From 4f7126f559fc01010ed9958e681dc1b151ea1429 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 | 76 ++++ Forms/Assessment-Tools/.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/Intake-Forms/.gitkeep | 0 .../FRM-MHO-001-New-Patient-Intake.md | 380 ++++++++++++++++++ Forms/Progress-Notes/.gitkeep | 0 Forms/Safety-Plans/.gitkeep | 0 Forms/Training/FRM-004-Training-Record.md | 72 ++++ Forms/Treatment-Plans/.gitkeep | 0 Policies/POL-001-Quality-Policy.md | 57 +++ README.md | 133 +++++- .../SOP-MHO-001-Initial-Evaluation.md | 292 ++++++++++++++ SOPs/Compliance/.gitkeep | 0 SOPs/Crisis-Management/.gitkeep | 0 SOPs/Documentation/.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/Intake-Assessment/.gitkeep | 0 SOPs/Safety/.gitkeep | 1 + SOPs/Treatment/.gitkeep | 0 Templates/SOP-Template.md | 62 +++ Work Instructions/WI-001-Template.md | 68 ++++ 27 files changed, 1969 insertions(+), 2 deletions(-) create mode 100644 .gitea/workflows/atomicai.yml create mode 100644 Forms/Assessment-Tools/.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/Intake-Forms/.gitkeep create mode 100644 Forms/Intake-Forms/FRM-MHO-001-New-Patient-Intake.md create mode 100644 Forms/Progress-Notes/.gitkeep create mode 100644 Forms/Safety-Plans/.gitkeep create mode 100644 Forms/Training/FRM-004-Training-Record.md create mode 100644 Forms/Treatment-Plans/.gitkeep create mode 100644 Policies/POL-001-Quality-Policy.md create mode 100644 SOPs/Clinical-Services/SOP-MHO-001-Initial-Evaluation.md create mode 100644 SOPs/Compliance/.gitkeep create mode 100644 SOPs/Crisis-Management/.gitkeep create mode 100644 SOPs/Documentation/.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/Intake-Assessment/.gitkeep create mode 100644 SOPs/Safety/.gitkeep create mode 100644 SOPs/Treatment/.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..3ddec82 --- /dev/null +++ b/.gitea/workflows/atomicai.yml @@ -0,0 +1,76 @@ +name: AtomicAI Mental Health Outpatient 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_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.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 Mental Health Outpatient 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 Mental Health Outpatient Quality Management. + + ## Your Expertise + - Behavioral health accreditation (Joint Commission BHC, CARF) + - Outpatient mental health treatment protocols + - Crisis intervention and safety planning + - Suicide risk assessment procedures + - Psychiatric medication management + - Therapy documentation standards + - HIPAA and 42 CFR Part 2 (substance abuse confidentiality) + - Telehealth/telepsychiatry protocols + - Group therapy and intensive outpatient programs + + ## Document Creation Guidelines + - Place Clinical SOPs in SOPs/Clinical/ + - Place Crisis Protocols in Protocols/Crisis/ + - Place Therapy SOPs in SOPs/Therapy/ + - Place Safety Plans in Forms/Safety/ + - Place Assessment Forms in Forms/Assessment/ + - Place Policies in Policies/ + + ## Numbering Convention + - SOP-MH-XXX for Mental Health SOPs + - SOP-CRS-XXX for Crisis SOPs + - PRO-XXX for Treatment Protocols + - ASM-XXX for Assessment Tools + - POL-XXX for Policies + - FRM-XXX for Forms + + Always create branches and submit changes as Pull Requests for review. + Prioritize patient safety, confidentiality, and evidence-based practices. + allowed_tools: 'Read,Edit,Grep,Glob,Write' + disallowed_tools: 'Bash,WebSearch' diff --git a/Forms/Assessment-Tools/.gitkeep b/Forms/Assessment-Tools/.