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Regulatory Compliance
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Protocols & Policies
The process of developing, disseminating, and implementing written standards of conduct, policies, and procedures to ensure that the organization meets and exceeds the legal and ethical standards applicable to it.
• An organization’s chief executive officer and its governing body designate a compliance officer to oversee and operate the compliance program and report directly to the officer or individuals responsible for it.
• Developing and delivering effective employee training programs.
• Developing and maintaining an open channel of communication that allows individuals to report compliance concerns anonymously.
• Develop and implement a process to respond appropriately to complaints, including disciplining employees when necessary.
• Monitoring of compliance and addressing the deficiencies through internal audits.
• Implementing corrective measures quickly and appropriately in response to detected criminal offenses. -
Legal Advisory & Consultation
Here is a list of some of the mandatory compliance laws regarding healthcare:
I) Laws related to governing the Hospital
• Society registration act
•Companies Act
• Clinical Establishments Bill
• Fire Safety RulesII) Laws Governing the Qualifications / Practice and Conduct of Professionals
• Indian Medical Council Act
• Indian Nursing Council Act
• The Dentists ActIII) Law Governing Storage / Sale of Drugs and Safe Medication
• Drugs and Cosmetics Act
• VAT Act
• Pharmacy Act
• Blood bank regulations under Drugs and Cosmetics rules
• Law Governing Biomedical Research
• Breeding and Experiments on Animals Amendment RulesIV) Law Governing Medico-Legal Aspects
• Consumer Protection Act
• Protection of Human Rights Act
• IPC section 52V) Law Governing the Safety of Patients, Public and Staff within the Hospital Premises and Environmental Protection
• Indian Boilers Act
• Gas Cylinder Rules
• Arms Act
• Vaccination ActVI) Laws Governing the Employment of Manpower
• Child Labour Act
• Bonus & Gratuity Act
• ESI Acts, Rules
• Industrial Disputes Act -
AAPC - 7 Steps to Achieve Compliance
By AAPC, the following Seven Steps should be taken to achieve compliance :
• Monitoring and auditing of internal processes.
• Standards of compliance and practice should be implemented.
• Designate a compliance officer or point of contact.
• Conduct appropriate training programs for the employees.
• Develop corrective actions in response to detected offenses.
• Establish open channels of communication.
• Publicize disciplinary standards and enforce them.