From 4361b19ce8f94f5c0515780f5803ada0285c0a2b Mon Sep 17 00:00:00 2001 From: AtomicQMS Service Date: Sat, 27 Dec 2025 11:24:16 -0500 Subject: [PATCH] Sync template from atomicqms-style deployment --- .gitea/workflows/atomicai.yml | 79 +++++ Forms/Contrast-Records/.gitkeep | 0 Forms/Dose-Logs/.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/Patient-Screening/.gitkeep | 0 .../FRM-RAD-001-CT-Procedure-Log.md | 262 ++++++++++++++ Forms/Protocol-Sheets/.gitkeep | 0 Forms/QC-Records/.gitkeep | 0 Forms/Training/FRM-004-Training-Record.md | 72 ++++ Policies/POL-001-Quality-Policy.md | 57 +++ README.md | 136 +++++++- SOPs/CT-Imaging/.gitkeep | 0 SOPs/Equipment/.gitkeep | 0 SOPs/General-Radiography/.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 ++++++ .../SOP-RAD-001-CT-Protocol.md | 328 ++++++++++++++++++ SOPs/MRI-Operations/.gitkeep | 0 SOPs/Nuclear-Medicine/.gitkeep | 0 SOPs/Safety/.gitkeep | 1 + SOPs/Ultrasound/.gitkeep | 0 Templates/SOP-Template.md | 62 ++++ Work Instructions/WI-001-Template.md | 68 ++++ 28 files changed, 1893 insertions(+), 2 deletions(-) create mode 100644 .gitea/workflows/atomicai.yml create mode 100644 Forms/Contrast-Records/.gitkeep create mode 100644 Forms/Dose-Logs/.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/Patient-Screening/.gitkeep create mode 100644 Forms/Procedure-Logs/FRM-RAD-001-CT-Procedure-Log.md create mode 100644 Forms/Protocol-Sheets/.gitkeep create mode 100644 Forms/QC-Records/.gitkeep create mode 100644 Forms/Training/FRM-004-Training-Record.md create mode 100644 Policies/POL-001-Quality-Policy.md create mode 100644 SOPs/CT-Imaging/.gitkeep create mode 100644 SOPs/Equipment/.gitkeep create mode 100644 SOPs/General-Radiography/.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/Imaging-Procedures/SOP-RAD-001-CT-Protocol.md create mode 100644 SOPs/MRI-Operations/.gitkeep create mode 100644 SOPs/Nuclear-Medicine/.gitkeep create mode 100644 SOPs/Safety/.gitkeep create mode 100644 SOPs/Ultrasound/.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..4a589b3 --- /dev/null +++ b/.gitea/workflows/atomicai.yml @@ -0,0 +1,79 @@ +name: AtomicAI Radiology 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 Radiology 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 Radiology and Medical Imaging Quality Management. + + ## Your Expertise + - ACR (American College of Radiology) accreditation + - Radiation safety and ALARA principles + - Mammography Quality Standards Act (MQSA) + - CT, MRI, Ultrasound, Nuclear Medicine protocols + - Image quality assurance and phantom testing + - PACS administration and DICOM standards + - Radiologist workflow optimization + - Contrast media safety protocols + - Pediatric imaging dose optimization + - Equipment quality control and calibration + - Critical results communication (ACR guidelines) + - Radiation dose monitoring and reporting + + ## Document Creation Guidelines + - Place Imaging SOPs in SOPs/Imaging/ + - Place Safety SOPs in SOPs/Radiation-Safety/ + - Place QC Protocols in Protocols/Quality-Control/ + - Place Equipment Forms in Forms/Equipment/ + - Place Patient Forms in Forms/Patient/ + - Place Policies in Policies/ + + ## Numbering Convention + - SOP-RAD-XXX for Radiology SOPs + - SOP-RSF-XXX for Radiation Safety SOPs + - SOP-QC-XXX for Quality Control SOPs + - PRO-XXX for Protocols + - POL-XXX for Policies + - FRM-XXX for Forms + + Always create branches and submit changes as Pull Requests for review. + Prioritize radiation safety, image quality, and patient care. + allowed_tools: 'Read,Edit,Grep,Glob,Write' + disallowed_tools: 'Bash,WebSearch' diff --git a/Forms/Contrast-Records/.gitkeep b/Forms/Contrast-Records/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Dose-Logs/.gitkeep b/Forms/Dose-Logs/.