Sync template from atomicqms-style deployment

Forms/FRM-001-Document-Change-Request.md

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+# 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*

Forms/FRM-003-CAPA-Form.md

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+# 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*

Forms/FRM-006-Audit-Checklist.md

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+# 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*

Forms/Procedure-Logs/FRM-RAD-001-CT-Procedure-Log.md

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+# 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*

Forms/Training/FRM-004-Training-Record.md

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+# 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*