ARCHETYPE Medication safety event (openEHR-EHR-EVALUATION.medication_safety_event.v1)

ARCHETYPE IDopenEHR-EHR-EVALUATION.medication_safety_event.v1
ConceptMedication safety event
DescriptionSummary of a patient safety event associated with medication for reporting purposes.
PurposeTo record a summary of a patient safety event associated with medication for reporting purposes.
References
Copyright© openEHR Foundation
AuthorsAuthor name: Dr Ian McNicoll
Organisation: Ocean Informatics, UK
Email: ian.mcnicoll@oceaninformatics.com
Date originally authored: 25/06/2012
Other Details LanguageAuthor name: Dr Ian McNicoll
Organisation: Ocean Informatics, UK
Email: ian.mcnicoll@oceaninformatics.com
Date originally authored: 25/06/2012
OtherDetails Language Independent{MD5-CAM-1.0.1=DE77C8A5A958AD6D3C30B89716CBF495}
Keywords
LifecycleAuthorDraft
Language useden
Citeable Identifier1013.1.1866
AllArchetype [runtimeNameConstraintForConceptName=null, archetypeConceptBinding=null, archetypeConceptDescription=Summary of a patient safety event associated with medication for reporting purposes., archetypeConceptComment=null, otherContributors=Anže Droljc, Marand s.i.i, Slovenia, originalLanguage=en, translators=Slovenian: ?
, subjectOfData=unconstrained, archetypeTranslationTree=null, topLevelToAshis={identities=[], other_participations=[], credentials=[], description=[], relationships=[], ism_transition=[], activities=[], items=[], data=[ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0235], code=at0235, itemType=ELEMENT, level=2, text=Main event for case?, description=Is this the principal or main event recorded during the case?, comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_BOOLEAN, bindings=null, values=Allowed values: {true}, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0002], code=at0002, itemType=ELEMENT, level=2, text=Safety event type, description=The type of event reported., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
New constraint
*

Constraint binding:
[SafetyEventType]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0003], code=at0003, itemType=ELEMENT, level=2, text=MEDRA classification, description=The category of event reported using MedDRA classification., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
*New constraint(sl)
**(sl)
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0004], code=at0004, itemType=ELEMENT, level=2, text=DateTime of event onset, description=The date and/or time that the adverse event took place., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0041], code=at0041, itemType=ELEMENT, level=2, text=Description of event, description=A narrative description of the medication safety event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0233], code=at0233, itemType=CLUSTER, level=2, text=Cause of event, description=Details of the estimated cause of the event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0233]/items[at0062], code=at0062, itemType=ELEMENT, level=3, text=Estimated cause of event, description=The reason suspected for this event occurring., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Verbal miscommunication [Verbal understanding]
  • Written miscomunication-Illegible handwritting [Written understanding]
  • Written miscomunication-Abbreviations [Illegible writing]
  • Written miscomunication-Non metric units of measurement [*]
  • Written miscomunication-Decimal point [*]
  • Misread or didnt read [*]
  • Misinterpretation of the order [*]
  • Sound-alike drug name [*]
  • Look-alike drug name [*]
  • Packaging-Inappropriate Packaging or Design [*]
  • Packing-Dosage form [*]
  • Packaging-Error due to similarity to another drug (colour, form, size) [*]
  • Packaging-Error due different strength [*]
  • Characteristics of the medicine [*]
  • Human factors-Lack of information/knowledge [*]
  • Work not accomplished [*]
  • Incomplete documentation [*]
  • Work overload, burn out syndrome [*]
  • Fatigue/Lack of sleep [*]
  • Confrontational or intimidating behaviour [*]
  • Control not carried out [*]
  • Inappropriate lighting [*]
  • Inappropriate temperature/humidity [*]
  • Frequent interuptions and distractions [*]
  • Lack of staff [*]
  • Other [*]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0233]/items[at0234], code=at0234, itemType=ELEMENT, level=3, text=Comment, description=An additional comment on the estimated cause of the event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0020], code=at0020, itemType=ELEMENT, level=2, text=Related trigger, description=Triggers thought to be related to this safety event recorded using IHCI classification., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of:
  •  Coded Text
    • Transfusion of Blood or Use of Blood Products [**(en)]
    • Acute Dialysis [**(en)]
    • Positive Blood Culture [**(en)]
    • X-Ray or Doppler Studies for Emboli or Deep Vein Thrombosis [**(en)]
    • Decrease in Hemoglobin or Hematocrit of 25% or Greater [**(en)]
    • Patient Fall [**(en)]
    • Pressure Ulcers [**(en)]
    • Readmission within 30 Days [**(en)]
    • Restraint Use [**(en)]
    • Healthcare-Associated Infections [**(en)]
    • In-Hospital Stroke [**(en)]
