From cd6332477f2576a9b1f72572fee6520a8ebfd03c Mon Sep 17 00:00:00 2001 From: AtomicQMS Service Date: Sat, 27 Dec 2025 11:24:13 -0500 Subject: [PATCH] Sync template from atomicqms-style deployment --- .gitea/workflows/atomicai.yml | 79 +++++ Forms/Equipment-Records/.gitkeep | 0 Forms/FRM-001-Document-Change-Request.md | 64 ++++ Forms/FRM-003-CAPA-Form.md | 91 +++++ Forms/FRM-006-Audit-Checklist.md | 56 +++ Forms/Infection-Control/.gitkeep | 0 .../FRM-EEG-001-Recording-Log.md | 316 +++++++++++++++++ Forms/Report-Templates/.gitkeep | 0 Forms/Requisition-Forms/.gitkeep | 0 Forms/Technical-Logs/.gitkeep | 0 Forms/Training/FRM-004-Training-Record.md | 72 ++++ Policies/POL-001-Quality-Policy.md | 57 +++ README.md | 134 +++++++- SOPs/Equipment/.gitkeep | 0 SOPs/Evoked-Potentials/.gitkeep | 0 SOPs/General/SOP-001-Document-Control.md | 112 ++++++ SOPs/General/SOP-002-CAPA.md | 134 ++++++++ SOPs/General/SOP-003-Training.md | 123 +++++++ SOPs/General/SOP-004-Internal-Audit.md | 136 ++++++++ SOPs/General/SOP-005-Management-Review.md | 114 ++++++ SOPs/Long-Term-Monitoring/.gitkeep | 0 .../SOP-EEG-001-Routine-EEG.md | 324 ++++++++++++++++++ SOPs/Routine-EEG/.gitkeep | 0 SOPs/Safety/.gitkeep | 1 + SOPs/Sleep-Studies/.gitkeep | 0 Templates/SOP-Template.md | 62 ++++ Work Instructions/WI-001-Template.md | 68 ++++ 27 files changed, 1941 insertions(+), 2 deletions(-) create mode 100644 .gitea/workflows/atomicai.yml create mode 100644 Forms/Equipment-Records/.gitkeep create mode 100644 Forms/FRM-001-Document-Change-Request.md create mode 100644 Forms/FRM-003-CAPA-Form.md create mode 100644 Forms/FRM-006-Audit-Checklist.md create mode 100644 Forms/Infection-Control/.gitkeep create mode 100644 Forms/Recording-Logs/FRM-EEG-001-Recording-Log.md create mode 100644 Forms/Report-Templates/.gitkeep create mode 100644 Forms/Requisition-Forms/.gitkeep create mode 100644 Forms/Technical-Logs/.gitkeep create mode 100644 Forms/Training/FRM-004-Training-Record.md create mode 100644 Policies/POL-001-Quality-Policy.md create mode 100644 SOPs/Equipment/.gitkeep create mode 100644 SOPs/Evoked-Potentials/.gitkeep create mode 100644 SOPs/General/SOP-001-Document-Control.md create mode 100644 SOPs/General/SOP-002-CAPA.md create mode 100644 SOPs/General/SOP-003-Training.md create mode 100644 SOPs/General/SOP-004-Internal-Audit.md create mode 100644 SOPs/General/SOP-005-Management-Review.md create mode 100644 SOPs/Long-Term-Monitoring/.gitkeep create mode 100644 SOPs/Recording-Procedures/SOP-EEG-001-Routine-EEG.md create mode 100644 SOPs/Routine-EEG/.gitkeep create mode 100644 SOPs/Safety/.gitkeep create mode 100644 SOPs/Sleep-Studies/.gitkeep create mode 100644 Templates/SOP-Template.md create mode 100644 Work Instructions/WI-001-Template.md diff --git a/.gitea/workflows/atomicai.yml b/.gitea/workflows/atomicai.yml new file mode 100644 index 0000000..33c0fd5 --- /dev/null +++ b/.gitea/workflows/atomicai.yml @@ -0,0 +1,79 @@ +name: AtomicAI Neurophysiology EEG Assistant + +on: + issue_comment: + types: [created] + issues: + types: [opened, assigned] + pull_request: + types: [opened, synchronize, assigned] + pull_request_review_comment: + types: [created] + +jobs: + claude-assistant: + runs-on: ubuntu-latest + if: | + github.actor != 'atomicqms-service' && + ( + (github.event_name == 'issue_comment' && contains(github.event.comment.body, '@atomicai') && github.event.comment.user.login != 'atomicqms-service') || + (github.event_name == 'issues' && github.event.action == 'opened' && contains(github.event.issue.body, '@atomicai')) || + (github.event_name == 'pull_request' && github.event.action == 'opened' && contains(github.event.pull_request.body, '@atomicai')) || + (github.event_name == 'pull_request_review_comment' && contains(github.event.comment.body, '@atomicai') && github.event.comment.user.login != 'atomicqms-service') || + (github.event.action == 'assigned' && github.event.assignee.login == 'atomicai') + + ) + permissions: + contents: write + issues: write + pull-requests: write + + steps: + - uses: actions/checkout@v4 + with: + fetch-depth: 0 + + - name: Run AtomicAI Neurophysiology EEG Assistant + uses: https://beta.atomicqms.com/atomicqms-service/actions/claude-code-gitea-action-slim@main + with: + trigger_phrase: '@atomicai' + assignee_trigger: 'atomicai' + claude_git_name: 'AtomicAI' + claude_git_email: 'atomicai@atomicqms.local' + custom_instructions: | + You are AtomicAI, an AI assistant specialized in Neurophysiology and EEG Laboratory Quality Management. + + ## Your Expertise + - ACNS (American Clinical Neurophysiology Society) guidelines + - EEG recording standards and electrode placement (10-20 system) + - Video-EEG monitoring protocols + - Evoked potentials (VEP, BAEP, SSEP) procedures + - EMG/Nerve conduction studies + - Equipment calibration and maintenance + - Technical quality assurance + - Patient safety during recordings + - Data management and archival standards + - Artifact recognition and troubleshooting + - Pediatric neurophysiology considerations + - Sleep study protocols (polysomnography) + + ## Document Creation Guidelines + - Place Technical SOPs in SOPs/Technical/ + - Place Clinical Protocols in Protocols/Clinical/ + - Place Equipment SOPs in SOPs/Equipment/ + - Place Quality Forms in Forms/Quality/ + - Place Patient Forms in Forms/Patient/ + - Place Policies in Policies/ + + ## Numbering Convention + - SOP-EEG-XXX for EEG SOPs + - SOP-EMG-XXX for EMG/NCS SOPs + - SOP-EQP-XXX for Equipment SOPs + - PRO-XXX for Clinical Protocols + - POL-XXX for Policies + - FRM-XXX for Forms + + Always create branches and submit changes as Pull Requests for review. + Focus on technical accuracy, patient safety, and data quality. + allowed_tools: 'Read,Edit,Grep,Glob,Write' + disallowed_tools: 'Bash,WebSearch' diff --git a/Forms/Equipment-Records/.gitkeep b/Forms/Equipment-Records/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/FRM-001-Document-Change-Request.md b/Forms/FRM-001-Document-Change-Request.md new file mode 100644 index 0000000..55c718a --- /dev/null +++ b/Forms/FRM-001-Document-Change-Request.md @@ -0,0 +1,64 @@ +# Document Change Request Form + +| Form ID | FRM-001 | Revision | 1.0 | +|---------|---------|----------|-----| + +--- + +## Section 1: Request Information + +| Field | Entry | +|-------|-------| +| Request Date | | +| Requested By | | +| Department | | + +## Section 2: Document Information + +| Field | Entry | +|-------|-------| +| Document Number | | +| Document Title | | +| Current Revision | | + +## Section 3: Change Description + +### Type of Change +- [ ] New Document +- [ ] Revision to Existing Document +- [ ] Document Obsolescence + +### Description of Change +*(Describe the proposed change in detail)* + + + + +### Reason for Change +*(Explain why this change is needed)* + + + + +## Section 4: Impact Assessment + +### Affected Areas +- [ ] Training Required +- [ ] Other Documents Affected +- [ ] Process