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800 SOUTH MAIN STREET

CORONA, CA 92882

NURSING SERVICES

Tag No.: A0385

Based on observation, interview, and record review, the facility failed to ensure the facility's policies and procedures were implemented, for four of 30 sampled patients (Patients 8, 13, 11, and 12), when:

1. For Patient 8, a pediatric (child) patient, intravenous fluid (Sodium Chloride 0.9%, administered through the vein) was administered using a pressure bag/rapid infuser (a special bag used to help the IV fluids either run faster or continuously flow into the patient) (A0410);

2. For Patient 13, a blood product was not administered timely in accordance with the facility's policy and procedure (A0405);

3. For Patient 11, oral hygiene was not provided every two hours as ordered by the physician (A0395); and

4. For Patient 12, assessment was not conducted at least every two hours while the patient was on restraints, in accordance with the facility's policy and procedure (A0395).

The cumulative effect of these systemic failures resulted in the patients to not be provided safe and quality care to meet the patient needs.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on observation, interview, and record review, the facility failed to ensure the facility's policies and procedures (P&P) were implemented for two of 30 sampled patients (Patients 11 and 12), when:

1. For Patient 11, oral hygiene was not provided every two hours.

This failure had the potential to lead to bacterial growth in the mouth and on surfaces of the teeth in a patient with an artificial airway which placed the patient at risk for ventilator-associated infections (infections related to a breathing machine) with the potential to further jeopardize the patient's health and lead to prolonged hospitalization); and

2. For Patient 12, assessment was not conducted at least every two hours while the patient was on restraints.

This failure had the potential for Patient 12's needs and worsening symptoms to go unnoticed which may lead to serious harm or injury for Patient 12 who was receiving medical care and treatment at the facility.

Findings:

1. On July 31, 2023, at 2:05 p.m., a review of Patient 11's medical record was conducted. Review of the facility document titled, "History and Physical [H&P]," dated July 27, 2023, indicated Patient 11 had a past medical history of anoxic brain injury (injury caused by lack of oxygen to the brain) and chronic respiratory failure (inefficient breathing) with tracheostomy (a tube placed into the airway to assist with breathing) who presented to the Emergency Department (ED) due to worsening shortness of breath. The H&P indicated Patient 11 was placed on a ventilator (machine to assist with breathing) for low oxygen saturation (blood oxygen, normal level is above 92%) levels.

Review of the facility document titled, "Order Sheet," dated July 27, 2023, at 2:51 p.m., indicated, "...Oral Care Protocol 07/27/23 [July 27, 2023] 14:52:00 [2:52 p.m.] ...NOW, Oral Care every 2 hours while on ventilator..."

During an interview on July 31, 2023, at 2:05 p.m., conducted with the Director of Quality (DOQ), the DOQ stated oral care is supposed to be provided every two hours for respiratory patients who are on a ventilator. The DOQ provided the facility policy and procedure (P&P) titled, "Critical Care - Mechanical Ventilation Liberation Guidelines," dated March 2021, and stated the P&P is the facility's only policy addressing oral care requirements for respiratory care of patients on ventilators.

During an interview on August 1, 2023, at 3:24 p.m., conducted with Registered Nurse (RN 3), RN 3 stated oral care is supposed to be performed every two hours for patients who have a tracheostomy and on a ventilator. RN 3 stated provision of oral care is rotated between the RNs and respiratory therapists (RT). RN 3 also stated oral care is supposed to be documented every two hours in the patient's electronic medical record under the hygiene or VAP (ventilator associated pneumonia, a lung infection) section.

During a concurrent interview and record review on August 2, 2023, at 10 a.m., conducted with the Director of Medical Surgical Telemetry (MSTD), Patient 11's nursing care flow sheets for hygiene, dated July 28, 2023, through August 1, 2023, were reviewed. The MSTD stated there was no documentation oral care was provided to Patient 11 every two hours during the following dates and times:

- On July 28, 2023, at 6 a.m. and at 10 p.m.;

- On July 29, 2023, at 2 a.m., and at 6 p.m.;

- On July 29, 2023, between 8:33 p.m. to July 30, 2023, at 3:17 a.m. (six hours and 44 minutes);

- On July 30, 2023, between 4:30 a.m. to 10 a.m. (five and a half hours), between 11:23 a.m. to 4 p.m. (five hours and 37 minutes), and at 6 p.m.;

- On July 31, 2023, between 2:26 a.m. to 7:23 a.m. (four hours and 57 minutes), between 10:47 a.m. to 2:01 p.m. (two hours and 14 minutes), and between 3 p.m. to 8 p.m. (five hours); and

- On August 1, 2023, at 6 a.m.

