105 CMR 130.330
Serious Complaint Procedure
Each hospital shall develop a written procedure that assures prompt and complete
investigations of all serious complaints filed against the hospital, employees of the hospital or
members of its medical or professional staff. The procedure shall include, at a minimum, the
following provisions:
(A) Designation of a senior member of the hospital administration as the person responsible for
overseeing the investigation of serious complaints lodged against the hospital, an employee or
member of the medical staff;
(B) Establishment of a reporting procedure that ensures the designated administrator will
receive within one day from hospital staff, in writing, reports of serious complaints;
(C) Development by the designated administrator of a written process of investigation, which
shall include the following:
(1) A process of fact-gathering that he or she will utilize, including provision for
interviewing of the complainant, patient, and relevant witnesses;
(2) Creation of a complaint file that includes the original report of complaint, progress
reports as investigation is carried out and outcome of investigation including action taken,
if any;
(3) Notification of the complainant of the outcome of the investigation.
(D) The complaint files shall be available for inspection by agents of the Department.