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The Hospital failed to have an effective Governing Body that was legally responsible for the conduct of the Hospital by failing to ensure the Hospital met the requirements of the Federal Hospital Conditions of Participation.

Findings included:

The Governing Body failed for 6 of 26 sampled patients (Patients #2, #8, #13, #14, #15, & #24) to ensure that the Medical Staff and the CEO (Chief Executive Officer) were accountable to the Governing Body for the quality of the medical care provided to patients.

Refer to TAG: A-0049, TAG: A-0057 and TAG: A-0083.

Based on records reviewed and interviews the Governing Body failed for 6 of 26 sampled patients (Patients #2, #8, #13, #14, #15, & #24) to ensure that the Medical Staff was accountable to the Governing Body for the quality of the medical care provided to patients.

Findings included:

1) The Governing Body failed to ensure that the Cardiovascular Medical Staff performed bed space surgery in accordance with the Conditions of Participation for Surgical Services, Anesthesia Services and Infection Control as follows: Informed consents for Anesthesia Services performed for the bed space surgery for (Patients #13, #14 and #24) were not completed, according to Hospital policy. Two (2) of 3 Cardiac Intensive Care Unit (CICU) patients (Patients #13 & #24) Medical Records provided no documentation to indicate a physician obtained informed consent for Patients' #13 and #14 who received anesthesia administered as deep sedation; general intravenous anesthesia and failed to maintain appropriate pre-anesthesia, intraoperative anesthesia, and post-operative anesthesia documentation to ensure qualified personnel administered anesthesia.

The Hospital provided no documentation to indicated policies and procedures for surgical care while performing surgery in the Cardiovascular Intensive Care Unit (CICU) and the Medical-Surgical Intensive Care Unit (MSICU) at the patient's bed side to ensure and maintain a high standard of patient care and safety, for 3 of 5 surgical sampled patients (Patients #13, #14 and #24).

2) The Governing Body failed to ensure that Emergency Department physician reviewed Patient #8's laboratory results prior to discharging Patient #8 to home.

The document titled Admission Documentation, dated 4/11/18, indicated Patient #8, a previously health young child, presented to the Emergency Department and physicians admitted Patient #8 to the Intensive Care Unit with a diagnosis of Diabetic Ketoacidosis (DKA, a life-threatening complication of diabetes). The Admission Documentation indicated glucose and ketones (abnormal findings indicative of possible diabetes) was present in a urinalysis performed on Patient #8 in the Emergency Department on the previous day.

There was no indication the Hospital responded to the abnormal urine test results prior to the patient's discharge from the Emergency Department.

The Surveyor interviewed Nurse Director #2 and Physician #1 at 1:30 P.M. on 5/17/18. The Nurse Director #2 and Physician #1 said the Emergency Department Attending Physician was responsible for reviewing the urinalysis prior to discharge and that the Emergency Department Attending Physician did not review Patient #8's urinalysis prior to discharging Patient #8 from the Emergency Department resulting in Patient #8's return to the Emergency Department the following day, 4/11/18, with DKA.

3) The Governing Body failed to ensure that a Surgeon injected the correct preparation of a medication into Patient #2's right eye.

Documentation provided by the Hospital, dated 2/8/18, indicated on 1/25/18, Patient #2 was examined at the Facility's Ophthalmology Clinic and was noted to have persistent corneal (the transparent layer forming the front of the eye) clouding (abnormal assessment finding that can effect vision). Documentation provided by the Hospital about this incident indicated that the medication Goniosol (eye medication for lubrication) was injected into Patient #2's right eye. The Goniosol contained preservatives, which can be toxic to the cornea and was not intended to be injected into the eye but was intended for topical use only.

4) The Governing Body failed to ensure the Cardiac Intensive Care (CICU) Medical Staff documented Patient #15's Extracorporeal Membrane Oxygenation (ECMO- life saving machine that circulated and oxygenated the blood outside of the body) cannula position in Patient #15's medical record, consistent with corrective actions after Patient #3's ECMO cannula decannulation (dislodged) event.

The Surveyor interviewed the Medical Surgical Intensive Care Unit Medical Director at 11:10 A.M. on 5/17/18. The Medical Surgical Intensive Care Unit Medical Director said Patient #3's ECMO cannula decannulated (out of position) and Patient #3 required Cardio-Pulmonary Resuscitation (CPR) and replacement of the ECMO cannula (a surgical procedure). The Medical Surgical Intensive Care Unit Medical Director said that corrective actions after Patient #3's ECMO decannulation event included that the Attending Physician would document the ECMO cannula position in the patient's electronic medical record.

One (1) of 26 sampled patients (Patient #15) the Medical Record provided no documentation to indicate an Attending Physician documented, in Patient #15's Electronic Medical Record, the ECMO cannula catheter's anatomical position in Patient #15's thoracic (chest) space. This was not consistent with the corrective action plan after Patient #3's ECMO cannula decannulation event.

Based on observations, records reviewed and interviews the Chief Executive Officer failed to be responsible for managing the entire Hospital, affecting 6 of 26 sampled patients (Patients #1, #8, #9, #13, #14 and #24).

Findings included:

1. For 4 of 26 sampled patients (Patients #1, #8, #9 & #13) the Chief Executive Officer failed to ensure that the Hospital Quality Assessment Performance Improvement (QAPI) Program implemented effective corrective actions after Patient #9's unexpected death; implemented corrective actions in the Cardiac Intensive Care Unit after Patient #3's Extracorporeal Membrane Oxygenation (ECMO) decannulation event; implemented corrective actions after Patient #8's admission for Diabetic Ketoacidosis (DKA, a life-threatening complication of diabetes) event; and, failed to ensure a thorough Hospital Internal Investigation after Patient #1's Unplanned removal of breathing tube (extubation) event.

a. Based on records reviewed and interviews the Hospital failed to ensure that remedial education was immediately performed and determined to be effective in achieving expected competencies following Patient #9's cardiac arrest. Training was conducted approximately 87 days following the incident; for Clinical Assistant #1, failed to ensure the plan was effective; and, failed to ensure the corrective action addressed the Clinical Associates role in silencing patients' alarms.

The Surveyor interviewed the Clinical Assistant #1 at 12:14 P.M. on 5/25/18. Clinical Assistant #1 said she was concerned about Patient #9's low temperature, couldn't hear a heartbeat, did not call for assistance, and left the room to get a nurse. Clinical Assistant did not identify that the sounding oximetry alarms were alerting her to a deterioration in patient #9's condition and instead, according to the hospitals' internal investigation the alarm was silenced at least three times. Clinical Assistant #1 said she did not know what she would do differently or how she would respond differently if this event occurred today.

b. The document titled Admission Documentation, dated 4/11/18, indicated Patient #8, a previously health young child, presented to the Emergency Department with changes in mental status, lethargy and unresponsiveness; physicians diagnosed Patient #8 with Diabetic Ketoacidosis and admitted Patient #8 to the Intensive Care Unit. The Admission Documentation indicated Patient #8 was examined in the Emergency Department the prior day and glucose and ketones (abnormal findings indicative of possible diabetes) were present in a urinalysis performed in the Emergency Department at that time.

The Surveyor interviewed Physician #1 at 1:30 P.M. on 5/17/18. Physician #1 said Patient #8's urine test was not evaluated by the Emergency Room Physician prior to discharge from the Emergency Room the prior day. Physician #1 said the proposed corrective action plan for Patient #8's event was not implemented by the time of the Survey.

c. Documentation provided by the Hospital, dated 3/21/18 regarding Patient #3's ECMO decannulation event, indicated an Attending Physician would document the ECMO cannula position in the patient's electronic medical record.

The Cardiovascular Surgery Inpatient MD Note, dated 5/22/18 indicated no Attending Physician documentation of Patient #13's anatomical position of the ECMO cannula as required in the corrective action plan regarding the event after Patient #3's ECMO decannulation.

d. The Admission Documentation, dated 2/10/17, indicated Patient #1, a newborn, was born with congenital birth defects resulting in abnormal lung development and functioning. Patient #1 experienced an unplanned extubation.

The Hospital provided no documentation to indicate thorough analysis of Patient #1's unplanned extubation.

2) The CEO failed to ensure that Anesthesia Services were appropriate to the scope of services offered as deep sedation and monitored anesthesia care, were administered by qualified staff in the Cardiac Intensive Care Unit (CICU). Five (5) CICU nurses (CICU RN #1, #3, #4, #5 and #6) administered doses of drugs, verbally ordered by a physician, to 3 of 3 Cardiac Intensive Care Unit (CICU) patients (#13, #14 and #24) for the purpose of inducing deep sedation to general anesthesia in the CICU.

The Hospital policy titled Medication Administration for Anesthesia Providers, dated 2/20/2018, indicated that the policy applied to all anesthesia delivery locations and applied to Attending Physicians, Certified Registered Anesthetists (CRNAs), student nurse anesthetists, anesthesia fellows & anesthesia residents (physicians in anesthesia training).

The Hospital provided no documentation to indicate that Registered Nurses (RN's #1, #3, #4 #5 and #6) were qualified to perform deep sedation.

3) The CEO failed to ensure that the Hospital was compliant with Federal regulations for the Condition of Participation for Infection Control regarding bed space surgery.

a. The Surveyor observed, on 5/21/18, open chest exploration surgery conducted in Patient #13's bed space, with 2 closed hanging privacy curtains, one open privacy curtain, people in surgical attire, people in street clothes, Hospital staff attending to monitors and computers in the threshold between the bed space and the hallway, a man observing from the hallway and people walking in and out of Patient #13's bed space during Patient #13's chest exploration surgery.

b. The Surveyor interviewed the Hospital Infection Control Preventionist and the Infection Control Physician, at 9:30 A.M. on 5/25/2018. The Hospital Infection Control Preventionist and the Infection Control Physician said they had not participated in the development of any policies to address infection control issues for surgery outside of the operating rooms on the Neonatal Intensive Care Unit, Cardiac Intensive Care Unit or the Medical-Surgical Intensive Care Unit.

4.) The CEO failed to ensure that the Hospital was compliant with the Federal regulation of the Patient Rights Condition of Participation.

a. Review of 2 of 3 CICU records of patients (Patients #13 & #24) who received anesthesia indicated the patients did not have documented informed consent for anesthesia given as deep sedation and or general intravenous anesthesia.

b. The List of Security Personnel, dated 05/24/18, indicated 32 Security Personnel hired since 01/01/18 had not received training and certification in child first aid and CPR.

c. The Surveyor interviewed the Clinical Regulatory Compliance Manager and the Patient Care Operations at 8:40 A.M. on 5/18/18. They said that the Roof-Top-Garden (a fresh air space) was on the 11th floor of the Hospital and opened on 5/13/18. They said that Hospital staff escorted Behavioral Health patients when visiting the Roof-Top-Garden.

The Surveyor interviewed the Behavioral Health Clinical Coordinator at 9:40 A.M. on 5/18/18. The Behavioral Health Clinical Coordinator said the Hospital did not offer any specific education to the Behavioral Health Staff regarding the Roof-Top-Garden emergency notification system(s) or procedures.

d. Hospital provided no documentation to indicate: a response was provided to a complainant, or that the name of contact at the hospital was provided, or what action was taken to investigate the grievance; or, the result of the grievance process.

Based on records reviewed and interviews, the Governing Body failed to ensure responsibility for one contracted service, security services, furnished in the Hospital that permitted the Hospital to comply with standard in the Condition of Participation for Patient Rights (TAG: A-0206), which required appropriate staff to have education, training, and demonstrated knowledge in first aid techniques and certification in the use of cardiopulmonary resuscitation (CPR), including required periodic recertification.

Findings included:

The Hospital's Use of Restraints or Seclusion policy, last modified 06/30/17, indicated that determination, application and removal of restraint for violent, self-destructive behavior occurred either by trained clinical staff, or by security personnel when directed by the appropriate clinical staff.

The Schedule of Security Services Terms and Conditions, dated 03/24/14, indicated a contracted service between the Hospital and a Security Service. The Schedule of Security Services Terms and Conditions indicated the Contracted Service personnel were compliant with applicable training requirements, and that the Contracted Service complied with rules and regulations of governmental authorities.

The Surveyor interviewed the Security Manager at 9:30 A.M. on 05/31/18. The Security Manager said thirty (30) newly hired Security Staff were not trained in child CPR from December 2017 through April 2018.

The Evaluation of Contracted Clinical Service, dated 03/31/18, indicated Hospital monitoring of the Contracted Service, and the Schedule of Security Services Terms and Conditions. The Evaluation did not include any documentation to indicate that Security Staff completed education, training, and demonstrated competency in first aid techniques and certification in the use of CPR, including required periodic recertification consistent with Hospital policy and Federal requirements of participation.

The Hospital was out of compliance with the Condition of Participation for Patient Rights.

Findings included:

The Hospital failed, for one patient grievance, to implement the process for prompt resolution of the patient grievance.

Refer to TAG: A-0123.

The Hospital failed to ensure anesthesia providers in the Cardiac Intensive Care Unit (CICU) obtained consent for the provision of anesthesia for two of three CICU patients (#13 and #24) prior to the delivery of services.

Refer to TAG: A-0131.

The Hospital failed to provide education to Behavioral Health Staff regarding Hospital emergency notification system(s) and procedures, and to provide an observational experience of the Roof-Top-Garden for patient environmental safety when providing vulnerable patients (behavioral health patients) fresh air in the open air Roof-Top-Garden.

Refer to TAG: 0144.

The Hospital failed to ensure that Security Personnel were certified in first aid techniques and in the use of cardiopulmonary resuscitation (CPR) to meet the needs of their infant and child population.

Refer to TAG: 0206.

Based on records reviewed and interviews, for one of one sampled patients (Patient #23), the Hospital failed to ensure that they implemented the required elements for responding to patient grievances to ensure a prompt resolution of the patient grievance.

Findings included:

The Hospital policy titled Process for Managing Patient and Family Grievances, dated 06/01/17, indicated that once the investigation was completed, the Patient Relations Representatives drafted a response to the complainant that included: name of contact at the Hospital; the steps taken to investigate the grievance, the result of the grievance process and date the process was completed.

The Patient Satisfaction Report, dated 12/2017, indicated that the Hospital received a patient complaint regarding bed bugs in a patient room. The Patient Satisfaction Report indicated Patient #10, a minor, found a bed bug in his/her bed and Patient #10's parent called Patient Advocacy due to concerns of bringing bed bugs home. The Patient Satisfaction Report indicated Patient #10's parent indicated that to them, the Patient Advocate did not understand the concerns, and Patient #10's parent wanted to know if the Hospital was going to pay for fumigation if the bed bugs were brought home. The Patient Satisfaction Report indicated Patient #10's parent also indicated that he/she was handed three bags of belongings to clean, and expressed concerns about the costly process of correcting this issue. The Patient Satisfaction Report indicated Patient #10's parent indicated that he/she did not receive any contact information if he/she needed to follow up, and that he/she never heard from the Nurse Manager, Nursing Administration, and that he/she was unaware if anyone representing the Hospital had spoken to Patient #10.

The Surveyor interviewed Patient Relations Specialist #2 at 7:35 A.M. on 5/30/18 regarding the grievance. Patient Relation Specialist #2 said she did not speak with Patient #10's parent but was familiar with the incident. Patient Relations Specialist #2 said that the Patient Relations Department did not consider the concerns raised on Patient #10's behalf as a complaint or a grievance.

The Hospital provided no documentation at the time of survey to indicate a response to the complainant or the name of contact at the Hospital; the steps taken to investigate the grievance; or, the result of the grievance process.

Based on records reviewed and interviews the Hospital failed to ensure anesthesia providers in the Cardiac Intensive Care Unit (CICU) obtained informed consents for the provision of Anesthesia Services for two of three CICU sampled patients (Patients #13 and #24) prior to delivery of Anesthesia Services.

Finding included:

The Hospital policy titled Informed Consent, dated 5/16/2016, indicated that informed consent was obtained by clinicians who were credentialed and or certified to perform the procedure or treatment. The Informed Consent policy indicated a properly executed informed consent document was consistent with Hospital policies and included but was not limited to the following criteria:

-Name of the Hospital where the procedure was to take place,

-Name of the specific procedure for which consent is being given,

-Name of the responsible clinician who performed the procedure,

-Statement that the procedure including anticipated benefits, material risks and alternative therapies was explained to the patient/representative,

-Signature or patient and/or patient's representative and

-Date and time the informed consent was obtained by the clinician.

The Informed Consent policy indicated that the clinician's signature on the consent form signified that the above was provided.

The Informed Consent policy indicated that an informed consent was required for administration of blood and blood products; moderate, deep sedation, and general anesthesia; and, all surgical or other invasive procedures.

Two (2) of 3 CICU medical records of patients who received anesthesia indicated the patients did not have documented informed consent for anesthesia given as deep sedation and/or general intravenous anesthesia.

Review of the medical record, indicated Patient #13 underwent surgical procedures on the CICU on 05/21/18 and 05/24/18 with deep sedation using intravenous narcotics.

The CICU Charge Nurse reviewed the medical record of Patient #13 with the Surveyor on 05/25/2018 and confirmed the patient underwent surgical procedures on 5/21/18 and 5/24/2018.

