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Based on interviews and document review, the facility's Governing Board failed to ensure contracted services were provided in a safe manner. Specifically, the Governing Body failed to ensure a contract with a flight transportation company was current and delineated duties to be performed by flight transportation staff at the facility. (Cross Reference A-1112)

Findings include:

Facility documents:

The Flight Transport Contract read, the effective date of the contract is April 10, 2015. The agreement is to auto renew for three years and then an additional 12 months after the end date. The flight transport staff will provide equipment and services utilizing critical care teams through air transportation services. The flight transport company agrees with the facility to provide air medical transportation services to patients. Each party will ensure all licenses and authorizations required to perform duties have been obtained and are in effect at all times required.

The Governing Board Bylaws, approved 6/2021 read, the board will establish governing policies for the operation of the corporation and facilities managed by the corporation. The Governing Board grants authorization to allied health personnel to provide services under the supervision of a medical staff member. The Board will select a Chief Executive Officer (CEO) to be the Board's representative in management of the facility. The Board may authorize the CEO to enter into any contract on behalf of the facility.

1. The facility failed to ensure the contract in place with a medical flight transportation company was current and delineated duties to be performed by flight transportation staff when providing patient care at the facility.

a. On 5/25/22 at 11:09 a.m., an interview was conducted with flight transportation Paramedic (Paramedic) #1. Paramedic #1 stated he was the base manager for the company near the facility's location and also performed flight care during the transport of patients. Paramedic #1 stated sometimes when the facility was busy or needed more staff, the flight transportation staff would assist in the emergency department (ED). Paramedic #1 explained when flight transportation staff assisted in the ED, the staff would operate within the company's guidelines.

Paramedic #1 stated some tasks and procedures within his scope in which he could perform at the facility if directed by a provider would be to put in a chest tube and assist with CPR and managing a patient's airway.

b. On 5/25/22 at 3:30 p.m., RN #3 was interviewed. RN #3 stated the flight transportation staff would assist the ED staff to perform patient care tasks such as starting IVs, administering medications and rounding on patients. She stated the flight transportation staff could administer medications such as Zofran (a medication given to prevent nausea or vomiting) or normal saline. RN #3 stated if flight transportation staff were to administer a medication, the ED nurse would pull or prepare the medication, the transportation staff would administer it, and the ED nurse would then document the administration in the medical record.

c. On 5/25/22 at 3:48 p.m., an interview was conducted with the Director of the Emergency Department (Director) #4. Director #4 explained when the ED was busy and staff needed assistance, sometimes the flight transportation staff would assist and would be called "Helping Hands". Director #4 stated the flight transportation staff were able to start IVs, assist patients with activities of daily living (ADLs) and grab supplies for staff. Director #4 stated when the flight transportation staff were assisting in the ED, they were not allowed to administer medications and were not allowed to perform invasive procedures.

This was in contrast to the interview with Paramedic #1who stated he could insert a chest tube at the facility and RN #3 who stated the flight transportation staff could administer medications.

d. On 5/26/22 at 8:37 a.m., an interview with the director of emergency medical services (Director #5) was conducted. Director #5 stated the flight transportation staff assisted the ED staff with tasks such as taking patients to the rest room, answering call lights, and assisting physicians with holding instruments. Director #5 stated he was not aware of a facility policy which outlined tasks the flight transportation staff were permitted to do in the ED. Director #5 further stated he was not aware of any training or orientation the flight transportation staff received prior to providing care to the patients in the ED.

e. On 5/25/22 at 1:28 p.m., Provider #13 was interviewed. Provider #13 stated flight transportation staff would assist in the ED to perform tasks under the supervision of the provider or nurse. He stated he did not believe the facility had a policy for guidance which outlined tasks the flight transportation staff could perform when they provided assistance in the ED.

f. On 5/26/22 at 7:59 a.m., an interview with the chief executive officer (CEO) #6 was conducted. CEO #6 stated she had overall responsibility for managing and directing the facility, including being ultimately responsible for the oversight of contracts and agreements.

CEO #6 explained the flight transportation staff would sometimes act as helping hands in the ED. CEO #6 further explained the term helping hands referred to assisting the ED staff with answering call lights and helping when the ED was busy. CEO #6 stated she did not know if the contract between the facility and the flight transportation company included utilizing the flight transportation staff with tasks in the ED. CEO #6 further stated the facility's contract with the flight transportation company expired in 2019 and was unable to locate a current contract with the flight transportation company.

Based on the manner and degree of the standard-level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.21 QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT was out of compliance.

A0286- The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will identify and reduce medical errors. The hospital must measure, analyze, and track adverse patient events. Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. Executive Responsibilities. The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: That clear expectations for safety are established.

Based on interviews and document review, the facility failed to ensure the quality assessment and performance improvement (QAPI) program implemented, measured and tracked performance improvement activities related to high-risk areas. Specifically, the facility's QAPI program failed to ensure Code Blue (medical emergency such as a cardiac and or respiratory arrest) events were reported and analyzed according to facility policy to implement preventive actions and learning in two of two pediatric Code Blue events and one of twelve adult Code Blue events reviewed. (Patients #1, #9 and #10) (Cross Reference A-1100)

Based on interviews and document review, the facility failed to ensure the quality assessment and performance improvement (QAPI) program implemented, measured and tracked performance improvement activities related to high-risk areas. Specifically, the facility's QAPI program failed to ensure Code Blue (medical emergency such as a cardiac and or respiratory arrest) events were reported and analyzed according to facility policy to implement preventive actions and learning in two of two pediatric Code Blue events and one of twelve adult Code Blue events reviewed. (Patients #1, #9 and #10) (Cross Reference A-1100)

Findings include:

Facility policies:

The Code Blue policy read, the purpose was to set forth procedures for processes, equipment and staff responsibilities during cardiopulmonary resuscitation of patients who demonstrate the absence of pulse and/or respirations. Utilize ACLS and PALS protocols as appropriate. Document the events on the Code Blue record. After the code, the house supervisor will initiate a debrief of three to five minutes to review what went well, what did not go well and opportunities for improvement. The charge nurse will enter or delegate someone to enter an Incident Report that will trigger the Quality and Safety to schedule a review of the event.

The Event Reporting policy read, event reports are used to document unexpected events and to monitor, evaluate and support ongoing improvement activities in patient care and safety. They also provide an early warning system which contributes to improved quality, safety and risk reduction. All event reports should be completed at the time of detection or prior to the end of the shift on which it occurred. This allows for quicker follow-up thus decreasing the likelihood of similar occurrences in the future. A complete investigation with identification of causal/ contributing factors and corrective actions is due for every event within 14 business days of submission of an event. Investigation for each report is documented in the investigation template.

The After Action Debrief and Root Cause Analysis policy read, After Action Debrief and Root Cause Analysis are methods use by health care institutions to analyze serious safety events and learn from them. Care investigation and analysis of patient safety events as well as strong corrective actions are essential to reduce risk and prevent patient harm. The Root Cause Analysis is a tool that is used to analyze patient safety events with the goal of preventing reoccurrence. However a more structured and systematic approach is used when reviewing the event.

References:

The Quality Assessment and Process Improvement Plan for Fiscal Year 2021 read,
the purpose of this plan is to provide the framework for continual prioritized improvement in the delivery of safe quality care. The Quality and Safety Department maintains an integrated, organization-wide performance improvement program to assist operational staff in improving clinical outcomes and maintain high quality patient care and safety. The department performs the following activities/functions: facilitates the patient safety event review process, including facilitating robust investigation of individual cases, analysis and reporting of safety event trends, and the development, implementation, sustainment and reporting of corrective action plans.

