IndustriesHealthcare providers
Patient safety event reporting software that closes the loop
A care organization needs every safety event reported, every root cause found in time, and a fix that's proven to hold. QMSdesk™ is patient safety event reporting software that takes each event from report to root cause analysis to CAPA, on deadlines your team can see.
Usual profiles for this work
Regulations they carry
ISO 9001; ISO 31000:2018; 21 CFR Part 11; ALCOA+ data-integrity principles; HIPAA (45 CFR Parts 160/164); The Joint Commission standards; EN 15224
- Retention floor
- 10 years
- Event workflows
- 11, including Adverse drug event and Near miss
- Key deadline
- Patient safety events: containment within 5 calendar days and investigation within 45 calendar days, each with a CAPA
A typical starting set. You choose your own profiles, and can add more at any time.
What changes for your organization
01
Anyone on shift can report
Every user can report an event. Control applies from triage onward, so the report is on record the moment it's made.
02
Root causes found on time
Containment is due in 5 days and the root cause analysis in 45. Reminders reach the owner early, then widen to the coordinator and the Quality Manager.
03
A fix you can prove
Every patient safety event ends in a CAPA, and every CAPA ends in an effectiveness check.
What the rules ask of you, and how QMSdesk supports it
Healthcare quality standards ask one thing above all: every safety event is reported, its root cause is found in time, and the fix is shown to hold. QMSdesk takes each event from report to root cause analysis to CAPA, on deadlines your team can see.
| Regulation | What it asks of you | How QMSdesk supports it |
|---|---|---|
| The Joint Commission | Accreditation standards, including how sentinel events are handled. | Root cause analysis due in 45 calendar days, within The Joint Commission's 45-business-day timeframe, and a CAPA raised every time. |
| EN 15224 | Quality management for healthcare services. | Carried by the Healthcare profile, with events, CAPAs, documents and training in one system. |
| 21 CFR Part 11 | Electronic records and signatures you can trust as much as paper. | Electronic signatures on a hash-chained audit trail. |
The Healthcare profile also adds a HIPAA privacy breach event type, which records each breach with its reporting deadline, and a Privacy Compliance Officer role. It helps your privacy team record breaches; meeting HIPAA (45 CFR Parts 160 and 164) stays with your organization.
Every customer also holds BASE, the quality baseline, which carries 21 CFR Part 11, ALCOA+, ISO 9001 and ISO 31000. The Healthcare profile sets up the workflows these standards call for. It configures your system; it doesn't certify it.
Patient safety event reporting software, step by step
A hospital or health system holds BASE and Healthcare. The Healthcare profile adds a patient safety event workflow of its own:
Step 1 of 4
Report
What happened, when, who reported it and how severe it was.
Step 2 of 4
Immediate response
Within 5 days: the action taken and the evidence of containment.
Step 3 of 4
Root cause analysis
Within 45 days: the root cause, its category and the investigation. The deadline follows The Joint Commission's 45-day timeframe for a sentinel event RCA.
Step 4 of 4
Signed stepClose
When the root cause analysis is complete, QMSdesk raises a linked CAPA. Every time, with no decision needed. The corrective and preventive work then runs on the CAPA, with its own action plan, verification and effectiveness check.
A missed deadline escalates the event but never blocks it, and a late step records the reason for the delay.
Healthcare quality management software for every event type
The Healthcare profile adds three more event types, each on the incident workflow:
- HIPAA privacy breach, with its reporting deadline recorded when it's reported;
- adverse drug event;
- near miss.
For each one, major and critical events require containment, and the CAPA decision is signed at closure.
Roles: Patient Safety Officer, Clinical Director, Infection Control Officer, Risk Management Director and a Privacy Compliance Officer role, alongside the nine standard roles every organization gets. Retention floor in QMSdesk: 10 years, applied to every record in your organization's QMSdesk.
Running a pharmacy too? Add the 503A profile for medication-dispensing nonconformances and a Chief Pharmacist role. See compounding pharmacy.
The modules that matter most
Quality events
Each event type runs on its own locked path. Records raised in error are cancelled with a signed reason and never deleted.
CAPA
The approved action plan raises the change control and training the fix needs. A failed effectiveness check raises a new linked CAPA, and the signed one stays as it was.
Risk management
A critical risk raises its CAPA automatically, once, and a maximum-severity risk never scores below High.
Training and competency
Approving a policy or procedure assigns its training automatically, and overdue training for a GxP-critical (critical to quality) role opens a risk.
Document control
Policies and procedures are signed at authoring, review and approval by three different people.
Reporting and analytics
Events are trended by type, severity, site and root cause. Every Command Center figure opens the records behind it.
Every tier includes every module: document control, quality events, CAPA, change control, training, risk, audits, supplier quality, management review and reporting. See the whole platform
Questions buyers ask
Is a CAPA raised for every patient safety event?
Yes. When the root cause analysis is complete, a linked CAPA is raised automatically. It's the one event workflow where no CAPA decision is needed, because a patient safety event always warrants corrective and preventive action.
Who can report a patient safety event?
Any user. Reporting is open to every role, and control applies from triage onward. QMSdesk is priced by organization tier, never per seat, so everyone who delivers care can have an account.
What happens if the 45-day deadline is missed?
The event escalates through a reminder ladder, and it's never blocked. A late step records the reason for the delay, so the record shows what happened.
Can we track adverse drug events and near misses?
Yes. Both are Healthcare event types, alongside HIPAA privacy breaches. Each runs on the incident workflow, with its CAPA decision signed at closure.
How is QMSdesk priced?
By organization tier, never per seat, and every tier includes every module. See pricing.