Simplifying Clinical Validation

clinical validation


There are many definitions for clinical validation (CV), but in healthcare, clinical validation is ensuring clinical evidence exists in the medical record for all documented diagnoses/conditions. CV differs from DRG validation in that DRG validation is from the coding and billing perspective and CV is from the clinical evidence perspective.  Clinical evidence is known by various terms, including, but not limited to, clinical indicators, clinical criteria, clinical support, clinical information, clinical rationale, clinical elements, supporting documentation, clinical clues, and medical necessity.

Clinical validation is not a new concept… there are multiple credible and official sources that have promoted the use of clinical evidence by both CDI and coding professionals in the last decade, including the query brief, ‘Managing an Effective Query Process’ published by AHIMA in 2008; MLN Matters SE1121, revised date 2012; the 2016 ACDIS/AHIMA query practice brief, Guidelines for Achieving a Compliant Query Practice; and also in several coding clinics, namely 1Q 2014 and 4Q 2016. It can be said that there are three general types of clinical validation, retrospective, second level, and concurrent, broken down by when the clinical validation is performed.


Retrospective Clinical Validation

Retrospective clinical validation is the process where the review is performed after coding and billing is completed and lies outside of the core CDI and coding role.  This type of clinical validation is used by Recovery Audit contractors and other third party auditors, as well as being utilized by the denials/compliance department when records are opened for a retrospective review after a denial notification.


Second Level Clinical Validation

Second level clinical validation typically involves post discharge/pre-bill records.  These records may originate from coding professional referrals, or from a concurrent second level CDI team that performs clinical validation at this stage in the process. Facilities may rely on their coding professionals to perform second level clinical validation, particularly if there is no CDI program or if the CDI program doesn’t have the bandwidth to perform concurrent CV on 100% of the records in addition to handling coding professional referrals. Not all facilities employ a second level clinical validation approach and when utilized, is usually limited to the most vulnerable diagnoses such as respiratory failure, sepsis, encephalopathy, and severe malnutrition, as well as other high profile diagnoses.


Concurrent Clinical Validation


As the name suggests, concurrent clinical validation is performed on pre-discharge records during the CDI process.  The main CDI role encompasses record review and gap identification, both of which involves recognition of the presence or absence of clinical evidence.  Clinical indicators noted during record review and utilized in gap identification are the same indicators used in concurrent clinical validation.

In fact, one must perform clinical validation before a gap can be determined.  If an individual can look at the signs, symptoms, results, and documentation, then identify a gap and appropriately apply the relevant clinical indicators to develop a query for a precise diagnosis, the opposite must be true – the individual must be able to note the documentation of a diagnosis or condition and isolate the relevant clinical indicators in the record, which describes clinical validation. Clinical validation is so tightly woven with the critical thinking process during record review and gap identification that an individual may not realize they are performing clinical validation because to identify a gap, the individual must first validate documentation in the medical record.

Consider the following:

–          How can a gap of the specificity of aspiration pneumonia be recognized without first clinically validating the documented diagnosis of pneumonia?

–          How can the need for the clarification of the type and/or acuity of CHF be recognized without first validating the documented diagnosis of CHF?


Clinical Evidence and Guidance Evidence


There are rules that govern the use of clinical validation in both the second level CV and concurrent CV processes.  The chief rules are found in the Uniform Hospital Discharge Data Set (UHDDS), which in addition to clear rules that govern the assignment of a principal diagnosis in the Official Guidelines for Coding and Reporting (OGCR) Section II. Selection of Principal Diagnosis, also provide minimal criteria that every secondary diagnosis must meet in order to have an assigned code in the OGCR Section III. Reporting Additional Diagnoses.  These rules also support the fact that not every diagnosis documented in the medical record must be assigned a code.

One question to consider – how can a CDI professional or coding professional assign a code for any secondary diagnosis if they don’t know the characteristic evaluation, treatment, procedures, nursing care or monitoring that typify the condition, or if that condition meets an extended length of hospital stay?  They must know the clinical evidence for that documented condition and by that very fact; they are performing clinical validation.

In addition to clinical evidence that supports and upholds the documentation of diagnoses and conditions, “guidance evidence” can be found in the official guidelines and coding clinics that back the use of clinical evidence to support code assignment during both second level and concurrent clinical validation.

The use of clinical evidence to support code assignment appears in the Official Guidelines for Coding and Reporting I.B.5 and I.B.6 which outlines the code assignment of signs and symptoms and the determination whether they are integral to a disease process or not.  To know this information, the individual assigning the codes must have knowledge of the clinical indicators of a condition to ascertain whether they are integral to that condition.  Coding clinics from 4Q 2015 and 3Q 2008 can be looked to for guidance as well, with both discussing that advice in coding clinic can be used as clinical clues to identify possible gaps in documentation and when applying guidelines.  Furthermore, a side benefit to successful concurrent and second level clinical validation processes is that clinical validation denials will decrease.  Denials can be fiscally detrimental to an organization, not only in the time and manpower necessary to fight the denials but that the reimbursement is unavailable until resolution.

By recognizing the value of critical thinking, clinical indicators, and guideline evidence in clinical validation, one can appreciate that clinical validation is inherent in the CDI and coding processes.  Every successful CDI professional and coding professional employs the act of clinical validation in their daily workflow as they continue to do the right thing for the patient.


Wishing you success!


Karen Newhouser, RN, BSN, CCM, CCDS, CCS, CDIP

Director of CDI Education


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