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Laws, Compliance Tools and Managerial Actions

Success Tip: Talk about the law, compliance tools and managerial actions in all coursework.

· Evaluate what the law requires the organization to do.

· Evaluate how compliance tools can be used to ensure legal compliance or correct legal problems.

· Evaluate how specific management actions can be taken to use compliance tools and ensure legal compliance.

What is a law?

A law arises from a Constitution, statute, regulation or court decision at the federal or state level. It sets the standard of conduct of what is required. Laws often include penalties that state what will happen if the requirements of the law are not met. This can include financial penalties or jail time. For example, HIPAA ;aw has both civil and criminal penalties.

Tip: Always start by knowing what the law requires and what the penalties are for non-compliance.

Examples:

Federal/State	Type of Law	Citation Example and Web Link
Federal	U.S. Constitution	U.S. Const. Art I https://constitution.findlaw.com/
Federal	Statute United States Code (U.S.C.)	42 U.S.C. 325 (2021) https://www.law.cornell.edu/uscode/text
Federal	Regulation Code of Federal Regulations (C.F.R.)	29 C.F.R. 151 (2021) https://www.ecfr.gov/
Federal	Federal Cases U.S. Supreme Court U.S. Court of Appeals U.S. District Court	Advocate Health Care Network v. Stapleton, No. 16-75 (2017) https://www.supremecourt.gov/opinions/slipopinion/21 Jones v. Smith, No. 3:2021cv12349 (2nd Cir. 2021) https://law.justia.com/cases/federal/appellate-courts/ Markson v. Knox, No. 1:2021cv01334 (Md. Ct. 2021) https://law.justia.com/cases/federal/district-courts/

State	State Constitution	Maryland Const. Art. IV https://law.justia.com/constitution/maryland/
State	State Statute	Maryland Mental Health Facilities §10-404 (2018) https://codes.findlaw.com/
State	State Rule	COMAR 09.11.02.01C(2)(a)(i) (2020) http://www.dsd.state.md.us/COMAR/ComarHome.html
State	State Cases	North Hospital v. Zenick, No. 34ag/21 (MD. Ct. App. 2021) https://law.justia.com/cases/maryland/

What is a Compliance or Risk Management Tool?

A compliance or risk management tool is something that is used to help an organization comply with the law. Any tool that is used to solve a problem should be evaluated to determine how it will apply to correct the specific problem. For example, a general tool such as a corporate checklist would need to be adapted to include items on the checklist to ensure that the company met a specific compliance goal such as avoiding discrimination in hiring.

Tip: Any managerial tool should be adjusted to meet the specific problem. Evaluate how to use the general principles of the tool to correct specific problems. Give reasons to support how your tools resolve the legal problem.

Tip 2: Use the week 12 managerial tools for compliance links throughout the course to assist with compliance tools for assignments.

Examples:

