The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

THE UNIVERSITY HOSPITAL 150 BERGEN ST NEWARK, NJ 07103 Dec. 10, 2018
VIOLATION: GOVERNING BODY Tag No: A0043
Based on observation, staff interview, and review of facility documents conducted November 27, 28, 29, 30, 2018, December 3, 5, 6, 7, and 10, 2018, it was determined that the Governing Body failed to demonstrate it is effective in carrying out its responsibilities for the operation and management of the hospital. The Governing Body failed to provide necessary oversight and leadership as evidenced by the lack of compliance with the following Conditions of Participation:

The facility failed to ensure that hand washing education for the entire hospital staff was increased after becoming aware the Qualification Testing for molecular isotopes identified the strain of Acinetobacter Baumannii in the FICN as the same strain of Acinetobacter Baumannii that is in the adult population. Cross Reference: CFR 482.12(b)

CFR 482.23 Nursing Services

The facility failed to ensure that registered nurses supervised and evaluated the nursing care of each patient.
Cross Reference: CRF 482.23(b)

The facility failed to ensure Registered Nurses evaluate the care of each patient, when appropriate, on an ongoing basis, including assessing the patient's needs, patient's health status, as well as the patient's response to interventions. Cross Reference: CRF 482.23(b)(5)

The baby was on a cardiac monitor. The alarm defaulted to a setting that was barely audible. The baby was found unresponsive and resuscitation was unsuccessful. Cross Reference: CRF 482:23(b)(3)

CFR 482.42 Infection Control

The facility failed to maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases.
Cross Reference: CRF 482:42(a)

The facility failed to ensure a hand hygiene program was implemented, and maintained hospital-wide for the prevention and control of infections and communicable diseases.
Cross Reference: CRF 482:42(a)(1)
VIOLATION: CHIEF EXECUTIVE OFFICER Tag No: A0057
Based on observations, staff interview, review of facility policies and procedures and review of facility documents, it was determined that the facility failed to provide a safe environment for all patients in the Neonatal Intensive Care Unit, also referred to as the FICN (F-Level Intensive Care Unit).

1. Upon interview on 11/27/18, Staff #5 stated the Qualification Testing for molecular isotopes identified the strain of Acinetobacter Baumannii in the FICN is the same strain of Acinetobacter Baumannii that is in the adult population. Staff #5 also stated that Staff #2 and Staff #8 are aware of it.

a. An email dated 11/25/18, addressed to Staff #8, states, "The recent NICU (strain of Acinetobacter Baumannii) seems the same as the major clone going around the [adult] ICUs... ."

b. The Acinetobacter Baumannii NICU isolates are dated 11/21/2018.

c. Staff #5 stated, "Currently we have eight (8) patients in house with MDR (multidrug-resistant) Acinetobacter. This is a list of the patients."

2. Upon review on 11/27/18 of the Hand Hygiene Education the following was noted:

a. Only 74% of the F-Level Intensive Care Unit staff received Hand Hygiene Education.

b. Only 20% of the PICU (Pediatric Intensive Care Unit) staff received Hand Hygiene Education.

c. Only 72% of the MICU (Medical Intensive Care Unit) staff received Hand Hygiene Education.

d. Only 55% of the CCU (Cardiac Care Unit) staff received Hand Hygiene Education.

e. Only 39% of the CTICU (Cardio Thoracic Intensive Care Unit) staff received Hand Hygiene Education.

f. Only 80% of the SICU (Surgical Intensive Care Unit) staff received Hand Hygiene Education.

g. Only 37.5% of the Float RN staff received Hand Hygiene Education.

3. Upon interview with Staff #5 on 11/27/18, he/she stated that 74% of the FICN staff received Hand Hygiene Education.
VIOLATION: NURSING SERVICES Tag No: A0385
Based on observation, medical record review, staff interviews, and review of facility documents, it was determined that the facility failed to ensure a well-organized and supervised nursing service, as evidenced by the lack of compliance with the following regulations:

482.23(b)The facility failed to ensure that registered nurses supervised and evaluated the nursing care of each patient.

1. On 12/3/18 at 14:00 PM, Patient #25 was found unresponsive. Cardiopulmonary resuscitation was unsuccessful. The baby was pronounced dead at 2:44 PM.

a. On 12/3/18 at approximately 12:30 PM, the Charge Nurse, Staff #24, was left to care for seven (7) babies from 12:30 PM until 13:15 PM, approximately 45 minutes.

b. A nasogastric tube feeding was started on Patient #25 on 12/3/18 at 12:30 PM by the Charge Nurse.

(i) There was no documented evidence in the baby's medical record that the baby was reassessed after the tube feeding was started until he/she was found unresponsive on 12/3/18 at 2:00 PM. Resuscitative efforts were unsuccessful. Cross Reference: CRF 482:23(b)

482.23(b)(5)The facility failed to ensure Registered Nurses evaluate the care of each patient when appropriate on an ongoing basis including assessing the patient's needs, patient's health status, as well as the patient's response to interventions.

1. Upon review of the Clinical Audit Data for the cardiac monitor assigned to the baby (Patient #25) the following was noted during the period of 12/2/18 1900 through 12/3/18, 1400:

a. Twenty-five (25) episodes of desaturation. (Oxygen desaturation occurs when the level of oxygen in the blood is decreased, resulting in not having enough oxygen).

b. Thirty-three (33) episodes of bradycardia. (Infantile bradycardia is a slow heart rate of below 100 beats per minute in an infant. Bradycardia is often accompanied by pauses in breathing).

c. Thirty-seven (37) episodes of asystole. (Asystole is a state of no cardiac electrical activity, no contractions of the muscular tissue of the heart and no cardiac output or blood flow).

d. Nine (9) episodes of apnea. (Apnea is cessation of breathing).

e. Four (4) episodes of ventricular fibrillation. (Ventricular fibrillation is a state of disordered electrical activity causing the heart's lower chambers, the ventricles to quiver/fibrilate instead of beating normally).

2. All of the above episodes were out of the normal range.

3. Upon interview, Staff #5 stated the alarm is triggered every time an episode occurs outside the normal range. Staff #5 confirmed the alarm was triggered during all of the above episodes of desaturation, bradycardia, asystole, apnea and ventricular fibrillation.

4. Upon interview, Staff #5 stated the infant (Patient #25) was on a cardiac monitor. The alarm defaulted to a setting that was barely audible. The infant was found unresponsive by the RN and resuscitation was unsuccessful. Cross Reference: CRF 482:23(b)(3)
VIOLATION: STAFFING AND DELIVERY OF CARE Tag No: A0392
A. Based on review of the facility Master Staffing Plan, review of facility documents, and staff interviews, it was determined that the facility failed to provide an adequate number of licensed Registered Nurses to provide nursing care to all patients as needed.

Findings include:

Reference: Facility policy, Master Staffing Plan, indicates, "...Policy: ...5.1 On a shift to shift basis, staffing requirements for each unit are reviewed by the Staffing Coordinator/Patient Care Coordinators/Nurse Managers/Assistant Nurse Managers to ensure that personnel assigned are adequate in number...to meet the patient care requirements. 5.2 When staffing levels cannot be maintained with permanent staff on a unit, the Staffing office personnel will supplement the staffing complement through reassignment or recruitment of Float Pool, Per Diem, Overtime, and agency Staff... 6. Minimum Nurse: Patient Ratios are established for each nursing unit (Attachment A). ... Attachment A ... FIN (Intermediate Nursery) Nurse/PT Ratio 1:4 ... FICN (Fetal Intensive Care Nursery) Nurse/PT Ratio 1:2 ..."

