Section 1345.65  Adverse Occurrences

a)         "Adverse occurrence" shall be defined for the purposes of this Section as:

1)         The death of a neonate under the licensee's care within 48 hours after delivery or attempted delivery, not including a stillbirth or miscarriage;

2)         The death after a pregnant or postpartum patient under the licensee's care within 48 hours after delivery or attempted delivery;

3)         The in-patient emergency hospitalization of a neonate under the licensee's care within 48 hours after delivery or attempted delivery; or

4)         The in-patient emergency hospitalization of a patient under the licensee's care within 48 hours after delivery or attempted delivery.

b)         "Emergency hospitalization" shall be defined for the purposes of this Section as a hospitalization of a neonate or patient suffering an acute injury or illness that poses an immediate risk to life or long-term health requiring immediate medical attention and that is related to delivery or attempted delivery.

c)         Maternal emergency hospitalization events reportable under this Section include:

1)         Acute myocardial infarction;

2)         Aneurysm;

3)         Acute renal failure;

4)         Adult respiratory distress syndrome;

5)         Amniotic fluid embolism;

6)         Cardiac arrest/ventricular fibrillation;

7)         Conversion of cardiac rhythm;

8)         Disseminated intravascular coagulation;

9)         Eclampsia;

10)       Heart failure/arrest;

11)       Puerperal cerebrovascular disorders;

12)       Pulmonary edema/acute heart failure;

13)       Severe anesthesia complications;

14)       Sepsis;

15)       Shock;

16)       Sickle cell disease with crisis;

17)       Air and thrombotic embolism;

18)       Blood products transfusion;

19)       Hysterectomy;

20)       Temporary tracheostomy;

21)       Ventilation;

22)       Hemorrhage or excessive laceration bleeding requiring repair;

23)       Retained placenta;

24)       Cord prolapse; or

25)       Other adverse conditions or occurrences equivalent to those listed above.

d)         Neonatal emergency hospitalization events reportable under this Section include:

1)         Severe birth trauma;

2)         Severe hypoxia/asphyxia;

3)         Severe shock and resuscitation;

4)         Neonatal severe respiratory complications;

5)         Neonatal severe infection;

6)         Neonatal severe neurological complications;

7)         Severe shock and resuscitation procedures;

8)         Neonatal severe respiratory procedures;

9)         Neonatal severe neurological procedures;

10)       Sepsis; or

11)       Other adverse conditions or occurrences equivalent to those listed above.

e)         A licensee shall report to the Division within 24 hours after each adverse occurrence that involves the death of a neonate or patient.  The report shall be submitted to the Division on a form provided by the Division and mailed to the Division or submitted electronically.

f)         A licensee shall report to the Division within 14 days after each adverse occurrence that involves the in-patient emergency hospitalization of a neonate or patient.  The report shall be submitted to the Division on a form provided by the Division and mailed to the Division or submitted electronically.

g)         The adverse occurrence report shall be in writing and shall include:

1)         The licensee's name and license number;

2)         The date and time of the occurrence;

3)         The location of the occurrence, including the name and address of the birth center, if applicable;

4)         The name of the patient;

5)         The name of the hospital involved in the occurrence, if any; and

6)         The circumstances involved in such occurrence.

h)         The adverse occurrence report is required by the Division to assist in its mission of protecting the public.  The filing of such report by a licensee shall not constitute an admission by the licensee of any wrongdoing, malpractice, error or omission in treatment, or even that the death or in-patient emergency hospitalization is related to the licensee's care.  A licensee shall be responsible for filing an adverse occurrence report only for those adverse occurrences of which the licensee has knowledge or should reasonably have been expected to have knowledge.  In the event that a licensee does not have knowledge or cannot reasonably be expected to have knowledge, but subsequently obtains actual knowledge of an adverse occurrence, then such licensee shall file an adverse occurrence report within 24 hours after obtaining knowledge of the death of a neonate or patient or within 14 days after obtaining knowledge of the in-patient emergency hospitalization of a neonate or patient.  An adverse occurrence report is an investigatory record and is confidential under Section 180 of the Act.

i)          Failure to provide such a report to the Division shall be grounds for discipline (see Section 100(a)(8) of the Act and Section 1345.70).

j)          A licensed certified professional midwife shall be deemed to be in compliance with the reporting requirements of this Section if the licensed certified professional midwife is employed by or is practicing at a birth center and the birth center submits the report required by this Section.