There was no documentation at the time of survey to indicate consent was received by the Hospital for the use of narcotics for deep sedation as preparation for surgical procedures performed on 05/21/18 and 05/24/18.

Review of Patient #24's medical record indicated Patient #24, underwent a bedside surgical procedure on 5/24/2018 on the CICU for a mediastinal (chest) exploration, chest washout and sternal closure.

The Surveyor interviewed Cardiac Attending Physician #2, just prior to the start of the surgical procedure for Patient #24 on 5/24/2018 at 11:30 A.M. Cardiac Attending Physician #2 said he planned to administer Patient #24, an infant, adequate doses of Fentanyl (a narcotic) to produce general anesthesia as the surgical procedure was quite painful. Cardiac Attending Physician #2 said Patient #24 was already receiving a Morphine (narcotic) continuous intravenous infusion for pain management, a Versed (anti-anxiety medication) continuous intravenous infusion for sedation and a neuromuscular blockade (medication to induce paralysis) intravenous continuous infusion to prevent self extubation (removal of the breathing tube).

Patient #24's Medical Record indicated no indication of documentation of an informed consent for Anesthesia as required by Hospital policy.

Based on observations, records reviewed and interviews, the Hospital failed to provide a safe environment for 3 patients (Patient #2, #8 and #9) out of 26.

- Patient #9 experienced a deterioration in clinical and medical condition to the point of cardiac arrest and died eight days later. It was determined that while under the care of a clinical assistant, the pulse oximetry alarm sounded and was silenced, but the staff member did not immediately inform a nurse or respond to the alarms and instead proceeded with changing Patient #9's diaper. Clinical Assistant #1 noted Patient #9 was cool to the touch and still, and had a low body temperature and attempted to listen to Patient #9's heart beat before informing a nurse.

- Patient #2 had medication injected into the right eye in error, resulting in clouding and swelling of the eye, which remained unresolved six months after the error.

- There was no communication process in the event staff needed assistance while with patients when accessing the roof-top-garden.

Findings included:

1.) The Admission Documentation, completed when the patient was admitted to the ECMO service in the Medical Intensive Care Unit dated 9/21/17, indicated Patient #9, an eight month old, was born with diagnoses which included lung disease, chronic respiratory failure, and pulmonary hypertension (high lung pressures).

Patient #9's medical records indicated that during the third day of BiPAP trial Patient #9 experienced a cardiac arrest of unknown etiology, was resuscitated, was placed on Extracorporeal Membrane Oxygenation ((ECMO), life-saving machine that circulates and oxygenates blood). The Admission Documentation indicated following the change in condition, Patient #9 was determined to be critically ill, having experienced what was documented as being a likely extensive hypoxic injury (defined as being due to lack of oxygen) to vital organs. Patient #9 died eight days later, on 9/28/17.

Patient #'9 plan of care indicated he/she was admitted to the intermediate care unit in September 2017 for the initiation of BiPAP (bi-level position airway pressure) and the plan included the use of an pulse oximetry machine, designed to make an audible sound to alert staff in the event that Patient #9's breathing became ineffective resulting in oxygen level dropping below a predetermined level or when the probe attached to an extremity no longer remained attached to the patient or when the patient's heart rate dropped or stopped.

The ECMO service admitting documentation, titled, Admission Documentation, indicated that on 9/21/17 the blood oxygen saturation level alarm went off in Patient #9's room; Clinical Assistant #1 entered the room; and, measured Patient #9's blood pressure at 8:23 A.M. as being 70/46.

The Admission Documentation indicated that at 8:49 A.M., 26 minutes after Clinical Assistant#1 obtained Patient #9's blood pressure a rapid response was called. The admission documentation indicated that after obtaining the blood pressure, Clinical Assistant #1 proceeded with morning care and she noted Patient #9 to have minimal chest rise (an abnormal finding indicative of possible sign of decreased breathing and she had difficulty appreciating (hearing) Patient #9's breathe sounds. The Admission Documentation indicated Clinical Assistant #1 left the room and sought Patient #9's nurse, who upon arrival, found Patient #9 unresponsive and activated the hospital's emergency call system. The Admission Documentation indicated when emergency response/treatment team arrived, Patient #9's pulse could not be consistently felt and resuscitation, in the form of chest compressions was started.

The Job Description Document for the Clinical Assistant, no date provided, indicates that the Clinical Assistant (CA) under regular supervision and following established procedures and instructions provides basic direct care to patients as delegated by a Registered Nurse. Assists patients with feeding and hygiene, obtains, measures and records routine information such as temperature pulse and blood pressure, and performs other related duties according to specific needs of the unit. Transports patients, supplies and equipment as needed. The Job Description Document for the Clinical Assistant does not indicate that auscultating (listening with a stethoscope) breath sounds, heart sounds, or patient assessment as part of their job responsibility or scope of practice.

The Hospital reviewed the incident involving Patient #9, which included interview with Clinical Assistant #1, other staff involved in Patient #9's care, documentation, and records of alarm studies, including when the alarm on the pulse oximetry monitor sounded prior to Patient #9's resuscitation.

The Hospital indicated that while Clinical Assistant #1 was with Patient #9, the pulse oximetry intermittently alarmed and was silenced at least three times, for approximately six minutes. The hospital documentation indicated that Clinical Assistant #1 obtained Patient #9's axillary (under arms) temperature, which was low at 35.8 degrees Celsius (96.44 ° Fahrenheit). The hospital indicated Clinical Assistant #1 expressed that she was concerned about Patient #9's low body temperature, felt Patient #9's extremities as being cool to the touch, and Patient #9 appeared "still," and after attempting to obtain Patient #9's heartbeat, the documentation indicated she yelled for assistance.

When interviewed on 5/25/18, Clinical Assistant #1 told the Surveyor that while providing care to Patient #9, on 9/21/17, that she responded to the pulse oximetry alarm and although she re-applied the probe to Patient #9's toe and observed a "couple of blips" on the machine, she did not recall the machine indicating a numerical reading. (Without a numerical reading, Patient #9's oxygen saturation level or pulse would not be known to be at an acceptable level or rate), and changed Patient #9's diaper. Clinical Assistant #1 told the Surveyor that after the diaper change she obtained Patient #9's temperature and she said she was concerned about it and then obtained a stethoscope to attempt to try to listen to Patient #9's heart, but was unable to hear one.

Although the hospital indicated that the clinical assistants were re-educated regarding pulse oximetry monitoring, review of the education did not indicate silencing of the alarm was addressed in the education to all clinical assistants. It is unclear based on this policy whether Clinical Assistants were to silence sounding alarms when providing care or in response to an activated alarm.

2) The Hospital failed to implement corrective actions for nursing training after medication, not intended to be injected directly into the eyes, was injected into Patient #2's eye in error, resulting in eye damage, which continued more than six months after the medication error.

The Department of Public Health's Healthcare Facility Report, dated 2/21/18, indicated the Hospital reported and implemented corrective action that included, eye medications that were not appropriate for intra-ocular injection into the eye should not be on the sterile field table during intra-ocular surgery unless this had been discussed with the Operating Room team as to the medications' purpose.

The Department of Public Health's Healthcare Facility Report indicated education included all Operating Room (OR) Registered Nurses, Surgical Technician Staff and OR surgeons with an estimated date of completion 3/15/18.

The Surveyor interviewed the Nurse Director of the Operating Rooms, at 11:00 A.M. on 5/17/18. The Nurse Director of the Operating Rooms said that OR nursing was 1 nurse short of being 100% compliant with training.

The Intraoperative Ophthalmology Medications Education Module, dated March, 2018, indicated it contained and was consistent with the Medication Safety Practices in the Perioperative Setting Policy. The Medication Safety Practices in the Perioperative Setting Policy indicated that the Scrub Technician labeled all containers and syringes with medications and solutions on the sterile field. The Intraoperative Ophthalmology Medications Education Module indicated that the Scrub Technician used active communication to verify the medication and or solution, the dose (when applicable), and the allergy status of the patient as it was passed to a surgical team member. The Intraoperative Ophthalmology Medications Education Module indicated that the Scrub Technician or member of the surgical team at the sterile field used active communication to alert the Circulating Nurse (nurse in charge of the room) and anesthesia team when a dose of medication was administered.

The Hospital provided no clear documentation to indicate that all OR Registered Nursing Staff were required to complete the Intraoperative Ophthalmology Medications Education, as indicated in the corrective action plan, after Patient #2's Adverse Patient Event.

The Intraoperative Ophthalmology Medications Education Transcript, dated 5/17/18, indicated OR Staff Meeting Minutes Attendance, dated 5/16/18, and the Satellite OR nursing staff list, dated 5/18/18, indicated that 11 OR nurses did not complete the Intraoperative Ophthalmology Medications Education Module as required by the corrective action plan.

The Surveyor interviewed Ophthalmology Surgeon #1, at 9:46 A.M. on 5/21/18. Ophthalmology Surgeon #1 said during the surgery, which took place on 11/29/17, she was unaware that the Goniosol contained preservatives and should not be administered by injection into the eye. Ophthalmology Surgeon #1 said she first discovered that the Goniosol medication should not have been used from an email that was sent to her approximately 4-5 weeks after the surgery. Ophthalmology Surgeon #1 said at the time she received the email she was out of the country and unavailable.

Ophthalmology Surgeon #1 said that as of 5/21/18, Patient #2's right eye was not totally healed, noting the eye was swollen and had notable cloudiness.

The Surveyor interviewed the Nurse Director of the OR, at 1:00 P.M. on 5/18/18. The Nurse Director of the OR said that the Education Module was sent to all OR Nurses along with a Situation, Background, Assessment, and Recommendation (SBAR), educational document. The Nurse Director of the OR said that the Education was not assigned or provided to Surgical Technicians.

The Nurse Director of the OR said the Education was for nurses only because the nurses were responsible for the medications and not the Scrub Technicians. This is not consistent with corrective action plan or Intraoperative Ophthalmology Medications Education Module.

The Nurse Director of the OR said the Scrub Technicians would know and understand "The Medication Safety Practices in the Perioperative Setting Policy," which was specifically referenced the Scrub Technician responsibility, the because information was covered in a staff meeting. The Nurse Director of the OR said the Hospital had no documentation that included signatures that all Scrub Technicians were re-educated regarding the Policy following the incident.

The Nurse Director of the OR said Clinical Coordinators and Managers performed patient care in the OR. The Nurse Director of the OR said that 3 of the 6 OR Clinical Coordinators and 1 of 2 of the Nurse Managers were not trained because Clinical Coordinators and Nurse Managers disseminated the information so they did not have to complete the Education Module. The Nurse Director of the OR said she did not know why some Clinical Coordinators and 1 Nurse Manager had completed the Net Learning, educational information while others had not.




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2.) The Hospital policy titled Patient Zones, dated 05/08/18, indicated Inpatient Psychiatry (Behavioral Health) patients who were evaluated as not actively suicidal had the right to go outside.

The Surveyor interviewed the Clinical Regulatory Compliance Manager and the Social Work Director at 8:40 A.M. on 5/18/18. The Clinical Regulatory Compliance Manager and the Social Work Director said that the Roof-Top-Garden, a fresh air space, was on the 11th floor of the Hospital and opened on 05/13/18. They said that Hospital staff escorted Behavioral Health patients when they accessed the Roof-Top-Garden.

The Surveyor interviewed the Behavioral Health Clinical Coordinator at 9:40 A.M. on 05/18/18. The Behavioral Health Clinical Coordinator said there was an inherent safety risk in taking a Behavioral Health patient outside, and that the Behavioral Health staff balanced a patient's right to fresh air with safety. The Behavioral Health Clinical Coordinator said that she would use her personal cellular phone to notify the Hospital if she needed assistance with a Behavioral Health patient, such as help in an emergency. The Behavioral Health Clinical Coordinator said the Hospital did not offer any specific education to the Behavioral Health Staff regarding the Roof-Top-Garden emergency notification system (s) or procedures.

The Surveyor interviewed the Clinical Regulatory Compliance Manager at 8:20 A.M. on 05/21/18. Although the Behavioral Health Clinical Coordinator told the Surveyor that she would use her personal cellular telephone in the event she needed to summons assistance, the Clinical Regulatory Compliance Manager said that cellular telephone reception was intermittent in the building.

Based on records reviewed and interviews the Hospital failed for 32 of 32 Security Personnel hired on or after 01/01/18, to ensure that Security Personnel were certified in first aid techniques and in the use of Cardio-Pulmonary Resuscitation (CPR) to meet the needs of their infant and child population for whom they may have to use a restraint.

Findings included:

The Surveyor interviewed the Clinical Regulatory Compliance Manager at 10:12 A.M. on 05/21/18, and at multiple times throughout the dates of survey. The Clinical Regulatory Compliance Manager said the Hospital cared for patients ranging in age from newborns to over the age of 18 years old.

The American Heart Association's 2015 Guidelines for CPR and Emergency Cardiovascular Care (ECC) indicated that an infant was aged less than one year, a child was aged one year to puberty, and an adult/adolescent was over the age of puberty.

The Hospital's Use of Restraints or Seclusion policy, dated 06/30/17, indicated that determination, application and removal of restraint for violent, self-destructive behavior occurred either by trained clinical staff or by Security Personnel when directed by the appropriate clinical staff.

The List of Security Personnel, dated 05/23/18, included 128 employees, 32 of whom were hired on or after 01/01/18.

The Surveyor interviewed the Patient Quality and Safety Nurse at 2:02 P.M. on 05/23/18. The Patient Quality and Safety Nurse provided the Surveyor with copies of first aid, CPR certification and restraint application education for two Security Personnel. The Patient Quality and Safety Nurse said the child CPR skills testing checklist had not been used for approximately six months prior to the start of survey. The Patient Quality and Safety Nurse said she was unsure how, in the absence of the child CPR skills testing checklist, the Hospital ensured proof of competency with child first aid and child CPR for security staff, and referred the Surveyor to the Security Manager.

The Surveyor interviewed the Security Manager at 3:29 P.M. in 05/23/18 and at multiple times throughout the dates of survey. The Security Manager said Security Personnel were provided by a Contracted Service. The Security Manager said that the Contracted Service changed the training programs provided to Security Personnel assigned to the Hospital in 12/2107 or 1/2018, without consulting himself or any Hospital staff. The Security Manager said he was told that the trainings no longer included child first aid and child CPR. The Security Manager said that in relation to the Surveyor's request to review some of the Security Personnel's education information, he discovered that all of the Security Personnel hired since 01/01/18 lacked training in child first aid and child CPR. The Security Manager said that because of the Hospital patient population, it was inappropriate for the Security Personnel not to be trained in child first aid and child CPR training.

The List of Security Personnel, dated 05/24/18 indicated 32 Security Personnel hired since 01/01/18 that had not received training and certification in child first aid and child CPR.

The Hospital is out of compliance with the Condition of Participation for Quality Assessment and Performance Improvement Program (QAPI).

Findings included:

The Hospital failed for for 6 of 26 sampled patients (Patients #1, #2, #8, #9, #15, #22) and 2 non-sampled patients (Non-Sampled Patients #1 & #2) to ensure that Hospital Quality Assessment & Performance Improvement (QAPI) Program activities provided effective corrective actions and implemented corrective actions after Patient #1's un-planned extubation event, Patient #2's medication event, Patient #8's unreviewed urinalysis, Patient 9's unexpected death, Patient #3's Extracorporeal Membrane Oxygenation (ECMO; life-saving machine that circulates and oxygenates blood) decannulation event, Patient #22's dual tourniquet event, and Non-Sampled Patients #1 & #2's discharge from the Emergency Room with indwelling intravenous catheters in place.

Refer To TAG: A-0283.

The Hospital failed to ensure that Hospital Quality Assessment and Performance (QAPI) Program activities provided a thorough Hospital Internal Investigation after Patient #1's Unplanned Extubation event on 02/13/17 and death on 02/16/17.

Refer To TAG: A-0286.

Based on records reviewed and interviews, Hospital Quality Assessment & Performance Improvement (QAPI) Program activities failed for 6 of 26 sampled patients (Patients #1, #2, #8, #9, #15 & #22) and 2 Non-sampled patients (Non-Sampled Patients #1 & #2), which occurred from 9/21/17 to 5/23/18, to ensure effective corrective actions and/or implementation of corrective actions by the time of the Survey.

Findings include:

1) The Hospital failed for 2 of 26 patients (Patients #2 & #9) to ensure that remedial education was effective in achieving expected competencies for 1 of 1 Clinical Assistants involved in an Adverse Patient Event in the Intermediate Care Program (ICP) Unit after Patient #9's death.

a. Patient #9's medical records indicated that during the third day of BiPAP (Bi-level positive airway pressure) trial, Patient #9 experienced a cardiac arrest of unknown etiology, was resuscitated, was placed on Extracorporeal Membrane Oxygenation ((ECMO), life-saving machine that circulates and oxygenates blood). The Admission Documentation indicated following the change in condition, Patient #9 was determined to be critically ill, having experienced what was documented as being a likely extensive hypoxic injury (defined as being due to lack of oxygen) to vital organs. Patient #9 died eight days later, on 9/28/17.