1. On 12/5/18, the Daily Assignment Sheets for the FICN for 12/2/18 and 12/3/18 were reviewed. During this time, two (2) out four (4) shifts failed to meet the 1:2 ratio.

a. On 12/2/18 on the 7 PM - 7 AM shift, the following was noted:

(i) There were four (4) RNs working on the unit at 7:00 PM, with a census of eleven (11) infants.

(ii) Three (3) RNs were each assigned to care for three (3) infants, exceeding the 1:2 ratio.

(iii) One (1) of those three (3) RNs, was also assigned as the Charge Nurse for the unit, in addition to his/her three (3) infant assignment.

b. On 12/3/18 on the 7 AM - 7 PM shift, the following was noted:

(i) There were four (4) RNs working on the unit at 7:00 AM, with a census of eleven (11) infants.

(ii) Staff #24, the Charge Nurse, was assigned three (3) infants at the start of the shift, exceeding the 1:2 ratio. At 9:00 AM, his/her assignment decreased to two (2) infants. When an additional RN, Staff #62, was pulled from FIN and reassigned to the FICN unit.

(iii) Staff #59 was assigned to care for two (2) infants at the start of the shift. At 9:45 AM, Staff #59 was assigned a new admission, increasing his/her assignment to three (3) infants, as well as being assigned to cover Labor and Delivery (L&D) to assist in problematic births and new admissions.

(iv) Staff #60 was assigned to care for three (3) infants at the start of the shift, exceeding the 1:2 ratio. At 9:00 AM, his/her assignment decreased to two (2) infants. At 13:20 Staff #60 was assigned a new admission, increasing his/her assignment back to three (3) infants for the remainder of the shift.

(v) Staff #61 was assigned to care for three (3) infants at the start of the shift, exceeding the 1:2 ratio. At 8:30 AM, his/her assignment decreased to two (2) infants.

(vi) At 9:00 AM, when Staff #62 arrived on the unit to assist with short staffing, he/she was assigned three (3) infants from 9:00 AM until 15:00 PM, exceeding the 1:2 ratio.

(vii) Upon interview, on 12/5/18 at 17:50 PM, Staff #24 confirmed that on 12/3/18 at approximately 12:30 PM, Staff #60 went to lunch, and immediately after, Staff #59 was pulled to L&D. Staff #24, the Charge Nurse, was left to care for Staff #59's three (3) infants, and Staff #60's two (2) infants, as well as his/her own two (2) infants assignment, for a total of seven (7) infants.

(viii) Staff #24 was caring for a total of seven (7) infants from 12:30 PM until 13:15 PM, approximately 45 minutes.

c. On 12/3/18 at 12:30 PM, during the time that Staff #24 was caring for seven (7) infants, he/she started a nasogastric tube feeding on Patient #25.

(i) At 13:15 PM Staff #59 and Staff #60 returned to the unit.

d. Upon interview on 12/5/18 with Staff #24, she/he stated when Staff #59 returned to the FICN on 12/3/18 at approximately 13:15 PM, she/he resumed assessing an admission she/he had started prior to being called to L&D at 12:30 PM. Staff #60 returned from lunch. Staff #60 was assigned the new admission that Staff #59 brought back from L&D.

(i) At 14:00 PM, Patient #25 was found unresponsive by Staff #59. Resuscitative efforts were immediately started. However, resuscitative efforts were unsuccessful.

(ii) There was no documented evidence in the medical record that Patient #25 was reassessed after the tube feeding was started at 12:30 PM until he/she was found unresponsive.

2. Upon interview on 12/5/18 at 5:45 PM, Staff #10 stated she/he was made aware of short staffing at the beginning of the 12/3/18, 7 AM - 7 PM shift. She/he pulled an RN from FIN at 9:00 AM to cover for short staffing in the FICN, however, she/he was not aware of the 1:7 ratio from 12/3/18, from 12:30 PM - 13:25 PM.

3. On 12/6/18, the Daily Assignment Sheets for the FICN from 11/26/18 to 12/5/18 were reviewed. Seven (7) out of twenty (20) shifts failed to meet the 1:2 ratio.

a. On 11/26/18 on the 7 AM - 7 PM shift, the following was noted:

(i) There were six (6) RNs working on the unit at 7:00 AM, with a census of eleven (11) infants.

(ii) One (1) RN was assigned to care for three (3) infants for the entire shift, exceeding the 1:2 ratio.

(ii) Another RN was assigned to care for two (2) infants at the start of the shift. At 2:15 PM, his/her assignment increased to three (3) infants, when he/she was assigned a new admission, exceeding the 1:2 ratio.

b. On 11/26/18 on the 7 PM - 7 AM shift, the following was noted:

(i) There were four (4) RNs working on the unit at 7:00 PM, with a census of eleven (11) infants.

(ii) One (1) RN was assigned to care for four (4) infants and two (2) RNs were assigned to care for three (3) infants each, exceeding the 1:2 ratio.

c. On 11/28/18 on the 7 PM - 7 AM shift, the following was noted:

(i) There were five (5) RNs working on the unit, at 7:00 PM, with a census of eleven (11) infants.

(ii) One (1) RN was assigned to care for three (3) infants, exceeding the 1:2 ratio.

d. On 11/29/18 on the 7 PM - 7 AM shift, the following was noted:

(i) There were five (5) RNs working on the unit at 7:00 PM, with a census of eleven (11) infants.

(ii) One (1) RN was assigned to care for three (3) infants each for the entire shift, exceeding the 1:2 ratio.

(iii) Another RN was assigned to care for two (2) infants at the start of the shift. At 3:00 AM, his/her assignment increased to three (3) infants, when he/she was assigned a new admission, exceeding the 1:2 ratio.

e. On 11/30/18 on the 7 PM - 7 AM shift, the following was noted:

(i) There were five (5) RNs working on the unit at 7:00 PM, with a census of twelve (12) infants.

(ii) Two (2) RNs were assigned to care for three (3) infants each for the entire shift.

(iii) A third RN was assigned to care for two (2) infants at the start of the shift. At 2:05 AM, his/her assignment increased to three (3) infants when he/she was assigned a new admission, exceeding the 1:2 ratio.

f. On 12/1/18 on the 7 AM - 7 PM shift, the following was noted:

(i) There were six (6) RNs working on the unit at 7:00 AM, with a census of thirteen (13) infants.

(ii) One (1) RN was assigned to care for three (3) infants for the entire shift.

(iii) Another RN was assigned to care for two (2) infants at the start of the shift. His/her assignment increased to three (3) infants, exceeding the 1:2 ratio. There was no documented evidence on the daily assignment sheet as to what time his/her assignment increased to three (3) infants.

g. On 12/4/18 on the 7 AM - 7 PM shift, the following was noted:

(i) There were four (4) RNs working on the unit at 2:00 PM, with a census of eight (8) infants.

(ii) One (1) RN was assigned three (3) infants between 4:00 PM and 7:00 PM, exceeding the 1:2 ratio.

(iii) Another RN was assigned four (4) infants between 2:00 PM and 7:00 PM, exceeding the 1:2 ratio.

These findings resulted in an Immediate Jeopardy (IJ). The IJ was removed on 12/5/18, upon receipt of an acceptable plan of correction.





