Healthcare Regulations and Compliance PDF

CHAPTER 1 2 Healthcare Regulations and Compliance Time allotment: 6 hours The lessons in this chapter are essential for ensuring that healthcare professionals are equipped with the knowledge and skills to navigate the complex ethical and legal landscape of...

CHAPTER 1 2 Healthcare Regulations and Compliance Time allotment: 6 hours The lessons in this chapter are essential for ensuring that healthcare professionals are equipped with the knowledge and skills to navigate the complex ethical and legal landscape of healthcare. By understanding the specific healthcare system in the Philippines, including the rights of patients, professionals can better advocate for and protect those under their care. Additionally, learning about quality improvement in healthcare settings fosters a culture of continuous enhancement, leading to better patient outcomes, more efficient practices, and overall improved healthcare delivery. TOPICS COVERED Lesson 4 Understanding Medical Ethics and Laws Lesson 5 Healthcare in the Philippines and Patient Rights Lesson 6 Quality Improvement in Healthcare Settings  LESSON 4 Understanding Medical Ethics and Laws LEARNING OBJECTIVES After studying this lesson, the students will be able to: Define Medical Ethics and Know its principles Differentiate the types of ethical problems Understand Ethical Codes Define and classify Medical Negligence Explain the importance of Medical Ethics Know the Philippine Healthcare Laws ETHICS can be defined as the thoughts, judgments, and actions on issues that have implications of moral right and wrong. comes from the Greek word "Ethike" which means habit, action, character. Ethics is a set of philosophical beliefs and practices concerned with the distinction between right and wrong. MEDICAL ETHICS branch of ethics that deals with moral issues in medical practice and focuses primarily on issues arising out of the practice of medicine. Medical Etiquettes The conventional laws, customs of courtesy, and the code of conduct governing the relationship of the physician with his professional colleagues. 6 Principles of Medical Ethics Beneficence Non-maleficence Autonomy To act in the best Do no harm The patient right to interest of the patient refuse or choose (consent) Justice Dignity Truthfulness/Honesty Who gets what Patient and doctor both The patient deserves to treatment on the merit have the right to dignity know the whole truth of illness about the illness and treatment BENEFICENCE The practitioner should act in "the best interest" of the patient - the procedure be provided with the intent of doing good to the patient. Patient's welfare is the first consideration. NON-MALEFICENCE "Above all, DO NO HARM."  Make sure that the procedure does not harm the patient or others in society. When interventions undertaken by physicians create a positive outcome while also potentially doing harm it is known as the "double effect". AUTONOMY Patient has freedom of thought, intention, and action when making decisions. Includes the need to tell the truth (veracity) and to be faithful to one's commitments (fidelity). For a patient to make a fully informed decision, they must understand all risks and benefits of the procedure and the likelihood of success. JUSTICE OR EQUITY Fair and equal distribution of scarce health resources, and the decision of who gets what treatment. The burdens and benefits of new or experimental treatments must be distributed equally among all groups in society. DIGNITY Refers to the intrinsic worth and respect owed to every human being, regardless of their health status, age, social standing, or abilities. TRUTHFULNESS/ HONESTY Emphasizes the importance of being truthful and transparent in all interactions with patients, colleagues, and the healthcare system. This principle requires healthcare professionals to provide accurate and complete information to patients, ensuring they fully understand their diagnosis, treatment options, and potential outcomes. The law reflects these principles as follows: Beneficence Justice Negligence Law Anti-discrimination law Non-Maleficence Autonomy Criminal Law Consent Negligence Law Confidentiality/Privacy Regulation Access to Records TYPES OF ETHICAL PROBLEMS Let, A = Agent C = Course of Action O = Outcome  1. Ethical Distress The agent (employee knows what course of action should take for the patient’s benefit, but there is a structural barrier to do it. 2. Ethical Dilemmas There are two or more courses of action, each of which is right or wrong. No matter which action will be chosen, something of value will be compromised. 