documents that such a release would have an adverse effect on the patient or another person. (e) Access to all medical records of patients will be afforded to members of the Medical Staff for bona fide study and research Projects consistent with Hospital policy, applicable federal and state law, and preserving the confidentiality of personal information concerning the individual patients. All such Projects will be approved by The Christ Hospital Institutional Review Board (TCHIRB). (f) Subject to the discretion of the President & Chief Executive Officer (or his or her designee), former members of the Medical Staff may be permitted access to information from the medical records of their patients covering all periods during which they attended to such patients in the Hospital. 3.3. Content of Record: (a) For every patient treated as an inpatient, a medical record will contain information to justify the medical necessity of the admission, continued hospitalization, and/or surgery or procedure. The medical record will describe the patient’s progress and response to medications and services. Medical records will also be kept for every scheduled ambulatory care patient and for every patient receiving emergency services. (b) Medical record entries will be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with the Hospital’s policies and procedures. Stamped signatures are not permitted in the medical record. (c) General Requirements. All medical records for patients receiving care in the hospital setting or at a Hospital-based ambulatory care location will document the information outlined in this paragraph, as relevant and appropriate to the patient’s care. This documentation will be the joint responsibility of the responsible practitioners and the Hospital: (1) identification data, including the patient’s name, sex, address, date of birth, and name of authorized representative; (2) status of any patient receiving behavioral health services; (3) patient’s language and communication needs, including preferred language for discussing health care; (4) authenticated or co-signed order for inpatient admission prior to discharge;
discharged from antepartum service, a patient admitted for less than 48 hours, and a newborn services short admission for less than 48 hours. (d) A death summary is required in any case in which the patient dies in the Hospital, regardless of length of admission. 12.4. Discharge of Minors and Incompetent Patients: Any individual who cannot legally consent to his or her own care will be discharged only to the custody of parents, guardian, or another responsible party unless otherwise directed by the parent, guardian, or court order. If the parent or guardian directs that discharge be made otherwise, that individual will so state in writing and the statement will become a part of the permanent medical record of the patient. 12.5. Discharge Instructions: (a) Upon discharge, the responsible practitioner, along with the Hospital staff, will provide the patient with information regarding why he or she is being discharged and educate that patient about how to obtain further care, treatment, and services to meet his or her identified needs, when indicated. (b) Upon discharge, the patient and/or responsible for providing continuing care will be given written discharge instructions. If the patient or representative cannot read and understand the discharge instructions, the patient or representative will be provided appropriate language resources to permit him or her to understand. (c) The responsible practitioner, along with the Hospital staff, will also arrange for, or help the family arrange for, services needed to meet the patient’s needs after discharge, when indicated. (d) When the Hospital determines the patient’s discharge needs, the responsible practitioner, along with the Hospital staff, promptly will provide appropriate information to the patient and the patient’s family when it is involved in decisionmaking and ongoing care. (e) When continuing care is needed after discharge, the responsible practitioner, along with the Hospital staff, will provide appropriate information to the other health care providers, including: (1) the reason for discharge; (2) the patient’s physical and psychosocial status; (3) a summary of care provided and progress toward goals; (4) community resources or referrals provided to the patient; and
(5) discharge medications. ARTICLE XIII TRANSFER TO ANOTHER HOSPITAL OR HEALTH CARE FACILITY 13.1. Transfer: The process for providing appropriate care for a patient, during and after transfer from the Hospital to another facility, includes: (a) assessing the reason(s) for transfer; (b) establishing the conditions under which transfer can occur; (c) evaluating the mode of transfer/transport to assure the patient’s safety; and (d) ensuring that the organization receiving the patient also receives necessary medical information and assumes responsibility for the patient’s care after arrival at that facility. 13.2. Procedures: (a) Patients will be transferred to another hospital or facility based on the patient’s needs and the Hospital’s capabilities. The responsible practitioner will take the following steps as appropriate under the circumstances: (1) identify the patient’s need for continuing care in order to meet the patient’s physical and psychosocial needs; (2) inform patients and their family members (as appropriate), in a timely manner, of the need to plan for a transfer to another organization; (3) involve the patient and all appropriate practitioners, Hospital staff, and family members involved in the patient’s care, treatment, and services in the planning for transfer; and (4) provide the following information to the patient whenever the patient is transferred: (i) the reason for the transfer;
ARTICLE XIV RESEARCH 14.1. General: (a) All research involving human subjects (sponsored or non-sponsored) will be conducted in a manner that minimizes risks to the welfare, health, and safety of the participants. Patient’s rights, including the right of privacy, will be preserved, and an informed consent form will be obtained from the patient, or his or her authorized representative, prior to such participation. (b) The TCHIRB is designated to oversee research on subjects conducted by the administration, nursing, medical and resident staff, or involving nonpublic information held by the Hospital. The purpose of the TCHIRB is to protect the rights and welfare of human subjects participating in research and to ensure that the human research conducted under this Article complies with all federal regulations, including those promulgated by the Department of Health and Human Services and the Food and Drug Administration at 45 C.F.R. §46 and 21 C.F.R. §§50, 56 and 812, and conforms to federal and state laws and the Hospital’s policies. The ethical principles are based on the Nuremburg Code, the Declaration of Helsinki, the Belmont Report, and the International Conference on Harmonization (Good Clinical Practices). (c) The President & Executive Officer is responsible for the appointment of members of the TCHIRB and the oversight of the TCHIRB. The Hospital may not approve research covered under this Article if it has not been approved by the TCHIRB; however, the Hospital administration may decline to conduct research previously approved by the TCHIRB. Investigators may not begin research involving human subjects until the TCHIRB has approved the study or has determined that it is exempt. 14.2. Prior Review of Proposed Research Projects: (a) The Administration of the Hospital will assist in determining the feasibility of protocols or proposals for research. Prior review of any proposed research project involving human subjects will be obtained from the appropriate service line executive medical director (and division chief, if applicable) to include assurances that: (1) the principal investigator has appropriate training and expertise, adequate resources and sufficient time allocation to conduct the research;