The Plan provides a structure to collect data for monitoring core services of the hospital, evaluating the core services per nationally-recognized standards of care, identifying patterns and trends, implementing actions for improvement, and monitoring actions to assure sustainability. The overall goals of the quality department are to encourage coordination and cooperation across the continuum of care; focus improvement activities on the reduction and elimination of risk of harm to our patients; identify and analyze high-risk or problem prone processes for improvement opportunities and recommend improvements as warranted.

The Adult Cardiac Arrest Algorithm as pictured in the The Advanced Cardiac Life Support (ACLS) Provider Manual, published 2020 by the American Heart Association, read, for asystole/ PEA- administer epinephrine as soon as possible. Perform 2 minutes of CPR and administer epinephrine at a dose of 1 mg every 3-5 minutes at a dose of 1 mg. If the patient has a shockable rhythm such as VF or pVT, shock the patient and perform CPR for 2 minutes. If the patient has a shockable rhythm, administer a second shock and perform CPR for 2 minutes with administration of epinephrine every 3-5 minutes. If the patient does not have a shockable rhythm and there are no signs of ROSC, perform CPR for 2 minutes with continued administration of epinephrine every 3-5 minutes. The Adult Cardiac Arrest Algorithm summaries the recommended sequence of CPR, rhythm checks, shocks and delivery of drugs based on expert consensus.

The ACLS Provider Manual read, drugs for PEA and asystole include epinephrine, and other medications depending on the cause of the arrest. For cardiac arrest with a nonshockable rhythm it is reasonable to administer epinephrine as soon as possible and repeat 1 mg of epinephrine every 3-5 minutes or every 4 minutes as a midrange. In cardiac arrest, epinephrine is indicated for VF, pVT, asystole and PEA.

Physiologic end points are generally considered the best indicators of resuscitation effectiveness. During CPR end tidal CO2 (ETCO2) is a relative indicator of cardiac output and should be used if possible. Without a way to measure CPR and understanding their performance providers cannot improve. CPR quality- use quantitative waveform capnography and if PETCO2 is low or decreasing reassess the CPR quality. For intubated patients the American Health Association recommends using waveform capnography to monitor CPR quality and optimize chest compressions. Persistently low PETCO2 values less than 10 mm Hg during CPR in intubated patients suggest that ROSC is unlikely and it is reasonable to try to improve chest compressions and vasopressor therapy.

The Pediatric Advanced Life Support Provider Manual, published 2020 by the American Heart Association, read, PALS in cardiac arrest- the immediate goal of therapeutic interventions for cardiac arrest is return of spontaneous circulation (ROSC) which occurs when organized cardiac rhythm on the monitor and palpable central pulses resume. PALS treatment of cardiac arrest may include the following: rhythm analysis, defibrillation, airway management and medication therapy. The Pediatric Cardiac Arrest Algorithm outlines the recommended sequence of CPR, shocks and medication administration for both shockable and nonshockable cardiac arrest rhythms.

The Pediatric Cardiac Arrest Algorithm as pictured in the PALS manual read, if the patient is in asystole or PEA, administer epinephrine as soon as possible. Perform CPR for 2 minutes and administer epinephrine every 3-5 minutes at a dose of 0.01 mg/kg with a max dose of 1 mg. If the patient is in VF or pVT, shock the patient and perform CPR for 2 minutes. If the patient does not have a shockable rhythm and no signs of ROSC proceed to Step 10, which read perform CPR for 2 minutes and administer epinephrine every 3-5 minutes. If the patient has a shockable rhythm following the first shock, perform as second shock and perform CPR for an additional two minutes with continued administration of epinephrine every 3-5 minutes.

The Broselow Pediatric Emergency Reference Tape 2017 Edition read, measure the child to determine weight/ color zones. If actual weight is available use tape as a calculator by going directly to the weight/ dosage box. The color zones as indicated by the child's measurement were as follows: Pink for 6-7 kilograms; red for 8-9 kilograms; purple for 10-11 kilograms, yellow for 12-14 kilograms, white for 15-18 kilograms, blue for 19-23 kilograms, orange for 24-29 kilograms and green for 30-36 kilograms. The calculation basis for resuscitation medications was as follows: for epinephrine 1:10,000 concentration the dosage calculation was 0.01 mg/kg; for sodium bicarbonate the dosage calculation was 1 mEq/kg.

For a child on the Red color zone, the dosages for resuscitation medications were as follows: for epinephrine 1:10,000 the dosage was 0.085 mg; for sodium bicarbonate 8.4% the dosage was 8.5 mEq; for Amiodarone the dosage was 42 mg.

For a child on the Purple color zone, the dosages for resuscitation medications were as follows: for epinephrine 1:10,000 the dosage was 0.1 mg; for sodium bicarbonate 8.4% the dosage was 10 mEq; for Amiodarone the dosage was 50 mg.

1. The facility's QAPI program failed to implement and monitor performance improvement activities in response to patient safety events related to Code Blue events in the Emergency Department (ED).

A. Medical Record Review

Review of medical records revealed the facility failed to ensure life support protocols based on the ACLS and PALS standards of practice were implemented during Code Blue events, to include the correct dosage and frequency of emergency medications and monitoring vital signs to ensure the effectiveness of CPR.

I. Patient #1's medical record was reviewed. Patient #1 presented to the ED on 2/5/22 at 2:17 p.m. with chest pain, shortness of breath and weakness. According to the Code Blue flow record and nursing notes in the medical record, Patient #1 went into cardiac arrest at 3:07 p.m. and CPR was initiated.

a. Review of the medical record revealed epinephrine (a hormone used to restore cardiac rhythm) was not administered every 3-5 minutes according to ACLS protocols during Patient #1's Code Blue event. As example:

Epinephrine was administered at 3:09 p.m. and not again until 15 minutes later at 3:24 p.m.

Epinephrine was administered at 3:28 p.m. and not again until 7 minutes later at 3:35 p.m.

Epinephrine was administered at 3:35 p.m. and not again until 10 minutes later at 3:45 p.m.

b. According to the vitals monitoring in Patient #1's medical record, Patient #1's documented end tidal CO2 was 6 and 7 throughout the Code Blue event. The ACLS manual read, if a patient's end tidal CO2 was persistently less than 10 it was reasonable to reassess the CPR quality and attempt to improve chest compressions and vasopressor therapy. However, there was no evidence in the medical record staff acknowledged the patient's low end tidal CO2 readings during the Code Blue event or reassessed the quality of CPR and vasopressor therapy.

II. Patient #9's medical record was reviewed. On 2/26/22 at 5:28 a.m. Patient #9 arrived to the ED. According to the nurse's triage note at 5:29 p.m., Patient #9 was found unresponsive and without a pulse at home and arrived to the ED via ambulance with CPR in progress. The ED Provider Note read Patient #9 was ten months old and the triage note read Patient #9 weighed 9.45 kg. Patient #9's weight would correspond to either the red or the purple zone on the Broselow tape.

a. Review of the medical record revealed epinephrine was not administered every 3-5 minutes according to PALS protocols. Patient #9 received two doses of epinephrine at 5:23 a.m. while en route to the facility via ambulance. Patient #9 arrived at the facility ED at 5:28 a.m. but did not receive epinephrine again until 5:44 a.m., which was 21 minutes after it was administered by the ambulance crew.

b. The medical record further revealed the documented administrations of emergency medications were not in accordance with the dosages recommended in the PALS protocols and Broselow tape. As example:

At 5:44 a.m. and 6:19 a.m., staff documented "0.9 epi" was administered. The documentation did not specify whether this was in mg or ml, however other administrations of epinephrine and emergency medications were documented in mg. According to the Broselow tape, a dosage of 0.9 mg of epinephrine was not recommended for any weight or color zone for a pediatric patient.