3. Dilemmas of Justice There are benefits to be distributed among several potential beneficiaries. Not everyone can receive a full measure of the benefit. On what basis should the distribution be made? 4. Locus of Authority There are 2 or more agents or authorities in this situation. Each believes he or she knows what outcome will benefit the patient the most, but only one authority will prevail. ETHICAL DECISION-MAKING PROCESS 1. Gather relevant information 2. Identifying the type of ethical problems 3. Determining the ethics approach to use 4. Exploring the practical alternatives 5. Completing the action ETHICAL CODES 5th Century BC Hippocratic Code 1948 Nuremberg Code, Declaration of Geneva 1964 Helsinki Declaration 2006 International Code of Medical Ethics HIPPOCRATIC CODE One of the earliest documents in medical ethics. Traditionally, all doctors recite this oath at swearing in. It is considered sacred for its religious foundation and sanctity. NUREMBERG CODE DECLARATION OF GENEVA HELSINKI DECLARATION INTERNATIONAL CODE OF MEDICAL ETHICS MEDICAL NEGLIGENCE “Defined as lack of exercising reasonable care and skill by physicians for treatment of a patient leading to endangering his health and life”. It can be either Legal or Ethical. LEGALLY WRONG ETHICALLY WRONG when the standard of medical care given to when the professional behavior falls patient is of inadequate. The negligence below which is expected from a doctor could be civil and criminal depending upon i.e. professional misconduct of infamous severity. conduct. CRITERIA TO PROVE NEGLIGENCE 1. Duty of Care 2. Dereliction of Duty/ Breach 3. Direct Causation 4. Damages TYPES OF DAMAGES Nominal Damages Punitive Damages Compensatory Damages General Damages Special Damages IMPORTANCE OF MEDICAL ETHICS The study of ethics prepares medical professionals to recognize difficult situations and to deal with them in a rational and principled manner. Ethics is also important in physicians' interactions with s society and their colleagues and for the conduct of medical research. Ethical principles such as respect for person, informed consent and confidentiality are basic to the physician-patient relationship. PHILIPPINE HEALTH CARE LAWS REPUBLIC ACT – an act passed by the Congress of the Philippines, while the form of government is Republican government. Republic Act 349 – Legalizes the use of human organs for surgical, medical and scientific purposes. Republic Act 1054 – Requires the owner, lessee or operator of any commercial, industrial or agricultural establishment to furnish free emergency, medical and dental assistance to his employees and laborers. Republic Act 1080 – Civil Service Eligibility Republic Act 1082 – Rural Health Unit Act Republic Act 1136 – Act recognizing the Division of Tuberculosis in the DOH Republic Act 1612 – Privilege Tax/Professional tax/omnibus tax should be paid January 31 of each year Republic Act 1891 – Act strengthening Health and Dental services in the rural areas Republic Act 2382 – Philippine Medical Act which regulates the practice of medicines in the Philippines Republic Act 2644 – Philippine Midwifery Act Republic Act 3573 – Law on reporting of Communicable Diseases Republic Act 4073 – Liberalized treatment of Leprosy Republic Act 4226 – Hospital Licensure Act requires all hospital to be licensed before it can operative Republic Act 5181 – Act prescribing permanent residence and reciprocity as qualifications for any examination or registration for the practice of any profession in the Philippines Republic Act 5821 – The Pharmacy Act Republic Act 5901 – 40 hours work for hospital workers Republic Act 6111 – Medicare Act Republic Act 6365 – Established a National Policy on Population and created the Commission on population Republic Act 6425 – Dangerous Drug Act of 1992 Republic Act 6675 – Generics Act of 1988 Republic Act 6713 – Code of Conduct and Ethical Standards for Public Officials and Employees Republic Act 6725 – Act strengthening the prohibition on discrimination against women with respect to terms and condition of employment Republic Act 6727 – Wage Rationalization Act Republic Act 6758 – Standardized the salaries Republic Act 6809 – Majority age is 18 years old Republic Act 6972 – Day care center in every Barangay Republic Act 7160 – Local Government Code Republic Act 7164 – Philippine Nursing Act of 