Sync template from atomicqms-style deployment
This commit is contained in:
77
.gitea/workflows/atomicai.yml
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77
.gitea/workflows/atomicai.yml
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name: AtomicAI Mental Health Inpatient Assistant
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on:
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issue_comment:
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types: [created]
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issues:
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types: [opened, assigned]
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pull_request:
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types: [opened, synchronize, assigned]
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pull_request_review_comment:
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types: [created]
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jobs:
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claude-assistant:
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runs-on: ubuntu-latest
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if: |
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github.actor != 'atomicqms-service' &&
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(
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(github.event_name == 'issue_comment' && contains(github.event.comment.body, '@atomicai')) ||
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(github.event_name == 'issues' && github.event.action == 'opened' && contains(github.event.issue.body, '@atomicai')) ||
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(github.event_name == 'pull_request' && github.event.action == 'opened' && contains(github.event.pull_request.body, '@atomicai')) ||
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(github.event_name == 'pull_request_review_comment' && contains(github.event.comment.body, '@atomicai')) ||
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(github.event.action == 'assigned' && github.event.assignee.login == 'atomicai')
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)
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permissions:
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contents: write
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issues: write
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pull-requests: write
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steps:
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- uses: actions/checkout@v4
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with:
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fetch-depth: 0
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- name: Run AtomicAI Mental Health Inpatient Assistant
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uses: https://beta.atomicqms.com/atomicqms-service/actions/claude-code-gitea-action-slim@main
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with:
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trigger_phrase: '@atomicai'
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assignee_trigger: 'atomicai'
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claude_git_name: 'AtomicAI'
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claude_git_email: 'atomicai@atomicqms.local'
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custom_instructions: |
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You are AtomicAI, an AI assistant specialized in Mental Health Inpatient Quality Management.
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## Your Expertise
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- Psychiatric hospital accreditation (Joint Commission, CMS)
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- Involuntary commitment and patient rights
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- Seclusion and restraint policies and documentation
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- Acute psychiatric stabilization protocols
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- Suicide precautions and observation levels
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- Medication administration in psychiatric settings
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- Milieu therapy and unit safety
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- Discharge planning and aftercare coordination
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- Behavioral emergency response (Code Green)
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- 42 CFR Part 2 and HIPAA compliance
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## Document Creation Guidelines
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- Place Clinical SOPs in SOPs/Clinical/
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- Place Safety SOPs in SOPs/Safety/
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- Place Emergency Protocols in Protocols/Emergency/
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- Place Nursing SOPs in SOPs/Nursing/
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- Place Patient Rights in Policies/Patient-Rights/
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- Place Assessment Forms in Forms/Assessment/
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## Numbering Convention
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- SOP-PSY-XXX for Psychiatric SOPs
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- SOP-SAF-XXX for Safety SOPs
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- SOP-NUR-XXX for Nursing SOPs
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- PRO-EMR-XXX for Emergency Protocols
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- POL-XXX for Policies
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- FRM-XXX for Forms
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Always create branches and submit changes as Pull Requests for review.
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Prioritize patient safety, dignity, and least restrictive interventions.
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allowed_tools: 'Read,Edit,Grep,Glob,Write'
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disallowed_tools: 'Bash,WebSearch'
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0
Forms/Admission-Forms/.gitkeep
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0
Forms/Admission-Forms/.gitkeep
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0
Forms/Assessment-Tools/.gitkeep
Normal file
0
Forms/Assessment-Tools/.gitkeep
Normal file
287
Forms/Assessment-Tools/FRM-MHI-002-Safety-Assessment.md
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287
Forms/Assessment-Tools/FRM-MHI-002-Safety-Assessment.md
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@@ -0,0 +1,287 @@
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# Inpatient Safety Assessment
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| Form ID | FRM-MHI-002 | Revision | 1.0 |
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|---------|-------------|----------|-----|
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---
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## Patient Information
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| Field | Entry |
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|-------|-------|
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| Patient Name | |
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| MRN | |
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| Date of Birth | |
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| Unit/Room | |
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| Admission Date | |
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| Date of Assessment | |
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| Time of Assessment | |
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| Assessor Name | |
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| Assessor Credentials | |
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---
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## Suicide Risk Assessment
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### Current Suicidal Ideation
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| Question | Response |
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|----------|----------|
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| Are you having thoughts of suicide or self-harm? | ☐ Yes ☐ No |
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| If yes, how often? | ☐ Fleeting ☐ Intermittent ☐ Persistent |
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| How strong is the urge to act on these thoughts? | ☐ None ☐ Mild ☐ Moderate ☐ Strong ☐ Overwhelming |
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| Do you have a plan? | ☐ Yes ☐ No |