    • Clostridium difficile Positive Stool [**(en)]
    • Partial Thromboplastin Time (PTT) Greater than 100 Seconds [**(en)]
    • International Normalized Ratio (INR) Greater than 6 [**(en)]
    • Glucose Less than 50 mg/dl [**(en)]
    • Rising BUN or Serum Creatinine Two Times (2x) over Baseline [**(en)]
    • Vitamin K Administration [**(en)]
    • Diphenhydramine (Benadryl) Administration [**(en)]
    • Romazicon (Flumazenil) Administration [**(en)]
    • Naloxone (Narcan) Administration [**(en)]
    • Anti-Emetic Administration [**(en)]
    • Over-Sedation/Hypotension [**(en)]
    • Abrupt Medication Stop [**(en)]
    • Intra- or Post-Operative Death [**(en)]
    • Mechanical Ventilation Greater than 24 Hours Post-Operatively [**(en)]
    • Intra-Operative Administration of Epinephrine, Norepinephrine, Naloxone, or Romazicon [**(en)]
    • Pneumonia Onset [**(en)]
    • Readmission to the Intensive Care Unit [**(en)]
    • Terbutaline Use [**(en)]
    • Platelet Count Less than 50,000 [**(en)]
    • Administration of Oxytocic Agents (such as oxytocin, methylergonovine, and 15-methyl-prostaglandin in the post-partum period) [**(en)]
    • Administration of General Anesthesia [**(en)]
    • Readmission to the ED within 48 Hours [**(en)]
    • Time in ED Greater than 6 Hours [**(en)]
    • Abnormal laboratory parameter [*]
    • Falsely abnormal laboratory parameter [*]
    • Unknown [**(en)]
    • No trigger [*]
  •  Text
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018], code=at0018, itemType=CLUSTER, level=2, text=Adverse effect, description=Details of one or more side effects., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0345], code=at0345, itemType=CLUSTER, level=3, text=Reaction details, description=Details of reaction, comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0345]/items[at0021], code=at0021, itemType=ELEMENT, level=4, text=Reaction, description=Description of the side-effect reported or observed using MEDRA or ATC codes., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
*New constraint(sl)
**(sl)
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0345]/items[at0346], code=at0346, itemType=ELEMENT, level=4, text=Comment, description=An additional comment on the Reaction details., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0108], code=at0108, itemType=ELEMENT, level=3, text=DateTime of reaction onset, description=The datetime at which the side effects began., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0222], code=at0222, itemType=ELEMENT, level=3, text=Severity, description=The severity of the reaction., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Low [*]
  • Medium [*]
  • High [*]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0022], code=at0022, itemType=ELEMENT, level=3, text=Liklihood of causation, description=An estimate of how likely the side-effects noted are due to the safety event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Low [*]
  • Medium [*]
  • High [*]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0236], code=at0236, itemType=CLUSTER, level=3, text=Intervention details, description=Details of interventions., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0236]/items[at0347], code=at0347, itemType=CLUSTER, level=4, text=Intervention additional details, description=*, comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0236]/items[at0347]/items[at0012], code=at0012, itemType=ELEMENT, level=5, text=Intervention, description=The clinical intervention undertaken to resolve or ameliorate the adverse effect, uses PCNE terminology., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Prescriber informed [**(en)]
  • Nurse informed/instructed [**(en)]
  • Dispensing rejected [**(en)]
  • Drug recalled from the ward [**(en)]
  • Dietary regime changed [**(en)]
  • Food supplement discontinued [**(en)]
  • Food supplement initiated [**(en)]
  • Reconstitution solvent changed [**(en)]
  • Diluent changed [**(en)]
  • Medical device (or change) suggested [*]
  • Drug changed [**(en)]
  • Dose increased [**(en)]
  • Dose decreased [**(en)]
  • Dosage form changed [**(en)]
  • Administration interval changed [**(en)]
  • Drug discontinued [**(en)]
  • Drug initiated [**(en)]
  • Drug administration rate changed [**(en)]
  • Route of administration changed [**(en)]
  • Resuscitation required [**(en)]
  • Heamodialysis required [**(en)]
  • Transplantation required [**(en)]
  • Transfusion required [**(en)]
  • Operating procedure required [**(en)]
  • Additional laboratory test(s) required [**(en)]
  • Physiotherapy required [**(en)]
  • Psychotherapy required [**(en)]
  • Error corrected [*]
  • Monitoring required [*]
  • Patient informed [*]
  • Other [**(en)]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0236]/items[at0347]/items[at0348], code=at0348, itemType=ELEMENT, level=5, text=Comment, description=*, comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0236]/items[at0014], code=at0014, itemType=ELEMENT, level=4, text=Intervention result, description=The result(s) of any interventions undertaken, recorded using MEDRA classification subset., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • *Intervencija preprečila, da bi zaplet dosegel pacienta(en) [*(en)]