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/Intake-Forms/.gitkeep b/Forms/Intake-Forms/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Intake-Forms/FRM-MHO-001-New-Patient-Intake.md b/Forms/Intake-Forms/FRM-MHO-001-New-Patient-Intake.md new file mode 100644 index 0000000..a369638 --- /dev/null +++ b/Forms/Intake-Forms/FRM-MHO-001-New-Patient-Intake.md @@ -0,0 +1,380 @@ +# Mental Health New Patient Intake Form + +| Form ID | FRM-MHO-001 | Revision | 1.0 | +|---------|-------------|----------|-----| + +--- + +## Patient Information + +| Field | Entry | +|-------|-------| +| Last Name | | +| First Name | | +| Preferred Name | | +| Date of Birth | | +| Age | | +| Sex | ☐ Male ☐ Female ☐ Other | +| Gender Identity | | +| Pronouns | | + +### Contact Information + +| Field | Entry | +|-------|-------| +| Address | | +| City, State, ZIP | | +| Home Phone | | +| Cell Phone | | +| Email | | +| Preferred Contact Method | ☐ Home ☐ Cell ☐ Email | +| OK to Leave Detailed Message? | ☐ Yes ☐ No | + +--- + +## Emergency Contact + +| Field | Entry | +|-------|-------| +| Name | | +| Relationship | | +| Phone | | +| Address | | + +--- + +## Referral Information + +| Field | Entry | +|-------|-------| +| Referred By | | +| Referring Provider Phone | | +| Primary Care Physician | | +| PCP Phone/Fax | | +| Current Therapist (if any) | | +| Current Prescriber (if any) | | + +--- + +## Reason for Seeking Treatment + +**What brings you in for treatment today?** + +**What are your main symptoms or concerns?** + +**When did these symptoms start?** + +**What do you hope to get out of treatment?** + +--- + +## Symptom Checklist + +*Check all symptoms you are currently experiencing:* + +### Mood Symptoms +☐ Depressed mood +☐ Loss of interest/pleasure +☐ Hopelessness +☐ Guilt +☐ Irritability +☐ Mood swings +☐ Elevated/euphoric mood +☐ Decreased need for sleep +☐ Racing thoughts +☐ Increased energy + +### Anxiety Symptoms +☐ Excessive worry +☐ Restlessness +☐ Difficulty concentrating +☐ Muscle tension +☐ Sleep problems +☐ Panic attacks +☐ Fear of social situations +☐ Specific phobias +☐ Obsessive thoughts +☐ Compulsive behaviors + +### Trauma Symptoms +☐ Flashbacks/intrusive memories +☐ Nightmares +☐ Avoiding reminders of trauma +☐ Emotional numbness +☐ Hypervigilance +☐ Easily startled + +### Psychotic Symptoms +☐ Hearing voices +☐ Seeing things others don't see +☐ Paranoid thoughts +☐ Unusual beliefs +☐ Confused thinking + +### Other Symptoms +☐ Difficulty concentrating +☐ Memory problems +☐ Impulsivity +☐ Anger problems +☐ Relationship difficulties +☐ Work/school problems +☐ Appetite changes +☐ Weight changes +☐ Fatigue/low energy +☐ Chronic pain + +--- + +## Suicidal/Self-Harm History + +| Question | Response | +|----------|----------| +| Are you currently having thoughts of suicide? | ☐ Yes ☐ No | +| Are you currently having thoughts of harming yourself? | ☐ Yes ☐ No | +| Have you ever attempted suicide? | ☐ Yes ☐ No | +| If yes, when and how? | | +| Have you ever engaged in self-harm (cutting, burning, etc.)? | ☐ Yes ☐ No | +| If yes, describe: | | + +--- + +## Psychiatric History + +### Previous Treatment + +| Treatment Type | Yes/No | Where | When | Helpful? | +|----------------|--------|-------|------|----------| +| Outpatient therapy | ☐ | | | ☐ Yes ☐ No | +| Outpatient psychiatry | ☐ | | | ☐ Yes ☐ No | +| Intensive outpatient (IOP) | ☐ | | | ☐ Yes ☐ No | +| Partial hospitalization (PHP) | ☐ | | | ☐ Yes ☐ No | +| Psychiatric hospitalization | ☐ | | | ☐ Yes ☐ No | +| Residential treatment | ☐ | | | ☐ Yes ☐ No | +| ECT | ☐ | | | ☐ Yes ☐ No | +| TMS | ☐ | | | ☐ Yes ☐ No | + +### Previous Diagnoses + +*Check all that you have been diagnosed with:* + +☐ Depression +☐ Bipolar Disorder +☐ Anxiety Disorder +☐ Panic Disorder +☐ PTSD +☐ OCD +☐ ADHD +☐ Schizophrenia/Schizoaffective +☐ Personality Disorder (type: _______) +☐ Eating Disorder +☐ Substance Use Disorder +☐ Autism Spectrum Disorder +☐ Other: _______________ + +--- + +## Current Medications + +| Medication | Dose | Frequency | Prescriber | +|------------|------|-----------|------------| +| | | | | +| | | | | +| | | | | +| | | | | +| | | | | + +### Past Psychiatric Medications + +*List medications you