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| If yes, describe plan: | |
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| Do you have access to means? | ☐ Yes ☐ No |
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| Do you intend to act on these thoughts? | ☐ Yes ☐ No ☐ Ambivalent |
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### Suicidal Behaviors
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| Behavior | Present |
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|----------|---------|
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| Recent suicide attempt (within 30 days) | ☐ Yes ☐ No |
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| If yes, date and method: | |
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| Interrupted or aborted attempt | ☐ Yes ☐ No |
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| Preparatory behaviors (writing note, giving away possessions, etc.) | ☐ Yes ☐ No |
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### Historical Risk Factors
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| Factor | Present |
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|--------|---------|
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| Previous suicide attempt(s) | ☐ Yes ☐ No |
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| If yes, number and methods: | |
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| Self-harm without suicidal intent | ☐ Yes ☐ No |
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| Family history of suicide | ☐ Yes ☐ No |
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| Previous psychiatric hospitalization | ☐ Yes ☐ No |
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### Clinical Risk Factors
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| Factor | Present |
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|--------|---------|
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| Depression | ☐ Yes ☐ No |
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| Hopelessness | ☐ Yes ☐ No |
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| Anxiety/agitation | ☐ Yes ☐ No |
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| Psychosis | ☐ Yes ☐ No |
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| Command hallucinations (self-harm) | ☐ Yes ☐ No |
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| Intoxication/withdrawal | ☐ Yes ☐ No |
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| Chronic pain/medical illness | ☐ Yes ☐ No |
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| Recent discharge from psychiatric hospital | ☐ Yes ☐ No |
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| Insomnia | ☐ Yes ☐ No |
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### Precipitating Factors
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| Factor | Present |
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|--------|---------|
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| Recent loss (relationship, job, housing) | ☐ Yes ☐ No |
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| Recent humiliation/shame | ☐ Yes ☐ No |
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| Legal problems | ☐ Yes ☐ No |
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| Financial problems | ☐ Yes ☐ No |
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| Anniversary of loss | ☐ Yes ☐ No |
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| Other: | ☐ Yes ☐ No |
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### Protective Factors
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| Factor | Present |
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|--------|---------|
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| Reasons for living | ☐ Yes ☐ No |
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| Future orientation | ☐ Yes ☐ No |
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| Social support | ☐ Yes ☐ No |
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| Religious/spiritual beliefs against suicide | ☐ Yes ☐ No |
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| Responsibility for children/pets | ☐ Yes ☐ No |
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| Fear of death/pain | ☐ Yes ☐ No |
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| Engaged in treatment | ☐ Yes ☐ No |
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| Therapeutic alliance | ☐ Yes ☐ No |
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### Suicide Risk Level
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☐ **Low Risk** - No current ideation, few risk factors, strong protective factors
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☐ **Moderate Risk** - Ideation without plan/intent, some risk factors, some protective factors
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☐ **High Risk** - Ideation with plan, intent, access to means; multiple risk factors; few protective factors
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☐ **Imminent Risk** - Immediate danger, requires 1:1 observation
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---
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## Violence/Homicide Risk Assessment
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### Current Homicidal/Violent Ideation
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| Question | Response |
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|----------|----------|
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| Are you having thoughts of hurting someone else? | ☐ Yes ☐ No |
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| Is there a specific person? | ☐ Yes ☐ No |
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| If yes, identify: | |
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| Do you have a plan to harm this person? | ☐ Yes ☐ No |
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| Do you have access to weapons? | ☐ Yes ☐ No |
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| Do you intend to act on these thoughts? | ☐ Yes ☐ No |
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### Historical Risk Factors
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| Factor | Present |
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|--------|---------|
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| History of violence | ☐ Yes ☐ No |
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| History of weapons use | ☐ Yes ☐ No |
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| Criminal history | ☐ Yes ☐ No |
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| History of impulsive behavior | ☐ Yes ☐ No |
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| Childhood conduct disorder | ☐ Yes ☐ No |
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| Victim of abuse/violence | ☐ Yes ☐ No |
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### Clinical Risk Factors
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| Factor | Present |
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|--------|---------|
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| Command hallucinations (violence) | ☐ Yes ☐ No |
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| Paranoid delusions | ☐ Yes ☐ No |
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| Manic symptoms | ☐ Yes ☐ No |
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| Active substance use | ☐ Yes ☐ No |
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| Medication non-adherence | ☐ Yes ☐ No |
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| Lack of insight | ☐ Yes ☐ No |
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### Situational Factors
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| Factor | Present |
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|--------|---------|
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| Active interpersonal conflict | ☐ Yes ☐ No |
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| Perceived threats | ☐ Yes ☐ No |
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| Access to potential victims | ☐ Yes ☐ No |
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| History with identified target | ☐ Yes ☐ No |
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### Violence Risk Level
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☐ **Low Risk** - No ideation, few risk factors
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☐ **Moderate Risk** - General ideation, some risk factors
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☐ **High Risk** - Specific ideation, identified target, plan, multiple risk factors
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### Duty to Warn/Protect
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| Field | Entry |
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|-------|-------|
