Patent Pending U.S. App. No. 64/165,563

Sample Audit Report — Acute STEMI Fibrinolysis Pathway | GALEX AI

Synthetic case — not a real patient. Every name, date, time, value and note in this report is fabricated for demonstration. No protected health information appears here. The clinical standards referenced are real and current; the case they are applied to is not.

GALEX AI · Forensic Clinical Record Audit

Acute STEMI — Fibrinolysis Pathway

Single-case documentation audit · Cardiology / Emergency Department

Case refSYN-CARD-0417
Age / Sex75 / M
HistoryHTN · T2DM
Presentation3 h from onset
PathwayFibrinolysis (no on-site PCI)
Records analysed214 pages
SourcesED · Nursing · Pharmacy · Lab · Imaging
Findings6 · 1 conflict

Summary

1

Confirmed gap
4

Documentation
2

Protocol-dependent
6

Total findings

A 75-year-old male with hypertension and type 2 diabetes presented three hours after symptom onset with inferior ST-elevation myocardial infarction. The facility has no on-site catheterisation laboratory. Fibrinolysis was administered.

Two high-priority findings concern the medication pathway and post-treatment assessment. The patient sits exactly on the age threshold, where the applicable rules diverge: the enoxaparin adjustment is a confirmed gap, while the clopidogrel decision falls on a point where published sources disagree and is reported as a conflict rather than a gap. The fibrinolytic dose is recorded as unconfirmed because whether age adjustment applies depends on an institutional protocol not supplied for this review.

Three moderate findings relate to documentation of pre-treatment screening and post-treatment assessment. One low finding relates to discharge documentation. One further criterion is shown separately because its applicability to this institution has not been established.

Every finding below carries its source. Each states the criterion applied, where that criterion comes from, the guideline version relied on, and a confidence note on whether the criterion is established guidance or depends on the institution’s own protocol. A finding whose criterion the institution does not accept should be closed, not actioned — and the criterion removed from the library.
This audit examines what the record documents. It does not establish that any error occurred, that any patient was harmed, or that any clinician departed from the standard of care. Several findings below may have an explanation that exists outside the documentation reviewed. Each requires evaluation by qualified clinical personnel.

Executive Summary

Clinical area Emergency Department / Cardiology
Pathway audited Acute STEMI — fibrinolysis
Charts in this report 1 (single-case demonstration)
Pages analysed 214
Criteria evaluated 16 (1 applicability unconfirmed)
Criteria met 6
Findings raised 6 — 1 confirmed gap, 4 documentation gaps, 2 protocol-dependent
Key observation Age thresholds diverge at exactly 75; one source conflict surfaced
System-level interventions proposed 8
Re-audit recommended 90 days

How to Read a Finding

Findings are not graded by how serious they sound. They are classified by why they are findings — whether the rule is settled, whether it depends on the institution, whether the sources disagree, or whether the record simply does not say. A quality team acts differently on each.

Class What it means and what to do with it
CONFIRMED GUIDELINE GAP The rule is clearly established in the applicable guideline and the record does not show compliance. Action: clinical review, then process change if confirmed.
PROTOCOL-DEPENDENT Whether the criterion applies depends on the institution’s own protocol, which was not supplied. Action: confirm the institutional position before treating this as a gap.
GUIDELINE CONFLICT Two relevant sources — or two parts of the same source — give different rules for this patient. The system does not choose between them. Action: clinical review to determine which applies.
DOCUMENTATION GAP Whether the action occurred cannot be determined from the records reviewed. This is not a statement that it did not occur. Action: check whether the information exists elsewhere before escalating.
OVER TARGET A measured interval exceeded a quality performance target. A performance target is not a standard of care. Action: trend it; a single case is not a signal.
MET The criterion was evaluated and the record documents compliance.
NOT APPLICABLE The criterion does not apply to this pathway or this institution. Action: remove it from the audit library.
None of these classes is a clinical conclusion. Every one terminates in the same place: a qualified professional decides whether the finding reflects a real issue, an explainable variation, or a documentation artefact. The system identifies; it does not conclude.