Review of the facility P&P titled, "Critical Care - Mechanical Ventilation Liberation Guidelines," dated March 2021, was conducted. The P&P indicated, "...Scope...This pertains to all adult patients who have needs that can only be addressed in the ICU [Intensive Care Unit, unit for critically ill patients] environment and are mechanically ventilated...All settings, parameters and alarms will be documented in complete detail on the ventilator flow sheet every two hours, unless the patient is unavailable or a supervisor has approved a lesser frequency..."

2. During an observation on July 31, 2023, at 11:09 a.m., in the Medical Surgical Telemetry unit, Patient 12 was observed lying in bed asleep, with tube feeding (liquid nutrition is being provided through a plastic tube into the stomach) infusing, and soft wrist restraints (device used to restrict movement) were observed attached to both of Patient 12's wrists.

On July 31, 2023, at 2:49 p.m., a concurrent interview and record review on July 31, 2023, at 2:49 p.m., conducted with the Clinical Systems Analyst (CSA), Patient 12's record was reviewed. Review of the facility document titled, "History and Physical," dated July 21, 2023, indicated Patient 12 has Alzheimer disease (a progressive disease that causes loss of memory and other important mental functions) and diabetes mellitus (condition when blood sugar is too high) who was brought to the facility for jaundice (yellow discoloration of the eyes and skin associated with problems with the liver, gallbladder, or pancreas) and altered mental status (confusion).

The facility document titled, "Order Sheet," dated July 30, 2023, at 10:18 p.m., indicated, "...Restraint Nonviolent 7/30/23 [July 30, 2023] 22:18:00 PDT [10:18 p.m.]...Interfering - medical treatment/healing, Soft Limb Left Upper Extremity [arms]I Soft Limb Right Upper Extremity [arms], Not interfering with device/treatment...Stop Date: 07/31/23 [July 31, 2023] 23:59 [11:59 p.m.]..."

Patient 12's nursing care flowsheets for documentation of non-violent restraint information, from July 30, 2023, at 8 a.m., through July 31, 2023, at 11:30 a.m., indicated Patient 12 was assessed on July 31, 2023, at 12:33 a.m., and at 7:30 a.m. The CSA stated there was no documentation Patient 12 was monitored or assessed every two hours while on restraints, on July 31, 2023, from 12:33 a.m. to 7:30 a.m.

Further review of Patient 12's nursing care flowsheets for documentation of non-violent restraint information, from July 31, 2023, at 11:30 a.m., through July 31, 2023, at 9:57 p.m., indicated Patient 12's restraints were discontinued on July 31, 2023, at 9:57 p.m.

The CSA stated there was no documentation Patient 12's restraint order was discontinued on July 31, 2023, from 12:33 a.m. to 7:30 a.m.

During an interview on August 2, 2023, at 10:45 a.m., conducted with Registered Nurse (RN 2), RN 2 stated restraints may be used if there is any type of interference with medical treatments, such as pulling an intravenous (a catheter is inserted into the vein for administration of medications and fluids) line. RN 2 stated restraints are only allowed to be removed temporarily for 15 to 20 minutes to observe if the patient remains calm and could be taken off restraints. RN 2 stated she would notify the physician if restraints were to be discontinued.

During continued interview, RN 2 stated a patient on restraints should be assessed every two hours which includes assessing if the patient's pulses are present, for swelling or redness, and if the patient is able to move their fingers. RN 2 stated the assessments are supposed to be documented in the patient's medical record every two hours.

Review of the facility P&P titled, "Restraint and Seclusion," dated June 2022, was conducted. The P&P indicated, "...SCOPE: All nursing staff and healthcare team members who are involved in direct patient care at [Hospital Name]...PURPOSE ...To provide for the safety of all patients, staff and visitors...POLICY...Patients in restraints/seclusion will be closely monitored and evaluated and immediately assisted if a potentially dangerous situation exists, i.e. choking, seizure, etc...Evaluation & [and] Monitoring - Licensed nurses and other qualified staff...Monitoring may include vital signs, respiratory, skin integrity, intake and output, hygiene and injury. Patients in medical restraints are evaluated/monitored at least every two (2) hours or more frequently, if necessary...Documentation of patient monitoring is completed every 2 hours and upon any change in condition...Documentation: Each episode of restraint contains at least the following documentation in patient's medical record...Initial assessment of the patient related to restraint use...Circumstances that led to the need for restraint and alternatives attempted...Complete order for restraint...Patient's response to intervention(s) used...Type of restraint and time restraint was applied and/or removed...Extremity(ies) to which restraint was applied, skin condition...Assessments of medical restraint will be documented at least every two (2) hours including...Temporary release of restraint may be considered with constant observation of patient during this period...Need for continuing use of restraints...DISCONTINUING...If restraint was discontinued, then a new order is obtained prior to reinitiating use of restraints..."