have tried in the past:* + +| Medication | Helpful? | Side Effects? | Reason Stopped | +|------------|----------|---------------|----------------| +| | ☐ Yes ☐ No | | | +| | ☐ Yes ☐ No | | | +| | ☐ Yes ☐ No | | | +| | ☐ Yes ☐ No | | | + +--- + +## Allergies + +☐ No Known Allergies + +| Medication/Substance | Reaction | +|---------------------|----------| +| | | +| | | + +--- + +## Substance Use History + +| Substance | Ever Used | Age First Used | Current Use | Amount/Frequency | Last Used | +|-----------|-----------|----------------|-------------|------------------|-----------| +| Alcohol | ☐ | | ☐ | | | +| Marijuana/Cannabis | ☐ | | ☐ | | | +| Cocaine/Crack | ☐ | | ☐ | | | +| Heroin/Opioids | ☐ | | ☐ | | | +| Methamphetamine | ☐ | | ☐ | | | +| Benzodiazepines (non-Rx) | ☐ | | ☐ | | | +| Tobacco/Nicotine | ☐ | | ☐ | | | +| Other: | ☐ | | ☐ | | | + +**Have you ever had treatment for substance use?** ☐ Yes ☐ No + +If yes, describe: + +--- + +## Medical History + +### Current Medical Conditions + +☐ None + +| Condition | Notes | +|-----------|-------| +| | | +| | | +| | | + +### Past Surgeries/Hospitalizations + +| Surgery/Hospitalization | Year | +|------------------------|------| +| | | +| | | + +### For Women + +| Field | Entry | +|-------|-------| +| Are you pregnant? | ☐ Yes ☐ No ☐ Maybe | +| Are you breastfeeding? | ☐ Yes ☐ No | +| Last menstrual period | | +| Using contraception? | ☐ Yes ☐ No | + +--- + +## Family Psychiatric History + +*Check all that apply to biological relatives:* + +| Condition | Mother | Father | Sibling | Grandparent | Other | +|-----------|--------|--------|---------|-------------|-------| +| Depression | ☐ | ☐ | ☐ | ☐ | ☐ | +| Bipolar Disorder | ☐ | ☐ | ☐ | ☐ | ☐ | +| Anxiety | ☐ | ☐ | ☐ | ☐ | ☐ | +| Schizophrenia | ☐ | ☐ | ☐ | ☐ | ☐ | +| Substance Abuse | ☐ | ☐ | ☐ | ☐ | ☐ | +| Suicide/Attempt | ☐ | ☐ | ☐ | ☐ | ☐ | +| ADHD | ☐ | ☐ | ☐ | ☐ | ☐ | +| Other: | ☐ | ☐ | ☐ | ☐ | ☐ | + +--- + +## Social History + +### Living Situation + +| Field | Entry | +|-------|-------| +| Who do you live with? | | +| Type of housing | ☐ Own ☐ Rent ☐ With family ☐ Homeless ☐ Other | +| Housing stability | ☐ Stable ☐ At risk ☐ Unstable | + +### Relationships + +| Field | Entry | +|-------|-------| +| Marital/Relationship status | ☐ Single ☐ Married ☐ Partnered ☐ Divorced ☐ Widowed | +| Children (ages) | | +| Quality of relationships | ☐ Good ☐ Fair ☐ Poor | +| Social support | ☐ Strong ☐ Some ☐ Limited ☐ None | + +### Education/Employment + +| Field | Entry | +|-------|-------| +| Highest education | | +| Current employment | ☐ Full-time ☐ Part-time ☐ Unemployed ☐ Disabled ☐ Retired ☐ Student | +| Occupation | | +| Work/school problems? | ☐ Yes ☐ No | + +### Legal + +| Field | Entry | +|-------|-------| +| Current legal issues? | ☐ Yes ☐ No | +| If yes, describe: | | +| History of incarceration? | ☐ Yes ☐ No | + +### Trauma History + +*Have you experienced any of the following?* + +☐ Physical abuse +☐ Sexual abuse +☐ Emotional/verbal abuse +☐ Neglect +☐ Domestic violence +☐ Witnessed violence +☐ Military combat +☐ Serious accident +☐ Natural disaster +☐ Other trauma: _______________ + +--- + +## Current Stressors + +*Rate your current stress level (1-10):* _____ + +*What are your main stressors right now?* + +--- + +## Strengths and Supports + +*What are your strengths?* + +*Who are your supports (family, friends, community)?* + +*What coping strategies do you currently use?* + +--- + +## Goals for Treatment + +*What would you like to accomplish through treatment?* + +1. +2. +3. + +--- + +## Signature + +| Field | Entry | +|-------|-------| +| Patient Signature | | +| Date | | +| Guardian Signature (if minor) | | +| Relationship to Patient | | + +--- + +## For Office Use + +| Field | Entry | +|-------|-------| +| Date Received | | +| Entered By | | +| Appointment Date | | +| Assigned Provider | | +| Notes | | + +--- + +*Form FRM-MHO-001 Rev 1.0 - Mental Health New Patient Intake Form* diff --git a/Forms/Progress-Notes/.gitkeep b/Forms/Progress-Notes/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Safety-Plans/.gitkeep b/Forms/Safety-Plans/.