Documented Timeline

14:10 Symptom onset (patient-reported, documented at triage)
           3 h 02 min to arrival — within the 12-hour fibrinolysis window
17:12 ED arrival · triage acuity 1
17:26 12-lead ECG performed — inferior ST elevation (16 min from arrival; target ≤10 min)
17:34 Cardiology contacted by phone
17:41 Nearest PCI centre contacted — estimated transfer 95 min
17:52 Fibrinolysis decision documented
17:59 Tenecteplase administered (47 min door-to-needle; target ≤30 min)
18:04 Enoxaparin administered
18:40 Nursing note: “patient more comfortable”
19:35 Nursing vitals recorded
19:50 Transfer ordered — 111 min post-lysis (decision interval)
20:15 Departed — 25 min after order (logistics interval)
22:50 Arrival at receiving facility

What Should Have Been Ordered · What Was Ordered · What Was Done

The table compares the documented care against the criteria loaded for this review. A gap in the final column means the record does not show the element — not that it did not occur.

Element Standard for this case Documented as ordered Documented as done Status
Eligibility window Fibrinolysis indicated within 12 h of symptom onset in STEMI Onset time recorded at triage 3 h 02 min — within window MET
Contraindication screen Documented review of absolute and relative contraindications Checklist referenced in note Completed checklist not in record GAP
12-lead ECG Within 10 min of arrival — quality performance target Ordered at triage 17:26 — 16 min OVER TARGET
Reperfusion strategy PPCI if available ≤120 min FMC; otherwise fibrinolysis Transfer 95 min estimated; fibrinolysis chosen Rationale documented OK
Door-to-needle ≤30 min — quality performance target — 47 min OVER TARGET
Fibrinolytic dose Weight-based: <60 kg 30 mg · 60–69 35 mg · 70–79 40 mg · 80–89 45 mg · ≥90 50 mg. Age-adjustment per institutional protocol Weight-based dose Administered per weight UNCONFIRMED
BP before lysis Documented; >180/110 is a relative contraindication Vitals ordered Last BP documented 40 min before lysis GAP
Enoxaparin Age ≥75 y: no IV bolus; 0.75 mg/kg SC q12h (max 75 mg first two doses) 30 mg IV bolus + 1 mg/kg SC q12h Both administered POTENTIAL GAP
Renal function CrCl before dosing; <30 → 1 mg/kg q24h Chemistry panel ordered 17:30 Creatinine resulted 18:22 — after dosing GAP
Antiplatelet Aspirin 162–325 mg; clopidogrel 300 mg load if ≤75 y, 75 mg if >75 y Aspirin 325 mg; clopidogrel 300 mg load Both administered MET
Reperfusion assessment Assessment 60–90 min post-lysis. Suspected failed reperfusion → immediate angiography with rescue PCI. ST resolution thresholds differ by territory: <50% anterior, <70% inferior Not documented as ordered No assessment in record before transfer POTENTIAL GAP
Neuro assessment Serial neurological checks post-fibrinolysis (ICH risk) “Neuro checks” in nursing plan One entry at 19:35; no interval documented GAP
Head CT If neurological change post-lysis Not ordered No neurological change documented N/A
Glycaemic control Monitoring in known diabetes Glucose ordered Two values documented OK
Transfer to PCI centre Transfer after fibrinolysis; early angiography thereafter. Timing target per institutional pharmaco-invasive protocol Ordered 19:50 — 111 min post-lysis Departed 20:15 — 25 min after order PROTOCOL-DEPENDENT
Statin High-intensity, initiated early Ordered Administered OK
Cardiac rehabilitation Referral documented at discharge Not documented Not documented GAP
Geriatric assessment Institutional protocol only — not a STEMI pathway requirement Not documented Not documented UNCONFIRMED

Age 75 Is Not One Threshold

This patient is exactly 75. That matters more than it appears, because the age cut-off is not uniform across the fibrinolysis regimen — and the record shows the two rules were applied inconsistently.