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/Patient-Screening/.gitkeep b/Forms/Patient-Screening/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Procedure-Logs/FRM-RAD-001-CT-Procedure-Log.md b/Forms/Procedure-Logs/FRM-RAD-001-CT-Procedure-Log.md new file mode 100644 index 0000000..757aead --- /dev/null +++ b/Forms/Procedure-Logs/FRM-RAD-001-CT-Procedure-Log.md @@ -0,0 +1,262 @@ +# CT Procedure Log + +| Form ID | FRM-RAD-001 | Revision | 1.0 | +|---------|-------------|----------|-----| + +--- + +## Patient Information + +| Field | Entry | +|-------|-------| +| Patient Name | | +| MRN | | +| Date of Birth | | +| Age | | +| Sex | ☐ Male ☐ Female | +| Weight | kg / lbs | +| Height | cm / in | + +--- + +## Exam Information + +| Field | Entry | +|-------|-------| +| Date of Exam | | +| Time Start | | +| Time End | | +| Ordering Physician | | +| Exam Type | | +| Accession Number | | +| Scanner ID | | + +--- + +## Clinical Information + +| Field | Entry | +|-------|-------| +| Indication | | +| Relevant History | | +| Prior CT exams? | ☐ Yes (Date: _______) ☐ No | + +--- + +## Pre-Procedure Screening + +### General Safety + +| Question | Response | +|----------|----------| +| Patient identity verified (2 identifiers)? | ☐ Yes | +| Order verified? | ☐ Yes | +| Procedure explained to patient? | ☐ Yes | +| Pregnancy status (if applicable) | ☐ Not pregnant ☐ Pregnant ☐ Unknown ☐ N/A | +| Metallic implants in scan area? | ☐ Yes (describe: _______) ☐ No | + +### Contrast Screening (if contrast study) + +| Question | Response | +|----------|----------| +| Contrast study? | ☐ Yes ☐ No → Skip to Technical Parameters | +| Previous contrast reaction? | ☐ Yes (describe: _______) ☐ No | +| Premedication given? | ☐ Yes ☐ No ☐ N/A | +| Allergies? | ☐ Yes (list: _______) ☐ NKDA | +| Kidney disease? | ☐ Yes ☐ No | +| Diabetes? | ☐ Yes ☐ No | +| Metformin use? | ☐ Yes ☐ No | +| eGFR/Creatinine | Value: _______ Date: _______ | +| Adequate renal function? | ☐ Yes ☐ No (radiologist notified) | + +### Consent + +| Field | Entry | +|-------|-------| +| Consent obtained? | ☐ Yes ☐ Waived (emergency) | +| Consent signed by | | +| Witnessed by | | + +--- + +## IV Access (for contrast studies) + +| Field | Entry | +|-------|-------| +| IV Access | ☐ Existing ☐ New | +| Gauge | ☐ 18G ☐ 20G ☐ 22G ☐ Other: | +| Location | ☐ Right AC ☐ Left AC ☐ Right Hand ☐ Left Hand ☐ Other: | +| Patency verified | ☐ Yes | +| Inserted by | | + +--- + +## Technical Parameters + +### Protocol Used + +| Field | Entry | +|-------|-------| +| Protocol Name | | +| Body Region | ☐ Head ☐ Neck ☐ Chest ☐ Abdomen ☐ Pelvis ☐ Spine ☐ Extremity ☐ Other | +| kVp | | +| mAs (or reference) | | +| Slice Thickness | mm | +| Pitch | | +| Gantry Rotation Time | sec | +| Scan Mode | ☐ Axial ☐ Helical | +| Coverage | | + +### Multi-Phase Studies + +| Phase | Delay (sec) | Acquired? | +|-------|-------------|-----------| +| Non-contrast | - | ☐ | +| Arterial | | ☐ | +| Portal Venous | | ☐ | +| Delayed | | ☐ | +| Other: | | ☐ | + +--- + +## Contrast Administration + +| Field | Entry | +|-------|-------| +| Contrast Agent | | +| Manufacturer | | +| Lot Number | | +| Expiration Date | | +| Concentration | mgI/mL | +| Volume Administered | mL | +| Injection Rate | mL/sec | +| Injection Method | ☐ Power Injector ☐ Hand Injection | +| Saline Flush | ☐ Yes Volume: ___mL ☐ No | +| Warming Used? | ☐ Yes ☐ No | + +### Contrast Timing + +| Field | Entry | +|-------|-------| +| Timing Method | ☐ Fixed Delay ☐ Bolus Tracking ☐ Test Bolus | +| Trigger Location (if tracking) | | +| Threshold (HU) | | +| Delay after trigger | sec | + +--- + +## Dose Information + +| Metric | Value | +|--------|-------| +| CTDIvol | mGy | +| DLP | mGy·cm | +| Scan Length | cm | +| Number of Series | | + +**Dose within reference level?