diff --git a/.gitea/workflows/atomicai.yml b/.gitea/workflows/atomicai.yml new file mode 100644 index 0000000..6a3526e --- /dev/null +++ b/.gitea/workflows/atomicai.yml @@ -0,0 +1,79 @@ +name: AtomicAI Blood Bank Assistant + +on: + issue_comment: + types: [created] + issues: + types: [opened, assigned] + pull_request: + types: [opened, synchronize, assigned] + pull_request_review_comment: + types: [created] + +jobs: + claude-assistant: + runs-on: ubuntu-latest + if: | + github.actor != 'atomicqms-service' && + ( + (github.event_name == 'issue_comment' && contains(github.event.comment.body, '@atomicai') && github.event.comment.user.login != 'atomicqms-service') || + (github.event_name == 'issues' && github.event.action == 'opened' && contains(github.event.issue.body, '@atomicai')) || + (github.event_name == 'pull_request' && github.event.action == 'opened' && contains(github.event.pull_request.body, '@atomicai')) || + (github.event_name == 'pull_request_review_comment' && contains(github.event.comment.body, '@atomicai') && github.event.comment.user.login != 'atomicqms-service') || + (github.event.action == 'assigned' && github.event.assignee.login == 'atomicai') + + ) + permissions: + contents: write + issues: write + pull-requests: write + + steps: + - uses: actions/checkout@v4 + with: + fetch-depth: 0 + + - name: Run AtomicAI Blood Bank 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 Blood Bank and Transfusion Medicine Quality Management. + + ## Your Expertise + - AABB (Association for the Advancement of Blood & Biotherapies) standards + - FDA blood establishment regulations (21 CFR 606) + - Blood typing and crossmatching procedures + - Component preparation and storage + - Transfusion reaction investigation + - Donor screening and eligibility + - Therapeutic apheresis procedures + - Inventory management and wastage reduction + - Temperature monitoring and cold chain + - Lookback and traceability procedures + - Emergency release protocols + - Massive transfusion protocols + + ## Document Creation Guidelines + - Place Testing SOPs in SOPs/Testing/ + - Place Component SOPs in SOPs/Components/ + - Place Transfusion SOPs in SOPs/Transfusion/ + - Place Donor Forms in Forms/Donor/ + - Place Reaction Forms in Forms/Reactions/ + - Place Policies in Policies/ + + ## Numbering Convention + - SOP-BB-XXX for Blood Bank SOPs + - SOP-TRN-XXX for Transfusion SOPs + - SOP-APH-XXX for Apheresis SOPs + - SOP-DON-XXX for Donor SOPs + - POL-XXX for Policies + - FRM-XXX for Forms + + Always create branches and submit changes as Pull Requests for review. + Prioritize patient safety, product integrity, and regulatory compliance. + allowed_tools: 'Read,Edit,Grep,Glob,Write' + disallowed_tools: 'Bash,WebSearch' diff --git a/Forms/Donor-Records/.gitkeep b/Forms/Donor-Records/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/FRM-001-Document-Change-Request.md b/Forms/FRM-001-Document-Change-Request.md new file mode 100644 index 0000000..55c718a --- /dev/null +++ b/Forms/FRM-001-Document-Change-Request.md @@ -0,0 +1,64 @@ +# Document Change Request Form + +| Form ID | FRM-001 | Revision | 1.0 | +|---------|---------|----------|-----| + +--- + +## Section 1: Request Information + +| Field | Entry | +|-------|-------| +| Request Date | | +| Requested By | | +| Department | | + +## Section 2: Document Information + +| Field | Entry | +|-------|-------| +| Document Number | | +| Document Title | | +| Current Revision | | + +## Section 3: Change Description + +### Type of Change +- [ ] New Document +- [ ] Revision to Existing Document +- [ ] Document Obsolescence + +### Description of Change +*(Describe the proposed change in detail)* + + + + +### Reason for Change +*(Explain why this change is needed)* + + + + +## Section 4: Impact Assessment + +### Affected Areas +- [ ] Training Required +- [ ] Other Documents Affected +- [ ] Process Changes Required +- [ ] Validation Impact + +### List Affected Documents + + +## Section 5: Approvals + +| Role | Name | Signature | Date | +|------|------|-----------|------| +| Requester | | | | +| Document Owner | | | | +| Quality Assurance | | | | + +--- + +*Form FRM-001 Rev 1.0* diff --git