At 5:36 a.m. staff documented 1 mEq of sodium bicarbonate was administered. The recommended dose for a child on the red zone of the Broselow tape was 8.5 mEq and for a child on the purple zone the recommended dose was 10 mEq. A dose of 1 mEq was not indicated for any weight or color zone on the Broselow tape.

c. At 5:52 a.m. the code record reflected 100 mg of Amiodarone was administered. However, for a child on the red color zone the dosage for Amiodarone was 42 mg and the dosage for a child on the purple zone was 50 mg.

III. Patient #10's medical record was reviewed. Patient #10 arrived to the ED on 3/14/22 at 3:58 a.m. with a chief complaint of cardiac arrest. According to the triage note and the Code Blue flow record, Patient #10 was not breathing and did not have a pulse on arrival and CPR was initiated at 3:59 a.m. According to the flow record Patient #10 was documented as "purple" and interviews with the RN who cared for Patient #10 revealed this meant the patient was on the purple zone of the Broselow tape.

a. According to the medical record epinephrine was not administered in accordance with the dosages recommended in the PALS protocol or the Broselow tape. Patient #10 received a total of four doses of epinephrine throughout the Code Blue event. The first administration read "04 mg epi" and the three subsequent administrations read 0.4 mg. According to the Broselow tape, for a child on the Purple color zone the dosage for epinephrine was 0.1 mg.

B. Patient Safety Events

I. Review of patient safety events associated with the medical records for Patient #1 and Patient #10 revealed the events were not investigated to ensure ACLS and PALS protocols were implemented during the Code Blue events.

a. On 2/5/22, a patient safety event report was entered related to Patient #1's encounter in the ED. The event report identified multiple issues which arose through the course of the patient's care, which included: lack of availability of a CT (computerized tomography, a type of diagnostic medical imaging) room and emergency cart; a pharmacist did not respond to assist with medications during the Code Blue; an incorrect overhead page was called for the Code Blue; staff did not know how to place the LUCAS (Lund University Cardiopulmonary Assist System, a device used to provide mechanical chest compressions to patients in cardiac arrest) device; and an expired medication was pulled and administered to the patient.

In the follow-up review for the event as documented in the facility's event reporting system a Root Cause Analysis (RCA) was planned and conducted in response to the event. As part of the event investigation, the ED Nurse Manager (Manager) #10 documented a chart review was conducted. The findings from the chart review included a timeline of Patient #1's care leading up to the Code Blue event and the timeline read, at 3:07 p.m. Patient #1 had no pulse and CPR was started. According to Manager #10's chart review, the Code Blue continued per ACLS guidelines with CPR done by the LUCAS.

This was in contrast to Patient #1's medical record, which revealed epinephrine was not administered according to the intervals recommended in the ACLS protocols.

i. Manager #10 also documented as part of the follow-up actions for the patient safety event she spoke with ED staff regarding use of the LUCAS, as the incident report read multiple staff did not know how to place the LUCAS device. The documentation read, staff from other departments who were present at the Code Blue had never used the LUCAS before and did not feel comfortable with it, however the ED staff felt comfortable using the LUCAS.

There was no documentation in the event follow-up to indicate Manager #10 identified the low end tidal CO2 readings for Patient #1 throughout the Code Blue event, which according to ACLS guidelines could indicate a need to reassess and improve CPR quality. There were no actions documented in the medical record or the review of the patient safety event to indicate staff evaluated whether the compressions delivered by the LUCAS device were effective during Patient #1's CPR.

b. On 3/14/22 a patient safety event report was entered in relation to Patient #10's encounter in the ED. According to Director #4's review of the event as documented in the event reporting system, staff performed the Code Blue according to PALS protocol.

This was in contrast to the review of Patient #10's medical record, which revealed the doses of epinephrine which were administered to Patient #10 throughout the Code Blue event were not in accordance with the dosage recommended by the PALS protocol and the Broselow tape.

II. Review of the patient safety event reports log revealed a patient safety event was not reported for the Code Blue event involving Patient #9. This was in conflict to the facility's Code Blue policy, which read after a Code Blue the charge nurse was to enter or delegate someone to enter an Incident Report which would then trigger the Quality and Safety to schedule a review of the event. As a patient safety event report was not entered, there was no evidence the Code Blue event involving Patient #9 was analyzed to identify contributing factors, determine whether facility protocols and standards of practice were followed, and implement any corrective actions needed.

C. Leadership Interviews

I. Leadership interviews revealed although the patient safety event reports associated with Patient #1 and Patient #10's Code Blue events were reviewed, the events were not analyzed to ensure the Code Blue events were conducted according to ACLS and PALS protocols. Interviews further revealed Code Blue events were to be reported and reviewed as patient safety events due to the high probability for errors and risk involved in Code Blues.

a. On 5/19/22 at 11:37 a.m., the Director of Emergency Medical Services (Director) #5 was interviewed. Director #5 stated he was the chair of the facility's code committee, which reviewed Code Blue events in the facility and worked to implement policies and procedures to guide Code Blue events.

Director #5 stated Code Blue events were reported as patient safety events, and the Code Blue was then debriefed and reviewed. He stated a Code Blue was discussed at the code committee if there were issues identified with the Code Blue event or any concerns were reported in the patient safety event.

Director #5 stated an RCA was completed in response to the Code Blue event involving Patient #1. He stated the RCA was then discussed in the Code Committee. Director #5 stated the learning and action items from the RCA related to training for use of the LUCAS device, how Code Blues were paged overhead, and appropriate staffing at the Code Blue.

Director #5 stated Patient #1's Code Blue flow record and medical record were not reviewed by the Code Committee. He stated to his knowledge the Code Blue event went well because staff did not report any medical issues during the RCA.

Director #5 reviewed Patient #1's Code Blue flow record and medical record during the interview. He stated based on review of the record epinephrine had not been administered according to ACLS protocols, and the patient's end tidal CO2 readings were lower than would be expected with high quality CPR compressions. Director #5 stated he had concerns with the documentation of the Code Blue, to include the medications which were given.

b. On 5/24/22 at 9:51 a.m., Registered Nurse (RN) #8 was interviewed. RN #8 stated a patient safety event report was to be entered for every Code Blue event which occurred. She stated this should occur before the end of the shift in which the Code Blue occurred. RN #8 stated it was important to enter a patient safety event report for Code Blues so there was additional documentation about the Code Blue event which could be referred back to and to prompt further review of the patient's medical record if needed.

c. On 5/24/22 at 11:50 a.m., Director #4 was interviewed. Director #4 stated according to facility policy, a safety event report was to be entered for every Code Blue event which occurred. She stated this was important so the Code Blue event could be reviewed.

Director #4 reviewed the code record and medical record for Patient #1. She stated according to the documentation in the medical record epinephrine was not administered every three to five minutes according to ACLS protocols and she was not able to identify a reason this occurred.

Director #4 stated she did not remember whether the review of the patient safety event report associated with Patient #1's Code Blue identified the lack of adherence to ACLS protocols for medication administration. She stated if such an issue was identified on review of a safety event it would be important to speak with staff who were present during the code, identify the reason ACLS policies were not followed and address those concerns. Director #4 stated to her knowledge these actions did not occur in response to the patient safety event involving Patient #1's Code Blue event.

