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    Chapter 19

    Clinical Laboratories

    Learning Objectives

    Familiarity with compliance risk areas in clinical laboratories

    Seven components of compliance program

    Multiple duties of a Compliance Officer

    Open communication lines with employees

    Techniques of auditing and monitoring

    Various responses to suspected misconduct and legal violations

    Benefits of an effective compliance program

    Introduction

    Description of clinical laboratory operations

    Scope and nature of the clinical laboratory industry

    OIG program guidance for clinical laboratories, its origins and purpose

    Compliance Risk Areas (I)

    Medical necessity

    Services paid only if covered, reasonable, and necessary for the patient

    Test requisition forms, annual physician notices, customized profiles, excessive utilization

    Billing

    Accurate coding of claims for services

    Documentation to support test requests

    Eliminate ambiguity before submitting claims

    Compliance Risk Areas (II)

    Reliance on standing orders

    Only for extended course of treatment

    Should be monitored and checked periodically

    Compliance with applicable HHS fraud alerts

    Keep staff informed of these alerts

    Marketing

    Honest, clear, correct, non-deceptive, and fully informative

    Compliance Risk Areas (III)

    Prices charged to physicians

    No inducements to gain physicians’ business

    Retention of records

    Records required by laws/programs must be retained

    Compliance as an factor in a performance plan

    Evaluating performance of managers & employees

    Managers’ duty to oversee subordinates’ compliance

    Key Elements of a Clinical Laboratory’s Compliance Program

    Policies, procedures, & standards of conduct

    Designating a Compliance Officer and Committee

    Conducting Effective Training and Education

    Developing Effective Lines of Communication

    Enforcing Standards Through Well-Publicized Disciplinary Guidelines

    Auditing and Monitoring

    Responding to Detected Offenses and Taking Corrective Action

    Written Policies, Procedures, and Standards of Conduct

    Explain how the laboratory wants its employees to behave in each of the risk areas

    Publicized to all employees

    Regularly updated

    Employees certify that they have received, read, and understood them

    Designating a Compliance Officer and a Compliance Committee

    CO is catalyst for the lab’s compliance activities

    Qualifications for a CO

    Full-time, sufficient authority, funding and staff, access to CEO and governing board

    List of CO functions

    CC assists and advises the CO

    List of CC functions

    Conducting Effective Training and Education

    Communicate policies, procedures, and standards of conduct to employees

    Curriculum of training sessions

    Basic training and Specialized training

    New employee training with annual updates

    Required attendance, condition of employment

    Developing Effective Lines of Communication

    Between lab CO and employees

    Facilitate reporting of suspected misconduct

    Several independent communication channels

    Documentation of all communications

    Confidentiality and non-retaliation policies

    Enforcing Standards Through Well-Publicized Disciplinary Guidelines

    For failure to follow laws & regulations, policies, procedures, and standards of conduct.

    Levels of disciplinary action to be imposed.

    Applied fairly and consistently.

    Conduct background checks on new employees.

    Avoid persons excluded or debarred.

    Auditing and Monitoring

    Monitoring and reporting on the lab’s compliance performance on a regular basis.

    Periodic compliance audits conducted by internal or external auditors.

    Recommended topics of compliance audits.

    Sampling techniques create baseline picture.

    List of other monitoring methodologies.

    Responding to Detected Offenses and Taking Corrective Action

    Internal investigation consisting of interviews and review of relevant documents,

    Determines nature & severity of violations.

    Range of corrective actions to be taken.

    More intense response when there is evidence of criminal or civil violations.

    Self-reporting of such violations.

    Benefits of an Effective Compliance Program (I)

    Reduces likelihood of false claims

    Identifies weaknesses in internal systems

    Provide high quality services

    Demonstrates commitment to responsible corporate conduct

    Insight into employee behavior regarding fraud

    Benefits of an Effective Compliance Program (II)

    Identifies & prevents illegal, unethical conduct

    Central source for info on fraud and abuse

    Facilitate employee reporting of potential problems

    Enable thorough investigation of misconduct

    Immediate and appropriate corrective action

    Reduces exposure to civil & criminal penalties

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    Questions ???

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