Changes Required +- [ ] Validation Impact + +### List Affected Documents + + +## Section 5: Approvals + +| Role | Name | Signature | Date | +|------|------|-----------|------| +| Requester | | | | +| Document Owner | | | | +| Quality Assurance | | | | + +--- + +*Form FRM-001 Rev 1.0* diff --git a/Forms/FRM-003-CAPA-Form.md b/Forms/FRM-003-CAPA-Form.md new file mode 100644 index 0000000..6790a8f --- /dev/null +++ b/Forms/FRM-003-CAPA-Form.md @@ -0,0 +1,91 @@ +# Corrective and Preventive Action (CAPA) Form + +| Form ID | FRM-003 | Revision | 1.0 | +|---------|---------|----------|-----| + +--- + +## Section 1: CAPA Identification + +| Field | Entry | +|-------|-------| +| CAPA Number | | +| Date Initiated | | +| Initiated By | | +| CAPA Owner | | +| Target Closure Date | | + +## Section 2: Classification + +### Type +- [ ] Corrective Action +- [ ] Preventive Action + +### Source +- [ ] Customer Complaint +- [ ] Internal Audit +- [ ] External Audit +- [ ] Process Deviation +- [ ] Nonconforming Product +- [ ] Management Review +- [ ] Other: ____________ + +### Priority +- [ ] Critical (5 business days) +- [ ] Major (15 business days) +- [ ] Minor (30 business days) + +## Section 3: Problem Description + +*(Describe the nonconformity or potential nonconformity)* + + + + +## Section 4: Immediate Containment + +*(Actions taken to contain the immediate impact)* + + + + +## Section 5: Root Cause Investigation + +### Investigation Method Used +- [ ] 5 Whys +- [ ] Fishbone Diagram +- [ ] Fault Tree Analysis +- [ ] Other: ____________ + +### Root Cause Determination + + + + +## Section 6: Corrective/Preventive Actions + +| Action | Responsible | Due Date | Status | +|--------|-------------|----------|--------| +| | | | | +| | | | | +| | | | | + +## Section 7: Effectiveness Verification + +| Criteria | Method | Result | +|----------|--------|--------| +| | | | + +Verification Date: ____________ +Verified By: ____________ + +## Section 8: Closure + +| Role | Name | Signature | Date | +|------|------|-----------|------| +| CAPA Owner | | | | +| Quality Approval | | | | + +--- + +*Form FRM-003 Rev 1.0* diff --git a/Forms/FRM-006-Audit-Checklist.md b/Forms/FRM-006-Audit-Checklist.md new file mode 100644 index 0000000..45bf0b6 --- /dev/null +++ b/Forms/FRM-006-Audit-Checklist.md @@ -0,0 +1,56 @@ +# Internal Audit Checklist + +| Form ID | FRM-006 | Revision | 1.0 | +|---------|---------|----------|-----| + +--- + +## Audit Information + +| Field | Entry | +|-------|-------| +| Audit Number | | +| Audit Date | | +| Area/Process Audited | | +| Lead Auditor | | +| Auditee(s) | | + +--- + +## Checklist Items + +| # | Requirement/Question | Reference | C/NC/NA | Evidence/Notes | +|---|---------------------|-----------|---------|----------------| +| 1 | Are current versions of applicable procedures available? | SOP-001 | | | +| 2 | Are personnel trained on applicable procedures? | SOP-003 | | | +| 3 | Are training records current and complete? | SOP-003 | | | +| 4 | Are records properly maintained and retrievable? | SOP-001 | | | +| 5 | Are nonconformities being documented and addressed? | SOP-002 | | | +| 6 | Are CAPAs being completed on time? | SOP-002 | | | +| 7 | Is equipment calibrated and maintained? | | | | +| 8 | Are process controls being followed? | | | | +| 9 | Are quality objectives being monitored? | | | | +| 10 | | | | | + +**Legend:** C = Conforming, NC = Nonconforming, NA = Not Applicable + +--- + +## Findings Summary + +| Finding # | Type | Description | Clause Reference | +|-----------|------|-------------|------------------| +| | | | | +| | | | | + +--- + +## Auditor Signature + +| Auditor | Signature | Date | +|---------|-----------|------| +| | | | + +--- + +*Form FRM-006 Rev 1.0* diff --git a/Forms/Infection-Control/.gitkeep b/Forms/Infection-Control/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Recording-Logs/FRM-EEG-001-Recording-Log.md b/Forms/Recording-Logs/FRM-EEG-001-Recording-Log.md new file mode 100644 index 0000000..bb6ebd8 --- /dev/null +++ b/Forms/Recording-Logs/FRM-EEG-001-Recording-Log.md @@ -0,0 +1,316 @@ +# EEG Recording Log + +| Form ID | FRM-EEG-001 | Revision | 1.0 | +|---------|-------------|----------|-----| + +--- + +## Patient Information + +| Field | Entry | +|-------|-------| +| Patient Name | | +| MRN | | +| Date of Birth | | +| Age | | +| Sex | ☐ Male ☐ Female | +| Study Date | | +| Study Time Start | | +| Study Time End | | +| Study Duration | minutes | + +--- + +## Ordering Information + +| Field | Entry | +|-------|-------| +| Ordering Physician | | +| Study Type | ☐ Routine EEG ☐ Sleep-Deprived EEG ☐ Ambulatory EEG ☐ Portable/Bedside ☐ Other: _______ | +| Clinical Indication | | +| Patient Location | ☐ Outpatient Lab ☐ Inpatient Unit: _______ ☐ ICU ☐ ED ☐ OR | + +--- + +## Clinical History + +| Field | Entry | +|-------|-------| +| Seizure History | ☐ Yes ☐ No ☐ Unknown | +| Last Seizure Date | | +| Seizure Type | ☐ Generalized ☐ Focal ☐ Unknown | +| Seizure Description | | + +### Current Medications (especially AEDs) + +| Medication | Dose | Last Taken | +|------------|------|------------| +| | | | +| | | | +| | | | +| | | | + +### Other Relevant History + +| Field | Entry | +|-------|-------| +| Brain surgery/lesions | ☐ Yes ☐ No Details: | +| Recent head injury | ☐ Yes ☐ No | +| Developmental delay | ☐ Yes ☐ No | +| Psychiatric history | ☐ Yes ☐ No | +| Previous EEG | ☐ Yes (Date: _______) ☐ No | + +--- + +## Pre-Recording Checklist + +| Item | Completed | +|------|-----------| +| Patient identity verified (two identifiers) | ☐ | +| Order verified | ☐ | +| Contraindications reviewed | ☐ | +| Patient/family educated on procedure | ☐ | +| Hair clean, no products | ☐ Yes ☐ No (document): | +| Sleep deprivation completed (if ordered) | ☐ Yes ☐ No ☐ N/A | +| Hours of sleep prior to EEG | hours | + +--- + +## Technical Information + +### Equipment + +| Field | Entry | +|-------|-------| +| EEG System | | +| Software Version | | +| Amplifier Serial # | | +| Electrode Type | ☐ Disc ☐ Cup ☐ Disposable ☐ Cap | + +### Electrode Placement + +| Field | Entry | +|-------|-------| +| Placement System | ☐ International 10-20 ☐ 10-10 ☐ Modified (describe) | +| Reference Electrode | | +| Ground Electrode | | +| Additional Electrodes | | + +### Impedance Check + +| Electrode | Pre (kΩ) | Post (kΩ) | +|-----------|----------|-----------| +| Fp1 | | | +| Fp2 | | | +| F7 | | | +| F3 | | | +| Fz | | | +| F4 | | | +| F8 | | | +| T3/T7 | | | +| C3 | | | +| Cz | | | +| C4 | | | +| T4/T8 | | | +| T5/P7 | | | +| P3 | | | +| Pz | | | +| P4 | | | +| T6/P8 | | | +| O1 | | | +| O2 | | | +| A1/M1 | | | +| A2/M2 | | | +| ECG | | | +| Other: | | | + +**All impedances <5 kΩ?** ☐ Yes ☐ No (document exceptions) + +--- + +## Recording Parameters + +| Parameter | Setting | +|-----------|---------| +| Sensitivity | µV/mm | +| Low Frequency Filter | Hz | +| High Frequency Filter | Hz | +| Notch Filter | ☐ On (___Hz) ☐ Off | +| Display Speed | mm/sec | +| Sampling Rate | Hz | + +### Montages Used + +☐ Longitudinal bipolar (double banana) +☐ Transverse bipolar +☐ Referential (average) +☐ Referential (ear) +☐ Other: _______ + +--- + +## Activation Procedures + +### Hyperventilation + +| Field | Entry | +|-------|-------| +| Performed? | ☐ Yes ☐ No | +| If No, reason: | ☐ Medical contraindication ☐ Patient unable ☐ Not ordered | +| Duration | minutes | +| Patient effort | ☐ Good ☐ Fair ☐ Poor | +| Start time | | +| Stop time | | +| EEG changes during HV? | ☐ Yes (describe) ☐ No | +| Clinical symptoms during HV? | ☐ Yes (describe) ☐ No | +| Build-up present? | ☐ Yes ☐ No | +| Resolution after HV? | ☐ Normal ☐ Prolonged | + +### Photic Stimulation + +| Field | Entry | +|-------|-------| +| Performed? | ☐ Yes ☐ No | +| If No, reason: | | +| Start time | | +| Stop time | | +| Lamp distance | cm | +| Eyes condition | ☐ Closed ☐ Open ☐ Both | + +**Frequencies tested and response:** + +| Frequency (Hz) | Photic driving? | Photoparoxysmal response? | +|----------------|-----------------|---------------------------| +| 1 | ☐ | ☐ | +| 3 | ☐ | ☐ | +| 5 | ☐ | ☐ | +| 7 | ☐ | ☐ | +| 10 | ☐ | ☐ | +| 13 | ☐ | ☐ | +| 15 | ☐ | ☐ | +| 18 | ☐ | ☐ | +| 20 | ☐ | ☐ | +| 25 | ☐ | ☐ | +| 30 | ☐ | ☐ | + +**Photomyoclonic response?** ☐ Yes ☐ No + +### Sleep + +| Field | Entry | +|-------|-------| +| Sleep achieved? | ☐ Yes ☐ No | +| Sleep stage achieved | ☐ Drowsy ☐ Stage I ☐ Stage II ☐ Deeper | +| Method | ☐ Natural ☐ Sleep-deprived ☐ Sedation (medication: _______) | +| Sleep spindles present? | ☐ Yes ☐ No | +| Vertex waves present? | ☐ Yes ☐ No | +| K-complexes present? | ☐ Yes ☐ No | + +--- + +## Patient State/Behavior During Recording + +| State | Time (approximate) | +|-------|-------------------| +| Awake, eyes open | | +| Awake, eyes closed | | +| Drowsy | | +| Asleep | | + +### Patient Cooperation + +☐ Excellent - fully cooperative +☐ Good - generally cooperative +☐ Fair - some difficulty +☐ Poor - unable to cooperate (describe): _______ + +--- + +## Technologist Observations + +### Clinical Events During Recording + +☐ No clinical events observed + +| Time | Event Description | EEG Correlation Noted? | +|------|------------------|------------------------| +| | | ☐ Yes ☐ No | +| | | ☐ Yes ☐ No | +| | | ☐ Yes ☐ No | + +### Artifacts Noted + +☐ Muscle/EMG +☐ Eye movement/blink +☐ Movement +☐ Electrode/technical +☐ 60 Hz/electrical +☐ ECG +☐ Respiration +☐ Sweat +☐ Other: _______ + +### Preliminary Observations (not interpretation) + +☐ Symmetric background +☐ Asymmetric background +☐ Slowing noted +☐ Sharp waveforms noted +☐ Seizure activity observed +☐ Other findings: _______ + +--- + +## Technical Quality Assessment + +| Criterion | Met? | +|-----------|------| +| Adequate duration (≥20 min) | ☐ Yes ☐ No | +| Acceptable impedances | ☐ Yes ☐ No | +| Multiple montages recorded | ☐ Yes ☐ No | +| Activation procedures completed | ☐ Yes ☐ N/A | +| Sleep recorded (if ordered) | ☐ Yes ☐ N/A | +| Minimal artifact | ☐ Yes ☐ No | +| Calibration documented | ☐ Yes ☐ No | + +**Overall Technical Quality:** ☐ Excellent ☐ Good ☐ Fair ☐ Poor + +--- + +## Post-Recording + +| Field | Entry | +|-------|-------| +| Electrodes removed | ☐ Yes | +| Scalp inspected | ☐ Normal ☐ Irritation noted: | +| Patient discharged from lab | Time: | +| Patient condition at discharge | ☐ Baseline ☐ Changed (describe): | +| Study uploaded to reading system | ☐ Yes | +| Priority | ☐ Routine ☐ Urgent ☐ STAT | + +--- + +## Technologist Attestation + +| Field | Entry | +|-------|-------| +| Technologist Name | | +| Credentials | | +| Signature | | +| Date | | +| Time | | + +--- + +## Physician Review (if immediate review) + +| Field | Entry | +|-------|-------| +| Reviewed By | | +| Date/Time | | +| Preliminary Impression | | +| Signature | | + +--- + +*Form FRM-EEG-001 Rev 1.0 - EEG Recording Log* diff --git a/Forms/Report-Templates/.gitkeep b/Forms/Report-Templates/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Requisition-Forms/.gitkeep b/Forms/Requisition-Forms/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Technical-Logs/.gitkeep b/Forms/Technical-Logs/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Training/FRM-004-Training-Record.md b/Forms/Training/FRM-004-Training-Record.md new file mode 100644 index 0000000..b66164d --- /dev/null +++ b/Forms/Training/FRM-004-Training-Record.md @@ -0,0 +1,72 @@ +# Training Record Form + +| Form ID | FRM-004 | Revision | 1.0 | +|---------|---------|----------|-----| + +--- + +## Section 1: Employee Information + +| Field | Entry | +|-------|-------| +| Employee Name | | +| Employee ID | | +| Department | | +| Job Title | | + +## Section 2: Training Information + +| Field | Entry | +|-------|-------| +| Training Title | | +| Training Date | | +| Training Duration | | +| Trainer Name | | +| Trainer Qualification | | + +### Training Type +- [ ] Initial Training +- [ ] Retraining +- [ ] Refresher +- [ ] Procedure Update + +### Delivery Method +- [ ] Classroom +- [ ] On-the-Job +- [ ] Self-Study +- [ ] Computer-Based +- [ ] Other: ____________ + +## Section 3: Training Content + +*(List topics covered or attach training materials)* + + + + +## Section 4: Assessment + +### Assessment Method +- [ ] Written Test +- [ ] Practical Demonstration +- [ ] Verbal Assessment +- [ ] Observation + +### Assessment Results + +| Metric | Result | +|--------|--------| +| Score (if applicable) | | +| Pass/Fail | | + +## Section 5: Signatures + +| Role | Name | Signature | Date | +|------|------|-----------|------| +| Trainee | | | | +| Trainer | | | | +| Supervisor | | | | + +--- + +*Form FRM-004 Rev 1.0* diff --git a/Policies/POL-001-Quality-Policy.md b/Policies/POL-001-Quality-Policy.md new file mode 100644 index 0000000..ebd85dd --- /dev/null +++ b/Policies/POL-001-Quality-Policy.md @@ -0,0 +1,57 @@ +# Quality Policy + +| Document ID | POL-001 | +|-------------|---------| +| Title | Quality Policy | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | + +--- + +## 1. Policy Statement + +[ORGANIZATION NAME] is committed to providing products and services that consistently meet customer requirements and applicable regulatory requirements. We strive for continual improvement of our Quality Management System to enhance customer satisfaction. + +## 2. Quality Objectives + +Our organization commits to: + +1. **Customer Focus**: Understanding and meeting customer needs and expectations +2. **Regulatory Compliance**: Maintaining compliance with all applicable regulations and standards +3. **Continuous Improvement**: Continually improving the effectiveness of our QMS +4. **Employee Engagement**: Ensuring all employees understand their role in quality +5. **Risk-Based Thinking**: Identifying and addressing risks and opportunities + +## 3. Management Commitment + +Top management demonstrates commitment to the QMS by: + +- Ensuring the quality