Quality Improvement Organization Manual (Pub. 100-10), Ch. 5 § 5125.2.5
Quality Improvement Initiative Root Cause Analysis
5125.2.5 – Quality Improvement Initiative Root Cause Analysis
(Rev. 28, Issued: 10-21-16, Effective: 10-21-16, Implementation: 10-21-16)
When a quality of care concern is confirmed and a referral initiated for a QII, the QIN-QIO
should consult with the practitioner(s) and/or provider(s) to determine the root cause. This
includes requesting that the practitioner(s) and/or provider(s) allow the QIO to review any root-
cause analysis independently completed.
To conduct an adequate root cause analysis, the QIO must clearly identify the following:
• The specific quality of care concern(s) at issue;
• The type of provider (facility) or practitioner (individual) specialty involved;
• How the concern(s) has affected the patient or patient care in general;
• The impact of the concern(s) on health care operations;
• Whether any injuries or harm resulted from the concern;
• The prevalence of the concern;
• Whether the concern was linked to CMS-identified or other nationally identified health
care initiatives;
• Any health care disparity issues associated with the concern(s);
• Whether the Quality Innovation Network-QIO and/or the Beneficiary and Family
Centered Care-QIO has any data or information giving evidence of other instances of the
same concern(s) within the same or a different provider setting(s) and with the same or a
different practitioner(s);
• Whether the practitioner(s) and/or provider(s) are willing to cooperate in the Quality
Improvement Initiative (NOTE: The failure to cooperate is not justification for initiating
sanction proceedings.); and
• Current baseline data relevant to the concern(s).
When the baseline needs to be established as part of conducting an adequate root-cause
analysis, the Quality Innovation Network-QIO must employ evidence-based techniques to obtain
a clear snapshot of the current environment. To determine the baseline, the Quality Innovation
Network- QIO must request data from the practitioner and/or provider that demonstrates other
occurrences of the same or related concerns (or opportunities for the same and/or similar
occurrences), including the timeframe during which the other instances occurred. Data before
and after the time period when the actual concern arose should be considered. In most instances,
QIOs should not request data for periods more than three (3) years before the time period when
the actual concern arose.
Both quantitative data and anecdotal information may be considered; however, emphasis should
be placed on obtaining quantitative data. The Quality Innovation Network-QIO should review its
own data or collaborate with the Beneficiary Family Centered Care-NCC to identify prior
occurrences of the same or similar concerns with the same practitioner and/or provider or other
practitioners and/or providers. Baseline data will be used to measure improvement(s) resulting
from specific intervention(s) implemented with the Intervention and Improvement Plan.
In conducting its analysis, a QIO should also consider any relevant information related to best
practices developed or identified by the QIO or other QIOs.