Director #4 reviewed the code record and medical record for Patient #9. She stated based on the documentation in the medical record epinephrine was not administered every three to five minutes according to the PALS protocols, and the dosages documented for epinephrine and sodium bicarbonate were not in alignment with the dosages recommended by PALS and the Broselow tape. She stated she did not review the patient's medical record to ensure the patient's care was appropriate and she did not review the Code Blue with ED staff.

Director #4 stated on review of the code record and medical record for Patient #9 she believed there were learning objectives which could be taken from the Code Blue event, such as documentation of the route and timeframes for medications. She stated in emergency situations staff acted to the best of their ability and protocols and standards were in place for Code Blue situations in accordance with best practice.

Director #4 stated when patient safety events were reported for events in the ED, either she or Manager #10 reviewed the event. She stated when she reviewed the medical record for a Code Blue event it was important to look at staff actions during the event and determine whether ACLS protocols were followed. She stated when fallouts were identified it was important to re-educate staff who were involved.

d. On 5/24/22 at 1:05 p.m., the Director of Compliance (Director) #17 was interviewed. Director #17 stated a patient safety event report was not entered for the Code Blue event involving Patient #9. She stated based on the facility's Code Blue policy a patient safety event report should have been completed for Patient #9.

e. On 5/24/22 at 1:31 p.m., the Director of Quality and Safety (Director) #16 was interviewed. Director #16 stated all staff were trained to enter patient safety event reports. She stated any Code Blue event was to be reported as a patient safety event, and she stated this was important so the facility could investigate further and identify improvement opportunities or trends.

Director #16 stated when a Code Blue was entered as a patient safety event, certain department leaders were triggered to review the event. She stated the leaders were then expected to investigate the event, which could include performing a review of the patient's medical record, speaking with other staff, or looking at policies and procedures. Director #16 stated the department leaders then entered their actions into the event reporting system within 14 days of the event.

Director #16 stated the quality department relied on the front line staff and department leaders to identify whether a policy was not followed or an event required further action, because the staff and department leaders had clinical expertise. She stated when department leaders reviewed a Code Blue event they should look at and document the times of certain interventions, such as the patient's vital signs, the times epinephrine was given or the times the patient's pulse was checked. Director #16 stated the department leader's investigation determined whether further education with staff was warranted or if a policy needed to be reviewed. She stated once department leaders completed their review of an event, the quality department ensured the investigation was complete and no further actions were needed.

Director #16 stated this process was important for patients because the facility learned from what staff did right and wrong and it was part of a culture of quality and safety. She stated investigating patient safety events helped to prevent errors and improve processes. Director #16 stated patient safety event reports which were entered by staff were the primary means for the quality department to identify these learnings.

Director #16 stated the action items she recalled in response to Patient #1's Code Blue event related to how Code Blues were to be called overhead and pharmacy responsibilities. She stated she did not recall any issues identified other than those which were described in the follow-up documented in the event reporting system.

According to the event follow-up and interview, the action items identified in response to Patient #1's Code Blue event related to pharmacy responsibilities to ensure expired medications were not available; re-education to staff for how to correctly page a Code Blue overhead; ensuring staff were trained to use the LUCAS device; and re-educating staff as to pharmacy's availability to respond to Code Blues. There was no documentation in the event review to indicate the department leader or quality department identified lack of adherence to ACLS protocols for medication administration and monitoring CPR quality in Patient #1's medical record.

Director #16 stated the facility's policy required Code Blue events to be reported as patient safety events because it was important for staff to report things which could go wrong and not only things staff knew went wrong. She stated Code Blue events involved high probability and high risk for error because these events were often chaotic and traumatic. Director #16 stated the intent to report Code Blues as patient safety events was to ensure extra oversight of those processes and provide staff the opportunity to identify if something needed to be changed.

Director #16 stated department leaders including managers were taught to review patient safety events by their director, and if the director did not have time to provide education the quality department could show a manager how to complete an investigation.

f. On 5/28/22 at 9:03 a.m., Manager #10 was interviewed. Manager #10 stated she was still learning how to review patient safety events. She stated she and Director #4 split up the events in the ED which needed to be reviewed.

Manager #10 stated when she investigated a patient safety event report she reviewed the details of the report and then looked at the medical record to determine what occurred. She stated when she reviewed a Code Blue event she ensured the necessary documentation of the Code Blue was present and she created a timeline of the events leading up to the Code Blue, including the time it began and ended. She stated she did not go in-depth in reviewing the times medications were given because this would be too time-consuming. Manager #10 stated it was important for medications to be documented accurately during a Code Blue, however when she reviewed a medical record for a Code Blue she did not look at whether medications were documented correctly.

Manager #10 stated she also did not do an in-depth review of the Code Blue itself to determine whether ACLS protocols were followed because staff usually followed those protocols unless the provider decided to deviate from the protocol. She stated if she documented in the event review follow-up ACLS guidelines were followed it was because staff documented CPR was performed and epinephrine was given. This was in contrast to review of Patient #1's medical record, in which epinephrine was not administered in accordance with the ACLS protocol.

Manager #10 stated all Code Blue events were to be reported as a patient safety event. She stated this was important because it ensured leadership could check in with staff and it allowed the quality department to investigate the events.

Manager #10 stated it was challenging to review medical records for patient safety events because the record review was time-consuming and she was limited in the time she was able to spend reviewing events. She stated she had enough time to review a basic timeline of the patient's care and any specific issues identified in a patient safety event report, however she did not believe she had the time or resources to review a chart in order to determine whether ACLS protocols were followed. Manager #10 stated she had not received formal training related to reviewing and investigating patient safety events.

Based on the manner and degree of the standard-level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.55 EMERGENCY SERVICES was out of compliance.

A1112 - There must be adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedures and needs anticipated by the facility. Based on interviews and document review, the facility failed to ensure contracted flight transportation staff were qualified, trained and provided with a scope of services in assisting with care for patients in the emergency department (ED).

A1100- The hospital must meet the emergency needs of patients in accordance with acceptable standards of practice. Based on interviews and document review, the facility failed to ensure life support protocols based on national standards of practice, specifically the ACLS (Advanced Cardiac Life Support) and PALS (Pediatric Advanced Life Support) protocols were implemented for patients who required resuscitation during Code Blue events. The failure was identified in two of two records reviewed for pediatric Code Blue events and one of twelve records reviewed for adult Code Blue events. (Patients #1, #9 and #10)

Based on interviews and document review, the facility failed to ensure life support protocols based on national standards of practice, specifically the ACLS (Advanced Cardiac Life Support) and PALS (Pediatric Advanced Life Support) protocols were implemented for patients who required resuscitation during Code Blue events. The failure was identified in two of two records reviewed for pediatric Code Blue events and one of twelve records reviewed for adult Code Blue events. (Patients #1, #9 and #10)

Findings include:

Facility policies:

The Code Blue policy read, the purpose was to set forth procedures for processes and staff responsibilities during cardiopulmonary resuscitation of patients who demonstrate the absence of a pulse and/or respirations. Criteria for calling a code blue include the absence of a pulse or respirations for 10 seconds and absence of cardiopulmonary effort which is non-sustainable for life. The below designated team will respond: emergency department (ED) provider; hospitalist; paramedic or EMS staff; nursing staff to include a registered nurse (RN) from obstetrics (OB), RN from ED and RN from the intensive care unit (ICU) or medical surgical floor; respiratory therapy; radiology and laboratory techs; pharmacy as requested and when available during normal operation hours; house supervisor.

