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Based on interview and record review, the facility failed to clearly explain and implement a procedure of how patient grievances are submitted and processed for two patients (Patient 5 and Patient 2) as evidenced by the facility failing to acknowledge and investigate complaints filed by the patients' family representative(s) as grievances.

Findings include:

1) Review of the "Complaint & Grievance" log for the time period of 09/13/2024 through 09/26/2024 revealed one entry, File Number FBK_143320, that did not have a resolution date. Reviewed the "Current Summary" documented by Patient Relations (PR) in the electronic system, which revealed the following:
Issue notification date: 09/19/2024.
Date of issue: 09/14/2024.
Feedback Categories marked included: Participation in care, Quality of care, Communication with family members, Explanation for reason for wait time and Information about medical condition/plan of care.
Issue Status: "Not Resolved."
Patient Relations notified by telephone voicemail 09/19/2024 at 11:53 (AM).
Voicemail: "...today is 19th of Sept I'm just calling regarding my daughters passing ...I do want to file a complaint/grievance at this hospital if you can please give me a call ..."
PR follow up notes included, but not limited to:
-"He has a lot of concerns regarding the transition to PICU ..."
-"Father asked what was taking so long why not getting them moved, the issue wasn't a room, it was about who/what nurse was taking her."
-"She started not holding her sats (oxygen saturation level) went down to the 70's, staff stood with the tanks unsure what to do the nurse decided they needed to bag her."
-"He's (father) been here long enough think that bagging her in Carter (medical unit) he thought she would pass there -So much time had passed, there was lack of urgency."
-"He stated he never met the case manager, social worker, and wanted to speak to the manager. ..."
Patient Relations expressed her condolences, and understood that he wanted to file a complaint/grievance although he was uncertain as to what he would like to be addressed at this time, to please not hesitate to contact me for any questions/assistance as she would like to assist with his issues of concern. At this time this will be considered to be a complaint upon [sic] father's stated grievances are received and will address at that time. Father acknowledged and will contact PR."
- Outcome Notes included:
09/19/2024: "PR message from father."
09/19/2024: "PR conversation with father uncertain as to filing of grievance at this time will contact PR upon decision."
09/23/2024: "PR discussion Quality/Risk"

Reviewed P1's medical record, which included a progress note by the Social Worker (SW)1 dated 09/16/2024 at 04:06 PM. The progress note acknowledged notice of fathers concerns. It included: "Father expressed understanding of care plan noting patient's increasing need for respiratory support. Father familiar with hospitalization from previous admissions in NICU (neonatal intensive care unit), Carter (medical unit), and PICU (pediatric intensive care unit); and noted familiarity with nursing practices."... Father felt he was doing most of patient care while in the Carter unit as ...nurses were "going in and out of the room." Father felt staff should have been more responsive. "He also stated that the RTs (Respiratory Therapists) seem "to be filling in for the nurses" in PICU. Father was frustrated as he didn't know where to go with his concerns. SW1 offered psychosocial support and Father was receptive to Patient Relations. SW1 collaborated with medical team and notified Patient Relations for follow up with this matter."

On 10/01/2024 at 01:00 PM, during an interview with Carter Unit Manager (UM)1, she said she had been at the hospital on 09/15/2024, when P1 was transferred to PICU, for a higher level of care. When asked if she was made aware P1's father verbalized concerns to SW1, she replied no. UM1 said she was informed by the Charge Nurse P1 was having respiratory issues and being transferred to PICU, but was not aware of concerns or delays. At that time, UM1 reviewed SW1's progress note, and said she had not seen it before. She said she had not been asked to investigation concerns regarding P1's care.

On 10/01/2024 at approximately 03:30 PM,during an interview with PICU UM2, she said she did not have knowledge of concerns about P1's care on her unit (PICU). At that time, she reviewed SW1's progress note, confirmed she was not aware of it and that she would have had to investigate further for specifics as to why the father felt the RT's were filling in for the nurses.

On 10/01/2024 at approximately 04:00 PM, during an interview with PR, she said this grievance had not moved forward or had any further investigation because the father had not called back to confirm the request to file a grievance, or identify the "specific issues" to follow up on. PR said she had not spoken with either of the nurse managers (Carter and PICU) about the progress note or conversation SW1 had with P1's father. At that time SW1's note was reviewed, and PR agreed there were issues identified in that note as well as during their phone conversation that should have been further investigated in a timely manner by the unit managers, regardless of no call back by the father with additional details.