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| Is there an identifiable potential victim? | ☐ Yes ☐ No |
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| Has duty to warn been triggered? | ☐ Yes ☐ No |
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| If yes, actions taken: | |
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| Notification date/time: | |
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| Law enforcement notified? | ☐ Yes ☐ No |
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| Potential victim notified? | ☐ Yes ☐ No |
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||||
---
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## Self-Harm Risk Assessment
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| Question | Response |
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|----------|----------|
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| Are you having urges to hurt yourself (without suicidal intent)? | ☐ Yes ☐ No |
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| Method typically used: | |
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| When did you last engage in self-harm? | |
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| What triggers self-harm urges? | |
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| How do you typically cope with these urges? | |
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|
||||
---
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## Elopement/AWOL Risk
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| Factor | Present |
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|--------|---------|
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| Expressed desire to leave AMA | ☐ Yes ☐ No |
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| Involuntary admission status | ☐ Yes ☐ No |
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| History of elopement | ☐ Yes ☐ No |
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| Agitation or restlessness | ☐ Yes ☐ No |
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| External pressures to leave | ☐ Yes ☐ No |
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| Poor insight into need for treatment | ☐ Yes ☐ No |
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||||
|
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### Elopement Risk Level
|
||||
|
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☐ Low ☐ Moderate ☐ High
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|
||||
---
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## Fall Risk Assessment
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| Factor | Points | Present |
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|--------|--------|---------|
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| Age 65+ | 2 | ☐ |
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| History of falls | 3 | ☐ |
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| Impaired gait/balance | 2 | ☐ |
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| Psychotropic medications | 2 | ☐ |
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| Sedation | 2 | ☐ |
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| Confusion/disorientation | 2 | ☐ |
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| Sensory impairment | 1 | ☐ |
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| Toileting frequency | 1 | ☐ |
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| **Total Score** | | |
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**Risk Level:** ☐ Low (0-4) ☐ Moderate (5-9) ☐ High (10+)
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---
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## Assigned Precautions
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### Observation Level
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||||
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☐ 1:1 Continuous (within arm's reach)
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☐ 1:1 Visual (constant visual)
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☐ Close observation (q5-15 min)
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☐ Routine observation (q15-30 min)
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☐ Open
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### Additional Precautions
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| Precaution | Ordered |
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|------------|---------|
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| Suicide precautions | ☐ |
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| Self-harm precautions | ☐ |
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| Violence precautions | ☐ |
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| Elopement precautions | ☐ |
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| Fall precautions | ☐ |
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| Seizure precautions | ☐ |
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| Aspiration precautions | ☐ |
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| Assault precautions | ☐ |
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||||
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### Environmental Modifications
|
||||
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☐ Safety room (ligature-resistant)
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☐ Remove sharps from access
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||||
☐ Remove potential ligature materials
|
||||
☐ Supervised shaving
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||||
☐ Supervised meals (plastic utensils)
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☐ Other: _____________
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|
||||
---
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## Plan
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||||
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**Immediate Safety Interventions:**
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||||
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||||
**Recommended Observation Level:**
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|
||||
**Rationale for Level:**
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||||
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||||
**Reassessment Schedule:**
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☐ Every shift
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☐ Daily
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||||
☐ Other: _____________
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||||
|
||||
---
|
||||
|
||||
## Physician Review
|
||||
|
||||
| Field | Entry |
|
||||
|-------|-------|
|
||||
| Physician Name | |
|
||||
| Date/Time Reviewed | |
|
||||
| Agrees with Assessment | ☐ Yes ☐ No |
|
||||
| Orders Modified? | ☐ Yes ☐ No |
|
||||
| Modifications: | |
|
||||
| Signature | |
|
||||
|
||||
---
|
||||
|
||||
## Reassessment Log
|
||||
|
||||
| Date/Time | Assessor | Risk Level Change | New Observation Level | Signature |
|
||||
|-----------|----------|-------------------|----------------------|-----------|
|
||||
| | | ☐ Yes ☐ No | | |
|
||||
| | | ☐ Yes ☐ No | | |
|
||||
| | | ☐ Yes ☐ No | | |
|
||||
| | | ☐ Yes ☐ No | | |
|
||||
|
||||
---
|
||||
|
||||
*Form FRM-MHI-002 Rev 1.0 - Inpatient Safety Assessment*
|
||||
64
Forms/FRM-001-Document-Change-Request.md
Normal file
64
Forms/FRM-001-Document-Change-Request.md
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@@ -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*
|
||||
91
Forms/FRM-003-CAPA-Form.md
Normal file
91
Forms/FRM-003-CAPA-Form.md
Normal file
@@ -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*
|
||||
56
Forms/FRM-006-Audit-Checklist.md
Normal file
56
Forms/FRM-006-Audit-Checklist.md
Normal file
@@ -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*
|
||||
0
Forms/Restraint-Records/.gitkeep
Normal file
0
Forms/Restraint-Records/.gitkeep
Normal file
0
Forms/Safety-Plans/.gitkeep
Normal file
0
Forms/Safety-Plans/.gitkeep
Normal file
72
Forms/Training/FRM-004-Training-Record.md
Normal file
72
Forms/Training/FRM-004-Training-Record.md
Normal file
@@ -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*
|
||||
0
Forms/Treatment-Plans/.gitkeep
Normal file
0
Forms/Treatment-Plans/.gitkeep
Normal file
57
Policies/POL-001-Quality-Policy.md
Normal file
57
Policies/POL-001-Quality-Policy.md
Normal file
@@ -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] |
|
||||
132
README.md
132
README.md
@@ -1,3 +1,133 @@
|
||||
# mental-health-inpatient
|
||||
# Mental Health Inpatient Services Quality Management System
|
||||
|
||||
A comprehensive QMS template designed for psychiatric hospitals, inpatient behavioral health units, and acute psychiatric care facilities.