policy is appropriate to the organization's purpose +- Ensuring quality objectives are established and compatible with strategic direction +- Ensuring integration of QMS requirements into business processes +- Promoting the use of the process approach and risk-based thinking +- Ensuring resources needed for the QMS are available +- Communicating the importance of effective quality management +- Ensuring the QMS achieves its intended results +- Engaging, directing, and supporting persons to contribute to QMS effectiveness + +## 4. Scope + +This policy applies to all employees, contractors, and processes within the scope of our Quality Management System. + +## 5. Communication + +This policy shall be: +- Communicated and understood within the organization +- Available to relevant interested parties as appropriate +- Reviewed for continuing suitability + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/README.md b/README.md index 5f95831..794edf9 100644 --- a/README.md +++ b/README.md @@ -1,3 +1,133 @@ -# neurophysiology-eeg +# Neurophysiology & EEG Laboratory Quality Management System -A comprehensive QMS template designed for EEG laboratories, neurophysiology departments, and neurodiagnostic services. \ No newline at end of file +A comprehensive QMS template designed for EEG laboratories, neurophysiology departments, and neurodiagnostic services. + +## 🧠 Designed For + +- **Hospital EEG Laboratories** - Inpatient and outpatient EEG services +- **Epilepsy Monitoring Units (EMU)** - Long-term video-EEG monitoring +- **Sleep Laboratories** - Polysomnography and sleep studies +- **Intraoperative Monitoring (IOM)** - Surgical neuromonitoring services +- **Evoked Potential Labs** - VEP, SSEP, BAEP testing +- **Pediatric Neurophysiology** - Neonatal and pediatric EEG +- **Research Neurophysiology** - Clinical research EEG programs + +## 📋 Regulatory Framework + +This template supports compliance with: + +- **ACNS** - American Clinical Neurophysiology Society guidelines +- **ASET** - American Society of Electroneurodiagnostic Technologists standards +- **ABRET** - Neurodiagnostic credentialing requirements +- **The Joint Commission** - Hospital accreditation (if applicable) +- **CMS** - Medicare technical component requirements +- **HIPAA** - Patient privacy requirements +- **AASM** - American Academy of Sleep Medicine (for sleep labs) +- **State Licensing** - Technologist licensing requirements +- **OSHA** - Workplace safety requirements +- **FDA** - Medical device regulations for EEG equipment + +## Repository Structure + +``` +├── SOPs/ +│ ├── Routine-EEG/ # Standard EEG, activation procedures, reporting +│ ├── Long-Term-Monitoring/ # Continuous EEG, video-EEG, EMU protocols +│ ├── Evoked-Potentials/ # VEP, SSEP, BAEP, motor EP procedures +│ ├── Sleep-Studies/ # PSG, MSLT, MWT protocols +│ ├── Equipment/ # Maintenance, calibration, electrode care +│ └── General/ # Document control, training, CAPA +├── Forms/ +│ ├── Requisition-Forms/ # EEG orders, clinical history forms +│ ├── Technical-Logs/ # Recording logs, montage documentation +│ ├── Report-Templates/ # EEG interpretation report templates +│ ├── Equipment-Records/ # Maintenance logs, calibration records +│ ├── Infection-Control/ # Electrode cleaning, disinfection logs +│ └── Training/ # Competency assessments, credentialing +├── Policies/ # Department policies +├── Work-Instructions/ # Step-by-step procedures +└── Templates/ # Document templates +``` + +## Document Numbering Convention + +- **POL-XXX**: Policies +- **SOP-EEG-XXX**: Routine EEG SOPs +- **SOP-LTM-XXX**: Long-Term Monitoring SOPs +- **SOP-EP-XXX**: Evoked Potential SOPs +- **SOP-SLP-XXX**: Sleep Study SOPs +- **SOP-EQ-XXX**: Equipment SOPs +- **WI-XXX**: Work Instructions +- **FRM-XXX**: Forms and Records + +## 🤖 AI-Powered Assistance + +This repository includes **AtomicAI**, your neurophysiology QMS assistant. Mention `@atomicai` in any issue or pull request to: + +- Draft EEG recording and reporting procedures +- Create long-term monitoring protocols +- Generate evoked potential testing SOPs +- Develop equipment maintenance procedures +- Create infection control protocols +- Review documents for ACNS compliance + +### Example Prompts + +- "@atomicai create an SOP for routine EEG recording with activation procedures" +- "@atomicai draft an epilepsy monitoring unit admission protocol" +- "@atomicai write a somatosensory evoked potential (SSEP) testing procedure" +- "@atomicai create an electrode application and skin preparation SOP" +- "@atomicai develop an EEG interpretation and reporting workflow" +- "@atomicai create a neonatal EEG recording protocol" + +## Getting Started + +1. **Establish Technical Standards** - Define recording parameters and montages +2. **Implement Quality Metrics** - Set up technical quality indicators +3. **Define Reporting Standards** - Standardize interpretation and reporting +4. **Set Up Equipment Maintenance** - Schedule calibration and maintenance +5. **Train Technologists** - Use competency assessment forms + +## Key Documents to Create First + +1. **Routine EEG Recording SOP** - Standard 20-minute EEG procedure +2. **Electrode Application SOP** - 10-20 system placement, skin prep +3. **Activation Procedures SOP** - Hyperventilation, photic stimulation +4. **EEG Report Template** - Standardized interpretation format +5. **Equipment Maintenance SOP** - Daily, weekly, monthly checks +6. **Infection Control Policy** - Electrode cleaning and disinfection +7. **Artifact Recognition Training** - Technical quality standards + +## Special Considerations for Neurophysiology + +### Technical Quality +- 10-20 electrode placement accuracy +- Impedance requirements (<5 kΩ) +- Filter and sensitivity settings +- Montage standardization +- Artifact identification and reduction + +### Recording Protocols +- Routine EEG duration and components +- Activation procedure requirements +- Special montages (referential, bipolar) +- Pediatric and neonatal considerations +- ICU and portable EEG protocols + +### Equipment Management +- Amplifier calibration schedules +- Electrode inventory and testing +- Computer system maintenance +- Video synchronization testing +- Backup and archive procedures + +### Infection Control +- Single-use vs. reusable electrodes +- Electrode gel handling +- Skin preparation products +- Equipment surface cleaning +- High-level disinfection requirements + +--- + +*This template is maintained by AtomicQMS. For questions, open an issue in this repository.