4. On 12/6/18, the Daily Assignment Sheets for the FIN for 11/20/18 through 11/29/18 were reviewed. During the ten (10) day period, there was a total of twenty (20) shifts. Thirteen (13) out of twenty (20) shifts failed to meet the 1:4 ratio.

a. On 11/20/18 on the 7 AM - 7 PM shift, the following was noted:

(i) There were two (2) Registered Nurses (RNs) working on the unit at 2:30 PM, with a census of ten (10) infants.

(ii) The two (2) RNs were assigned to care for five (5) infants each, exceeding the 1:4 ratio.

b. On 11/20/18 on the 7 PM - 7 AM shift, the following was noted:

(i) There were two (2) RNs working on the unit at 7:00 PM, with a census of ten (10) infants.

(ii) The two (2) RNs were assigned to care for five (5) infants each, exceeding the 1:4 ratio.

c. On 11/21/18 on the 7 PM - 7 AM shift, the following was noted:

(i) There were three (3) RNs working on the unit at 7:00 PM, with a census of thirteen (13) infants. One (1) RN was pulled from FIN to work on FICN.

(ii) One (1) RN was assigned to care for five (5) infants and one (1) RN was assigned to care for six (6) infants, exceeding the 1:4 ratio.

d. On 11/22/18 on the 7 AM - 7 PM shift, the following was noted:

(i) There were three (3) RNs working on the unit at 7:00 AM, with a census of thirteen (13) infants.

(ii) One (1) RN was assigned to care for five (5) infants, exceeding the 1:4 ratio.

e. On 11/23/18 on the 7 AM - 7 PM shift, the following was noted:

(i) There were three (3) RNs working on the unit at 5:45 PM, with a census of thirteen (13) infants.

(ii) One (1) RN was assigned to care for five (5) infants, exceeding the 1:4 ratio.

f. On 11/23/18 on the 7 PM - 7 AM shift, the following was noted:

(i) There were three (3) RNs working on the unit at 7:00 AM, with a census of thirteen (13) infants.

(ii) One (1) RN was assigned to care for five (5) infants, exceeding the 1:4 ratio.

g. On 11/24/18 on the 7 AM - 7 PM shift, the following was noted:

(i) There were three (3) RNs working on the unit at 3:30 PM, with a census of fifteen (15) infants.

(ii) Three (3) RNs were assigned to care for five (5) infants each, exceeding the 1:4 ratio.

h. On 11/24/18 on the 7 PM - 7 AM shift, the following was noted:

(i) There were three (3) RNs working on the unit at 7:00 PM, with a census of fifteen (15) infants.

(ii) Three (3) RNs were assigned to care for five (5) infants each, exceeding the 1:4 ratio.

i. On 11/25/18 on the 7 AM - 7 PM shift, the following was noted:

(i) There were three (3) RNs working on the unit at 7:00 AM, with a census of thirteen (13) infants.

(ii) One (1) RN was assigned to care for five (5) infants, exceeding the 1:4 ratio.

j. On 11/25/18 on the 7 PM - 7 AM shift, the following was noted:

(i) There were three (3) RNs working on the unit at 7:00 PM, with a census of thirteen (13) infants.

(ii) One (1) RN was assigned to care for five (5) infants, exceeding the 1:4 ratio.

k. On 11/26/18 on the 7 AM - 7 PM shift, the following was noted:

(i) There were three (3) RNs working on the unit at 7:00 AM, with a census of thirteen (13) infants.

(ii) One (1) RN was assigned to care for five (5) infants, exceeding the 1:4 ratio.

l. On 11/26/18 on the 7 PM - 7 AM shift, the following was noted:

(i) There were three (3) RNs working on the unit at 7:00 PM, with a census of fourteen (14) infants.

(ii) Two (2) RNs were assigned to care for five (5) infants each, exceeding the 1:4 ratio.

m. On 11/29/18 on the 7 PM - 7 AM shift, the following was noted:

(i) There were two (2) RNs working on the unit at 7:00 PM, with a census of nine (9) infants.

(ii) One (1) RN was assigned to care for five (5) infants, exceeding the 1:4 ratio.

5. Staff #3 stated that they will pull an RN from FIN to FICN, if FICN is short staffed.





B. Based on observation, staff interviews, and facility documents, it was determined that the facility failed to ensure patient needs are met.

Findings include:

1. Upon interview on 12/5/18 at 5:45 PM, with Staff #10, (Assistant Director of the FICN, FIN and PICU) she/he stated:

a. On, 12/3/18, Staff #59, was assigned to Patient #25 and was also assigned as "ADM 1" (she/he would be the first RN to be called to L&D, should there be a problematic delivery).

b. The Charge Nurse, Staff #24 took over Staff #59's patients during this time.

2. Upon interview on 12/5/18 at 5:50 PM, Staff #60 stated:

a. "When nurses go on break or are pulled to L&D, the nurses do not endorse patients to another nurse."

b. "The Charge Nurse takes over the assignments."

c. On 12/3/18, Staff #60 went on break immediately prior to when Staff #59 was pulled to L&D.

d. On 12/3/18, Patient 25's nurse, Staff #59, returned from L&D at approximately 1:15 PM with the new admission, Patient #49.

e. The new admission was assigned to Staff #60. He/she was performing an admission assessment on Patient #49 and stated "I did not hear any alarms going off."

f. At approximately 2:00 PM, Staff #59 found Patient #25 unresponsive.

3. Upon interview on 12/5/18 at 5:55 PM, Staff #24 stated:

a. Both Staff #59 and Staff #60 left the unit at about the same time.

(i) Staff #60 went on break.

(ii) Staff #59 was pulled to L&D immediately after.

b. At 12:30, Staff #24 started a nasogastric feeding on the baby, (Patient #25).

c. Staff #59 returned from L&D with Patient #49, the new admission, which was assigned to Staff #60.

d. Staff #59 went directly to the admission she had gotten earlier that day, Patient #50, to complete the assessment.

e. At 2:00 PM, Staff #59 went to check on Patient #25, the baby was unresponsive.

4. The Charge Nurse, Staff #24, was caring for:

a. Three (3) patients of her own, Staff #59's two (2) patients and Staff #60's two (2) patients, totaling seven (7) patients for 45 minutes. This exceeds the 1:2 ratio.

5. As per Staff #3, she/he stated, in the case where the charge nurse was assigned 7 infants to care for, the Charge Nurse should have called Staff #10, the Assistant Director of the FICN, FIN and PICU, and ask for assistance.

6. Upon interview on 12/6/18, Staff #68 stated that he/she was called to the FICN/NICU on 12/3/18 to examine the Philips MP70 Cardiac monitor. Staff #68 stated, "The monitor did not malfunction. The alarm was audible. However, it sounded like a whisper."

a. Review of the 12/3/18 Clinical Engineering Department On-Call work order indicated:

(i) "Philips MP70 Troubleshoot/Verify Proper Operation Audible Alarm [SIC] Note: Alarm must be reset Upon Recycle of AC Power [SIC]."

b. During a Tour of the FICN/NICU on 12/5/18, surveyors examined the Philips MP70 Cardiac monitor that was assigned to Patient #25 during the event of 12/3/18. The alarm was barely audible, making it difficult to hear.

These findings resulted in an Immediate Jeopardy (IJ). The IJ was removed on 12/5/18, upon receipt of an acceptable plan of correction.
VIOLATION: RN SUPERVISION OF NURSING CARE Tag No: A0395
Based on staff interviews, medical record review and review of facility documents, it was determined that the facility failed to ensure patient needs are met.

