Continuous improvement in compliance can proceed systematically

Provider organizations should not dread continuous improvement in compliance and can apply several techniques to simple problems to bring about simple solutions. In a Health Care Compliance Association (HCCA) webinar entitled “Continuous Improvement in Compliance,” presenter Alan Wileman, Corporate Compliance Manager at Shriners Hospitals for Children, discussed applying principles from Lean and Six Sigma to improve function and eliminate waste in company functioning.

Improvement methodologies

Wileman noted that compliance goals evolve, and that the OIG uses subjective terms for compliance matters such as “reasonable,” “appropriate,” and “meaningful.” What is meaningful or reasonable for one compliance area may not be sufficient for another area or at a later date. Overall, lowering risk is the focus of many compliance tasks, but there may be better ways to bring about that desired result.

Improvement methodologies such as Lean, Six Sigma, and project management have been proven to streamline procedures, eliminate waste, and bring value. Lean ideas and practices originally derived from industrial manufacturing, and have one main purpose: eliminating waste. Six Sigma is often grouped with Lean concepts, and focuses on eliminating error waste by removing variation in procedures. According to Six Sigma, there may be multiple ways to do the same thing, but there is always a best way to do so that reduces variation. Project management focuses on clearly defined terms, roles, and goals in order to successfully complete a project—a non-routine operation with a definite beginning, end, and goal.

Waste

According to Wileman, there are several types of waste. Among those discussed included talent, inventory, waiting, defects, and motion. Compliance departments should ensure that a particular task is being completed by the employee whose strengths play to that area. Motion waste comes from requiring employees to move around the work area too much in unnecessary ways, when communication could effectively be conducted in a non-face-to-face manner or when a workplace could be reorganized to provide a better workflow.

Toolkit

Reorganization also applies to employees’ personal workspaces, which should be uncluttered and only contain the necessary, crucial supplies. Wileman suggests adding the “5S” strategy to an operation’s compliance toolkit. The five elements are: sort, set in order, shine, standardize, and sustain. These elements ensure that a workspace is stocked as necessary, arranged to promote efficiency, neat, organized consistently with other spaces, and sustained in this manner. For tasks, the “DMAIC” acronym is made up of the elements define, measure, analyze, improve, and control. Once a problem is clearly defined, it is easier to map out the process, identify the cause of the problem, implement the solution, and maintain the solution over time.

Wolters Kluwer Holiday

We will not be posting September 1 or September 4 due to Labor Day. The Wolters Kluwer Legal and Regulatory U.S. Health Law Editorial Team wishes you a safe and happy holiday. We will resume our regular posting schedule on Tuesday, September 5.

Compounding pharmacy enjoined from manufacturing until remedial measures are implemented

Isomeric Pharmacy Solutions LLC (Isomeric) and three executives are permanently enjoined from manufacturing and distributing drugs considered adulterated in violation of the federal Food, Drug and Cosmetic Act (FDC Act) (21 U.S.C. §301 et seq.). The injunction was entered in the Utah district court following a complaint entered by the Department of Justice (DOJ) after finding that Isomeric, a compounding pharmacy, was producing drugs under insanitary conditions.

Isomeric

Isomeric manufactures, labels, and distributes drugs, particularly injectable hormones and corticosteroids, as well as ophthalmic drops. Most of the drugs are directly distributed to physicians. The company initiated three recalls in 2016 involving three types of injectable drugs. In April 2017, Isomeric recalled all lots of non-expired drug products that should have been sterile and were compounded between October 4, 2016 and February 7, 2017.

Complaint

According to the complaint, the FDA found that Isomeric repeatedly found several types of microorganisms in the air and on surfaces that should have been sterile. Products that were manufactured in these areas were prepared in insanitary conditions. The FDA found that Isomeric deviated from current good manufacturing practice requirements, and failed to thoroughly review discrepancies or failures found in batches of drugs.

The injunction was entered through a consent decree as part of a settlement. Isomeric and its chief executive officer, chief sales officer, and chief operating officer will not resume manufacturing, holding, or distributing drugs until proper remedial measures have been taken.

Sessions creates opioid fraud detection unit, focuses on 12 districts

Twelve federal districts have been selected to participate in an Opioid Fraud and Abuse Detection Unit, created by the Department of Justice (DOJ). The DOJ will fund twelve Assistant United States Attorneys for three year terms to focus solely on investigating and prosecuting fraud related to prescription opioids. Attorney General Jeff Sessions announced the program’s formation at the Columbus Police Academy in Ohio.

Data analytics program

The unit will consist of a data analytics program, which will allow targeted investigation and prosecution. Sessions stated that the team would use such information as physicians who prescribe opioids at a higher rate than peers, the average age of patients receiving the prescriptions, and pharmacies dispensing large amounts of opioids to focus its investigation.

The federal prosecutors, located in districts across the country, will work with various agencies to investigate and prosecute opioid fraud, including pill mills and unlawful diversion of opioids. Most of the districts are located in the east and Midwest, such as Florida, Michigan, Alabama, Kentucky, Ohio, and West Virginia.