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on interview and record review, the facility failed to ensure a blood product was administered in accordance with the facility's policies and procedures during blood administration, for one of 30 sampled patients (Patient 13).

This failure had the potential to cause worsening symptoms for Patient 13, such as serious heart and breathing conditions, and a delay in treatment, which could negatively affect the patient's health and safety.

Findings:

During a concurrent interview and record review, on August 1, 2023, at 10:45 a.m., conducted with the Clinical Systems Analyst (CSA), Patient's 13's electronic medical record (EMR) was reviewed. Review of the facility document titled, "History and Physical (H&P)," dated July 29, 2023, indicated Patient 13 was admitted for sepsis (serious blood infection) and urinary tract infection. The H&P also indicated Patient 13 had a history of hypertension (high blood pressure).

Review of the facility document titled, "Transfuse Blood Product," dated July 31, 2023, at 4:33 a.m., indicated, "...Requested Start Date/Time 7/31/2023 [July 31, 2023] 4:33 [4:33 a.m.] ...Transfuse Priority: Now...# [number] of Units: 1 [one] Unit...Nurse reviewed by [Name of registered nurse (RN)] on 7/31/2023 at 5:35 [5:35 a.m.]."

Review of Patient 13's "Progress Note - Nurse," dated July 31, 2023, at 7 a.m., indicated, "...At around 0100 [1 a.m.]...notices patient heart rate fluctuates from 88-160 [beats per minute, normal heart rate for adults 60 to 100 beats per minute]...At around 0210 [2:10 a.m.] patient found hypotensive [low blood pressure]...At around 0400 [4 a.m.] critical values from lab [laboratory] - hgb [hemoglobin, a protein in red blood cells that carries oxygen] 6.6 [grams per deciliter (g/dl), normal level for females is 12.1 to 15.1 g/dl, unit of measurement]...Night covering provider made aware. Orders placed..."

Review of the facility document titled, "Dispense Packing List," dated July 31, 2023, at 9:30 a.m., indicated the blood product for Patient 13 was dispensed (picked up from the laboratory), on July 31, 2023, at 9:30 a.m.

Review of Patient 13's "Transfusion Summary," on July 31, 2023, indicated the blood transfusion was started by a registered nurse (RN) on July 31, 2023, at 9:39 a.m.

The CSA stated the blood product was ordered by the physician on July 31, 2023, at 4:33 a.m., to start "Now" and was started by a RN at 9:39 a.m. (five hours and six minutes after the initial order was received).

During an interview, on August 2, 2023, at 10:45 a.m., conducted with RN 2, RN 2 stated when a blood product is ordered as "Now," it means to administer it to the patient within 30 min to one hour once the blood is ready. RN 2 stated for blood transfusion, she would get consent from the patient, then take the transfusion checklist form to pick up the blood from the blood bank.

During a follow up record review, on August 2, 2023, at 1:50 p.m., conducted with the Director of Education Director (DOE), an untitled document indicating blood product information for Patient 13 was reviewed. The document indicated one unit of red blood cells (blood cells which deliver oxygen to the tissues in the body) was "available" on July 31, 2023, at 6:19 a.m.

During a concurrent interview and record review, on August 2, 2023, at 2:20 p.m., conducted with the Laboratory Director (LD), an untitled document indicating blood product information for Patient 13 was reviewed. The LD stated the laboratory technician entered the information into the computer system when the blood was ready to be picked up. The LD stated, as a courtesy, the laboratory may call the RN to let the RN know the blood is available however, it is not required in the policy for the laboratory to call the nurse. The LD also stated there is a place in the EMR for the nurse to check if the blood is available. The LD confirmed and stated the blood for Patient 13 was available on July 31, 2023, at 6:19 a.m., for the nurse to pick up. The LD further stated it is the responsibility of the nurse to pick up the blood from the laboratory when it is ready.

A review of the facility policy and procedure (P&P) titled, "Blood and Blood Product Transfusion - 1001," last revision date of February 2021, indicated, "...Scope: Providers, Nurses and Laboratory personnel are governed by this policy...The purpose of this policy is to provide guidelines for the safe administration and to promote safe and optimal use of blood and blood components...The Registered Nurse or provider is responsible for initiating blood transfusions... Blood products are obtained from the Clinical Laboratory...Documentation of blood, blood components and plasma derivatives occur in [EMR System]...RN/designee goes to the Blood Bank with patient information...Blood Bank staff marks the blood/blood component as dispensed...Hand-off the blood to the RN/designee...Products obtained from the Pharmacy are handled in the same manner as other medication..."