  • *Intervencija popolnoma odpravila posledice, ki jih je zaplet povzročil pacientu(en) [*(en)]
  • *Intervencija delno odpravila posledice, ki jih je zaplet povzročil pacientu(en) [*(en)]
  • *Intervencija ni odpravila posledic, ki jih je zaplet povzročil pacientu(en) [*(en)]
  • *Intervencija ni bila možna(en) [*(en)]
  • *Rezultat intervencije ni poznan(en) [*(en)]
  • *Zmanjšanje stroškov zdravljenja(en) [*(en)]
  • *Skrajšan čas hospitalizacije(en) [*(en)]
  • *Pacient je bil odpuščen(en) [*(en)]
  • *Izboljšana kvaliteta življenja(en) [*(en)]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0353], code=at0353, itemType=ELEMENT, level=2, text=Side effect recurrence, description=This information is aplicable when at least one Intervention is Dose decreased or Drug discontinued, comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Yes [*]
  • No [*]
  • NA [*]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0349], code=at0349, itemType=CLUSTER, level=2, text=Actual patient outcome details, description=*, comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0349]/items[at0042], code=at0042, itemType=ELEMENT, level=3, text=Actual patient outcome, description=The overall impact actually experienced by the patient., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • [A] Circumstances or events that have the capacity to cause error [*]
  • [B] An error that did not reach the patient [*]
  • [C] An error that reached the patient but did not cause harm [*]
  • [D] An error that reache the patient and reqired monitoring or intervention to confirm that it resulted in no harm to the patient [*]
  • [E] Temporary harm to the patient and required intervention [*]
  • [F] Temporary harm to the patient and required initial or prolonged hospitalization [*]
  • [G] Permanent patient harm [*]
  • [H] Intervention required to sustain life [*]
  • [I] Patient death [*]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0349]/items[at0350], code=at0350, itemType=ELEMENT, level=3, text=Comment, description=An additional comment on the Actual patient outcome comment., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0231], code=at0231, itemType=ELEMENT, level=2, text=Potential patient outcome, description=An assessment of potential impact on the patient if interventions had been unsuccesful. Uses the MERP index. other remediation had not occured., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • [A] Circumstances or events that have the capacity to cause error [*]
  • [B] An error that did not reach the patient [*]
  • [C] An error that reached the patient but did not cause harm [*]
  • [D] An error that reache the patient and reqired monitoring or intervention to confirm that it resulted in no harm to the patient [*]
  • [E] Temporary harm to the patient and required intervention [*]
  • [F] Temporary harm to the patient and required initial or prolonged hospitalization [*]
  • [G] Permanent patient harm [*]
  • [H] Intervention required to sustain life [*]
  • [I] Patient death [*]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0043], code=at0043, itemType=ELEMENT, level=2, text=Patient outcome category, description=The caetgory of impact on the patient's life., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Clinical [*]
  • Personal [*]
  • Economic [*]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0232], code=at0232, itemType=ELEMENT, level=2, text=Additional comment, description=Any additional comment or narrative., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237], code=at0237, itemType=CLUSTER, level=2, text=Summary details, description=Details included only in Case Summary., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0238], code=at0238, itemType=ELEMENT, level=3, text=Admission diagnosis classification, description=Admission diagnosis using ICD classification., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
*New constraint(sl)
**(sl)
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0239], code=at0239, itemType=ELEMENT, level=3, text=Discharge diagnosis classification, description=Discharge diagnosis using ICD classification., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
*New constraint(sl)
**(sl)
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0249], code=at0249, itemType=ELEMENT, level=3, text=Link to main event, description=A link to the main case event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_EHR_URI, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241], code=at0241, itemType=CLUSTER, level=3, text=Oncological case details, description=Details required for oncological cases., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241]/items[at0240], code=at0240, itemType=ELEMENT, level=4, text=TNM classification, description=Malignant disease classification using TNM., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
*New constraint(sl)
**(sl)
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241]/items[at0244], code=at0244, itemType=ELEMENT, level=4, text=Effectiveness of therapy, description=*, comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Completely effective [The therapy has been fully effective.]
