Draft Details
- Technology in home and community care settings...
- Draft Standard
- Legal Notice for Draft Standards
- Preface
- + 0 Introduction
- 0.1 Overview
- 0.2 Guiding principles
- 0.3 Typical home health workflow
- + 1 Scope
- 1.1 Purpose
- 1.2 Application
- 1.3 Limitations
- 1.4 Terminology
- 1.5 Units of measure
- 2 Reference publications
- 3 Definitions, abbreviations, and symbols
- + 4 Quality management (QMS)
- 4.1 General
- + 4.2 Organisational commitment
- 4.2.1 Client needs
- 4.2.2 Leadership responsibilities
- 4.2.3 Quality policy
- + 4.2.4 Responsibility, authority, and communicat...
- 4.2.4.1 Internal communication
- 4.2.4.2 Position descriptions
- 4.2.5 Resources
- + 4.3 Performance evaluation
- 4.3.1 Monitoring, measurement, analysis, and ev...
- 4.3.2 Key performance indicators (KPIs)
- + 4.4 Planning
- 4.4.1 Risk management committee
- 4.4.2 Risk and opportunity
- 4.4.3 Management and mitigation
- 4.4.4 Policies
- 4.4.5 Quality objectives
- 4.4.6 Change management
- 4.4.7 Communication plan
- + 4.5 Documentation and records
- 4.5.1 Records
- + 4.5.2 Document control
- 4.5.2.1 General
- 4.5.2.2 Removal and replacement
- 4.5.3 Storage and retention
- + 4.6 Review and oversight
- 4.6.1 General
- + 4.6.2 Audits
- 4.6.2.1 Auditors
- 4.6.2.2 Follow-up
- 4.6.3 Input for leadership review
- 4.6.4 Report
- + 5 Procurement
- 5.1 General
- + 5.2 Technology criteria
- 5.2.1 Adaptability
- 5.2.2 Accessibility
- 5.2.3 Efficacy and effectiveness
- 5.2.4 Availability
- 5.2.5 Cost
- 5.2.6 Disposal and recycling
- 5.2.7 Emergency and backup
- 5.2.8 Support, training and maintenance
- + 5.3 Best practices
- 5.3.1 General
- 5.3.2 Documentation
- 5.3.3 Information management
- 5.3.4 Determining factors
- 5.3.5 Soliciting information in advance of proc...
- + 5.4 Procurement approaches
- 5.4.1 Direct award
- 5.4.2 Notice of intent
- + 5.4.3 Invitational Bid
- 5.4.3.1 Open bids
- 5.4.3.2 Existing contracts
- 5.4.3.3 Unsolicited proposals
- + 5.5 Process
- 5.5.1 General
- 5.5.2 Planning
- + 5.5.3 Preparation for procurement
- 5.5.3.1 Consultation
- 5.5.3.2 Evaluation methods
- 5.5.3.3 Evaluation tools
- 5.5.3.4 Scoring and weighting
- 5.5.3.5 Instruction for participants
- 5.5.3.6 Non-disclosure agreements
- 5.5.3.7 Conflict of Interest
- 5.5.4 Proposal Solicitation
- + 5.5.5 Communications with vendors
- 5.5.5.1 Publishing the Request for proposals
- 5.5.5.2 Limiting communication
- 5.5.5.3 Responding to questions
- 5.5.5.4 Proposal closing date and time
- + 5.6 Vendor Proposal evaluation
- 5.6.1 General
- 5.6.2 Evaluating ability to meet mandatory requ...
- 5.6.3 Technical or functional evaluation
- 5.6.4 Sharing of financial information
- + 5.7 Award
- 5.7.1 Offer of contract
- + 5.7.2 Vendor contract
- 5.7.2.1 General terms
- 5.7.2.2 Specific terms
- 5.7.2.3 Information sharing
- + 5.8 Vendor Feedback
- 5.8.1 Complaints
- 5.8.2 Debrief Policy
- 5.8.3 Feedback development
- 5.9 Process evaluation
- + 6 Workforce
- 6.1 General
- + 6.2 HCC direct and indirect provider
- 6.2.1 Policies and procedures
- + 6.2.2 Education and training
- 6.2.2.1 General
- 6.2.2.2 Core competencies
- 6.2.2.3 Training
- 6.2.3 Safety and quality assurance processes
- + 7 HCC technology
- + 7.1 Assessment
- + 7.1.1 Client needs, abilities, and resources
- 7.1.1.1 Reassessment and adjustment
- 7.1.1.2 Documentation
- + 7.1.2 Home and community care environment
- 7.1.2.1 General
- 7.1.2.2 Conduct in client’s living environment
- + 7.1.2.3 Environment assessment
- 7.1.2.3.1 General
- 7.1.2.3.2 Physical space
- 7.1.2.3.3 Building systems and services
- 7.1.2.3.4 Hazards
- 7.1.2.3.5 Waste
- 7.1.2.3.6 Supply storage area
- + 7.1.3 Selection
- 7.1.3.1 General
- 7.1.3.2 Ethical considerations
- 7.1.3.3 Client and care partner consultation
- + 7.1.4 Client and care partner training
- 7.1.4.1 General
- 7.1.4.2 Client training support
- + 7.2 Implementation
- 7.2.1 General
- 7.2.2 Pre-installation assessment
- 7.2.3 Compliance and safety check
- 7.2.4 Physical installation
- 7.2.5 Site testing and calibration
- 7.2.6 Configuration and customization
- + 7.2.7 Client and care partner training