Findings include:

1. On 12/3/18 at 2:00 PM, Patient #25 was found unresponsive, resuscitation efforts were unsuccessful.

2. Upon review of the Clinical Audit Data of the Philips MP70 Cardiac Monitor for Patient #25, for the period of 12/2/18 at 1900 through 12/3/18 at 1400. The following was identified:

a. There were twenty-five (25) episodes of desaturation (oxygen desaturation occurs when the level of oxygen in the blood is decreased, resulting in not having enough oxygen), for Patient #25.

b. The patient's oxygen (O2) saturation (sat) levels were as follows:

(i) 12/2/18 at 1916 - O2 sat 76%

(ii) 12/2/18 at 2027 - O2 sat 68%

(iii) 12/2/18 at 2244 - O2 sat 72%

(iv) On 12/3/18 between 0014 - 0057, there were five (5) episodes of desaturation ranging from 71% to 82%

(v) 12/3/18 at 0133 - O2 sat 78%

(vi) 12/3/18 at 0155 - O2 sat 81%

(vii) 12/3/18 at 0446 - O2 sat 78%

(viii) 12/3/18 at 0506 - O2 sat 32%

(ix) 12/3/18 at 0740 - O2 sat 79%

(x) 12/3/18 at 0809- O2 sat 74%

(xi) 12/3/18 at 0845 - O2 sat 81%

(xii) 12/3/18 at 0901 - O2 sat 73%

(xiii) 12/3/18 at 0954 - O2 sat 80%

(xiv) 12/3/18 at 1052 - O2 sat 83%

(xv) 12/3/18 at 1102 - O2 sat 75%

(xvi) 12/3/18 at 1136 - O2 sat 83%

(xvii) 12/3/18 at 1207 - O2 sat 77%

(xviii) 12/3/18 at 1213 - O2 sat 76%

(xix) 12/3/18 at 1217 - O2 sat 79%

(xx) 12/3/18 at 1234 - O2 sat 74%

(xxi) 12/3/18 at 1301 - O2 Sat 70%

c. On 12/3/18 Patient #25 had:

(i) Thirty-three (33) episodes of bradycardia (bradycardia is a slow heart rate of below 100 beats per minute in an infant. Bradycardia is often accompanied by pauses in breathing), beginning at 1312 and ending at 1357, ranging between 75 - 31 beats per minute.

(ii) Thirty-seven (37) episodes of asystole (a state of no cardiac electrical activity, no contractions of the muscular tissue of the heart and no cardiac output or blood flow) between 1234 and 1400.

d. At approximately 1235, Staff #24 manually paused the cardiac monitor alarm to start the tube feeding. Staff #24 restarted the alarm at 1237.

e. From 1317 to 1324 there were "nine (9) episodes of apnea (cessation of breathing)." The episode that started at 1324, lasted "thirty four (34) minutes." The apnea episode ended at 1358.

f. At 1359 there were "four (4) episodes" of ventricular fibrillation (a state of disordered electrical activity causing the heart's lower chambers, the ventricles to quiver/fibrilate instead of beating normally).

g. At 1400 the alarm was silenced.

h. There was no documented evidence in the medical record that any interventions were taken for the above episodes. There was no documented evidence in the medical record that these episodes occurred.

(i) The above findings were confirmed by Staff #5.

2. Review of the Philips MP70 Cardiac Monitor in-services dated indicated only 17 of 21 RNs participated in the in-service.

3. Review of the Nursing Flow Sheets for the period of 12/2/18 at 1900 through 12/3/18 at 1300, revealed information conflicting with the Clinical Audit Data of the Philips MP70 Cardiac Monitor for Patient #25.
The following was identified:

a. 12/2/18 at 1900 - Pulse 164 [beats per minute], Sinus Tachycardia; O2 sat 100%

b. 12/2/18 at 1940 - Pulse 165; O2 sat 99%

c. 12/2/18 at 2000 - Pulse 163; O2 sat 100%

d. 12/2/18 at 2100 - Pulse 166; O2 sat 99%

e. 12/2/18 at 2200 - Pulse 160; O2 sat 99%

f. 12/3/18 at 0000 - Pulse 160; O2 sat 98%

g. 12/3/18 at 0100 - Pulse 161; O2 sat 100%

h. 12/3/18 at 0200 - Pulse 159; O2 sat 98%

i. 12/3/18 at 0300- Pulse 159; O2 sat 98%

j. 12/3/18 at 0400- Pulse 164; O2 sat 98%

k. 12/3/18 at 0500- Pulse 163; O2 sat 98%

l. 12/3/18 at 0600- Pulse 147; O2 sat 96%

m. 12/3/18 at 0700- Pulse 162; O2 sat 96%

n. 12/3/18 at 0800- Pulse 160; O2 sat 96%

o. 12/3/18 at 0900- Pulse 163; O2 sat 98%

p. 12/3/18 at 1000- Pulse 166; O2 sat 97%

q. 12/3/18 at 1100- Pulse 166; O2 sat 97%

r. 12/3/18 at 1200- Pulse 166; O2 sat 96%

s. A late entry was made by Staff #59 on 12/3/18 at at 2316: "1300- Pulse 170"

t. Upon interviews with Staff #24 and Staff #60, Staff #59 returned to FICN on 12/3/18 between 1315 and 1320.

u. Upon interview, Staff #3 confirmed that Staff #59 made the above late entry on 12/3/18 at 2316, documenting: "1300- Pulse 170"

4. The Clinical Audit Data of the Philips MP70 Cardiac Monitor and the Nursing Flow sheets showed conflicting information for Patient #25. Staff #5 stated the RNs take the information from the monitor and enter it into the flow sheet. He/she was unable to explain the reason the information between the monitor and the flow sheet did not match.

Reference: Facility Skills document, Feeding tube: Enteral Nutrition (Neonatal) states, "Assessment and Preparation ... 10. Assess the neonate's abdomen for distention, discoloration, and visible bowel loops before every bolus or intermittent feeding or periodically during a continuous infusion. Include abdominal girth in the assessment by measuring around the neonate's abdomen over the umbilicus."

1. On 12/3/18 at 1230, Staff #24 started a nasogastric tube feeding on Patient #25.

a. Upon interview, Staff #69, Nurse Educator, stated that the FICN process is to document the assessment on the flow sheet, before the feeding begins. The process is:

(i) Listen to bowel sounds

(ii) Take an abdominal girth measurement

(iii) Elevate head of bed [reverse Trendelenburg]

(iv) Observe neonatal response to feeding

(v) Monitor for emesis

b. There is no documented evidence of the above assessments having been completed for Patient #25 during the 12/3/18, 1230 feeding.

2. Review of the Discharge Summary notes indicate: "found with acute decompensation, found unresponsive with vomiting, apnea, received [SIC] cardiopulmonary resuscitation x 37 minutes without response and pronounce [SIC]. on 12/03/2018 at 2:44 PM."

