Create compliance manual before Feds show up
Create living’ manual that won’t gather dust
It’s your choice: Do you want to create your own compliance manual with the help of your agency’s board of directors, reserving the right to dictate its content, scope, and length? Or would you prefer having the guidance of the Federal government after investigators have stormed your agency, put your business in disarray, and possibly even demanded repayments and filed charges against your agency?
That may be your choice, says Lawrence M. Leahy, MHA, CHE, CHCE, compliance officer and director of program integrity for Ruth Constant and Associates in Victoria, TX.
You’d better choose now, because in your role as quality manager at your agency, you’ll be the one most likely putting together the compliance manual, says Donna J. Escallier, RN, BSN, director of CQI and education for Partners Home Care (formerly the Five Hospital Homebound Elderly Program) in Chicago.
"The QI department is the best place to get input because of [staff’s] knowledge of regulations, changing interpretations, and general quality issues," she says. "We take things up and we bring things down."
Leahy agrees. "They have to be actively involved in the process," he says. "If I was a QI coordinator and I was not actively involved in helping to create that plan and process, then I would question my organization’s commitment to compliance."
Though the actual compliance plan at Escallier’s agency was created by an outside health care attorney and then tailored to the agency, the plan itself charged Escallier, as the director of CQI, to create a compliance manual for the agency.
Manual kept accessible to staff
In it she compiled all the regulations the agency has to follow, such as the American Nurses Association (ANA) standards of clinical practice, the home health practice standards, the state’s nursing practice act, her agency’s code of ethics, and the ANA’s code of ethics. The manual is kept in her office, where it is accessible to all staff.
Leahy’s 52-page compliance manual, which he created in 18 months with the guidance of his agency’s board of directors and the president of the agency, also is accessible to staff in his office.
While Leahy considers the manual a living document that is subject to ongoing revisions and updates, he offers quality managers tips for creating their own compliance manuals:
• Locate the responsibility for compliance with the board of directors.
In chapter one, Leahy spells out the board’s compliance roles and responsibilities, specifying that he acts as compliance officer for the agency on the board’s behalf. This tells the board it has an active part in the compliance process, says Leahy. "We require that once a year they go to a seminar on fraud and abuse or compliance and the agency pays for it," he says.
The board also approved the plan in a resolution that is included in the manual prior to the table of contents.
• Document your process for documenting compliance.
The manual dictates how delegation of authority files, agency files (such as personnel files), and compliance program files (such as problem response files, internal investigation case files, and training files) should be kept.
"Training files document your program," Leahy says. "It shows: Here’s what we did last year; here are problems we found; here is how we corrected them. We keep [staff inservice] sign-in sheets, lesson plans, evaluations, and overheads."
He stresses that chapter two in his manual on documentation details the process for creating your agency’s "QI paper trail."
• Show your process for making sure those in positions of responsibility are capable of handling it.
Chapter three on delegation of authority details the agency’s process for due diligence in avoiding conflicts of interest and for pre-employment screening. This is an important chapter, with elements taken from The Federal Sentencing Guidelines, says Leahy. "They want you as an organization to have a process for ensuring that people in responsible positions are responsible. "We prohibit [offering] a financial benefit to someone else in exchange for a financial benefit to our organization."
• Create a separate chapter to deal with standards and procedures for reducing potential criminal activity.
The billing bugaboo; the homebound status hoopla; you’ve heard about problems with these already. Chapter four details the agency’s statements and processes regarding items such as patient confidentiality and agency financial confidentiality, financial reporting, and offering discounts. It also states the agency’s policies on discrimination, kickbacks, and gratuities. Leahy says he will be rewriting this chapter to include the process for verifying homebound status, doctor’s orders, and getting nurses’ notes on time.
• Don’t forget safety and health.
Chapter five states that the safety program is under Leahy, and lists the agency’s intention to comply with OSHA and the EPA, as well as its policy on complying with workers’ compensation laws. It also states that the agency requires employees to use protective equipment and to take protective measures.
• Formalize your training program.
"If it’s not in writing, it won’t get done," says Leahy. Chapter six provides for historical documentation to prove what his agency does to teach employees about compliance.
Escallier’s compliance manual charged her with staff compliance education. To meet this obligation, she compiled an inservice that she holds annually on the most important aspects of compliance, such as the major regulatory issues affecting billing for visits not made, determining homebound status, and the Medicare Conditions of Participation. For this she created a two-page summary sheet of compliance issues that staff must sign, saying they understand the information in it. (See summary sheet, inserted in this issue.) This sheet also goes in the new hire package. Escallier discusses compliance with each new hire and documents that training in their files.
She created a sign that hangs in the agency, stating the agency’s commitment to compliance. She also contributes to a quarterly human resources newsletter articles on topics such as preparing for JCAHO and state surveys, and regular compliance issues that arise from each department, such as finance and medical records.
Finally, she offers this advice to quality managers fulfilling their staff education obligations dictated by their compliance manual: Conduct several smaller inservices on compliance for each discipline when the plan is first implemented, to offer the opportunity for staff to ask specific, "what-if" questions regarding their department’s operations and their personal activities.
• Don’t forget about procedures for handling external investigations.
A nerve-wracking investigation by the FBI a few years ago taught Leahy not to wait for trouble, but to anticipate it and prepare staff to meet it head on. For 15 months between 1989 and 1991, the agency wrangled with federal authorities, but was exonerated of any wrongdoing. The employee who caused all the trouble in the first place pled guilty to embezzlement and was sentenced to 24 months in the federal penitentiary.
Chapter seven of Leahy’s manual describes the procedure for staff to follow when investigators arrive, such as notifying the agency’s director and verifying the investigator’s authenticity and credentials. It includes provisions for keeping a "log book" to document the investigation, including the items that should be listed in the log book, such as names, titles, business addresses, and office phone numbers of all investigators; investigators’ time of arrival and departure; photocopies of investigator’s credentials; and titles of all documents removed. It also lists employee rights during an investigation. (See sample, inserted in this issue.)
"The log book is important because it creates a historical record and is important to your legal representation," says Leahy. For example, staff would document that the investigators would not let staff call the corporate office, and would note all documents that were taken from the agency.
Six years later, the FBI still has not returned certain personnel records that cannot be replaced, but the agency has documented what was taken, Leahy says.
It also lists government agencies that could investigate an agency and what they would look for.
• Don’t be scared to improve on The Federal Sentencing Guidelines.
The guidelines don’t require that you have a chapter on how to conduct internal investigations when a problem is reported, but Leahy recommends that you have one in your manual. The sentencing guidelines should be used a framework for your plan and manual, but he stresses the need to provide a historical document so someone could more easily step into your role as compliance officer. Chapter eight in Leahy’s manual does this, complete with copies of documents used during investigations, such as the internal investigation checklist, the compliance office intake form (see samples, inserted in this issue), the survey letter, and the client questionnaire. (See Homecare Quality Management, February 1998, pp. 22-23.)
• Specify your role.
In chapter nine, Leahy spells out his role as compliance officer, and makes it clear he is not a substitute for the agency’s normal grievance process.
• Require review.
Chapter 10 briefly states that the agency’s compliance program will be reviewed annually in light of findings of any external investigations that occurred, findings of internal investigations, and the agency and employee codes of ethics.
While Leahy recommends that you have your compliance program and manual reviewed by an attorney, his wasn’t. However, after the FBI investigation, he says his agency’s manual has the FBI’s "stamp of approval."
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