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Classification Level Data Class Data Class Description Data Element Data Element Description Applicable Standards Submitter Name Submitter Organization Submission Date
Level 0 Vital Signs

Physiologic measurements of a patient that indicate the status of the body’s life sustaining functions.

 Total Intake The total volume that the patient received during a calendar day, through all sources of access (e.g. intravenous, enteral, oral, peritoneal, pleural, intrathecal, intravesicular, rectal)

LOINC 9097-7 Fluid balance 24hrs SNOMED CT 251856003 Fluid balance

 Ali Abbas MD UCSF
Level 0 Vital Signs

Physiologic measurements of a patient that indicate the status of the body’s life sustaining functions.

 Urine Output The total urine output during a calendar day, from all sources including voids, bladder catherization, urostomy, nephrostomy tubes.

LOINC 9097-7 Fluid balance 24hrs SNOMED CT 251856003 Fluid balance

 Ali Abbas MD UCSF
Level 0 Health Status Assessments

Assessments of a health-related matter of interest, importance, or worry to a patient, patient’s family, or patient’s healthcare provider that could identify a need, problem, or condition.

 Insomnia Screening

Insomnia is a very common complaint in the general population and can contribute to a state of inadequate or mistimed sleep, which can affect general health, mental wellbeing and daytime functioning. Several screening tools exist to identify and severity of insomnia, including the Insomnia Severity Index. Insomnia is a common, treatable condition that often goes undiagnosed and can negatively affect general physical and mental health. Insomnia is very common, the American Academy of Sleep Medicine reports that approximately 30% - 40% of US adults report symptoms of insomnia at some point in a given year. Insomnia is a common, treatable condition that often goes undiagnosed and can nagatively affect general physical and mental health. Charles M. Morin, PhD, Geneviève Belleville, PhD, Lynda Bélanger, PhD, Hans Ivers, PhD, The Insomnia Severity Index: Psychometric Indicators to Detect Insomnia Cases and Evaluate Treatment Response, Sleep, Volume 34, Issue 5, 1 May 2011, Pages 601–608, https://doi.org/10.1093/sleep/34.5.601

SNOMED CT, ICD-10/11 and HL7 all contain terminologies that cover Sleep Health. International Statistical Classification of Diseases and Related Health Problems (11th ed,; ICD-11; World Health Organization, 2019) https://www.nlm.nih.gov/healthit/snomedct/index.html https://icd.who.int/en https://www.hl7.org/fhir/terminologies-systems.html

 Christopher M. Miller, MD National Heart Lung and Blood Institute, NIH
Level 0 Newborn's Delivery Information Birth Weight

The weight of the infant/fetus at birth/delivery.

LOINC codes exist for each of the proposed data elements: 11884-4 - Gestational age Estimated 73766-8 - Place where birth occurred [US Standard Certificate of Live Birth] 64710-7 - Was your pregnancy a live birth, stillbirth, miscarriage, abortion, or ectopic pregnancy [PhenX] 8339-4 - Birth weight Measured 8305-5 - Body height --post partum 9272-6 - 1 minute Apgar Score 9274-2 - 5 minute Apgar Score 9271-8 - 10 minute Apgar Score

 TICIA Louise GERBER Health Level Seven International
Level 0 Work Information Job Employer Phone Phone number of the individual's employer. Sarah Gaunt The Association of Public Health Laboratories (APHL)
Level 0 Work Information Job Title

Name of the job position held by an individual.

 Sarah Gaunt The Association of Public Health Laboratories (APHL)
Level 0 Pregnancy Information Number of Prenatal Visits

The total number of prenatal visits for the mother.

LOINC codes exist for each of the proposed data elements:

68493-6: Prenatal visits for this pregnancy #

69044-6: Date first prenatal visit

69461-2 Mother's body weight --at delivery

73772-6 The number of fetal deaths this delivery

73773-4 - Number of infants in this delivery delivered alive

57722-1 - Birth plurality of Pregnancy

 Adam Bazer, MPD Integrating the Healthcare Enterprise USA (IHE USA)
Level 0 Vital Signs

Physiologic measurements of a patient that indicate the status of the body’s life sustaining functions.

 Total Output The total volume that the patient put out during a calendar day, from all sources, including urine, stool, and drains like chest tubes, surgical drains, intrathecal catheters, external ventricular drains, peritoneal catheters.

LOINC 9097-7 Fluid balance 24hrs SNOMED CT 251856003 Fluid balance

 Ali Abbas MD UCSF
Level 0 Medications

Pharmacologic agents used in the diagnosis, cure, mitigation, treatment, or prevention of disease.

 Medication Start/End Date

The start and end date of a medication order.

 Sandi Mitchell J P Systems, Inc.
Level 0 Pregnancy Information Mother’s Prepregnancy Weight

The weight of the mother before becoming pregnant.