3. Review of the Progress notes in Medical Record #25 (page 271) indicated the following:

a. On 12/2/18 at 1900, Staff #76 charted: "... mild subcostal retractions and Tachycardia throughout this shift. HR [Heart Rate] between 160's - 170's."

b. On 12/2/18 at 1940, Staff #77 charted: "...Will monitor for apneas, bradycardias and desaturations. No acute respiratory distress noted at this timed [SIC] ... To Decrease [SIC] work of breathing. Pt [SIC] will be continued on HFN/C [High Flow Nasal Cannula] and monitored."

c. At 12/3/18 at 0034 Staff #49 charted: "At about 2335 [on 12/2/18], during blood work, noticed discoloration on both feet. Dr.(name of physician) [Staff #78] was notified who came to assess the baby [SIC], and there was good capillary refill. Dr. (name of physician) [Staff #78] later said to keep eye on it [SIC] ..."

d. At 12/3/18 at 0652, Staff #49 charted: "At about 0300, mom called and was notified of the discoloration on the R/L [Right/Left] feet and she said that she saw that on Saturday [12/1/18] ..." Note was continued on page 272.

e. Review of the Progress notes in Medical Record #25 (page 272) indicate, after a 0652 nurse's note, there are no progress notes charted until 12/3/18 at 1444 by Staff #82.

f. "RT [Respiratory Therapist] arrived at bedside and assisted in manually ventilating patient while compressions were being performed. Patient orally intubated by attending physician ... Resuscitation continued until 1444."

g. At 12/3/18 at 2135, Staff #49 charted: "At about 2018, the deceased body of (Name of Patient) [Patient #25], was endorsed to me by (Name of nurse) [Staff #59].

h. A late note was entered on 12/3/18 by Staff #25 states, "1230 NGT placement checked, 0 aspirate obtained. 60 ml SCN 30 [Name of formula] given via NGT over 90 minutes. 1315 (name of nurse) Staff #59 assumed care."

i. A late note entered on 12/4/18 by Staff #59 states, "1400- Found Baby (name of baby) [Patient #25] mouth and nares covered with formula, with circumoral cyanosis. Pick [SIC] up baby and back blows given. Called Dr. [name of physician] Staff #52 to baby's bedside. Suctioned baby's nares and mouth and stimulated to no avail. Monitor not registering heart rate or saturation ... Repositioned for intubation, formula coming out of baby [SIC] mouth and nares, suctioned. Noted abdomen to be grossly distended. Inserted OGT [orogastric tube] and aspirated stomach content. Nothing came out on aspiration ... Baby pronounced at 1444."

4. Review of Staffing for the FICN indicated the following:

a. On 12/3/18 on the 7 AM - 7 PM shift, the following was noted:

(i) There were four (4) RNs working on the unit at 7:00 AM, with a census of eleven (11) infants.

(ii) Staff #24, the Charge Nurse, was assigned three (3) infants at the start of the shift, exceeding the 1:2 ratio. At 9:00 AM, his/her assignment decreased to two (2) infants. When an additional RN, Staff #62, was pulled from FIN and reassigned to the FICN unit.

(iii) Staff #59 was assigned to care for two (2) infants at the start of the shift. At 9:45 AM, was assigned a new admission, increasing his/her assignment to three (3) infants, as well as being assigned to cover Labor and Delivery (L&D) to assist in problematic births and new admissions.

(iv) Staff #60 was assigned to care for three (3) infants at the start of the shift, exceeding the 1:2 ratio. At 9:00 AM, his/her assignment decreased to two (2) infants. At 13:20 PM, Staff #60 was assigned a new admission, increasing his/her assignment to increased to three (3).

(v) Staff #61 was assigned to care for three (3) infants at the start of the shift, exceeding the 1:2 ratio. At 8:30 AM, his/her assignment decreased to two (2) infants.

(vi) At 9:00 AM, when Staff #62 arrived on the unit to assist with short staffing, he/she was assigned three (3) infants from 9:00 AM until 15:00 PM, exceeding the 1:2 ratio.

(vii) Upon interview, on 12/5/18 at 17:50 PM, Staff #24 confirmed that on 12/3/18 at approximately 12:30 PM, Staff #60 went to lunch, and immediately after, Staff #59 was pulled to L&D. Staff #24, the Charge Nurse, was left to care for Staff #59's three (3) infants, and Staff #60's two (2) infants, as well as his/her own two (2) infant assignment.

(viii) Staff #24 was caring for a total of seven (7) infants from 12:30 PM until 13:15 PM, approximately 45 minutes.

(ix) Staff #24 in addition to caring for 7 infants, on 12/2/18 at 12:30 PM, started a nasogastric tube feeding on Patient #25.

5. At 14:00 PM, Patient #25 was found unresponsive by Staff #59. Resuscitation was started immediately by the FICN team. Resuscitative efforts were unsuccessful.
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on medical record review, staff interviews, and review of facility documents, it was determined that the facility failed to ensure a sanitary environment to avoid sources and transmission of infections and communicable diseases.

The facility failed to maintain a sanitary environment to avoid sources and transmission of infections and communicable diseases.
Cross Reference: CRF 482:42(a)

The facility failed to ensure a hand hygiene program was implement, and maintained hospital-wide for the prevention and control of infections and communicable diseases.
Cross Reference: CRF 482:42(a)(1)
VIOLATION: INFECTION CONTROL OFFICER(S) Tag No: A0748
Based on observation, staff interview and review of facility documents, it was determined that the facility failed to ensure that its infection control policies were implemented.

Findings include:

Reference #1: Facility policy, Use of Cidex OPA High Level Disinfectant, states, "...Procedure: ...6. Affix label with solution use life (expiration date) on Cidex OPA container. The use life (time the solution should be usable once poured out of the bottle and placed into use) is 2 weeks (14 days). ...12. Cover the Cidex OPA solution tray securely and soak instruments /devices for 12 minutes at a minimum temperature of 20 degrees C (68 degrees Fahrenheit)...a. Monitor the temperature of the solution, verify correct temperature before each use. b. The solution is NOT to be used unless the solution is at the required temperature..."

1. On 11/29/18 at 11:34 AM, in the decontamination area, in the presence of Staff #9, Staff #26, and Staff #27, a white basin labeled "Cidex solution" was dated 11/26/18.

a. Upon interview, Staff #27 confirmed that the Cidex solution is used to soak instruments needing High Level Disinfection (HLD) and that the sticker represents the date the solution expires and must be discarded.

b. The HLD log for the Cidex solution was requested. The log indicated that the following instrumentation was disinfected in expired solution:

(i) On 11/27/18 at 2:45 PM, a Respiratory Probe

(ii) On 11/29/18 at 11:45 PM, five (5) Respiratory Probes

c. The HLD log for the Cidex solution, indicated that on 11/14/18, three (3) Respiratory Probes were soaked at a temperature of sixty-six (66) degrees Fahrenheit, which is below the required minimum temperature of sixty-eight (68) degrees Fahrenheit.

2. The above findings were confirmed by Staff #27.

Reference #2: Facility policy, Pre-Processing Treatment of Instruments in Ancillary Departments/Units, states, "...III. Policy All instruments will be properly accounted for throughout use and pre-treated with a hospital approved enzymatic foam product prior to delivery to the Central Sterile Processing Department (CSPD) for sterilization. IV. Procedure ...D. The RN (Registered Nurse) or designee will be responsible for ensuring that the instruments are treated with approved enzymatic foam or gel. Immediately following the procedure...iv. Generously spray both sides of the instruments(s) [sic] using hospital approved enzymatic foam..."

1. On 11/29/18 at 11:45 AM, in the decontamination area, in the presence of Staff #9, Staff #26 and Staff #27, the following was observed:

a. The following soiled trays were on the counter and contained instruments that were visibly soiled with dry red residue, and did not appear to be sprayed with a point of use enzymatic spray:

(i) Thoracotomy Pan 14

(ii) Basic Hand and Neck set 2

(iii) Long Major Basic 15

b. Staff #9 and Staff #27 confirmed that the instruments appeared dry and did not appear to be sprayed with a point of use enzymatic spray.

c. Upon interview, Staff #29 confirmed that at times, instrument trays arrive in the CSPD, without being pre-treated with a point of use spray.

d. The facility failed to ensure soiled surgical instruments are pre-treated with an enzymatic spray immediately following a procedure, as per facility policy.

