Ga. Comp. R. & Regs. R. 111-8-10-.27 - Reports to the Department

(1) Clinical laboratories shall report to the Department evidence of selected infectious diseases on forms provided by the Department.

(2) Clinical laboratories making such reports concerning infectious diseases shall not be held liable for having violated a trust or confidential relationship. The reports shall be deemed confidential and not subject to public inspection.

(3) Reports of Serious Incidents/Events. The laboratory shall report to the Department the following incidents:

(a) Fatal transfusion reactions or transfusion complications affecting the patients;

(b) Laboratory testing errors which have resulted in the death or serious injury to a patient or employee;

(c) Significant interruptions in service vital to the continued safe operation of the facility, such as the loss of electricity, gas or water services.

(4) The laboratory shall make the initial report of the serious incident/ event within twenty-four (24) hours or by the next regular business day from when the reportable event occurred, or from when the laboratory has reasonable cause to believe that the reportable event has occurred. The initial report shall be received by the Department in confidence and shall include at least the following:

(a) The name of the laboratory;

(b) The date of the event or the anticipated event and the duration of the incident, if known;

(c) Any immediate corrective actions that the laboratory has taken or expects to take.

(5) Within forty-five (45) days following the resolution of the event, the laboratory shall prepare a written report which includes a root cause analysis on systems and processes associated with the event to identify those improvements that are within the control of the laboratory that will be made to help prevent similar occurrences. The complete report shall be available to the Department for inspection at the facility. The laboratory is not required to complete a written report or a root cause analysis on interruptions in service for which the laboratory did nothing that contributed to the interruption in service.

(6) The Department will hold the initial self-report concerning the reportable serious incident/event in confidence and not release it to the public. However, where the Department determines that a rule violation related to the reported serious incident/event has occurred, the Department will initiate a separate complaint investigation of the incident. The separate complaint investigation report and survey results concerning the serious incident/event will not be kept confidential.

(7) Where a licensed laboratory is operated as an organized service of the licensed hospital, the laboratory may comply with the requirements for reporting serious incidents/events set forth in this rule by submitting its reports to the Department through the hospital- wide peer review committee, so long as the reports are made in a timely manner. Only one self-report of each serious incident/event is required to be made for the licensed laboratory that is operating within a licensed hospital.

Notes

Ga. Comp. R. & Regs. R. 111-8-10-.27

O.C.G.A. §§ 31-7-15 and 31-22-1et seq.

Original Rule entitled "Reports to the Department" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.