* diff --git a/SOPs/Equipment/.gitkeep b/SOPs/Equipment/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Evoked-Potentials/.gitkeep b/SOPs/Evoked-Potentials/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/General/SOP-001-Document-Control.md b/SOPs/General/SOP-001-Document-Control.md new file mode 100644 index 0000000..b64ef52 --- /dev/null +++ b/SOPs/General/SOP-001-Document-Control.md @@ -0,0 +1,112 @@ +# Standard Operating Procedure: Document Control + +| Document ID | SOP-001 | +|-------------|---------| +| Title | Document Control | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Quality Assurance | + +--- + +## 1. Purpose + +To establish a procedure for the creation, review, approval, distribution, and control of documents within the Quality Management System. + +## 2. Scope + +This procedure applies to all controlled documents including: +- Policies +- Standard Operating Procedures (SOPs) +- Work Instructions +- Forms and Templates +- Specifications +- External documents of external origin + +## 3. Responsibilities + +### 3.1 Document Owner +- Responsible for document content and accuracy +- Initiates document creation and revision +- Ensures periodic review is performed + +### 3.2 Quality Assurance +- Maintains the document control system +- Assigns document numbers +- Manages document distribution +- Archives obsolete documents + +### 3.3 Approvers +- Review and approve documents before release +- Ensure documents are adequate for intended purpose + +## 4. Procedure + +### 4.1 Document Creation + +1. Identify the need for a new document +2. Request document number from Quality Assurance +3. Draft document using appropriate template +4. Include all required header information +5. Submit for review and approval + +### 4.2 Document Review and Approval + +1. Route document to appropriate reviewers +2. Reviewers provide comments within 5 business days +3. Author addresses all comments +4. Final approval by designated approver +5. Quality Assurance releases document + +### 4.3 Document Numbering + +Documents shall be numbered according to the following convention: + +| Type | Prefix | Example | +|------|--------|---------| +| Policy | POL | POL-001 | +| SOP | SOP | SOP-001 | +| Work Instruction | WI | WI-001 | +| Form | FRM | FRM-001 | + +### 4.4 Revision Control + +1. All changes require documented justification +2. Changes follow same review/approval process as new documents +3. Revision number increments with each approved change +4. Revision history maintained in document footer + +### 4.5 Document Distribution + +1. Current versions available in document control system +2. Obsolete versions marked and archived +3. Training on new/revised documents as needed + +### 4.6 Periodic Review + +1. Documents reviewed at least every 2 years +2. Review documented even if no changes made +3. Reviews may result in revision or reaffirmation + +## 5. Related Documents + +- FRM-001 Document Change Request Form +- FRM-002 Document Review Record + +## 6. Definitions + +| Term | Definition | +|------|------------| +| Controlled Document | Document managed under document control system | +| Obsolete | Document no longer valid for use | +| Revision | Updated version of a document | + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/General/SOP-002-CAPA.md b/SOPs/General/SOP-002-CAPA.md new file mode 100644 index 0000000..8dace85 --- /dev/null +++ b/SOPs/General/SOP-002-CAPA.md @@ -0,0 +1,134 @@ +# Standard Operating Procedure: Corrective and Preventive Action (CAPA) + +| Document ID | SOP-002 | +|-------------|---------| +| Title | Corrective and Preventive Action | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Quality Assurance | + +--- + +## 1. Purpose + +To establish a systematic process for identifying, investigating, correcting, and preventing nonconformities and potential nonconformities. + +## 2. Scope + +This procedure applies to: +- Product and process nonconformities +- Customer complaints +- Audit findings +- Process deviations +- Potential nonconformities identified through risk analysis + +## 3. Definitions + +| Term | Definition | +|------|------------| +| Corrective Action | Action to eliminate the cause of a detected nonconformity | +| Preventive Action | Action to eliminate the cause of a potential nonconformity | +| Root Cause | Fundamental reason for a nonconformity | +| Effectiveness Check | Verification that implemented actions achieved desired results | + +## 4. Responsibilities + +### 4.1 CAPA Owner +- Investigates the issue +- Identifies root cause +- Develops and implements corrective/preventive actions +- Verifies effectiveness + +### 4.2 Quality Assurance +- Manages CAPA system +- Assigns CAPA numbers +- Tracks CAPA status +- Reviews and approves CAPAs +- Reports CAPA metrics to management + +### 4.3 Management +- Provides resources for CAPA implementation +- Reviews CAPA trends +- Ensures timely closure + +## 5. Procedure + +### 5.1 CAPA Initiation + +1. Identify nonconformity or potential nonconformity +2. Document issue on CAPA Form (FRM-003) +3. Classify severity and priority +4. Assign CAPA owner + +### 5.2 Investigation + +1. Gather relevant data and evidence +2. Interview personnel involved +3. Review related documents and records +4. Use appropriate investigation tools: + - 5 Whys + - Fishbone Diagram + - Failure Mode Analysis + +### 5.3 Root Cause Analysis + +1. Identify potential root causes +2. Verify root cause through evidence +3. Document root cause determination +4. Consider systemic implications + +### 5.4 Action Development + +1. Develop corrective/preventive actions +2. Assign responsibilities and due dates +3. Assess actions for: + - Appropriateness to problem severity + - Impact on other processes + - Resource requirements + +### 5.5 Implementation + +1. Execute approved actions +2. Document implementation evidence +3. Update affected documents/processes +4. Provide training as needed + +### 5.6 Effectiveness Verification + +1. Define effectiveness criteria +2. Allow sufficient time for actions to take effect +3. Collect and analyze data +4. Document verification results +5. If ineffective, reopen CAPA for further action + +### 5.7 Closure + +1. Review all CAPA documentation +2. Verify all actions completed +3. Confirm effectiveness verified +4. Obtain approval for closure + +## 6. CAPA Metrics + +Quality Assurance shall track and report: +- Number of open CAPAs +- CAPA aging +- On-time closure rate +- Effectiveness rate +- CAPAs by category/source + +## 7. Related Documents + +- FRM-003 CAPA Form +- SOP-003 Nonconforming Product Control +- SOP-004 Customer Complaints + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/General/SOP-003-Training.md b/SOPs/General/SOP-003-Training.md new file mode 100644 index 0000000..22538c1 --- /dev/null +++ b/SOPs/General/SOP-003-Training.md @@ -0,0 +1,123 @@ +# Standard Operating Procedure: Training and Competence + +| Document ID | SOP-003 | +|-------------|---------| +| Title | Training and Competence | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Human Resources / Quality | + +--- + +## 1. Purpose + +To ensure personnel performing work affecting product quality are competent based on appropriate education, training, skills, and experience. + +## 2. Scope + +This procedure applies to: +- All employees