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HomeMy WebLinkAboutInformed ConsentIdaho Department of Correction Standard Operating Procedure Division of Education Treatment and Reentry Control Number: 401.06.03.070 Version: 3.0 Page Number: 1 of 4 Adopted: 3-1-2001 Reviewed: 07-30-2013 Title: Informed Consent This document was approved by Shane Evans, chief of Division of Education Treatment and Reentry on 07/30/2013 (signature on file). Open to the general public: yes BOARD OF CORRECTION IDAPA RULE NUMBER 401 Medical Care POLICY DOCUMENT NUMBER 401 Hospitalization, Institutional Clinical Services, and Treatment DEFINITIONS Standardized Terms and Definitions List Contract Medical Provider: A private company under contract with the Department to provide comprehensive medical, dental, and/or mental health services to the incarcerated offender population. A contract medical provider may include private prison companies and other entities under contract with the Department to operate the Idaho Correctional Center (ICC) and other out-of-state facilities housing Department offenders. Facility Health Authority: The contract medical provider employee who is primarily responsible for overseeing the delivery of medical services in an Idaho Department of Correction (IDOC) facility. Health Authority: The Department employee who is primarily responsible for overseeing or managing the Department’s medical and mental health services. The health authority is commonly referred to as the health services director. Informed Consent: The agreement by a patient to a treatment, examination, or procedure after the patient receives the material facts about the nature, consequences, and risks of the proposed treatment, examination, or procedure; the alternatives to it; and the prognosis, if the proposed treatment is not undertaken. PURPOSE The purpose of this standard operating procedure (SOP) is to establish procedures to afford offenders the opportunity to evaluate knowledgeably the options available and the attendant risks of interventions recommended for the diagnosis and treatment of conditions affecting health status. Control Number: 401.06.03.070 Version: 3.0 Title: Informed Consent Page Number: 2 of 4 SCOPE This SOP applies to all Idaho Department of Correction (IDOC) employees, offenders, contract medical providers and subcontractors . RESPONSIBILITY Health Authority The health authority is responsible for: • Monitoring and overseeing all aspects of healthcare services ; and • The implementation and continued practice of the provisions provided in this SOP. When healthcare services are privatized, he will also be responsible for : • Reviewing and approving (prior to implementation) all applicable contract medical provider policy, procedure, and forms ; and • Monitoring the contract medical provider’s performance, to include but not limited to reviewing processes, procedures, forms, and protocols employed by the contract medical provider to ensure compliance with all healthcare-related requirements provided in this SOP and in National Commission on Correctional Health Care (NCCHC) standard P -I-05, Informed Consent. (See section 2 of this SOP.) Contract Medical Provider When healthcare services are privatized, the contract medical provider is responsible for: • Implementing and practicing all provisions of this SOP, unless specifically exempted by written contractual agreements ; • Ensuring that all aspects of this SOP and NCCHS standard P -I-05 are addressed by applicable contract medical provider policy and procedure; • Ensuring facility health authorities utilize all applicable contract medical provider policy, procedure, forms, and educational information to fulfill all healthcare- related requirements provided in this SOP, NCCHC s tandard P-I-05, or as indicated in their respective contractual agreement(s); and • Ensuring all applicable contract medical provider policy, procedure, and forms are submitted to the health authority for review and approval prior to implementation. Nothing in this SOP shall be construed to relieve the contract medical provider(s) of any obligation and/or responsibility stipulated in respective contractual agreements. Facility Health Authority The facility health authority will be responsible for: • Ensuring the presence of an adequate number of appropr iately trained staff are available to meet the requirements of this SOP; and Control Number: 401.06.03.070 Version: 3.0 Title: Informed Consent Page Number: 3 of 4 • Establishing and monitoring applicable contract medical provider policy and procedure to ensure that all elements of this SOP and NCCHC standard P-I-05 are accomplished as required. Table of Contents General Requirements .............................................................................................................. 3 1. Guidelines ........................................................................................................................... 3 2. Compliance ......................................................................................................................... 4 References ................................................................................................................................ 4 GENERAL REQUIREMENTS 1. Guidelines The contract medical provider is responsible for supplying and providing any forms indicated in this section. • The healthcare provider is obligated to provide information sufficient for an offender to make an informed decision to consent to or refuse recommended healthc are intervention. If the offender requests, a more detailed explanation must be provided to include details of the recommended procedure or treatment, the viable alternatives, and any material risks to the recommended procedure or treatment. If an offender does not speak English or Spanish, a written interpretation or telephone interpretation service must be provided in the language spoken. • Prior to any invasive healthcare procedure that has major adverse health risks being performed, written informed consent shall be obtained from the offender. The process for informing and clarifying understanding of the procedure (e.g., face-to- face contact, discussion of the alternative(s), associated risks, etc.) must be documented in the healthcare record. In addition, all signed consents must be witnessed by someone other than the attending practitioner. • When an offender has a health condition that requires diagnostic evaluation or prescribed treatment, the prescribing practitioner must discuss the following with the offender:  The procedure or treatment to be undertaken;  Any alternative procedures or methods of treatment available;  Any associated risks; and  The prognosis (if the proposed treatment is not undertaken). All areas discussed must be documented in the offender’s healthcare record. If the offender does not speak English or Spanish, a written interpretation or telephone interpretation service must be provided in the language spoken. • The offender must be asked if further explanation of the recommended prescribed treatment or diagnostic evaluation is required. If not, the recommended treatment or evaluation is prescribed. • The informed consent form will be completed and signed by the offender for the following procedures: Control Number: 401.06.03.070 Version: 3.0 Title: Informed Consent Page Number: 4 of 4  Incision and drainage;  Skin removal, including biopsy;  Cauterization;  Allergy shots;  Contraception methods/prescription;  All major and minor surgical procedures;  Immunizations;  Psychotropic/neuroleptic medication;  Articular injections;  Other procedures in which there is a probability of major adverse risks; and  All invasive dental procedures. • The prescribing provider must sign an informed consent form indicating that information sufficient to provide informed consent was given to the offender. • The completed informed consent form must be placed in the appropriate section of the healthcare record. • The offender's informed consent is not required for the following circumstances:  For a life-threatening emergency that requires immediate medical intervention to prevent certain death or serious permanent impairment;  For the emergency care of an offender who does not have the mental capacity to provide informed consent and for whom there is not sufficient time to obtain a court order;  When there is a court order to provide the medical treatment or procedure; or  When informed consent is given by a legal guardian. • In the situations described above where informed consent is not obtained, all aspects of the offender's medical condition and reasons for medical intervention must be documented in the progress notes of the offender's healthcare record. 2. Compliance Compliance with this SOP and all related Department -approved protocols will be monitored by the health authority (or designee) by using various sources to include: this SOP, clinical practice guidelines, routine reports, program reviews, and record reviews. The health authority (or designee) must conduct two (2) audits a year (or more frequently as desired based on prior audit results). The audits must consi st of monitoring applicable contract medical provider and IDOC policy and procedures, applicable NCCHC standards, and the review of a minimum of 15 individual records. REFERENCES National Commission on Correctional Health Care (NCCHC), Standard P -I-05, Informed Consent – End of Document –