N.J. Admin. Code § 8:43E-10.6 : HEALTH — GENERAL LICENSURE PROCEDURES AND STANDARDS APPLICABLE TO ALL LICENSED FACILITIES — PATIENT OR RESIDENT SAFETY REQUIREMENTS AND REPORTABLE EVENTS —10.6 - Reporting of serious preventable adverse events

(a) A health care facility shall report to the Department or, in the case of a State psychiatric hospital, to the Department of Human Services, every serious preventable adverse event that occurs in the facility.

1. The Department shall deem Medicare and/or Medicaid nursing homes that are otherwise compliant with applicable Federal reporting statutes and regulations, as well as with 52:27G-7.1 and N.J.A.C. 8:39, to be in compliance with (a) above, and shall not require facilities deemed compliant to file reports in accordance with this section.

2. Adult and pediatric day health care services facilities and facilities that provide home-based services, that is, home health care facilities, hospice facilities, assisted living residences, comprehensive personal care homes, and assisted living programs, shall report only those serious preventable adverse events that are within the control of the facility or directly caused by, or related to, services of the facility.

i. With respect to serious preventable adverse events related to health care services provided directly to residents of an assisted living residence, comprehensive personal care home or assisted living program by another health care facility, the facility directly providing the service shall report the event to the Department.

(b) A facility shall notify the Department, or the Department of Human Services, as applicable, of the occurrence of an event subject to mandatory reporting, pursuant to (a) above, no later than five business days after the facility discovers the occurrence of the event.

1. If a facility does not have all the information required pursuant to (c) below for a complete report, the facility shall submit a partial report on a serious preventable adverse event within the time specified in (b) above, and shall then update this initial partial report as soon as the other information required pursuant to (c) below becomes available.

2. If a facility discovers an event subject to mandatory reporting pursuant to (a) above and the event occurred in a different facility, such as the erroneous retention of an object in the body after surgery, the facility that discovers the event shall notify the Department within the time specified in (b) above, but shall be exempt from the requirement to perform a root cause analysis of the event.

i. If the facility that discovers the event knows the identity of the facility where the event occurred, the reporting facility shall include this information in its notice to the Department.

(c) A facility shall submit, pursuant to (a) above, the form provided at subchapter Appendix A, incorporated herein by reference, which includes the following information:

1. The facility name, license number, and address, and the name and title of the person submitting the report;

2. A brief description of the event, including the impact on the patient or resident;

3. The date and time the event occurred;

4. Where the patient or resident was when the event occurred;

5. The date and time the facility became aware of the event;

6. How the event was discovered;

7. The patient or resident's billing and medical record number, date of admission or ambulatory encounter, demographic information, and, for inpatients, whether the patient was admitted directly, by transfer, or through the emergency department;

8. The type of serious preventable adverse event, using the categories provided at (e) through (j) below;

9. The immediate corrective actions the facility took to eliminate or reduce the adverse impact of the event and to prevent future similar events;

10. If the facility previously submitted a partial report on the event pursuant to (b)1 above, the report number assigned to the prior report by the Department; and

11. If the facility previously submitted a report on the event containing incorrect information, the report number assigned to the prior report by the Department and the correct information.

(d) Facilities shall report the information required pursuant to (c) above by means of telefacsimile using the form provided in subchapter Appendix A.

1. The telefacsimile number to which facilities are to submit event reports to the Department is (609) 530-4850.

2. The telephone number facilities may use to obtain additional information concerning the event report and form is (609) 530-7473.

(e) Types of serious preventable adverse events include, but are not limited to, the categories listed in (f) through (j) below.

1. A facility shall report in the appropriate category events that are not specifically listed that meet the definition of a serious preventable adverse event.

2. Based on the types of services a facility provides, some categories may not be applicable; for example, surgical events could only occur at facilities that perform surgical procedures.

3. For purposes of this section, "associated with" means that it is reasonable to assume initially that the serious preventable adverse event was due to the referenced course of care; however, further investigation or a root cause analysis of the event may be needed to confirm or refute the presumed relationship.

(f) Patient or resident care management-related events include, but are not limited to:

1. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days or, in the case of a non-residential health care facility, still present at discharge, associated with a medication error (such as errors involving the wrong drug, wrong dose, wrong patient or resident, wrong time, wrong rate, wrong preparation, or wrong route of administration);

2. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days or, in the case of a non-residential health care facility, still present at discharge, associated with a hemolytic reaction due to the administration of ABO/HLA-incompatible blood or blood products;

3. Maternal death, loss of body part, disability or loss of bodily function lasting more than seven days or still present at discharge associated with labor or delivery in a low-risk pregnancy while in a health care facility;

4. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days or, in the case of a non-residential health care facility, still present at discharge associated with hypoglycemia, the onset of which occurs while the patient or resident is being cared for in the health care facility;

5. Death or kernicterus associated with failure to identify and treat hyperbilirubinemia in a neonate while the neonate is a patient in a health care facility;

6. Stage III or IV pressure ulcers acquired after admission of the patient or resident to a health care facility.

i. Progression from stage II to stage III is excluded from the meaning of (f)6 above, provided that stage II was recognized and documented upon admission; and

7. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days or, in the case of a non-residential health care facility, still present at discharge, associated with spinal manipulative therapy provided in a health care facility.