Reviewed the facility policy titled "Complaint and Grievance Management," last revised 11/2020. The policy included the following:
- "KMCWC (Kapiolani Medical Center for Women and Children) has established a process for prompt resolution of patient/patient representative complaints and grievances ..."
- "The Patient Relations Coordinator, at the direction of the Grievance Committee, gathers, investigates, and responds to patient grievances received via telephone, in person or in writing."
- "Complaint: A concern from a patient or patients representative regarding the quality or appropriateness of patient care or services. Concerns will be classified as a complaint if they can be effectively addressed by the staff prevent at the time the complaint is received. "Staff present" includes any staff present at the time of complaint or who quickly respond to address the complaint including clinical managers, administration, and patient relations."
- "Grievance: ...If the patient care complaint cannot be resolved at the time of the complaint by staff present, it is postponed for later resolution, is referred to other staff for later resolution, requires investigation, and/or requires further actions for resolution, the complaint is considered a grievance for the purpose of these requirements."
- "Receipt and Reporting of Complaints: ... D. If a concern is not immediately resolved, referral is made to the manager/director who has authority to work with the patient/patient's authorized representative to resolve issues. If the matter can not be resolved within a reasonable time by the manager/director, or if the matter requires further investigation and /or further actions for resolution by the manager/director, it should be referred to the Patient Relations Coordinator. ..."
- "Acknowledgment, Review and Resolution: ...C. Grievances will be resolved within seven (7) working days of receipt whenever possible. If the grievance cannot be resolved within seven (7) days, the reporter will be notified that the hospital is still working to resolve the grievance and that the hospital and that the hospital will follow-up with a written response within a stated timeframe. ..."
"D. A grievance will be considered closed at the time it has been resolved to the patient/patient's authorized representative's satisfaction. In situations where satisfaction is not possible even where appropriate and reasonable action has been taken on the patient's behalf, the grievance is considered closed. E. Response will include name of hospital, contact person, steps taken on behalf of the patient to investigate the grievance, results of the investigation, including follow-up actions as appropriate, date of completion. ..."


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2) Patient (P)2 is a 3-year-old male admitted to the acute care facility on 08/19/24. On 09/18/24, a complaint was received by the state agency (SA) from P2's family representative (FR)6 regarding several concerns she had about the quality-of-care P2 was receiving at the time in the Pediatric Intensive Care Unit (PICU). FR6 documented that she had spoken to "management" about her concerns and had "gone to the news to raise awareness." On 09/20/24, during a follow-up phone call to FR6, she reported that she had spoken to the PICU Unit Manager (UM2) about her concerns and had been referred to the Patient Relations Coordinator (PR).

On 09/27/24, an interview was done with FR6 at P2's bedside. FR6 stated that she had finally gotten a call back from PR the day before and that PR told her she didn't think FR6 needed any follow-up because she had thought FR6's concerns were resolved. FR6 confirmed that neither UM2 or PR had followed up with her, either in person or in writing, regarding the investigation and resolution of the concerns she had discussed with them. FR6 also confirmed that despite having different nurses assigned that were providing better care than before, she did not feel that the concerns she had expressed earlier were "resolved" to her satisfaction.

Based on interviews, document and medical record review, the facility did not adjust their performance improvement activities and implement effective processes to be able to analyze data, identify quality of care issues, investigate, identify trends, and take reasonable and appropriate actions to improve the quality of care when a high volume of new staff nurses were brought on board. Specifically, the facility failed to: 1) identify a significant increase in medication errors in a timely manner, or investigate and identify opportunities to reduce additional errors. 2) thoroughly investigate one patient's (P)1 grievance for quality of care issues and 3) the pediatric flow committee did not refer a delay in P1's transfer to the Quality department for further investigation. In addition, when incidents occurred, the learning was not disseminated throughout the hospital.

Findings include:

1) Cross Reference A-0122 Patient Rights-Grievance Review
A grievance from P1's father regarding quality of care and the time it took to transfer to higher level of care was not investigated to determine if the grievance was confirmed or not confirmed and to identify any areas for improvement, and implement action plans if needed.

2) P1 was a 4-year-old with past pertinent medical history that included prematurity, bronchopulmonary dysphasia (chronic form of injury to lungs that affects preterm newborns), seizure disorder, and global developmental delay (failure to meet milestones in several areas of intellectual functioning). She was admitted to the medical unit (Carter) on 09/14/2024, for respiratory distress and fever. Her condition worsened and she was transferred to the Pediatric Intensive Care Unit (PICU) on 09/15/2024.
Record review (RR) of medical records revealed the following entries:
09/15/2024 Nursing Progress Note:
"...Around 0815 (AM) pt. (P1) was increased to 8L (liters of oxygen) HFNC (high flow nasal cannula). House supervisor made aware per Charge nurse." "Around 0851 MD confirmed PICU transfer."
"At 0900 the MD reported to this nurse that he turned the patient O2 (oxygen) to 10L HFNC and that he was in contact with PICU to obtain a bed. ..."
"From 0900-1100 we were still awaiting a bed in PICU for the patient."
"Around 1115 this nurse was informed a bed was available and preparation to get the patient transferred was taking place."
" ...The patients saturations (oxygen) were fluctuating between 90 and low 80's with no improvement and increased WOB (work of breathing), we decided to bag the patient. ...We continued to bag the patient on 10L via portable tank, she was sating at 99%. Transport took place (to PICU) while Charge Nurse continued bagging the patient. ..."
P1 was transferred to PICU approximately 12:00 PM.

09/15/2024 Physician (MD)1 and Resident Physician (RMD) progress note:
Date of Service 09/15/2024 06:22 AM: "Subjective: .Due to hypoxia and severe respiratory distress, oxygen increased to 10L HFNC and then to 15L HFNC. Pt (patient) discussed with MD2 (PICU attending) who accepted pt for transfer. There were delays in pt's transfer and pt with persistent hypoxia requiring CPAP (continuous positive airway pressure) with face mask at bedside to maintain O2 sats >90%. ..."
Assessment & Plans: "...Is requiring 10L HFNC and needs Vapotherm (mask-free ventilatory support with high velocity therapy, where HFNC provides oxygenation support.) or likely CPAP so will transfer to higher level of care given worsening respiratory status. ..." Signed by RMD.
"PATH (Physician at Teaching Hospitals/attestation) STATEMENT: I saw and evaluated the patient. Discussed with resident and agree with resident's findings and plan as documented in the resident's note except where noted in bold/italic and strikeout. In addition, my findings are: ... Pulse(!) 175 ...Resp (Respirations) (!) 60. ...severe retractions/abdominal breathing with nasal flaring ... There is high suspicion for staphylococcus pneumonia given rapid progression of her symptoms and worsening of her CXR (chest x-ray). She requires an escalation of her level of care and will be transferred to the PICU..." Signed by MD1.
This progress note included the following "Revision History:"
9/15/2024 12:48 PM MD1
9/15/2024 12:46 PM MD1
9/15/2024 11:34 AM RMD