|
||||
|
||||
## 🏥 Designed For
|
||||
|
||||
- **Psychiatric Hospitals** - Freestanding behavioral health facilities
|
||||
- **Hospital Psychiatric Units** - Inpatient psych units within general hospitals
|
||||
- **Crisis Stabilization Units** - Short-term acute psychiatric care
|
||||
- **Child/Adolescent Psychiatric Units** - Pediatric behavioral health
|
||||
- **Geriatric Psychiatric Units** - Older adult mental health care
|
||||
- **Forensic Psychiatric Facilities** - Court-ordered treatment settings
|
||||
- **Residential Treatment Centers** - Extended care facilities
|
||||
|
||||
## 📋 Regulatory Framework
|
||||
|
||||
This template supports compliance with:
|
||||
|
||||
- **The Joint Commission** - Behavioral Health Care accreditation
|
||||
- **CMS Conditions of Participation** - Psychiatric hospital requirements
|
||||
- **State Mental Health Authority** - State licensing regulations
|
||||
- **42 CFR Part 482** - Hospital Conditions of Participation
|
||||
- **HIPAA** - Patient privacy requirements
|
||||
- **EMTALA** - Emergency psychiatric presentations
|
||||
- **State Commitment Laws** - Involuntary treatment regulations
|
||||
- **APA Practice Guidelines** - Psychiatric treatment standards
|
||||
- **NPSG** - National Patient Safety Goals (behavioral health)
|
||||
- **Nurse Practice Act** - Psychiatric nursing regulations
|
||||
|
||||
## Repository Structure
|
||||
|
||||
```
|
||||
├── SOPs/
|
||||
│ ├── Admission-Discharge/ # Voluntary/involuntary admission, discharge planning
|
||||
│ ├── Assessment/ # Psychiatric evaluation, risk assessment, treatment planning
|
||||
│ ├── Safety/ # Suicide prevention, elopement, environmental safety
|
||||
│ ├── Restraint-Seclusion/ # Use, monitoring, debriefing, documentation
|
||||
│ ├── Medication/ # Psychotropic meds, PRN protocols, monitoring
|
||||
│ └── General/ # Document control, training, CAPA
|
||||
├── Forms/
|
||||
│ ├── Admission-Forms/ # Consent, legal status, voluntary/involuntary
|
||||
│ ├── Assessment-Tools/ # PHQ-9, GAD-7, Columbia, mental status
|
||||
│ ├── Safety-Plans/ # Suicide safety plans, precaution levels
|
||||
│ ├── Restraint-Records/ # Restraint/seclusion orders, monitoring logs
|
||||
│ ├── Treatment-Plans/ # Individualized treatment plans, goals
|
||||
│ └── Training/ # Competency assessments
|
||||
├── Policies/ # Institutional policies
|
||||
├── Work-Instructions/ # Step-by-step procedures
|
||||
└── Templates/ # Document templates
|
||||
```
|
||||
|
||||
## Document Numbering Convention
|
||||
|
||||
- **POL-XXX**: Policies
|
||||
- **SOP-ADM-XXX**: Admission/Discharge SOPs
|
||||
- **SOP-ASM-XXX**: Assessment SOPs
|
||||
- **SOP-SAF-XXX**: Safety SOPs
|
||||
- **SOP-RS-XXX**: Restraint/Seclusion SOPs
|
||||
- **SOP-MED-XXX**: Medication SOPs
|
||||
- **WI-XXX**: Work Instructions
|
||||
- **FRM-XXX**: Forms and Records
|
||||
|
||||
## 🤖 AI-Powered Assistance
|
||||
|
||||
This repository includes **AtomicAI**, your mental health QMS assistant. Mention `@atomicai` in any issue or pull request to:
|
||||
|
||||
- Draft admission and assessment procedures
|
||||
- Create suicide risk assessment protocols
|
||||
- Generate restraint/seclusion procedures
|
||||
- Develop medication management SOPs
|
||||
- Create safety and elopement prevention plans
|
||||
- Review documents for Joint Commission compliance
|
||||
|
||||
### Example Prompts
|
||||
|
||||
- "@atomicai create an SOP for suicide risk assessment using Columbia-Suicide Severity Rating Scale"
|
||||
- "@atomicai draft an involuntary admission procedure per state requirements"
|
||||
- "@atomicai write a restraint/seclusion policy meeting CMS requirements"
|
||||
- "@atomicai create a psychiatric medication monitoring protocol"
|
||||
- "@atomicai develop an elopement prevention and response procedure"
|
||||
- "@atomicai create a therapeutic milieu safety checklist"
|
||||
|
||||
## Getting Started
|
||||
|
||||
1. **Align with State Laws** - Review involuntary commitment and patient rights laws
|
||||