a/Forms/FRM-003-CAPA-Form.md b/Forms/FRM-003-CAPA-Form.md new file mode 100644 index 0000000..6790a8f --- /dev/null +++ b/Forms/FRM-003-CAPA-Form.md @@ -0,0 +1,91 @@ +# Corrective and Preventive Action (CAPA) Form + +| Form ID | FRM-003 | Revision | 1.0 | +|---------|---------|----------|-----| + +--- + +## Section 1: CAPA Identification + +| Field | Entry | +|-------|-------| +| CAPA Number | | +| Date Initiated | | +| Initiated By | | +| CAPA Owner | | +| Target Closure Date | | + +## Section 2: Classification + +### Type +- [ ] Corrective Action +- [ ] Preventive Action + +### Source +- [ ] Customer Complaint +- [ ] Internal Audit +- [ ] External Audit +- [ ] Process Deviation +- [ ] Nonconforming Product +- [ ] Management Review +- [ ] Other: ____________ + +### Priority +- [ ] Critical (5 business days) +- [ ] Major (15 business days) +- [ ] Minor (30 business days) + +## Section 3: Problem Description + +*(Describe the nonconformity or potential nonconformity)* + + + + +## Section 4: Immediate Containment + +*(Actions taken to contain the immediate impact)* + + + + +## Section 5: Root Cause Investigation + +### Investigation Method Used +- [ ] 5 Whys +- [ ] Fishbone Diagram +- [ ] Fault Tree Analysis +- [ ] Other: ____________ + +### Root Cause Determination + + + + +## Section 6: Corrective/Preventive Actions + +| Action | Responsible | Due Date | Status | +|--------|-------------|----------|--------| +| | | | | +| | | | | +| | | | | + +## Section 7: Effectiveness Verification + +| Criteria | Method | Result | +|----------|--------|--------| +| | | | + +Verification Date: ____________ +Verified By: ____________ + +## Section 8: Closure + +| Role | Name | Signature | Date | +|------|------|-----------|------| +| CAPA Owner | | | | +| Quality Approval | | | | + +--- + +*Form FRM-003 Rev 1.0* diff --git a/Forms/FRM-006-Audit-Checklist.md b/Forms/FRM-006-Audit-Checklist.md new file mode 100644 index 0000000..45bf0b6 --- /dev/null +++ b/Forms/FRM-006-Audit-Checklist.md @@ -0,0 +1,56 @@ +# Internal Audit Checklist + +| Form ID | FRM-006 | Revision | 1.0 | +|---------|---------|----------|-----| + +--- + +## Audit Information + +| Field | Entry | +|-------|-------| +| Audit Number | | +| Audit Date | | +| Area/Process Audited | | +| Lead Auditor | | +| Auditee(s) | | + +--- + +## Checklist Items + +| # | Requirement/Question | Reference | C/NC/NA | Evidence/Notes | +|---|---------------------|-----------|---------|----------------| +| 1 | Are current versions of applicable procedures available? | SOP-001 | | | +| 2 | Are personnel trained on applicable procedures? | SOP-003 | | | +| 3 | Are training records current and complete? | SOP-003 | | | +| 4 | Are records properly maintained and retrievable? | SOP-001 | | | +| 5 | Are nonconformities being documented and addressed? | SOP-002 | | | +| 6 | Are CAPAs being completed on time? | SOP-002 | | | +| 7 | Is equipment calibrated and maintained? | | | | +| 8 | Are process controls being followed? | | | | +| 9 | Are quality objectives being monitored? | | | | +| 10 | | | | | + +**Legend:** C = Conforming, NC = Nonconforming, NA = Not Applicable + +--- + +## Findings Summary + +| Finding # | Type | Description | Clause Reference | +|-----------|------|-------------|------------------| +| | | | | +| | | | | + +--- + +## Auditor Signature + +| Auditor | Signature | Date | +|---------|-----------|------| +| | | | + +--- + +*Form FRM-006 Rev 1.0* diff --git a/Forms/QC-Records/.gitkeep b/Forms/QC-Records/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Temperature-Logs/.gitkeep b/Forms/Temperature-Logs/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Testing-Logs/.gitkeep b/Forms/Testing-Logs/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/Forms/Testing-Logs/FRM-BB-001-Compatibility-Testing-Log.md b/Forms/Testing-Logs/FRM-BB-001-Compatibility-Testing-Log.md new file mode 100644 index 0000000..9bce099 --- /dev/null +++ b/Forms/Testing-Logs/FRM-BB-001-Compatibility-Testing-Log.md @@ -0,0 +1,248 @@ +# Compatibility Testing Log + +| Form ID | FRM-BB-001 | Revision | 1.0 | +|---------|-------------|----------|-----| + +--- + +## Patient Information + +| Field | Entry | +|-------|-------| +| Patient Name | | +| MRN | | +| Date of Birth | | +| Sex | ☐ Male ☐ Female | +| Location/Unit | | +| Ordering Physician | | +| Date of Request | | +| Time of Request | | + +--- + +## Specimen Information + +| Field | Entry | +|-------|-------| +| Date Collected | | +| Time Collected | | +| Collected By | | +| Phlebotomist ID | | +| Tube Type | ☐ EDTA ☐ Clot ☐ Both | +| Specimen Acceptable? | ☐ Yes ☐ No (reason: _______) | +| Previous Records Available? | ☐ Yes ☐ No ☐ N/A | + +--- + +## ABO/Rh Typing + +### Current Sample + +| Test | Result | Interpretation | +|------|--------|----------------| +| Anti-A | ☐ Pos ☐ Neg | | +| Anti-B | ☐ Pos ☐ Neg | | +| Anti-D | ☐ Pos ☐ Neg | | +| A1 Cells | ☐ Pos ☐ Neg | | +| B Cells | ☐ Pos ☐ Neg | | + +**ABO Type:** ☐ A ☐ B ☐ AB ☐ O + +**Rh Type:** ☐ Positive ☐ Negative + +**Weak D Testing (if applicable):** +☐ Not performed ☐ Positive ☐ Negative + +### Historical Results (if available) + +| Date | ABO | Rh | Source | +|------|-----|----|--------| +| | | | | +| | | | | + +**Results Consistent?** ☐ Yes ☐ No (see discrepancy resolution) + +--- + +## Antibody Screening + +| Field | Entry | +|-------|-------| +| Method | ☐ Tube ☐ Gel ☐ Solid Phase | +| Enhancement | ☐ LISS ☐ PEG ☐ None | +| Screen Cell Lot # | | +| Expiration Date | | + +### Screen Cell Results + +| Cell | Immediate Spin | 37°C | AHG | CC | +|------|----------------|------|-----|-----| +| I | | | | | +| II | | | | | +| III | | | | | + +**Antibody Screen Result:** ☐ Negative ☐ Positive + +**If Positive, Antibody Identified:** + +--- + +## Antibody Identification (if screening positive) + +| Field | Entry | +|-------|-------| +| Panel Lot # | | +| Method | | +| Antibody(ies) Identified | | +| Clinical Significance | ☐ Yes ☐ No | +| Phenotyped Units Required? | ☐ Yes ☐ No | +| Phenotype Requirements | | + +| Panel Cell | Results | Antigen Correlation | +|------------|---------|---------------------| +| 1 | | | +| 2 | | | +| 3 | | | +| 4 | | | +| 5 | | | +| 6 | | | +| 7 | | | +| 8 | | | +| 9 | | | +| 10 | | | +| 11 | | | + +--- + +## Crossmatch + +### Unit 1 + +| Field | Entry | +|-------|-------| +| Unit Number | | +| ABO/Rh | | +| Expiration Date | | +| Antigen Typed? | ☐ Yes: _______ ☐ No ☐ N/A | + +| Phase | Result | Interpretation | +|-------|--------|----------------| +| Immediate Spin | ☐ Compatible ☐ Incompatible | | +| 37°C | ☐ Compatible ☐ Incompatible | | +| AHG | ☐ Compatible ☐ Incompatible | | +| Coombs Control | ☐ Valid ☐ Invalid | | + +**Final Result:** ☐ Compatible ☐ Incompatible + +### Unit 2 + +| Field | Entry | +|-------|-------| +| Unit Number | | +| ABO/Rh | | +| Expiration Date | | +| Antigen Typed? | ☐ Yes: _______ ☐ No ☐ N/A | + +| Phase | Result | Interpretation | +|-------|--------|----------------| +| Immediate Spin | ☐ Compatible ☐ Incompatible | | +| 37°C | ☐ Compatible ☐ Incompatible | | +| AHG | ☐ Compatible ☐ Incompatible | | +| Coombs Control | ☐ Valid ☐ Invalid | | + +**Final Result:** ☐ Compatible ☐ Incompatible + +### Unit 3 + +| Field | Entry | +|-------|-------| +| Unit Number | | +| ABO/Rh | | +| Expiration Date | | +| Antigen Typed? | ☐ Yes: _______ ☐ No ☐ N/A | + +| Phase | Result | Interpretation | +|-------|--------|----------------| +| Immediate Spin | ☐ Compatible ☐ Incompatible | | +| 37°C | ☐ Compatible ☐ Incompatible | | +| AHG | ☐ Compatible ☐ Incompatible | | +| Coombs Control | ☐ Valid ☐ Invalid | | + +**Final Result:** ☐ Compatible ☐ Incompatible + +--- + +## Electronic Crossmatch (if applicable) + +| Field | Entry | +|-------|-------| +| Two ABO/Rh on file? | ☐ Yes ☐ No | +| Results consistent? | ☐ Yes ☐ No | +| Antibody screen negative? | ☐ Yes ☐ No | +| Computer system validated? | ☐ Yes | + +--- + +## Special Requirements + +| Requirement | Ordered? | Provided? | +|-------------|----------|-----------| +| CMV Negative | ☐ | ☐ | +| Irradiated | ☐ | ☐ | +| Leukoreduced | ☐ | ☐ | +| Washed | ☐ | ☐ | +| Volume Reduced | ☐ | ☐ | +| HbS Negative | ☐ | ☐ | +| Antigen Negative: _______ | ☐ | ☐ | + +--- + +## Results Summary + +| Field | Entry | +|-------|-------| +| ABO/Rh | | +| Antibody Screen | ☐ Negative ☐ Positive | +| Antibodies Identified | | +| Units Crossmatched | | +| Units Compatible | | +| Units Available for Issue | | + +--- + +## Verification + +### Performed By + +| Field | Entry | +|-------|-------| +| Technologist Name | | +| Tech ID | | +| Date | | +| Time | | +| Signature | | + +### Reviewed By (if required) + +| Field | Entry | +|-------|-------| +| Reviewer Name | | +| Date | | +| Signature | | + +--- + +## Discrepancy Resolution (if applicable) + +| Field | Entry | +|-------|-------| +| Type of Discrepancy | | +| Investigation Performed | | +| Resolution | | +| Resolved By | | +| Date | | +| Supervisor Review | | + +--- + +*Form FRM-BB-001 Rev 1.0 - Compatibility Testing Log* 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/Transfusion-Records/.gitkeep b/Forms/Transfusion-Records/.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 5029735..2c6b012 100644 --- a/README.md +++ b/README.md @@ -1,3 +1,132 @@ -# blood-bank +# Blood Bank & Transfusion Services Quality Management System -A comprehensive QMS template designed for blood banks, transfusion services, and blood component preparation facilities. \ No newline at end of file +A comprehensive QMS template designed for blood banks, transfusion services, and blood component preparation facilities. + +## 🩸 Designed For + +- **Hospital Blood Banks** - Transfusion services and compatibility testing +- **Blood Collection Centers** - Donor recruitment and phlebotomy operations +- **Regional Blood Centers** - Component manufacturing and distribution +- **Apheresis Centers** - Therapeutic and donor apheresis programs +- **Cord Blood Banks** - Umbilical cord blood collection and processing +- **Plasma Collection Facilities** - Source plasma operations +- **Reference Laboratories** - Complex immunohematology testing + +## 📋 Regulatory Framework + +This template supports compliance with: + +- **FDA 21 CFR 606** - Current Good Manufacturing Practice for Blood and Blood Components +- **FDA 21 CFR 630** - Requirements for Blood and Blood Components +- **AABB Standards** - Standards for Blood Banks and Transfusion Services +- **CAP** - College of American Pathologists accreditation requirements +- **CLIA** - Clinical Laboratory Improvement Amendments +- **The Joint Commission** - Hospital accreditation standards +- **ISBT 128** - International coding standards for blood products +- **OSHA Bloodborne Pathogens** - Employee safety requirements +- **State Regulations** - State-specific blood banking requirements + +## Repository Structure + +``` +├── SOPs/ +│ ├── Donor-Services/ # Donor screening, phlebotomy, reactions +│ ├── Component-Preparation/ # Manufacturing, labeling, pooling +│ ├── Testing/ # Compatibility, infectious disease, antibody ID +│ ├── Transfusion/ # Ordering, issuing, administration, reactions +│ ├── Inventory-Management/ # Storage, expiration, look-back +│ └── General/ # Document control, training, CAPA +├── Forms/ +│ ├── Donor-Records/ # DHQ, consent, deferral forms +│ ├── Testing-Logs/ # Crossmatch, antibody, QC records +│ ├── Transfusion-Records/ # Order forms, consent, reaction reports +│ ├── Temperature-Logs/ # Blood storage equipment monitoring +│ ├── QC-Records/ # Reagent QC, equipment calibration +│ └── Training/ # Competency assessments +├── Policies/ # Institutional policies +├── Work-Instructions/ # Step-by-step procedures +└── Templates/ # Document templates +``` + +## Document Numbering Convention + +- **POL-XXX**: Policies +- **SOP-DON-XXX**: Donor Services SOPs +- **SOP-CMP-XXX**: Component Preparation SOPs +- **SOP-TST-XXX**: Testing SOPs +- **SOP-TXN-XXX**: Transfusion SOPs +- **SOP-INV-XXX**: Inventory Management SOPs +- **WI-XXX**: Work Instructions +- **FRM-XXX**: Forms and Records + +## 🤖 AI-Powered Assistance + +This repository includes **AtomicAI**, your blood bank QMS assistant. Mention `@atomicai` in any issue or pull request to: + +- Draft donor screening and collection SOPs +- Create compatibility testing procedures +- Generate transfusion reaction investigation protocols +- Develop component preparation workflows +- Create equipment validation and QC procedures +- Review documents for FDA/AABB compliance + +### Example