A review of the facility P&P titled, "Medication Administration and Monitoring Policy - MM 0809," last review date April 6, 2023, indicated, "...Purpose...Medications will be administered in safe, accurate, and consistent manner...STAT medication orders will be given within 30 minutes. NOW medication orders will be given within 60 minutes..."

A review of the facility P&P titled, "Physician's Orders 1400," last revision date August 2015, indicated, "...Purpose: To provide guidelines for physician's order documentation and processing...Policy...Each physician order must be reviewed by nurse...Physician's orders are carried out until cancelled or until the patient goes to surgery...All physician orders are reviewed immediately for identification of STAT orders...

BLOOD TRANSFUSIONS AND IV MEDICATIONS

Tag No.: A0410

Based on interview and record review, the facility failed to ensure intravenous (IV, administration through a catheter inserted into a vein) fluid (Sodium Chloride 0.9%, a type of IV fluid) was administered in accordance with the facility's policies and procedures, for one of 30 sampled patients (Patient 8).

This failure resulted in IV fluid administration errors for Patient 8 which may have contributed to Patient 8's deterioration and/or death.

Findings:

On July 31, 2023, at 2:30 p.m., Patient 8's medical record was reviewed. The facility's untitled document indicated Patient 8 was two years old and was brought to the facility's Emergency Department (ED) on February 18, 2023, at 7:34 p.m., for vomiting.

Review of the facility's document titled, "ED Physician Record," dated February 18, 2023, at 7:29 p.m., indicated, "...Weight 15.1 kilograms [kg, unit of measurement]..."

Review of the facility's document titled, "Orders," indicated, "...Patient [Patient 8]...Sodium Chloride 0.9% intravenous solution [type of fluids administered intravenously] (Sodium Chloride 0.9% Bolus [given all at once] (Neo [neonatal, children 30 days old or less]/Peds [pediatric, child]) 302 milliliters [ml, unit of measurement, one ml is equivalent to one cubic centimeter {cc,unit of measurement}])...IV Piggyback [administered into a primary IV tubing through a secondary IV tubing], Once...Administer over 60 minutes, Bolus Rate: 302 ml/hr (hour)..."

Review of the facility's untitled document indicated a 24-gauge IV catheter (thin needle used on children) was inserted in Patient 8's right hand on February 18, 2023, at 10:10 p.m.

Review of the facility's untitled document indicated Sodium Chloride 0.9% intravenous solution started infusing on February 18, 2023, at 10:15 p.m.

Review of the facility's document titled, "Nurses Note," indicated, "...Performed on: February 18, 2023 at 10:24 p.m...Mother yelling "She's having a seizure, She's having a seizure..."

Review of the facility's document titled, "Cardiopulmonary Record," dated February 18, 2023, indicated, "...Time arrest noted: 2224 [10:24 p.m.]...Weight 15.1 kg...Resuscitation Completion...Time 2338 [11:38 p.m.]...Time pronounced [time of death] 2338...Died - efforts terminated..."

Review of the facility's undated document titled, "Employee Corrective Action Report," was reviewed. The document indicated "...Employee Name: [Name of RN 1]...Termination...Briefly state facts or events leading to the filing of the report...On February 18, 2023, a Code White [hospital emergency code for resuscitation a child] was initiated in the Emergency Department for Patient 8. Due to the unexpected patient outcome, the case was reviewed post event following the hospital normal processes. Initially there were no care issues identified. In early March, additional information was provided to hospital leadership and further investigation was conducted which included staff interviews and further review of the medical record. A full Root Cause Analysis (RCA) [process of discovering the root cause of a problem in order to identify appropriate solutions] was conducted, and it was determined that [Name of RN 1] deviated from hospital policy and standard nursing practice in several ways that impacted the normal delivery of safe patient care. These deviations from hospital policy and procedure were serious in nature and included violations in process or procedure for the following hospital policies and procedures: Policy 809, Medication Administration and Monitoring", Policy 868, "IV Medication Administration and Fluid Replacement Guidelines for Pediatric and Neonates", Policy 012, "IV Therapy in infants and children in the ED, and Policy 1222, "Code White". In addition to this, it was discovered that while the code was still in progress, [Name of RN 1] left the code (room two), entered the room where the code [code white] started [on Patient 8]. The pressure infuser bag was reported as missing, but found inside the room behind the linen inside the cabinet. [Hospital Name] expects each staff member to meet standards of patient and nursing care, to follow safety protocols and hospital policy and procedures to always ensure patient safety. Due to the unsafe practices shown with this patient, [Name of RN 1's] employment is being terminated effective today June 1, 2023."