  • Partially effective [The therpay has been partially effective.]
  • Disease status unchanged [*]
  • Ineffective - disease progressing unchecked. [The therapy has been ineffective and the disease is progressing unchecked.]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241]/items[at0242], code=at0242, itemType=ELEMENT, level=4, text=Order of treatment, description=???????, comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241]/items[at0243], code=at0243, itemType=ELEMENT, level=4, text=Reason for case closure, description=Reason for the case being closed., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Treatment complete [*]
  • Treatment aborted [*]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241]/items[at0268], code=at0268, itemType=ELEMENT, level=4, text=Reason treatment aborted, description=The reason why the treatment was aborted., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0351], code=at0351, itemType=ELEMENT, level=2, text=Medications involved, description=The medicine, vaccine or other therapetic good being ordered, administered to or used by the subject, comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0352], code=at0352, itemType=ELEMENT, level=2, text=Medications administered, description=Medications administered is used to enter wrongly administered drug for Safety event type *at0254 Pacient dobil drugo zdravilo od predpisanega* Wrong drug administered to a patient, comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null]], capabilities=[], state=[], context=[], events=[], source=[], content=[], target=[], details=[], provider=[], protocol=[], contacts=[]}, topLevelItems={data=ResourceSimplifiedHierarchyItem [path=ROOT_/data[at0001], code=at0001, itemType=ITEM_TREE, level=0, text=null, description=null, comment=null, uncommonOntologyItems=null, occurencesFormal=1..1, occurencesText=Mandatory, cardinalityFormal=1..1, cardinalityText=mandatory, subCardinalityFormal=0..*, subCardinalityText=Minimum of 0 items, dataType=ITEM_TREE, bindings=null, values=null, extendedValues=null]}, addHierarchyItemsTo=data, currentHierarchyItemsForAdding=[ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0235], code=at0235, itemType=ELEMENT, level=2, text=Main event for case?, description=Is this the principal or main event recorded during the case?, comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_BOOLEAN, bindings=null, values=Allowed values: {true}, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0002], code=at0002, itemType=ELEMENT, level=2, text=Safety event type, description=The type of event reported., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
New constraint
*

Constraint binding:
[SafetyEventType]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0003], code=at0003, itemType=ELEMENT, level=2, text=MEDRA classification, description=The category of event reported using MedDRA classification., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
*New constraint(sl)
**(sl)
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0004], code=at0004, itemType=ELEMENT, level=2, text=DateTime of event onset, description=The date and/or time that the adverse event took place., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0041], code=at0041, itemType=ELEMENT, level=2, text=Description of event, description=A narrative description of the medication safety event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0233], code=at0233, itemType=CLUSTER, level=2, text=Cause of event, description=Details of the estimated cause of the event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0233]/items[at0062], code=at0062, itemType=ELEMENT, level=3, text=Estimated cause of event, description=The reason suspected for this event occurring., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Verbal miscommunication [Verbal understanding]
  • Written miscomunication-Illegible handwritting [Written understanding]
  • Written miscomunication-Abbreviations [Illegible writing]
  • Written miscomunication-Non metric units of measurement [*]
  • Written miscomunication-Decimal point [*]
  • Misread or didnt read [*]
  • Misinterpretation of the order [*]
  • Sound-alike drug name [*]
  • Look-alike drug name [*]
  • Packaging-Inappropriate Packaging or Design [*]
  • Packing-Dosage form [*]
  • Packaging-Error due to similarity to another drug (colour, form, size) [*]
  • Packaging-Error due different strength [*]
  • Characteristics of the medicine [*]
  • Human factors-Lack of information/knowledge [*]
  • Work not accomplished [*]
  • Incomplete documentation [*]
  • Work overload, burn out syndrome [*]