2. The above finding was confirmed by Staff #27.

Reference #3: Facility policy, Monitoring of Steam Sterilization Cycles, states, "...Procedure: ... Frequency of BI Testing: ...d). after any major repair. (3 consecutive BI [Biological Indicator] tests must be performed and all must be negative. ...Follow with 3 consecutive Bowie-dick tests. ...1. Note: a major repair is defined as outside the scope of normal maintenance such as welds of the pressure vessel, replacement of the chamber door or a major piping assembly or rebuilds or upgrades of controls..."

1. On 11/29/18 in the CSPD, a request was made for the facility's validation log for the Getinge sterilizers. Staff #27 confirmed that the facility does not keep a validation log. Staff #27 explained that all work done on the sterilizers is maintained through work orders.

a. The work order titled, "Corrective Maintenance Work Order" # , dated 11/7/18, was reviewed, and the following was indicated:

(i) The Getinge 733 HC Sterilizer #1 was aborted due to air entering the sterilizer. The door gasket was replaced.

(ii) A dart cycle was performed. A steam leak was found in the lower piping section, and it was repaired.

(iii) The CSPD staff attempted to run another cycle and the display read, "water in drain will replace switch tomorrow."

(iv) On 11/8/18, the Sterilizer was leaking water from a 12 inch brass pipe. The pipe and drain switch were replaced.

b. The sterilization records for the Getinge Sterilizer #1 were requested. The Censitrac Sterilization Report was provided and reviewed, and the following was noted:

(i) After the Major Repair, three (3) BI cycles were run and one (1) Bowie-Dick test.

(ii) Upon interview, Staff #27 stated that three (3) BI cycles and only one (1) Bowie-Dick cycle were run, as the work completed was not considered a major repair.

The above finding resulted in an Immediate Jeopardy (IJ). The IJ was removed on 11/30/18, upon receipt of an acceptable plan of correction.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

A. Based on observation, staff interviews, review of facility documents and nationally recognized guidelines, it was determined that the facility failed to ensure that a sanitary environment is provided.

Findings include:

Reference #1: Facility policy, Hand Hygiene, states, "...IV. Policy A. In patient care areas, all personnel will perform hand hygiene at the appropriate 5 Moments for hand hygiene as defined by the World Health Organization (WHO): ...Moment 3: after contact with body fluids/contaminated items. Clean your hands as soon as the task involving an exposure risk to body fluids has ended (& after glove removal). ...Moment 5: after contact with any item/equipment in the patient zone, then leaving the patient zone. ...B. Gloves/PPE (Personal Protective Equipment): ...3. hand hygiene will be performed when gloves and other personal protective equipment are removed ... Hand washing decontamination: ... Remove all hand and wrist jewelry ... wet hands with water ... Note: Entire procedure should take 40 - 60 seconds ... One Minute Scrub for Neonatal Intensive Care Unit: ... 1. Remove rings, watches, and bracelets before beginning hand scrub (exception: plain wedding bands). 2. Remove debris from underneath fingernails using a nail cleaner under running water. 3. Scrub hands and forearms, up to elbows for 30 seconds, using antimicrobial solution. 4. Dry hands and forearms completely. ..."

Reference #2: BD E-Z Scrub 160 (Surgical Scrub Brush/Sponge with nail cleaner), to be used with a surgical scrub solution. Refer to surgical scrub solution directions for use.

Reference #3: ICS3 (Infection Control System 3, states, "... Pre wet hands with running water ... rub vigorously for 15 seconds and rinse with water ..."

1. Upon interview on 11/27/18, Staff #5 stated the Qualification Testing for molecular isotopes identified the strain of Acinetobacter Baumannii in the FICN/NICU is the same strain of Acinetobacter Baumannii that is in the adult population. Staff #5 also stated that Staff #2 and Staff #8 are aware of it.

a. An email dated 11/25/18, addressed to Staff #8, states, "The recent NICU [Neonatal Intensive Care Unit, also referred to as FICN] (Acinetobacter Baumannii strain) seems the same as the major clone going around the [adult] ICUs."

b. The Acinetobacter Baumannii NICU isolates are dated 11/21/2018.

c. Staff #5 stated, "Currently we have eight (8) patients in house with MDR (multidrug-resistant) Acinetobacter. This is a list of the patients."

2. Upon review on 11/27/18 of the Hand Hygiene Education for the FICN staff, it was noted that only 74% of the staff received Hand Hygiene Education.

a. Upon interview with Staff #5 on 11/27/18, he/she stated that as of 11/27/18 only 74% of the FICN staff received Hand Hygiene Education.

b. Review of the facility Staff Education forms, received by Staff #5 on 11/27/18, indicated the Hand Hygiene education for the FICN was 11/1/18 to 11/27/18.

3. During a tour of the FICN on 11/27/18, the following was noted:

a. Staff #53 entered the unit through the side door, transporting an x-ray machine.

b. Staff #53 did not wash his/her hands prior to entering the unit and did not perform the one minute scrub.

c. Upon interview, Staff #53 stated, "The x-ray machine was not cleaned before I entered the unit. When I finish here, I will take the x-ray machine upstairs to a designated spot and I will clean the machine there."

d. The above finding was confirmed with Staff #3.





4. During a tour of the FICN on 11/28/18, the following was noted:

a. Outside the entrance to the FICN, there is a sink for visitors use. A soap dispenser and a box of BD E-Z Scrub 160 (surgical scrub brush/sponge with nail cleaner) are attached to the wall over the sink. Gloves and plastic gowns are on top of the cabinet that is next to the sink. Plastic bags, that hold personal belongings, are in the top drawer of the cabinet.

(i) Signage for a one minute scrub is posted over the sink.

(ii) There are no posted instructions regarding gowns, gloves, or the plastic bags used to hold personal belongings.

(iii) The soap dispenser did not have a label.

b. The Clerk Staff Meeting Agenda dated 11/20/18, for the FICN, states, "Assist all parents coming in for visitation with proper hand hygiene. Ensure proper hand hygiene on every personnel entering the unit." Staff #10 stated that Staff #11 monitors and educates the parents and grandparents of the infants. Staff #10 stated that Staff #11 monitors the hand hygiene of all visitors and personnel entering the unit.

(i) The education for the parents, grandparents and visitors consists of the one minute scrub, applying a gown before entering the patient care area, and the bagging of personal belongings.

(ii) Staff #11 is a Unit Secretary, with no clinical background.

(iii) The Unit Secretary is stationed inside the FICN. The hand wash/scrub area is located outside the door to the FICN. The hand wash/scrub area is not visible to Staff #11 unless she/he opens the door and steps outside to monitor the area.

c. Patient #1's father was observed performing the one minute scrub under the direction of Staff #11.

(i) Staff #11 instructed Patient #1's father to discard the nail cleaner.

(ii) Patient #1's father was touching the faucet with his arms while performing the one minute scrub.

(iii) Patient #1's father dropped the sponge into the sink. Staff #11 stated to Staff #3, "Should he use the sponge if it fell in the sink?"

(iv) Staff #11 did not instruct Patient #1's father to remove debris from underneath his fingernails using a nail cleaner under running water, scrub his hands and his forearms up to his elbows for 60 seconds, and dry his hands and forearms completely.

d. Patient #2's father was observed performing the one minute scrub under the direction of Staff #11.

(i) Staff #11 instructed Patient #2's father to discard the nail cleaner.

(ii) Patient #2's father was touching the soap dispenser and towel dispenser with his hands while performing the one minute scrub.