LOINC codes exist for each of the proposed data elements: Last menstrual period start date: 8665-2 Delivery date Estimated: 11778-8 Body weight --pre current pregnancy: 56077-1

 Adam Bazer, MPD Integrating the Healthcare Enterprise USA (IHE USA)
Level 0 Outcomes Study

Research study that the subject is enrolled in

HL7.org FHIR R4 v4.0

 Sandi Mitchell J P Systems, Inc.
Level 0 Outcomes Participant(s) Who was involved in the adverse event or the potential adverse event and what they did

HL7.org FHIR R4 v4.0

 Sandi Mitchell J P Systems, Inc.
Level 0 Outcomes Contributing Factor

Contributing factors suspected to have increased the probability or severity of the adverse event

HL7.org FHIR R4 v4.0

 Sandi Mitchell J P Systems, Inc.
Level 0 Outcomes Outcome

Outcome of the event – i.e. death, hospitalization, fever

HL7.org FHIR R4 v4.0

 Sandi Mitchell J P Systems, Inc.
Level 0 Health Status Assessments

Assessments of a health-related matter of interest, importance, or worry to a patient, patient’s family, or patient’s healthcare provider that could identify a need, problem, or condition.

 Sleep Quality

Describes patient sefl-perception of overall sleep quality. Sleep quality can affect general health and can be bi-directionally associated with associated with various diseases and disorders. Several instruments exist for characterizing general sleep quality including the Pittsburgh Sleep Quality Index. Buysse, D. J., Reynolds III, C. F., Monk, T. H., Berman, S. R., & Kupfer, D. J. (1989). The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Research, 28(2), 193–213.

SNOMED CT, ICD-10/11 and HL7 all contain terminologies that cover Sleep Health. International Statistical Classification of Diseases and Related Health Problems (11th ed,; ICD-11; World Health Organization, 2019) https://www.nlm.nih.gov/healthit/snomedct/index.html https://icd.who.int/en https://www.hl7.org/fhir/terminologies-systems.html

 Christopher M. Miller, MD National Heart Lung and Blood Institute, NIH
Level 0 Outcomes Recorder

Who recorded the adverse event

HL7.org FHIR R4 v4.0

 Sandi Mitchell J P Systems, Inc.
Level 0 Explanation of Benefit

Health data as reflected in a patient's Explanation of Benefits (EOB) statements, typically derived from claims and other administrative data.

 Line Noncovered Amount

Medical: The portion of the cost of this service that was deemed not eligible by the insurer because the service or member was not covered by the subscriber contract.
Pharmacy: Non-Covered Amount represents the NCPDP financial response field Amount Exceeding Periodic Benefit Maximum.

NUBC, CPT, HCPCS, HIPPS, ICD-9, ICD-10, DRGs, NDC, POS, NCPDP codes, and X12 codes.

 Mark Roberts Leavitt Partners
Level 0 Health Status Assessments

Assessments of a health-related matter of interest, importance, or worry to a patient, patient’s family, or patient’s healthcare provider that could identify a need, problem, or condition.

 Obstructive Sleep Apnea Screening

The recognition of Obstructive Sleep Apnea (OSA) is important in reducing the disease burden of cardiovascular disease. OSA is strongly correlated with cardiovascular disorders and management of this condition may facilitate better control of cardiovascular disorders leading to improved patient outcomes. Several OSA screening tools exist, including the STOP Questionaire and the Epworth Sleepiness Scale. Chung F, Yegneswaran B, Liao P, et al. STOP Questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology 2008:108;812-21. Johns MW. A new method for measuring daytime sleepiness: The Epworth Sleepiness Scale. Sleep 1991; 14(6):540-5.

SNOMED CT, ICD-10/11 and HL7 all contain terminologies that cover Sleep Health. International Statistical Classification of Diseases and Related Health Problems (11th ed,; ICD-11; World Health Organization, 2019) https://www.nlm.nih.gov/healthit/snomedct/index.html https://icd.who.int/en https://www.hl7.org/fhir/terminologies-systems.html

 Christopher M. Miller, MD National Heart Lung and Blood Institute, NIH
Level 0 Explanation of Benefit

Health data as reflected in a patient's Explanation of Benefits (EOB) statements, typically derived from claims and other administrative data.

 Claim Referring Physician Network Status

Indicates the network status of the referring physician.

NUBC, CPT, HCPCS, HIPPS, ICD-9, ICD-10, DRGs, NDC, POS, NCPDP codes, and X12 codes.

 Mark Roberts Leavitt Partners
Level 0 Vital Signs

Physiologic measurements of a patient that indicate the status of the body’s life sustaining functions.

 Individual Administering Vital Signs

Identify the role of the individual taking the vital signs, differentiating between inputs that are from a care team member, patient or family/caregiver, as separate from an automated device or home monitoring system.

For care team members: Examples include but are not limited to National Provider Identifier (NPI) and National Council of State Boards of Nursing Identifier (NCSBN ID).

For FDA approved devices: FDA Unique Device Identification (UDI) System

 Tayler Williams American Medical Informatics Association (AMIA)