Patient #9's plan of care indicated he/she was admitted to the Intermediate Care Unit in September 2017 for the initiation of BiPAP, and the plan included the use of a pulse oximetry, a machine, designed to make an audible sound to alert staff in the event that Patient #9's breathing became ineffective resulting in oxygen levels dropping below a predetermined level or when the probe attached to an extremity no longer remained attached to the patient, or when the patient's heart rate dropped or stopped.

The ECMO service admitting documentation, titled, Admission Documentation, indicated that on 9/21/17 the blood oxygen saturation level alarm went off in Patient #9's room; Clinical Assistant #1 entered the room; and measured Patient #9's blood pressure at 8:23 A.M. as being 70/46.

The Admission Documentation and related hospital records, indicated that at 8:49 A.M., 26 minutes after Clinical Assistant#1 obtained Patient #9's blood pressure a rapid response was called. The admission documentation indicated that after obtaining the blood pressure, Clinical Assistant #1 proceeded with morning care and during the care, she noted Patient #9 to have minimal chest rise (an abnormal finding indicative of possible sign of decreased breathing and she had difficulty appreciating (hearing) Patient #9's breathe sounds. The Admission Documentation indicated Clinical Assistant #1 left the room and sought Patient #9's nurse, who upon arrival, found Patient #9 unresponsive and activated the hospital's emergency call system. The Admission Documentation indicated, when emergency response/treatment team arrived, Patient #9's pulse could not be consistently felt and resuscitation, in the form of chest compressions was started.

The Hospital reviewed the incident involving Patient #9, which included interview with Clinical Assistant #1, other staff involved in Patient #9's care, documentation, and records of alarm studies, including when the alarm on the oxygen saturation monitors sounded prior to Patient #9's resuscitation.

The record titled, Research Data "HTM Review, " is a record of the information recorded by the pulse oximeter on the day of Patient #9's cardiac arrest. The hospital's investigation included an analysis of the data obtained from the pulse oximeter, which indicated that during the 26 minutes from when the patient's blood pressure was taken and when the nurse was alerted, the pulse oximeter was silenced at least three times, while Clinical Assistant #1 was alone and providing care to Patient #9.

The hospital's investigation indicated that while with Patient #9, Clinical Assistant #1 noted Patient #9's body was cool, but did not immediately inform a nurse. Patient #9's condition deteriorated to the point of cardiac arrest.

In response to incident the Hospital indicated they would educate clinical staff the three modules, which were developed in response to Patient #9's cardiac arrest. The modules included Communication, Oximetry Monitoring, and Response in Emergency Situations.

a. Clinical Assistant (CA) #1's training was validated as being completed between 12/19/17 and 1/18/18; the first training having occurred 87 days after Patient #9's cardiac arrest.

The Surveyor interviewed the Clinical Assistant involved in the incident on 5/25/18, at 12:14 P.M. When the Surveyor asked the CA "What would you do differently if this incident occurred today? " The CA answered, words to the effect, "I don't know." The Surveyor then asked the question, "If the very same thing occurred today, what would you do or how would you respond?" The CA responded words to the effect of, "I don't' know."

A review of the documentation for the other clinical assistants indicated they were first trained 11/20/17, 57 days following the incident.

Although the corrective actions included that clinical staff would be educated in response to incident involving Patient #9, as of the date of survey, the hospital provided documentation to support that 18 clinical assistants received the education out of 308 clinical assistants employed at the hospital.

b. The hospital's internal investigation indicated that while Clinical Assistant #1 was with Patient #9, the pulse oximetry intermittently alarmed and was silenced at least three times, for approximately six minutes. Clinical Assistant #1 said that the Clinical Assistant obtained Patient #9's axillary (under arms) temperature, which was low at 35.8 degrees Celsius (96.44 ° Fahrenheit). The hospital indicated Clinical Assistant #1 was concerned about the low body temperature, felt Patient #9's extremities as being cool and said Patient #9 appeared "still" and after attempting to obtain Patient #9's heart beat, yelled for assistance.

When interviewed on 5/25/18, Clinical Assistant #1 told the Surveyor that while providing care to Patient #9, on 9/21/17, that she responded to the alarm and although she re-applied the oxygen saturation probe to Patient #9's toe and observed a "couple of blips" on the machine, she did not recall the machine indicating a numerical reading.

The document titled Research Data (HTM Review) indicated that on 9/21/17, the oxygen saturation probe monitor showed the following: from 8:15 A.M.-8:22 A.M. an intermittant wave form; 8:22 A.M. a good pleuth (wave form); at 8:26 A.M. the wave form was lost, at 8:29 a pleuth was noted; from 8:31 A.M. - 8:37 A.M. there was intermittent capture of activity (difficult to call a wave form or artifact in this setting). No numerical readings were noted. Without a numerical reading, Patient #9's oxygen saturation level or pulse would not be known to be at an acceptable level or rate.

Clinical Assistant said after applying the pulse oximeter proble she proceeded to change Patient #9's diaper. Clinical Assistant #1 told the Surveyor that after the diaper change she obtained Patient #9's temperature and she said she was concerned about it and then obtained a stethoscope to attempt to try to listen to Patient #9's heart, but was unable to hear a heartbeat.

Although the hospital indicated that the clinical assistants were re-educated regarding oximetry monitoring, review of the education did not indicate silencing of the alarm was addressed in the education to all clinical assistants. It is unclear based on this policy whether Clinical Assistants were to silence sounding alarms when providing care or in response to an activated alarm.

c. The education provided to clinical assistants in response to the incident included that they were to obtain patient's apical pulses when determining placement of the pulse oximetry. Listening to a heart beat requires an assessment, including how to determine the apex of heart. Review of the job description for clinical assistant does include information indicating they are qualified to perform this task.

The facility failed to develop a mechanism for establishing effectiveness of the training, or to check for retention of educational material.

d. The documentation was inconsistent regarding how Clinical Assistant #1 obtained the nurse. For instance, the Admission documentation indicated she left the room to obtain the nurses and the investigation indicated she said she yelled for a nurse. During interview, Clinical Assistant #1 said she left the room to obtain the nurse. The hospital's investigation does not address the inconsistency in the clinical assistant's information about the incident.

2) The Hospital failed to implement corrective actions for nursing training after medication, not intended to be injected directly into the eyes, was injected into Patient #2's eye in error, resulting in eye damage, which continued more than six months after the error.

The Department of Public Health's Healthcare Facility Report, dated 2/21/18, indicated the Hospital reported and implemented corrective action that included, eye medications that were not appropriate for injection into the eye should not be on the sterile field table during intra-ocular surgery unless this had been discussed with the Operating Room team as to the medications' purpose. The Department's Healthcare Facility Report indicated education included all Operating Room (OR) Registered Nurses, Surgical Technician Staff and OR surgeons with an estimated date of completion 3/15/18.

The Surveyor interviewed the Nurse Director of the Operating Rooms, at 11:00 A.M. on 5/17/18. The Nurse Director of the Operating Rooms said that OR nursing was 1 nurse short of being 100% compliant with training.

The Intraoperative Ophthalmology Medications Education Module, dated March, 2018, indicated it contained and was consistent with the Medication Safety Practices in the Perioperative Setting Policy. The Medication Safety Practices in the Perioperative Setting Policy indicated that the Scrub Technician labeled all containers and syringes with medications and solutions on the sterile field. The Intraoperative Ophthalmology Medications Education Module indicated that the Scrub Technician used active communication to verify the medication and or solution, the dose (when applicable), and the allergy status of the patient as it was passed to a surgical team member. The Intraoperative Ophthalmology Medications Education Module indicated that the Scrub Technician or member of the surgical team at the sterile field used active communication to alert the Circulating Nurse (nurse in charge of the room) and anesthesia team when a dose of medication was administered.

The Hospital provided no clear documentation to indicate that all OR Registered Nursing Staff were required to complete the Intraoperative Ophthalmology Medications Education, as indicated in the corrective action plan, after Patient #2's Adverse Patient Event.

The Intraoperative Ophthalmology Medications Education Transcript, dated 5/17/18, indicated OR Staff Meeting Minutes Attendance, dated 5/16/18, and the Satellite OR nursing staff list, dated 5/18/18, indicated that 11 OR nurses did not complete the Intraoperative Ophthalmology Medications Education Module as required by the corrective action plan.

The Surveyor interviewed the Nurse Director of the OR, at 1:00 P.M. on 5/18/18. The Nurse Director of the OR said that the Education Module was sent to all OR Nurses along with a Situation, Background, Assessment, and Recommendation (SBAR), educational document. The Nurse Director of the OR said that the Education was not assigned or provided to Surgical Technicians. The Nurse Director of the OR said the Education was for nurses only because the nurses were responsible for the medications and not the Scrub Technicians. This is not consistent with corrective action plan or Intraoperative Ophthalmology Medications Education Module. The Nurse Director of the OR said the Scrub Technicians would know and understand "The Medication Safety Practices in the Perioperative Setting Policy," which was specifically referenced the Scrub Technician responsibility, the because information was covered in a staff meeting. The Nurse Director of the OR said the Hospital had no documentation that included signatures that all Scrub Technicians were re-educated regarding the Policy following the incident.

The Nurse Director of the OR said Clinical Coordinators and Managers performed patient care in the OR. The Nurse Director of the OR said that 3 of the 6 OR Clinical Coordinators and 1 of 2 of the Nurse Managers were not trained because Clinical Coordinators and Nurse Managers disseminated the information so they did not have to complete the Education Module. The Nurse Director of the OR said she did not know why some Clinical Coordinators and 1 Nurse Manager had completed the Net Learning, educational information while others had not.


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3) The Hospital Quality Assessment & Performance Improvement (QAPI) Program activities failed to implement corrective action(s) after an Emergency Department physician did not review Patient #8's laboratory results prior to discharging Patient #8, resulting in an Intensive Care Unit admission the following day for Diabetic Ketoacidosis (DKA, a life-threatening complication of diabetes).

The document titled Intensive Care Unit (ICU) Admission Documentation, dated 4/11/18, indicated Patient #8, a previously health young child, presented to the Emergency Department with changes in mental status, lethargy and unresponsiveness; physicians diagnosed Patient #8 with Diabetic Ketoacidosis (DKA) and admitted Patient #8 to the Intensive Care Unit. The ICU Admission Documentation indicated Patient #8 was examined in the Emergency Department the prior day and glucose and ketones (abnormal findings indicative of possible diabetes) were present in a urinalysis performed in the Emergency Department the prior day.

There was no response to the abnormal urinalysis prior to Patient #8's discharge home on 4/10/18.

The document titled Quality Assessment and Performance Improvement (QAPI) Plan, dated 3/20/18, indicated Hospital QAPI activities tracked patient events, analyzed their causes, implemented preventive actions and mechanisms that included feedback and learning throughout the Hospital.

The Event Report & Review Algorithm, dated 1/18/18, indicated that local leaders implemented immediate activities to ensure patient safety.

The Hospital policy titled Communication of Critical laboratory Results, dated 10/14/16, indicated Critical Results were a subset of abnormal results that may be life-threatening and needed immediate attention on the part of a provider. The policy indicated Critical Results were verbally communicated by a laboratory technologist to a provider who could take action as soon as possible, but no more than 30 minutes after a verified result. The policy indicated a list of critical results was included in the Critical Laboratory Values Reference Tool. The Critical Laboratory Values Reference Tool indicated documentation of sugar positive urine test was not listed as a critical laboratory result.

The Surveyor interviewed Nurse Director #2 and Physician #1 at 1:30 P.M. on 5/17/18. Nurse Director #2 and Physician #1 said they conducted the Hospital Internal Investigation related to Patient #8's urinalysis results. The Nurse Director #2 and Physician #1 said the Emergency Department Attending Physician was responsible for reviewing the urinalysis prior to discharge and that the Emergency Department Attending Physician did not review Patient #8's urinalysis prior to discharging Patient #8 from the Emergency Department on 4/10/18. Nurse Director #2 and Physician #1 said that Hospital policy did not consider glucose present in a urinalysis as a critical laboratory result. Physician #1 said an action plan proposed to the Hospital included incorporating sugar positive urine test results of non-diabetic children as included in the Hospital policy titled Communication of Critical Laboratory Results. Physician #1 said another action plan proposed to the Hospital included incorporating an electronic transfer of laboratory results into the Emergency Department physician electronic medical record (EMR) for review prior to discharge.

Physician #1 said the proposed action plans were not implemented after Patient #8's event or by the time of the Survey.

4) Hospital Quality Assessment Performance Improvement (QAPI) Program activities failed for 1 of 26 sampled patients (Patients #1) to ensure a thorough Hospital Internal Investigation after Patient #1's Unplanned Extubation event.

The Report, dated 2/26/17, indicated Patient #1 had an unplanned extubation event.

The Hospital provided no documentation to indicate the Hospital performed a thorough analysis of Patient #1's Unplanned Extubation event.

The Surveyor interviewed Clinical Regulatory Compliance Manager at 12:12 P.M. on 5/30/18. The Clinical Compliance Manager said that the Report related to Patient #1's Unplanned Extubation event was submitted as a mortality event in error, and the Hospital did not re-categorize the report as an Unplanned Extubation.

5) The Medical Intensive Care Unit Nursing Note, dated at 1/13/18 at 6:04 P.M., indicated Patient #3 was found to have a dislodged arterial cannula event while on ECMO; Patient #3 required 20 minutes of Cardio-Pulmonary Resuscitation (CPR) and died on 5/3/18.

Documentation provided by the Hospital, dated 3/21/18, indicated that in response to Patient #3's ECMO decannulation event, an attending physician would document the ECMO cannula position in the patient's electronic medical record.

Hospital Quality Assessment & Performance Improvement Program activities failed for 1 of 26 sampled patients (Patient #15) to ensure a Cardiac Intensive Care Unit Attending Physician documented Patient #15's ECMO (ECMO, a life-saving machine that circulated and oxygenated blood) cannula position as required by the corrective action plan in response to Patient #3's previous ECMO decannulation event on 1/13/18.

The Surveyor interviewed the Medical Surgical Intensive Care Unit Medical Director at 11:10 A.M. on 5/17/18. The Medical Surgical Intensive Care Unit Medical Director said that corrective actions included that the attending physician would document the ECMO cannula position in the patient's electronic medical record.

The Surveyor observed at 2:30 P.M. on 5/23/18 that Patient #15 was treated with Extracorporeal Membrane Oxygenation on the Cardiac Intensive Care Unit. The Surveyor observed that Patient #15's electronic medical record indicated no documentation of the ECMO cannula position.

The Cardiac Intensive Care Unit (CICU) Progress MD Note, dated 5/22/18 indicated no documentation of Patient #15's ECMO cannula position in the thoracic space as required by the corrective action plan after Patient #3's ECMO decannulation event.

The Cardiovascular Surgery Inpatient MD Note, dated 5/22/18 indicated no Surgeon documentation of the ECMO cannula position.

The Surveyor interviewed the Cardiac Intensive Care Unit Medical Director at 11:30 A.M. on 5/30/18. The Cardiac Intensive Care Unit Medical Director said at the time of the Survey, that the cardiovascular medical team was words to the effect of, "working on" documentation of the ECMO placement.

6) Hospital Quality Assessment & Performance Improvement Program activities failed to thoroughly analyze events regarding 2 non-sampled patients (Non-Sampled Patients #1 & #2) discharged from the Emergency Department with an indwelling intravenous catheter and QAPI activities failed to analyze an event regarding Patient #22's incorrectly labeled tourniquet machines.

a. The Intravascular Access Report, dated 1/1/18 through 5/18/18, indicated the Hospital Emergency Department discharged 2 patients (Non-Sampled Patients #1 & #2) with an intravenous catheter.

The Hospital provided no documentation to indicated analysis or corrective actions implemented to prevent patients from being discharged from the Emergency Department with an indwelling intravenous catheter.

The Surveyor interviewed the Chief Nursing Officer (CNO) and Associate Chief Nursing Officer, at 10:00 A.M. on 5/25/28. The CNO said at the time of the Survey, that the Hospital was words to the effect of, "working on it."

b. The document titled Quality Assessment and Performance Improvement Plan, dated 3/20/18, indicated the purpose of the QAPI Program was to improve patient care by systematic analysis and systemic action. The QAPI Plan indicated it applied to all locations of the Hospital, including locations with operating rooms.

The Hospital policy titled Perioperative Use of a Tourniquet, dated 6/1/17, indicated procedures for the use of tourniquets in perioperative limb procedures. The Perioperative Use of a Tourniquet policy did not indicate a procedure for dual tourniquet use; the policy did not indicate a procedure for labeling tourniquet machines.

The Intravenous (IV) Vascular Access Report, dated 1/1/18 through 5/18/18, indicated Operating Room Staff applied an arm tourniquet label and a leg tourniquet label to the tourniquet machines (a machine that automatically tightens a tourniquet) incorrectly. (A limb without the intended tourniquet when operated on may cause increased risk for bleeding and a limb with the unintended tourniquet may cause decreased blood circulation to the limb.)

The Surveyor interviewed Nurse Manager #2, at 11:00 A.M. on 5/25/18. Nurse Manager #2 that she implemented a corrective action plan that included clear labeling on the arm tourniquet machine and leg tourniquet machine indicating, which extremity was attached. Nurse Manager #2 said that she was not doing a formal audit for staff compliance with the corrective action implemented.