(g) Environmental events include, but are not limited to:

1. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days or, in the case of a non-residential health care facility, still present at discharge, associated with an electric shock while being cared for in a health care facility.

i. Events involving planned treatments, such as electric countershock (heart stimulation) or elective cardioversion, are excluded from the meaning of (g)1 above;

2. Incidents in which a line designated for oxygen or other gas to be delivered to a patient or resident contains the wrong gas or is contaminated by toxic substances and results in patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days or, in the case of a non-residential health care facility, still present at discharge;

3. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days or, in the case of a non-residential health care facility, still present at discharge, associated with a burn incurred from any source while in a health care facility;

4. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days or, in the case of a non-residential health care facility, still present at discharge, associated with a fall while in a health care facility; and

5. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days, or in the case of a non-residential health care facility, still present at discharge, associated with the use of restraints or bedrails while in a health care facility.

(h) Product or medical device-related events include, but are not limited to:

1. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days or, in the case of a non-residential health care facility, still present at discharge, associated with use of generally detectable contaminated drugs, medical devices, or biologics provided by the health care facility, regardless of the source of contamination or product.

i. For purposes of (h)1 above, "generally detectable" means capable of being observed with the naked eye or with the use of detection devices in general use;

2. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days, or in the case of a non-residential health care facility, still present at discharge, associated with the use or function of a medical device in patient or resident care in which the device is used or functions other than as intended, including, but not limited to, catheters, drains, and other specialized tubes, infusion pumps, and ventilators;

3. Intravascular air embolism that occurs while the patient or resident is in the facility.

i. Paragraph (h)3 above does not include deaths or disability associated with neurosurgical procedures known to present a high risk of intravascular air embolism; and

4. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days or, in the case of a non-residential health care facility, still present at discharge, associated with the use of a new or reprocessed single-use device in patient or resident care in which the device is used or functions other than as intended.

(i) Surgery-related events include, but are not limited to:

1. Surgery initiated (whether or not completed) on a patient that is not consistent with the patient's documented informed consent, including, but not limited to, a surgical procedure intended for a patient "A" that is initiated on the wrong body part of patient "A," and a surgical procedure intended for another patient of the facility, but initiated on patient "A".

i. Surgery-related events exclude emergent situations that occur in the course of surgery and as to which exigency precludes obtaining informed consent;

2. Retention of a foreign object in a patient after surgery, excluding objects intentionally implanted as part of a planned intervention, objects present prior to surgery that were intentionally retained, and retained broken microneedles; and

3. Intraoperative or post-operative (that is, within 24 hours) coma, death, or other serious preventable adverse event in any patient of an ambulatory surgery facility, in any hospital same-day surgery patient, or in any American Society of Anesthesiologists (ASA) Class I hospital inpatient;

i. Paragraph (i)3 above includes all patient deaths, coma or other serious preventable adverse events in situations where anesthesia was administered, regardless of whether the planned surgical procedure was carried out.

(j) Patient or resident protection-related events include, but are not limited to:

1. Discharge of an infant to the wrong person, excluding patient or resident abductions covered under N.J.A.C. 8:34E-10.11(b);

2. Patient or resident death, loss of body part, disability or loss of bodily function lasting more than seven days associated with patient or resident elopement; and

3. Patient or resident suicide or attempted suicide while in a health care facility.

i. Paragraph (j)3 above does not include deaths or disability resulting from self-inflicted injuries that were the reason for admission to the health care facility.

(k) A facility shall submit to the Department a root cause analysis of every serious preventable adverse event subject to mandatory reporting pursuant to (a) above no later than 45 days after the submission of the initial report of the event using the form provided at subchapter Appendix B, incorporated herein by reference.

1. The mailing address to which facilities are to submit reports to the Department is:

Patient Safety Initiative

Health Care Quality Assessment

Department of Health and Senior Services

25 Scotch Road, Suite 10

Ewing, NJ 08628-2500

2. The Department shall deem Medicare and/or Medicaid nursing homes that are otherwise compliant with applicable Federal reporting statutes and regulations, and with 52:27G-7.1 and N.J.A.C. 8:39, to be in compliance with (k) above, and shall not require facilities deemed compliant to file root cause analyses in accordance with this section.

3. State-operated psychiatric hospitals shall comply with the requirements for submission of RCAs set forth in policies and procedures of the Department of Human Services.

(l) The root cause analysis performed by a facility in response to a report of an occurrence of a serious preventable adverse event may vary in substance and complexity, depending on the nature of the facility and the event involved, but shall include the following general components:

1. A description of the event, including when, where and how the event occurred and the adverse outcome for the patient or resident;

2. An analysis of why the event happened that includes an analysis not only of the direct cause(s) of the event, but also potential underlying causes related to the design or operation of facility systems;

3. The corrective action(s) taken for those patients or residents affected by the event;

4. The method for identifying other patients or residents or settings having the potential to be affected by the same event and the corrective action(s) to be taken;

5. The measures to be put into place or systematic changes needed to reduce the likelihood of similar events in the future; and

6. How the corrective action(s) will be monitored to assess their impact.

(m) The Department shall:

1. Review an RCA to determine whether it satisfies the criteria in ( l) above; and

2. Return an RCA that does not meet the criteria in ( l) above to the facility for revision and shall not consider the RCA complete until the Department determines that the RCA meets the criteria in ( l) above.

(n) The Department anticipates the development of an Internet web-based electronic reporting system, but in the interim shall require facilities to submit event reports pursuant to (d) above and to submit root cause analyses pursuant to (k) above.

1. The Department shall provide notice to facilities on the reporting medium to be used, including telephone and facsimile numbers, e-mail addresses and/or web addresses.

(o) Single copies of the forms provided at subchapter Appendices A and B, suitable for photocopying, are available upon request to the Patient Safety Initiative at the address set forth at subsection (d) above and are also available for download from the Department's Forms web page at and also from the program's web page at .

N.J. Admin. Code § 8:43E-10.6