1991 Republic Act 7170 – Law that govern organ donation Republic Act 7192 – Women in development nation building Republic Act 7277 – Magna Carta of Disabled Persons Republic Act 7305 – The Magna Carta of public Health Workers Republic Act 7392 – Philippine Midwifery Act of 1992 Republic Act 7432 – Senior Citizen Act Republic Act 7600 – Rooming In and Breastfeeding Act of 1992 Republic Act 7610 – Special protection of children against abuse, exploitation and discrimination act Republic Act 7624 – Drug Education Law Republic Act 7641 – New Retirement Law Republic Act 7658 – An act prohibiting the employment of children below 15 years of age Republic Act 7719 – National Blood Service Act of 1994 Republic Act 7875 – National Health Insurance Act of 1995 Republic Act 7876 – Senior Citizen Center of every Barangay Republic Act 7877 – Anti-sexual harassment Act of 1995 Republic Act 7883 – Barangay Health workers Benefits and Incentives Act of 1992 Republic Act 8042 – Migrant Workers and Overseas Filipino Act of 1995 Republic Act 8172 – Asin Law Republic Act 8187 – Paternity Leave Act of 1995 Republic Act 8203 – Special Law on Counterfeit Drugs Republic Act 8282 – Social Security Law of 1997 (amended RA 1161) Republic Act 8291 – Government Service Insurance System Act of 1997 (amended PD 1146) Republic Act 8344 – Hospital Doctors to treat emergency cases referred for treatment Republic Act 8423 – Philippine Institute of Traditional and Alternative Medicine Republic Act 8424 – Personal tax Exemption Republic Act 8749 – The Philippine Clean Air Act of 1999 Republic Act 8981 – PRC Modernization Act of 2000 Republic Act 9165 – Comprehensive Dangerous Drugs Act 2002 Republic Act 9173 – Philippine Nursing Act of 2002 Republic Act 9288 – Newborn Screening Act PRESIDENTIAL DECREE – An order of the President. This power of the President which allows him/her to act as legislators was exercised during the Marshall Law period. Presidential Decree 46 – An act making it punishable for any public officials or employee, whether of the national or local government, to receive directly or indirectly any gifts or valuable things Presidential Decree 48 – Limits benefits of paid maternity leave privileges to four children Presidential Decree 69 – Limits the number of children to four (4) tax exemption purposes Presidential Decree 79 – Population Commission Presidential Decree 147 – Declares April and May as National Immunization Day Presidential Decree 148 – Regulation on Woman and Child Labor Law Presidential Decree 166 – Strengthened Family Planning program by promoting participation of private sector in the formulation and implementation of program planning policies. Presidential Decree 169 – Requiring Attending Physician and/or persons treating injuries resulting from any form of violence. Presidential Decree 223 – Professional Regulation Commission Presidential Decree 442 – Labor Code Promotes and protects employee’s self-organization and collective bargaining rights. Provision for a 10% right differential pay for hospital workers. Presidential Decree 491 – Nutrition Program Presidential Decree 539 – Declaring last week of October every as Nurse’s Week. October 17, 1958 Presidential Decree 541 – Allowing former Filipino professionals to practice their respective professions in the Philippines so they can provide the latent and expertise urgently needed by the homeland Presidential Decree 568 – Role of Public Health midwives has been expanded after the implementation of the Restricted Health Care Delivery System (RHCDS) Presidential Decree 603 – Child and Youth Welfare Act / Provision on Child Adoption Presidential Decree 626 – Employee Compensation and State Insurance Fund. Provide benefits to person covered by SSS and GSIS for immediate injury, illness, and disability. Presidential Decree 651 – All births and deaths must be registered 30 days after delivery. Presidential Decree 825 – Providing penalty for improper disposal garbage and other forms of uncleanliness and for other purposes. Presidential Decree 851 – 13th Month pay Presidential Decree 856 – Code of Sanitation Presidential Decree 965 – Requiring applicants for Marriage License to receive instruction on family planning and responsible parenthood. Presidential Decree 996 – Provides for compulsory basic immunization for children and infants below 8 years of age. Presidential Decree 1083 – Muslim Holidays Presidential Decree 1359 – A law allowing applicants for Philippine citizenship to take