The Hospital provided no documentation to indicate Hospital wide analysis to ensure Hospital wide implementation of this corrective action in the other Hospital locations where a tourniquet machine was used.

Based on records reviewed and interviews Hospital Quality Assessment and Performance (QAPI) Program activities failed to ensure a thorough Hospital Internal Investigation after Patient #1's Unplanned Extubation event.

Findings included:

The Admission Documentation, dated 2/10/17, indicated Patient #1, a newborn, was born with Congenital defects, which caused abnormal lung development and functioning]. The Admission Documentation indicated Patient #1 was intubated, with a breathing tube, at 1 minute of life.

The Inpatient Ongoing Documentation, dated 2/16/17, indicated Patient #1 had a cardiac arrest after self extubation (unplanned extubation) versus a mucus plugging (of the endotracheal tube) on 2/13/17. Patient #1 was emergently provided Extracorporeal Membrane Oxygenation (ECMO, a life-saving machine that circulated and oxygenated blood for cardiac and respiratory life support). The Inpatient Ongoing Documentation indicated Patient #1 died on 2/16/17.

The Surveyor interviewed Physician #3 and Registered Nurse #1 at 1:00 P.M. on 5/25/18, who were identified as the Leaders of the Unplanned Extubation Committee. Physician #3 and Registered Nurse #1 said the Unplanned Extubation Committee tracked and reviewed information for trends for Unplanned Extubation events. They said that the Hospital computerized event reporting system had specific questions regarding Unplanned Extubation events. Physician #3 and Registered Nurse #1 said a unit based Physician, Registered Nurse and Respiratory Therapist Team reviewed and analyzed all Unplanned Extubation events that occurred on their assigned unit that were submitted into the event reporting system.

The document titled Airway Management Event, dated 5/25/18, indicated investigational questions, to be completed by the Hospital, regarding Unplanned Extubation events, with details of the Unplanned Extubation event including resolution and outcomes.

Physician #3 and Registered Nurse #1 said that the Team answered specific, detailed investigational questions about Unplanned Extubation events and that this information was communicated for review in the computerized event reporting system.

Documentation provided by the Hospital, dated 2/26/17, indicated the Patient #1 had an inadvertent extubation. The Documentation provided by the Hospital, indicated no documentation that the Hospital Internal Investigation analyzed specific questions regarding Unplanned Extubation events, as described by Physician #3 and RN #1.

The Hospital provided no documentation to indicate a thorough analysis of Patient #1's Unplanned Extubation event.

The Hospital was out of compliance with the Condition of Participation for Medical Staff.

Findings included:

The Medical Staff failed to examine the credentials of 1 of 5 Cardiac Service Medical Staff (Nurse Practitioner #1) before granting sedation privileges in accordance with Medical Staff By laws, rules and regulations.

Refer to TAG: A-0341.

Based on records review and interviews the Medical Staff failed for 6 of 26 sampled patients (Patients #2, #8, #13, #14, #15, & #24) to be accountable to the Governing Body for the quality of the medical care provided to the patients.

Refer to TAG: A-0347.

Based on records reviewed and interview for the credentialing processes, the Medical Staff failed to examine the credentials of 1 of 5 Cardiac Service Medical Staff (Nurse Practitioner #1) before granting sedation privileges in accordance with Medical Staff By laws, rules and regulations.

Findings included:

Medical Staff Bylaws, dated 7/19/2016, indicated Nurse Practitioners were credentialed as advanced practice clinicians and had their credentials and privileges approved through the Credentials Committee, the Medical Staff Executive Committee and the Board of Trustee's approval processes or in such other manner as shall parallel that for applicants to the Medical Staff.

Medical Staff Bylaws indicated the Medical Staff must request and be granted additional privileges for deep sedation that required the following documentation on Sedation Request Privilege Form: completion of the Net Learning ( NL-computer based education class) on an educational Annual Sedation Module, Advanced Cardiac Life Support (ACLS) or Pediatric Advanced Life Support (PALS ) certification, Policy Review of the Patient Sedation policy with attestation, Board Certification or Board Eligibility in Anesthesiology, Pediatric Critical Care, Cardiology (Cardiac Intensive Care Unit, CICU) physicians, Neonatal-Perinatal Medicine, or Pediatric Emergency Medicine. Medical Staff Bylaws indicated for Moderate Sedation (procedural sedation) the following requirements: Completion of Net Learning Annual Sedation Module, ACLS, Neonatal Resuscitation Program (NRP) or PALS certificate and Policy Review (Patient Sedation Policy) Request was made for procedural sedation.

The Credential File for Nurse Practitioner #1 indicated she was appointed for two years on 12/29/2017. Review of Nurse Practitioner #1's credential file indicated that the Delineation of Privileges Form, approved on 11/1/2017, indicated Nurse Practitioner #1 had no anesthesia privileges but that the Nurse Practitioner was approved to order and administer procedural sedation (moderate sedation). The Credential File indicated Nurse Practitioner #1 did not have the pre-requisites required to be granted procedural sedation on 11/1/2017 in that Nurse Practitioner #1 did not have evidence of completion of the educational Annual Sedation Module until 2/12/2018. The Credential File indicated Nurse Practitioner #1 was not credentialed to order, administer or provide deep anesthesia.

The Surveyor interviewed the Credentialing Officer at 1:15 P.M. on 5/30/2018. The Credentialing Officer said that she had not been getting (obtaining) the Sedation Request Privilege Form for Nurse Practitioners and had not been holding them (the Nurse Practitioners) accountable for the criteria as specified by the Medical Staff By laws for credentialing of privileges for administration of moderate or deep sedation.

Refer: TAG: A-0408.

Based on records reviewed and interviews the Medical Staff failed for 6 of 26 sampled patients (Patients #2, #8, #13, #14, #15, & #24) to ensure accountability to the Governing Body for the quality of the medical care provided to the patients.

Findings included:

1) The Medical Staff failed to ensure that the Cardiovascular Services performed bed space surgery in accordance with the Conditions of Participation for Surgical Services, Anesthesia Services and Infection Control. The Medical Staff failed to ensure that the Medical Staff obtained informed consents for Anesthesia Services performed for the bed space surgery of 3 sampled patients (Patients #13, #14 and #24), failed to ensure appropriate anesthesia, pre-anesthesia, intraoperative anesthesia, and post-operative anesthesia documentation and failed to ensure qualified personnel administered anesthesia.

The Hospital provided no documentation to indicated policies and procedures for surgical care while performing surgery in the Cardiovascular Intensive Care Unit (CICU) and the Medical-Surgical Intensive Care Unit (MSICU) to ensure and maintain a high standard of patient care and safety, for 3 of 5 surgical cases reviewed (#13, #14 and #24).

Two (2) of 3 Cardiac Intensive Care Unit (CICU) patients (Patients #13 & #24) Medical Records indicated no documentation to indicated a physician obtained informed consents for Patients #13 and #24 who received anesthesia administered as deep sedation and/or general intravenous anesthesia.

The Hospital policy for titled Informed Consent, dated 5/16/2016, indicated informed consent was obtained by clinicians who were not credentialed and or certified to perform the procedure or treatment.

2) The Medical Staff failed to ensure an Emergency Department physician reviewed Patient #8's laboratory results prior to discharging Patient #8 to home.

The document titled Admission Documentation, dated 4/11/18, indicated Patient #8 (a young child) presented to the Emergency Department yesterday with ear pain and vaginal rash, physicians diagnosed Patient #8 with an ear infection and discharged Patient #8 home with antibiotics (to treat the ear infection). The Admission Documentation indicated glucose (and ketones (abnormal findings indicative of possible diabetes) as present in a urinalysis performed in the Emergency Department. The Admission Documentation indicated Patient #8, a previously health young child, presented to the Emergency Department the following day, 4/11/18, with changes in mental status, lethargy and unresponsiveness; physicians diagnosed Patient #8 with Diabetic Ketoacidosis (a life-threatening complication of diabetes) and a admitted Patient #8 to the Intensive Care Unit.

The Surveyor interviewed Physician #1 at 1:30 P.M. on 5/17/18. Physician #1 said the Emergency Department Attending Physician was responsible for reviewing the urinalysis prior to discharge. Physician #1 said that the Emergency Department Attending Physician did not review Patient #8's urinalysis prior to discharging Patient #8 from the Emergency Department.

3) The Medical Staff failed to ensure that a Surgeon injected the correct preparation of a medication into Patient #2's right eye.

Documentation provided by the Hospital, dated 2/18/18, indicated on 1/25/17, Patient 2 was examined at the Facility's Ophthalmology Clinic and was noted to have persistent corneal clouding (abnormal finding, which effects vision). Documentation provided by the facility about this incident indicated that the medication Goniosol (eye lubricant) was directly injected into Patient #2's right eye. The Goniosol contained preservatives, which can be toxic to the cornea and was not intended to be injected into the eye, but rather used topically.

4) The Medical Staff failed to ensure the Cardiovascular Medical Staff implemented the corrective action for an Attending Physician to document Extracorporeal Membrane Oxygenation (ECMO) cannula placement in the Electronic Medical Record (EMR) of Patient #15, consistent with the corrective action plan after Patient #3's ECMO cannula decannulation event.

One (1) of 26 sampled patients (Patient #15) the Medical Record indicated no documentation to indicate an Attending Physician documented the ECMO cannula placement in the EMR, consistent with the corrective action plan after Patient #3's ECMO cannula decannulation event on 1/13/18.

The Hospital was out of compliance with the Condition of Participation for Nursing Services.

Findings included:

The Hospital failed to ensure Nursing Services determined the qualifications including education of nursing personnel and staff necessary to provide nursing care to patients who were scheduled for ophthalmologic surgery.

Refer to TAG: A-0386.

The Hospital failed to ensure that drugs were prepared and administered in accordance with Federal and State laws, and accepted standards of practice when 6 CICU nurses (CICU RN #1, #2, #3, #4, #5 and #6) administered doses of drugs verbally ordered by a physician to 3 of 3 Cardiac Intensive Care Unit (CICU) patients (#13, #14 and #24) for the purpose of inducing deep sedation to general anesthesia in the CICU.

The Hospital failed to ensure that CICU Nurses practiced within their scope of practice by allowing CICU Nurses to administer deep sedation which was not in compliance with Hospital policy and the CICU nurses were not qualified providers of Anesthesia Services.

Refer to TAG: A-0405.

Based on records reviewed and interviews the Nursing Services failed to ensure that they determined the types (qualifications including education) of nursing personnel and staff necessary to provide nursing care to patients who were scheduled for ophthalmologic surgery.

Findings include:

The Hospital failed to implement corrective actions after Patient #2's intra-ocular (in the eye) medication error event, resulting in continued eye damage, more than six months after the medication error.

The Procedural Notes, dated 11/29/17, indicated Patient #2, a 4.5 month old, was born with diagnoses which included hypocalcemia, failure to thrive, and bilateral glaucoma. The Procedural Notes indicated that on 11/29/17, Patient #2 was scheduled for a Trabeculectomy of the right eye (surgical procedure used in the treatment of glaucoma to relieve intraocular pressure). The Procedural Notes indicated that during the procedure, Goniosol (eye medication used for lubrication) was injected into the anterior chamber of the eye.

The Procedural Notes, dated 12/6/17, indicated that a left eye Trabeculectomy was postponed due to ongoing cloudiness (eye problem that can lead to decreased vision as the cornea is normally clear) in Patient #2's right eye.

Documentation provided by the Hospital, dated 2/8/18, indicated on 1/25/18, Patient #2 was examined at the Facility's Ophthalmology Clinic and was noted to have persistent corneal (the transparent layer forming the front of the eye) clouding. Documentation provided by the facility about this incident indicated that the medication Goniosol, eye lubrication, contained preservatives, which can be toxic to the cornea and was not intended to be injected into the eye but was intended for topical use only.

The Surveyor interviewed Ophthalmology Surgeon #1, at 9:46 A.M. on 5/21/18. Ophthalmology Surgeon #1 said during the surgery, which took place on 11/29/17, she was unaware that the Goniosol contained preservatives and should not be administered by injection into the eye. Ophthalmology Surgeon #1 said she first discovered that the Goniosol medication should not have been administered into the eye from an email sent to her approximately 4-5 weeks after the surgery. Ophthalmology Surgeon #1 said that the Hospital notified Patient #2's family as she was unavailable. Ophthalmology Surgeon #1 said that as of 5/21/18, Patient #2's right eye is not totally healed, noting the eye was swollen and has notable cloudiness.

The Department of Public Health's (DPH) Healthcare Facility Report, dated 2/21/18, indicated the Hospital reported and implemented corrective action that included, eye medications that were not appropriate for intra-ocular (into the eye) use should not be on the sterile field table during intra-ocular surgery unless this had been discussed with the Operating Room team as to the medications' purpose. The DPH Healthcare Facility Report indicated education included all Operating Room (OR) Room Registered Nurses, Surgical Technician Staff and OR surgeons with an estimated date of completion 3/15/18.

The Surveyor interviewed the Nurse Director of the Operating Rooms, at 11:00 A.M. on 5/17/18. The Nurse Director of the Operating Rooms said that OR nursing was 1 nurse short of being 100% compliant with the education.

The Intraoperative Ophthalmology Medications Education Module, dated March, 2018, contained the "Medication Safety Practices in the Perioperative Setting Policy". The Medication Safety Practices in the Perioperative Setting Policy indicated that the Scrub Technician labeled all containers and syringes with medications and solutions on the sterile field. The Intraoperative Ophthalmology Medications Education Module indicated that the Scrub Technician used active communication to verify the medication and or solution, the dose (when applicable), and the allergy status of the patient as it is passed to a surgical team member. The Intraoperative Ophthalmology Medications Education Module indicated that the Scrub Technician or member of the surgical team at the sterile field used active communication to alert the circulating nurse (nurse in charge of the room) and anesthesia team when a dose of medication was administered.

The Hospital provided no clear documentation of all OR Registered Nursing Staff that were required to complete the Intraoperative Ophthalmology Medications Education, indicated in the corrective action plan, after Patient #2's Adverse Patient Event. The Intraoperative Ophthalmology Medications Education Transcript, dated 5/17/18, the OR Staff Meeting Minutes Attendance, dated 5/16/18, and the Satellite OR nursing staff list, dated 5/18/18, indicated that 11 OR nurses did not complete the Intraoperative Ophthalmology Medications Education Module as required by the corrective action plan.

The Surveyor interviewed the Nurse Director of the OR again at 1:00 P.M. on 5/18/18. The Nurse Director of the OR said that the Education Module was sent to all OR nurses along with a Situation, Background, Assessment, and Recommendation (SBAR) document. The Nurse Director of the OR said that the Education was not assigned to Surgical Technicians. The Nurse Director of the OR said the Education was for nursing only because the nurses were responsible for the medications and not the Scrub Technicians. The Nurse Director of the OR said the Scrub Technicians would know and understand "The Medication Safety Practices in the Perioperative Setting Policy" (that specifically referenced the Scrub Technician responsibility), the information was covered in a staff meeting. The Nurse Director of the OR said the Hospital had no documentation that included signatures that all Scrub Technicians were aware of the Policy. The Nurse Director of the OR said that 3 of the 6 OR Clinical Coordinators and 1 of 2 Nurse Managers were not trained as Clinical Coordinators and Managers disseminated the information so they did not have to complete the Education Module. The Nurse Director of the OR said she did not know why the Clinical Coordinators and 1 Nurse Manager had completed the education while others had not.

Based on observations, records reviewed and interviews, the Hospital failed to ensure that drugs were prepared and administered in accordance with Federal and State laws, and accepted standards of practice when 5 CICU (Cardiac Intensive Care Unit) nurses (CICU RN #1, #3, #4, #5 and #6) administered doses of drugs, verbally ordered by a physician, to 3 of 3 CICU patients (Patients #13, #14 and #24) for the purpose of inducing deep sedation to general anesthesia in the CICU. The Hospital failed to ensure that CICU Nurses practiced within the scope of nursing practice as CICU nurses were observed to administer deep sedation which was not in compliance with Hospital policy and the CICU nurses were not qualified providers of Anesthesia Services.

Finding included:

The Policy titled Patient Sedation for Procedures, dated 12/19/16, indicated Registered Nurses were not credentialed to perform deep sedation.

The Provision of Anesthesia Services policy, undated, provided by hospital administration on 5/25/2018, indicated that individuals authorized to administer anesthesia, which was defined in the policy as general, regional, monitored anesthesia care and deep sedation (collectively referred to as anesthesia) were those privileged by Medical Staff and included: a qualified anesthesiologist, a doctor of medicine or osteopathy or a certified registered nurse anesthetist (CRNA).

The Surveyor interviewed the Chief of the Anesthesia Services at 10:00 A.M. on 5/29/2018. The Chief or Anesthesia Services said that in CICU the physicians were only providing deep sedation and not general anesthesia. The Chief or Anesthesia Services said that he agreed that the line between deep sedation and general anesthesia was not well defined and a patient could easily go from one level to the other (deep sedation and general anesthesia).