** ☐ Yes ☐ No (explain: _______) + +--- + +## Image Quality Assessment + +| Criterion | Satisfactory? | +|-----------|---------------| +| Positioning correct | ☐ Yes ☐ No | +| Coverage adequate | ☐ Yes ☐ No | +| No significant motion artifact | ☐ Yes ☐ No | +| Contrast enhancement adequate (if applicable) | ☐ Yes ☐ No ☐ N/A | +| Noise level acceptable | ☐ Yes ☐ No | + +**Overall Technical Quality:** ☐ Diagnostic ☐ Limited ☐ Non-diagnostic + +**If limited/non-diagnostic, explain:** + +**Repeat acquisition required?** ☐ Yes ☐ No + +--- + +## Patient Monitoring (Contrast Studies) + +### During Injection + +| Time | BP | HR | SpO2 | Symptoms | +|------|----|----|------|----------| +| Pre-injection | | | | | +| Post-injection | | | | | + +### Post-Procedure Observation + +| Field | Entry | +|-------|-------| +| Observation time | minutes | +| Any adverse reactions? | ☐ Yes (complete Reaction section) ☐ No | +| IV site condition at removal | ☐ Normal ☐ Swelling ☐ Erythema ☐ Extravasation | + +--- + +## Adverse Reaction (if occurred) + +| Field | Entry | +|-------|-------| +| Time of onset | | +| Type of reaction | ☐ Mild ☐ Moderate ☐ Severe | +| Symptoms | | +| Treatment given | | +| Outcome | ☐ Resolved ☐ Transferred for care | +| Radiologist notified | ☐ Yes Time: | +| Adverse Event Report filed | ☐ Yes Report #: | + +--- + +## Extravasation (if occurred) + +| Field | Entry | +|-------|-------| +| Estimated volume extravasated | mL | +| Location | | +| Symptoms | ☐ Pain ☐ Swelling ☐ Erythema ☐ Blistering | +| Treatment | ☐ Elevation ☐ Ice ☐ Warm compress ☐ Other | +| Follow-up instructions given | ☐ Yes | +| Incident report filed | ☐ Yes | + +--- + +## Post-Procedure + +| Field | Entry | +|-------|-------| +| Patient condition at discharge | ☐ Stable ☐ Other: | +| Instructions provided | ☐ Hydration ☐ Metformin hold ☐ Reaction warning signs ☐ Other | +| Images sent to PACS | ☐ Yes | +| Priority | ☐ Routine ☐ Urgent ☐ STAT | + +--- + +## Special Circumstances/Notes + +--- + +## Technologist Attestation + +| Field | Entry | +|-------|-------| +| Technologist Name | | +| RT(R)(CT) # | | +| Signature | | +| Date | | +| Time | | + +--- + +## Radiologist Review (if applicable at time of exam) + +| Field | Entry | +|-------|-------| +| Radiologist Name | | +| Preliminary Findings | | +| Signature | | + +--- + +*Form FRM-RAD-001 Rev 1.0 - CT Procedure Log* diff --git a/Forms/Protocol-Sheets/.gitkeep b/Forms/Protocol-Sheets/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/QC-Records/.gitkeep b/Forms/QC-Records/.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 2b0d019..9e4213e 100644 --- a/README.md +++ b/README.md @@ -1,3 +1,135 @@ -# radiology +# Radiology & Medical Imaging Quality Management System -A comprehensive QMS template designed for radiology departments, imaging centers, and diagnostic imaging services. \ No newline at end of file +A comprehensive QMS template designed for radiology departments, imaging centers, and diagnostic imaging services. + +## 🩻 Designed For + +- **Hospital Radiology Departments** - Full-service diagnostic imaging +- **Outpatient Imaging Centers** - Freestanding radiology facilities +- **Interventional Radiology** - Image-guided procedures +- **Breast Imaging Centers** - Mammography and breast MRI +- **Nuclear Medicine** - PET, SPECT, and nuclear imaging +- **Radiation Oncology** - Therapeutic radiology