centralized repository for AJCC data elements. This would facilitate EHR systems' use of the data elements that the AJCC develops and maintains.

Date (and optionally time) when specimen was received by the testing laboratory

V2 = SPM-18 (Specimen Received Date/Time) https://www.hl7.eu/refactored/segSPM#248 and also in OBR-14 (Specimen Received Date/Time) = https://www.hl7.eu/refactored/segOBR.html#248 in versions before SPM segment was added, in FHIR = https://build.fhir.org/specimen-definitions.html#Specimen.receivedTime

The DI portion of the UDI placed on the lowest package level of a device that is required to meet UDI label requirements. If the device is not packaged, the UDI may be on the device itself, thereby satisfying both the UDI label and the direct mark (DM) requirement if the UDI is intended to be permanent. The primary DI is the main (primary) lookup for a medical device and meets the requirements to uniquely identify a device through its distribution and use. Taken from FDA Data Elements Reference Table - see https://www.fda.gov/media/88408/download

Please see FDA UDI regulation and FDA Data Elements Reference Table - see https://www.fda.gov/media/88408/download. Please see FDA Formats by Accredited Issuing Agency that shows the structured of each of the parts of the UDI as a complete standard - https://www.fda.gov/media/96648/download UDI-DI and all AccessGUDID data elements are listed in NCI Thesaurus. See https://www.nlm.nih.gov/research/umls/sourcereleasedocs/current/NCI_FDA/index.html#:~:text=%20The%20NCI%20Thesaurus%20includes%20the%20following%20FDA,Global%20Unique%20Device%20Identification%20Database%20%28GUDID%29%20More%20

For both Clinical (cT), Pathological (pT) and Neoadjuvant (ycT or ypT), the T Category is defined as the size and/or contiguous extension of the primary tumor. Note: The roles of the size component and the extent of contiguous spread are specifically defined for each cancer site. Primary Tumor (T) Categories: Primary tumor categories have specific notations to describe the existence, size, or extent of the tumor. TX: No information about the T category for the primary tumor, or it is unknown or cannot be assessed T0: No evidence of a primary tumor Tis: Carcinoma in situ T1, T2, T3, or T4: Primary invasive tumor, for which a higher category generally means • an increasing size • an increasing local extension, or • both

SNOMED CT has content related to the AJCC T category under the hierarchy of 385356007 'Tumor stage finding' but it is outdated and inaccurate. SNOMED CT codes do not always make a distinction between clinical and pathological classifications (e.g. cT1 and pT1) and are represented by the same SNOMED CT code 23351008 'T1 category'). SNOMED CT does not have complete T,N,M staging terminology and is an incomplete data set. Most importantly, the SNOMED structure is not a good fit for the AJCC data elements that can change as new editions/versions of the AJCC Cancer Staging System are published. However, the AJCC is planning on submitting the data elements to the National Library of Medicine’s Value Set Authority Center (VSAC), in parallel to the submission to USCDI. The AJCC feels that VSAC would be an appropriate centralized repository for AJCC data elements. This would facilitate EHR systems' use of the data elements that the AJCC develops and maintains.