Board Examination pending their naturalization. Presidential Decree 1519 – Gives Medicare benefits to all government employees regardless of status of appointment. Presidential Decree 1636 – requires compulsory membership in the SSS and self-employed Presidential Decree 4226 – Hospital Licensure Act PROCLAMATION – an official declaration by the Chief Executive / Office of the President of the Philippines on certain programs / projects / situation Proclamation No.6 – UN’s goal of Universal Child Immunization; involved NGOs in the immunization program Proclamation No. 118 – Professional regulation Week is June 16 to 22 Proclamation No. 499 – National AIDS Awareness Day Proclamation No. 539 – Nurse’s Week – Every third week of October Proclamation No. 1275 – Declaring the third week of October every year as “Midwifery Week” LETTER OF INSTRUCTION – An order issued by the President to serve as a guide to his/her previous decree or order. LOI 47 – Directs all school of medicine, nursing, midwifery and allied medical professions and social work to prepare, plan and implement integration of family planning in their curriculum to require their graduate to take the licensing examination. LOI 949 – Act on health and health related activities must be integrated with other activities of the overall national development program. Primary Health Care (10-19-79) LOI 1000 – Government agencies should be given preference to members of the accredited professional organization when hiring EXECUTIVE ORDER – an order issued by the executive branch of the government to implement a constructional mandate or a statutory provision. Executive Order 51 – The Milk Code Executive Order 174 – National Drug Policy on Availability, Affordability, Safe, Effective and Good Quality drugs to all Executive Order 180 – Government Workers Collective Bargaining Rights Guidelines on the right to Organize of government employee. Executive Order 203 – List of regular holidays and special holidays Executive Order 209 – The Family Code (amended by RA 6809) Executive Order 226 – Command responsibility Executive Order 503 – Provides for the rules and regulations implementing the transfer of personnel, assets, liabilities, and records of national agencies whose functions are to be devoted to the local government units. Executive Order 857 – Compulsory Dollar Remittance Law Other Important Information Administrative Order 114 – Revised/updated the roles and functions of the Municipal Health Officers, Public Health Nurses, and Rural Midwives ILO Convention 149 – Provides the improvement of life and work conditions of nursing personnel. A car accident Let us consider a scenario where Sarah, driving carefully within the speed limit, gets rear- ended at a traffic signal by a distracted driver, Mark, who was texting on his phone. As a result: She suffers physical injuries and incurs medical expenses amounting to P5,000 for treatment and therapy. She endures pain, suffering, and emotional distress due to the accident, valued at P15,000. It turns out Mark has a history of multiple traffic violations and was driving under the influence of alcohol during this accident. The court, in this case, awards an additional P50,000 to deter Mark and others from similar reckless behavior in the future. Suppose Sarah had a clause in her insurance that entitled her to specific damages in the event of an accident even without any quantifiable losses. In this scenario, the court might award damages of P1,000, acknowledging the breach of rights despite no significant financial loss. How much are the Nominal Damages? How much are the Special Damages? How much are the General Damages? How much are the Punitive Damages?  LESSON 5 Healthcare in the Philippines and Patient Rights LEARNING OBJECTIVES After studying this lesson, the students will be able to: Know the law in operating a healthcare facility Understand what Universal Healthcare Act means REPUBLIC ACT 4226 – HOSPITAL LICENSURE ACT requires all hospitals to be licensed before it can operate REVISED RULES AND REGULATIONS GOVERNING THE REGISTRATION, LICENSURE, AND OPERATION OF HOSPITALS AND OTHER HEALTH FACILITIES IN THE PHILIPPINES SECTION 1. Title. — These rules shall be known as the “Revised Rules and Regulations Governing the Registration, Licensure, and Operation of Hospitals and Other Health Facilities in the Philippines.” SECTION 2. Authority. — These rules are issued to implement the provisions of R.A. 4226: Hospital Licensure Act consistent