Utilize ACLS and PALS protocols as appropriate. Document the events on the Code Blue Record. The Provider (LIP, licensed independent practitioner) roles and responsibilities include to maintain control of the environment and lead the team by providing clear communication and direction. The Provider will direct the overall resuscitative efforts and issue all medical and resuscitative orders including medications.

The policy referenced and included an attachment titled "Roles and Responsibilities." The Code Team Leader was listed as the Nurse Supervisor and then the LIP, and the responsibilities included to direct the Code Blue according to ACLS and PALS protocols. The Recorder role was listed as the Primary, Medical Surgical or OB RN and the responsibilities included to document events of the code on the Code Blue record and communicate times to team members. The Medication Management role was listed as the ED or ICU RN and the responsibilities included to administer ACLS interventions such as medications and communicate clearly the medications and dosing to the recorder. The Pharmacist responsibilities included medication and dosing consultation.

References:

The Pediatric Advanced Life Support Provider Manual, published 2020 by the American Heart Association, read, High performance teams are essential to successful resuscitation attempts. High performance teams carry out their roles in highly effective manners, resulting in superior performance and timing which can translate to improved survival for patients in cardiac arrest. What distinguishes high-performance teams from others is that each member is committed to ensuring the highest-quality performance of the team rather than simply following orders. A high performance team needs to focus on coordination to include proficiency in roles, and will incorporate timing, quality and administration of the appropriate procedures during cardiac arrest.

Roles in a high-performance group- the Team Leader organizes the group and is responsible for making sure everything is done at the right time in the right way. The Team Members must be proficient in performing the skills in their scope of practice, knowledgeable about the algorithms, and clear about role assignments. Roles include the medications role, who administers medications, and the recorder role, who records the time of interventions and medications and announces when these are next due. Team member tasks include: intervening if a team member is about to administer a drug incorrectly; noting significant changes in the patient's clinical condition; repeating orders and questioning them if the slightest doubt exists.

Recognizing cardiac arrest- cardiac arrest is associated with one of the following rhythms: Asystole, which is a cardiac standstill without discernible electrical activity; pulseless electrical activity (PEA) which described any organized electrical activity on an ECG or cardiac monitor that is associated with no palpable pulses; ventricular fibrillation (VF) in which the heart has no organized rhythm or coordinated contractions; pulseless ventricular tachycardia (pVT) in which the ventricular rhythm is rapid and regular but is a form of pulseless arrest.

PALS in cardiac arrest- the immediate goal of therapeutic interventions for cardiac arrest is return of spontaneous circulation (ROSC) which occurs when organized cardiac rhythm on the monitor and palpable central pulses resume. PALS treatment of cardiac arrest may include the following: rhythm analysis, defibrillation, airway management and medication therapy. The Pediatric Cardiac Arrest Algorithm outlines the recommended sequence of CPR, shocks and medication administration for both shockable and nonshockable cardiac arrest rhythms.

The objectives for medication administration during cardiac arrest are to increase coronary and cerebral perfusion pressures and blood flow, accelerate heart rate, correct and treat the possible cause of cardiac arrest and suppress arrhythmias. Epinephrine is used for cardiac arrest associated with VF/ PVT as well as asystole and PEA. High doses may be harmful and high dose IV epinephrine is not recommended because it offers no survival advantage. Sodium bicarbonate is recommended for symptomatic patients with hyperkalemia, antidepressant overdose or overdose of other sodium channel blocking agents, however routine administration in cardiac arrest is not recommended.

The Pediatric Cardiac Arrest Algorithm as pictured in the PALS manual read, if the patient is in asystole or PEA, administer epinephrine as soon as possible. Perform CPR for 2 minutes and administer epinephrine every 3-5 minutes at a dose of 0.01 mg/kg with a max dose of 1 mg. If the patient is in VF or pVT, shock the patient and perform CPR for 2 minutes. If the patient does not have a shockable rhythm and no signs of ROSC proceed to Step 10, which read perform CPR for 2 minutes and administer epinephrine every 3-5 minutes. If the patient has a shockable rhythm following the first shock, perform as second shock and perform CPR for an additional two minutes with continued administration of epinephrine every 3-5 minutes.

For persistent VF/ pVT- if IV access is established, administer epinephrine every 3-5 minutes while compressions continue. This will generally result in epinephrine delivery after every other rhythm check. For asystole/ PEA- provide high-quality CPR, deliver epinephrine as soon as possible. Administer epinephrine every 3-5 minutes if cardiac arrest persists. This will generally result in epinephrine delivery after every other rhythm check.

The Advanced Cardiac Life Support Provider Manual, published 2020 by the American Heart Association, read, successful high-performance teams have medical expertise and mastery of resuscitation skills but also demonstrate effective communication and team dynamics. The roles and tasks for members of high-performance teams were the same to those described above in the PALS provider manual.

The Adult Cardiac Arrest Algorithm as pictured in the ACLS manual read, for asystole/ PEA- administer epinephrine as soon as possible. Perform 2 minutes of CPR and administer epinephrine at a dose of 1 mg every 3-5 minutes at a dose of 1 mg. If the patient has a shockable rhythm such as VF or pVT, shock the patient and perform CPR for 2 minutes. If the patient has a shockable rhythm, administer a second shock and perform CPR for 2 minutes with administration of epinephrine every 3-5 minutes. If the patient does not have a shockable rhythm and there are no signs of ROSC, perform CPR for 2 minutes with continued administration of epinephrine every 3-5 minutes. The Adult Cardiac Arrest Algorithm summaries the recommended sequence of CPR, rhythm checks, shocks and delivery of drugs based on expert consensus.

PEA and asystole- drugs for PEA and asystole include epinephrine, and other medications depending on the cause of the arrest. For cardiac arrest with a nonshockable rhythm it is reasonable to administer epinephrine as soon as possible and repeat 1 mg of epinephrine every 3-5 minutes or every 4 minutes as a midrange. In cardiac arrest, epinephrine is indicated for VF, pVT, asystole and PEA.

Vasopressors optimize cardiac output and blood pressure and evidence shows that using vasopressors favors initial resuscitation with ROSC. Epinephrine is used using resuscitation primarily for vasoconstriction which increases cerebral and coronary blood flow during CPR> When IV access is available give epinephrine 1 mg IV during CPR after the second shock and repeat every 3-5 minutes or every 4 minutes as a midrange, i.e.. every other rhythm check. Because these medications can improve diastolic blood pressure, coronary artery perfusion pressure and the rate of ROSC, the American Health Association continues to recommend their use.

Physiologic end points are generally considered the best indicators of resuscitation effectiveness. During CPR end tidal CO2 (ETCO2) is a relative indicator of cardiac output and should be used if possible. Without a way to measure CPR and understanding their performance providers cannot improve. CPR quality- use quantitative waveform capnography and if PETCO2 is low or decreasing reassess the CPR quality. For intubated patients the American Health Association recommends using waveform capnography to monitor CPR quality and optimize chest compressions. Persistently low PETCO2 values less than 10 mm Hg during CPR in intubated patients suggest that ROSC is unlikely and it is reasonable to try to improve chest compressions and vasopressor therapy.

The Broselow Pediatric Emergency Reference Tape 2017 Edition read, measure the child to determine weight/ color zones. If actual weight is available use tape as a calculator by going directly to the weight/ dosage box. The color zones as indicated by the child's measurement were as follows: Pink for 6-7 kilograms; red for 8-9 kilograms; purple for 10-11 kilograms, yellow for 12-14 kilograms, white for 15-18 kilograms, blue for 19-23 kilograms, orange for 24-29 kilograms and green for 30-36 kilograms. The calculation basis for resuscitation medications was as follows: for epinephrine 1:10,000 concentration the dosage calculation was 0.01 mg/kg; for sodium bicarbonate the dosage calculation was 1 mEq/kg.