The Surveyor observed Patient #24's surgical procedure on 5/24/2018 at 11:30 A.M. The Cardiac Attending Physician #2 said he planned to give Patient #24 intravenous (IV) Fentanyl (an opioid narcotic) in sufficient doses to produce general anesthesia since the planned procedure (chest exploration, chest wash out, closure of the sternum and chest wall) were all very painful procedures. Cardiac Attending Physician #2 said he would monitor the hemodynamics (blood pressure, pulse, pulmonary pressures, mean arterial pressures) very closely to keep adequate the Fentanyl on board (effective) to keep the baby adequately anesthetized.

The Surveyor observed that after prep and drape and an appropriate time out, the Cardiac Attending Physician #2 began by instructing the CICU RN #1 to prepare and administer doses of Fentanyl and Versed (medication for sedation).

The Manufacturer's Package Insert, dated 11/1/2017, for anesthesia by Fentanyl, indicated that the dose was 0.5 to 20 mcg/kg (kilogram) per dose given IV. Manufacturer's Package Insert indicated a maintenance intravenous infusion of 1-2 mcg/kg/hour also may be used. Manufacturer's Package Insert indicated induction of anesthesia and maintenance of anesthesia, for children 2-12 years old, 2-3 milligrams per kilograms was recommended.

The first dose of Fentanyl was 60 micrograms (mcg or 10 mcg per kilogram (kg) as the baby weighed 6 kg). CICU RN #1 prepared the medication and doubled checked it with Cardiac Attending Physician #2 before pushing (rapid administration) the medication into the IV line.

The Surveyor heard Cardiac Attending Physician #2 order CICU RN #1 to administer a dose of Vecuronium (a paralytic drug) 26 milligrams (mgs) IV push and 2 mg of Versed IV push. The Surveyor observed Cardiac Attending Physician #2 continued to order doses of Fentanyl that were administered by CICU RN #1, based on subtle changes in the hemodynamics (vital signs) but the patient did not respond to painful stimuli (to the procedure). The Surveyor observed four doses of 60 mcg Fentanyl ordered by the Cardiac Attending Physicians #2 and then administered by the CICU RN #1.

The Personnel File for CICU RN #1 on 5/29/2018 indicated the nurse was not credentialed as a CRNA and did not have any evidence of sedation training on the transcript for training reviewed from 2010 to 2018.

The Medication Administration Record (MAR) and intraoperative record, dated 5/29/2018 indicated Patient #13 underwent surgery and received doses of Fentanyl consistent with deep sedation to general induction doses of anesthesia on 5/21/18 and 5/24/18. Patient #13 weighed 3.8 kg.

The MAR, dated 5/29/2018, indicated all ordered doses of Fentanyl given for deep sedation were recorded as given by the CICU nurses on the medication administration record.

The MAR, dated 5/21/2018, indicated CICU RN #3 administered to Patient #13- 38 mcg of Fentanyl IV at 11:07 A.M. (10 mcg/kg) and at 11:35 A.M. administered 19 mcg of Fentanyl 5 mcg/kg which were both anesthesia (deep sedation) dose levels of Fentanyl.

The MAR, dated on 5/24/2018, indicated that during a surgical procedure, CICU RN #4 administered 38.3 mcg (10 mcg/kg) at the start of the surgical procedure, which was an anesthesia (deep sedation) dose of Fentanyl.

Medical Record review indicated the Patient #14 underwent surgical procedures on the CICU with deep sedation on 5/2, 5/3 and 5/4/2018.

Review of Medication Administration Record (MAR) from 4/30/2018 - 5/4/2018, indicated Patient #14 was on a opioid intravenous (IV) drip for pain management and an IV drip of Versed (anti-anxiety medication) for sedation. The surgical consent, dated 5/2/2018 indicated Patient #14 had a chest exploration and washout (a washout is a procedure where the surgeon flushes out the open chest cavity with saline or with an antibiotic solution. The flush goes into the pleural and mediastinal spaces around the lungs and the heart to remove any clots and debris that may have been debrided from the incision line and then is suctioned out) and received induction doses of the narcotic, Fentanyl, a total dose of 400 mcg over 4 minutes.

The Manufacturer's Package Insert, for Anesthesia, dated 11/1/2017, indicated the dose was 0.5 to 20 mcg/kg per dose given intravenously and that a maintenance intravenous infusion of 1-2 mcg/kg/hour also may be used. The patient weighed 54 kg, therefore the dose given was to be 8 mcg/kg.

The Medical Record indicated Patient #14 had a chest wash out on 5/3/2018 and the MAR, dated 5/3/2018 indicated the patient received a total dose of 200 mcg of Fentanyl over 4 minutes, for deep sedation administered by CICU RN #5.

The Surgical Consent, dated 5/4/2018, indicated Patient #14 underwent a chest exploration, washout and Extracorporeal Membrane Oxygenation (ECMO, life-saving machine that ciruclated and oxygenated blood for cardiac and respiratory support) cannula clamp trial. Review of the MAR indicated CICU RN #6 administered a total dose of 1000 mcg of Fentanyl in two doses over 7 minutes to Patient #14.

The Surveyor interviewed CICU Charge Nurse approximately at 10:00 A.M. on 5/25/2018. The CICU Charge Nurse said the CICU nurses were not certified nurse anesthetists (CRNAs) but had training in moderate sedation.

Based on observation, records reviewed and interviews, the Cardiac attending team in the Cardiac Intensive Care Unit (CICU) failed to use the Hospital Verbal Order policy and procedure to document verbal orders given by two Cardiac Attending Physicians (CAP #2 and #3) during surgical procedures done on the CICU.

Findings included:

The Hospital Verbal Order policy, dated 3/18/2018, indicated the policy applies to all settings and all clinicians. The Verbal Order policy indicated that clinicians were responsible for accurate reporting and documentation of verbal orders and that the order must contain the name and credentials of the authorized prescriber and receiver, date, time and all components of the order. The Verbal Order policy indicated authorized prescriber countersigned the order within 48 hours. The Verbal Order policy indicated nurse practitioners, physician assistants or trainees could only sign orders he/she prescribed.

The Surveyor observed on 5/24/2018, a surgical procedure on the CICU on Patient #24. The Surveyor heard Cardiac Attending Physician #2 verbally order deep sedation doses of Fentanyl to be administered by CICU RN #1. The Surveyor heard CICU RN #1 verify the medication doses with CICU RN #2, then observed CICU RN #1 administer the medication doses and then observed CICU RN #2 document the medications on Patient #24's Medication Administration Record (MAR). The Surveyor observed this procedure of medication administration occur multiple times. The Surveyor observed that the ordering physician, Cardiac Attending Physician #2, did not document or counter-sign in Patient #24's MAR the medications he ordered. The Surveyor observed multiple doses of Fentanyl (narcotic for pain and anesthesia) were ordered as well as Versed (medication for sedation), an anti-anxiety medication and one dose of Vecuronium, a neuromuscular blocking agent for paralysis.

The Surveyor interviewed CICU RN #2, at 12:00 P.M. on 5/24/2018. CICU RN #2 said [as the Surveyor observed CICU RN #2 point to Nurse Practitioner (NP) #1 standing across the bed space] that NP #1 recorded what she (NP #1) heard Cardiac Attending Physician #2 order and she (NP #1) wrote the order in Patient #24's medical record. CICU RN #2 said she was not sure if NP #1 wrote the medication order as a Verbal Order Read Back (VORB, medication safety check). CICU RN #2 said CICU RN #1 gave the medication and the second nurse (herself, CICU RN #2), verified the dose and documented the medication doses in Patient #24's MAR.

Physician Orders on 5/24/2018, indicated that the medications observed administered to Patient #24 by verbal order during the procedure, were written in the orders by the NP #1 as if she prescribed them. The Physician Orders had no documentation of Cardiac Attending Physician #2's name as the prescriber of the medications as the medications were documented as ordered by NP #1 but observed as verbally ordered by Cardiac Attending Physician #2 who was responsible to sign medication orders as medication verbal order by policy.

Review of the medical record indicated Patient #13 underwent a surgical procedure on the CICU at the patient's bedside under deep sedation on 5/24/2018.

The Surveyor interviewed the CICU Charge Nurse on 5/25/2018 at 11:00 A.M. The CICU Charge Nurse said she was present the day of the procedure and that Cardiac Attending Physician #3 gave the verbal orders for the sedation medications to the CICU RN #5 who administered them.

Physician Orders indicated no verbal orders were written for Patient #13 by Cardiac Attending Physician #3.

Physician Orders dated 5/24/2018 indicated the medication ordered and administered for the 5/24/2018 surgical procedure were written by NP #2 who was also at the patient's bedside during the procedure according to the intraoperative record. The CICU Charge Nurse said the medication orders were verbally given by Cardiac Attending Physician #3 not NP #2.

Review of the Medical Record for Patient #14 indicated on 5/4/2018, NP #3 wrote in the Physician Orders that she prescribed the sedation medications that were verbally ordered by Cardiac Attending Physician #1 during a surgical procedure performed on the CICU on 5/4/2018. NP #3 wrote in the Physician Orders that she prescribed the sedation medications that were verbally ordered by Cardiac Attending Physician #1.

The Surveyor interviewed CICU Charge Nurse at 11:00 A. M. on 5/25/2018. CICU Charge Nurse said it was the practice of the Cardiac Service in the CICU to have Nurse Practitioners write verbal orders in the physician section of the electronic health record for sedation and paralytic medications ordered by the Cardiac Attending Physicians during surgical procedures that were done on the CICU, even though the NP did not give the verbal orders during the surgical procedure (this practice was not consistent with the Hospital Verbal Order Policy).

The Hospital was out of compliance with the Condition of Participation for Infection Control.

Findings included:

The Hospital failed for 3 of 3 Intensive Care Units, [the Neonatal Intensive Care Unit (NICU), Cardiovascular Intensive Care Unit (CICU) and the Medical-Surgical Intensive Care Unit (MSICU)] to ensure that infection control officers developed policies and procedures, had input into existing policies for surgeries and procedures conducted outside of the Operating Room in order to address the maintenance of a sanitary environment; to ensure implementation of active surveillance strategies, and to address aseptic practices used in surgery and invasive procedures outside the Operating Room.

Refer to TAG: A-0749.

Based on records reviewed and interviews, the Infection Control Officers did not develop or have input into existing policies for surgeries and procedures done outside of the operating room on the NICU (Neonatal Intensive Care Unit), Cardiovascular Intensive Care Unit (CICU) and MSICU (Medical-Surgical Intensive Care Unit) in order to address maintenance of a sanitary environment, active surveillance strategies, and aseptic practices used in surgery and invasive procedures outside the operating room.

Findings included:

Review of the policy titled Bedside Surgery in the NICU, dated 5/21/2018, indicated no indication of representation of the Infection Control Department participating in the development of the policy. The Hospital provided no polices or procedures for the CICU or the MSICU for aseptic practices or sanitary environment for Bedside Surgery.

The Surveyor interviewed the Hospital Infection Control Preventionist and the Infection Control Physician, at 9:30 A.M. on 5/25/2018. The Hospital Infection Control Preventionist and the Infection Control Physician said they had not participated in the development of any policies or procedures to address infection control issues for surgery performed outside of the operating rooms on the NICU, CICU or the MSICU.

The Surveyor observed on 5/21/2018 between 12:00 P.M. and 1:30 P.M., a surgical procedure being performed in an open bay (bed space) room in the CICU, for Patient #13. Several infection control breaches were observed that increased the risk of infection for Patient #13 during the procedure. For example:

a) The bed space was located between two other open bay rooms that are only separated by cloth curtains and the other bays were occupied by children and their parents during the open chest operation. The Surveyor observed that the curtains were moved and bumped into by the many staff that were in the room during the surgery, possibly spreading dust and other debris into the surgical field and the open chest wound. The Surveyor observed that there were 3 Staff (including the surgeon) assisting with the procedure (operation). The Surveyor observed, in addition, there was a Circulating Nurse, a Registered CICU Nurse documenting on a computer in the corner inside the bed space and a Respiratory Therapist moving in and out of the bed space. The Surveyor observed Patient #13 was covered with a surgical drape and Patient #13's chest had an open incision which exposed Patient #13's heart. The Surveyor observed that the bed space was sectioned off with a 3 foot high yellow plastic fence which allowed anyone walking by to look into the bed space. Several Staff (3 to 6 other staff) were observed to move in and out of the bed space and staff was observed to stand about 3 feet from the end of the operating table. The Surveyor observed that these Staff were wearing scrubs (hospital attire) with street clothes exposed beneath them and face masks. The Surveyor observed that Staff did not use hand sanitizer when entering or leaving the room. The Surveyor observed, at 1:30 P.M. on 5/21/18, people dressed in street clothes in Patient #13's bed space during the surgical procedure.

b) The Surveyor observed, at 1:00 P.M. on 5/21/2018, the Attending Physician (as identified by the CICU Charge Nurse) walk in and out of Patient #13's bed space during the procedure (open chest exploration). The Surveyor observed a man with a badge and dressed in street clothes observed Patient #13's procedure from the hallway and proceed to walk into Patient #13's bed space at 1:30 P.M. on 5/21/18.

c) The Surveyor interviewed Cardiac Intensive Care Unit (CICU) Charge Nurse #1, at 12:00 P.M. on 5/21/18. The CICU Charge Nurse said that the Hospital did not require people to change (into surgical attire) because "it was only a procedure." This was inconsistent with the hospital's surgical attire policy.

d) The Surveyor interviewed Cardiac Attending Physician #1 at 1:30 P.M. on 5/21/18. Cardiac Attending Physician #1 said she did not know the identity of the man with a badge and in street clothes observing Patient #13's procedure from the hallway then proceeded to walk into Patient #13's bed space at 1:30 P.M. on 5/21/18.

e) The Surveyor interviewed CICU Charge Nurse at 2:05 P.M. on 5/21/18. CICU Charge Nurse said nothing was done, as far as environmental cleaning or disinfection, to prepare Patient #13's bed space prior to the procedure.

f) The Surveyor observed on 5/21/2018 at 12:00 P.M., directly over the surgical field and Patient #13's (the child's) open chest and sterile field, a mobile (infant toy) hanging from a lamp handle. The Surveyor observed as Staff moved around the room, they bumped into equipment causing the mobile to sway above Patient #13's open chest wound, potentially spreading infectious organisms into the open wound.

The Infection Control Officer provided the Surveyor, at 10:00 A.M. on 5/25/2018, an undated chart that indicated Hospital infection control data on Surgical Site Infections (SSI) for cardiac cases with delayed sternal closures, compared to primary (closed at time of surgery) sternal closures and overall (total) cardiac SSI for the past three years at the Hospital. The chart indicated the infection rate for delayed sternal closure was 3 to 3.5 times higher. The chart's data indicated no documentation for the location where the sternal closures were performed, an Operating Room, or Out of OR Surgeries such as at a patient bed space.

On 5/25/2018 at 10:00 A.M., the Infection Control Officer said she had not performed any separate surveillance of SSI on the CICU where they had been doing surgery outside of the operating room to evaluate if there was an increase in SSI in the out of the OR Surgeries.

The Surveyor interviewed the Vice President for Cardiovascular and Critical Care Services, at approximately 11:00 A.M. on 5/29/2018. The Vice President for Cardiovascular and Critical Care Services said it would be a good idea to collect and analyze that data related to surgical procedures performed outside of the operating room.

The Surveyor observed, at 12:00 P.M. on 5/21/2018 and at 11:30 A.M. on 5/24/2019, surgical procedures performed on the CICU. The Surveyor observed no environmental cleaning done pre (before) or post (after) the surgical procedure to reduce bacterial load (amount of infectious organisms in the environment) or presence of potential infectious material (an example was dust) in the room (bed space).

CICU Staff provided no documentation to indicate policies or procedures for room cleaning.

The Surveyor interviewed CICU Nurse Manager at approximately 10:00 A.M. on 5/25/2018. The CICU Nurse Manager said they do terminal cleaning of the unit after the patient is discharged.

The Hospital was out of compliance with the Condition of Participation for Surgical Services.

The Hospital failed to provide well organized surgical services in accordance with acceptable standards of practice. The Hospital performed surgical services to critically ill children in the Cardiac Intensive Care Unit (CICU) and the Medical-Surgical Intensive Care Unit (MSICU) without established policies and procedures that ensure safety and that were approved by the Governing Body.

Findings included:

The Hospital failed to ensure that the scope of Surgical Services provided in the Intensive Care Units (Cardiac Intensive Care Unit, CICU; the Medical-Surgical Intensive Care Unit, MSICU and the Neonatal Intensive Care Unit, NICU), were approved by the Hospital's Governing Body or Medical Executive Committee and that there were approved policies or procedures for the CICU or MSICU staff regarding the nature or extent of Surgical Services that could be provided in these units.

Refer to: TAG A-0941.

The Hospital failed to have policies and procedure designed to govern surgical care to assure and maintain a high standard of patient care and safety while performing bed side surgery in the CICU and MSICU, and all operating rooms related to tourniquet use.

The Hospital failed to have fire safety policies and procedures in open bay adjoining rooms in the CICU where the Operating Room (OR) team assessed the fire risk as moderate during observed cases where families were allowed to remain in the adjoining rooms and other infant patients remained in those adjoining open bay rooms.

Refer to: TAG A-0951.