Agent Age rule At exactly 75 What the record shows Status
Clopidogrel Guideline dosing table: 300 mg load if ≤75 y, 75 mg if >75 y.
Other sources state the cut-off as ≥75 y.
Sources disagree at exactly 75. Under ≤75 the load is correct; under ≥75 it is not. 300 mg load given GUIDELINE CONFLICT
Enoxaparin No IV bolus if ≥75 y; 0.75 mg/kg SC q12h 75 is ≥75 → bolus should be omitted 30 mg IV bolus given POTENTIAL GAP
Tenecteplase Weight-based. Age adjustment per institutional protocol and applicable evidence Depends on the institution’s protocol Weight-based dose; no age consideration documented UNCONFIRMED
Why this matters at exactly 75. The clopidogrel loading dose derives from CLARITY-TIMI 28, which enrolled patients aged 18 to 75 — so 75-year-olds were inside the population that established it, which is the basis for the ≤75 formulation. The enoxaparin rule derives from a separate evidence base using ≥75. The guidelines carried each threshold forward as written, and published sources do not state the clopidogrel cut-off uniformly: some render it as ≤75 / >75, others as <75 / ≥75.

The system does not resolve that conflict. It reports it. A patient at 74 or 76 raises no question; a patient at exactly 75 does, and the answer belongs to a clinician applying the institution’s chosen source — not to an audit engine picking one silently.

An audit rule written as “age ≥75 triggers all adjustments” would have raised the clopidogrel dose as a gap, with no indication that the question is contested. A rule written as “age >75” would have missed the enoxaparin adjustment entirely. Each criterion has to carry the threshold from its own source — which is why every finding in this report states where its rule comes from, and why a conflict between sources is reported as a conflict rather than silently decided.

This is the behaviour worth testing when evaluating any audit system: give it a patient who sits exactly on a contested threshold and see whether it manufactures certainty or surfaces the ambiguity.

Findings

Finding 01Protocol-dependent

Age-adjusted fibrinolytic dosing strategy is not documented

What the record shows Tenecteplase weight-based full dose ordered and administered to a 75-year-old patient.

Criterion applied Whether an age-adjusted fibrinolytic strategy applies to patients aged 75 and older under the institution’s own STEMI protocol.

Evidence base In STREAM-1, full-dose tenecteplase in patients aged ≥75 produced an excess of intracranial haemorrhage; after a protocol amendment halving the dose, no further ICH occurred in that cohort. STREAM-2 supported half-dose tenecteplase in older patients. European Society of Cardiology guidance recommends half-dose tenecteplase for patients aged ≥75.

Important qualification The 2025 ACC/AHA ACS guideline presents tenecteplase dosing on a weight basis and does not, in that table, mandate an automatic halving by age alone. This finding therefore asks whether the institution’s protocol addresses age adjustment — it does not assert that full dose was incorrect under US guidance.

Why it warrants review The record contains no documented consideration of age in the dosing decision. Whether the institution requires that consideration is a question for its own protocol.

Criterion source Institutional STEMI fibrinolysis protocol (not supplied for this review)
Evidence cited STREAM-1 (NEJM 2013); STREAM-2 (2023); ESC STEMI guidance
US guideline 2025 ACC/AHA ACS Guideline — weight-based dosing table
Confidence Criterion applicability depends on institutional protocol

Medication administration record, 17:59 · Physician order, 17:52 · Registration record, DOB

Finding 02Confirmed guideline gap

Enoxaparin IV bolus administered despite age ≥75

What the record shows 30 mg IV bolus followed by 1 mg/kg SC every 12 hours.

Criterion applied At age 75 and older the IV bolus is omitted and the subcutaneous dose is reduced to 0.75 mg/kg every 12 hours, maximum 75 mg for the first two doses.