  • Fatigue/Lack of sleep [*]
  • Confrontational or intimidating behaviour [*]
  • Control not carried out [*]
  • Inappropriate lighting [*]
  • Inappropriate temperature/humidity [*]
  • Frequent interuptions and distractions [*]
  • Lack of staff [*]
  • Other [*]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0233]/items[at0234], code=at0234, itemType=ELEMENT, level=3, text=Comment, description=An additional comment on the estimated cause of the event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0020], code=at0020, itemType=ELEMENT, level=2, text=Related trigger, description=Triggers thought to be related to this safety event recorded using IHCI classification., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=CHOICE, bindings=null, values=Choice of:
  •  Coded Text
    • Transfusion of Blood or Use of Blood Products [**(en)]
    • Acute Dialysis [**(en)]
    • Positive Blood Culture [**(en)]
    • X-Ray or Doppler Studies for Emboli or Deep Vein Thrombosis [**(en)]
    • Decrease in Hemoglobin or Hematocrit of 25% or Greater [**(en)]
    • Patient Fall [**(en)]
    • Pressure Ulcers [**(en)]
    • Readmission within 30 Days [**(en)]
    • Restraint Use [**(en)]
    • Healthcare-Associated Infections [**(en)]
    • In-Hospital Stroke [**(en)]
    • Clostridium difficile Positive Stool [**(en)]
    • Partial Thromboplastin Time (PTT) Greater than 100 Seconds [**(en)]
    • International Normalized Ratio (INR) Greater than 6 [**(en)]
    • Glucose Less than 50 mg/dl [**(en)]
    • Rising BUN or Serum Creatinine Two Times (2x) over Baseline [**(en)]
    • Vitamin K Administration [**(en)]
    • Diphenhydramine (Benadryl) Administration [**(en)]
    • Romazicon (Flumazenil) Administration [**(en)]
    • Naloxone (Narcan) Administration [**(en)]
    • Anti-Emetic Administration [**(en)]
    • Over-Sedation/Hypotension [**(en)]
    • Abrupt Medication Stop [**(en)]
    • Intra- or Post-Operative Death [**(en)]
    • Mechanical Ventilation Greater than 24 Hours Post-Operatively [**(en)]
    • Intra-Operative Administration of Epinephrine, Norepinephrine, Naloxone, or Romazicon [**(en)]
    • Pneumonia Onset [**(en)]
    • Readmission to the Intensive Care Unit [**(en)]
    • Terbutaline Use [**(en)]
    • Platelet Count Less than 50,000 [**(en)]
    • Administration of Oxytocic Agents (such as oxytocin, methylergonovine, and 15-methyl-prostaglandin in the post-partum period) [**(en)]
    • Administration of General Anesthesia [**(en)]
    • Readmission to the ED within 48 Hours [**(en)]
    • Time in ED Greater than 6 Hours [**(en)]
    • Abnormal laboratory parameter [*]
    • Falsely abnormal laboratory parameter [*]
    • Unknown [**(en)]
    • No trigger [*]
  •  Text
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018], code=at0018, itemType=CLUSTER, level=2, text=Adverse effect, description=Details of one or more side effects., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0345], code=at0345, itemType=CLUSTER, level=3, text=Reaction details, description=Details of reaction, comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0345]/items[at0021], code=at0021, itemType=ELEMENT, level=4, text=Reaction, description=Description of the side-effect reported or observed using MEDRA or ATC codes., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
*New constraint(sl)
**(sl)
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0345]/items[at0346], code=at0346, itemType=ELEMENT, level=4, text=Comment, description=An additional comment on the Reaction details., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0108], code=at0108, itemType=ELEMENT, level=3, text=DateTime of reaction onset, description=The datetime at which the side effects began., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_DATE_TIME, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0222], code=at0222, itemType=ELEMENT, level=3, text=Severity, description=The severity of the reaction., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Low [*]
  • Medium [*]
  • High [*]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0022], code=at0022, itemType=ELEMENT, level=3, text=Liklihood of causation, description=An estimate of how likely the side-effects noted are due to the safety event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Low [*]
  • Medium [*]