performing quality-affecting activities +- Contractors and temporary personnel +- Personnel requiring GxP training + +## 3. Responsibilities + +### 3.1 Supervisors/Managers +- Identify training needs for their personnel +- Ensure training is completed before performing tasks +- Evaluate competence of personnel +- Maintain department training records + +### 3.2 Human Resources +- Coordinate training programs +- Maintain central training database +- Track training compliance +- Archive training records + +### 3.3 Quality Assurance +- Develop QMS-related training +- Approve training curricula for GxP activities +- Audit training compliance + +### 3.4 Employees +- Complete assigned training on time +- Maintain current qualifications +- Report training needs to supervisor + +## 4. Procedure + +### 4.1 Training Needs Assessment + +1. Identify competence requirements for each role +2. Document requirements in job descriptions +3. Assess current competence of personnel +4. Identify training gaps + +### 4.2 Training Curriculum Development + +1. Define learning objectives +2. Develop training materials +3. Identify delivery method: + - Classroom + - On-the-job + - Self-study + - Computer-based +4. Define assessment criteria +5. Obtain approval from Quality (for GxP training) + +### 4.3 Training Delivery + +1. Schedule training session +2. Document attendance +3. Deliver training per curriculum +4. Assess comprehension through: + - Written test (minimum 80% passing) + - Practical demonstration + - Supervisor observation + +### 4.4 Training Documentation + +Training records shall include: +- Employee name and ID +- Training title and date +- Trainer name and qualifications +- Assessment results +- Signatures + +### 4.5 Retraining Requirements + +Retraining is required when: +- Significant document revisions occur +- Performance deficiencies identified +- Extended absence from job function +- Periodic requalification due + +### 4.6 New Employee Orientation + +All new employees shall complete: +1. Company orientation +2. Quality system overview +3. Job-specific training +4. SOP read and understand for applicable procedures + +## 5. Training Records Retention + +- Training records maintained for duration of employment +- Records retained 3 years after employee departure +- Records available for regulatory inspection + +## 6. Related Documents + +- FRM-004 Training Record Form +- FRM-005 Training Assessment Form +- Job Descriptions + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/General/SOP-004-Internal-Audit.md b/SOPs/General/SOP-004-Internal-Audit.md new file mode 100644 index 0000000..749d6a5 --- /dev/null +++ b/SOPs/General/SOP-004-Internal-Audit.md @@ -0,0 +1,136 @@ +# Standard Operating Procedure: Internal Audit + +| Document ID | SOP-004 | +|-------------|---------| +| Title | Internal Audit | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Quality Assurance | + +--- + +## 1. Purpose + +To establish a systematic approach for conducting internal audits to verify the effectiveness of the Quality Management System. + +## 2. Scope + +This procedure covers: +- QMS process audits +- Compliance audits +- Product audits +- System audits + +## 3. Definitions + +| Term | Definition | +|------|------------| +| Audit | Systematic, independent examination to determine conformance | +| Auditor | Person qualified to perform audits | +| Finding | Observation of conformance or nonconformance | +| Observation | Noted item not rising to level of finding | + +## 4. Responsibilities + +### 4.1 Lead Auditor +- Plans and schedules audits +- Prepares audit checklists +- Conducts audit activities +- Reports audit findings + +### 4.2 Quality Manager +- Maintains audit program +- Qualifies auditors +- Reviews audit reports +- Reports to management + +### 4.3 Auditee +- Provides access to areas/records +- Responds to findings +- Implements corrective actions + +## 5. Procedure + +### 5.1 Annual Audit Schedule + +1. Develop annual audit schedule considering: + - Previous audit results + - Process criticality + - Regulatory requirements + - Changes to processes +2. Ensure all QMS processes audited at least annually +3. Obtain management approval +4. Communicate schedule to affected areas + +### 5.2 Auditor Qualification + +Auditors shall: +- Complete auditor training course +- Conduct at least 2 audits under supervision +- Be independent of area being audited +- Maintain competence through ongoing audits + +### 5.3 Audit Preparation + +1. Review applicable procedures and standards +2. Review previous audit reports +3. Prepare audit checklist +4. Notify auditee of audit scope and schedule +5. Confirm auditor availability + +### 5.4 Conducting the Audit + +1. Hold opening meeting with auditee +2. Execute audit checklist +3. Gather objective evidence: + - Document review + - Personnel interviews + - Process observation +4. Document findings with evidence +5. Classify findings: + - Major Nonconformance + - Minor Nonconformance + - Observation +6. Hold closing meeting + +### 5.5 Audit Reporting + +1. Complete audit report within 5 business days +2. Report shall include: + - Audit scope and criteria + - Personnel interviewed + - Findings with evidence + - Recommendations +3. Distribute report to auditee and management + +### 5.6 Finding Resolution + +1. Auditee responds with corrective action plan within 10 business days +2. Quality reviews and approves plan +3. Auditee implements corrective actions +4. Auditor verifies effectiveness +5. Close finding upon verification + +## 6. Audit Records + +Maintain for 5 years: +- Audit schedules +- Checklists +- Reports +- Corrective action records + +## 7. Related Documents + +- FRM-006 Audit Checklist Template +- FRM-007 Audit Report Template +- SOP-002 CAPA + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/General/SOP-005-Management-Review.md b/SOPs/General/SOP-005-Management-Review.md new file mode 100644 index 0000000..dd82006 --- /dev/null +++ b/SOPs/General/SOP-005-Management-Review.md @@ -0,0 +1,114 @@ +# Standard Operating Procedure: Management Review + +| Document ID | SOP-005 | +|-------------|---------| +| Title | Management Review | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Quality Assurance | + +--- + +## 1. Purpose + +To ensure top management reviews the Quality Management System at planned intervals to ensure its continuing suitability, adequacy, and effectiveness. + +## 2. Scope + +This procedure applies to the periodic management review of the QMS, including all processes and quality objectives. + +## 3. Frequency + +Management reviews shall be conducted: +- At least annually +- More frequently if significant changes occur +- As needed based on quality performance + +## 4. Responsibilities + +### 4.1 Quality Manager +- Prepares management review agenda and materials +- Facilitates the meeting +- Documents meeting minutes and action items +- Tracks completion of action