09/15/2024 09:55 AM, MD2 (accepting physician in PICU) Progress note:
Diagnosis included but not limited to Pneumonia of Both Lungs due to Infectious Organism, Coronavirus NL63 infection, Acute Respiratory Failure with Hypoxia, and Respiratory Distress.
Complex Technologic and Medical Interventions included Vapotherm and Precedex Infusion (sedation).
"Subjective: ...She (P1) developed increasing O2 requirement, and was placed on high flow nasal cannula. CXR obtained yesterday revealed worsening pulmonary infiltrates bilaterally compared to the x-ray on admission. ... Her status continued to worsen with continued fever, respiratory distress. HFNC O2 increased to 8LPM and later to 10LPM. ...Arrangements made for transfer to the PICU for increased level of care."
"Plan: Noninvasive pulmonary support with Vapotherm. ...Arrange for PICC (peripherally inserted central catheter-delivers medications, or other treatments directly to the central veins) line. ..."
"Exam: ... In moderately severe respiratory distress with tachypnea, retractions, nasal flaring ..."

On 10/01/2024 at 08:45 AM, interviewed MD2, He said the PICU tries to hold a bed, so one is always available to accept an emergent patient. MD2 said he was familiar with P1's case and on 09/15/2024, PICU was extremely busy. He said he did not examine P1 when she was on the medical unit, but spoke to the physician about her status and started his progress note at that time.(09:55 AM). He said the goal is to get orders in as quickly as possible and get the patient to the unit. MD2 went on to say they usually have Residents on the floor, but that day he was the only one on the unit. He said they were trying to expedite P1's transfer. He said he spoke with the attending, reviewed the chart and accepted the patient. MD2 explained it is up to the Charge Nurse when to actually bring the patient up. MD2 said he put in orders, but there was a delay getting the PICC line inserted, obtaining a blood gas, and administering medication ordered for restlessness and sedation prior to PICC insertion. He went on to say he had given verbal instructions to the nurse who had been assigned to care for P1's prior to arrival, but when he went into the patient room, there was a different nurse. Inquired if MD2 had been involved in any discussions regarding a potential delay in transfer, and he said it was brought up at a recent "pediatric flow meeting," which is held on zoom. He said he usually does not attend that meeting and did not know the structure of this committee, or what the follow up had been.

Reviewed P1's orders from MD2', which included but not limited to the following:
09/15/2024 09:46 AM: "Transfer Patient/Bed Request"
09/15/2024 12:02 PM: High Flow Nasal Cannula (Vapotherm) 15 LPM, FIO2: .25-1.0, Keep O2 sat > 93%
09/15/2024 12:02 PM: "Obtain consent and evaluate for placement of PCVL (MD order to contact to PICC Team, to evaluate the pt and insert a PICC line)."
09/15/2024 12:02 PM: "POCT (point of care testing) Blood Gas-Capillary (heel stick) PRN (as needed)."
09/15/2024 12:02 PM: "POCT Blood Gas -Venous (from PICC line) Q12H (every 12 hours)."
09/15/2024 12:21 PM: "POCT Blood Gas- Venous PRN (Modified order of above)"
09/15/2024 12:21 PM: ketamine 50 MG/ML inj, Dose 15.0 mg PRN IV, Start :09/15/24, End: 09/15/2024."

Record Review of Medical Records revealed the following timeline of interventions:
09/15/2024 at 11:49 PM, the first venous blood gas was drawn. At 11:52 Resulted and critical labs flagged, with notification to MD.
09/15/2024 at 05:10 PM, Medication Administration Record:: Ketamine 15 mg IV, "PRN comment: Per MD request for PICC placement. May repeat Q15 min per MD request. Start: 09/15/2024 1220...."
09/15/2024 at 05:20 PM, Flowsheet Data: PICC Dual lumen catheter placement.
09/15/2024 at 05:35 PM, Ketamine 15 mg IV .

On 10/01/2024 at 11:37 AM interviewed the Nursing House Supervisor (HS) on duty the day shift 09/15/2024. She said one of the HS's responsibilities is bed control. She said she was messaged P1 was going on 6L high flow oxygen and it was MD1's plan to transfer to PICU. The HS said she went to Carter, touched base with the Charge, and gave PICU Charge Nurse the heads up about the transfer. She said when she went to see P1, she was told MD1 hadn't yet gotten acceptance from the PICU physician, and was waiting to hear back from him. She said P1 "looked OK right now." The HS said she contacted the Charge RN on PICU to find out when they could take P1, and at that time the Charge asked if there was any resources to help the unit as they had two patients that needed an RN to accompany to MRI. The HS directed her to call the transport nurse and sent one of the supervisors to also assist. She did not know what time the Intensivist accepted the transfer. The HS went back to round on Carter, and P1was still there, but bedside nurse had already given report.