For a child on the Red color zone, the dosages for resuscitation medications were as follows: for epinephrine 1:10,000 the dosage was 0.085 mg; for sodium bicarbonate 8.4% the dosage was 8.5 mEq; for amiodarone the dosage was 42 mg.

For a child on the Purple color zone, the dosages for resuscitation medications were as follows: for epinephrine 1:10,000 the dosage was 0.1 mg; for sodium bicarbonate 8.4% the dosage was 10 mEq; for amiodarone the dosage was 50 mg.

1. The facility failed to ensure life support protocols based on the ACLS and PALS standards of practice were implemented during Code Blue events, to include the correct dosage and frequency of emergency medications and monitoring vital signs to ensure the effectiveness of CPR.

A. Interviews with facility staff and leadership involved in Code Blue events revealed ACLS and PALS protocols were to be implemented during Code Blue events in order to guide resuscitation efforts, to include the dosage and frequency of emergency medications.

I. On 5/25/22 at 11:09 a.m., the Flight Paramedic (Paramedic) #1 was interviewed. Paramedic #1 stated he had participated in Code Blue events in the facility's ED and assisted with different tasks during a Code Blue. He stated the staff member responsible for medication management during a Code Blue was responsible to call out intervals for medications and refer to the guidelines or protocols for resuscitative interventions. Paramedic #1 stated staff followed ACLS protocols during a Code Blue event. He stated it was important to adhere to ACLS protocols because they were the "golden rule" for resuscitation during a cardiac arrest.

Paramedic #1 stated he had not observed situations in which the physician leading the Code Blue event directed staff to perform an intervention which was not in alignment with ACLS protocols. He stated if such a situation occurred he would need further information to understand the rationale to deviate from the protocol or change a medication interval.

Paramedic #1 stated during a pediatric Code Blue, the Broselow tape and PALS algorithms determined which medications were administered and the correct dosage. He stated the dosage for emergency medications was weight-based because there was less room for error with children and it was important to administer the medication as closely as possible to the recommended dosage. Paramedic #1 stated if a physician ordered an emergency medication at a significantly higher dose than the recommended dose per the PALS and Broselow references, he would need to understand the rationale for the discrepancy because the dosages outlined in the national standards were decided and accepted by a board of experts.

II. On 5/25/22 at 2:36 p.m., the Clinical Pharmacist (Pharmacist) #7 was interviewed. Pharmacist #7 stated although he did not respond to every Code Blue in the facility, pharmacy would respond to a Code Blue if available to assist with medications.

Pharmacist #7 stated during a pediatric Code Blue event, the emergency medications given were to be dosed according to the patient's weight. He stated if the patient's weight was not known, staff would utilize the Broselow tape as a reference to determine the correct medication dosage. He stated the tape was used to estimate the patient's weight as it was not always possible to obtain an accurate weight during a Code Blue situation.

Pharmacist #7 stated it was important to give the correct weight-based dose for emergency medications because if the dose was not accurate the medication could be subtherapeutic (dose of a drug lower than what is usually prescribed to treat a disease) or supratherapeutic (amount of a drug that is greater than the therapeutic concentration or maximum dose in a medical treatment) for the child. He stated staff should give as close to the correct dosage as possible according to the Broselow tape because the dosages stipulated by the Broselow tape had been validated in studies and were the most effective in a cardiac arrest situation. Pharmacist #7 stated if a supratherapeutic dose of epinephrine was given to a pediatric patient there was a potential risk of hypertensive emergency or stroke.

Pharmacist #7 stated if the dosage of epinephrine recommended for a pediatric patient was 0.1 mg according to the Broselow tape, he could not think of a situation in which it would be recommended to administer a significantly higher dose of 0.4 mg unless the patient had overdosed on beta blockers. He stated if this higher dose was ordered during a Code Blue event he would not feel confident to administer the dose due to the potential for harm to the patient. Pharmacist #7 stated he had never observed a situation in which the physician leading a pediatric Code Blue asked for a dose which was not recommended according to the Broselow reference.

Pharmacist #7 stated according to ACLS protocols, epinephrine was the first-line medication which was to be administered for a patient in PEA or asystole. He stated according to the protocols the time intervals were to administer epinephrine every 3-5 minutes, which allowed the medication sufficient time to circulate and become effective. He stated he had confidence in the administration intervals as recommended by the ACLS algorithms because they were demonstrated to be most effective. Pharmacist #7 stated he was not aware of a situation in which a Code Blue team should cease administration of epinephrine for a patient still in cardiac arrest, and if this was recommended by the physician leading the Code Blue he would need further information to understand the reasoning behind the provider's direction.

III. On 5/24/22 at 9:51 a.m., RN #8 was interviewed. RN #8 stated during a Code Blue event staff of multiple disciplines responded and coordinated the resuscitation interventions. She stated all of the nurses who responded to Code Blue events were ACLS certified and would ensure medications such as epinephrine were administered when appropriate. She stated epinephrine was administered every five minutes during a cardiac arrest to help with the patient's cardiac conductivity.

RN #8 stated during a pediatric Code Blue, if the patient was in PEA or asystole the first medication to be given was epinephrine, and it should be administered as soon as the patient had IV access. She stated as she had not been involved in a pediatric Code Blue event for a long time, she would rely on her team and the PALS protocols in that situation.

RN #8 stated the Broselow tape was used during a pediatric cardiac arrest to determine the dosages of emergency medications. She stated the patient's length on the tape approximated the patient's weight and corresponded to a color, and staff then followed the medication dosage for the appropriate color. She stated staff should document the color on the Broselow tape which was utilized during a pediatric Code Blue. RN #8 stated it was important to closely follow the recommended dosages on the Broselow tape because this ensured the correct amount of medication was administered to the patient.

IV. On 5/19/22 at 11:37 a.m., the Director of Emergency Medical Services and Chair of the Code Blue Committee (Director) #5 was interviewed. Director #5 stated epinephrine was to be administered as soon as possible at the beginning of a cardiac arrest and every three to five minutes thereafter. He stated staff followed ACLS protocols for administration of medications during a Code Blue event. Director #5 stated the only time epinephrine would not be administered during a Code Blue event was if the patient regained pulses or had a cardiac rhythm for which the ACLS protocols did not recommend epinephrine, such as ventricular tachycardia with a pulse.

Director #5 stated it was important to administer epinephrine every three to five minutes during a cardiac arrest because epinephrine had a short half-life and the effectiveness of the drug decreased if not administered according to the recommended frequency.

Director #5 stated the facility had a LUCAS (Lund University Cardiopulmonary Assist System, a device used to provide mechanical chest compressions to patients in cardiac arrest) device available for use during Code Blue events. He stated staff monitored the patient's end-tidal CO2 (the level of carbon dioxide released at the end of an exhaled breath which reflects the adequacy with which carbon dioxide is carried in the blood) to monitor the quality of chest compressions during CPR. He stated with high quality chest compressions the patient should have an end tidal CO2 greater than 10, and this was routinely monitored during Code Blue events.

V. On 5/25/22 at 1:28 p.m., Provider #13 was interviewed. Provider #13 stated during a Code Blue event the provider was the team leader and oversaw what medications were given, the intervals for pulse checks and medications, and giving orders for interventions. He stated ACLS and PALS protocols were used as guidelines during a Code Blue event.