services +- **Teleradiology Services** - Remote interpretation services + +## 📋 Regulatory Framework + +This template supports compliance with: + +- **ACR** - American College of Radiology accreditation +- **The Joint Commission** - Hospital accreditation (diagnostic imaging) +- **FDA** - Medical device regulations, MQSA (mammography) +- **CMS** - Medicare imaging requirements +- **State Radiation Control** - State licensing and inspection +- **NRC** - Nuclear Regulatory Commission (if radioactive materials) +- **HIPAA** - Patient privacy and image security +- **OSHA** - Radiation worker safety +- **AAPM** - Medical physics standards +- **ACR Appropriateness Criteria** - Clinical decision support + +## Repository Structure + +``` +├── SOPs/ +│ ├── General-Radiography/ # X-ray, fluoroscopy, portable imaging +│ ├── CT-Imaging/ # CT protocols, contrast administration +│ ├── MRI-Operations/ # MRI safety, protocols, contrast +│ ├── Ultrasound/ # US protocols, transducer care +│ ├── Nuclear-Medicine/ # Radiopharmaceutical handling, imaging +│ ├── Equipment/ # QC, maintenance, calibration +│ └── General/ # Document control, training, CAPA +├── Forms/ +│ ├── Patient-Screening/ # MRI safety, contrast allergy, pregnancy +│ ├── Protocol-Sheets/ # Imaging protocol documentation +│ ├── QC-Records/ # Daily QC, equipment logs +│ ├── Contrast-Records/ # Contrast administration, reactions +│ ├── Dose-Logs/ # Radiation dose tracking +│ └── Training/ # Competency assessments +├── Policies/ # Department policies +├── Work-Instructions/ # Step-by-step procedures +└── Templates/ # Document templates +``` + +## Document Numbering Convention + +- **POL-XXX**: Policies +- **SOP-RAD-XXX**: General Radiography SOPs +- **SOP-CT-XXX**: CT Imaging SOPs +- **SOP-MRI-XXX**: MRI Operations SOPs +- **SOP-US-XXX**: Ultrasound SOPs +- **SOP-NM-XXX**: Nuclear Medicine SOPs +- **SOP-EQ-XXX**: Equipment SOPs +- **WI-XXX**: Work Instructions +- **FRM-XXX**: Forms and Records + +## 🤖 AI-Powered Assistance + +This repository includes **AtomicAI**, your radiology QMS assistant. Mention `@atomicai` in any issue or pull request to: + +- Draft imaging protocol SOPs +- Create patient screening and safety procedures +- Generate equipment QC protocols +- Develop contrast administration procedures +- Create radiation dose tracking systems +- Review documents for ACR compliance + +### Example Prompts + +- "@atomicai create an SOP for MRI patient screening and safety" +- "@atomicai draft a CT contrast administration and reaction protocol" +- "@atomicai write a mammography quality control procedure per MQSA" +- "@atomicai create an equipment QC log for digital radiography" +- "@atomicai develop a radiation dose optimization protocol" +- "@atomicai create a portable X-ray infection control procedure" + +## Getting Started + +1. **Establish Safety Programs** - Implement MRI, radiation, and contrast safety +2. **Define Imaging Protocols** - Standardize protocols by exam type +3. **Set Up Equipment QC** - Daily, weekly, and monthly QC schedules +4. **Implement Dose Monitoring** - Track and optimize radiation dose +5. **Train Technologists** - Use competency assessment forms + +## Key Documents to Create First + +1. **MRI Safety Screening SOP** - Patient and personnel safety +2. **CT Contrast Administration SOP** - IV contrast protocols and reactions +3. **Equipment QC Procedures** - Daily QC for each modality +4. **Radiation Dose Tracking Policy** - DRL monitoring and optimization +5. **Mammography QC Program** - MQSA-required procedures +6. **Image Quality Review SOP** - Technologist quality feedback +7. **Critical Results Communication** - Urgent