USCDI Export for the Public

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 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

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.

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.

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 (cN), Pathological (pN) and Neoadjuvant (ycN or ypN), the N Category is defined as Cancer in the regional lymph nodes as defined for each cancer site, including • absence or presence of cancer in regional node(s), and/or • number of positive regional nodes, and/or • involvement of specific regional nodal groups, and/or • size of nodal metastasis or extension through the regional node capsule, and/or • In-transit and satellite metastases, somewhat unique manifestations of nonnodal intralymphatic regional disease, usually found between the primary tumor site and draining nodal basins. Regional Lymph Node (N) Categories Categorizing regional lymph node involvement depends on its existence and extent. NX No information about the N category for the regional lymph nodes, or it is unknown or cannot be assessed N0 No regional lymph node involvement with cancer and for some disease sites, nonnodal regional disease as noted earlier N1, N2, or N3 Evidence of regional node(s) containing cancer, with • an increasing number, and/or • regional nodal group involvement, and/or • size of the nodal metastatic cancer deposit, or • non-nodal regional disease as noted earlier for melanoma and Merkel cell carcinoma, and for colorectal carcinoma

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.

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.

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.

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

Inability to obtain or purchase adequate clothing or to wash and maintain clothing in adequate condition. (LOINC) LA30126-9 Synonym: (SNOMEDCT) 46017004 Clothing disheveled 248164005 Clothing dirty 225521004 Clothes need changing " (ICD-10-CM) Z59.66 (Lack of adequate clothing)

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?

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?

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 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?

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

A measure of the estimated average quantity of tobacco product used in a 24hr period. o Smoking Tobacco Use A general estimate of the number of cigarettes, cigars, or bowls (pipe) with Nicotine smoked in a 24hr period. Question Prompt: Average number of cigarettes, cigars, or bowls (pipe) smoked per day o E-Cigarettes Use Count of the number of disposable cigarettes, prefilled cartridges/pods, or refillable bottles with nicotine smoked in a 24hr period. Question Prompt: Average number of disposable e-cigarettes, prefilled cartridges/pods, or refillable bottles smoked per day o Smokeless Tobacco Use Amount of smokeless Tobacco consumed in a 24hr period. Question Prompt: Average number of pinches of smokeless tobacco consumed per day

There are SNOMED and LOINC Codes for most of the data elements but new codes will be requested for eCigarette use.

A question about how often an individual uses or used any tobacco product. An ordered reference standard related to the use of tobacco within a period of time. Element from the TAPS Tool: In the PAST 12 MONTHS, how often have you used any tobacco product (for example, cigarettes, e-cigarettes, cigars, pipes, or smokeless tobacco)? Value: 1. Daily or almost daily (displayed as "0"): a subjective response that something happens daily or almost daily 2. Weekly (displayed as "1"): Every week 3. Monthly (displayed as "2"): Every month 4. Less than Monthly (displayed as "3"): An event that occurs less frequently than once a month 5. Never (displayed as "4"): Not ever, at no time in the past (or future).

Elements were recently submitted for inclusion in LOINC.

Use of the tobacco plant leaf or its products. The predominant use of tobacco is by smoke inhalation of cigarettes, pipes, and cigars. Smokeless tobacco refers to a variety of tobacco products that are either sniffed, sucked, or chewed. An electronic cigarette is a vaporizer device that simulates smoking by providing some of the aspects of smoking that includes nicotine but without combusting tobacco. These products include psychoactive ingredient, nicotine. Question Prompt: Any use of tobacco (or nicotine-containing) products? Permissible Values: o Never (SNOMED: 702979003) An individual who has never consumed tobacco products in their lifetime. o Former (SNOMED: 702975009) An individual who has consumed tobacco products in his or her lifetime but who had quit consumption at the time of question. o Current - Daily (SNOMED: TBD) An individual who has consumed tobacco products in his or her lifetime, and who does so every day. o Current - Occasionally (SNOMED: TBD) An individual who has consumed tobacco products in his or her lifetime, who uses now, but does not use every day. o Unknown (SNOMED: TBD) An individual for whose tobacco product use is unknown.

There are SNOMED and LOINC Codes for most of the data elements but new codes will be requested for eCigarette use.

Lack of voluntary control over urination or defecation

LOINC