Why it warrants review This is the dosing regimen for patients under 75. Combined with Finding 01, the record suggests the age-based adjustment set was not applied at any point in the medication pathway. Both findings concern bleeding risk in the same patient.

Criterion source 2025 ACC/AHA ACS Guideline — enoxaparin dosing with fibrinolysis
Rule Age ≥75: omit IV bolus; 0.75 mg/kg SC q12h, max 75 mg first two doses
Confidence Established US guideline recommendation

Pharmacy verification, 18:01 · MAR, 18:04 · Physician order, 17:53

Finding 03Documentation gap

No documented post-fibrinolysis reperfusion assessment before transfer

What the record shows No repeat 12-lead ECG, and no other documented reperfusion assessment, between fibrinolysis at 17:59 and transfer departure at 20:15.

Criterion applied The record should permit assessment of reperfusion following fibrinolysis. ECG at 60–90 minutes is the usual instrument, evaluated together with symptom resolution and haemodynamic status; ST-segment resolution thresholds differ by infarct territory — below 50% in anterior leads, below 70% in inferior leads. This is an inferior STEMI, so the applicable threshold is 70%. ACC/AHA recommends immediate angiography with rescue PCI for suspected failed reperfusion.

Why it warrants review Reperfusion assessment is multimodal, and the finding is the absence of any documented assessment rather than the absence of one specific test. Without it, the 136-minute interval to transfer departure is not interpretable from the documentation: it may reflect an appropriate clinical picture, or a missed rescue window.

Criterion source 2025 ACC/AHA ACS Guideline — failed reperfusion and rescue PCI
Instrument ECG at 60–90 min, interpreted with clinical status
Confidence Established; the assessment is required, the specific modality is clinical judgement

ECG log, complete record · Transfer documentation, 20:15 · Nursing notes, 18:00–20:15

Finding 04Documentation gap

Blood pressure not documented immediately before fibrinolysis

What the record shows Last documented blood pressure 40 minutes before lytic administration. Patient has documented hypertension.

Criterion applied Blood pressure above 180/110 is a relative contraindication to fibrinolysis. Screening should be documented proximate to administration.

Why it warrants review The record does not show the value on which the contraindication screen was based. The screen may have been performed without being documented.

Vital signs flow sheet, 17:19 · MAR, 17:59 · Problem list

Finding 05Documentation gap

Renal function assessment preceding anticoagulant dosing is not identifiable in the record

What the record shows Chemistry panel ordered 17:30, creatinine resulted 18:22. Enoxaparin administered 18:04. No prior creatinine, eGFR or calculated creatinine clearance appears in the documents provided.

Criterion applied Creatinine clearance below 30 mL/min requires enoxaparin 1 mg/kg every 24 hours regardless of age.

Important qualification A prior value, an eGFR from an earlier encounter, or known renal status may well have informed the dosing decision without appearing in the records supplied for this review. The finding is that the basis is not identifiable in the documentation, not that renal function was unknown to the clinician.

Why it warrants review The renal basis for the administered dose is not identifiable in the reviewed documentation, nor is any reassessment once the result returned.

Criterion source 2025 ACC/AHA ACS Guideline — enoxaparin renal dose adjustment
Rule CrCl <30 mL/min: 1 mg/kg q24h regardless of age
Confidence Established; documentation finding, not a dosing determination

Laboratory order, 17:30 · Result timestamp, 18:22 · MAR, 18:04 · Problem list

Finding 06Protocol-dependent

Post-fibrinolysis neurological checks without documented intervals

What the record shows Nursing plan references neurological checks. One assessment documented at 19:35, 96 minutes after lysis.

Criterion applied Serial neurological assessment following fibrinolysis at the interval defined by institutional protocol, given intracranial haemorrhage risk. No universal interval is asserted here — the institution’s own protocol was not supplied.

Why it warrants review The documentation does not establish the monitoring frequency actually applied, nor the interval the institution requires. Given the enoxaparin finding, bleeding risk in this patient warrants the question being answered.

