Every homeowner knows that you have to periodically and thoroughly inspect a house to make sure the roof isn’t leaking, the heating/air conditioning filters are changed, the gutters are cleaned, and the house is generally in good repair and working order. A compliance program is no different.
A key element of an effective compliance program is a system of measures, checks and balances to ensure the compliance program itself is working. According to the OIG’s March 16, 2000 Compliance Guidance for Nursing Facilities, “how a nursing facility assesses its compliance program performance is integral to its success.” Each of the elements of a compliance program should be evaluated to assess the program’s overall effectiveness. According to the OIG the program should be assessed periodically, at least annually, to determine if all parts of the program are working.
The job of assessing the effectiveness of a facility’s compliance program should generally be handled, or at least managed, by the compliance officer and/or compliance committee. So, the compliance officer should have sufficient experience, or have access to individuals on the compliance committee with sufficient experience, to adequately assess the various functions of the facility, including billing, clinical care, and general operations. He or she also needs a sufficient commitment of financial and manpower resources, and the authority, to both implement and carry out the compliance program, and to assess periodically assess its success.
Here are some of the questions the OIG has suggested in its compliance guidance for nursing facilities as appropriate measures of a compliance program’s effectiveness. These are not meant to be exhaustive, but do offer one approach compliance officers and committees might use to evaluate their compliance program, and some of the key areas of inquiry which should be part of that evaluation:
- Has the facility developed and distributed written compliance policies, standards and practices that identify specific areas of vulnerability (i.e., risk areas)?
- Are the facility’s compliance policies and procedures comprehensive enough in light of the risk areas identified by the facility?
- Are those policies/procedures working, as judged by employees’ reactions to them?
- For example, do employees repeatedly violate compliance policies and expectations because the facility’s guidance to employees does not adequately address key risk areas, or is written in legalese or is otherwise not clear?
- Do employees flagrantly disobey compliance directives and employee standards/codes of conduct?
- Do employees observe senior management observing compliance instructions and standards?
- Do a compliance officer’s other duties within the company, if any, compromise his/her role as compliance officer or in other positions he or she occupies?
- Regarding compliance training for owners, Board members, senior management and employees in general:
- How frequently are employees trained?
- Are employees tested after training?
- Do training materials adequately summarize the key risk areas, standards of conduct and operational aspects of the compliance program so that employees know what is expected of them and those around them (including other employees and contractors) and how to respond when they witness or become aware of individuals who do not meet those expectations?
- Are compliance educators properly trained to present the information needed to understand all aspects of the compliance program?
- Does the facility maintain records of employee training, including the number of training hours annually?
- Regarding lines of communication between employees, the compliance officer and committee, and senior management:
- Do compliance policies inform employees regarding what they should be reporting, to whom and by what mechanism (i.e., oral reports to supervisors, hotline calls, written reports), and that these may be anonymous?
- Are employees confident they can report compliance issues without fear of retaliation from management?
- Are employees actually making compliance reports, do they relate to actual compliance issues, and are they reporting them through the channels set up under the compliance program for that purpose?
- Do employees seek clarification from the compliance officer or committee or their supervisors regarding compliance issues about which they have questions?
- Regarding guidance to employees on disciplinary actions that can result from compliance program violations (including both violations of the standards of conduct and appropriate participation in compliance efforts such as training, reporting suspected violations, and so forth):
- Does the compliance officer or committee periodically examine the number and types of disciplinary actions taken in response to compliance program violations?
- Are such sanctions applied evenly and consistently or selectively and haphazardly?
- Are sanctions applied regardless of an employee’s role or function in the organization and/or their perceived importance to the organization?
- Is there evidence that employees of all levels do not understand the importance of compliance and the potential sanctions for violations of compliance standards and expectations?
- Regarding ongoing auditing and monitoring of the compliance program:
- Do audits focus on all pertinent departments of the company or facility?
- Do audits cover compliance with all applicable laws as well as Federal and private payor requirements?
- Are results of past audits, pre-established baselines and/or prior survey and complaint investigation results evaluated?
Are the elements of the compliance program itself, in addition to compliance with the substantives laws the program addresses, also monitored and audited?
- Are auditing techniques valid and are audits conducted by objective reviewers?
- Regarding the task of responding to suspected or confirmed compliance violations and implementing corrective actions:
- Are reported or suspected compliance violations immediately and thoroughly investigated.
- If compliance violations are confirmed, does the company implement effective corrective actions to prevent recurrence?
- Is the corrective action taken sufficient in light of the specific violation(s) identified and confirmed?
- Do compliance officials properly differentiate between matters, such as simple overpayments, which are best handled through normal repayment channels, and violations of applicable law that constitute actual compliance violations?
- Where required by applicable State or Federal law, are actual violations of Federal or State health care program laws reported to the appropriate authorities?
- Does the facility or company create and maintain adequate documentation of its compliance program, the auditing and monitoring functions, and the results of investigations of suspected compliance violations, consistent with the advice of risk management and legal experts, where applicable?
In addition to the type of self-assessment described above which is conducted or coordinated by the Compliance Officer and/or Committee, each provider’s owners and/or Board of Directors should engage in self-assessment. The following suggested elements of that assessment, posed in the form of potential audit questions, are taken directly from recent publications by the OIG regarding the expected role of the Board of Directors in quality of care oversight. The same sort of inquiries could be utilized by the Board to examine company performance on a range of other issues, including financial, anti-kickback issues, false claims issues, and so forth. We have provided the quality of care example below as a sample tool and also because the OIG has focused significantly in recent years on the Board’s role in overseeing quality of care.
Board of Directors’ Oversight of Quality of Care Board Self-Evaluation
Commitment: The directors can evaluate and demonstrate their commitment, and their organization’s commitment, to providing quality resident care by responding to the following questions:
- Does the board receive regular reports on quality?
- Do the board members understand the reports they receive?
- Are board members receiving training on quality?
- Is quality part of strategic and capital planning?
- Are adequate resources devoted to staff training and retention?
Process: The directors can address identified risks and monitor quality improvement through key structural processes designed to track and measure quality, and should evaluate the effectiveness of the following:
- Regular reports to the board on quality data and issues;
- Frequent and focused board-level discussions of quality reports;
- Coordinated management response, with board oversight, to identified quality problems;
Investment in staff retention, training, and competency.
Outcomes: There are key outcome categories that have proven to be valuable and effective in assisting the board with meeting their oversight responsibilities. The following questions can help boards of directors use these key categories of outcome information to review the actual performance of the organization on identified quality of care standards.
- How does management measure whether the residents are having good quality outcomes and is this tracking being consistently reported to the board in a useful way?
- What does the trended facility survey data indicate regarding compliance with regulations, current year compared to previous year?
- What does the trended resident outcomes data in key quality measure areas suggest with regard to quality of care provided?
- What do satisfaction surveys submitted by families and patients conclude about their facility experiences?
- What does staff turnover rate data indicate regarding retention and the basis for improvement/lack of improvement in the ability to retain key facilities staff?