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/Forms/Treatment-Plans/.gitkeep b/Forms/Treatment-Plans/.gitkeep new file mode 100644 index 0000000..e69de29 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 b3df78a..60b47ba 100644 --- a/README.md +++ b/README.md @@ -1,3 +1,132 @@ -# mental-health-outpatient +# Mental Health Outpatient Services Quality Management System -A comprehensive QMS template designed for outpatient mental health clinics, counseling centers, and behavioral health practices. \ No newline at end of file +A comprehensive QMS template designed for outpatient mental health clinics, counseling centers, and behavioral health practices. + +## 🧠 Designed For + +- **Community Mental Health Centers** - Publicly funded outpatient services +- **Private Psychiatric Practices** - Outpatient psychiatry and medication management +- **Counseling and Therapy Centers** - Individual, group, and family therapy +- **Child/Adolescent Mental Health** - Pediatric outpatient behavioral health +- **Substance Abuse Treatment** - Outpatient addiction services +- **Intensive Outpatient Programs (IOP)** - Structured day treatment +- **Partial Hospitalization Programs (PHP)** - Day hospital services + +## 📋 Regulatory Framework + +This template supports compliance with: + +- **The Joint Commission** - Behavioral Health Care accreditation +- **CARF** - Commission on Accreditation of Rehabilitation Facilities +- **State Mental Health Authority** - State licensing and certification +- **HIPAA** - Mental health information privacy +- **42 CFR Part 2** - Substance abuse treatment confidentiality +- **State Licensing Boards** - Psychologist, social worker, counselor regulations +- **Medicare/Medicaid** - Outpatient mental health billing requirements +- **APA Practice Guidelines** - Evidence-based treatment standards +- **SAMHSA** - Substance abuse treatment guidelines + +## Repository Structure + +``` +├── SOPs/ +│ ├── Intake-Assessment/ # Referral, intake, diagnostic evaluation +│ ├── Treatment/ # Therapy protocols, medication management +│ ├── Crisis-Management/ # Crisis response, safety planning, hospitalization +│ ├── Documentation/ # Progress notes, treatment plans, outcomes +│ ├── Compliance/ # Consent, confidentiality, records +│ └── General/ # Document control, training, CAPA +├── Forms/ +│ ├── Intake-Forms/ # Registration, consent, authorization, history +│ ├── Assessment-Tools/ # PHQ-9, GAD-7, AUDIT, depression/anxiety scales +│ ├── Treatment-Plans/ # Initial and updated treatment plan templates +│ ├── Safety-Plans/ # Crisis plans, safety contracts +│ ├── Progress-Notes/ # Session documentation templates +│ └── Training/ # Competency assessments +├── Policies/ # Practice policies +├── Work-Instructions/ # Step-by-step procedures +└── Templates/ # Document templates +``` + +## Document Numbering Convention + +- **POL-XXX**: Policies +- **SOP-INT-XXX**: Intake/Assessment SOPs +- **SOP-TX-XXX**: Treatment SOPs +- **SOP-CRS-XXX**: Crisis Management SOPs +- **SOP-DOC-XXX**: Documentation SOPs +- **SOP-CMP-XXX**: Compliance SOPs +- **WI-XXX**: Work Instructions +- **FRM-XXX**: Forms and Records + +## 🤖 AI-Powered Assistance + +This repository includes **AtomicAI**, your outpatient mental health QMS assistant. Mention `@atomicai` in any issue or pull request to: + +- Draft intake and assessment procedures +- Create treatment protocols for specific conditions +- Generate crisis intervention and safety planning SOPs +- Develop progress note documentation standards +- Create consent and confidentiality procedures +- Review