finding notification + +## Special Considerations for Radiology + +### Patient Safety +- MRI screening (implants, devices, pregnancy) +- Contrast allergy and reaction management +- Radiation dose optimization (ALARA) +- Pregnancy screening and shielding +- Pediatric dose reduction + +### Equipment Quality Control +- Daily QC phantoms and tests +- Annual physics surveys +- Preventive maintenance schedules +- Calibration verification +- Service documentation + +### Imaging Protocols +- Standardized protocol libraries +- Indication-based protocol selection +- Dose optimization techniques +- Image quality standards +- Protocol deviation documentation + +### Regulatory Compliance +- ACR accreditation maintenance +- MQSA requirements (mammography) +- State radiation inspection preparation +- Credentialing and privileging +- Peer review programs + +--- + +*This template is maintained by AtomicQMS. For questions, open an issue in this repository.* diff --git a/SOPs/CT-Imaging/.gitkeep b/SOPs/CT-Imaging/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Equipment/.gitkeep b/SOPs/Equipment/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/General-Radiography/.gitkeep b/SOPs/General-Radiography/.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/Imaging-Procedures/SOP-RAD-001-CT-Protocol.md b/SOPs/Imaging-Procedures/SOP-RAD-001-CT-Protocol.md new file mode 100644 index 0000000..52c3717 --- /dev/null +++ b/SOPs/Imaging-Procedures/SOP-RAD-001-CT-Protocol.md @@ -0,0 +1,328 @@ +# Standard Operating Procedure: CT Imaging Protocol + +| Document ID | SOP-RAD-001 | +|-------------|-------------| +| Title | Computed Tomography (CT) Imaging Protocol | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Radiology/Diagnostic Imaging | + +--- + +## 1. Purpose + +To establish standardized procedures for performing computed tomography (CT) examinations to ensure patient safety, optimal image quality, and regulatory compliance with ACR, state, and federal requirements. + +## 2. Scope + +This procedure applies to all CT examinations including: +- Non-contrast CT studies +- Contrast-enhanced CT studies +- CT angiography (CTA) +- CT-guided procedures +- Emergency/trauma CT + +## 3. Responsibilities + +### 3.1 CT Technologist +- Screen patients for contraindications +- Position patient properly +- Select and execute protocols +- Assess image quality +- Monitor patient during examination + +### 3.2 Radiologist +- Approve protocols +- Supervise contrast administration +- Interpret studies and generate reports +- Manage contrast reactions + +### 3.3 Radiology Nurse (if applicable) +- Assess IV access +- Administer contrast +- Monitor for reactions +- Provide patient care + +### 3.4 Medical Physicist +- Establish dose optimization protocols +- Perform quality control +- Monitor radiation exposure + +## 4. Definitions + +| Term | Definition | +|------|------------| +| CTDI | CT Dose Index - measure of radiation output | +| DLP | Dose Length Product - total dose metric | +| HU | Hounsfield Units - density measurement | +| kVp | Kilovoltage peak | +| mAs | Milliampere-seconds | +| MPR | Multiplanar reconstruction | + +## 5. Equipment and Materials + +- CT scanner (accredited) +- Power injector +- Contrast media (iodinated) +- IV supplies +- Emergency equipment and medications +- Shielding devices +- Patient monitoring equipment + +## 6. Procedure + +### 6.1 Pre-Examination + +#### 6.1.1 Order Verification +- [ ] Valid physician order present +- [ ] Appropriate indication documented +- [ ] Protocol selection appropriate for indication +- [ ] Prior imaging reviewed (if available) + +#### 6.1.2 Patient Identification +- Verify using two identifiers +- Confirm exam matches order +- Review clinical history + +#### 6.1.3 Safety Screening + +**For all patients:** +- [ ] Pregnancy status (women of childbearing age) +- [ ] Previous CT studies (cumulative dose awareness) +- [ ] Ability to cooperate with positioning +- [ ] Metal implants/devices in scan field + +**For contrast studies - additional screening:** + +| Risk Factor | Check | +|-------------|-------| +| Previous contrast reaction | ☐ Yes ☐ No | +| Allergies (iodine, shellfish) | ☐ Yes ☐ No | +| Kidney disease/elevated creatinine | ☐ Yes ☐ No | +| Diabetes (metformin use) | ☐ Yes ☐ No | +| Thyroid disease | ☐ Yes ☐ No | +| Multiple myeloma | ☐ Yes ☐ No | +| Age >70 years | ☐ Yes ☐ No | +| Dehydration | ☐ Yes ☐ No | + +**Renal Function Assessment:** +| eGFR Level | Risk | Action | +|------------|------|--------| +| ≥60 | Low risk | Proceed | +| 45-59 | Moderate risk | Hydration, consider alternatives | +| 30-44 | High risk | Alternative imaging preferred, radiologist approval | +| <30 | Very high risk | Avoid unless emergent, nephrology consult | + +#### 6.1.4 Consent +- Explain procedure and risks +- Obtain informed consent for contrast (if applicable) +- Document consent + +### 6.2 Patient Preparation + +#### 6.2.1 Preparation by Exam Type + +| Exam Type | Preparation Required | +|-----------|---------------------| +| Head CT | Remove metallic objects from head/neck | +| Chest CT | Breathing instructions, arms above head | +| Abdomen/Pelvis CT | Oral contrast (if ordered), full bladder (pelvic) | +| CT Angiography | IV access, contrast protocol | +| CT Colonography | Bowel preparation | + +#### 6.2.2 IV Access for Contrast +- Assess vein suitability +- 20-gauge or larger preferred for power injection +- Verify patency with saline flush +- Secure catheter properly + +### 6.3 Patient Positioning + +#### 6.3.1 Standard Positions + +| Body Part | Position | Gantry Entry | +|-----------|----------|--------------| +| Head | Supine, neutral | Head first | +| Neck | Supine, neck extended | Head first | +| Chest | Supine, arms up | Head or feet first | +| Abdomen | Supine, arms up | Head first | +| Pelvis | Supine, arms up | Feet first | +| Extremity | Per protocol | Varies | + +#### 6.3.2 Positioning Considerations +- Center patient in gantry +- Use positioning aids as needed +- Apply shielding where appropriate +- Ensure patient comfort +- Remove all artifacts from scan field + +### 6.4 Protocol Selection and Parameters + +#### 6.4.1 Dose Optimization Principles +- ALARA (As Low As Reasonably Achievable) +- Use automatic exposure control (AEC) +- Size-appropriate protocols +- Limit scan range to clinical question + +#### 6.4.2 Standard Protocol Parameters + +| Protocol | kVp | mAs | Slice Thickness | Pitch | +|----------|-----|-----|-----------------|-------| +| Head routine | 120 | Auto | 5mm | N/A (axial) | +| Chest routine | 120 | Auto | 5mm/1.25mm | 1.0-1.5 | +| Abdomen routine | 120 | Auto | 5mm/2.5mm | 1.0-1.5 | +| CT Angiography | 100-120 | Auto | 0.625-1.25mm | 0.8-1.0 | +| Low-dose chest | 100-120 | Reduced | 1.25mm | 1.0-1.5 | + +#### 6.4.3 Pediatric Considerations +- Reduce kVp and mAs based on weight/age +- Use pediatric-specific protocols +- Apply "Image Gently" principles +- Minimize number of phases + +### 6.5 Contrast Administration + +#### 6.5.1 Contrast Selection + +| Indication | Contrast Type | Concentration | +|------------|---------------|---------------| +| Routine enhanced | Low-osmolar | 300-350 mgI/mL | +| CT Angiography | Low-osmolar | 350-370 mgI/mL | +| High-risk patients | Iso-osmolar | 270-320 mgI/mL | + +#### 6.5.2 Contrast