$397.00
LabCendence™ Recovery Home & Sober Living CLIA-Waived Testing Documentation Kit
**Professional Laboratory Testing Documentation & Operational Management System**
**DIGITAL DOWNLOAD | EDITABLE WORD & EXCEL FILES | $397**
Establish, organize, and manage a CLIA-waived testing documentation program for recovery homes, sober living residences, and related substance-use recovery facilities.
The LabCendence™ Recovery Home & Sober Living CLIA-Waived Testing Documentation Kit provides an integrated collection of editable standard operating procedures, operational forms, startup guidance, and an advanced Excel management dashboard.
Designed for recovery facility owners, administrators, program directors, compliance personnel, and professionals responsible for point-of-care drug screening operations.
WHAT'S INCLUDED
1. CLIA-Waived Testing Implementation Guide
A practical, step-by-step guide covering:
- Determining whether the proposed testing requires CLIA certification
- Understanding federal and state requirements
- Selecting appropriate FDA CLIA-waived test systems
- Preparing the CMS-116 application
- Establishing testing responsibilities
- Organizing testing areas and specimen collection processes
- Implementing manufacturer-specific quality control procedures
- Training personnel and documenting competency
- Preparing for operational readiness
- Establishing ongoing quality oversight
2. Twelve Editable Standard Operating Procedures
Includes SOP templates addressing:
1. Testing Program Administration
2. Personnel Roles, Training & Authorization
3. Resident Identification & Specimen Collection
4. Waived Urine Drug Screening Workflow
5. Test Kit Inventory, Storage & Expiration
6. Quality Control & Test System Checks
7. Results Documentation & Communication
8. Presumptive Results & Reference Laboratory Referrals
9. Invalid Results, Errors & Corrective Action
10. Confidentiality, Access & Record Security
11. Testing Area Safety & Infection Prevention
12. Program Management Review
Each SOP requires facility-specific customization and approval before implementation.
3. Thirty Editable Operational Forms
A comprehensive collection of forms covering:
- Facility readiness assessments
- CLIA applicability determination
- CMS-116 application preparation
- State licensing and permit verification
- Laboratory director designation
- Approved testing menus
- Staff authorization and training
- Competency observations
- Specimen identification and collection
- Drug screening documentation
- Quality control records
- Inventory and expiration tracking
- Temperature excursions
- Equipment maintenance
- Testing incidents and corrective actions
- Confidentiality reviews
- Monthly quality monitoring
- Management reviews
- Certificate renewal tracking
- Internal readiness assessments
4. Advanced 16-Tab Excel Management Dashboard
An editable operational management workbook featuring:
- Executive Dashboard
- Setup and Instructions
- Resident Drug Screening Log
- Chain of Custody Referrals
- Rapid Test Cup Quality Control
- Test Kit Inventory
- Temperature and Storage Monitoring
- Staff Training and Authorization
- Staff Competency
- OSHA and Biohazard Inspection
- Result Exceptions
- Incident and CAPA Management
- CLIA Licensing
- Monthly Quality Review
- Management Action Tracker
- Reference Lists and Configuration
**Excel features include:**
- Automated operational calculations
- Quality-control event tracking
- Inventory monitoring
- Temperature excursion identification
- Staff training status monitoring
- CAPA and management-action tracking
- Monthly activity summaries
- Three Excel charts
- Dropdown selections and structured data-entry fields
The workbook is intended for coded operational information and is not an electronic health record.
5. Customer Documentation
Includes:
- Read Me First
- Table of Contents and Complete File Inventory
WHO IS THIS KIT FOR?
- Recovery Home Owners
- Sober Living Facility Operators
- Substance-Use Recovery Programs
- Behavioral Health Program Administrators
- Recovery Residence Managers
- Laboratory Compliance Consultants
- Point-of-Care Testing Coordinators
- Healthcare Quality and Compliance Professionals
DIGITAL DOWNLOAD DETAILS
You will receive one ZIP package containing seven files:
- 6 editable Microsoft Word documents
- 1 Microsoft Excel workbook
**Physical products will not be shipped.**
IMPORTANT REGULATORY INFORMATION
CLIA requirements depend on the purpose and use of testing results. Recovery homes and sober living residences are not automatically exempt from CLIA requirements.
Facilities must determine the applicable certification pathway, confirm state and local requirements, and obtain any necessary authorizations before beginning CLIA-covered testing.
All SOPs and forms require customization to the facility, approved test systems, current manufacturer instructions, and applicable requirements.
Presumptive drug screening results must not be represented as definitive confirmation.
This product is an educational and operational documentation resource. Purchasing it does not provide CLIA certification, government approval, professional licensure, legal advice, or a guarantee of regulatory compliance.
SOFTWARE REQUIREMENTS
Microsoft Word and Microsoft Excel or compatible software capable of opening DOCX and XLSX files.
Users should verify workbook functionality in their intended software before operational implementation.
LICENSE
Single-facility use.
The purchaser may edit and customize the documents for internal use at one facility.
Resale, redistribution, sublicensing, and public sharing of the original templates are prohibited.
**LabCendence™ Regulatory Advisors**
Professional Laboratory Documentation, Quality Management & Regulatory Compliance Resources.
Your files will be available to download once payment is confirmed.
But please contact me if you have problems with your order
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