Nursing care plan · Nursing assessment, 19:35 · Flow sheet, 17:59–20:15

Finding 07Documentation gap

Ownership of cardiac rehabilitation referral not documented in the transfer process

What the record shows No referral in the discharge or transfer documentation.

Criterion applied Cardiac rehabilitation referral following myocardial infarction is a Class 1 recommendation.

Why it warrants review In a transferred patient the referral is frequently the receiving facility’s responsibility. The finding is not that the referral was omitted, but that the transfer documentation does not record who owns it. That is a handoff question, not a clinical one.

Transfer summary, 20:10 · Discharge documentation

Optional Criteria — Applicability Not Established

One criterion in the library loaded for this review has no basis in the STEMI fibrinolysis pathway and depends entirely on institutional policy:

Optional criterionNot counted as a finding

Geriatric assessment for patients aged ≥75 with polypharmacy

Status Not documented in this record. Not counted among the nine findings, because its applicability to this institution has not been established.

Why it is shown To make the point that a criterion the institution does not use should be removed from the library, not reported as a gap. A report padded with findings nobody will action trains the team to ignore the report.

Criterion source Institutional protocol (not supplied)
Guideline basis None — not a STEMI pathway requirement
Disposition Confirm or remove — see Action A9

GALEX AI · Clinical Record Audit

See This Run Against Your Own Records

A no-cost assessment on a record set you define — your service line, your scope, 20 to 30 charts. You judge whether the findings are useful.

Recommended Actions

Findings without an owner and a date do not close. The actions below are proposed for the quality team to accept, modify or reject — the organisation decides what applies to its own processes.

# Recommended action Suggested owner Timeframe How to verify it worked
A1 Build the enoxaparin age rule into the order set as a prompt (≥75: omit IV bolus, 0.75 mg/kg SC q12h). Encode each agent’s threshold from its own source rather than applying one age rule across the regimen — clopidogrel uses ≤75, enoxaparin uses ≥75, and they diverge at exactly 75. Confirm the institution’s position on fibrinolytic age adjustment separately. Pharmacy & Therapeutics with Cardiology 30 days Re-audit fibrinolysis cases aged ≥75. Measure: proportion where age-adjusted dosing appears in the record. Target set by the committee.
A2 Add a pharmacy verification step that flags age ≥75 on any fibrinolysis order before release. Pharmacy Director 30 days Flag fires on test orders. Measure: overrides logged and reviewed monthly.
A3 Make the 60–90 minute reperfusion ECG an automatic downstream order triggered by lytic administration, rather than a separate physician action. Cardiology with EHR/Informatics 60 days Measure: proportion of fibrinolysis cases with a documented ECG 60–90 min post-lysis.
A4 Review the door-to-needle pathway against the documented intervals. The 47-minute interval in this case breaks down as 16 min to ECG, 26 min to decision, 7 min to administration — the decision interval is where the time sits. ED Medical Director with Quality 60 days Measure: median and 90th percentile door-to-needle across fibrinolysis cases. Segment by shift and day of week.
A5 Require a documented blood pressure within a defined interval before lytic administration, and a completed contraindication checklist retained in the record rather than referenced in a note. ED Nursing with Cardiology 30 days Measure: proportion of cases with a BP documented within the defined window and a retained checklist.
A6 Define the post-fibrinolysis neurological assessment interval explicitly in the nursing order, rather than as a care-plan reference. Nursing Leadership 45 days Measure: proportion of cases with neurological assessments documented at the defined interval.
A7 Add estimated creatinine clearance to the fibrinolysis order set so renal dosing is available at the point of ordering rather than after administration. Pharmacy with Laboratory 60 days Measure: proportion of cases with renal function available before the first anticoagulant dose.
A8 Clarify with the receiving PCI centre which facility owns the cardiac rehabilitation referral in transferred cases, and record the decision in the transfer template. Cardiology with Case Management 90 days Measure: proportion of transfers where referral responsibility is documented.
A9 Confirm whether the institution has a protocol requiring geriatric assessment for patients aged ≥75 with polypharmacy. If it does not, remove the criterion from the audit library so it stops generating findings that nobody will action. Quality Director 30 days Audit library updated. The criterion is either confirmed as institutional policy and applied consistently, or removed.
On A9. A criterion that does not apply to the institution generates findings nobody will act on, and findings nobody acts on train the team to ignore the report. Removing criteria is as important as adding them.