  • High [*]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0236], code=at0236, itemType=CLUSTER, level=3, text=Intervention details, description=Details of interventions., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0236]/items[at0347], code=at0347, itemType=CLUSTER, level=4, text=Intervention additional details, description=*, comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0236]/items[at0347]/items[at0012], code=at0012, itemType=ELEMENT, level=5, text=Intervention, description=The clinical intervention undertaken to resolve or ameliorate the adverse effect, uses PCNE terminology., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Prescriber informed [**(en)]
  • Nurse informed/instructed [**(en)]
  • Dispensing rejected [**(en)]
  • Drug recalled from the ward [**(en)]
  • Dietary regime changed [**(en)]
  • Food supplement discontinued [**(en)]
  • Food supplement initiated [**(en)]
  • Reconstitution solvent changed [**(en)]
  • Diluent changed [**(en)]
  • Medical device (or change) suggested [*]
  • Drug changed [**(en)]
  • Dose increased [**(en)]
  • Dose decreased [**(en)]
  • Dosage form changed [**(en)]
  • Administration interval changed [**(en)]
  • Drug discontinued [**(en)]
  • Drug initiated [**(en)]
  • Drug administration rate changed [**(en)]
  • Route of administration changed [**(en)]
  • Resuscitation required [**(en)]
  • Heamodialysis required [**(en)]
  • Transplantation required [**(en)]
  • Transfusion required [**(en)]
  • Operating procedure required [**(en)]
  • Additional laboratory test(s) required [**(en)]
  • Physiotherapy required [**(en)]
  • Psychotherapy required [**(en)]
  • Error corrected [*]
  • Monitoring required [*]
  • Patient informed [*]
  • Other [**(en)]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0236]/items[at0347]/items[at0348], code=at0348, itemType=ELEMENT, level=5, text=Comment, description=*, comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0018]/items[at0236]/items[at0014], code=at0014, itemType=ELEMENT, level=4, text=Intervention result, description=The result(s) of any interventions undertaken, recorded using MEDRA classification subset., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • *Intervencija preprečila, da bi zaplet dosegel pacienta(en) [*(en)]
  • *Intervencija popolnoma odpravila posledice, ki jih je zaplet povzročil pacientu(en) [*(en)]
  • *Intervencija delno odpravila posledice, ki jih je zaplet povzročil pacientu(en) [*(en)]
  • *Intervencija ni odpravila posledic, ki jih je zaplet povzročil pacientu(en) [*(en)]
  • *Intervencija ni bila možna(en) [*(en)]
  • *Rezultat intervencije ni poznan(en) [*(en)]
  • *Zmanjšanje stroškov zdravljenja(en) [*(en)]
  • *Skrajšan čas hospitalizacije(en) [*(en)]
  • *Pacient je bil odpuščen(en) [*(en)]
  • *Izboljšana kvaliteta življenja(en) [*(en)]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0353], code=at0353, itemType=ELEMENT, level=2, text=Side effect recurrence, description=This information is aplicable when at least one Intervention is Dose decreased or Drug discontinued, comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Yes [*]
  • No [*]
  • NA [*]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0349], code=at0349, itemType=CLUSTER, level=2, text=Actual patient outcome details, description=*, comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0349]/items[at0042], code=at0042, itemType=ELEMENT, level=3, text=Actual patient outcome, description=The overall impact actually experienced by the patient., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • [A] Circumstances or events that have the capacity to cause error [*]
  • [B] An error that did not reach the patient [*]
  • [C] An error that reached the patient but did not cause harm [*]
  • [D] An error that reache the patient and reqired monitoring or intervention to confirm that it resulted in no harm to the patient [*]
  • [E] Temporary harm to the patient and required intervention [*]
  • [F] Temporary harm to the patient and required initial or prolonged hospitalization [*]
  • [G] Permanent patient harm [*]
  • [H] Intervention required to sustain life [*]
  • [I] Patient death [*]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0349]/items[at0350], code=at0350, itemType=ELEMENT, level=3, text=Comment, description=An additional comment on the Actual patient outcome comment., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0231], code=at0231, itemType=ELEMENT, level=2, text=Potential patient outcome, description=An assessment of potential impact on the patient if interventions had been unsuccesful. Uses the MERP index. other remediation had not occured., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • [A] Circumstances or events that have the capacity to cause error [*]
  • [B] An error that did not reach the patient [*]
  • [C] An error that reached the patient but did not cause harm [*]