items + +### 4.2 Top Management +- Attends management review meetings +- Reviews QMS performance data +- Makes decisions on QMS improvements +- Allocates resources as needed + +### 4.3 Department Managers +- Provides input data for their areas +- Attends management review +- Implements assigned action items + +## 5. Management Review Inputs + +The following shall be considered: + +### 5.1 Actions from Previous Reviews +- Status of action items +- Effectiveness of implemented actions + +### 5.2 Changes in Context +- Internal changes (organization, resources) +- External changes (regulations, market) + +### 5.3 QMS Performance +- Customer satisfaction and feedback +- Quality objectives achievement +- Process performance metrics +- Nonconformities and corrective actions +- Audit results +- Supplier performance + +### 5.4 Resource Adequacy +- Personnel +- Infrastructure +- Work environment + +### 5.5 Risk and Opportunities +- Risk assessment results +- Effectiveness of risk controls +- New opportunities identified + +### 5.6 Improvement Opportunities +- Process improvements +- Product improvements +- QMS enhancements + +## 6. Management Review Outputs + +Decisions and actions related to: +- Improvement of QMS and processes +- Product improvement +- Resource needs +- Changes to quality policy or objectives + +## 7. Documentation + +### 7.1 Meeting Minutes +- Date and attendees +- Items discussed +- Decisions made +- Action items with owners and due dates + +### 7.2 Record Retention +- Management review records retained for 5 years +- Available for regulatory inspection + +## 8. Related Documents + +- FRM-008 Management Review Agenda Template +- FRM-009 Management Review Minutes Template + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/Long-Term-Monitoring/.gitkeep b/SOPs/Long-Term-Monitoring/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Recording-Procedures/SOP-EEG-001-Routine-EEG.md b/SOPs/Recording-Procedures/SOP-EEG-001-Routine-EEG.md new file mode 100644 index 0000000..e42f318 --- /dev/null +++ b/SOPs/Recording-Procedures/SOP-EEG-001-Routine-EEG.md @@ -0,0 +1,324 @@ +# Standard Operating Procedure: Routine EEG Recording + +| Document ID | SOP-EEG-001 | +|-------------|-------------| +| Title | Routine Electroencephalography (EEG) Recording | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Neurophysiology/EEG Laboratory | + +--- + +## 1. Purpose + +To establish standardized procedures for recording routine electroencephalograms (EEG) in accordance with American Clinical Neurophysiology Society (ACNS) guidelines to ensure high-quality recordings for accurate interpretation. + +## 2. Scope + +This procedure applies to routine EEG recordings including: +- Routine awake EEG +- Routine EEG with sleep +- Activation procedures (hyperventilation, photic stimulation) +- Portable/bedside EEG +- Ambulatory EEG + +## 3. Responsibilities + +### 3.1 EEG Technologist +- Prepare patient for recording +- Apply electrodes according to 10-20 system +- Perform recording per protocol +- Monitor recording quality +- Perform activation procedures +- Document relevant observations + +### 3.2 Electroneurodiagnostic Technologist (R.EEG.T or CNIM) +- Supervise EEG recordings +- Perform complex studies +- Train and mentor technologists +- Ensure quality standards + +### 3.3 Interpreting Physician (Neurologist/Epileptologist) +- Review and interpret recordings +- Provide clinical correlation +- Generate diagnostic report +- Recommend follow-up studies + +## 4. Definitions + +| Term | Definition | +|------|------------| +| 10-20 System | International electrode placement system | +| Montage | Arrangement of electrode channels for display | +| Impedance | Resistance between electrode and scalp | +| Sensitivity | Amplitude of EEG display (µV/mm) | +| Activation | Procedures to provoke abnormalities (HV, photic) | + +## 5. Equipment and Materials + +- Digital EEG recording system +- Electrodes (disc, cup, or disposable) +- Electrode paste/gel (conductive) +- Skin preparation materials (abrasive gel/paste) +- Measuring tape +- Electrode placement cap or headbox +- Impedance meter +- Photic stimulator +- Video recording system +- Calibration equipment + +## 6. Procedure + +### 6.1 Patient Preparation + +#### 6.1.1 Pre-Procedure Verification +1. Confirm patient identity (two identifiers) +2. Verify physician order and indication +3. Review relevant history: + - Seizure history + - Current medications (especially AEDs) + - Sleep deprivation (if ordered) + - Recent seizure activity + +4. Patient Instructions Verified: + - [ ] Hair clean, dry, no styling products + - [ ] Sleep deprivation completed (if ordered) + - [ ] Medications taken as instructed + - [ ] No caffeine morning of test (if applicable) + +#### 6.1.2 Patient Education +- Explain procedure and duration +- Describe electrode application process +- Explain activation procedures +- Discuss what to expect during recording + +### 6.2 Electrode Application + +#### 6.2.1 Measurement and Marking + +**10-20 System Measurements:** +1. Measure nasion to inion (anterior-posterior) +2. Mark Fpz at 10% from nasion +3. Mark Fz at 30%, Cz at 50%, Pz at 70% +4. Mark Oz at 10% from inion + +5. Measure preauricular points (transverse) +6. Mark T3/T4 at 10% from preauricular +7. Mark C3/C4 at 30% +8. Mark Cz at 50% (should match A-P) + +9. Measure head circumference +10. Mark remaining positions per 10-20 system + +#### 6.2.2 Standard Electrode Positions + +| Position | Location | Hemisphere | +|----------|----------|------------| +| Fp1, Fp2 | Frontopolar | Left, Right | +| F3, F4 | Frontal | Left, Right | +| C3, C4 | Central | Left, Right | +| P3, P4 | Parietal | Left, Right | +| O1, O2 | Occipital | Left, Right | +| F7, F8 | Anterior Temporal | Left, Right | +| T3, T4 | Mid-Temporal | Left, Right | +| T5, T6 | Posterior Temporal | Left, Right | +| Fz | Frontal | Midline | +| Cz | Central | Midline | +| Pz | Parietal | Midline | +| A1, A2 | Ear/Mastoid | Reference | + +#### 6.2.3 Electrode Application Process +1. Part hair at electrode site +2. Clean scalp with abrasive gel +3. Apply conductive paste to electrode +4. Affix electrode to scalp +5. Secure with tape, collodion, or cap +6. Repeat for all electrodes + +#### 6.2.4 Impedance Check +- Check impedance for all electrodes +- Target: <5 kΩ +- Maximum acceptable: <10 kΩ +- Document impedance values +- Reapply electrodes if impedance excessive + +### 6.3 Recording Setup + +#### 6.3.1 System Configuration +| Parameter | Standard Setting | +|-----------|-----------------| +| Sensitivity | 7 µV/mm | +| Low frequency filter | 1 Hz | +| High frequency filter | 70 Hz | +| Notch filter | 60 Hz (if needed) | +| Time constant | 0.16 seconds | +| Paper speed/display | 30 mm/sec | + +#### 6.3.2 Standard Montages + +**Longitudinal Bipolar (Double Banana):** +- Fp1-F7, F7-T3, T3-T5, T5-O1 +- Fp1-F3, F3-C3, C3-P3, P3-O1 +- Fz-Cz, Cz-Pz +- Fp2-F4, F4-C4, C4-P4, P4-O2 +- Fp2-F8, F8-T4, T4-T6, T6-O2 + +**Transverse Bipolar:** +- F7-Fp1, Fp1-Fp2, Fp2-F8 +- T3-C3, C3-Cz, Cz-C4, C4-T4 +- T5-P3, P3-Pz, Pz-P4, P4-T6 + +**Referential:** +- All electrodes referenced to average or specific electrode + +#### 6.3.3 Calibration +1. Perform square wave calibration +2. Document calibration signal +3. Verify all channels responding appropriately + +### 6.4 Recording Procedure + +#### 6.4.1 Recording Timeline + +| Phase | Duration | Activity | +|-------|----------|----------| +| Initial | 5-10 min | Eyes closed, relaxed wakefulness | +| Eyes open/closed | 2-3 cycles | Assess reactivity | +| Hyperventilation | 3-5 min | Deep breathing | +| Post-HV | 2-3 min | Recovery period | +| Photic stimulation | 5-10 min | Flashing lights | +| Drowsiness/Sleep | As able | Natural or sleep-deprived | +| Total Recording | 20-40 min | Minimum per ACNS | + +#### 6.4.2 Routine Recording Protocol + +1. **Resting Recording** + - Eyes closed, relaxed + - Minimize movement + - Record representative sample + +2. **Eyes Open/Closed** + - Command to open eyes (10 seconds) + - Command to close eyes + - Document alpha reactivity + - Repeat 2-3 times + +3. **Hyperventilation (if not contraindicated)** + + **Contraindications:** + - Recent stroke + - Significant cardiovascular disease + - Respiratory compromise + - Sickle cell disease + - Pregnancy + - Intracranial hemorrhage + + **Procedure:** + - Explain deep, rapid breathing + - Patient breathes deeply for 3-5 minutes + - Document effort level + - Continue recording 2-3 minutes post-HV + - Document any symptoms or findings + +4. **Photic Stimulation** + + **Standard Frequencies:** + 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 18, 20, 25, 30 Hz + + **Procedure:** + - Position photic stimulator 30 cm from face + - Eyes closed + - 10 seconds at each frequency + - 10 second pause between frequencies + - Document any clinical responses + - Stop if clinical seizure occurs + +5. **Sleep Recording (if ordered)** + - Encourage natural drowsiness + - Record drowsiness transition + - Record sleep if achieved + - Document sleep stages observed + +### 6.5 Documentation During Recording + +Technologist must annotate: +- [ ] Patient state (awake, drowsy, asleep) +- [ ] Eye movements and blinks +- [ ] Movement artifacts and cause +- [ ] Patient activities (talking, coughing) +- [ ] Clinical events observed +- [ ] Activation procedures (start/stop times) +- [ ] Any technical problems + +### 6.6 Recording Quality Checks + +Throughout recording, monitor for: +| Issue | Action | +|-------|--------| +| Electrode pop/artifact | Check connection, reapply if needed | +| Movement artifact | Reposition patient, note cause | +| Sweat artifact | Cool patient, apply antiperspirant | +| Muscle artifact | Relax jaw/neck, adjust position | +| 60 Hz interference | Check grounds, move cables | + +### 6.7 Post-Recording + +1. **Electrode Removal** + - Remove electrodes carefully + - Clean paste from scalp + - Inspect scalp for irritation + - Provide patient aftercare instructions + +2. **Equipment Care** + - Clean reusable electrodes + - Disinfect equipment per protocol + - Store equipment properly + +3. **Documentation** + Complete FRM-EEG-001 including: + - Recording duration + - Montages used + - Activation procedures performed + - Patient cooperation level + - Technical quality assessment + - Technologist observations + +## 7. Special Considerations + +### 7.1 Pediatric Patients +- May require sedation (per physician order) +- Age-appropriate electrode sizes +- Modified activation procedures +- Parent/guardian present as appropriate + +### 7.2 ICU/Portable EEG +- Increased artifact sources +- Document artifact causes +- Extended recording times may be needed +- Coordinate with bedside care + +## 8. Quality Control + +| Metric | Target | +|--------|--------| +| Electrode impedance <5 kΩ | >90% of electrodes | +| Recording duration meets minimum | 100% | +| Activation procedures completed | 100% (unless contraindicated) | +| Technical quality adequate for interpretation | >95% | + +## 9. References + +- ACNS Guideline 1: Minimum Technical Requirements for Performing Clinical EEG +- ACNS Guideline 6: Recording EEG +- ASET Standards of Practice +- ABRET Certification Requirements + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/Routine-EEG/.gitkeep b/SOPs/Routine-EEG/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Safety/.gitkeep b/SOPs/Safety/.gitkeep new file mode 100644 index 0000000..dcf2c80 --- /dev/null +++ b/SOPs/Safety/.gitkeep @@ -0,0 +1 @@ +# Placeholder diff --git a/SOPs/Sleep-Studies/.gitkeep b/SOPs/Sleep-Studies/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Templates/SOP-Template.md b/Templates/SOP-Template.md new file mode 100644 index 0000000..2e9f35e --- /dev/null +++ b/Templates/SOP-Template.md @@ -0,0 +1,62 @@ +# Standard Operating Procedure: [Title] + +| Document ID | SOP-XXX | +|-------------|---------| +| Title | [Title] | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | [DEPARTMENT] | + +--- + +## 1. Purpose + +[State the purpose of this procedure] + +## 2. Scope + +[Define the scope and applicability] + +## 3. Responsibilities + +### 3.1 [Role 1] +- [Responsibility] +- [Responsibility] + +### 3.2 [Role 2] +- [Responsibility] +- [Responsibility] + +## 4. Definitions + +| Term | Definition | +|------|------------| +| | | + +## 5. Procedure + +### 5.1 [Section Title] + +[Procedure steps] + +### 5.2 [Section Title] + +[Procedure steps] + +## 6. Related Documents + +- [List related procedures, forms, etc.] + +## 7. References + +- [External standards, regulations, etc.] + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/Work Instructions/WI-001-Template.md b/Work Instructions/WI-001-Template.md new file mode 100644 index 0000000..68167f1 --- /dev/null +++ b/Work Instructions/WI-001-Template.md @@ -0,0 +1,68 @@ +# Work Instruction: [Title] + +| Document ID | WI-001 | +|-------------|--------| +| Title | [Title] | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | [DEPARTMENT] | + +--- + +## 1. Purpose + +[Describe the purpose of this work instruction] + +## 2. Scope + +[Define what activities this instruction covers] + +## 3. Safety Precautions + +- [List any safety requirements] +- [Personal protective equipment needed] +- [Hazards to be aware of] + +## 4. Equipment/Materials Required + +| Item | Specification | +|------|---------------| +| | | +| | | + +## 5. Procedure + +### Step 1: [Title] +[Detailed instructions] + +### Step 2: [Title] +[Detailed instructions] + +### Step 3: [Title] +[Detailed instructions] + +## 6. Acceptance Criteria + +[Define what constitutes successful completion] + +## 7. Records + +| Record | Location | Retention | +|--------|----------|-----------| +| | | | + +## 8. References + +- [Related SOPs] +- [Specifications] +- [Standards] + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] |