- 7.2.7.1 General
- 7.2.7.2 Training program
- + 7.2.8 Emergency planning and protocols
- 7.2.8.1 Planning
- 7.2.8.2 Protocols
- 7.2.9 Documentation and support information
- 7.2.10 Follow-up and feedback
- + 7.3 Maintenance
- 7.3.1 Scheduled maintenance
- 7.3.2 Preventative maintenance
- + 7.3.3 Inspections
- 7.3.3.1 Frequency and scheduling
- 7.3.3.2 Checklist
- 7.3.3.3 Documentation and reporting
- + 7.3.3.4 Corrective actions
- 7.3.3.4.1 Actions
- 7.3.3.4.2 Documentation
- 7.3.3.4.3 Training and competency
- 7.3.3.4.4 Site inspections
- 7.3.3.5 Emergency preparedness
- + 7.3.4 Repair
- 7.3.4.1 General
- + 7.3.4.2 Repair protocols
- 7.3.4.2.1 Helpline
- 7.3.4.2.2 Categorization
- 7.3.4.2.3 Contractors
- 7.3.4.2.4 Tracking
- + 7.3.4.3 Service contracts and warranties
- 7.3.4.3.1 General
- 7.3.4.3.2 Documentation
- + 7.3.4.4 Troubleshooting guide
- 7.3.4.4.1 General
- 7.3.4.4.2 Support for client and care partners
- 7.3.4.4.3 Training
- 7.3.4.5 Feedback and continuous improvement
- 7.3.4.6 Quality improvement for repairs
- + 7.3.5 Return and replacement
- 7.3.5.1 Replacement policy
- + 7.3.5.2 Replacement process
- 7.3.5.2.1 General
- 7.3.5.2.2 Electronic replacement management
- 7.3.5.2.3 Replacement coordinators
- + 7.3.5.3 Inventory management for replacements
- 7.3.5.3.1 General
- 7.3.5.3.2 Predictive analytics
- 7.3.5.3.3 Supplier relationships
- 7.3.5.4 Client communication
- + 7.3.6 Recalls
- 7.3.6.1 Circulation of recall information
- 7.3.6.2 Recall report
- + 7.3.7 Reprocessing
- 7.3.7.1 General
- 7.3.7.2 Ensuring ability to perform reprocessin...
- 7.3.7.3 Reposable (limited use) HCC technology
- + 7.4 Digital health technology
- 7.4.1 General
- 7.4.2 Health information specialists
- + 7.4.3 Installation and configuration of central...
- 7.4.3.1 General
- 7.4.3.2 Privacy impact assessment
- 7.4.3.3 Security threat risk assessment
- 7.4.4 Locally deployed systems
- 7.4.5 Cloud based software
- 7.4.6 Integration with existing HCC technology
- + 7.4.7 Health information standards
- 7.4.7.1 Interoperability
- 7.4.7.2 Electronic health record
- 7.4.7.3 Data security and privacy
- 7.4.7.4 Telehealth and remote monitoring
- 7.4.7.5 Wearable and mobile app
- 7.4.7.6 Home health monitoring systems
- 7.4.7.7 Training
- 7.4.7.8 Feedback mechanisms
- + 7.5 Management
- 7.5.1 General
- + 7.5.2 Resource management (supplies, refills, a...
- + 7.5.2.1 Inventory management system
- 7.5.2.1.1 General
- 7.5.2.1.2 Components
- 7.5.2.1.3 Stock level tracking
- + 7.5.2.2 Storage and handling
- 7.5.2.2.1 General
- 7.5.2.2.2 Environmental requirements
- 7.5.2.2.3 Labeling and categorization
- 7.5.2.2.4 Training
- + 7.5.2.3 Stock rotation
- 7.5.2.3.1 General
- 7.5.2.3.2 Auditing
- 7.5.2.3.3 Barcode or RFID systems
- 7.5.2.3.4 Refill processes
- + 7.5.2.4 Automated reordering
- 7.5.2.4.1 General
- 7.5.2.4.2 Stock level maintenance
- 7.5.2.4.3 Validation and adjustment
- + 7.5.2.5 Emergency stock
- 7.5.2.5.1 General
- 7.5.2.5.2 Requirements review
- 7.5.2.5.3 Audits
- + 7.5.2.6 Spare parts management
- 7.5.2.6.1 General
- 7.5.2.6.2 High-turnover parts
- 7.5.2.6.3 Supplier management
- 7.5.2.6.4 Usage management
- + 7.5.2.7 Forecasting and demand planning
- 7.5.2.7.1 Data analytics
- 7.5.2.7.2 Advanced forecasting
- + 7.5.2.8 Sustainability practices
- 7.5.2.8.1 General
- 7.5.2.8.2 Supplier selection
- 7.5.2.8.3 Supplier sustainability
- 7.5.2.8.4 Staff training
- 7.5.2.9 Documentation and compliance
- 7.5.3 Change management
- + 7.5.4 Waste management
- 7.5.4.1 General
- 7.5.4.2 Personal information management
- + 7.5.5 Risk management
- 7.5.5.1 General
- + 7.5.5.2 Risk assessment
- 7.5.5.2.1 Comprehensive risk identification
- 7.5.5.2.2 Risk identification team
- 7.5.5.2.3 Risk evaluation
- 7.5.5.2.4 Documentation
- 7.5.5.2.5 Software
- + 7.5.5.3 Risk mitigation strategies
- 7.5.5.3.1 Device maintenance
- 7.5.5.3.2 Predictive analytics
- 7.5.5.4 Redundancy and backup systems
- 7.5.5.5 Fail-safe mechanisms and alarms
- + 7.5.6 Emergency management
- 7.5.6.1 Emergency management plan
- 7.5.6.2 Training
- + 7.5.6.3 Adverse events response
- 7.5.6.3.1 Incident and adverse event management...