with E.O. 102: Redirecting the Functions and Operations of the Department of Health. SECTION 3. Purpose. — These rules are promulgated to protect and promote the health of the people by ensuring the rights to quality health service appropriate to the level of care through the regulation of hospitals and other health facilities. SECTION 4. Scope. — The rules and regulations embodied herein shall apply to all government and private hospitals and other health facilities. SECTION 5. Regulatory Agency. — The Department of Health through the Bureau of Health Facilities and Services in the Office for Health Regulation shall exercise the regulatory functions. SECTION 6. Definition. — A hospital is a health facility for the diagnosis, treatment and care of individuals suffering from deformity, disease, illness or injury, or in need of surgical, obstetrical, medical or nursing care. It is an institution where there are installed bassinets or beds for 24-hour use or longer by patients in the management of deformities, diseases, injuries, abnormal physical and mental conditions, maternity cases. SECTION 7. Classification of Hospitals and other Health Facilities. — Hospitals and other health facilities shall be classified as follows: 7.1 Government or Private 7.2 General or Special 7.3 Service Capability 7.1 GOVERNMENT OR PRIVATE 7.1.1 Government/ Public. — operated and maintained partially or wholly by the national, provincial, city or municipal government, or other political units, or by any department, division board of agency thereof.  7.1.2 Private. — privately owned, established, and operated with funds through donation, principal, investment, or other means, by any individual, corporation, association, or organization. 7.2 GENERAL OR SPECIAL 7.2.1 General — provides services for all types of deformity, disease, illness, or injury. 7.2.2 Special — primarily engaged in the provision of specific clinical care and management. A first level referral hospital, second level referral hospital, third level referral hospital, or infirmary, may provide special clinical service(s). 7.3 SERVICE CAPABILITY 7.3.1 First Level Referral Hospital — 7.3.1.1 on-departmentalized hospital that provides clinical care and management on the prevalent diseases in the locality 7.3.1.2 Clinical services include general medicine, pediatrics, obstetrics and gynecology, surgery, and anesthesia 7.3.1.3 Provides appropriate administrative and ancillary services (clinical laboratory, radiology, pharmacy) 7.3.1.4 Provides nursing care for patients who require intermediate, moderate and partial category of supervised care for 24 hours or longer 7.3.2 Second Level Referral Hospital — 7.3.2.1 Departmentalized hospital that provides clinical care and management on the prevalent diseases in the locality, as well as forms of treatment, surgical procedure, and intensive care 7.3.2.2 Clinical services provided in the First Level Referral Hospital, as well as specialty clinical care 7.3.2.3 Provides appropriate administrative and ancillary services (clinical laboratory, radiology, pharmacy) 7.3.2.4 Nursing care provided in the First Level Referral Hospital, as well as total and intensive skilled care 7.3.3 Third Level Referral Hospital - 7.3.3.1 Teaching and training hospital that provides clinical care and management on the prevalent diseases in the locality, as well as specialized and sub-specialized forms of treatment, surgical procedure, and intensive care 7.3.3.2 Clinical services provided in the Second Level Referral Hospital, as well as sub-specialty clinical care  7.3.3.3. Provides appropriate administrative and ancillary services (clinical laboratory, radiology, pharmacy) 7.3.3.4 Nursing care provided in the Second Level Referral Hospital, as well as continuous and highly specialized critical care REPUBLIC ACT No. 11223 – Universal Health Care Act PATIENT RIGHTS AND HEALTHCARE COMPLIANCE THE RIGHTS OF THE PATIENTS 1. Right to Appropriate Medical Care and Humane Treatment 2. Right to Informed Consent 3. Right to Privacy and Confidentiality 4. Right to Information 5. Right to Choose Health Care Provider and Facility 6. Right to Self-Determination 7. Right to Religious Belief 8. Right to Medical Records 9. Right to Leave 10. Right to Refuse Participation in Medical Research 11. Right to Correspondence and to Receive Visitors 12. Right to Express Grievances  13. Right to be Informed of His Rights and Obligations as a Patient WHAT IS THE PURPOSE OF HEALTHCARE COMPLIANCE? The