§ 51.3. Notification.
(a) A health care facility shall notify the Department in writing at least 60 days prior to the intended commencement of a health care service which has not been previously provided at that facility.
(b) A health care facility shall notify the Department in writing at least 60 days prior to the intended date of providing services in new beds it intends to add to its approved complement of beds.
(c) A health care facility shall provide similar notice at least 60 days prior to the effective date it intends to cease providing an existing health care service or reduce its licensed bed complement.
(d) A health care facility shall submit to the Department architectural plans and blueprints of proposed new construction, alteration or renovation to the facility. This material shall be submitted at least 60 days before the initiation of construction, alteration or renovation. The Department will review these documents to assure compliance with relevant life safety code and other regulatory requirements. The Department will respond to the facility by either issuing an approval or disapproval or requesting further information within 45 days of receipt of the facilitys submission. The facility may not initiate construction, alteration or renovation until it has received an approval from the Department.
(e) If a health care facility is aware of information which shows that the facility is not in compliance with any of the Departments regulations which are applicable to that health care facility, and that the noncompliance seriously compromises quality assurance or patient safety, it shall immediately notify the Department in writing of its noncompliance. The notification shall include sufficient detail and information to alert the Department as to the reason for the failure to comply and the steps which the health care facility shall take to bring it into compliance with the regulation.
(Editors Note: Under section 314 of the act of March 20, 2002 (P. L. 154, No. 13) (act), subsections (f) and (g) are abrogated with respect to a medical facility upon the reporting of a serious event, incident or infrastructure failure pursuant to section 313 of the act.)
(f) If a health care facility is aware of a situation or the occurrence of an event at the facility which could seriously compromise quality assurance or patient safety, the facility shall immediately notify the Department in writing. The notification shall include sufficient detail and information to alert the Department as to the reason for its occurrence and the steps which the health care facility shall take to rectify the situation.
(g) For purposes of subsections (e) and (f), events which seriously compromise quality assurance or patient safety include, but are not limited to, the following:
(1) Deaths due to injuries, suicide or unusual circumstances.
(2) Deaths due to malnutrition, dehydration or sepsis.
(3) Deaths or serious injuries due to a medication error.
(5) Transfers to a hospital as a result of injuries or accidents.
(6) Complaints of patient abuse, whether or not confirmed by the facility.
(8) Surgery performed on the wrong patient or on the wrong body part.
(9) Hemolytic transfusion reaction.
(10) Infant abduction or infant discharged to the wrong family.
(11) Significant disruption of services due to disaster such as fire, storm, flood or other occurrence.
(12) Notification of termination of any services vital to the continued safe operation of the facility or the health and safety of its patients and personnel, including, but not limited to, the anticipated or actual termination of electric, gas, steam heat, water, sewer and local exchange telephone service.
(13) Unlicensed practice of a regulated profession.
(14) Receipt of a strike notice.
(h) A health care facility shall send the written notification required under subsections (a)(f) to the director of the division in the Department responsible for the licensure of the health care facility.
(i) Information contained in the notification submitted to the Department by a facility under subsection (e) or (f) may not, unless otherwise ordered by a court for good cause shown, be produced for inspection or copying by, nor may the contents thereof be disclosed to, a person other than the Secretary, the Secretarys representative or another government agency, without the consent of the facility which filed the report.
(j) The Secretary and the Secretarys representative shall use the information contained in the notification from the facility only in connection with the enforcement of the Departments responsibilities under the act, or other applicable statutes within the Departments jurisdiction.
(k) The notification requirements of this section do not require a facility, in providing a notification under subsection (e) or (f), to include information which is deemed confidential and not reportable to the Department under other provisions of Federal or State law or regulations.
(l) A health care facility may not commence the provision of new health care services or provide services in new beds until it has been informed by the Department that it is in compliance with all licensure requirements.
This section cited in 28 Pa. Code § 201.14 (relating to responsibility of licensee).
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