2. **Establish Safety Protocols** - Implement suicide prevention and environmental safety
|
||||
3. **Define Assessment Standards** - Standardize psychiatric evaluation tools
|
||||
4. **Set Up Medication Monitoring** - Configure psychotropic medication protocols
|
||||
5. **Train Staff** - Crisis intervention and de-escalation training
|
||||
|
||||
## Key Documents to Create First
|
||||
|
||||
1. **Suicide Risk Assessment SOP** - Standardized screening and intervention
|
||||
2. **Involuntary Admission Procedure** - Legal holds and commitment process
|
||||
3. **Restraint and Seclusion Policy** - CMS-compliant R/S procedures
|
||||
4. **Environmental Safety Checklist** - Ligature risk and contraband
|
||||
5. **Elopement Prevention SOP** - Risk assessment and precautions
|
||||
6. **Treatment Planning SOP** - Individualized treatment plan development
|
||||
7. **Discharge Planning Procedure** - Safe transitions and aftercare
|
||||
|
||||
## Special Considerations for Psychiatric Inpatient Care
|
||||
|
||||
### Patient Safety
|
||||
- Suicide risk screening and assessment
|
||||
- Environmental safety (ligature points, sharps)
|
||||
- Contraband prevention and searches
|
||||
- Elopement risk and prevention
|
||||
- Patient supervision levels
|
||||
|
||||
### Legal and Rights
|
||||
- Voluntary vs. involuntary status
|
||||
- Informed consent for treatment
|
||||
- Patient rights notification
|
||||
- Grievance procedures
|
||||
- Advance directives and healthcare proxies
|
||||
|
||||
### Restraint and Seclusion
|
||||
- Least restrictive interventions
|
||||
- Physician orders and time limits
|
||||
- Continuous monitoring requirements
|
||||
- Debriefing and documentation
|
||||
- Reduction initiatives
|
||||
|
||||
### Treatment
|
||||
- Psychiatric evaluation and diagnosis
|
||||
- Treatment plan development
|
||||
- Medication management and monitoring
|
||||
- Group and individual therapy
|
||||
- Discharge planning and aftercare
|
||||
|
||||
---
|
||||
|
||||
*This template is maintained by AtomicQMS. For questions, open an issue in this repository.*
|
||||
|
||||
0
SOPs/Admission-Discharge/.gitkeep
Normal file
0
SOPs/Admission-Discharge/.gitkeep
Normal file
0
SOPs/Assessment/.gitkeep
Normal file
0
SOPs/Assessment/.gitkeep
Normal file
112
SOPs/General/SOP-001-Document-Control.md
Normal file
112
SOPs/General/SOP-001-Document-Control.md
Normal file
@@ -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] |
|
||||
134
SOPs/General/SOP-002-CAPA.md
Normal file
134
SOPs/General/SOP-002-CAPA.md
Normal file
@@ -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] |
|
||||
123
SOPs/General/SOP-003-Training.md
Normal file
123
SOPs/General/SOP-003-Training.md
Normal file
@@ -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] |
|
||||
136
SOPs/General/SOP-004-Internal-Audit.md
Normal file
136
SOPs/General/SOP-004-Internal-Audit.md
Normal file
@@ -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] |
|
||||
114
SOPs/General/SOP-005-Management-Review.md
Normal file
114
SOPs/General/SOP-005-Management-Review.md
Normal file
@@ -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] |
|
||||
0
SOPs/Medication/.gitkeep
Normal file
0
SOPs/Medication/.gitkeep
Normal file
327
SOPs/Patient-Care/SOP-MHI-001-Admission-Assessment.md
Normal file
327
SOPs/Patient-Care/SOP-MHI-001-Admission-Assessment.md
Normal file
@@ -0,0 +1,327 @@
|
||||
# Standard Operating Procedure: Psychiatric Inpatient Admission and Assessment
|
||||
|
||||
| Document ID | SOP-MHI-001 |
|
||||
|-------------|-------------|
|
||||
| Title | Psychiatric Inpatient Admission and Comprehensive Assessment |
|
||||
| Revision | 1.0 |
|
||||
| Effective Date | [DATE] |
|
||||
| Author | [AUTHOR] |
|
||||
| Approved By | [APPROVER] |
|
||||
| Department | Inpatient Psychiatry |
|
||||
|
||||
---
|
||||
|
||||
## 1. Purpose
|
||||
|
||||
To establish standardized procedures for the admission and comprehensive psychiatric assessment of patients to the inpatient psychiatric unit, ensuring safety, regulatory compliance, and appropriate treatment planning.
