Keeping compliance and quality of care/patient safety in separate boxes puts health care organizations at risk of enforcement actions, according to a top official from the HHS Office of Inspector General (OIG). Oversight of quality and patient safety should be incorporated into compliance processes to help organizations “mitigate risk of patient harm,” as OIG explained in its new General Compliance Program Guidance (GCPG), and that includes the risk assessment.^[1]

“The risk assessment process of any company that does business with federal health care programs must integrate quality and patient safety,” said Felicia Heimer, deputy chief of OIG’s administrative and civil remedies branch. “Why? Because quality and patient safety are top compliance issues for hospitals and other providers and many providers are unaware of their compliance vulnerabilities related to quality and patient safety because they don’t subject their quality and safety processes to the same scrutiny they might devote to other compliance concerns like billing and coding or reviewing financial relationships.” A joint risk assessment should also consider findings from peer review.

The dangers of walls between compliance and quality/patient safety are not academic.

“In every case we handled where there was a quality concern or instance of patient harm, without fail those organizations maintained compliance and quality programs that are siloed,” Heimer said at HCCA’s Compliance Institute April 14.^[2]

She cited the 2022 false claims settlement with Providence Health & Services in Washington state.^[3] “This is a prime example of how an incident within one distinct part of an organization can quickly become a problem for the entire organization and an example of an organization that has a mature compliance assessment and management process as well a very mature compliance program,” she said. “Those two functions were so siloed that a situation arose in one of Providence’s medical centers where there was a neurosurgeon who was performing medically unnecessary surgeries on patients who didn’t need them. There were suboptimal outcomes for a number of patients, and here you had quality failures that collided with compliance failures to result in this very notable case.”