Provider #13 stated dosages for pediatric patients were weight based, and during a Code Blue the Broselow tape was used to guide the medication dosage. Provider #13 stated he could not think of any situations when a significantly higher dose than what was recommended on the Broselow tape would be administered, and in general the guidelines on the Broselow tape were followed closely.

B. Review of medical records revealed ACLS and PALS protocols were not followed during Code Blue events in the Emergency Department (ED).

I. Patient #1's medical record was reviewed. Patient #1 presented to the ED on 2/5/22 at 2:17 p.m. with chest pain, shortness of breath and weakness. According to the Code Blue flow record and nursing notes in the medical record, Patient #1 went into cardiac arrest at 3:07 p.m. and CPR was initiated.

a. According to the flow record, 0.8 mg of epinephrine was administered at 3:07 p.m. when CPR was initiated. Epinephrine was administered again two minutes later at 3:09 p.m. According to the flow record Patient #1 did not have a pulse at 3:10 p.m. and the LUCAS device was applied for chest compressions.

Staff documented a rhythm change for Patient #1 at 3:21 p.m. at which time the patient was in ventricular fibrillation (VF, an abnormal heart rhythm in which the heart does not pump blood). Epinephrine was not administered again until 3:24 p.m., which was 15 minutes after it was administered at 3:09 p.m. There was no evidence in the 12 minutes between 3:09 p.m. and 3:21 p.m., Patient #1 had a change in heart rhythm or cardiac activity which would preclude epinephrine to be given every three to five minutes according to ACLS protocols.

b. At 3:28 p.m. Patient #1 received 1 mg of epinephrine, at which time he was documented to be in pulseless electrical activity (PEA, a form of cardiac arrest in which a heart monitor displays a heart rhythm which should produce a pulse but does not). Patient #1 did not receive epinephrine again until 3:35 p.m., which was seven minutes later.

c. The next documented administration of epinephrine was at 3:45 p.m., which was ten minutes after the most recent dose was given at 3:35 p.m. During this time period Patient #1 was documented as being in PEA.

According to the ACLS protocols and algorithm epinephrine was to be administered every three to five minutes for a patient in PEA.

d. According to the vitals monitoring present in Patient #1's medical record, Patient #1's end tidal CO2 was documented throughout the Code Blue event. At 3:25 and 3:30 p.m. Patient #1's end tidal CO2 was 7. At 3:31 and 3:37 p.m. Patient #1's end tidal CO2 was 6. At 3:40 p.m. the end tidal CO2 was 7 and at 3:45 p.m. the end tidal CO2 was 6.

According to the interview with Director #5 and ACLS protocols, if a patient's end tidal CO2 was persistently less than 10 it was reasonable to reassess the CPR quality and attempt to improve chest compressions and vasopressor therapy. However, there was no evidence in the medical record staff acknowledged the patient's low end tidal CO2 readings during the Code Blue event or reassessed the quality of the compressions delivered by the LUCAS device. According to the medical record, vasopressor therapy was not administered according to the intervals for epinephrine recommended by ACLS protocols.

II. Patient #9's medical record was reviewed. On 2/26/22 at 5:28 a.m. Patient #9 arrived to the ED. According to the nurse's triage note at 5:29 p.m., Patient #9 was found unresponsive and without a pulse at home and arrived to the ED via ambulance with CPR in progress. The ED Provider Note read, Patient #9 was ten months old and the triage note read, Patient #9 weighed 9.45 kg. Patient #9's weight would correspond to either the red or the purple zone on the Broselow tape.

For a child on the Purple color zone, the dosages for resuscitation medications were as follows: for epinephrine 1:10,000 the dosage was 0.1 mg; for sodium bicarbonate 8.4% the dosage was 10 mEq; for amiodarone the dosage was 50 mg.

a. The Code Blue flow record was reviewed. According to the record, Patient #9 received two doses of epinephrine at 5:23 a.m., which was five minutes prior to the patient's arrival at the ED. The next documented administration of epinephrine was at 5:44 a.m. This was 21 minutes after the most recent administration. During this time period it was documented on each pulse check Patient #9 had no pulse and no heart rate or rhythm was documented.

According to PALS protocols epinephrine was to be administered every three to five minutes for a pediatric patient in asystole, PEA, VF or pVT.

b. At 5:44 a.m., when epinephrine was administered to Patient #9, the code record read "0.9 epi." According to the Broselow tape, the dosage of epinephrine for a patient on the red color zone was 0.085 mg and for a patient on the purple color zone the dosage was 0.1 mg. A dose of 0.9 mg was not indicated for any color zone on the Broselow tape.

The code record did not indicate whether the documented dose of 0.9 was mg or ml, however on subsequent administrations of epinephrine the dose was documented in mg.

c. At 5:36 a.m. the code record reflected 1 mEq of sodium bicarbonate was administered. According to the Broselow tape, for a child on the red color zone the dosage for sodium bicarbonate was 8.5 mEq and the dosage for a child on the purple color zone was 10 mEq. A dose of 1 mEq was not indicated for any color zone on the Broselow tape.

According to the PALS protocol, sodium bicarbonate was recommended for patients with hyperkalemia (high potassium levels) or suspected overdose of antidepressants or other sodium channel blocking agents, however it was not recommended for routine administration in pediatric cardiac arrest. There was no evidence in the medical record for hyperkalemia or suspected overdose.

d. At 5:52 a.m. the code record reflected 100 mg of amiodarone was administered. However, for a child on the red color zone the dosage for amiodarone was 42 mg and the dosage for a child on the purple zone was 50 mg.

e. At 5:54 a.m. Patient #9 was documented as having attained return of spontaneous circulation (ROSC). At 6:15 a.m. Patient #9 again lost pulses and CPR was resumed. Atropine was administered first at 6:16 a.m. and epinephrine was given second at 6:19 a.m. According to the PALS algorithm and staff interviews epinephrine was the first-line medication for a patient in PEA or asystole and was to be administered as soon as possible. There was no indication on the PALS algorithm or protocols administration of atropine should precede administration of epinephrine.

The administration of epinephrine documented at 6:14 a.m. again read "0.9 epi," which did not specify whether the dosage was in mg or ml. However, the other medications after Patient #9 lost pulses and required resumption of CPR were documented in mg. According to the Broselow tape, there was no color zone or weight for which the recommended dose was 0.9 mg.

III. Patient #10's medical record was reviewed. Patient #10 arrived to the ED on 3/14/22 at 3:58 a.m., with a chief complaint of cardiac arrest. According to the triage note and the Code Blue flow record, Patient #10 was not breathing and did not have a pulse on arrival and CPR was initiated at 3:59 a.m.

a. According to the flow record Patient #10 was documented as "purple" on the Broselow tape. Patient #10 received a total of four doses of epinephrine through the Code Blue event. The first administration read "04 mg epi" and the three subsequent administrations read 0.4 mg. According to the Broselow tape, for a child on the Purple color zone the dosage for epinephrine was 0.1 mg.

C. Interviews with facility staff, providers and leadership revealed ACLS and PALS protocols were not implemented during the Code Blue events involving Patients #1, #9 and #10. Interviews further revealed lack of consistent knowledge regarding life support protocols and staff roles during a Code Blue event.

I. Patient #1

a. On 5/19/22 at 11:37 a.m., Director #5 was interviewed. Director #5 reviewed the code record and electronic medical record for Patient #1.

Director #5 reviewed the end tidal CO2 readings for Patient #1 during the Code Blue event. He stated if chest compressions were high quality, a patient should have end tidal CO2 values above 10. He stated Patient #1's end tidal CO2 was 6 or 7 throughout the Code Blue event. Director #5 stated the patient's end tidal CO2 values were not what he would expect to see if CPR was effective.