The Hospital failed to obtain properly executed informed consents for planned non-emergent surgical procedures for 3 of 3 CICU patients (#13, #14 and #24), in a total sample of 5 surgical records reviewed.

Refer to: TAG A-0955.

Based on observations, records reviewed and interviews, the scope of Surgical Services provided in the Intensive Care Units (Cardiac Intensive Care Unit (CICU); Medical-Surgical Intensive Care Unit, (MSICU); and the Neonatal Intensive Care Unit (NICU), were not approved by the Hospital's Governing Body or Medical Executive Committee and there were no approved policies or procedures for the CICU or MSICU regarding the nature or extent of surgical services that could be provided in these units.

Findings included:

The regulations define surgery using the definition of the American College of Surgeons. The definition is: surgery is performed for the purpose of structurally altering the human body by the incision or destruction of tissues and is part of the practice of medicine. Surgery is also the diagnostic or therapeutic treatment of conditions or diseases processes by any instruments causing localized alteration or transposition of live human tissue which include lasers, ultrasound, ionizing radiation, scalpels, probes and needles, the tissue can be cut , burned (cautery), vaporized, frozen, sutured, probed or manipulated by closed reductions from major dislocation or fractures or otherwise altered by mechanical, thermal, light-based, electromagnetic or chemical means. Injection of diagnostic or therapeutic substances into body cavities, internal organs, joints, sensory organs and the central nervous system also is considered to be surgery (this does not include the administration by nursing personnel of some injections, subcutaneous, intramuscular and intravenous when ordered by a physician). All of these surgical procedures are invasive.

The Surveyor observed, at 1:30 P.M. on 5/21/2018, Patient #13's surgical procedure (the procedure was a mediastinal exploration and debridement of the open chest incision, epicardial echo, possible de-cannulation from ECMO (extra corporeal membrane oxygenation) and possible narrowing of the BTs ((Blaloch-Taussig) shunt (a surgical procedure used to increase pulmonary blood flow for palliation in duct dependent cyanotic heart defects like pulmonary atresia) being performed in an open bay (bed space) room on the CICU.

ECMO (extra corporeal membrane oxygenation) is a short-term means of providing life support in people who are seriously ill. Specifically, ECMO infuses oxygen into the blood and removes carbon dioxide. It can also provide hemodynamic (blood pressure) support. ECMO is a means of partial cardiopulmonary bypass and is used outside the operating room. ECMO is often used to take stress off the lungs and heart for several days, which theoretically promotes healing. It's used in patients who, if emergently treated, their chances of survival are good, and who would otherwise probably die without ECMO. Being placed on ECMO requires a surgical procedure but it is usually done in a patient's room. The patient is sedated and given pain medication and an anti-coagulant to minimize blood clotting. A surgeon, assisted by an operating room team, inserts the ECMO catheters into either an artery or vein. Removal of the ECMO catheters is also a surgical procedure that can be done by surgeon with assistance of an operating room team at the patient's bedside.

The Surveyor observed on 5/21/2018 between 12:00 P.M. and 1:30 P.M., the surgical procedure being performed in an open bay (bed space) room in the CICU, for Patient #13. The bed space was located between two other open bay rooms that are only separated by curtains and were occupied by children and their parents during the procedure. The Surveyor observed that the curtains were moved and bumped into by the many staff that was in the room during the surgery. The Surveyor observed that there were 3 Staff, including the surgeon, assisting with the procedure (operation). The Surveyor observed, a Circulating Nurse and a Registered CICU Nurse, documenting on a computer in the corner inside the bed space and a Respiratory Therapist moving in and out of the bed space. The Surveyor observed Patient #13 was covered with a surgical drape and Patient #13's chest had an open incision which exposed Patient #13's heart. The Surveyor observed that the bed space was sectioned off with a 3 foot high yellow plastic fence which allowed anyone walking by to look into the bed space. Several Staff (3 to 6 other staff) were observed to move in and out of the bed space and staff was observed to stand about 3 feet from the end of the operating table. The Surveyor observed that these Staff were wearing scrubs (hospital attire) with street clothes exposed beneath them and face masks. The Surveyor observed that Staff did not use hand sanitizer when entering or leaving the room. The Surveyor observed, at 1:30 P. M. on 5/21/18, people dressed in street clothes in Patient #13's bed space during the surgical procedure.

The Surveyor observed, at 1:00 P.M. on 5/21/2018, the Attending Physician (as identified by the CICU Charge Nurse) walk in and out of Patient #13's bed space during the procedure (open chest exploration). The Surveyor observed a man with a badge and dressed in street clothes observed Patient #13's procedure from the hallway and proceed to walk into Patient #13's bed space at 1:30 P.M. on 5/21/18.

The Surveyor interviewed Cardiac Intensive Care Unit (CICU) Charge Nurse #1, at 12:00 P.M. on 5/21/18. The CICU Charge Nurse said that the Hospital did not require people to change (into surgical attire) because what was being performed "was only a procedure."

The Surveyor interviewed Cardiac Attending Physician #1 at 1:30 P.M. on 5/21/18. Cardiac Attending Physician #1 said she did not know the identity of the man (with a badge and in street clothes observing Patient #13's procedure from the hallway then proceeded to walk into Patient #13's bed space at 1:30 P.M. on 5/21/18.

The Surveyor interviewed CICU Charge Nurse at 2:05 P.M. on 5/21/18. CICU Charge Nurse said nothing was done to prepare Patient #13's bed space prior to the procedure.

The Surveyor observed on 5/21/2018 at 12:00 P.M., directly over the surgical field and Patient #13's (the child's) open chest and sterile field, was a mobile (infant toy) hanging from a lamp handle. The Surveyor observed as Staff moved around the room they bumped into equipment causing the mobile to sway above Patient #13's open chest wound, potentially spreading infectious organisms into the open wound. The Surveyor observed at 2:01 P.M. on 5/21/2018, the Surgeon attempted to close the child's chest (pulling the sternum together with large steel wires and then suturing the skin together) and the chest closure failed as evidenced by clinical deterioration of hemodynamic vital signs and oxygenation parameters.

The Surveyor interviewed the Vice President of Cardiovascular and Critical Care Services at 10:00 A.M. on 5/25/2018. The Vice President of Cardiovascular and Critical Care Services said the Bedside Surgery in the NICU policy applied to all the ICUs.

The Hospital policy titled Bedside Surgery in the NICU, dated 5/21/2018, indicated a policy specific to the NICU and procedures done in the NICU. The Bedside Surgery policy indicated no indication that the policy was approved by the Medical Executive Committee or the Governing Body. The Bedside Surgery in the NICU policy, indicated the policy and procedure addressed who can benefit from such surgery, types of cases that can be done at the bedside, patient privacy, surgical procedure implementation and documentation standards for all disciplines involved including anesthesia. The Bedside Surgery in the NICU policy indicated no indication of housekeeping requirements (cleaning and disinfection are area before and after surgery), general infection control strategies and fire safety for patients and visitors.

The Surveyor interviewed the CICU Charge Nurse at 11:00 A.M. on 5/25/2018. The CICU Charge Nurse said she had not seen the Bedside Surgery in the NICU policy and the CICU did not follow this policy.

The Surveyor interviewed the Vice President of Cardiovascular and Critical Care Services at 11:00 A.M. on 5/25/2018. The Vice President of Cardiovascular and Critical Care Services said that the NICU Bedside Surgery Policy did not apply to the other ICUs and there were no specific policies and procedures for surgical procedures in the CICU and MSICU but they were working on a draft.

Based on observations, records reviewed and interviews the Hospital failed to ensure the Hospital had policies and procedures for Surgical care while performing surgery in the Cardiovascular Intensive Care Unit (CICU) and the Medical-Surgical Intensive Care Unit (MSICU), for 3 of 6 surgical cases reviewed (#13, #14 and #24) and failed for 1 of 26 sampled patients (Patient #22) to ensure there were policies governing safe tourniquet use in the operating rooms, to assure and maintain a high standard of patient care and safety.

Findings include:

Review of policies and procedures indicated only the NICU (Neonatal Intensive Care Unit) had Bedside surgery policies and procedures. These procedures addressed privacy, criteria for a bedside surgery, implementation procedures for bedside surgical procedures to include anesthesia and consent.

The Surveyor interviewed the CICU Charge Nurse and CICU Nurse Manager at 11:00 A.M. on 5/25/2018. The CICU Charge Nurse and Nurse Manager said the Hospital had no policies and procedures specific to the CICU for bedside surgery like in the NICU. They said there was a procedure check list on the procedure cart that included items such as but not limited to warming the antibiotic irrigation in the blanket warmer at the beginning of the shift (see #10 below), administer intravenous antibiotic dose one hour before surgery, hang universal check list in order that the surgical team could use it, discontinue heparin (blood thinning medication) two hours before procedure and get consent.

Hospital Logs, undated, but provided by the hospital administration on 5/23/2018, indicated the amount of surgical procedures performed in the Intensive Care Units for the past year. The Logs indicated 269 surgeries, procedures (chest closures or explorations) in the CICU where approximately 35 were emergent procedures (done to save the life of the patient) and the rest were scheduled surgeries (done at times convenient to the surgeon and clinical staff) at the patient's bedside; in the MSICU 42 procedures (included cannulation for ECMO) of which approximately 12 were emergent procedures and the rest were normal bedside procedures; and the NICU with 10 surgical cases or procedures all emergent.

The List of Surgical Procedures Performed on the CICU, provided by the CICU Nurse Manager on 5/23/2018 at 2:00 P.M., indicated the following procedures were performed on the CICU: vacuum dressing change, ECMO cannulation and ECMO de-cannulation, bronchoscopy; chest closure (surgery), chest washout (surgery), and chest exploration (surgery); and PA (pulmonary artery) banding (surgery).

The Surveyor interviewed the Vice President (VP) of Cardiovascular and Critical Care Services at 2:00 P.M. on 5/25/2018. The VP said that the Governing Body or Medical Executive Committee did not approve the above listed surgeries to be performed in the CICU.

The Hospital policy titled Bedside Surgery in the NICU, dated 5/21/2018, had no indications for procedures for safety from fire in the NICU, CICU or MSICU surgical environments.

The Surveyor observed, at 11:30 A.M. on 5/29/2018, Patient #24 undergo a chest exploration, mediastinal washout and chest closure on the CICU. The Surveyor observed during the time out (safety check) prior to surgery, the Circulating Nurse told the surgical team the fire risk for the surgery was "moderate." The Surveyor observation of the room indicated there was no fire extinguisher in the room and after the surgery was completed the Surveyor observed the nearest fire extinguisher was located 40-50 feet from the room. The Surveyor observed that families were allowed to remain in the adjoining rooms as well as the infant patients.

The Surveyor interviewed the Circulating Nurse at 11:30 A.M., on 5/29/2018. The Circulating Nurse said that the main operating rooms all have their own fire extinguishers in each room. The Circulating Nurse said she had participated in multiple surgical cases performed on the CICU but did not know where the fire extinguishers were. The Circulating Nurse said Staff put wet sponges on the surgical field as the procedure for mitigating a moderate fire risk. The Circulating Nurse said she did not know about the safety procedures for visitors and/or patients in the next bay. The Circulating Nurse said if there was a fire, someone would pull the fire alarm.

The Hospital provided no policies or procedures for aseptic and sterile surveillance of bed space surgical procedures.

The Surveyor observed at 1:30 P.M. on 5/21/2018, a surgical procedure being performed in an open bay room (bed space) on the CICU. Patient #13 was covered with a surgical drape and Patient #13's chest was exposed and open. The Surveyor observed directly over the surgical field and the child's open chest and sterile field, was a mobile (infant toy) hanging from a lamp handle. The Surveyor observed Staff move around the room bumping into equipment, the mobile swayed above the child's open chest wound, potentially spreading infectious organism (bacteria) into the open wound. The Surveyor observed that policies and procedures for proper surgical attire were not implemented consistently in this environment by all entering the surgical area.

The Hospital policy titled Surgical Environment and Attire, dated 8/12/15, indicated all personnel entering restricted spaces must wear hospital, provided scrub attire or single use jump suits or gowns, surgical hats or hoods, surgical face masks, identification badges were to be worn and visible at all times, head and facial hair are to covered, Personal Protective Equipment (gown, glove, mask) was to be worn when entering a restricted area (surgical room) if the sterile supplies were open and if participating in a sterile or unsterile procedure. The Surgical Environment and Attire policy indicated, if worn, personal clothing was to be contained within the surgical scrub attire.

The Surveyor observed, at 1:30 P.M. on 5/21/2018, a surgical procedure being performed in an open bay room on the CICU that was between two rooms that was separated by curtains. The Surveyor observed the curtains moved and bumped into by the many Staff that was in the room during the surgery. The Surveyor observed that there were 3 Staff to include the Surgeon assisting with the operation which was a chest washout and exploration. The Surveyor observed Patient #13 was covered with a surgical drape, his/her chest was exposed and open, exposing his/her heart and lungs. The Surveyor observed several Staff move in and out of the room and stand about 3 feet from the end of the operating table. The Surveyor observed Staff was wearing scrubs with street clothes exposed under the scrubs and face masks. The Surveyor observed, at 1:30 P. M. on 5/21/18, people dressed in street clothes in Patient #13's bed space during the surgical procedure.

The Surveyor interviewed the Cardiac Intensive Care Unit (CICU) Charge Nurse, at 12:00 P.M. on 5/21/18. The CICU Charge Nurse said that the Hospital did not require people to change (into surgical attire) because it was "only a procedure."

The Surveyor interviewed the CICU Nurse Manager at 10:00 A.M. on 5/23/2018. The CICU Nurse Manager said that there were no written housekeeping procedures before or after a surgical case that he was aware of to prepare the room for a surgical procedure or to clean and disinfect the room after a procedure. The CICU Nurse Manager said the CICU terminally disinfected the room once the patient was transferred or discharged. The CICU Nurse Manager said that the Surgery Staff removed all surgical instruments in a case cart.

The Hospital provided no policies for the CICU to ensure patient privacy during surgical procedures performed on the unit.

The Surveyor observed at 1:30 P.M. on 5/21/2018, a surgical procedure being performed in an open bay room on the CICU. The open bay room was between two rooms that was separated by curtains and was occupied by children and their parents during the surgical procedure. The Surveyor observed the curtains moved and bumped into by the many Staff that was in the room during the surgery. The Surveyor observed 3 Staff to include the Surgeon assisting with the operation. Patient #13 was covered with a surgical drape but the chest was exposed and open. The Surveyor observed the room was sectioned off with a 3 foot high yellow plastic fence which allowed anyone walking by in the hallway to look into the room to include non-essential Staff and visitors.

The Surveyor observed, at 1:30 P.M. on 5/21/18, a man with a badge and in street clothes observing Patient #13's procedure from the hallway and proceeded to walk into Patient #13's bed space.

The Surveyor interviewed Cardiac Attending Physician #1 at 1:30 P.M. on 5/21/18. Cardiac Attending Physician #1 said she did not know the identity of the man (with a badge and in street clothes) but he was allowed to enter the surgical environment without restriction.

The CICU Nurse Manager said Nursing shifts were 12 hours on the CICU. The CICU Nurse Manager said for scheduled surgical procedures antibiotic irrigation solutions were received on the CICU in the morning and placed in the blanket warmer which was confirmed by review of the reference for Chest procedures on the CICU checklist.

The Surveyor interviewed the CICU Charge Nurse at 11:00 A.M. on 5/23/2018. The CICU Charge Nurse said the nurses take the irrigation solutions out of the blanket warmer when preparing the room for the surgical procedure.

The Surveyor observed the blanket warmer, on 5/23/2018 at approximately 10:30 A.M., was set at 130 degrees Fahrenheit (F).

The Hospital policy titled Warming Cabinets for Blankets and Fluids, dated 2/10/2012, indicated that once fluids are removed from the warmer they should be allowed to cool. The policy indicated fluids used for irrigation must be in bags and their over pouches or plastic pour bottles with the cap secured and undisturbed.

Information obtained from pharmacy, dated 6/6/2018, indicated that the antibiotic solutions used to irrigate baby's chest cavities are compounded in the pharmacy using a 500 cc bag of normal saline with Neomycin- Polysporin antibiotic solution and could be stored refrigerated at temperatures of 2-8 degrees centigrade (45-86 degrees F) for up to 7 days. Information provided by the pharmacy on 6/62018 indicated the antibiotic solution does not lose its effectiveness when heated at temperatures to 130 degrees F.

The Hospital provided no documentation, policy or specific Hospital protocol for how to safely warm the irrigation solution in the blanket warmer on the CICU.

The Association of Perioperative Registered Nurses, AORN, Standards and Recommended Practices, dated 2012, indicated fluids used for intracorporeal (inside the body cavity) irrigation should not exceed 98.6 degrees F [37 degrees Celsius (C)] or approximate body temperature due to the potential to cause burns. The AORN Standards for Practice indicated the temperature of fluid on the sterile field should be measured using a sterile thermometer or a commercially available intraoperative irrigation warming bath to ensure it does not exceed 98.6 degrees F. The AORN Standards for Practice indicated solutions warmed to higher temperatures should be cooled to normal body temperature before used inside the body cavity.

The CICU did not follow Hospital policy for having intact bags in their original over pouches in the blanket warmer and the Hospital provided no procedure for checking the temperature of the irrigation solution once removed from the warming cabinet before irrigating a patient's open chest.

