Current through Rules and Regulations filed through September 23, 2024
(1) The facility shall develop, adopt, implement, and enforce policies and procedures to ensure that each patient is:
(a) Provided communication of information in a manner effective for the patient, which may include the services of an interpreter or written form, as appropriate;
(b) Fully advised of their medical condition in terms that they understand, or, if they are unable to understand, their representative is so advised;
(c) Informed of all treatment modalities and settings for the treatment of end stage renal disease, and of the criteria for suitability for each treatment modality and setting;
(d) Informed about, and given the opportunity to participate in, all decisions about care, including the right to refuse treatment and the medical consequences of refusal;
(e) Informed about all services provided by the facility, the qualifications and training of staff providing services, and the charges for services provided;
(f) Informed of the facility's reprocessing of dialyzers or bloodlines, if supplies are reused;
(g) Transferred or discharged only for medical reasons, for the welfare of the patient, other patients, or staff, or for on payment of fees, and given at least thirty (30) days advance notice of the transfer or discharge unless such delay presents significant risk to the patient or others, and that there is documentation of efforts to resolve issues leading to discharge when the discharge is against the patient's wishes;
(h) Provided information about, and allowed to formulate, advance directives and have them honored in accordance with current statutes; and
(i) Informed of the facility's internal mechanisms for receiving and responding to complaints from patients and others regarding services, and the mechanisms for filing a grievance or complaint against the facility through the licensing agency, without fear of denial of services or retaliation by the facility.
(2) The facility shall inform each patient upon admission of their responsibilities in the treatment process, and of the facility's rules regarding patient conduct.
(3) The facility shall report to the Department whenever any of the following incidents involving patients receiving dialysis services through the facility occurs:
(a) Any unanticipated patient death not related to the natural course of the illness or the patient's underlying condition occurring at the facility or as a direct result of treatment received in the facility;
(b) Any serious injury resulting from the malfunction or intentional or accidental misuse of patient care equipment;
(c) Exsanguination while at the facility;
(d) Any patient dialyzed with another patient's dialyzer where the facility reuses the hemodialyzers;
(e) Any deviation in fulfilling the patient prescription which results in a significant adverse patient outcome;
(f) Any sexual or physical assault of or by a patient which is alleged to have occurred in the facility.
(4) The facility shall make an initial report of the incident within twenty-four (24) hours or by the next business day from when the incident occurred, or from when the facility has reasonable cause to suspect a reportable incident. The initial report shall be received by the Department in confidence, and shall include at least:
(a) The name of the facility;
(b) The date of the incident and that date that the facility became aware that a possible reportable incident may have occurred;
(c) The medical record number(s) of any affected patient(s);
(d) The type of incident suspected, with a brief description of the incident; and
(e) Any immediate corrective action or preventative action taken by the facility to ensure against the replication of the incident prior to the completion of the facility investigation.
(5) The facility is required to conduct an investigation of any of the incidents listed above and to complete and retain on site a written report of the results of the investigation within forty-five (45) days of the discovery of the incident. The complete report of the investigation shall be available to the Department for inspection at the facility, and shall contain at least the following:
(a) An explanation of the circumstances surrounding the incident, including the results of a root cause analysis or other appropriate quality improvement process or tool;
(b) Any findings and conclusions associated with the review; and
(c) A summary of any actions taken to correct identified problems associated with the incident, and to reduce the potential for recurrence of the incident.
O.C.G.A. §§
31-44-3, 31-5-5, 31-7-131 and 31-7-133.
