Document Control
INDN uses this database as the document control system
What is QPulse?
The frequency that death reports are sent to INDN for review
What is a monthly basis?
A condition that appears undesirable but cannot be cited as a non-conformance
What is an observation?
The PI team would host this type of event to quickly identify and solve issues. It involves key process participants focusing on solving a narrowly scoped process improvement opportunity
What is an RIE (rapid improvement event)?
A Q-Pulse workflow used to report some type of deviation
What is a variance?
INDN follows these processes to ensure that documents are consistent, accurate, updated, readily available to staff, and reviewed or modified as needed
What are document control processes?
Death list reviews are a requirement of this regulating body
What is CMS (centers for medicaid services)?
This is the first step of the auditing process
What is alerting appropriate leadership?
This committee typically meets once a quarter. It consists of CEO, COO, directors, managers, and team member representation from all departments
What is the QAPI Committee?
This severity level is typically assigned when a sentinel event has occurred
What is level 4?
A high-level document that explains regulations or expectations that must be followed
What is a policy?
This occurs when a hospital experiences a patient death but did not refer the patient to INDN
What is a death not reported?
The primary contact for inspection personnel and the leader of inspections for external/third party audits
Who is the Manager, Regulatory Compliance
Where team members can find all scheduled, open PI events
Used for both real and perceived issues when an external party identifies a deviation or expresses dissatisfaction with INDN or a partner
What is a customer complaint?
Controlled documents will be reviewed and revised at this frequency
What is annually or as needed?
This is how you would rectify an incorrect or incomplete CTOD on a patient's referral worksheet
What is adding a task for the CSC who took the CTOD call?
At minimum, each internal operating system will be audited at this frequency
This tool is used to determine how a change will affect other departments or processes
What is an Impact Assessment?
Team members may submit this when additions, deletions, or updates need to be made to a controlled document
What is a change request?
This is created in iTransplant when a patient was not referred by a facility
What is a DRR (death record referral)?
The internal auditor or designee shall maintain all internal audit records for this timeperiod
What is ten years?
As defined by AATB, this is “an undesirable effect or untoward complication in a recipient consequent to or reasonable related to cells and/or tissue transplantation.”
What is an adverse event?