Sutter Health will pay $3.2 million after federal investigators said they uncovered hundreds of alleged failures to safeguard controlled substances at two Northern California facilities. The agreement covers the Sutter Medical Center pharmacy in midtown Sacramento and the Sutter Fairfield Surgery Center in Fairfield, following a probe that began after a December 19, 2020 death and audits that reached back several years. The settlement resolves civil claims tied to recordkeeping lapses, inventory problems and diversion controls, and it layers new oversight requirements onto the health system.
Feds Say Drug Rules Were Broken Hundreds of Times
According to the U.S. Attorney’s Office for the Eastern District of California, Drug Enforcement Administration investigators identified at least 628 alleged violations across the two sites, with 360 at the Sutter Medical Center pharmacy and 268 at the Fairfield surgery center. Prosecutors say the alleged failures included not reporting thefts or losses, incomplete biennial inventories, missing controlled-substance order records and weak diversion controls. The office said the settlement resolves the government’s civil allegations and noted that the DEA conducted the investigations.
What Investigators Documented
Federal records show the DEA’s review of the Sutter Medical Center pharmacy flagged hundreds of electronic order-linking and recordkeeping errors between late 2019 and early 2021. The Fairfield audit covered March 2016 through December 2019 and found widespread record inaccuracies and other compliance gaps. The executed settlement agreement lays out the specific violations and the time frames the agency examined and states, “The claims resolved by this settlement are allegations only, and there has been no determination of liability.” A Justice Department document details the audit findings at length.
Settlement Terms and New Oversight
Under the deal, the Sutter entities agreed to pay $3.2 million and accept non-monetary conditions that include enhanced monitoring, monthly reconciliation reporting to the DEA, employee screening for anyone with automated access to controlled drugs, and training on recordkeeping and diversion prevention. The agreement also requires prompt reporting of theft or significant loss and other procedural changes aimed at reducing diversion risks, according to a Justice Department filing. The settlement includes a three-year compliance window and a process for the government to raise alleged breaches of the terms…