Volume and Rate + +| Exam Type | Volume | Rate | +|-----------|--------|------| +| Head with contrast | 100 mL | 1-2 mL/sec | +| Chest with contrast | 100-125 mL | 2-3 mL/sec | +| Abdomen with contrast | 100-150 mL | 2-3 mL/sec | +| CT Angiography | 75-125 mL | 4-5 mL/sec | + +#### 6.5.3 Timing Methods +- Fixed delay (empiric) +- Bolus tracking (threshold trigger) +- Test bolus (timing determination) + +### 6.6 Image Acquisition + +1. **Scout/Topogram** + - Acquire scout images + - Verify positioning and coverage + - Set scan range + +2. **Pre-Contrast (if applicable)** + - Acquire non-contrast images + - Assess for baseline findings + +3. **Contrast Injection (if applicable)** + - Verify IV patency + - Program injector parameters + - Monitor injection + +4. **Post-Contrast Acquisition** + - Acquire at appropriate phase(s) + - Arterial: 25-35 seconds + - Portal venous: 60-70 seconds + - Delayed: 3-5 minutes (as needed) + +5. **Image Review** + - Review images for quality + - Assess for artifacts + - Repeat if technically inadequate + +### 6.7 Post-Examination + +#### 6.7.1 Patient Care After Contrast +- Monitor for 15-30 minutes +- Assess IV site +- Provide hydration instructions +- Advise on potential delayed reactions +- Metformin patients: follow institutional protocol + +#### 6.7.2 Documentation +- Complete FRM-RAD-001 CT Procedure Log +- Document dose metrics (CTDIvol, DLP) +- Record contrast details +- Note any adverse events +- Submit images to PACS + +### 6.8 Image Post-Processing + +| Reconstruction | Application | +|----------------|-------------| +| Soft tissue | Routine interpretation | +| Bone | Skeletal evaluation | +| Lung | Pulmonary parenchyma | +| 3D/MPR | Vascular, complex anatomy | +| MIP | Angiography | + +## 7. Contrast Reaction Management + +### 7.1 Reaction Classification + +| Severity | Symptoms | Action | +|----------|----------|--------| +| Mild | Nausea, urticaria (limited), warmth | Observe, treat symptoms | +| Moderate | Extensive urticaria, bronchospasm, hypotension | Medical treatment, monitor | +| Severe | Anaphylaxis, cardiac arrest, seizure | Emergency response, call code | + +### 7.2 Emergency Equipment +Available in CT suite: +- Oxygen and suction +- Emergency medications (epinephrine, diphenhydramine, etc.) +- IV fluids +- Defibrillator/AED +- Crash cart + +## 8. Radiation Safety + +### 8.1 Dose Monitoring +- Record CTDIvol and DLP for each exam +- Compare to diagnostic reference levels +- Investigate outliers + +### 8.2 Diagnostic Reference Levels + +| Exam | CTDIvol (mGy) | DLP (mGy·cm) | +|------|---------------|--------------| +| Head | 60 | 1000 | +| Chest | 15 | 400 | +| Abdomen | 20 | 700 | +| Abdomen/Pelvis | 20 | 900 | + +## 9. Quality Control + +| Activity | Frequency | +|----------|-----------| +| Daily warm-up and calibration | Daily | +| Water phantom QC | Daily/Weekly | +| CT number accuracy | Weekly | +| Spatial resolution | Monthly | +| Physicist review | Annually | + +## 10. Documentation + +- FRM-RAD-001 CT Procedure Log +- FRM-RAD-002 Contrast Administration Record +- FRM-RAD-003 Adverse Reaction Report +- Dose reports +- QC logs + +## 11. References + +- ACR Practice Parameter for CT +- ACR Manual on Contrast Media +- Image Gently Campaign +- AAPM CT Protocols +- State radiation regulations + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/MRI-Operations/.gitkeep b/SOPs/MRI-Operations/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Nuclear-Medicine/.gitkeep b/SOPs/Nuclear-Medicine/.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/Ultrasound/.gitkeep b/SOPs/Ultrasound/.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] |