As a Quality Manager this could be dialogue you have with your staff.

Examples of corporate compliance and JCAHO compliance merging. A lab manager and a Quality Manager get together to discuss how they can be efficient and effective in meeting all the regulations that they have.

I suggest that the lab manager sees you, the Quality Manager, as a resource as it relates to all types of regulations. Because, I believe that is what the improvement director’s job is, coordinate the improvement of anything that needs improvement in the organization. Right now, the Feds are directing us to be very conscious of our processes related to how we manage the patient-beneficiary’s resources. That is an outcome also. So here we are moving around the compliance loop again! Clinical outcomes, management outcomes it all dovetails.

There should be a Departmental version of the compliance plan. This should include all the policies that need to be in place. You will see that the compliance plan at the lab level, cascades into the organizational/facility’s compliance plan - after the policies are set up monitoring and evaluation of their operations are required.

So, if your facility are not monitoring the Corporate Compliance Plan as the "Project of the Year", you might think about having managers share one reporting session on "How the CCP in influencing what our dept does." The resources being spent by all the departments that have to bring up compliance methodologies into being is staggering. Yet, the QM Department can help them with their P-D-C-A cycling, reporting formats and communication mechanisms for progress to be reported into the "system".

Improvement is improvement, it all takes resources. No group knows better than those who manage improvement how critical communication is in any improvement project. Everything is already in place to let the information flow about managing CCP process. We did this with Safety in the early ‘90’s. Safety is now the job of everyone, like quality, why not compliance to ethical behavior? Use the existing systems - let process communication flow. Administration will be happy to see a report of operational outcomes as "in compliance" as well as clinical topics.

In addition, there are lots of articles about compliance as a hospital project at www.snaconsulting.com - click on Newsroom. The articles can be downloaded. They are written from a Quality, Risk, Safety and Utilization management perspective. The dovetail with all JCAHO standards that are applicable.

I have put the introduction to the Lab Compliance Plan below - there is more

INTRODUCTION

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) and other Federal agencies charged with responsibility for enforcement of Federal law have emphasized the importance of voluntarily developed and implemented compliance plans. In recent years, the OIG has been asked to supply guidance as to the elements of a model compliance plan. The purpose of this issuance, therefore, is to respond to those requests by providing some guidance to health care providers that supply clinical laboratory testing services for Medicare and Medicaid beneficiaries. Like other compliance plan models that will be issued for other areas of the health care community, this guidance is based upon the OIG’s experience in fraud investigations of clinical laboratories, the Health Care Financing Administration’s (HCFA) regulations and guidelines, requirements imposed on clinical laboratories in corporate integrity agreements negotiated by the OIG, and input from the clinical laboratory industry.

The government, especially the OIG, has a zero tolerance policy towards fraud and abuse and will use its extensive statutory authorities to reduce fraud in Medicare and other federally funded health care programs. Compliance plans offer the health care provider an opportunity to participate in a nationwide effort to reduce fraud and abuse in our national health care programs. The OIG believes that through a partnership with the private sector, significant reductions in fraud and abuse can be accomplished. Compliance plans offer a vehicle to achieve that goal.

This information is being supplied to assist laboratory providers in crafting and refining their own compliance plans. Elements of these guidelines can be used by all laboratories, regardless of size, to establish a compliance program. We are not suggesting that all laboratories must implement all of the compliance elements discussed in this document, nor do we suggest that a laboratory that does not incorporate all of these elements will be at a disadvantage when under the scrutiny of the OIG or other governmental agency. Rather, these guidelines represent the government’s suggestions on how to correct and prevent fraudulent activity, and they can be tailored to fit the individual needs and financial realities of any clinical laboratory, be it an independent national laboratory, a hospital laboratory, or a small, regional laboratory. We expect variations reflecting the specific factual context in which each individual laboratory operates.

This model compliance plan focuses on topic areas recently addressed in corporate integrity agreements with several players in the laboratory industry. Consequently, this model laboratory compliance plan is not all inclusive as to subject matter. We recognize that laboratories are accountable for complying with far more laws, regulations and guidelines than we have tried to cover in this model, and we believe that laboratories implementing compliance plans should address any and all areas where abuse may be prevalent in the industry. For example, the OIG suggests that laboratory compliance programs should include training on topics such as, the anti-kickback act, Stark self-referral issues and CLIA requirements. Depending on the nature of its business, a laboratory also may need to add specific measures covering areas such as ESRD testing and billing, which is governed by rules and regulations and which has been subject to abuse by many companies. Ultimately, each company bears the responsibility for determining the appropriate topic areas and measures to be included in its compliance program.

We see this model compliance plan as a dynamic document, and therefore, one that may be modified or expanded as we gather more information and knowledge about best practices and successful compliance plans. Through this document, we are attempting to provide guidance and structure to assist providers as they attempt to comply with our civil, criminal and health care laws. All providers should be aware that the development and implementation of compliance programs can raise a host of sensitive and complex legal issues. Nothing stated herein should substitute for or be used in lieu of legal advice from competent, experienced counsel. In addition, it should be noted that implementing a compliance program will not provide a laboratory with immunity from criminal, civil or administrative prosecution, but it may be a relevant factor in negotiations with the Office of Inspector General.

COMPLIANCE PLAN ELEMENTS

Every laboratory adopting a compliance plan should develop a program and policies that ensure that the plan is implemented and enforced. Compliance plans that are merely cosmetic are not effective and, in the long run, may harm the laboratory. The OIG suggests that the comprehensive compliance program should include, at a minimum, the following elements: