Compliance Tool: Model Whistleblower Protection Policy

The best way to avoid being sued by whistleblowers is to encourage employees to report their compliance concerns to the lab. This gives you the opportunity to identify and correct problems that you may not know about and which, if left undetected, could expose your lab to significant liability risk. But employees won’t come forward if they fear retaliation or think that you’re going to sweep their concerns under the rug. In fact, this is precisely the culture and mentality that’s likely to result in the whistleblower lawsuits you’re seeking to prevent. The solution is to implement a policy that protects whistleblowing activity at your lab. Here’s a model policy that you can adapt for your own circumstances.

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Whistleblower Protection Policy

1. PRINCIPLES

ABC Laboratories [replace this stand-in lab name with the name of your lab] is committed to ensuring that all aspects of its operations are carried out in compliance with regulatory, ethical, professional, and other applicable laws and standards. ABC Laboratories also expects all personnel at every level to share this commitment to compliance and integrity in all their activities. Our lab will not tolerate any illegal or unethical behavior, including but not limited to fraud, criminal acts, regulatory violations, or violations of other policies, practices, and standards established by ABC Laboratories.

2. PURPOSE

ABC Laboratories recognizes that whistleblowing plays an essential role in any organization’s efforts to maintain the highest levels of compliance. The purpose of this Policy is to establish principles, protocols, and procedures to nurture and protect whistleblowing activity and ensure that all ABC Laboratories personnel recognize that they not only may but must come forward to report activities that they know or reasonably believe are illegal, dishonest, unethical, or otherwise improper—without fear of reprisal, retaliation, or retribution of any kind, and with the knowledge that ABC Laboratories will take their reports seriously.

3. DEFINITIONS

For purposes of this Policy:

“Employee” includes any person employed by ABC Laboratories regardless of position, compensation, or job status, including temps, interns, and volunteers.

“Illegal activity” includes, without limitation, any activity engaged in by ABC Laboratories or any of its directors, officers, managers, supervisors, employees, physicians, nurses, clients, customers, patients, suppliers, vendors, or other agents, that is illegal, dishonest, unethical, in breach of laboratory policies, procedures, or protocols, or otherwise improper.

“Retaliation” includes the following: termination; discipline; discrimination; demotion; reassignment; denial of raises, bonuses, promotions, or other rewards; reductions in compensation or benefits; violence; threat of violence; intimidation; coercion or any other form of adverse treatment of an employee in retribution or reprisal for engaging in whistleblowing, even where reprisal or retribution is only one motive for such adverse treatment.

“Whistleblowing” means good faith reporting by an ABC Laboratories employee of conduct, behavior, or activity that the employee knows or reasonably believes to be illegal activity, whether reported internally to ABC Laboratories or externally to federal, state, or municipal government investigators, courts, administrative tribunals, or other public agents or bodies.

4. REPORTING PROCEDURES

4.1 Initial Report

Employees should report any illegal activity that they witness or know about as soon as possible. Reports may be oral or in writing and should list the following information:

• The names of the person/people who committed the illegal activity, if known
• The date of the illegal activity
• A detailed description of the illegal activity

4.2 Reporting Channels

Employees may report the illegal activity to one of the following:

Option 1: Their supervisor or superior, or their department.

Option 2: If employees feel that Option 1 is inappropriate, for example, because their supervisor or superior committed or is involved in the illegal activity, they may report to [person or department designated to receive reports of wrongdoing—provide at least one external option in case the designated recipient is involved in the alleged illegal activity].

Option 3: Employees may also report illegal activity to the 24/7/365 Hotline that ABC Laboratories has established to receive confidential and anonymous reports of illegal activity at [list contact number or website URL]. The Hotline will provide the employee a confidential PIN allowing for further confidential communication via the Hotline.

None of these reporting channels supplants or is intended to supplant the employee’s right to report the illegal activity to an external government or public official or agency.

4.3 Receipt of Reports

Upon receiving a report of illegal activity, the recipient must immediately forward the report to the ABC Laboratories Compliance Officer for initial review. After initial review, the matter will be considered resolved if the report does not list adequate information about the illegal activity to allow for an appropriate investigation.

5. INVESTIGATION PROCEDURES

5.1 Investigator

ABC Laboratories has designated [name or position] to investigate reports of illegal activity (the “Default Investigator”). However, if the Compliance Officer determines that it would not be appropriate for the Default Investigator to investigate reports of illegal activity, such as because that person is or could reasonably be perceived to be in a conflict of interest, or otherwise not impartial or unbiased in conducting the investigation, the Compliance Officer must either investigate the matter personally or assign the investigation to another person, which may include an external investigator.

5.2 Investigation Principles

The investigator will investigate the report of illegal activity promptly, fairly, independently, and confidentially, taking care to protect the identity of the persons involved. All persons, including the whistleblowing employee, must fully cooperate in the investigation.

5.3 Acknowledgement of Report

The investigator will within [X] business days contact the employee who reported the illegal activity to acknowledge receipt of the report [within 5-8 days is considered a reasonable timeframe to contact those who report illegal activity]. Employees who report illegal activity via the ABC Laboratories Hotline will be assigned a unique case identifier and password enabling them to return to the provider website after [X] business days to assess response to the report and to anonymously answer any follow-up questions.

5.4 Investigation Report

The investigator must perform the investigation and prepare a report that includes:

• A general description of what happened
• Contributing and root causes of any illegal activity committed
• Recommendations of corrective actions to address the contributing and root causes to eliminate or minimize the risk of a similar occurrence going forward

The status, and to the extent possible, the outcome of the incident investigation must be communicated to the whistleblowing employee as soon as possible, either directly if the employee gave their name and contact information, or via the Hotline provider if the employee used the Hotline.

6. CONFIDENTIALITY

All reports of illegal activity and the identity of the employee who submits them will be kept confidential and not be disclosed except where permitted by law and/or necessary to enable a full and proper investigation and resolution. Reports will be accessible only to persons that the investigator determines have a “need to know” and where such access will not otherwise compromise or interfere with the independence, effectiveness, and integrity of the investigation.

7. NON-RETALIATION

ABC Laboratories will not retaliate against or permit any of its directors, officers, managers, supervisors, employees, or other agents to commit retaliation against any employee for whistleblowing, provided that employees acted in good faith and with the reasonable belief that illegal activity occurred. Those found to engage in retaliation in violation of this Policy will be subject to discipline up to and including termination.

Protection against retaliation applies even if the employee’s allegations of illegal activity are found to lack truth or merit if employees reported them in good faith and with the reasonable belief that they were true. However, employees who report illegal activity in bad faith, such as by making deliberately false accusations to harass ABC Laboratories or members of its staff, will be subject to discipline up to and including termination.

8. RETENTION OF RECORDS

Reports of illegal activity, records from the investigation, and other documentation pertaining to the matter are the property of ABC Laboratories and will be kept confidential in accordance with ABC Laboratories’ privacy and information security policies and retained in accordance with applicable records retention policies.