On 10/1/24 at 12:25 PM, interviewed Registered Nurse (RN)5, who was assigned to P1 on the medical unit 09/15/2024. RN5 said that morning, P1 was tachycardic (high pulse rate), tachypneic (rapid shallow breathing) and required quite a bit of deep suctioning. She said they were talking about transfer, and working on getting her up to PICU. She did not know what the delay was, but knew the PICU was very busy. RN5 said at one point she was up to 10L of oxygen and desaturated when getting ready to transfer. When asked if they had thought about calling the "Early Response Team (rapid response)," she said they had all the resources they needed right there, MD, respiratory and nursing staff, just needed to get her to PICU.

On 10/01/2024 at 01:00 PM, interviewed the Unit Manager (UM)1 of Carter. She said she was in the hospital on 09/15/2024 and was informed by the Charge Nurse that P1 was having respiratory issues and was probably going to be transferred to PICU. She said she was not made aware of any concern or delay. When asked if she had done any review of the case, she said it was discussed at the Pediatric flow meeting. When asked if there were any improvement opportunities identified, she replied "Nothing I can recall from the meeting."

On 10/01/2024 at approximately 01:15 PM during an interview with the Quality Director (QD), she explained the Pediatric Flow meeting was an informal meeting held about 30 minutes every week. She said it is led by a pediatrician and invitations sent to leadership to join by zoom. There is no attendance or minutes taken for this meeting. The QD said they discuss cases where there might be opportunities to improve flow throughout the hospital. She said if something needs further investigation, it should be referred and there is a formal process for review."

3) On 10/01/2024, during an interview with the QD, inquired if the facility had identified any specific quality indicators to monitor the quality of care and oversight of the large group of new nursing staff. Although the facility had a structured Quality Improvement Plan in place that monitored several indicators on a routine basis, with data reported on a monthly basis, with a large volume of new workforce, they needed to put processes in place to collect data and monitor the quality of care in a more timely manner during the transition. The data collection and processes remained the same. A request was made for data on medication errors.

Reviewed the document of medication errors provided by QD, which revealed the following nursing related medication errors:
September 1 through September 12, there were a total of six medication errors reported:
09/02/2024: "Rate incorrect"
09/03/2024: "Med incorrect"
09/07/2024: "Duplication of therapy"
09/08/2924: "Dose Omitted/Not Given"
09//06/2024: "Wrong Dose"
09/03/2024: "medications switched"
September 13 through September 24 (influx of large number of new staff), there were a total of 26 errors reported:
09/15/2024: "Dose Omitted/Not Given"
09/18/2024: "Med-Incorrect"
09/18/2024: "Dose Omitted/Not Given"
09/17/2024: "Dose Omitted/Not Given"
09/16/2024: "Med Timing Issue"
09/19/2024: "Wrong Dose"
09/18/2024: "Dose Omitted/Not Given"
09/19/2024: "Med Timing Issue"
09/20/2024: "Out of Sequence"
09/20/2024: "Order not followed"
09/20/2024: "Other Controlled substance documented given but returned..."
09/21/2024: "Storage incorrect"
09/22/2024: "Incorrect weight"
09/22/2024: "Other Short-acting insulin not given"
09/23/2024: "Wrong Dose"
09/21/2024: "Storage Incorrect"
09/22/2024: "Incorrect weight"
09/22/2024: "Dose Omitted/Not Given"
09/22/2024: "Incorrect weight"
09/22/2024: "Other Short acting insulin not given"
09/23/2024: "Wrong Dose"
09/23/2024: "Order Not Followed"
09/24/2024: "Med Process Order Incorrect"
09/21/2024: "Dose Omitted/Not Given"
09/24/2024: "Dose Omitted/Not Given"
09/23/2024: "Dose Omitted/Not Given"


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4) A review of the facility's policy and procedure (P&P), Performance Improvement Program, noted it did not have an effective date, nor had it been approved by the Medical Executive Committee or Board of Directors. Also noted the P&P was "New." An interview with the QD on 10/01/24 at 02:51 PM confirmed that although the facility had an expansive Quality Assessment and Performance Improvement plan, the Performance Improvement Program P&P was still being finalized.

Based on interviews, observations,document and record review, there were situations identified in which the nursing staff failed to demonstrate the delivery of care met the standard of nursing practice. Due to the nature of the deficiencies, this resulted in a Condition Level deficiency in Nursing Services.

Findings include:

1) Cross Reference A395 RN Supervision of Nursing Care
Nursing did not demonstrate competency in the oversite/supervision of one patient (P)1. There was lack of evidence P1's needs were assessed on an ongoing basis and that her treatment plan was implemented in a timely manner according to standards of nursing practice and hospital policy. According to hospital policy, P1 met PEWS (system refers to assessment tools that incorporate the clinical manifestations that have the greatest impact on patient outcome) score for staff to call the "Early Response Team" for early warning signs of deterioration, the staff failed to implement the protocol. In addition, the Medical Unit (Carter) patient care guidelines did not include the amount of oxygen support (Liters (L) per minute(min)) or delivery systems that can be safely managed on the medical unit.

2) Cross Reference A396 Nursing Care Plan
Investigation revealed nursing staff did not implement a care plan that met Patient 2's needs.

3) Cross Reference A398 Supervision of Contract Staff
Investigation revealed the orientation of licensed staff did not include adequate education regarding the hospital policy/practice that blood could be administrated through a peripherally inserted central (PICC) line. As a result of this deficiency, there were unnecessary attempts to establish a peripheral intravenous line on one patient (P)1.