|
||||
|
||||
## 2. Scope
|
||||
|
||||
This procedure applies to all psychiatric inpatient admissions including:
|
||||
- Voluntary admissions
|
||||
- Involuntary/emergency detentions
|
||||
- Transfers from other facilities
|
||||
- Forensic admissions
|
||||
- Medical clearance requirements
|
||||
|
||||
## 3. Responsibilities
|
||||
|
||||
### 3.1 Admitting Psychiatrist
|
||||
- Conduct psychiatric evaluation
|
||||
- Determine admission criteria met
|
||||
- Establish initial treatment plan
|
||||
- Complete admission documentation
|
||||
|
||||
### 3.2 Nursing Staff
|
||||
- Conduct nursing admission assessment
|
||||
- Complete safety assessment and precautions
|
||||
- Inventory personal belongings
|
||||
- Orient patient to unit
|
||||
|
||||
### 3.3 Social Worker
|
||||
- Conduct psychosocial assessment
|
||||
- Contact family/supports
|
||||
- Begin discharge planning
|
||||
- Assess resource needs
|
||||
|
||||
### 3.4 Mental Health Technicians
|
||||
- Assist with admission process
|
||||
- Implement observation levels
|
||||
- Secure patient belongings
|
||||
|
||||
## 4. Definitions
|
||||
|
||||
| Term | Definition |
|
||||
|------|------------|
|
||||
| Voluntary Admission | Patient consents to hospitalization |
|
||||
| Involuntary Hold | Legal detention for evaluation/treatment without consent |
|
||||
| 1:1 Observation | Continuous direct observation by staff member |
|
||||
| Elopement Precautions | Measures to prevent unauthorized departure |
|
||||
| Medical Clearance | Confirmation patient is medically stable for psychiatric unit |
|
||||
|
||||
## 5. Procedure
|
||||
|
||||
### 5.1 Pre-Admission Requirements
|
||||
|
||||
#### 5.1.1 Medical Clearance
|
||||
|
||||
Before admission to psychiatric unit, patient must have:
|
||||
- [ ] Medical history and physical examination
|
||||
- [ ] Vital signs within acceptable parameters
|
||||
- [ ] Laboratory studies per protocol
|
||||
- [ ] Medical conditions stabilized or treatment plan in place
|
||||
- [ ] Clearance from ED physician or medicine consultant
|
||||
|
||||
**Minimum Laboratory Studies:**
|
||||
| Test | Required |
|
||||
|------|----------|
|
||||
| Complete Blood Count | ☐ |
|
||||
| Comprehensive Metabolic Panel | ☐ |
|
||||
| Urinalysis | ☐ |
|
||||
| Urine Drug Screen | ☐ |
|
||||
| Blood Alcohol Level | ☐ |
|
||||
| Pregnancy Test (if applicable) | ☐ |
|
||||
| Additional (as indicated) | |
|
||||
|
||||
#### 5.1.2 Legal Status Determination
|
||||
|
||||
| Status | Documentation Required |
|
||||
|--------|------------------------|
|
||||
| Voluntary | Signed voluntary admission form |
|
||||
| Involuntary | Completed legal detention documents, physician certification |
|
||||
| Court-Ordered | Court order, sheriff documentation |
|
||||
| Minor | Parent/guardian consent OR court order |
|
||||
|
||||
### 5.2 Admission Process
|
||||
|
||||
#### 5.2.1 Patient Arrival
|
||||
1. Greet patient and escort to admission area
|
||||
2. Verify identity with two identifiers
|
||||
3. Confirm legal status and documentation
|
||||
4. Apply identification band
|
||||
|
||||
#### 5.2.2 Safety Search and Contraband Removal
|
||||
|
||||
**Required for all admissions:**
|
||||
- [ ] Wand metal detector screening
|
||||
- [ ] Personal search (same-gender staff)
|
||||
- [ ] Belongings search
|
||||
- [ ] Remove and secure contraband
|
||||
|
||||
**Contraband List:**
|
||||
| Always Remove | Document Securely |
|
||||
|--------------|-------------------|
|
||||
| Sharps, blades | Medications |
|
||||
| Ligature materials (belts, cords, laces) | Valuables |
|
||||
| Drugs/alcohol | Electronics (per policy) |
|
||||
| Weapons | Lighters/matches |
|
||||
| Glass items | |
|
||||
|
||||
Document all items on FRM-MHI-001 Belongings Inventory.
