Informed Consent and Non- Patient Specific Standing Orders Holly M. Dellenbaugh Senior Attorney, NYSDOH August 16, 2012 Disclaimer The contents of this presentation should not be The contents of this presentation should not be construed to represent any government agency determination or policy. These materials are for instructional use only and are not intended as a substitute for independent legal advice. 1
Informed Consent Means patient has voluntarily agreed to proposed treatment Must have capacity to consent Must understand: Condition Nature and purpose of treatment Risks/benefits of treatment (or lack thereof) Refusal to Consent Capacity to consent = capacity to refuse treatment Person who understands his or her condition and the nature, risks and benefits of the proposed and alternative treatments cannot be forced to undergo such medical treatment 2
Failure to obtain consent General Rule: Health care provider must obtain informed consent prior to treatment Failure to obtain consent can give rise to lawsuit for medical malpractice, negligence, assault or battery Failure to obtain consent may also be professional misconduct (Ed. Law 6530(26); 8 NYCRR 29.1(b)(11)) Effective consent Oral Written Demonstrative 3
Who is a Minor? Person under the age of 18 (Gen. Obligations Law 1-202; PHL 2504) Considered to lack adult s knowledge of consequences and lack capacity to use knowledge he/she has Law seeks to protect minors from their own folly/ignorance Who can consent for minor? Parent Court-appointed guardian Person in parental relation (Gen. Oblig. Law 5-1551, PHL 2164) 4
What does parental relation mean? Person designated in signed, dated writing by parent of minor For immunizations only, includes custodian who has assumed care because parents/ guardians of minor: Are dead, imprisoned, or mentally ill; Are committed to an institution; Have abandoned child; or Are living outside the state or whereabouts are unknown Who else can consent? For children in foster care: Local Commissioner of Social Services For minors in correctional facilities: commitment order deemed to grant minor capacity to consent to routine health treatment (Corrections Law 140) 5
Immunizations Special treatment under PHL 2504(5) Consent for immunization may be given by: Person in parental relation to child as defined in PHL 2164 Grandparent, adult sibling, adult aunt/uncle caring for child Adult caring for child who has written authorization to consent to child s care EXCEPTION: If person has reason to believe minor s parent or legal guardian objects to immunization, then person may not consent Exceptions to the Rule Minors who are: Emancipated Parents Married Pregnant 6
NOTE As with any person seeking medical treatment, a minor who cannot adequately understand the risks and benefits of treatment cannot consent to care, regardless of legal status Emancipated Minors Emancipation defined as the renunciation of parental rights to a child Parents can no longer make decisions for child, and child is entitled to consent to medical care Result of an act/omission by the parent child cannot accomplish it alone 7
Emancipation cont. Requires a case by case determination As long as child is a minor, presumption is that he/she is not emancipated Very little case law in New York discussing emancipated minor s right to consent to health care Courts have considered emancipated when Married In the armed services Living as if emancipated Economically independent through gainful employment 8
Public Health Law 2504 Enabling certain persons to consent for certain medical, dental, health and hospital services Codifies and expands common law rules Parents/Married Minors Married minor can make own health care decisions, and the consent of another person is not necessary (PHL 2504(1)) Minor who is a parent can also make all of his/her own health care decisions (PHL 2504(1)) Minor parent can also consent to all health services for his or her children 9
Pregnant Minors Minor who is pregnant can consent to all health services relating to prenatal care (PHL 2504(3)) Virtually any medical, dental, health or hospital treatment that a pregnant woman receives could be regarded as relating to prenatal care Emergency Situations Health services may be rendered to minor without consent if: in the physician s judgment, an emergency exists and the person needs immediate medical attention and attempt to secure consent would delay treatment and increase risk to the patient s life or health (PHL 2504(4)) 10
Basic Principle? Where a physician or surgeon is confronted with an emergency which endangers the life or health of the patient, or [in which] suffering or pain may be alleviated, it is his duty to do that which the occasion demands. Sullivan v. Montgomery, 279 N.Y.S. 575, 577 (City Ct. 1935) Good Faith Exception Anyone who: acts in good faith based upon patient s representation that she is eligible to consent under PHL 2504 is deemed to have received effective consent (PHL 2504(6)) 11
Confidentiality Person who consents to medical care has the right to keep it confidential. (PHL 18) After emergency care without parental consent, information can still be disclosed to the parent or guardian Confidentiality cont. BUT rule is not absolute discretion Provider may withhold information if disclosure would have a detrimental effect on: provider s relationship with the minor, care and treatment of the minor, or minor s relationship with her parent/guardian 12
Non-Patient Specific Standing Orders Non-Patient Specific Standing Orders Non-patient specific order may authorize administration of specified immunization agents for a specified period of time to an entire group of persons (e.g., school children, employees, patients of a nursing home, etc.) Physician or CNP may issue a non-patient specific y y p p standing order for immunizations to RN or pharmacists (See Ed. Law 6527(6)(7), 6909(4)(5)(7)) 13
RNs RNs administering immunizations under a non- patient specific standing order and protocol must be currently certified in CPR (8 NYCRR 64.7(a)(3)) LPN may not independently execute a standing order cannot perform assessment BUT RN may delegate actual administration of immunization to LPN once assessment is complete Requirements? Set forth at 8 NYCRR 64.7 Among other things, RN must: o Maintain a copy of the non-patient specific order o Assess each recipient for conditions that would preclude immunization o Obtain consent o Inform recipient of potential side effects/adverse reactions, orally and in writing, prior to immunization o Report adverse outcome to Vaccine Adverse Event Reporting System o Provide written instructions regarding appropriate course of action in the event of adverse reactions (e.g., Vaccine Information Statements) o Provide a signed certificate of immunization o For all potential recipients, maintain a record of immunization or refusal to be immunized 14
Pharmacists Education Law amended in 2008 Allows pharmacists to administer certain adult immunizations (See Ed. Law 6527, 6801, 6909; 8 N.Y.C.R.R. 63.9) May immunize persons > 18 years Influenza and pneumococcal immunizations only Recent change in the law also permits herpes zoster vaccination, but not under a non-patient specific order. Pharmacists cont. Order must be issued by a physician or CNP with a practice within the county in which the immunization is administered (or if administered i d in a county with a population of 75,000 or less, with a practice site in an adjoining county) May not administer immunizations unless certified by the Department of Education Training includes techniques for screening individuals and Training includes techniques for screening individuals and obtaining informed consent; techniques of administration; indications, precautions and contraindications; recordkeeping; and handling emergencies (e.g. anaphylaxis) 15
Requirements? Set forth at 8 NYCRR 63.9 Among other things, pharmacist must: o Ensure that each potential recipient is assessed for contraindications o Have emergency anaphylaxis treatment agents etc. available on site o Inform each recipient of potential side effects and adverse reactions, orally and in writing, prior to immunization o Obtain consent o Provide written instructions regarding the appropriate course of action in the event of adverse reactions o Provide a copy of the appropriate vaccine information statement o Provide a signed certificate of immunization o Communicate information i to the recipient's i primary health h care practitioner i o Report adverse outcomes to VAERS o Keep a record of all persons immunized o Provide information to recipients on the importance of having a primary health care practitioner Questions? 16