(iii) Staff #11 did not instruct Patient #2's father to remove debris from underneath his fingernails using a nail cleaner under running water, scrub his hands and forearms up to his elbows for 60 seconds, and dry his hands and forearms completely.

e. Staff #13, an RN, was observed washing his/her hands for 13 seconds.

f. The above findings were confirmed with Staff #3.

5. Upon interview, Staff #5 confirmed that the product in the unlabeled soap dispenser is ICS3 Antiseptic Hand Wash. This is the soap the parents use to perform the one minute scrub.

a. The BD E-Z Scrub 160 instructions state, "to be used with a surgical scrub solution. Refer to surgical scrub solution directions for use."

b. The ICS3 Antiseptic Hand Wash is not a surgical scrub solution.

c. The above finding was confirmed with Staff #5.

6. During a tour of the FICN on 11/29/18, the following was noted:

a. At 10:30 AM, Staff #15, an RN, was observed washing his/her hands for ten (10) seconds.

b. At 10:40 AM, Staff #21, an RN, was observed washing his/her hands for thirteen (13) seconds.

c. At 10:42 AM, Staff #16, an RN, was observed performing the one minute scrub wearing a bracelet and a ring.

d. At 11:10 AM, Staff #17, a NA (Nursing Assistant), was observed donning and doffing his/her gloves. Staff #17 did not sanitize his/her hands prior to donning gloves and after doffing gloves.

e. At 11:12 AM, Staff #17, a NA, was observed donning and doffing his/her gloves. Staff #17 did not sanitize his/her hands prior to donning gloves and after doffing gloves.

f. At 11:14 AM, Staff #17, a NA, was observed donning and doffing his/her gloves. Staff #17 did not sanitize his/her hands prior to donning gloves and after doffing gloves.

g. At 11:20 AM, Staff #20, a Respiratory Therapist, was observed washing his/her hands for eight (8) seconds.

h. At 11:23 AM, Staff #15, an RN, was observed washing his/her hands for twelve (12) seconds.

i. At 11:35 AM, Staff #13, an RN, was observed washing his/her hands for fourteen (14) seconds.

j. At 11:36 AM, Staff #22, a Physician, was observed washing his/her hands for eight (8) seconds.

k. At 11:55 AM, Staff #22, a Physician, was observed washing his/her hands for five (5) seconds.

l. At 11:59 AM, Staff #22, a Physician, was observed doffing his/her gloves. Staff #22 did not sanitize his/her hands after doffing.

m. At 12:00 PM, Staff #24, an RN, was observed carrying a wet diaper, through the FICN, with gloved hands. Staff #24 placed the diaper on the scale. Staff #24 disposed of the diaper and while wearing the same gloves, opened the container of saniwipes and took a saniwipe out of the container, wiped the scale with the saniwipe, discarded the saniwipe, doffed his/her gloves, and then sanitized his/her hands.

n. At 12:05 PM, Staff #13, an RN, was observed washing his/her hands for eight (8) seconds.

o. At 12:10, Staff #22, a Physician, was observed cleaning a magnifying glass that was used to examine an infant's eyes. Staff #22 cleaned the magnifying glass with a Sani-Cloth then walked through the FICN holding the magnifying glass in his/her bare hand.

p. The above findings were confirmed with Staff #3.

7. On 11/29/18 at 12:25 PM, in OR #8, during the cleaning and disinfecting of the OR between patients, the following was observed:

a. Staff #31, was preparing soiled surgical instruments to be transported to the Sterile Processing Department. Staff #31 doffed his/her gloves and failed to perform hand hygiene prior to reaching into the clean box of gloves, and donning another pair of gloves.

b. Staff #32 was cleaning and disinfecting patient care equipment. Staff #32 doffed his/her gloves, and failed to perform hand hygiene prior to reaching into the clean box of gloves, and donning another pair of gloves.

c. Staff #33 was cleaning and disinfecting the back instrument table and mayo stand. Staff #33 doffed his/her gloves and failed to perform hand hygiene prior to exiting the OR, obtaining a new pair of gloves from the housekeeping cart, and reaching into the yellow basin of Oxivir Five 16 Concentrate to obtain a presoaked cloth.

8. During a tour of the FICN on 11/30/18, the following was noted:

a. At 10:26 AM, Staff #15, an RN, was observed washing his/her hands for ten (10) seconds.

b. At 10:30 AM, Staff #15, an RN, was observed washing his/her hands for seven (7) seconds.

c. The above findings were confirmed with Staff #3.

These findings resulted in an Immediate Jeopardy. The IJ was removed on 11/30/18 upon receipt of an acceptable plan of correction.

Reference #4: Facility policy, Infection Control, "... Transmission Based Isolation Precautions ... designed for patients with symptoms and/or documented or suspected infection or colonization with a MDR (Multidrug-Resistant) organism or communicable disease. ... References: Guidelines for Isolation Precautions ... cdc.gov ... Droplet Precautions ... Visitors will be educated regarding the transmission of diseases requiring Droplet Isolation Precautions ..."

Reference #5: CDC (Center for Disease Control and Prevention) ... https://www.cdc.gov/infectioncontrol/guidelines/isolation, states, " ... I.B.3.b. Droplet transmission. Droplet transmission is, technically, a form of contact transmission, and some infectious agents transmitted by the droplet route also may be transmitted by the direct and indirect contact routes. However, in contrast to contact transmission, respiratory droplets carrying infectious pathogens transmit infection when they travel directly from the respiratory tract of the infectious individual to susceptible mucosal surfaces of the recipient, generally over short distances, necessitating facial protection ..."

1. During a tour of the Pediatric Intensive Care Unit (PICU) on 12/07/18 at 12:30 PM, the following was noted:

a. Patient #26, a [AGE] year old baby, had a diagnosis of Respiratory Syncytial Virus (RSV). The patient was on droplet isolation precautions.

(i) The patient was in an isolation room, but the door to the patient's room was open.

(ii) The patient's mother was in the room wearing a gown, gloves, and a mask. The mask was positioned around her neck, not over her mouth and nose.

(iii) The Nursing Care Plan did not address isolation precautions.

(iv) The Nursing Care Plan did not address education regarding isolation precautions.

(v) Staff were unable to provide documentation that the patient's mother was educated regarding isolation precautions.

b. Patient #27, a baby, had a diagnosis of bronchiolitis. According to the Assistant Director of the unit, the patient was on droplet isolation precautions while RSV was being ruled out.

(i) The patient was in an isolation room, but the door to the patient's room was open.

(ii) The patient's mother was in the room wearing a gown and gloves. She was not wearing a mask.

(iii) The patient's father was in the room wearing a gown, gloves, and a mask. The mask was positioned under his nose, not over his nose.

(iv) Staff #46, a RN, stated, "The patient's mother is breastfeeding. She doesn't have to wear a mask."

(v) The Nursing Care Plan did not address isolation precautions.

(vi) The Nursing Care Plan did not address education regarding isolation precautions.

(vii) Staff #11 was unable to provide documentation that the patient's parents were educated regarding isolation precautions.

2. During a tour of the PICU on 12/10/18, the following was noted:

a. Patient #26 remained on droplet isolation.

(i) Two staff members were in the room wearing gowns, gloves, and masks.

(ii) The patient's mother was in the room. She was not wearing a gown, gloves, or a mask.

(iii) Staff #45, a RN, stated, "The patient's mother should be wearing a gown, gloves, and a mask."

(iv) Patient 26's mother was provided education after surveyors identified the lack of education.