During an interview and record review conducted with the Chief Nursing Officer (CNO) on July 31, 2023, at 3:25 p.m., the CNO provided a document titled, "Certificate of Death." This document indicated, "...INFORMATIONAL, NOT A VALID DOCUMENT TO ESTABLISH IDENTITY...Information as it should appear...Probable Air Embolism Rapid Air in the Intravenous Line..."

The CNO stated Patient 8's Certificate of Death "was amended after we were informed of how Registered Nurse (RN) 1 administered the IV solution, which was not by our policies." The CNO stated RN 1 was terminated after our investigation due to not following the facility's policies and unsafe practices. The CNO stated, during the interview with RN 1, RN 1 had stated she took a Sodium Chloride 1000 ml bag, spiked it, poured out what she thought was about 300 ml left in the bag, respiked the IV fluid bag, and placed a pressure bag/rapid infuser (a device used to pressurize a bag containing intravenous fluids to rapidly infuse the fluids into the patient) on the IV fluid bag. The CNO stated, "We do not use pressure bags/rapid infuser on pediatric patients." The CNO stated pressure bags/rapid infusers are used only on adult trauma patients. The CNO stated during an interview with Licensed Vocational Nurse (LVN) 1, LVN 1 had stated upon entering Patient 8's room, she noticed the IV bag with the pressure bag/rapid infuser on it was flatter than a pancake. The CNO stated LVN 1 had stated she disconnected the IV and Patient 8 was transported to another room where the code white (hospital code for medical emergency on a child) was conducted. The CNO stated LVN 1 had stated she withdrew at least 30 cubic centimeters [cc, unit of measurement] of air from Patient 8's IV before any medications could be administered.

On August 1, 2023, at 10:30 a.m., an interview was conducted with the Director of Education (DOE). The DOE stated all nurses are provided an onboarding education checklist which included education on how and when to use a level one infuser/rapid infuser (device used to infuse large amounts of fluids or blood into a patient) and it is reviewed annually. The DOE stated RN 1 received education on the rapid infuser on February 11, 2023, per her competency sheet. The DOE stated we do not use any type of rapid infuser or pressure bag on infants or pediatrics and the staff were made aware of this through continued education.

A review of the journal article titled, "Venous Air Embolism During Home Infusion Therapy" dated January 2002, indicated, "...Venous Air Embolism (VAE) can occur spontaneously when there is an open venous structure five centimeters (cms, unit of measurement) or more above the heart or if air is delivered under pressure into the venous system, such as during a laparoscopy or mishaps with infusion bags. The morbidity and mortality of VAE are related to the volume of air, rate of entrainment, the patient's underlying cardiorespiratory status, and the patient's position. Morbidity [illnesses] and mortality [death] occur as a consequence of right ventricular outflow obstruction [obstruction of the blood from the heart to the body] or end-organ [organs such as the kidneys] dysfunction from left-sided obstruction of coronary or cerebral vasculature [obstruction of the blood flow from the body to the heart] as air passes across a patent foramen ovale [connection between the big blood vessels for blood coming into and going out of the heart] or through the pulmonary circulation [blood circulation in the lungs]..."

According to the article titled, "Venous Gas Embolism," dated October 3, 2022, published by the National Library of Medicine of the National Institue of Health (a nationally accepted institution), "...To produce symptoms, it is estimated that more than 5 ml/kg of air has to be introduced into the venous system. However, complications can occur with even 20 ml of air. Sometimes even injection of 1 to 2 ml of air into the CNS can be fatal..."

A review of the facility's policy and procedure (P&P) titled, "IV Therapy in Infants Children ED," revised June 2021, was conducted. The P&P indicated, "...Purpose: To establish guidelines for the safe insertion and maintenance of IV therapy in pediatric patients...Guidelines- Pediatric IV therapy shall be provided, following established guidelines...Infusion pump with pre-set occlusion of 100 mmHg (millimeters of mercury, measurement of pressure)...No more than a 500 milliliters (ml) IV solution bag will be used for children weighing less than 36 kilograms (kgs)..."

A review of the facility's policy and procedure (P&P) titled, "IV Medication Administration and Fluid Replacement Guidelines for Pediatrics and Neonates," revised February 2020, indicated, "...Purpose: To establish weight -based guidelines for safe medication administration and IV therapy...Preferred method to prime tubing is to use the pump...For patients who weigh less than 36 kg, use a 500 ml bag for maintenance fluids..."