Tool Examples	How it could be used to limit risk or comply with the law
Litigation Hold Letter	A litigation hold letter is issued to ensure that electronic and other evidence is preserved for litigation by putting a hold on destruction of relevant evidence while litigation is pending.
Contracts and Contract Clauses	A contract should comply with the law and include contract clauses to limit the risk of the organization should a dispute arise. A contract should be adapted to meet the needs of the specific situation and risks.
Cloud Based Contract Management System	A cloud based contract management system helps ensure that the organization complies with the requirements of the contract and tracks the life cycle of the contract to limit risk from non-renewal or renegotiation.
Corporate documents including policies and procedures	Corporate documents set the standards, vision, rules for the organization to meet. They ensure consistency of managerial actions and should be complied with. Any management actions should comply with both law as well as organizational documents and policies.
Enterprise Document Management (EDM) System	An Enterprise Document Management System (EDM) creates is a way to keep all organizational documents in digital forma for prompt review and retrieval. This gives the organization a system wide process to manage, use, and archive documents.
HHS OIG Compliance Protocol	The HHS OIG Compliance protocol provides elements an organization can use to comply with the law and limit the risk of fraud and abuse.
COSO Internal Control Framework	The COSO Internal Control Framework provides a number of controls that can be used in order to reduce risk within an organization. General principles of control can be adapted to manage specific organizational risks..
Health Information Technology	Health Information Technology can be used as a compliance and risk management tool when the tool is set up to comply with specific legal requirements and to limit risk of non-compliance.
Code of Ethics from a Professional Organization or from the Hospital, Clinic or Care Facility	A Code of Ethics sets an ethical standard for those who belong to the organization. Many organizations require a person to sign the Code of Ethics as indication that they agree and will comply with the ethical standards. This ensures high ethical behavior which improves the likelihood of legal compliance as well and limits the risk of wrongdoing.
Security Risk Assessment (SRA)	This is an assessment of the security risk to health information within an organization. It is required by law and helps ensure compliance with the law.
Health Information Technology or other Internal Audits	Internal audits give an organization a chance to catch problems before an outside auditor, government regulator, or accreditation agency comes in and finds a problem. This allows the organization to correct the problem in order to comply with legal requirements.
Checklists	Checklists can be for a variety of activities and include a surgical checklist, hiring, termination, or evaluation checklist to ensure that all steps for safety are taken before a procedure or activity. Checks can ensure consistency in legal compliance no matter who is conducting the activity.
AHRQ, NCQA, Joint Commission Guidelines. and HHS OIG Compliance Guidelines	Guidelines provide a tool to meet high standard of practice. They are not enforced like the law, but set high standards that improve compliance and prevent problems.
Sample Forms and Documents	Sample forms can help an organization set up a form for patient intact, informed consent, consent refusal, prevent violence, or encourage patient safety, ensure advanced directives comply with state law, or take other actions in a way that minimizes risk and complies with the law.
Training Tools	Formal training tools can be used to provide employee training on HIPAA, OSHA Safety, or other issues to encourage patient safety, legal compliance, etc.

What are Managerial Actions?

Managerial actions are things that you can DO as a manager to comply with the law. These actions may include ways to use compliance and risk management tools to comply with the law. Something that the government does is not a managerial action. For example, issuing a litigation hold letter would be a managerial action to preserve evidence when a lawsuit is anticipated.

Tip: Any recommended managerial actions should be specific to the problem and correct the problem, reduce the risk, and prevent future problems. Always explain how the recommended action will do this. Include reasons to support your recommended managerial actions.

Examples:

Managerial Action	Related Tool	Legal Problem it could correct
Issue a Litigation Hold Letter as soon as you know a lawsuit will be filed.	Litigation Hold Letter	This would ensure evidence is preserved for the lawsuit that is anticipated before issuing the litigation hold letter.
Add an arbitration clause to a contract to keep a contract dispute out of court and the public limelight.	Contract clauses	This could keep an contract issue form going to court and limit public exposure to the issue.
Create a new policy on bullying to prevent bullying in the workplace.	Corporate Documents	When an issue arises a policy can be created to prevent the issue in the future and ensure that if it arises it is consistently handled in conjunction with the policy.
Train employees on how to use the health information technology system to keep PHI private and secure with a quiz at the end of training as a knowledge check..	Training Tools	Any training should be specific to the legal problem and provide specific information to employees so that the problem is less likely to recur.
Establish a corrective action plan for an employee who is chronically late to work with a 30 day follow up meeting.	Corporate Documents	This allows the manager to correct a problem a specific employee is having. It should be followed up with review to see if the corrective actions were properly implemented by the employee after a preset period such as 30, 60 and/or 90 days.
Create a checklist for patient discharge to ensure everything that needs to be completed prior to discharge is completed.	Checklists	This ensures that patient meets medical criteria for discharge, has received any training or medication for discharge, and that the discharge is in compliance with the law.
Conduct an internal medical record audit to see if initial visit coding is supported by the medical record documentation.	Audits	An internal audit allows the organization to review its own records related to legal standards and make needed changes to comply with the law before an outside auditor, regulator or accreditor comes in to audit and finds a problem.
Create a hospital protocol for opioid use disorder (OUD) screening based on national guidelines to ensure consistent screening of all patients.	Forms and Guidelines	Protocols ensure consistent actions for all who do the same activity. Forms ensure that the information that needs to be captured to comply with the law is on the form.