Prompts + +- "@atomicai create an SOP for ABO/Rh typing per AABB standards" +- "@atomicai draft a massive transfusion protocol" +- "@atomicai write a transfusion reaction workup procedure" +- "@atomicai create an antibody identification SOP" +- "@atomicai develop a platelet storage and monitoring procedure" +- "@atomicai create a blood product irradiation SOP" + +## Getting Started + +1. **Review Regulatory Requirements** - Align with FDA and AABB standards +2. **Customize Testing SOPs** - Adapt for your testing methodologies +3. **Set Up Temperature Monitoring** - Configure equipment monitoring logs +4. **Establish QC Program** - Implement reagent and equipment QC +5. **Train Personnel** - Use competency assessment forms + +## Key Documents to Create First + +1. **ABO/Rh Typing SOP** - Foundation for compatibility testing +2. **Crossmatch Procedure** - Immediate spin, IS, AHG methods +3. **Blood Product Storage SOP** - Temperature requirements by component +4. **Transfusion Reaction Workup** - Investigation and reporting procedure +5. **Massive Transfusion Protocol** - Emergency release procedures +6. **Donor Screening Questionnaire** - DHQ and mini-physical +7. **Look-Back Procedure** - Post-donation information handling + +## Special Considerations for Blood Banking + +### Donor Management +- Donor screening and eligibility criteria +- Hemoglobin/hematocrit requirements +- Deferral registry management +- Adverse reaction documentation +- Donor notification procedures + +### Component Preparation +- Whole blood processing timelines +- Component specifications (Hct, plt count, etc.) +- Leukoreduction requirements +- Irradiation and pathogen reduction +- Labeling and ISBT 128 compliance + +### Compatibility Testing +- Sample requirements and retention +- Testing algorithm (type, screen, crossmatch) +- Antibody identification workups +- Computer crossmatch validation +- Emergency release procedures + +### Transfusion Safety +- Two-patient-identifier verification +- Bedside compatibility check +- Transfusion reaction recognition +- Hemovigilance reporting +- Near-miss documentation + +--- + +*This template is maintained by AtomicQMS. For questions, open an issue in this repository.* diff --git a/SOPs/Component-Preparation/.gitkeep b/SOPs/Component-Preparation/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Donor-Services/.gitkeep b/SOPs/Donor-Services/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Donor-Services/SOP-BB-001-Donor-Screening.md b/SOPs/Donor-Services/SOP-BB-001-Donor-Screening.md new file mode 100644 index 0000000..6dd5f5c --- /dev/null +++ b/SOPs/Donor-Services/SOP-BB-001-Donor-Screening.md @@ -0,0 +1,234 @@ +# Standard Operating Procedure: Blood Donor Screening + +| Document ID | SOP-BB-001 | +|-------------|-------------| +| Title | Blood Donor Screening and Eligibility | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Donor Services | + +--- + +## 1. Purpose + +To establish standardized procedures for screening potential blood donors to ensure donor safety and the safety of the blood supply in accordance with FDA, AABB, and state regulations. + +## 2. Scope + +This procedure applies to: +- Whole blood donations +- Apheresis donations (platelets, plasma, red cells) +- Autologous donations +- Directed donations + +## 3. Responsibilities + +### 3.1 Donor Registration Staff +- Verify donor identity +- Complete registration process +- Explain donor education materials + +### 3.2 Donor Screening Personnel +- Conduct health history interview +- Perform mini-physical examination +- Determine donor eligibility + +### 3.3 Medical Director +- Establish deferral criteria +- Review complex eligibility questions +- Authorize exceptions when appropriate + +## 4. Definitions + +| Term | Definition | +|------|------------| +| Allogeneic | Donation intended for another person | +| Autologous | Donation for one's own use | +| Deferral | Temporary or permanent exclusion from donation | +| DHQ | Donor History Questionnaire | + +## 5. Equipment and Materials + +- FDA-approved Donor History Questionnaire +- Blood pressure monitor (calibrated) +- Thermometer +- Hemoglobin/hematocrit testing device +- Venipuncture supplies for sample collection +- Donor education materials +- Deferral registry access + +## 6. Procedure + +### 6.1 Donor Registration + +1. **Identity Verification** + - Require valid government-issued photo ID + - Verify name, date of birth + - Check against deferral registry + - Record donor identification number + +2. **Educational Materials** + - Provide donor education materials + - Ensure donor has read and understood: + - Risk behaviors + - Signs/symptoms requiring self-deferral + - Post-donation instructions + - Document acknowledgment + +### 6.2 Health History Interview + +1. **Questionnaire Administration** + - Use current FDA-approved DHQ version + - Conduct in private setting + - Allow donor to self-complete or assist as needed + - Review all responses with donor + +2. **Key Assessment Areas** + + **General Health** + - [ ] Feeling healthy today + - [ ] Weight ≥110 lbs (50 kg) + - [ ] Age requirements met + - [ ] No recent illness/infection + + **Medical History** + - [ ] Medications (prescription and OTC) + - [ ] Chronic conditions + - [ ] Recent surgeries/procedures + - [ ] Cancer history + - [ ] Heart/lung conditions + - [ ] Bleeding disorders + + **Infectious Disease Risk** + - [ ] Fever in past 3 days + - [ ] Travel history (endemic areas) + - [ ] Vaccinations (recent) + - [ ] Tattoos/piercings (recent) + - [ ] Contact with infectious diseases + + **Risk Behaviors** + - [ ] Sexual history per FDA guidance + - [ ] IV drug use + - [ ] Incarceration history + +3. **Interview Documentation** + - Record date and time + - Interviewer signature + - Donor signature affirming truthfulness + +### 6.3 Mini-Physical Examination + +| Parameter | Acceptable Range | Action if Outside Range | +|-----------|------------------|------------------------| +| Temperature | ≤99.5°F (37.5°C) | Defer | +| Blood Pressure | Systolic 90-180 mmHg, Diastolic 50-100 mmHg | Defer if outside | +| Pulse | 50-100 bpm, regular | Defer if irregular or outside range | +| Hemoglobin | ≥12.5 g/dL (female), ≥13.0 g/dL (male) | Defer | +| Weight | ≥110 lbs | Defer | +| Arms | Free of lesions, track marks | Defer if concerning | + +1. **Temperature** + - Measure oral temperature + - Wait 10 min if donor consumed hot/cold beverages + +2. **Blood Pressure and Pulse** + - Donor seated 2-3 minutes before measurement + - Use appropriate cuff size + - Record all values + +3. **Hemoglobin Testing** + - Perform fingerstick using approved device + - Follow manufacturer instructions + - Record result and device lot number + +4. **Arm Inspection** + - Examine both arms + - Check for: + - Skin lesions or infections + - Track marks + - Suitable veins + +### 6.4 Eligibility Determination + +1. **Eligible to Donate** + - All criteria met + - No deferral conditions identified + - Document approval + - Proceed to collection + +2. **Temporary Deferral** + - Document specific reason + - Calculate reinstatement date + - Provide deferral notice to donor + - Record in deferral registry + - Common reasons: + | Reason | Deferral Period | + |--------|-----------------| + | Low hemoglobin | 56 days minimum | + | Tattoo/piercing | Per state/facility policy | + | Recent vaccination | Varies by vaccine | + | Travel to endemic areas | Varies by location | + | Medication | Varies by drug | + +3. **Permanent Deferral** + - Document reason + - Notify donor in writing + - Record in deferral registry + - Offer post-donation counseling if appropriate + +### 6.5 Confidential Unit Exclusion + +- Offer confidential opportunity to self-exclude +- Provide private means (ballot, sticker, phone call) +- Document without identifying donor choice +- Units designated for discard are processed but not used + +## 7. Special Situations + +### 7.1 Therapeutic Phlebotomy +- Prescription required +- Separate eligibility criteria may apply +- Label units appropriately + +### 7.2 Autologous Donation +- Less stringent hemoglobin requirements +- Must meet basic safety criteria +- Physician order required + +### 7.3 Directed Donation +- Same eligibility criteria as allogeneic +- Document relationship to recipient + +## 8. Documentation + +- FRM-BB-001 Donor Registration