– Chapter19ComplianceII.pptx

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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


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


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


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 #038; employees

Managers’ duty to oversee subordinates’ compliance

Key Elements of a Clinical Laboratory’s Compliance Program

Policies, procedures, #038; 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 #038; 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.

Sling 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 #038; 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 #038; 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 #038; criminal penalties

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