documents for accreditation compliance + +### Example Prompts + +- "@atomicai create an SOP for psychiatric intake evaluation" +- "@atomicai draft a crisis intervention and safety planning protocol" +- "@atomicai write a progress note documentation standard per billing requirements" +- "@atomicai create a treatment plan template for depression" +- "@atomicai develop a no-show and missed appointment policy" +- "@atomicai create a telehealth informed consent procedure" + +## Getting Started + +1. **Establish Consent Procedures** - Configure informed consent and authorization forms +2. **Standardize Assessments** - Implement validated screening tools +3. **Define Documentation Standards** - Set up progress note and treatment plan templates +4. **Create Crisis Protocols** - Establish safety planning and escalation procedures +5. **Train Clinicians** - Use competency assessment forms + +## Key Documents to Create First + +1. **Intake Assessment SOP** - Standardized evaluation process +2. **Treatment Planning Policy** - Individualized treatment plan requirements +3. **Crisis Response Procedure** - Suicidal/homicidal ideation management +4. **Safety Plan Template** - Client crisis planning tool +5. **Progress Note Standards** - Documentation requirements for sessions +6. **Informed Consent Forms** - Treatment consent, HIPAA, 42 CFR Part 2 +7. **Telehealth Policy** - Virtual care protocols and consent + +## Special Considerations for Outpatient Mental Health + +### Intake and Assessment +- Referral management and triage +- Comprehensive diagnostic evaluation +- Validated screening instruments +- Treatment matching and level of care +- Insurance authorization + +### Treatment Services +- Evidence-based therapy protocols +- Medication evaluation and management +- Group therapy programming +- Family and couples therapy +- Care coordination with other providers + +### Crisis Management +- Suicide risk assessment +- Safety planning +- Crisis hotline resources +- Hospitalization criteria and procedures +- Post-crisis follow-up + +### Documentation and Compliance +- HIPAA and 42 CFR Part 2 requirements +- Progress note medical necessity +- Treatment plan updates +- Outcome measurement +- Supervision and peer review + +--- + +*This template is maintained by AtomicQMS. For questions, open an issue in this repository.* diff --git a/SOPs/Clinical-Services/SOP-MHO-001-Initial-Evaluation.md b/SOPs/Clinical-Services/SOP-MHO-001-Initial-Evaluation.md new file mode 100644 index 0000000..2eda8f4 --- /dev/null +++ b/SOPs/Clinical-Services/SOP-MHO-001-Initial-Evaluation.md @@ -0,0 +1,292 @@ +# Standard Operating Procedure: Outpatient Mental Health Initial Evaluation + +| Document ID | SOP-MHO-001 | +|-------------|-------------| +| Title | Outpatient Mental Health Initial Evaluation | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Outpatient Mental Health | + +--- + +## 1. Purpose + +To establish standardized procedures for conducting comprehensive initial mental health evaluations for new outpatient patients to ensure accurate diagnosis, appropriate treatment planning, and regulatory compliance. + +## 2. Scope + +This procedure applies to all initial evaluations for outpatient mental health services including: +- Adult psychiatric evaluation +- Child/adolescent psychiatric evaluation +- Psychological evaluation +- Intake assessment for therapy +- Medication management evaluation +- Telehealth evaluations + +## 3. Responsibilities + +### 3.1 Psychiatrist/Psychiatric NP/PA +- Conduct psychiatric diagnostic evaluation +- Establish diagnoses +- Initiate medication treatment +- Refer for therapy as indicated + +### 3.2 Therapist/Counselor +- Conduct therapy intake assessment +- Establish treatment goals +- Initiate therapy services +- Coordinate care with prescriber + +### 3.3 Psychologist +- Conduct psychological evaluations +- Administer psychological testing +- Provide diagnostic clarification +- Treatment recommendations + +### 3.4 Support Staff +- Schedule evaluations appropriately +- Collect intake paperwork +- Verify insurance and authorizations +- Facilitate check-in process + +## 4. Definitions + +| Term | Definition | +|------|------------| +| Chief Complaint | Primary reason for seeking treatment | +| Mental Status Examination | Structured assessment of current mental functioning | +| DSM-5 | Diagnostic and Statistical Manual of Mental Disorders, 5th Edition | +| PHQ-9 | Patient Health Questionnaire (depression screen) | +| GAD-7 | Generalized Anxiety Disorder scale | + +## 5. Procedure + +### 5.1 Pre-Evaluation Preparation + +#### 5.1.1 Intake Paperwork +Complete prior to evaluation: +- [ ] Demographic information +- [ ] Insurance information +- [ ] Consent for treatment +- [ ] HIPAA acknowledgment +- [ ] Release of information (prior providers) +- [ ] Symptom questionnaires +- [ ] Medical history form +- [ ] Medication list + +#### 5.1.2 Records Review +If available, review: +- Prior mental health records +- Recent medical records +- Hospitalization summaries +- Previous psychological testing +- Current medication list + +### 5.2 Initial Evaluation Components + +#### 5.2.1 Psychiatric Diagnostic Evaluation + +**Chief Complaint and Present Illness** +- Current symptoms in patient's words +- Onset and duration +- Severity and frequency +- Impact on functioning +- Precipitating factors +- What has helped/not helped + +**Psychiatric History** +| Element | Detail | +|---------|--------| +| Previous diagnoses | | +| Previous hospitalizations | Dates, location, reason | +| Previous outpatient treatment | Providers, duration, helpfulness | +| Previous medications | Name, dose, response, side effects | +| ECT/TMS/other treatments | | +| Suicide attempts | Method, intent, lethality, medical treatment | +| Self-harm history | | +| Violent behavior | | + +**Substance Use History** +| Substance | Ever Used | Current Use | Last Use | Quantity/Frequency | +|-----------|-----------|-------------|----------|---------------------| +| Alcohol | ☐ | ☐ | | | +| Cannabis | ☐ | ☐ | | | +| Opioids | ☐ | ☐ | | | +| Stimulants | ☐ | ☐ | | | +| Benzodiazepines | ☐ | ☐ | | | +| Tobacco/Nicotine | ☐ | ☐ | | | +| Other | ☐ | ☐ | | | + +- Substance use treatment history +- Withdrawal history +- Periods of sobriety + +**Medical History** +- Chronic conditions +- Current medications +- Allergies (medications, environmental, food) +- Recent labs (if available) +- Primary care provider + +**Family History** +- Psychiatric disorders +- Substance use disorders +- Suicide +- Response to medications (if known) + +**Social History** +| Domain | Information | +|--------|-------------| +| Education | Highest level, any difficulties | +| Employment | Current status, history | +| Living situation | With whom, stability | +| Relationships | Marital status, support system | +| Legal | Current or pending legal issues | +| Trauma history | Abuse, neglect, other trauma | +| Military | Branch, combat exposure, discharge status | +| Cultural/spiritual | Relevant beliefs/practices | + +**Developmental History** (especially for children/adolescents) +- Pregnancy/birth complications +- Developmental milestones +- School performance +- Peer relationships +- Behavioral issues + +**Mental Status Examination** +| Domain | Findings | +|--------|----------| +| Appearance | Dress, grooming, hygiene, apparent age | +| Psychomotor | Activity level, retardation, agitation | +| Attitude | Cooperative, guarded, hostile | +| Eye contact | Good, poor, variable | +| Speech | Rate, rhythm, volume, coherence | +| Mood | Patient's stated mood | +| Affect | Range, congruence, appropriateness | +| Thought process | Linear, tangential, circumstantial, loose | +| Thought content | Delusions, obsessions, preoccupations | +| Perceptions | Hallucinations (type), illusions | +| Cognition | Orientation, attention, memory | +| Insight | Good, fair, poor | +| Judgment | Good, fair, poor | + +**Risk Assessment** +| Risk | Assessment | +|------|------------| +| Suicide | Ideation, plan, intent, means, attempts | +| Violence | Ideation, target, plan, history | +| Self-harm | Current urges, methods, history | +| Risk level | Low / Moderate / High | + +**Diagnosis (DSM-5)** +| Priority | Diagnosis | ICD-10 Code | +|----------|-----------|-------------| +| Primary | | | +| Secondary | | | +| Additional | | | +| Substance | | | +| Medical | | | + +**Treatment Plan** +- Medication recommendations +- Therapy recommendations +- Frequency of follow-up +- Laboratory monitoring +- Referrals +- Patient goals + +### 5.3 Standardized Assessments + +Administer as indicated: +| Assessment | Population | Purpose | +|------------|------------|---------| +| PHQ-9 | Adults | Depression severity | +| GAD-7 | Adults | Anxiety severity | +| C-SSRS | All | Suicide risk | +| MDQ | Mood disorders | Bipolar screening | +| ASRS | Adults | ADHD screening | +| PCL-5 | Trauma history | PTSD screening | +| AUDIT | Alcohol use | Alcohol use disorder | +| DAST-10 | Drug use | Drug use disorder | + +### 5.4 Informed Consent + +Discuss and document: +- Nature of recommended treatment +- Expected benefits +- Potential risks and side effects +- Alternatives (including no treatment) +- Right to refuse or withdraw +- Confidentiality and limits +- Emergency procedures + +### 5.5 Safety Planning + +For patients with elevated risk: +- [ ] Complete safety plan (FRM-MHO-002) +- [ ] Provide crisis resources +- [ ] Establish emergency contact +- [ ] Reduce access to means +- [ ] Schedule appropriate follow-up + +### 5.6 Care Coordination + +- [ ] Request records from prior providers +- [ ] Communicate with PCP as indicated +- [ ] Coordinate with other treaters +- [ ] Referral to appropriate level of care if needed + +## 6. Special Considerations + +### 6.1 Telehealth Evaluations +- Verify patient location and identity +- Confirm emergency contact and local resources +- Assess appropriateness for telehealth +- Document telehealth consent + +### 6.2 Child/Adolescent Evaluations +- Include parent/guardian interview +- School information as relevant +- Developmentally appropriate assessment +- Assent/consent as appropriate + +### 6.3 Geriatric Evaluations +- Cognitive screening +- Capacity assessment if concerns +- Medical complexity consideration +- Caregiver involvement + +## 7. Documentation + +- Initial evaluation note (complete within 72 hours of visit) +- Consent forms +- Standardized assessment scores +- Safety plan (if applicable) +- Release of information forms + +## 8. Quality Metrics + +| Metric | Target | +|--------|--------| +| Evaluation completed within scheduled time | >90% | +| Documentation complete within 72 hours | 100% | +| Suicide risk assessment documented | 100% | +| Treatment plan documented | 100% | +| Follow-up scheduled | 100% | + +## 9. References + +- American Psychiatric Association Practice Guidelines +- DSM-5 Diagnostic Criteria +- State mental health regulations +- Payer documentation requirements + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | diff --git a/SOPs/Compliance/.gitkeep b/SOPs/Compliance/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Crisis-Management/.gitkeep b/SOPs/Crisis-Management/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Documentation/.gitkeep b/SOPs/Documentation/.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/Intake-Assessment/.gitkeep b/SOPs/Intake-Assessment/.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/Treatment/.gitkeep b/SOPs/Treatment/.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] |