4) Cross Reference 410 Blood Transfusion
The hospital did not have a blood administration policy and procedure approved by the medical staff that addressed (1) the correct choice of vascular access, (2) the minimum size catheter required for transfusion, and (3) that a note from the Registered Nurse who inserted the peripheral intravenous central catheter had the authority to determine the line could be used for transfusion, in place of a physician's order.

Based on interviews, document and record review (RR), Nursing Staff did not demonstrate competency in the oversight of one patient (P)1. There was lack of evidence P1's needs were assessed on an ongoing basis and that the treatment plan was implemented in a timely manner according to standards of nursing practice and hospital policy. Although P1 met the criteria for calling the "Early Response Team," the staff did not initiate the protocol for early warning signs of deteriorating condition. In addition, the Medical Unit (Carter) patient care guidelines did not include the amount of oxygen support (Liters (L) per minute(min)) or delivery system appropriate for a patient to be managed on the medical unit.

Findings include:

1) P1 was a 4-year-old with past pertinent medical history that included prematurity, bronchopulmonary dysphasia (chronic form of injury to lungs that affects preterm newborns), seizure disorder, and global developmental delay (failure to meet milestones in several areas of intellectual functioning). She was admitted to the medical unit (Carter) on 09/14/2024, for respiratory distress and fever. Her condition worsened and she was transferred to the Pediatric Intensive Care Unit (PICU) on 09/15/2024 at approximately 12:02 PM.

2) Cross Reference A283. Quality Improvement Activities
On 09/15/2024, there was a delay in P1's transfer from the medical unit to the PICU.

3) Reviewed P1's medical records. The records revealed the oxygen support P1 required was as follows:
- 09/14/2024 at 09:45 AM, P1 was transferred from the Emergency Room to Carter on 4L (liters)/min (minute) by traditional nasal cannula (NC- delivers 2-6 L/min).
- 09/14/2024 at 04:09 PM, P1 required 6L/min and switched from NC to HFNC (high flow nasal cannula-delivers higher flow rate)
- 09/15/2024 at 09:00 AM, P1 required 10L/min HFNC.
- 09/15/2024 at 12:02 PM. documented transfer to PICU and placed on Vapotherm (nasal delivery system capable of flow rate of 40L/min.) at 14 L/min.

4) Reviewed Physician (MD)2's orders placed on 09/15/2024. The orders included, but not limited to the following:
09:46 AM: Transfer Patient/Bed Request
12:02 PM: High flow Nasal Cannula 15LPM, FiO2:0.25-1.0 keep O2 sat >93%
12:02 PM: Insert PICC (peripheral intravenous central catheter)
12:02 PM: POCT (point of care test) Blood Gas-Venous
12:02 PM: POCT Blood Gas-Capillary
12:21 PM: Ketamine (sedative) 50 mg (milligrams/Ml (milliliter) inj (Ketalar) intravenous (IV) PRN (as needed)

5) Reviewed P1's medical records, which revealed the following:
09/15/2024 at 05:10 PM Ketamine 15 mg IV
09/15/2024 at 05:20 PM: PICC Dual lumen placed
09/15/2024 at 05:35 PM: Ketamine 15 mg IV
09/15/2024 11:50 PM: First Blood Gas (Venous) obtained

6) On 10/01/2024 at 08:45 AM, interviewed MD2, who accepted P1 in PICU. He said he did not examine P1 when she was on the medical unit, but spoke to the physician about her status and started his progress note at that time.(09:55 AM). He said the goal is to get orders in as quickly as possible and get the patient to the unit. MD2 said there was a delay getting the PICC line inserted, obtaining a blood gas, and administering medication for restlessness and sedation prior to PICC insertion. MD2 said he was there when P1 arrived to the unit, and immediately increased the flow rate to 20L/min. He said he had already written orders, and "she really needed central access (PICC). MD2 said he was leaving for the day and someone grabbed him going out the door to ask about a blood gas for P1. He said "if the line (PICC) position was OK, just use the line (for blood gas)." At that time, he realized the PICC line had not been inserted yet. He went to see P1 and "Child was very agitated when I walked in." He asked if the Ketamine (for agitation) he ordered had been given, and it had not. MD2 said his intent was that she would have the Ketamine to relax her, prior to the procedure. He went on to say there was some confusion regarding the consent for the PICC insertion. "Normally we get verbal consent from families, but the PICC nurse's understanding was we needed written consent. I told him I had already gotten verbal consent, but he was redirected to do a line somewhere else, so couldn't get P1's in until later