|
||||
|
||||
#### 5.2.3 Observation Level Assignment
|
||||
|
||||
| Level | Criteria | Monitoring |
|
||||
|-------|----------|------------|
|
||||
| 1:1 Continuous | Active suicidal/homicidal, severe agitation | Within arm's reach |
|
||||
| Close Observation | Recent attempt, high risk | Every 5-15 minutes |
|
||||
| Routine | Low/moderate risk | Every 15-30 minutes |
|
||||
| Open | No safety concerns | Per unit routine |
|
||||
|
||||
### 5.3 Psychiatric Evaluation
|
||||
|
||||
#### 5.3.1 Comprehensive Psychiatric Assessment
|
||||
|
||||
**Required within 24 hours of admission:**
|
||||
|
||||
1. **Chief Complaint and History of Present Illness**
|
||||
- Current symptoms and duration
|
||||
- Precipitating events
|
||||
- Previous episodes
|
||||
- Current stressors
|
||||
|
||||
2. **Psychiatric History**
|
||||
- Previous diagnoses
|
||||
- Hospitalizations
|
||||
- Outpatient treatment
|
||||
- Medication trials
|
||||
- ECT or other treatments
|
||||
|
||||
3. **Suicide/Violence Risk Assessment**
|
||||
|
||||
**Suicide Risk:**
|
||||
| Factor | Present |
|
||||
|--------|---------|
|
||||
| Current ideation | ☐ Yes ☐ No |
|
||||
| Plan | ☐ Yes ☐ No |
|
||||
| Intent | ☐ Yes ☐ No |
|
||||
| Access to means | ☐ Yes ☐ No |
|
||||
| Previous attempts | ☐ Yes ☐ No |
|
||||
| Protective factors | |
|
||||
|
||||
**Violence Risk:**
|
||||
| Factor | Present |
|
||||
|--------|---------|
|
||||
| Homicidal ideation | ☐ Yes ☐ No |
|
||||
| Identified target | ☐ Yes ☐ No |
|
||||
| History of violence | ☐ Yes ☐ No |
|
||||
| Command hallucinations | ☐ Yes ☐ No |
|
||||
| Access to weapons | ☐ Yes ☐ No |
|
||||
|
||||
4. **Substance Use History**
|
||||
- Substances used
|
||||
- Quantity, frequency, route
|
||||
- Last use
|
||||
- Withdrawal history
|
||||
- Treatment history
|
||||
|
||||
5. **Medical History**
|
||||
- Chronic conditions
|
||||
- Current medications
|
||||
- Allergies
|
||||
- Recent medical issues
|
||||
|
||||
6. **Family History**
|
||||
- Psychiatric disorders
|
||||
- Substance use disorders
|
||||
- Suicide history
|
||||
|
||||
7. **Social/Developmental History**
|
||||
- Education
|
||||
- Employment
|
||||
- Living situation
|
||||
- Relationships
|
||||
- Legal history
|
||||
- Trauma history
|
||||
|
||||
8. **Mental Status Examination**
|
||||
| Domain | Findings |
|
||||
|--------|----------|
|
||||
| Appearance | |
|
||||
| Behavior | |
|
||||
| Speech | |
|
||||
| Mood | |
|
||||
| Affect | |
|
||||
| Thought Process | |
|
||||
| Thought Content | |
|
||||
| Perceptions | |
|
||||
| Cognition | |
|
||||
| Insight | |
|
||||
| Judgment | |
|
||||
|
||||
9. **Diagnosis (DSM-5)**
|
||||
- Primary diagnosis
|
||||
- Secondary diagnoses
|
||||
- Medical conditions
|
||||
- Psychosocial stressors
|
||||
|
||||
### 5.4 Nursing Admission Assessment
|
||||
|
||||
Complete within **8 hours** of admission:
|
||||
|
||||
- [ ] Vital signs
|
||||
- [ ] Pain assessment
|
||||
- [ ] Fall risk assessment
|
||||
- [ ] Skin assessment
|
||||
- [ ] Nutritional screen
|
||||
- [ ] Medication reconciliation
|
||||
- [ ] Allergies verified
|
||||
- [ ] Current symptoms
|
||||
- [ ] Functional status
|
||||
- [ ] Sleep patterns
|
||||
- [ ] Safety precautions implemented
|
||||
|
||||
### 5.5 Treatment Planning
|
||||
|
||||
#### 5.5.1 Initial Treatment Plan (within 24 hours)
|
||||
- Provisional diagnoses
|
||||