3. Upon interview, Staff #2 stated, "Our facility follows SHEA (Society for Healthcare Epidemiology of America) guidelines.

a. The facility policy, "Infection Control, Transmission Based Isolation Precautions," references the CDC. SHEA is not referenced in the facility policy addressing isolation precautions.

These findings resulted in an Immediate Jeopardy. The IJ was removed on 12/10/18 upon receipt of an acceptable plan of correction.

Reference #6: Centers for Disease Control and Prevention (CDC) website <<http://www.cdc.gov/injectionsafety/providers/provider_faqs_med-prep.html>> titled 'FAQs Regarding Safe Practices for Medical Injections' states, "... 1. How should I draw up medications? ... Parenteral medications should be accessed in an aseptic manner. This includes using a new sterile syringe and sterile needle to draw up medications while preventing contact between the injection materials and the non-sterile environment. Proper hand hygiene should be performed before handling medications and the rubber septum should be disinfected with alcohol prior to piercing it."

1. On 12/07/18, during an observation of Patient #28 on Unit H Yellow, the following was noted:

a. Staff #63 was observed drawing up Toradol 15 milligrams to be given intravenously and Heparin 5000 units to be given subcutaneously. Staff #63 did not disinfect the rubber septum with alcohol prior to piercing it.

b. The above finding was confirmed with Staff #6.

2. On 12/10/18, during an observation of Patient #30 on Unit D Green, the following was noted:

a. Staff #64 washed his/her hands for ten (10) seconds, donned gloves, and then injected the patient with Heparin subcutaneously.

b. The above finding was confirmed with Staff #6.

Reference #7: Sani-Cloth Germicidal Disposable Cloth Instructions for Use (IFU), states, "... General Guidelines for Use ... 2. ... When not in use, keep lid closed to prevent moisture loss. ..."

Reference #8: Signage posted outside the FICN, depicts a picture of a cell phone with a line drawn through it.

1. During a tour of the FICN on 11/29/18, the following was noted:

a. Three (3) Super Sani-Cloth germicidal disposable cloth containers did not have the top of the container closed.

b. Staff #40, a Physician, was holding a cell phone with his/her bare hand.

c. Staff #41, a Registered Dietician, was holding a cell phone with his/her bare hand.

d. Patient #3's father was holding a cell phone with his bare hand and using the phone to photograph the baby.

e. The above findings were confirmed by Staff #3.

2. During a tour of the PICU on 11/28/18, the following was noted:

a. Dust and dirt particles were noted on the floor.

b. The above finding was confirmed with Staff #43.





Reference #9: Society of Gastroenterology Nurses and Associates (SGNA), Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes 2018 states, "...Endoscope Reprocessing Protocol...9. Storage...Key considerations in storage include: ...d. Each facility should determine a method of documentation and traceability to the endoscope and reusable accessories..."

1. On 11/30/18 at 10:39 AM, in the endoscope decontamination area, in the presence of Staff #35 and Staff #36, the following was noted:

a. Staff #36 was observed manually cleaning and disinfecting an Olympus Gastroscope.

(i) After cleaning and disinfecting the scope, Staff #36 was observed placing the scope and accessories into the Olympus OER Pro Automated Endoscopic Reprocessor (AER), along with a scope previously placed in the AER.

(ii) Staff #36 indicated that the Olympus OER Pro can reprocess two scopes and its accessories at the same time.

(iii) Upon interview, Staff #36 indicated that the scope accessories are reusable. The accessories are placed in the metal-like cup within the AER.

(iv) Staff #35 and Staff #36 confirmed that the reusable accessories are not reprocessed with each scope, nor are the accessories stored with the scope they were used with, as a unique set, for tracking purposes.

(v) At 10:45 AM, Staff #35 confirmed that the Medical Special Procedures (MSP) department follows SGNA guidelines and recommendations.

2. The facility policy, Reprocessing Immersible Flexible Endoscopes with Automated Endoscopic Reprocessor (AER), failed to address traceability of reusable endoscope accessories, in accordance with the SGNA Standards referenced above.

Reference #10: Association of periOperative Registered Nurses (AORN) 2017 Edition Guidelines For PeriOperative Practice, Guideline for Environmental Cleaning Recommendation II states, "The patient should be provided with a clean, safe environment... II.h. Mattresses and padded positioning device surfaces (e.g.. OR beds, arm boards, patient transport carts) should be moisture-resistant and intact. Absorbent or nonintact surfaces may become reservoirs for microorganisms and may harbor pathogens."

1. On 11/29/18 at 11:58 AM, in the Operating Room (OR) corridor, Staff #30 confirmed that the Surgical Services Department follows AORN guidelines and recommendations.

2. On 11/29/18 at 12:25 PM, in OR #8, during cleaning and disinfecting of the OR between patients, the following was observed:

a. A patient armboard had a tear in the outer material exposing the inner foam material, which contained a dried, dark red stain.

b. Multiple gel patient positioning devices had tape and cracks in the outer gel material.

3. The above findings were confirmed by Staff #30.

Reference #11: Facility policy, Infection prevention Guidelines for Preventing Transmission of Multidrug resistant (MDR) Organisms, states, "...Policy: ...Room Cleaning: Room cleaning will be prioritized for patients on Contact Precautions. Focus will be on cleaning and disinfecting frequently touched surfaces...and equipment in the immediate vicinity of the patient. the Physical Plant Department-Environmental Services Division will terminally clean the room when the patient is discharged , transferred to another room or unit and/or when Contact Isolation Precautions are discontinued..."

1. On 11/27/18 at 16:00, during a tour of Room #F183, the neonatal isolation room, the following was observed:

a. There was a sink with multiple white metal cabinets underneath.

(i) The exterior surface of the cabinets were chipped and peeling in multiple locations, exposing a reddish color paint.

(ii) The interior of the cabinets contained a brownish rust-like residue on the bottom and sides.

(iii) The interior of the sink contained a whitish residue and a small piece of wet paper towel.

b. At 16:15 PM, Staff #10 confirmed the following:

(i) Infant supplies are kept in the cabinets and drawers.

(ii) The room was last used for an infant on contact precautions for Acinetobacter Baumannii.

(iii) After the infant was discharged , the room was terminally cleaned, and was now patient ready.

2. The above findings were confirmed with Staff #3 and Staff #10.





B. Based on observation, staff interviews, and medical record review, it was determined that the facility failed to ensure that infection control education was provided to patients and family.

Findings Include:

1. During a tour of SICU (Surgical Intensive Care Unit) on 11/28/18, the following was noted:

a. Upon interview, Staff #72 stated that Patient #14 is on contact isolation.

(i) Review of Medical Record #14, in the presence of Staff #75, failed to show any documentation that the patient and/or family were educated regarding isolation precautions.

b. Upon interview, Staff #72 stated that Patient #16 is on contact isolation.

(i) Staff #72 was unable to provide documentation that the patient and/or family were educated regarding isolation precautions.

c. Upon interview, Staff #72 stated that Patient #17 is on contact isolation.

(i) Staff #72 was unable to provide documentation that the patient and/or family were educated regarding isolation precautions.

2. The above findings were confirmed with Staff #54 and Staff #74.

3. During a tour of MICU (Medical Intensive Care Unit), on 11/28/18 at 1435, the following was noted:

a. Upon Interview, Staff #79 stated Patient #7, Patient #13, and Patient #11 were on isolation precautions.

b. Staff #79 was unable to provide documentation that Patient #7, Patient #13, Patient #11, and/or family, were educated on isolation precautions.

4. The above findings were confirmed with Staff #80, Staff #81 and Staff #9.