7) Reviewed the hospital policy titled "Early Response Team (ERT)" effective date 2/2024. The policy included, but not limited to the following:
-"Statement: The intent of this policy is to provide a systematic method of early identification and rescue of patients prior to the onset of a medical crisis."
-"Early Response Team (ERT): A team of healthcare providers that responds to hospitalized patients with early signs of deteriorating on non-intensive care units to prevent respiratory or cardiac arrest."
-"...[facility] recognizes that prior to the onset of a medical crisis, subtle signs may be evident which, if identified and managed with appropriate intervention, can optimize patient care and outcomes. We have established Early Response Teams to be available to provide timely evaluation and rescue of patient in deteriorating medical conditions. ..."
- "Pediatric Early Response Team- PICU RN, Respiratory Therapist, Pediatric Admitting Resident and House Supervisor. A Pediatric Intensivist will assist the team as needed. "
- "III. Responsibility of Bedside Nurse A. Patient assessment per policy and as clinically indicated. B. Educate patient and family of criteria and number to call to activate the appropriate ERT. C. Calculation and documentation of the appropriate scoring system (pediatric or adult) based on the algorithms for that scoring system with each vital sign & assessment or change in patient condition. 1. Pediatric Early Warning Score (PEWS) for pediatric patients. ..."
- "IV. Guidelines for Calling ERT A. Any time a staff member is worried about a patient. B. Acute change from baseline in heartrate, blood pressure, respiratory rate or work of breathing., O2 saturation despite supplemental oxygen, level of consciousness. ... E. Change in baseline score from scoring tool used. ...F. Anytime a family member believes their child ...has any of the above conditions or has a concern with a change of condition. Families to call 13500 to initiate ERT."
- "V. Procedure A. Staff member will call an ERT if there is worrisome change or concern about the patient's condition, or if the patient meets criteria based on the PEWS...(see Attachment C)."
- Attachment A was a flowchart based on the patients PEWS score. The start of the algorithm was "Families often know the child best. Please remember to listen to their concerns and advocate for them." The second step was "PEWS assessment by RN on admission and with routine vitals or change of condition." The remainder of the algorithm was based on what the child's PEW score was. For a score over or equal to 6 (six), the chart directs staff to "Automate ERT: Notify charge RN and call PBX (operator) to initiate ERT." For a PEWS score of 5, the chart directs staff to "Initiate "watcher" huddle: Notify charge RN, Ped Admitting pager, and RT (Respiratory Therapist). Resident to bring intern", then "Resident to document and reassess within 1 (one) hour. ..."

RR of P1's vital signs revealed the following. PEWS scores:
09/14/2024 04:12 AM: PEWS 6 (ER)
09/14/2024 06:08 AM: PEWS 2 (ER)
09/14/2024 08:19 AM: PEWS 5 (ER)
09/14/2024 09:46 AM: Transfer to Carter (Medical)
09/14/2024 10:25 AM: PEWS 8
09/14/2024 12:06 PM: PEWS 11 (Temperature 101.2)
09/14/2024 01:43 PM and 04:09 PM: PEWS 8
09/14/2024 06:00 PM and 08:29 PM: PEWS 11
09/14/2024 10:01 PM: PEWS 6
09/14/2024 11:50 PM Temperature 101
09/15/2024 00:33 AM and 02:05 AM: PEWS 7
09/15/2024 06:55 AM: PEWS 9
09/15/2024 07:41 AM and 08:17 PEWS 7 (oxygen increased to 8 L/min at 08:17 AM)
09/15/2024 10:01 AM PEWS 10 (oxygen increased to 10 L/min at approximately 09:00 AM)
09/15/2024 12:02 PM Transfer to Pediatric Intensive Care (Manual bag/Mask, CPAP (continual positive airway pressure) held during transport)
09/15/2024 12:06 PM PEWS 10 (Vapotherm (High velocity, high flow oxygen support not available on Carter) at 14 L/min)
Although P1 met the PEWS score to call an ERT early in her admission on Carter, the staff did not initiate the protocol for additional resources or assistance to expedite transfer..

8 ) On 10/01/24 at 12:25 PM, interviewed Registered Nurse (RN)5, who was assigned to P1 on the medical unit 09/15/2024. RN5 said that morning, P1 was tachycardic (high pulse rate), tachypneic (rapid shallow breathing) and required quite a bit of deep suctioning. She said they were talking about transfer, and working on getting her up to PICU. She did not know what the delay was, but knew the PICU was very busy. RN5 said at one point she was up to 10L of oxygen and desaturated (low oxygen saturation level) when getting ready to transfer. When asked if they thought about calling the "Early Response Team (rapid response)," she said they had all the resources they needed right there, MD, respiratory and nursing staff, just needed to get her to PICU.

On 10/01/2024 at 01:00 PM, interviewed the Unit Manager (UM)1 of Carter. She said the medical unit cares for patients "up to 6 liters of high flow (oxygen)," and if someone requires more oxygen support, they are transferred to PICU, because they do not use Vapotherm on the medical floor. Inquired if the type of oxygen support required for patient on medical floor is defined in policy, she said she thought it was in the units patient care guidelines, but later reported it was not. Inquired if she knew how long P1 had been on her unit with oxygen >6L, she said she did not know.

Based on interview and record review, the hospital failed to ensure that the nursing staff implemented nursing care plans that reflected patient's goals and the nursing care to be provided to meet the patient's needs. As a result of this deficient practice, Patient (P)2 did not have his needs met and was placed at risk for a decrease in health status.

Findings include:

Patient (P)2 is a 3-year-old male admitted to the acute care facility 08/19/24. On 09/18/24, a complaint was received by the state agency (SA) from P2's family representative (FR)6 regarding several concerns she had about the quality-of-care P2 was receiving at the time in the Pediatric Intensive Care Unit (PICU). Amongst her concerns was that on the night shift on 09/15/24, P2's diaper had not been changed, had been placed on backwards, was left tangled up in the medical equipment/monitor wires, was not sufficiently turned every 2 hours, monitor alarms were ignored, and he wasn't suctioned in a timely manner, causing his oxygen saturation to decrease more frequently than normal.

On 09/27/24, an interview was done with FR6 at P2's bedside. At this time, FR6 showed the State Agency (SA) time-stamped photos taken on her phone shortly after midnight on 09/16/24, and again at 06:58 AM, showing P2 in the same position (on his back), with his diaper clearly on backwards, and his torso and both arms tangled in monitor wires.

