Multiple definitive diagnoses with signs/symptoms Preferred: Multiple diagnoses only Alternate: Diagnoses and signs/symptoms Note: Always include signs/symptoms not associated with diagnosis EXAMPLE 3 Multiple provisional diagnoses with signs/symptoms Preferred: Multiple provisional diagnoses and signs/symptoms Alternate: Signs/symptoms only Note: Always include signs/symptoms not associated with diagnosis EXAMPLE 4 Example Reported LLT Selected Preferred Option 1 Anaphylactic reaction, rash dyspnea, hypotension, and laryngospasm Anaphylactic reaction Anaphylactic reaction Rash Dyspnea Hypotension Laryngospasm 2 Possible myocardial infarction with chest pain, dyspnea, diaphoresis Myocardial infarction Chest pain Dyspnea Diaphoresis Chest pain Dyspnea Diaphoresis 3 Pulmonary embolism, myocardial infarction, and congestive heart failure with chest pain, cyanosis, shortness of breath, and Pulmonary embolism Myocardial infarction Congestive heart failure Pulmonary embolism Myocardial infarction Congestive heart failure Chest pain
blood pressure decreased Cyanosis Shortness of breath Blood pressure decreased 4 Chest pain, cyanosis, shortness of breath, and blood pressure decreased. Differential diagnosis includes pulmonary embolism, myocardial infarction, and congestive heart failure Pulmonary embolism Myocardial infarction Congestive heart failure Chest pain Cyanosis Shortness of breath Blood pressure decreased Chest pain Cyanosis Shortness of breath Blood pressure decreased Always include signs/ symptoms not associated with diagnosis Myocardial infarction, chest pain, dyspnea, diaphoresis, ECG changes and jaundice Myocardial infarction Jaundice (note that jaundice is not typically associated with myocardial infarction) 3.2 – Death and Other Patient Outcomes Death, disability, and hospitalization are considered outcomes in the context of safety reporting and not usually considered ARs/AEs. Outcomes are typically recorded in a separate manner (data field) from AR/AE information. A term for the outcome should be selected if it is the only information reported or provides significant clinical information. (For reports of suicide and self-harm, see Section 3.3). 3.2.1 Death with ARs/AEs Death is an outcome and not usually considered an AR/AE. If ARs/AEs are reported along with death, select terms for the ARs/AEs. Record the fatal outcome in an appropriate data field. Example
3.3.3 Fatal suicide attempt If a suicide attempt is fatal, select the term that reflects the outcome instead of the attempt only. Example Reported LLT Selected Comment Suicide attempt resulted in death Completed suicide Record death as an outcome 3.4 – Conflicting/Ambiguous/Vague Information When conflicting, ambiguous or vague information is reported, term selection to support appropriate data retrieval may be difficult. When this occurs, attempt to obtain more specific information. If clarification cannot be achieved, select terms as illustrated in the examples below (Sections 3.4.1 through 3.4.3). 3.4.1 Conflicting information Example Reported LLT Selected Comment Hyperkalemia with a serum potassium of 1.6 mEq/L Serum potassium abnormal LLT Serum potassium abnormal covers both of the reported concepts (note: serum potassium of 1.6 mEq/L is a low result, not high) 3.4.2 Ambiguous information Example Reported LLT Selected Comment GU pain Pain Effort should be made to obtain clarification of the meaning of "GU" from the source so
Example Reported LLT Selected Comment Glucose 40 mg/dL Glucose low Glucose is clearly below the reference range Ambiguous investigation result Example Reported LLT Selected Comment His glucose was 40 Glucose abnormal In this example, no units have been reported. Select LLT Glucose abnormal if clarification cannot be obtained 3.14.2 Investigation results consistent with diagnosis When investigation results are reported with a diagnosis, select only a term for the diagnosis if investigation results are consistent with the diagnosis. Example Reported LLT Selected Comment Elevated potassium, K 7.0 mmol/L, and hyperkalemia Hyperkalemia It is not necessary to select LLT Potassium increased 3.14.3 Investigation results not consistent with diagnosis When investigation results are reported with a diagnosis, select a term for the diagnosis and also select terms for any investigation results that are not consistent with the diagnosis. Example Reported LLT Selected Comment Alopecia, rash, and elevated Alopecia Elevated potassium is
Note that “abuse” terms not associated with drugs/substances are in this SOC*, regardless of whether they refer to the person or to the condition, as illustrated in the table below: LLT PT Child abuse Child abuse Child abuser Elder abuse Elder abuse Elder abuser (See Section 3.23.2 concerning illegal/criminal acts). 3.23.2 Illegal acts of crime or abuse Terms for illegal acts of crime and abuse (excluding those related to drug/substance abuse) are in SOC Social circumstances, such as LLT Physical assault. LLTs representing the perpetrator are linked to PTs describing the unlawful act committed. PTs representing the victim of unlawful acts generally begin with “Victim of… ”. Example Reported LLT Selected Comment Patient’s history indicates that patient is a known sexual offender Sexual offender Perpetrator; LLT Sexual offender links to PT Sexual abuse in SOC Social circumstances Patient was a childhood sexual assault victim Childhood sexual assault victim Victim; LLT Childhood sexual assault victim links to PT Victim of sexual abuse in SOC Social circumstances 3.24 – Medical and Social History Example Reported LLT Selected History of gastrointestinal bleed Gastrointestinal bleed