The Surveyor interviewed Cardiac Attending Physician #1 at 10:00 A.M. on 5/23/2018. Cardiac Attending Physician #1 said the decision to perform surgery on the CICU was a clinical decision made by the Cardiac Attending Physician and the Surgeon based on the child's instability (vital signs) and a risk and benefit analysis discussion between the Cardiac Attending Physician and the Surgeon before a decision to proceed with an "on the unit" (bedside procedures) surgery. The Cardiac Attending Physician said there were no written policies for criteria for bedside procedures in the CICU as it was per the clinical decision making of the Cardiac Attending Physician and the Surgeon.

Medical Staff Rules and Regulation Articles II Medical Records, dated 7/9/2016, indicated that physicians must write progress notes at least daily in the intensive care units that were relevant, succinct and clinically pertinent by the appropriate disciplines to permit continuity of care.

Physician Progress Notes for Patients' #13, #14 and #24, who all had surgical procedures on the CICU, indicated no documentation of clinical decision making between the Cardiac Attending Physician and the Surgeon prior to proceeding to surgical procedures on the CICU.

Review of the medical record for Patient #13 indicated the patient had a mitral valve repair on 4/23/2018 at 6 days old and later that day had a cardiac arrest requiring ECMO for life support, a bedside chest exploration with a wash out was done with removal of a clot from the pulmonary artery and the proximal shunt. The infant was unstable per review of physician progress notes. On 4/26/2018, review of a brief operative note indicated ECMO was discontinued in the operating room when the mitral valve was reworked. On 5/2/2018, review of the medical record indicated Patient #13 went to the operating room again for a pacemaker implant. On 5/16/2018, the patient had a cardiac arrest again, requiring ECMO support. On 5/21 and 5/24/2018, the medical record indicated Patient #13 had bedside procedures on the unit, not in the operating room, without evidence of any clinical decision making between the surgeon and the cardiac attending evident in the physician progress notes as to why the surgery had to be done in the CICU at the bedside.

The Surveyor interviewed the CICU Charge Nurse at 11:00 A.M. on 5/25/2018. The CICU Charge Nurse said that pacemaker implant (insertion of wires into the heart to deliver electrical impulses to stimulate or regulate heart beats when the heart rate is low or too high) had to be done in the Operating Room and could not be done on the unit so the patient and the ECMO equipment were taken to the OR. On 5/21 and 5/24/2018, the procedures were done at the bedside so staff did not have to transport the infant and the equipment to the OR.

On 5/25/2018 at 11:00 A.M., the CICU Charge Nurse said sometimes the infants are too unstable to move to the OR and risk changes in the infant's cardiac status and ventilatory status.

Review of the medical record indicated Patient #13 had a non-emergent mediastinal exploration and wash out of the chest on 5/21/18. On 5/24/18, medical record review indicated the patient had another exploration and washout with a ECMO clamp trial. Physician's Progress Notes, dated 5/20, 5/21, 5/23 and 5/24/2018 prior to both procedures, failed to indicate documentation of procedures' risk and benefits were discussed with Surgery before proceeding with the procedure on the CICU.

The CICU CN assisted the Surveyor with record review on 5/25/2018 and said there was no documentation of medical surgical clinical decision making between the Cardiac Attending Physician and the Surgeon prior to proceeding to surgical procedures on the CICU

Review of the medical record for Patient #14 indicated the patient had a non-emergent chest exploration on 5/1/2018, and 5/3/2018 and a chest closure on 5/4/18. Physician's Progress Notes, dated 4/30, 5/1, 5/2, 5/3, and 5/4/2018 prior to all three procedures, did not indicate any documentation that a review of the procedures risk and benefits being performed on the CICU were discussed with Surgery. The CICU CN said there was no documentation of procedures' risk and benefits were discussed with Surgery before proceeding with the surgical procedure on the CICU.

The Surveyor observed Patient #24, at 11:30 A.M. on 5/29/2018, to have had a non-emergent chest exploration, wash out and closure in the CICU with removal of a retained tourniquet.

Review of the Physician's Progress Notes in Patient #24's medical record, dated 5/28 and 5/29/2018, prior to both procedures, failed to indicate any documentation that the procedures' risk and benefits were discussed with the Surgeon prior to the surgical procedure being performed on the CICU in the patient's bed space.

On 5/29/2018 at 2:00 P.M., the CICU CN said there was no documentation of medical surgical clinical decision making, prior to proceeding with the surgical procedures, in Patient #24's physician progress notes when she reviewed the record.


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Review of the AORN (Association of PeriOperative Registered Nurses) standards (2012) for use of tourniquets indicated that a pneumatic (air inflated) tourniquet cuff should be selected and applied in manner to minimize the risk of injury to the patient. The correct surgical site should be verified before application of the tourniquet cuff.

Review of the Intravenous (IV) Vascular Access Report, dated 1/1/18 through 5/18/18, indicated Operating Room Staff applied Patient #22's arm tourniquet label and leg tourniquet label to the tourniquet machines (a machine that automatically tightens a tourniquet) incorrectly. The Intravenous (IV) Vascular Access Report indicated Operating Room Staff applied Patient #22's arm tourniquet label on the leg tourniquet machine and Operating Room Staff applied Patient #22's leg tourniquet label to the arm tourniquet machine and this was incorrect. (A limb without the intended tourniquet when operated on may cause increased risk for bleeding and a limb with the unintended tourniquet may cause decreased blood circulation to the limb.)

The Surveyor interviewed Nurse Manager #2, at 11:00 A.M. on 5/25/18. Nurse Manager #2 said Hospital staff could make dual limb tourniquet procedure mistakes and that the mistake had happened before however not on her unit.

The Hospital policy titled Perioperative Use of a Tourniquet, dated 6/1/17, indicated procedures for the use of tourniquets in perioperative limb procedures. The Perioperative Use of a Tourniquet policy did not indicate a procedure for dual tourniquet use; the policy did not indicate a procedure for labeling tourniquet machines.

Based on Records reviewed and interviews the Hospital failed to obtain properly executed informed consents for non-emergent, planned surgical procedures for 3 of 3 CICU (cardiac Intensive Care Unit) patients (#13, #14 and #24), in a total sample of 8 surgical records reviewed. Findings include:

According to the hospital policy titled "Informed Consent" last modified on 5/16/2016, informed consent is obtained by clinicians who are credentialed and/or certified to perform the procedure or treatment. A properly executed consent document is consistent with hospital policies and includes but is not limited to:

-Name of the hospital where the procedure is to take place,

-Name of the specific procedure for which consent is being given,

-Name of the responsible clinician who is performing the procedure,

-Statement that the procedure including anticipated benefits, material risks and alternative therapies was explained to the patient/representative,

-Signature or patient and/or patient's representative, and

-Date and time the informed consent was obtained by the clinician.

The clinician's signature on the consent signifies that the above was provided.

Consent was required for administration of blood and blood products, moderate and deep sedation and general anesthesia, all surgical or other invasive procedures. Blood product administration requires consent and has two forms for consent: a onetime blood transfusion consent and a Blood Transfusion Extended consent. There is no mention of extended consent for a one time procedural consent.

For 3 of 3 surgical sampled patients (Patients #13, #14 and #24) reviewed in the CICU, consents were not properly executed per policy. For example:

For Patient #13, a onetime procedural consent for a mediastinal exploration and debridement, epicardial echo, possible de-cannulation for ECMO and possible narrowing of BTs (Blalock-Taussig) shunt (a surgical procedure used to increase pulmonary blood flow for palliation in duct dependent cyanotic heart defects like pulmonary atresia) was found in the clinical record. The consent lacked time and date and the surgeon signed (although not legible) on the patient representative's line. The consent had a checkbox that allowed for blood transfusions up to 7 days after the procedure and the box was automatically checked (Preprinted check on the form) so the patient or representative cannot uncheck and refuse.

This blood transfusion consent for 7 days was found on all one time procedural consents.

For Patient #14, an underage child, several consents were signed by a non-English speaking parent representative without the assistance of an interpreter although an interpreter had been used on some other consents. For procedures on 5/3 (chest exploration and wash out); 5/4 (bronchoscopy); on 5/7 (two procedures -Bronchoscopy and chest tube insertion) and on 5/10 (insertion of a central line catheter) no interpreter was used to explain the procedure and get informed consent from the non- English speaking parent representative.

During an interview, at 11:00 A.M. on 5/25/2018, the CICU Charge Nurse said an interpreter should have been used to obtain all the consents for Patient #14.

For Patient #24, a consent for chest closure with wash out was obtained on 5/25/2018 by a Physician Assistant via telephone from the patient's mother. The consent listed the clinician as a physician (named) and his associates.

The surgery was observed by the Surveyor at 11:30 A.M. on 5/25/2018 and the surgeon listed on the consent as performing the surgery was not the surgeon who actually performed the surgery. The consent also did not include all the procedures done, as the surgeon also did a chest exploration.

Review of the credentialing file of the Physician Assistant who obtained the consent indicated the Physician Assistant was not credentialed and/or certified to perform the procedure or treatment and therefore was not eligible to obtain the consent.

For all 3 patients, record review indicated there were no consents for anesthesia for procedures done on the CICU when the patients were given deep sedation and/or general anesthesia via Intravenous (IV) medication or monitored anesthesia care.

The Hospital was out of compliance with the Condition of Participation for Anesthesia Services.

Findings included

Based on observation, record review, review of policies and interview, the hospital failed to furnish anesthesia services that were provided in a well organized manner, mostly affecting practice in the Cardiac Intensive Care Unit (CICU).

The Hospital failed to ensure that the organization of Anesthesia Services in the Hospital were appropriate to the scope of services offered as deep sedation and monitored anesthesia care were administered by unqualified staff in the CICU.

Refer to TAG: A-1001.

The Hospital failed to ensure that for 3 of 3 CICU patients (Patients #13, #14 and #24), a pre- anesthesia evaluation was completed and documented by an individual qualified to administer anesthesia, performed within 48 hours prior to surgery or a procedure requiring anesthesia services.

Refer to TAG: A-1003.

The Hospital failed to ensure that an intraoperative anesthesia record was completed for 3 of 3 CICU patients (Patients #13, #14 and #23), each patient receiving general and/or deep sedation per the hospital policy and that the record contained the name of the provider of anesthesia services.


Refer to TAG: A-1004.

The Hospital failed to ensure for 3 of 3 CICU patients (Patients #13, #14 and #24), a post anesthesia evaluation was completed within 48 hours after surgery or a procedure requiring anesthesia services.

Refer to TAG: A-1005.

Based on observations, records reviewed and interviews, the Anesthesia Services, to include deep sedation and monitored anesthesia care were administered by unqualified Cardiovascular Intensive Care Unit (CICU) Registered Nurses (RN) (RN's #1, #3, #4 #5 and #6) in the CICU under direction of Cardiac Attending Physicians which violated the regulations and hospital policy for who was qualified to administered anesthesia.

Findings included:

The Hospital policy titled Provision of Anesthesia Services, undated but provided on 5/24/2018 by hospital administration, indicated that for the provision of general, regional and monitored anesthesia (MAC) and deep sedation (collectively known as anesthesia), only those individuals privileged by the Medical Staff were permitted to administer anesthesia. The Provision of Anesthesia Services policy indicated these individuals may include: a qualified anesthesiologist, a doctor of medicine or osteopathy (other than an anesthesiologist), a certified registered nurse anesthetist (CRNA) as defined in the Medicare Conditions of Participation. The Provision of Anesthesia Services policy indicated that its scope was organization wide and as referenced within, portion of all this the policy applied to all areas involved in the provision of anesthesia services.

The Hospital policy titled Medication Administration for Anesthesia Providers, dated 2/20/2018, indicated that the policy applied anesthesia delivery locations and applied to Attending Physicians, Certified Registered Anesthetists (CRNA)s, student nurse anesthetists, anesthesia fellows and anesthesia residents (physicians in anesthesia training).

The Medication Administration for Anesthesia Providers policy indicated that an anesthesia provider in the process of preparing or administering medications must verify the identity of all medication with another clinician before administration by performing an Independent Double Check. The Medication Administration for Anesthesia Providers policy indicated the policy was waived (not used) during emergencies. The Medication Administration for Anesthesia Providers policy indicated the double check procedure could be performed with two anesthesia providers or if only one anesthesia provider was working alone, he/she could verify the medication vial, content and concentration, weight based dosage with a circulating (operating room) nurse. The Medication Administration for Anesthesia Providers policy indicated that for medications, except those routinely used in anesthesia described within the policy two Medical Doctor's (MD) (or MD and CRNA/RN) were required to independently visualize the medication and calculate the amount necessary prior to administration.

The Policy titled Patient Sedation for Procedures, dated 12/19/16, indicated credentialing of non-anesthesiologist MD/ Nurse Practitioner (NP) for provision of deep sedation required prior approval of the Anesthesiologist-in-Chief.

The Hospital provided no documentation to indicate that CICU Registered Nurses were credentialed as CRNA's to perform deep sedation.

During an interview on 5/29/2018 at 10:00 A.M., the Chief of the Anesthesia Services said that in CICU, the physicians only provided deep sedation, not general anesthesia. The Chief said that the line between deep sedation and general anesthesia is not well defined and a patient can easily go from one to the other. The Chief said that because the infants come from the operating room already intubated and sedated, they are already in sedation, therefore it was his belief that by adding more sedation during procedures it is a continuation of anesthesia from the operating room not new sedation/anesthesia event so evaluation, consent and re- evaluation are not necessary. The Chief said if the infant were to self-extubate then the period of analgesia and sedation ends and a new evaluation and consent would be needed.

The Chief said he did not know the CMS regulations well. The Chief said if the infant went to the operating room than the anesthesia staff would do a pre-anesthesia assessment if it was older than 30 days (not consistent with hospital policy which says 48 hours) and write a brief note.

Review of the hospital policies indicated that credentialing of nurse practitioners (NP) to provide deep sedation is in violation of regulations since NP are not qualified providers of anesthesia under the regulations unless they are CRNAs and credentialed by the hospital to perform the duties as a CRNA. An NP may be credentialed to do moderate sedation which is not defined by regulations as anesthesia.

On 5/29/2018 at 11:30 A.M., the Surveyor observed the following:

Patient #24, a 9 month old baby, was being prepped in CICU for a bedside surgery. The patient was already intubated and sedated with intravenous (IV) narcotics to manage pain, IV sedation with Ativan to manage agitation from being intubated and on paralytic IV agent to prevent self extubation. The patient was described by staff as moderately sedated.

Cardiac Attending Physician (CAP) #2 told the Surveyor he planned to give the patient IV Fentanyl (an opioid narcotic) in sufficient doses to produce general anesthesia since the planned procedure (chest exploration, chest wash out, closure of the sternum and chest wall) were all very painful procedures. CAP #2 said he would monitor the hemodynamics (Blood pressure, pulse, pulmonary pressures, mean arterial pressures) very closely to give adequate Fentanyl to keep the baby adequately anesthetized.

The patient was monitored accordingly. In the room was respiratory therapy to monitor the ventilator settings, the surgeon, a physician assistant to act as the first assistant to the surgeon, the scrub nurse, the circulating nurse, a nurse practitioner (NP), CAP #2, two CICU registered nurses (CICU RN #1 and #2) at a computer by the head of the bed with access to the IV lines and the Surveyor.

After prep and drape of the patient and an appropriate time out, the CAP #2 began by instructing the CICU RN #1 to prepare and administer doses of Fentanyl (narcotic analgesic) and Versed (anti-anxiety agent). According to the manufacturer's package insert for Fentanyl, dated 11/1/2017, for anesthesia effects, the dose is 0.5 to 20 mcg/kg per dose given intravenously. A maintenance intravenous infusion of 1-2 mcg/kg/hour also may be used. For induction and maintenance of anesthesia in children 2-12 years old 2-3 milligrams per kilograms is recommended.

The first dose of Fentanyl was 60 micrograms (mcg or 10 mcg per kilogram (kg) as the baby weighed 6 kg). CICU RN #1 drew up the dose and doubled checked it with CAP #2 before pushing the medication into the IV line. CAP #2 then ordered CICU RN #1 to given a dose of Vecuronium (a paralytic drug) 26 milligrams (mgs) IV push and 2 mg of Versed IV push. CAP #2 continued to order doses of Fentanyl that were given by CICU RN #1, based on subtle changes in the hemodynamics but the patient did not respond to painful stimuli such as surgical debridement of the wound. The Surveyor counted four doses of 60 mcg Fentanyl ordered by the CAP #2 and then administered by CICU RN #1.

Review of the personnel file for CICU RN #1 on 5/29/2018 indicated the nurse was not credentialed as a CRNA and did not have any evidence of sedation training on the transcript for training reviewed from 2010 to present. CICU RN #1 was acting outside her scope of practice by administering deep sedation as she was not a qualified provider of anesthesia services.

Review of the Medication Administration Record (MAR) and Intraoperative Record, dated 5/29/2018 indicated Patient #13 underwent surgery and received doses of Fentanyl consistent with deep sedation to general induction doses of anesthesia on 5/21/18 and 5/24/18. Patient #13 weighed 3.8 kg.