A review of P2's care plan flow sheet from 07:00 PM on 09/15/24 to 07:00 AM on 09/16/24, revealed the night shift registered nurse (RN)2 assigned to P2 had briefly documented on the flow sheet three times during the 12-hour shift. Once at 12:58 AM, once at 04:38 AM, and lastly at 06:04 AM where she documented a set of vital signs. Although perineal care was documented as done at 12:58 AM and 04:38 am, no diaper change or absorbent pad changes were documented as she had done on her previous 12-hour shift. Review of the care plan flow sheet for the same 12-hour night shift on 09/18/24 and 09/19/24 (by a different nurse) revealed documentation recorded every 2-3 hours.

On 09/26/24 at 10:50 AM, an interview was done with Unit Manager (UM)2 in her office. UM2 confirmed that she spoke to FR6 the morning of 09/16/24 about her concerns. UM2 stated that she spoke to the day shift nurse who relieved RN2 as well as the Charge Nurse who worked the night shift. Both were able to confirm care concerns with RN2. UM2 reported that RN2 was "released" for not meeting their standards of care.

Based on interviews, document, policy and medical record reviews, investigation revealed the orientation of licensed staff did not include the hospital protocol for administration of blood through a peripherally inserted central (PICC) catheter. As a result of this deficiency, there were unnecessary attempts to establish a peripheral intravenous line on one patient (P)5.

Findings include:

1) P5 is a premature male neonate (newborn) admitted to the NICU (neonatal intensive care unit) for further management of prematurity. One of P5's diagnosis was "anemia of neonatal prematurity (lower red blood cell count). P5 received a blood transfusion on 08/14/2024 and required another one on 09/13/2024 for a hematocrit of 22.3. At the time, P5 had a PICC line in the left leg, # 1.9 Fr (size of catheter) Argyle dual lumen.

The hospital grievance log was reviewed, which revealed the following:
On 09/14/2024, "Mother (of P5) verbalized concern with staff as they were trying [sic] care for her child regarding lab draws, IV (intravenous line) placement, blood transfusion, blood culture, ...services that were trying to be provided which were [sic] there no orders for."
The summary report of the complaint included: "Supervisor: Spoke to ...bedside RN (Registered Nurse). Bedside RN reports she saw an order for a workup but after reviewing the chart with RN, Supervisor explained to RN there should be specific lab orders for the workup. Bedside RN also reports she has never transfused blood via a PICC. Supervisor explained we can transfuse in a double lumen PICC, and is noted under the notes by PICC team (RN's who insert the line). Reviewed the notes with RN in EPIC (electronic medical record). ..."

Reviewed the orientation of the licensed staff, who started on 09/11/2024. The orientation included multiple stations with education on specific topics. One station was blood administration and labs, which had a handout, but the station did not cover the hospital policy/practice of administration of blood through a PICC line.

Reviewed the NICU (neonatal intensive care unit) specific orientation checklist used to document competency. The section titled "Assessment & care of the neonatal patient," included the competency statement "Demonstrates procedure for administration of blood products to the neonate." The method marked for validating this competency was "V," which was Verbal Discussion.

Reviewed the orientation resource packet provided to all new licensed NICU staff. It is the expectation that the new staff keep this packet with them as a resource at all times. The packet included, but not limited to:
- "Neonatal Intensive Care Unit Patient Care Guidelines 2023." The guidelines had a section for blood transfusions, which included "G. ...Do not infuse through PICC without MD order or noted by PICC team in EPIC (EPIC Staff Alert)."
- "Central Line Principles" - This document stated blood can be administered through either of a #2 Fr dual lumen PICC OR the red lumen (21g) of the #2.6 Fr dual lumen PICC; no blood transfusions though a single lumen PICC (due to clotting issues).

Reviewed an "EPIC Staff Alert" that was entered by the PICC team nurse after insertion of a line. The alert included: "Lab draws may be done from secondary (short) lumen, ... May also use secondary lumen for blood transfusions if necessary. ..." The Quality Director said the alert is not part of the permanent medical record and is not retrievable after a patient is discharged.

Reviewed the facility policy titled "Patient Pretransfusion Identification and Blood Administration," effective date 7/2024. The policy does not include blood can be administered via PICC line with a physician order or an EPIC staff alert generated by a PICC RN. There was no policy approved by the medical staff for administering blood via PICC line, catheter size required, or approved protocol for the PICC RN to enter the "EPIC Staff Alert."

On 09/27/2024 at 04:00 PM interviewed RN6, who was the primary nurse for P5 on 09/13/2024 She said she had nine years of experience traveling at several different hospitals. 09/13/2024 was her first day on the unit, and P5 needed blood cultures, CBC, CRP and a blood transfusion. She went on to say she had never worked at a facility that routinely gave blood through a PICC line on neonates, but would on occasion, see a note in the physician's order "May give blood through PICC line." RN6 said she wasn't sure, but thought she made two unsuccessful attempts to start a peripheral IV line in the arm. She said there was another new nurse assisting her, who also hadn't given blood through a PICC, but did not know her name. RN6 said "I hate to stick baby if I don't have to."

On 09/27/2024 at 10:00 AM, during an interview with the NICU Clinical Supervisor (CS), she said she and the Educator were asked to help with blood draw and IV on P5. RN6 told her the baby needed "septic work up" and was trying to get an IV started. The CS said she went to review P5's orders and saw a CBC and CRP, but there was no blood culture order. She said the MD validated a blood culture was not ordered. The CS said they saw the baby had a duel lumen PICC, which could be used for the lab draws and transfusion. The CS reviewed with the RN hospital policy was they could use PICC lines for transfusions, and to always validate orders for what specific tests were ordered, as a "septic work up" may differ from facility to facility.