- Initial medication orders
|
||||
- Observation level
|
||||
- Activity level
|
||||
- Diet
|
||||
- Laboratory/diagnostic orders
|
||||
- Consultation requests
|
||||
- Initial goals
|
||||
|
||||
#### 5.5.2 Comprehensive Treatment Plan (within 72 hours)
|
||||
- Multidisciplinary input
|
||||
- Patient participation
|
||||
- Measurable goals
|
||||
- Interventions by discipline
|
||||
- Discharge criteria
|
||||
- Estimated length of stay
|
||||
|
||||
### 5.6 Patient Rights and Orientation
|
||||
|
||||
#### 5.6.1 Rights Information
|
||||
Provide and document receipt of:
|
||||
- [ ] Patient rights document
|
||||
- [ ] Grievance procedure
|
||||
- [ ] Privacy practices
|
||||
- [ ] Voluntary/involuntary rights specific to status
|
||||
- [ ] Right to refuse treatment (voluntary)
|
||||
- [ ] Advance directive information
|
||||
|
||||
#### 5.6.2 Unit Orientation
|
||||
- [ ] Room assignment
|
||||
- [ ] Unit layout (exits, bathroom, common areas)
|
||||
- [ ] Schedule (meals, groups, visiting)
|
||||
- [ ] Rules and expectations
|
||||
- [ ] How to contact staff
|
||||
- [ ] Telephone use
|
||||
- [ ] Personal belongings policy
|
||||
|
||||
### 5.7 Special Populations
|
||||
|
||||
#### 5.7.1 Minors
|
||||
- Parental/guardian involvement
|
||||
- Age-appropriate assessments
|
||||
- Educational needs assessment
|
||||
- Child protective services notification if indicated
|
||||
|
||||
#### 5.7.2 Geriatric Patients
|
||||
- Enhanced medical monitoring
|
||||
- Cognitive assessment
|
||||
- Fall precautions
|
||||
- Medication review for appropriateness
|
||||
|
||||
#### 5.7.3 Forensic Patients
|
||||
- Legal hold documentation
|
||||
- Notification requirements
|
||||
- Security considerations
|
||||
- Court date tracking
|
||||
|
||||
## 6. Documentation
|
||||
|
||||
- FRM-MHI-001 Belongings Inventory
|
||||
- FRM-MHI-002 Admission Safety Assessment
|
||||
- FRM-MHI-003 Suicide Risk Assessment
|
||||
- Psychiatric Evaluation
|
||||
- Nursing Admission Assessment
|
||||
- Social Work Assessment
|
||||
- Treatment Plan
|
||||
- Patient Rights Acknowledgment
|
||||
|
||||
## 7. Regulatory Compliance
|
||||
|
||||
| Regulation | Requirement |
|
||||
|------------|-------------|
|
||||
| The Joint Commission | Assessment within 24 hours |
|
||||
| CMS | Treatment plan within 72 hours |
|
||||
| State Mental Health Code | Involuntary hold procedures |
|
||||
| EMTALA | Medical screening examination |
|
||||
|
||||
## 8. References
|
||||
|
||||
- State mental health statutes
|
||||
- The Joint Commission standards
|
||||
- CMS Conditions of Participation
|
||||
- Institutional policies
|
||||
|
||||
---
|
||||
|
||||
## Revision History
|
||||
|
||||
| Rev | Date | Description | Author |
|
||||
|-----|------|-------------|--------|
|
||||
| 1.0 | [DATE] | Initial release | [AUTHOR] |
|
||||
0
SOPs/Restraint-Seclusion/.gitkeep
Normal file
0
SOPs/Restraint-Seclusion/.gitkeep
Normal file
1
SOPs/Safety/.gitkeep
Normal file
1
SOPs/Safety/.gitkeep
Normal file
@@ -0,0 +1 @@
|
||||
# Placeholder
|
||||
62
Templates/SOP-Template.md
Normal file
62
Templates/SOP-Template.md
Normal file
@@ -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] |
|
||||
68
Work Instructions/WI-001-Template.md
Normal file
68
Work Instructions/WI-001-Template.md
Normal file
@@ -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] |
|
||||
Reference in New Lab Ticket
Block a user