purpose of healthcare compliance is to ensure that healthcare organizations, professionals, and facilities adhere to laws, regulations, and ethical standards to provide safe, high-quality, and ethical care to patients and clients. Who Is Responsible for Healthcare Compliance? The primary function of the The Food and Drug Administration is Department is the promotion, responsible for protecting the public health protection, preservation, or by ensuring the safety, efficacy, and restoration of the health of the security of human and veterinary drugs, people through the provision and biological products, and medical devices; delivery of health services and and by ensuring the safety of our nation's through the regulation and food supply, cosmetics, and products that encouragement of providers of emit radiation. health goods and services. The agency is responsible for licensing, The Department of Health (DOH) is monitoring, and regulation of cosmetics, mandated to be the over-all drugs, foods, household hazardous technical authority on health. The products, medical devices and major mandate of DOH is to provide electromagnetic radiation emitting devices, national policy direction and develop pesticides, tobacco and related products, national plans, technical standards, and vaccines for safety, efficacy, and and guidelines on health. quality in the Republic of the Philippines. THE CONSEQUENCES OF NON-COMPLIANCE If a healthcare organization is non-compliant, it will face fines and legal charges, not to mention a damaged reputation. HOW TO ENSURE COMPLIANCE IN HEALTHCARE SETTINGS? 1. Develop clear policies 2. Designate a compliance officer 3. Train Employees 4. Conduct compliance audits 5. Deal with noncompliance immediately  LESSON 6 Quality Improvement in Healthcare Settings LEARNING OBJECTIVES After studying this lesson, the students will be able to: 1. Understand what Quality Improvement means 2. Know the framework needed for patient care WHAT IS QUALITY IMPROVEMENT IN HEALTHCARE REALLY ABOUT? “Quality improvement is the systematic approach that is guided by data to improve the quality and safety of healthcare delivery. Quality improvement focuses on care that is safe, timely, effective, efficient, equitable, and patient- centered.” Dr. Debra Sowell, DNP, RN Clinical faculty in graduate nursing programs at Southern New Hampshire University (SNH). Quality improvement professionals review patient and other medical data and analyze processes used to provide care. Then, using that information, they work to identify areas of improvement and highlight areas of excellence, said Sowell. This work aims to improve patient outcomes, achieve efficiency in the delivery of medical care, and reduce healthcare costs. WHAT ARE EXAMPLES OF QUALITY IMPROVEMENT INITIATIVES IN HEALTHCARE? According To Sowell, Other Real-World Impacts of Quality Improvement in Healthcare Include: Reduced hospital readmissions Improved care coordination among departments Decreased medication administration errors Improved electronic medical record documentation Reduced medication-related adverse events Optimized sepsis care Decreased number of urinary catheter infections Most examples of quality improvement in healthcare are guided by a framework developed by the Institute of Medicine (IOM), which identifies six primary goals for patient care. According to the framework, patient care should be: 1. Safe - Avoiding harm to patients during their medical treatment.  2. Effective - Providing medical services to patients who could benefit from them and avoiding the use of services that are unlikely to result in better patient outcomes. 3. Timely - Reducing wait times and delays for appointments and treatment. 4. Efficient - Avoiding waste of medical equipment, supplies, time and energy. 5. Equitable - Ensuring quality of care does not vary because of patient characteristics like gender, ethnicity, geography, and socioeconomics. 6. Patient-centered - Respecting individual patient preferences and ensuring that patients are valued and involved in decisions related to their care. What is the Importance of Quality Improvement in Healthcare? When healthcare systems focus on quality improvement, they can create significant change within a medical institution, achieving everything from financial savings to, most importantly, saving patient lives. A focus on quality improvement in healthcare can also better prepare an institution to handle a large-scale emergency or medical event.