2) There was no feedback or education to the other new licensed staff regarding the hospital policy, and the orientation was not revised to include this important information.

Based on interviews and document review, the hospital blood administration policy and procedure approved by the medical staff did not include all required elements. Specifically, the policy did not address the correct choice of vascular access, whether a physician order is required to use a PICC (peripheral intravenous central catheter) line for transfusion, or that a note from the PICC team Registered Nurses is acceptable to inform staff the line may be used for infusion. In addition, the medical staff did not approve what size catheter was required for transfusion.

Findings include:

On 09/27/2024 at 10:00 AM, during an interview with the NICU Clinical Supervisor (CS), she said the hospital practice is that they can administer blood through a PICC line if it is a double lumen. When inquired if this needed a physician (MD) order, she said the MD would either put a note in the order the PICC could be used for blood administration, or the Registered Nurse, from the PICC team, who inserted line would put "an alert note" in EPIC (electronic medical record).

Reviewed the facility policy titled "Patient Pretransfusion Identification and Blood Administration," effective date 7/2024. The policy does not include blood can be administered via PICC line, and does not address if a physician order is required. There was no policy approved by the medical staff for administering blood via PICC line, catheter size required, or approved protocol for the PICC RN to enter the "EPIC Staff Alert."

Cross Reference A410 Supervision of Contract Staff
The orientation of licensed staff did not include adequate education on the hospital blood administration practice of using a PICC line for transfusion in the neonate.

Based on observation, interview, and record review, the facility failed to implement, as documented in its policies and procedures, a process for preventing and controlling the transmission of infections within the hospital, as evidenced by observations of transmission-based precautions (TBP) not being followed.

Findings include:

On 09/26/24 at 09:50 AM, entered the Pediatric Intensive Care Unit (PICU) with the Director of Patient Safety and Quality Services (QD). The first room observed on the unit was Room 2. The digital screen to the left of the room door indicated the date, room number, patient name, assigned nurse and assigned respiratory therapist for the day, on a predominantly white screen. Almost half of the digital screen displayed a solid yellow square indicating the following TBP details:

"Droplet Precautions Clean hands when entering and leaving the room. Surgical mask, gown and gloves are required to enter room. Eye protection required for activities causing potential eye splashes. Use dedicated patient care equipment. Discard PPE [personal protective equipment] prior to leaving room."

Interview with QD at this time revealed that each room had a digital screen outside the door which displayed any patient-specific information, including but not limited to, any TBP. QD confirmed that all staff were trained and expected to review the digital screen prior to entering the patient rooms.

On 09/26/24 at 03:10 PM, observed Registered Nurse (RN)3 enter Room 2 without donning (putting on) a gown or gloves. At 03:11 PM, observed a Housekeeper (HK)1 enter the same room without donning a gown or gloves. At 03:12 PM, conducted an interview with the Unit Manager (UM)2 outside Room 2, asking about the TBP indicated on the digital screen. UM2 stated that the patient in Room 2 (Patient (P)3) was no longer on any TBP. Queried when the TBP order was discontinued. While doing a concurrent record review of P3's electronic health record (EHR), UM2 was unwilling or unable to provide an answer to the question. Queried why the digital screen was still displaying Droplet Precautions if P3 was not on TBP any longer. At 03:15 PM, UM2 stated that the digital screen outside of Room 2 was "not working." Queried whether or not staff were trained to review the digital screen and follow the instructions displayed. UM2 explained that while staff are trained to follow instructions displayed on the digital screen, if the staff knew that P3 was no longer on Droplet Precautions, she did not expect them to wear the gown and gloves.

On 09/26/24 at 03:44 PM, an interview with Quality and Services Staff Member (QS) was done in the Conference Room. Regarding the Droplet Precautions order for P3, QS reported that the order was started on 09/04/24, and was still active, meaning it had not been discontinued. Regarding the digital screens outside the patient rooms, QS stated that per the Director of Pediatric Services, the digital screens on the PICU were malfunctioning and in the process of being replaced. As a result, they were not being used. State Agency queried, if the digital screens were not operational, why were staff still being trained to look at them, as confirmed by both QD and UM2. QS stated she would find out.

On 10/01/24 at 11:07 AM, an interview was done with the Infection Preventionist (IP) in the Conference Room. Per the IP, all TBP should show on the digital screens in the PICU and should be followed by anyone entering the room. When asked about the process of how the TBP instructions transfer to the screen, IP replied that as soon as the TBP order is started (or discontinued) in the EHR system, it automatically populates to the "Innovation" digital/electronic screens. IP continued that for any TBP ordered, it should be displayed on the digital screen, and her expectation is that anyone entering the affected room dons the proper PPE prior to entering the room, including housekeeping. IP also stated that as far as she knew, the digital screens in the PICU were operational. IP stated that she confirms this by conducting daily rounds on the unit. After explaining the observations made on 09/26/24 regarding P3's TBP, IP agreed that the practices observed were not in alignment with the facility's Policy and Procedure for Isolation [TBP].

Record review of P3's EHR confirmed that the Droplet Precautions order started on 09/04/24 and was discontinued on 09/27/24, a day after the deficient practice was observed.