  • [D] An error that reache the patient and reqired monitoring or intervention to confirm that it resulted in no harm to the patient [*]
  • [E] Temporary harm to the patient and required intervention [*]
  • [F] Temporary harm to the patient and required initial or prolonged hospitalization [*]
  • [G] Permanent patient harm [*]
  • [H] Intervention required to sustain life [*]
  • [I] Patient death [*]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0043], code=at0043, itemType=ELEMENT, level=2, text=Patient outcome category, description=The caetgory of impact on the patient's life., comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Clinical [*]
  • Personal [*]
  • Economic [*]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0232], code=at0232, itemType=ELEMENT, level=2, text=Additional comment, description=Any additional comment or narrative., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237], code=at0237, itemType=CLUSTER, level=2, text=Summary details, description=Details included only in Case Summary., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0238], code=at0238, itemType=ELEMENT, level=3, text=Admission diagnosis classification, description=Admission diagnosis using ICD classification., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
*New constraint(sl)
**(sl)
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0239], code=at0239, itemType=ELEMENT, level=3, text=Discharge diagnosis classification, description=Discharge diagnosis using ICD classification., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
*New constraint(sl)
**(sl)
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0249], code=at0249, itemType=ELEMENT, level=3, text=Link to main event, description=A link to the main case event., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_EHR_URI, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241], code=at0241, itemType=CLUSTER, level=3, text=Oncological case details, description=Details required for oncological cases., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=1..*, cardinalityText=, subCardinalityFormal=null, subCardinalityText=null, dataType=CLUSTER, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241]/items[at0240], code=at0240, itemType=ELEMENT, level=4, text=TNM classification, description=Malignant disease classification using TNM., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=Constraint:
*New constraint(sl)
**(sl)
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241]/items[at0244], code=at0244, itemType=ELEMENT, level=4, text=Effectiveness of therapy, description=*, comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Completely effective [The therapy has been fully effective.]
  • Partially effective [The therpay has been partially effective.]
  • Disease status unchanged [*]
  • Ineffective - disease progressing unchecked. [The therapy has been ineffective and the disease is progressing unchecked.]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241]/items[at0242], code=at0242, itemType=ELEMENT, level=4, text=Order of treatment, description=???????, comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241]/items[at0243], code=at0243, itemType=ELEMENT, level=4, text=Reason for case closure, description=Reason for the case being closed., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_CODED_TEXT, bindings=null, values=
  • Treatment complete [*]
  • Treatment aborted [*]
, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0237]/items[at0241]/items[at0268], code=at0268, itemType=ELEMENT, level=4, text=Reason treatment aborted, description=The reason why the treatment was aborted., comment=null, uncommonOntologyItems=null, occurencesFormal=0..1, occurencesText=Optional, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0351], code=at0351, itemType=ELEMENT, level=2, text=Medications involved, description=The medicine, vaccine or other therapetic good being ordered, administered to or used by the subject, comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null], ResourceSimplifiedHierarchyItem [path=/data[at0001]/items[at0352], code=at0352, itemType=ELEMENT, level=2, text=Medications administered, description=Medications administered is used to enter wrongly administered drug for Safety event type *at0254 Pacient dobil drugo zdravilo od predpisanega* Wrong drug administered to a patient, comment=null, uncommonOntologyItems=null, occurencesFormal=0..*, occurencesText=Optional, repeating, cardinalityFormal=null, cardinalityText=null, subCardinalityFormal=null, subCardinalityText=null, dataType=DV_TEXT, bindings=null, values=, extendedValues=null]], minIndents={}, termBindingRetrievalErrorMessage=null]