Director #5 reviewed the administrations of epinephrine as recorded on the Code Blue flowsheet. He confirmed there were no additional administrations of epinephrine documented elsewhere in the medical record. Director #5 stated between 3:09 p.m. and 3:24 p.m. there was no epinephrine administered to Patient #1. He stated during this interval the only reason epinephrine would not be administered was if the patient's cardiac rhythm changed.

According to Patient #1's medical record, Patient #1 had no pulses and was in PEA at 3:08 p.m. At 3:21 p.m. Patient #1 was documented to be in VF and had no pulses. Between 3:09 p.m. when epinephrine was administered and 12 minutes later at 3:21 p.m. when staff first documented a rhythm change to VF there was no administration of epinephrine.

Director #5 stated epinephrine also was not given between 3:28 p.m. and 3:35 p.m. which was a longer interval than recommended, and he did not see in the medical record a reason for the delay in administration of epinephrine. Director #5 stated between 3:35 p.m. and 3:45 p.m. epinephrine was not administered and he did not see documentation to explain why it was not given.

According to Patient #1's medical record, Patient #1 was documented to be in PEA in the seven minutes between 3:28 p.m. and 3:35 p.m., and in the ten minutes between 3:35 p.m. and 3:45 p.m. According to ACLS protocols, for a patient in PEA epinephrine was to be administered every 3-5 minutes.

Director #5 stated according to the documentation in Patient #1's medical record, epinephrine was not administered according to the intervals recommended by the ACLS protocols. He stated prior to the interview he was not aware the ACLS algorithm for medication administration was not followed during Patient #1's Code Blue event.

b. On 5/24/22 at 11:50 a.m., the ED Director (Director) #4 was interviewed. ED Director #4 reviewed the code record and electronic medical record for Patient #1.

Director #4 stated during a cardiac arrest, 1 mg of epinephrine was administered every three to five minutes. She stated during Patient #1's Code Blue event epinephrine was given at 3:09 p.m. and again at 3:24 p.m. She stated 15 minutes was longer than the recommended interval, and on review of the record she did not know why epinephrine was not administered.

Director #4 stated epinephrine was also not given between 3:28 p.m. and 3:35 p.m., and again between 3:35 p.m. and 3:45 p.m. She stated these intervals were also longer than the recommended frequency of three to five minutes. Director #4 stated according to the documentation in the code record and the medical record ACLS protocols for epinephrine administration were not followed during Patient #1's cardiac arrest.

Director #4 reviewed the end tidal CO2 readings for Patient #1 during the Code Blue event. She stated the patient's end tidal CO2 was six or seven throughout the Code Blue. She stated based on these readings, staff should have re-evaluated the compressions which were performed during Patient #1's CPR to ensure the compressions delivered were adequate. She stated if the LUCAS device was in use and the patient's end tidal CO2 reading were not within expected ranges, staff should have ass

Based on interviews and document review, the facility failed to ensure contracted flight transportation staff were qualified, trained and provided with delineated duties for staff to perform at the facility as contracted staff.

Findings include:

References:

The Flight Transport Contract read, the effective date of the contract is April 10, 2015. The agreement is to auto renew for three years and then an additional 12 months after the end date. The Flight Transport staff will provide equipment and services utilizing critical care teams through air transportation services. The Flight Transport company agrees with the facility to provide air medical transportation services to patients. Each party will ensure all licenses and authorizations required to perform duties have been obtained and are in effect at all times required.

The Governing Board Bylaws, approved 6/2021 read, the board will establish governing policies for the operation of the corporation and facilities managed by the corporation. The Governing Board grants authorization to allied health personnel to provide services under the supervision of a medical staff member. The Board will select a Chief Executive Officer (CEO) to be the Board's representative in management of the facility. The Board may authorize the CEO to enter into any contract on behalf of the facility.

1. The facility failed to ensure flight transportation staff were oriented and qualified to provide patient care in the ED.

a. Review of the contract between the facility and a contracted flight transportation company revealed the contract was dated April 10, 2015. Upon request, the facility was unable to provide a current contract. The expired contract showed no evidence of delineated tasks the flight staff were allowed to perform while assisting in the ED.

b. On 5/25/22 at 3:29 p.m., an interview was conducted with RN #3. RN #3 stated she was unsure of the flight staff's scope of practice. RN #3 stated flight staff could start intravenous lines (IVs), administer certain medications, start IV Normal Saline (NS) infusions, and round on patients in the ED. Furthermore, RN #3 stated when the flight staff administered medications, the nurse would go into the medical record to document the administration and comment on who administered the medication and at what time it was given. RN #3 stated the flight staff would inform the nurse of what medications they were unable to administer.

c. On 5/25/22 at 11:09 a.m., an interview was conducted with flight transportation Paramedic (Paramedic) #1. Paramedic #1 stated he was the base manager for the company near the facility's location and also performed flight care during the transport of patients. Paramedic #1 stated sometimes when the facility's ED was busy or needed more staff, the flight transportation staff would assist in the emergency department (ED). Paramedic #1 explained when flight transportation staff assisted in the ED, the flight transportation staff would operate within the company's guidelines. Paramedic #1 stated he had not had orientation to the facility to work as a staff member in the ED, instead would just inform facility staff what tasks or procedures he could or could not perform.

Paramedic #1 stated some tasks and procedures within his scope in which he could perform at the facility, if directed by a provider, would be to put in a chest tube, assist with CPR, and manage a patient's airway.

d. On 5/25/22 at 3:48 p.m., an interview was conducted with the Director of the Emergency Department (Director) #4. Director #4 explained when the ED was busy and staff needed assistance, sometimes the flight transportation staff would assist and would be called "Helping Hands". Director #4 stated the flight transportation staff were able to start IVs, assist patients with activities of daily living (ADLs) and grab supplies for staff. Director #4 stated when the flight transportation staff were assisting in the ED, they were not allowed to administer medications and were not allowed to perform invasive procedures.

This was in contrast to the interview with Paramedic #1 who stated he could insert a chest tube as part of the tasks he could perform at the facility. This was also in contrast to the interview with RN #3 who stated flight staff administered medications and started NS infusions.

Director #4 then stated she had never seen the flight staff's scope of practice and the facility did not have any policies regarding the flight staff. Director #4 also stated she was unsure of who was responsible for keeping a personnel file for the flight staff.

e. On 5/25/22 at 1:28 p.m., Provider #13 was interviewed. Provider #13 stated flight transportation staff would assist in the ED to perform tasks under the supervision of the provider or nurse. He stated he did not believe the facility had a policy regarding the tasks which the flight transportation staff could perform when they provided assistance in the ED. Provider #13 stated it would be helpful to have a defined scope for the flight transportation staff because they provided valuable assistance to the ED staff, especially during night shifts when the ED was short-staffed.

f. On 5/26/22 at 8:37 a.m., an interview with the director of emergency medical services (Director #5) was conducted. Director #5 stated the flight transportation staff would come into the facility on standby and help the ED staff with tasks such as taking patients to the restroom, answering call lights, and assisting physicians with holding instruments. Director #5 stated he was not aware of a facility policy outlining the tasks the flight transportation staff were allowed to do in the ED. Director #5 further stated he was not aware of any training or orientation the flight transportation staff received prior to providing care to the patients in the ED.

Director # 5 also stated flight staff were not allowed to administer medications or perform any invasive procedures on their own. However, this was in contrast to the interview with RN #3 who stated flight staff administered medications and inserted IVs. This was also in contrast to the interview with Paramedic #1 who stated flight staff could insert chest tubes.