The MAR, dated 5/29/2018, indicated all ordered doses of Fentanyl given for deep sedation were recorded as given by the CICU nurses on the medication administration record.

The MAR, dated 5/21/2018, indicated the CICU RN #3 administered to Patient #13- 38 mcg of Fentanyl IV at 11:07 A.M. (10 mcg/kg) and at 11:35 A.M. administered 19 mcg of Fentanyl (5 mcg/kg), which were both anesthesia (deep sedation) dose levels of Fentanyl.

Review of the MAR, dated on 5/24/2018, indicated that during a surgical procedure, CICU RN #4 administered 38.3 mcg (10 mcg/kg) at the start of the surgical procedure, which was an anesthesia (deep sedation) dose of Fentanyl.

Record review indicated Patient #14 underwent surgical procedures on the CICU with deep sedation on 5/2, 5/3 and 5/4/2018.

Record review indicated the Patient #14 was on a opioid intravenous (IV) drip for pain management and an IV drip of Versed (anti-anxiety medication) for sedation. The surgical consent, dated 5/2/2018 indicated Patient #14 had a chest exploration and washout (a washout is a procedure where the surgeon flushes out the open chest cavity with saline or with an antibiotic solution. The flush goes into the pleural and mediastinal spaces around the lungs and the heart to remove any clots and debris that may have been debrided from the incision line and then is suctioned out) and received induction doses of the narcotic, Fentanyl, a total dose of 400 mcg over 4 minutes.

The Manufacturer's Package Insert, for anesthesia, dated 11/1/2017, indicated the dose was 0.5 to 20 mcg/kg per dose given intravenously and that a maintenance intravenous infusion of 1-2 mcg/kg/hour also may be used. The patient weighed 54 kg, therefore the administration dose was 8 mcg/kg.

The medical record indicated Patient #14 had a chest wash out on 5/3/2018 and the MAR, dated 5/3/2018 indicated the patient received a total dose of 200 mcg of Fentanyl for deep sedation administered by CICU RN #5.

Based on records reviews, policy review and interviews, the Hospital failed to ensure for 3 of 3 Cardiac Intensive Care Unit (CICU) sampled patients (Patients #13, #14 and #24) a pre- anesthesia evaluation was completed and documented by an individual qualified to administer anesthesia, performed within 48 hours prior to surgery or a procedure requiring anesthesia services, in a total of 6 surgical records reviewed.

Findings include:

1.) The Hospital policy titled Provision of Anesthesia Services, undated but provided by hospital administration on 5/24/2018, indicated the pre-anesthesia evaluation must be performed within 48 hours of surgery requiring anesthesia services. The Provision of Anesthesia Services policy indicated an evaluation at a minimum must contain a review of medical history, allergies and drug history, interview and patient examination, notation of anesthesia risk according to standards of practice (American Society of Anesthesia, ASA, classification of risk) and development of a plan of the patient's anesthesia care including the type of medications for induction, maintenance and post-operative care a discussion with the patient (or patient's representative) of the risks and benefits of the delivery of anesthesia. The Provision of Anesthesia Services policy defined deep sedation as monitored anesthesia.

The ASA physical status classification system is a system for assessing the fitness of patients before surgery and there were 6 categories:

a. Healthy person,

b. Mild systemic disease,

c. Severe systemic disease,

d. Severe systemic disease that is a constant threat to life,

e. A moribund person who is not expected to survive without the operation.

f. A declared brain-dead person whose organs are being removed for donor purposes.

The Provision of Anesthesia Services policy indicated that a re-assessment immediately prior to administration must be done to ensure the patient was ready for induction and this assessment must be completed by qualified personnel. The Provision of Anesthesia Services policy indicated a re-assessment at a minimum must evaluate vital signs and a summary statement or note entered into the medical record that the reassessment was completed. The Provision of Anesthesia Services policy indicated the anesthesia plan must be documented in the medical record by a qualified individual prior to administration of anesthesia.

Review of the medical record for Patient #13 indicated the patient underwent surgical procedures on the CICU on 5/21 and 5/24/2018.

The Medical Record for Patient #13 indicated no documentation that pre-anesthesia evaluations were completed consistent with the Provision of Anesthesia Services policy.

2.) Review of the medical record for Patient #24 indicated on 5/21/2018 Patient #24 was intubated and received intravenous (IV) opioid pain management with Morphine, IV sedation with the medication Versed and was on an IV neuromuscular blockade (paralyzing) medication to prevent self extubation, had a mediastinal exploration and wound debridement, epicardial echocardiogram (Epicardial echocardiography is performed by placing the ultrasound transducer on the epicardium (outermost layer of the surface of the heart), and narrowing of the Blalock-Taussig (BT) shunt (a surgical procedure used to increase pulmonary blood flow for palliation in duct dependent cyanotic heart defects like pulmonary atresia, which are common causes of blue baby syndrome) while on the CICU.

The Medication Administration Record (MAR), dated 5/21/2018, indicated the CICU nurse administered the Patient #24 two doses of Fentanyl [38 micrograms (mcg) IV at 11:07 A.M. at the start of the procedure] and at 11:35 A.M. administered 19 mcg IV.

The MAR, dated 5/21/2018, indicated Patient #24 weighed 3.8 kilograms (pounds) therefore this dose was 10 mcg/kg and the second dose was 5 mcg/kg.

The Manufacturer's Package Insert (instructions), dated 11/1/2017, indicated these doses were consistent with doses for anesthesia (0.5 to 20 mcg/kg per dose administered intravenously).

The Surveyor interviewed the Chief of Anesthesia at 10:00 A.M. on 5/29/2018. The Chief of Anesthesia said that infants receiving opioids for pain management needed higher doses for sedation due to opioid tolerance.

Patient #13's medical record indicated Patient #13 underwent another surgical procedure on the CICU for a chest washout and chest exploration on 5/24/2018.

The MAR dated 5/24/2018, indicated that CICU RN #1 documented administering a total dose of 12 mg Morphine, 38.3 mcg Fentanyl and 0.8 milligrams of Versed on the orders of Cardiac Attending Physician #3.

The Medical Record for Patient #24 did not indicate any documentation of a pre- anesthesia evaluation consistent with Hospital policy. The Medical Record for Patient #24 did not indicate any documentation of documentation of an anesthesia plan for either surgery.

The Surveyor interviewed the CICU Charge Nurse who assisted with the record review, at 11:00 A.M. on 5/23/2018. The CICU Charge Nurse said there was no anesthesia evaluation for either surgery. The CICU Charge Nurse said that the Cardiac Attending Physicians were listed on the intraoperative record as the "ICU provider" under anesthesia but review of the intraoperative record indicated Cardiac Attending Physician's names did not appear except in the section of the intraoperative report that listed all the staff in the operative suite by name and role and listed the Cardiac Attending Physician as the ICU attending for his/her role.

The CICU Charge Nurse said she was present for both procedures and the usual procedure was that the Cardiac Attending Physician ordered the medication verbally and the nurse administered the medication to the patient. The CICU Charge Nurse said that the Nurse Practitioner in the patient room wrote all orders for sedation medication down on a piece of paper and then wrote the medication orders under her (Nurse Practitioner) name in the patients' Medical Record. The CICU Charge Nurse said the orders were not written as verbal orders with read back (double check for safety) for the ordering provider (Cardiac Attending Physician) to sign and verify.

3.) The Medical Record for Patient #14 indicated the patient underwent surgical procedures in the CICU on 5/2 (chest washout and ECMO de-cannulation), 5/3 (chest washout) and on 5/4/18 (chest exploration and closure of the sternum).

The Medical Record indicated there was an anesthesia pre- evaluation, dated 5/1/2018 for a planned date of surgery of 5/4/2018 for a scheduled procedure of ECMO de-cannulation and chest washout. The anesthesia pre- evaluation, dated 5/1/2018, indicated the anesthesia plan was for general anesthesia, which was discussed with the patient's representative who agreed with the plan. The Medical Record indicated there was no documentation that the anesthesia evaluation included an ASA risk evaluation as required by Hospital and regulatory requirements.

Medical record review indicated Patient #14 went to the operating room for a tracheostomy on 5/22/2018. The Medical Record indicated there was no documentation of a pre-anesthesia evaluation within 48 hours of the procedure as required. Review of the medical record indicated the patient underwent general anesthesia for the procedure.

4.) The Medical Record for Patient #24 indicated the patient underwent a surgical procedure on 5/24/2018 on the CICU for a mediastinal exploration, chest washout and sternal closure.

The Surveyor interviewed Cardiac Attending Physician #2 on 5/24/2018 at 11:30 A.M., just prior to Patient #24's surgery. Cardiac Attending Physician #2 said he planned to give Patient #24 adequate doses of Fentanyl (powerful narcotic) to product general anesthesia as the procedures were quite painful. Cardiac Attending Physician #2 said Patient #24 was already on a Morphine drip intravenously for pain management, a Versed drip for sedation and a neuromuscular blockade (paralyzing medication) IV constant infusion to prevent self extubation.

Patient #24's Record review indicated no indication of documentation of an anesthesia evaluation as required.

Based on records reviewed, review of policies and interviews, the Hospital failed for 3 of 3 Cardiac Intensive Care Unit (CICU) sampled patients (Patients #13, #14 and #23), in a total of 6 surgical records reviewed, to ensure that an intraoperative anesthesia record was completed for each patient receiving general or deep sedation, per the Hospital policy and that the record contained the name of the provider of anesthesia services.

Findings include:

1.) The Hospital policy titled Provision of Anesthesia Services, undated and provided to the Surveyor on 5/24/2018, indicated that for the provision of general, regional and monitored anesthesia (MAC) and deep sedation (collectively known as anesthesia), patients shall be appropriately monitored during the administration of anesthesia. The Provision of Anesthesia Services policy indicated monitoring shall be documented on an intraoperative, intra-procedure anesthesia record and the documentation shall address at a minimum:

a. name and hospital identification number of the patient,

b. name of practitioner who administered anesthesia and as applicable, the name and profession of the supervising anesthesiologist,

c. name dosage, route and time of administration of drugs and anesthesia agents,

d. techniques used and patient positions, including insertion/use of any intravascular or airway devices; name and amounts of IV fluids, including blood and blood products,

e. time based documentation of vital signs as well as oxygenation and ventilation parameters and

f. any complications, adverse reactions, or problems occurring during anesthesia, including time and description of symptoms, vital signs, treatments rendered and patient response to treatment.


The Surveyor observed, at 11:30 A.M. on 5/29/2018, the following, Patient #24, a 9 month old baby, was being prepped in the CICU for a bedside surgery. Patient #24 was already intubated (breathing tube and breathing machine) and sedated with intravenous (IV) narcotics to manage pain, IV sedation with Ativan to manage agitation from being intubated and on paralytic IV agent (medication to paralyze) to prevent self extubation. Patient #24 was described by staff as moderately sedated.

The Surveyor interviewed Cardiac Attending Physician #2 during the observation at 11:30 A.M. on 5/29/2018. Cardiac Attending Physician #2 said to the Surveyor that he planned to give Patient #24 IV Fentanyl (an opioid narcotic) in sufficient doses to produce general anesthesia since the planned procedure (chest exploration, chest wash out, closure of the sternum and chest wall) were all very painful procedures. Cardiac Attending Physician #2 said he would monitor the hemodynamics (blood pressure, pulse, pulmonary (lung) pressures, and mean arterial pressures) very closely to keep adequate Fentanyl on board (administered) to keep the baby adequately anesthetized.

The Surveyor observed that the Cardiac Attending Physician #2 did not document on an intraoperative anesthesia record as required. The Surveyor observed the Cardiac Attending Physician #2 dictated anesthesia medications to be given by nursing personnel who documented on the Medication Administration Record (MAR). The Surveyor observed nursing staff document vital signs, respiratory therapy document ventilator settings and oxygenation. The Surveyor observed the Cardiac Attending Physician #2 as he watched the hemodynamics screen (monitor) and ordered medications based on assessment of the hemodynamics (vital signs).

The Intraoperative Record, dated 5/29/2018, completed by the Surgical Team and the Brief Operative Note, dated 5/29/2018, completed by the Surgeon, failed to indicate any documentation of anesthesia as being provided or that the anesthesia administered was administered under the order of Intensive Care Unit Attending by the CICU RNs.

2.) Medical record review for Patient #13 who underwent surgery at 11:30 A.M. on 5/29/2018 in the CICU, received doses of Fentanyl consistent with deep sedation to general induction doses of anesthesia. The Medical Record failed to indicate any documentation for an intraoperative anesthesia record in the Patient #13's Medical Record.

The MAR, dated 5/29/2018, indicated all ordered doses of deep sedation were recorded as given by the CICU nurses on the Medication Administration Record for Patient #13.

The vital sign flow record in the electronic health record (EHR), dated 5/29/2018, indicated Patient #13's vital signs were recorded on the nursing flow sheets and respiratory therapists recorded ventilation (breathing machine) parameters on their flow sheets.

The Medical Record indicated no indication of documentation of the name of the Cardiac Attending Physician who ordered the deep sedation drugs to be administered by nursing staff. The Medical Record indicated no indication of documentation of accountability by the Cardiac Attending Service for anesthesia services provided to Patient #13.

3.) Review of the medical record indicated Patient #14 underwent surgical procedures on the CICU with deep sedation on 5/2, 5/3 and 5/4/2018.

Review of the MAR dated 5/2 through 5/4/2018, indicated Patient #14 was on constant intravenous infusion of an opioid medication for pain management and a constant intravenous infusion of Versed (anti-anxiety medication) for sedation. The medical record indicated that on 5/2/2018, Patient #14 underwent a chest exploration and washout (flushing of the chest cavity with usually a solution of normal saline and antibiotics) and received induction of anesthesia with (high) doses of the narcotic Fentanyl, a total dose of 400 mcg over 4 minutes.

The Manufacturer's Package Insert (instructions), dated 11/1/2017, indicated that for anesthesia, the dose was 0.5 to 20 mcg/kg (micrograms per kilogram) per dose administered intravenously. The Manufacturer's Package Insert indicated that maintenance dose of anesthesia for intravenous infusion of 1-2 mcg/kg/hour also may be used.

Review of the medical record for Patient #14 indicated the patient weighed 54 kg (therefore the dose administered was 8 mcg/kg).

Review of the medical record indicated Patient #14 underwent a chest wash out in the CICU on 5/3/2018 and received a total dose of 200 mcg of Fentanyl for deep sedation.

Review of the medical record indicated Patient #14 underwent a chest exploration, washout and Extracorporeal Membrane Oxygenation (ECMO, heart-lung by-pass machine) clamp trial on the CICU and was given a total dose of 1000 mcg of Fentanyl on 5/4/2018 for deep sedation.

The Medical Record for Patient #14 indicated no documentation of an intraoperative anesthesia record for Patient #14's three surgeries consistent with the hospital requirements for anesthesia.

The Surveyor interviewed the Chief of the Anesthesia Services, at 10:00 A.M. on 5/29/2018. The Chief of the Anesthesia Services said that in CICU the physicians only provided deep sedation not general anesthesia. The Chief of the Anesthesia Services said that the line between deep sedation and general anesthesia was not well defined and a patient could easily progress from one to the other (deep sedation and general anesthesia).

Based on records reviewed, review of policies and interviews, the Hospital failed to ensure that for 3 of 3 Cardiac Intensive Care Unit (CICU) sampled patients (Patients #13, #14 and #24), in a total of 6 surgical medical records reviewed, a post anesthesia evaluation was completed within 48 hours after surgery or a procedure requiring Anesthesia Services.

Findings include:

The Hospital policy titled Provision of Anesthesia Services, undated and provided to the Surveyor on 5/24/2018, indicated that for the provision of general, regional and monitored anesthesia (MAC) and deep sedation (collectively known as anesthesia), indicated that a post anesthesia evaluation must be completed and documented no later than 48 hours after surgery or a procedure requiring anesthesia and must be done by a practitioner qualified to administer anesthesia. The Provision of Anesthesia Services policy indicated that the evaluation must conform to current standards of anesthesia care and was clearly documented and addressed the following:

a. respiratory function

b. cardiovascular function

c. mental status

d. temperature

e. pain

f. nausea and vomiting

g. post-operative hydration

h. depending on the specific surgery or procedure performed addition monitoring may be necessary.

The Provision of Anesthesia Services policy indicated for patients unable to participate in an evaluation due to mechanical ventilation and post-operative sedation, a notation in the medical record should include the reason of patient's inability to participate as well as expectations for recovery time, if applicable.

Review of the medical record indicated Patient #14 had surgical procedures on 5/2, 5/3 and 5/4/2018, under deep sedation in the CICU. The Medical Record indicated no documentation of post anesthesia evaluations as required following these surgeries.

Review of the medical record indicated Patient #13 had surgical procedures conducted in the CICU on 5/21 and on 5/24/18 under deep sedation. The Medical Record indicated no documentation of post anesthesia evaluations as required following these surgeries.

Review of the medical record for Patient #24 indicated the patient had a surgical procedure on 5/25/2018 conducted in the CICU under deep sedation general Intravenous (IV) anesthesia. The Medical Record indicated no documentation of a post anesthesia evaluation, as of 5/29/2018, consistent with Hospital policy.