- 7.5.6.3.2 Reporting system
- 7.5.6.3.3 Incident response team
- 7.5.7 Addressing safety of returned products
- 7.5.8 Site inspections for safety and risk
- 7.5.9 Completion of scheduled maintenance
- 7.5.10 Preventive maintenance processes
- 7.5.11 Quality assurance considerations
- + 8 Infection prevention and control (IPAC)
- 8.1 General
- 8.2 IPAC best practices
- 8.3 Roles and responsibilities
- 8.4 Terminology
- 8.5 Human factors
- 8.6 Client care setting
- 8.7 Community care settings
- 8.8 Documentation
- 8.9 Adverse event reporting
- + 8.10 Medical device reprocessing
- 8.10.1 General
- + 8.10.2 Manufacturers instructions for use (MIFU...
- 8.10.2.1 General
- 8.10.2.2 New technologies
- 8.10.2.3 Review of the MIFUs
- 8.10.2.4 Medical device verification for reproc...
- 8.10.2.5 MIFUs validation
- 8.10.2.6 MIFU clarity
- 8.10.2.7 Ensuring ability to perform reprocessi...
- 8.10.2.8 Reposable (limited use) medical device...
- 8.10.2.9 Sterilization containers
- 8.11 Disposable or single-use medical HCC techn...
- 8.12 Sharps
- + 8.13 Personal protective equipment
- 8.13.1 General
- 8.13.2 Labelling
- 8.13.3 Medical devices
- + Annex A – (Informative) HCC technology example...
- A.1 General
- A.2 Telehealth and remote monitoring:
- A.3 Health and vital sign monitoring:
- A.4 Safety devices:
- A.5 Assistive devices:
- A.6 Transfer aids:
- A.7 Chronic condition management:
- A.8 Orthopedic supports:
- A.9 Wound care and treatment:
- A.10 Cognitive health care:
- A.11 Nutrition and diet management:
- A.12 Home-based rehabilitation:
1.1 Purpose
This Standard is intended to support the use of technology in the provision of home and community care, and in making investments that will improve the quality of care while prioritizing the safety, security, and privacy of both clients and care providers and their personal health information.
1.2 Application
The standard provides requirements and recommendations for technology to support the continuum of care of clients being supported in the home and community care settings. This includes, but is not limited to mechanisms for evaluation, selection, procurement, infrastructure requirements, set-up, implementation, information management, data management, data entry, transfer, storage, emergency planning, communication and maintenance.
This standard is intended for all those who are directly or indirectly associated with the support and use of technology in home and community care environments. This includes governments, institutions (both public and private), service providers, other partners (e.g., designers, manufacturers, suppliers), clients and their care partners assisting in home and community care.
1.3 Limitations
This Standard does not address requirements for
a) HCC technology purchased privately;
Note: HCC technology purchased privately as part of a contract with an HCC organization will be subject to the requirements of the standard.
b) the management of medications, medication devices and systems, and medication reconciliation (see CAN/HSO 34014:2019);
c) home hemodialysis or peritoneal dialysis (see CSA Z364.5 and CSA Z364.6).
Note: This standard is complementary to CSA Z364.5 and Z364.6.
d) direct client care; and
Note: Direct client care includes professional practice guidance (e.g. wound care by nurse) and clinical care.
e) The standard will apply in general to the HCC technology which incorporate AI however does not specifically look at the unique considerations likely required for technology of this nature.
Note: This is considering the urgency of how AI is shaping health care.
1.4 Terminology
In this Standard, “shall” is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; “should” is used to express a recommendation or that which is advised but not required; and “may” is used to express an option or that which is permissible within the limits of the Standard.
Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material.
Notes to tables and figures are considered part of the table or figure and may be written as requirements.
Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.
1.5 Units of measure
The values given in SI units are the units of record for the purposes of this Standard. The values given in parentheses are for information and comparison only.
You may comment on any section of this document by clicking the “Submit Comment” link at the bottom of the relevant section.