Page 1Page 2Page 3Page 4Page 5Page 6Page 7Page 815. Legal and Regulatory Issues PLAB 1223/1023 C 10115.Legal and Regulatory IssuesA. General Ethical Legal Principles1. Laws governing medicine and medical ethics complement and overlap each other.a. In the past, decisions were made by doctors and other health professionals.b. Consumers and patients have become more aware, more critical and much morewilling to sue anyone the lawyer feels is at fault, including the phlebotomist.2. Must act in a professional and respectful manner at all times.a. Follow professional code of ethicsb. Evaluate difficult situations and apply the code of ethics.c. Take responsibility for actions2. Statutory laws are written laws enacted by state legislatures and the US congress, up tocourts to interpret application of law..3. Administrative law is the implementation of statutes and ordinances by the executivebranch of government through its departments and agencies.4. Judicial law resolves disputes in accordance with laws.a. State and federal trial courtsb. Appeals courts (intermediate courts)c. Supreme courtB. General Legal Terminology - fill in the following portion of the lecture guide (1-20) on yourown. You will be responsible for these terms on the upcoming exam.1. Assault2. Battery3. Bioethics4. Breach of duty15. Legal and Regulatory Issues PLAB 1223/1023 C 1025. Civil Law6. Criminal actions7. Defendant8. Ethics9. False imprisonment10. Felony11. Informed consent12. Invasion of privacy13. Liable15. Legal and Regulatory Issues PLAB 1223/1023 C 10314. Litigation process15. Malpractice16. Misdemeanor17. Negligence18. Plaintiff19. Respondeat superior20. TortC. Negligence1. There has been a significant increase over the years in the number of legal cases in whichthe lab is directly or indirectly involved.2. Negligence is “violation of duty to exercise reasonable skill and care performing a task”.3. Involves four key points.a. Duty-responsibilities of HCW to patientb. Breach of duty-was duty unavoidably breachedc. Proximate causation-did breach of duty contribute to or cause injury.d. Damages-patient must show they were actually damaged by negligent act.D. Patient confidentiality1. Violation of the right of privacy, another example of negligence.15. Legal and Regulatory Issues PLAB 1223/1023 C 1042. Confidentialitya. No one but the patient may release patient results without a clinical need to know.b. Patient/employee lab results are strictly confidential.3. Negligence can be sought if employees or patient’s drug abuse results are released toanyone but the patient’s doctor or authorized individuals.a. Employee or athlete drug or alcohol abuse screening or HIV testing are examples.b. Confidential materials includes:1) communications between doctor and patient,2) patient’s verbal statements,3) and non-verbal communications such as lab result.4. HIV status of patienta. Some states do not allow HCWs to know the HIV status of a patientb. In case of accidental needle stick patient must give consent for testing.E. Malpractice1. Defined as improper or unskillful care of a patient by an HCW, or any unreasonable lack ofskill or professional misconduct.2. Relationship between doctor and patient is a contractual one involving the followingelements:a. Offer by the physician to provide a service.b. Acceptance by the patient for treatment.c. Consideration - patient accepts treatment and pays for care.3. Contract implies obligations on both parts.4. Physician must provide a standard of care.a. Patient hurt during blood collection.b. Patient must prove that HCW failed to follow standard of care.c. Standard of care determined by what a reasonably prudent person would do undersimilar circumstancesF. Standard of Care1. If patient is injured during blood collection must prove that standard of care was notfollowed2. Based on standard practice in the field, what are the most a reasonably prudent personwould do under similar circumstances.3. For laboratories this is an expanding area as national standards are set.G. Informed consent1. Defined-“voluntary permission by a patient to allow touching, examination, and/ortreatment by health care providers.”2. If patient requires treatment that is of potential risk, the doctor must explain risks andalternatives prior to asking patient to sign informed consent form.15. Legal and Regulatory Issues PLAB 1223/1023 C 1053 Form is required for surgical experiments or other invasive procedures.4. Largest area of litigation which is the primary reason the phlebotomist must explain bloodcollection procedures in simple terms.4. Special consent for children, unconscious adults or emergency situations.5. Implied Consent exists when immediate action is required to save a patient’s life orprevent permanent impairment.H. Statute of Limitations1. Law that defines how soon after injury a plaintiff must file a lawsuit or be forever barredfrom doing so.2. Purpose is to prevent threat of lawsuit for forever3. Two year limit in most states for professional negligence4. Complete and accurate documentation is criticalI. Legal claims and Defense in Malpractice Suit1. First pleading filed is complaint-states cause of action2. Proceeds to discovery-oral testimony from witnesses3. Deposition-testimony of witness in writing4. Court orders can be obtained to examine documents pertaining to case.5 . If you are involved in a deposition follow the following guidelines:a. Answer only the questions asked.b. Be organized in your recollectionsc. Do not be antagonisticd. Explain lab/blood collection process in simple termse. Do not overdramatize the factsf. Dress neatly and groom appropriatelyg. Be polite, sincere and courteoush. Be sure to ask for clarification on questions you do not understand I. In you are not sure of an answer indicate that in your response6. Expert Witnessa. Gives information concerning practices patterns and levels of skill.b. Patient’s expert witness will testify that care was negligent and the standard of carewas not provided.7 Evidence is used to prove or disprove a lawsuit8. How to avoid a lawsuita. Perform blood collection according to National standardsb. Obtain consentc. Do not violate confidentialityd. Maintain blood collection area with appropriate supplies, esp safetye. Exhibit good listening skillsf. Report