Form +- Donor History Questionnaire (completed) +- FRM-BB-002 Mini-Physical Results +- Deferral notification (if applicable) +- Consent for donation + +## 9. Quality Control + +| Activity | Frequency | +|----------|-----------| +| Hemoglobin device QC | Per manufacturer | +| BP monitor calibration | Annually | +| DHQ version check | Monthly | +| Staff competency | Annually | + +## 10. References + +- FDA Guidance for Industry: Blood Establishment Registration +- AABB Standards for Blood Banks and Transfusion Services +- 21 CFR Part 606 - Current Good Manufacturing Practice for Blood +- State regulations for blood collection + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | 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/Inventory-Management/.gitkeep b/SOPs/Inventory-Management/.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/Testing/.gitkeep b/SOPs/Testing/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Transfusion/.gitkeep b/SOPs/Transfusion/.gitkeep new file mode 100644 index 0000000..e69de29 diff --git a/SOPs/Transfusion/SOP-BB-002-Blood-Transfusion.md b/SOPs/Transfusion/SOP-BB-002-Blood-Transfusion.md new file mode 100644 index 0000000..7064bdb --- /dev/null +++ b/SOPs/Transfusion/SOP-BB-002-Blood-Transfusion.md @@ -0,0 +1,242 @@ +# Standard Operating Procedure: Blood Transfusion Administration + +| Document ID | SOP-BB-002 | +|-------------|-------------| +| Title | Blood Transfusion Administration | +| Revision | 1.0 | +| Effective Date | [DATE] | +| Author | [AUTHOR] | +| Approved By | [APPROVER] | +| Department | Transfusion Services | + +--- + +## 1. Purpose + +To establish standardized procedures for the safe administration of blood and blood components to minimize transfusion errors and adverse reactions. + +## 2. Scope + +This procedure applies to the administration of: +- Packed red blood cells (PRBCs) +- Fresh frozen plasma (FFP) +- Platelets (random donor and apheresis) +- Cryoprecipitate +- Granulocytes + +## 3. Responsibilities + +### 3.1 Ordering Physician +- Determine transfusion indication +- Order appropriate blood component +- Obtain informed consent +- Respond to transfusion reactions + +### 3.2 Blood Bank/Transfusion Service +- Perform compatibility testing +- Issue blood products +- Maintain inventory +- Investigate transfusion reactions + +### 3.3 Nursing Staff +- Verify patient identity and blood product +- Administer transfusion +- Monitor for reactions +- Document transfusion + +## 4. Definitions + +| Term | Definition | +|------|------------| +| Crossmatch | Compatibility test between donor RBCs and recipient serum | +| Type and Screen | ABO/Rh typing and antibody screen | +| Transfusion Reaction | Adverse response to blood transfusion | +| Emergency Release | Issue of uncrossmatched blood in emergencies | + +## 5. Procedure + +### 5.1 Pre-Transfusion + +1. **Physician Order Review** + - Verify order includes: + - Patient identification + - Blood product type + - Number of units + - Rate/duration + - Special requirements (irradiated, CMV-negative, etc.) + - Confirm indication appropriate + +2. **Type and Screen/Crossmatch** + - Collect sample per specimen requirements + - Label at bedside with two identifiers + - Complete blood bank request form + - Allow time for testing (45 min - 1 hour typical) + +3. **Informed Consent** + - Explain benefits and risks + - Discuss alternatives + - Answer patient questions + - Obtain written consent (FRM-BB-003) + - Document in medical record + +4. **Pre-Transfusion Assessment** + - Baseline vital signs: + - Temperature + - Pulse + - Respiratory rate + - Blood pressure + - Assess IV access (18-20 gauge preferred) + - Review history of previous reactions + +### 5.2 Blood Product Issue + +1. **Request Blood from Blood Bank** + - Verify order and patient identification + - Note any special requirements + - Confirm expected time of transfusion + +2. **Blood Bank Verification (Issue)** + - Match unit to patient (ABO, Rh, crossmatch) + - Check expiration date + - Inspect unit for abnormalities: + - Hemolysis + - Clots + - Discoloration + - Bag integrity + +3. **Transport** + - Transport promptly (within 30 minutes) + - Do