Re-audit

The actions above are process changes. Whether they worked is a measurement question, not an opinion. A re-audit on a comparable record set — same service line, same inclusion criteria — is what establishes that. The interval should be long enough for the change to take effect and short enough to catch drift; for order-set changes, 90 days is a common choice.

This report identifies documentation findings and proposes actions for consideration. It does not determine that any error occurred, that any patient was harmed, or that any clinician departed from the standard of care. Whether each finding reflects a real process issue, an explainable variation or a documentation artefact is a determination for qualified clinical personnel within the organisation.

How the Pattern Matters More Than the Cases

A single case shows whether a rule was applied. It cannot show whether the rule is reliably applied. The enoxaparin finding here may reflect an isolated decision, or it may reflect that the order set carries one age threshold across a regimen whose agents use different ones.

That distinction is the practical difference between case review and pattern review. A single case produces a conversation about one patient. The same finding recurring across a record set produces a question about the order set, the pharmacy verification step, or the protocol itself — which is what a quality programme can actually change.

In an aggregate run this finding would be reported as a rate: the proportion of fibrinolysis cases in patients aged 75 and older where the age-adjusted dosing appears in the record. That number is what a quality committee acts on. This single-case report is shown here because it makes the method visible; the institutional output is the aggregate.

This Report Is Level 1

A single-chart audit shows the method. It is not the product a quality programme buys, because one case cannot establish a pattern and a pattern is what a committee can act on.

Level Scope What it produces
1 — Chart audit One record Findings with evidence linkage, as shown above. Useful for a specific case review or an adverse event reconstruction.
2 — Service-line audit 20–30 records, one pathway Compliance rates per criterion. “Age-adjusted dosing documented in 71% of eligible cases” is a number a committee can act on; a single case is not.
3 — Cross-domain view Multiple service lines Where findings concentrate — by domain, unit, shift or criterion. Shows whether a problem is local or systemic.
4 — Re-audit Same criteria, later period Whether the intervention worked. Pattern → intervention → re-audit → measurement. This is the loop that quality improvement actually runs on.
The value is not in finding nine issues in one chart. It is in showing that the same criterion fails in a measurable proportion of cases, locating the process step where it fails, and measuring whether the fix held.

Limitations of This Analysis

  • → The analysis examines documentation. An absent entry does not establish that an action did not occur.
  • → Criteria are only as current as the library loaded for the review. Clinical guidance changes, and guidance differs between bodies — a criterion drawn from European guidance may not reflect US practice, and vice versa. Each finding states its source for that reason.
  • → Where a criterion depends on institutional protocol and that protocol was not supplied, the finding records the question rather than asserting a deviation.
  • → Some findings may have explanations recorded outside the documents provided.
  • → Timing findings depend on documented timestamps, which may not reflect the moment of the clinical action.
  • → A single case cannot establish a pattern. Aggregate analysis is required for that.
  • → No finding in this report constitutes a clinical or legal conclusion.
Important. This is a synthetic demonstration report. No real patient data appears in it. GALEX AI is an AI-assisted clinical record audit platform. It identifies findings that may warrant review by qualified professionals. It does not determine that malpractice, negligence, patient harm, causation or liability occurred, and it does not determine that any clinician breached the applicable standard of care. It does not replace clinical judgment, medical opinion, legal advice, or an organisation’s quality, risk management and peer review programmes. Clinical standards change; confirm current guidance against the issuing body’s own published materials before relying on any criterion referenced here. Nisimblat Consulting LLC · St. Petersburg, Florida.