Ga. Comp. R. & Regs. R. 111-8-40-.07 - Hospital Inspections and Required Reports to the Department

(1) Inspections by the Department. The hospital shall be available during all hours of operation for observation and examination by properly identified representatives of the Department.

(a) Initial Inspection. There shall be an initial inspection of a hospital prior to the opening date in order to determine that the hospital is in substantial compliance with these rules. Prior to this initial inspection, the hospital shall submit to the Department:

1. A copy of the certificate of occupancy;

2. Verification of building safety and fire safety from local and state authorities; and

3. Evidence of appropriate approvals by the state architect.

(b) Periodic Inspections. The hospital shall be subject to periodic inspections to determine that there is continued compliance with these rules, as deemed necessary by the Department.

(c) Random Inspections. The hospital may be subject to additional or more frequent inspections by the Department where the Department receives a complaint alleging a ruleviolation by the hospital or the Department has reason to believe that the hospital is in violation of these rules.

(d) Plans of Correction. If violations of these licensing rules are identified, the hospital will be given a written report of the violation that identifies the rules violated. The hospital shall submit to the Department a written plan of correction in response to the report of violation, which states what the hospital will do, and when, to correct each of the violations identified. The hospital may offer an explanation or dispute the findings or violations in the written plan of correction, so long as an acceptable plan of correction is submitted within ten (10) days of the hospital's receipt of the written report of inspection. If the initial plan of correction is unacceptable to the department, the hospital will be provided with at least one (1) opportunity to revise the unacceptable plan of correction. The hospital shall comply with its plan of correction.

(e) Accreditation in Place of Periodic Inspection. The Department may accept the accreditation of a hospital by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), the American Osteopathy Association (AOA), or other approved accrediting body, in accordance with specific standards determined by the Department to be substantially equivalent to state standards, as representation that the hospital is or remains in compliance with these rules.

1. Hospitals accredited by an approved accrediting body shall present to the Department a copy of the full certification or accreditation report each time there is an inspection by the accreditation body and a copy of any reports related to the hospital's accreditation status within thirty (30) days of receipt of the final report of the inspection.

2. Hospitals accredited by an approved accrediting body are excused from periodic inspections. However, these hospitals may be subjected to random inspections by the Department for continuation of the permit when:

(i) A validation study of the accreditation process is necessary;

(ii) There has been a complaint alleging a rule violation which the Department determines requires investigation;

(iii) The Department has reason to believe that there is a patient incident or situation in the hospital that presents a possible threat to the health or safety of patients; or

(iv) There are additions to the services previously offered by the hospital which the Department determines requires an on-site visit.

(2) Required Reports to the Department.

(a) Patient Incidents Requiring Report.

1. The hospital's duly constituted peer review committee(s) shall report to the Department, as required below, whenever any of the following incidents involving hospital patients occursor the hospital has reasonable cause to believe that a reportable incident involving a hospital patient has occurred:

(i) Any unanticipated patient death not related to the natural course of the patient's illness or underlying condition;

(ii) Any rape which occurs in a hospital;

(iii) Any surgery on the wrong patient or the wrong body part of the patient; and

(iv) Effective three (3) months after the Department provides written notification to all hospitals the hospital's duly constituted peer review committee(s) shall also report to the Department, whenever any of the following incidents involving hospital patients occurs or the hospital has reasonable cause to believe that a reportable incident involving a hospital patient has occurred:

(I) Any patient injury which is unrelated to the patient's illness or underlying condition and results in a permanent loss of limb or function;

(II) Second or third degree burns involving twenty (20) percent or more of the body surface of an adult patientor fifteen (15) percent or more of the body surface of a child which burns were acquired by the patient in the hospital;

(III) Serious injury to a patient resulting from the malfunction or intentional or accidental misuse of patient care equipment;

(IV) Discharge of an infant to the wrong family;

(V) Any time an inpatient, or a patient under observation status, cannot be located, where there are circumstances that place the health, safety, or welfare of the patient or others at risk and the patient has been missing for more than eight (8) hours;and

(VI) Any assault on a patient, which results in an injury that requires treatment.

2. The hospital's peer review committee(s) shall make the self-report of the incident within twenty-four (24) hours or by the next regular business day from when the hospital has reasonable cause to believe an incident has occurred. Theself-report shall be received by the Department in confidence and shall include at least:

(i) The name of the hospital;

(ii) The date of the incident and the date the hospital became aware that a reportable incident may have occurred;

(iii) The medical record number of any affected patient(s);

(iv) The type of reportable incident suspected, with a brief description of the incident; and

(v) Any immediate corrective or preventative action taken by the hospital to ensure against the replication of the incident prior to the completion of the hospital's investigation.

3. The hospital's peer review committee(s) shall conduct an investigation of any of the incidents listed above and 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:

(i) An explanation of the circumstances surrounding the incident, including the results of a root cause analysisor other systematic analysis;

(ii) Any findings or conclusions associated with the review; and

(iii) A summary of any actions taken to correct identified problems associated with the incident and to prevent recurrence of the incident and also any changes in procedures or practices resulting from the internal evaluation using the hospital's peer review and quality management processes.

4. The Department shall hold the self-report made through the hospital's peer review committee(s) concerning a reportable patient incident in confidence as a peer review document or report and not release the self-report to the public. However, where the Department determines that a rule violation related to the reported patient incident has occurred, the Department will initiate a separate complaint investigation of the incident. The Department's complaint investigation and the Department's report of any rule violation(s) arising either from the initial self-report received from the hospital or an independent source shall be public records.

(b) Other Events/Incidents Requiring Report.

1. The hospital shall report to the Department whenever any of the following events involving hospital operations occurs or when the hospital becomes aware it is likely to occur, to the extent that the event is expected to cause or causes a significant disruption of patient care:

(i) A labor strike, walk-out, or sick-out;

(ii) An external disaster or other community emergency situation; and

(iii) Aninterruption of services vital to the continued safe operation of the facility, such as telephone, electricity, gas, or water services.

2. The hospital shall make a report of the event within twenty-four (24) hours or by the next regular business day from when the reportable event occurred or from when the hospital has reasonable cause to anticipate that the event is likely to occur. The report shall include:

(i) The name of the hospital;

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

(iii) The anticipated effect on patient care services, including any need for relocation of patients; and

(iv) Any immediate plans the hospital had made regarding patient management during the event.

3. Within forty-five (45) days following the discovery of the event, the hospital shall complete an internal evaluation of the hospital's response to the event where opportunities for improvement relating to the emergency disaster preparedness plan were identified. The hospital shall make changes in the emergency disaster preparedness plan as appropriate. The complete report of the evaluation shall be available to the Department for inspection at the facility.

Notes

Ga. Comp. R. & Regs. R. 111-8-40-.07

O.C.G.A. §§ 31-2-7, 31-2-8, 31-7-2.1, 31-7-15, 31-7-133, 31-7-140 and 50-18-72.

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