not store in nursing unit refrigerators + - Return to blood bank if transfusion delayed >30 min + +### 5.3 Bedside Verification (CRITICAL) + +**Two qualified staff must verify at bedside:** + +| Item to Verify | Check | +|----------------|-------| +| Patient wristband name matches blood bag | ☐ | +| Patient wristband MRN matches blood bag | ☐ | +| Patient wristband DOB matches blood bag | ☐ | +| ABO/Rh on blood bag matches compatibility label | ☐ | +| Unit number on blood bag matches compatibility label | ☐ | +| Expiration date is valid | ☐ | +| Blood product type matches order | ☐ | +| Blood bag appears normal (no clots, hemolysis) | ☐ | +| Patient confirms identity (if possible) | ☐ | + +**DO NOT TRANSFUSE IF ANY DISCREPANCY EXISTS** + +### 5.4 Transfusion Administration + +1. **Blood Administration Set** + - Use blood administration set with 170-260 micron filter + - Prime set with normal saline only + - Never add medications to blood products + - Maximum hang time: 4 hours + +2. **Compatible IV Fluids** + | Compatible | NOT Compatible | + |------------|----------------| + | 0.9% Normal Saline | Lactated Ringer's | + | | Dextrose solutions | + | | Medications | + +3. **Infusion Rates** + | Product | Initial Rate (first 15 min) | Routine Rate | Maximum Time | + |---------|---------------------------|--------------|--------------| + | PRBCs | 2 mL/min (50 mL) | Per order/tolerance | 4 hours | + | FFP | 2 mL/min | 10 mL/min or per order | 4 hours | + | Platelets | 2 mL/min | Per tolerance | 4 hours | + | Cryoprecipitate | 2 mL/min | Per tolerance | 4 hours | + +4. **Monitoring Schedule** + | Time | Action | + |------|--------| + | Pre-transfusion | Baseline vital signs | + | 15 minutes | Vital signs + assessment | + | 30 minutes | Vital signs | + | Hourly | Vital signs | + | Post-transfusion | Final vital signs + assessment | + +### 5.5 Transfusion Reaction Management + +**Signs/Symptoms Requiring Immediate Action:** +- Fever (≥1°C rise) +- Chills/rigors +- Hypotension or hypertension +- Tachycardia +- Dyspnea/respiratory distress +- Chest or back pain +- Hives/urticaria/rash +- Nausea/vomiting +- Hemoglobinuria (dark urine) +- Anxiety/sense of doom + +**Immediate Response:** +1. STOP the transfusion immediately +2. Keep IV line open with normal saline +3. Notify physician immediately +4. Check vital signs +5. Verify patient/blood product identities +6. Notify blood bank +7. Complete FRM-BB-004 Transfusion Reaction Report +8. Return blood bag and tubing to blood bank +9. Collect post-reaction blood and urine samples + +**Reaction Workup** +| Sample | Purpose | +|--------|---------| +| EDTA tube (lavender) | DAT, visual hemolysis check | +| Clot tube (red/gold) | Repeat crossmatch, visual hemolysis | +| First voided urine | Hemoglobinuria | +| Blood cultures | If bacterial contamination suspected | + +### 5.6 Post-Transfusion + +1. **Documentation** + - Product type and unit number + - Start and end times + - Volume transfused + - Vital signs (all) + - Adverse reactions (or "none") + - Patient response + +2. **Disposition of Blood Bag** + - Per facility policy (typically to blood bank) + - Retain for minimum time specified + +## 6. Special Situations + +### 6.1 Emergency/Massive Transfusion +- O-negative PRBCs for females of childbearing potential +- O-positive PRBCs for others acceptable in emergencies +- Type-specific blood as soon as available +- Activate massive transfusion protocol if indicated + +### 6.2 Pediatric Transfusion +- Adjusted volumes (10-15 mL/kg) +- Smaller filter volumes +- Consider irradiated products + +## 7. Documentation + +- FRM-BB-003 Transfusion Consent Form +- FRM-BB-004 Transfusion Reaction Report +- Transfusion Record (in EMR or paper) +- Blood bank compatibility record + +## 8. References + +- AABB Standards for Blood Banks and Transfusion Services +- AABB Technical Manual +- FDA regulations 21 CFR 606 +- Circular of Information for Blood and Blood Components + +--- + +## Revision History + +| Rev | Date | Description | Author | +|-----|------|-------------|--------| +| 1.0 | [DATE] | Initial release | [AUTHOR] | 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] |