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Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation for §482.23 - Nursing Services was met when:

1) The facility did not ensure its staff to carry out the STAT (immediately or without delay) physician orders for blood transfusion and lactic acid blood tests (blood test primarily ordered to help determine if someone has lactic acidosis which is commonly caused by inadequate amount of oxygen in cells and tissues) for Patient 1 in a safe and timely manner. (Cross reference A-0392)


2) The facility did not ensure its staff to follow the facility's policy and procedure for shift hand-off (off-going staff giving patient care report to the oncoming staff) and monitoring Patient 1 while she was undergoing blood transfusion. (Cross reference A-0392 and A-410)


3) The facility staff did not adhere to its policy and procedure on blood administration. (Cross Reference A-410)


The cumulative effect of these systemic problems resulted in the facility's inability to ensure the provision of quality health care in a safe environment.

41283

Based on observations, interviews, and record reviews, the facility failed to ensure its staff to : 1) carry out the STAT (immediately or without delay) physician orders for blood transfusion and lactic acid blood tests (blood test primarily ordered to help determine if someone has lactic acidosis which is commonly caused by inadequate amount of oxygen in cells and tissues) for Patient 1 in a safe and timely manner, and 2) follow the facility's policy and procedure for shift hand-off (off-going staff giving patient care report to the oncoming staff) and monitoring Patient 1 while she was undergoing blood transfusion. These failures resulted in Patient 1 not receiving the blood transfusion as ordered and Patient 1 not getting the follow-up Lactic Acid blood tests as ordered. Patient 1 died of Cardiac Arrest (sudden loss of cardiac function when the heart abruptly stops beating) due to Anemia (Anemia is a condition in which you lack enough healthy red blood cells to carry adequate oxygen to your body's tissues) and Iron Deficiency (A condition where a lack of iron in the body leading to anemia).

Findings:

During a review of the "Emergency Department (ED) Provider Notes" for Patient 1, dated 5/21/2020, at 10:31 a.m., the ED Provider Note indicated, Patient 1 was an elderly female with a past medical history including diabetes, chronic kidney disease, hyperlipidemia (an abnormally high concentration of fats or lipids in the blood), hypertension, anemia, diverticulosis (the condition of having multiple pouches (diverticula) in the large intestines that are not inflamed). The ED provider notes indicated, Patient 1's chief complaints were weakness and shortness of breath. The ED provider notes indicated, Patient 1 had her blood drawn for multiple diagnostic tests on 5/21/2020, at 9:40 a.m. Patient 1 had two lab results that came back that indicated critical values. Patient 1's hemoglobin (a red protein responsible for transporting oxygen in the blood) was 6 g/dl (grams per deciliter), where the reference range for the facility's laboratory was 11.5-15 g/dl. Patient 1's Lactic Acid was 2.2 mmol/L (millimoles per liter), where the reference range was 0.5-1.9 mmol/L. Patient 1's course at the ED indicated, "Hemoglobin 6, likely explains sx (symptoms), plan to transfuse." ..."Dark stool, guaiac + (a positive test result on stool samples indicates that abnormal, occult (hidden) bleeding was occurring somewhere in the digestive tract)." ... "Starting with one (1) unit PRBC's (Packed Red Blood Cells- also known as packed cells, are red blood cells that have been separated for blood transfusion)."

During a review of a facility document titled, "Laboratory Services General Information", dated 2/29/2020, the Laboratory Services General Information indicated, critical values are considered life threatening and require prompt physician attention.

During a review of Patient 1's "ED to Hospital Admission Orders", dated 5/21/2020, the ED to Hospital admission orders indicated, on 5/21/2020, at 9:34 a.m., Physician A ordered, "Lactic Acid every three hours STAT." Comments: Registered Nurse please cancel second lactate (lactic acid) lab order if initial result is less than 2.0 mmol/L. On 5/21/2020, at 9:59 a.m., Physician A ordered, "Prepare PRBC (Packed Red Blood Cells), 1 unit STAT". Reason for Transfusion: "Rapid, Ongoing Blood Loss."

During an interview on 6/11/2020, at 2:05 p.m., with Licensed Staff B (LSB), LSB stated, his understanding of STAT orders that it had to be carried out immediately or within an hour. LSB stated that Patient 1 was symptomatic for COVID-19 (Coronavirus Disease of 2019) and was tested at the Emergency Department. LSB also stated that he was giving report to Licensed Staff C (LSC) at the COVID Unit, when the blood bank called to inform him that the 1 unit of PRBC was ready for pick-up. LSB stated that the volume of 1 unit of PRBC was 300 ml.

During an interview on 6/16/2020, at 1:01 p.m., with Physician A, Physician A stated, "All my orders at the ED are STAT orders." Physician A stated he expected stat orders for blood transfusion to be given at least within the hour when blood product becomes available from the blood bank.

During a review of the "ED Nursing Notes" for Patient 1, dated 5/21/2020, at 11:24 a.m., authored by LSB, the note indicated, "Report called to Licensed Nurse C (LSC) to include MD DX (Medical Doctor's Diagnosis), patient history and assessment, doctor's orders, labs (laboratory tests) done with critical values, medications given, tests done, and pending orders (Blood bank called-ready for pick-up). Floor to initiate transfusion. Patient transferred to a room by ED Transport."

During a review of a document titled, "Results History" for Patient 1, the Results History indicated, on 5/21/2020, at 11:57 a.m., "Units of Packed Red Blood Cells available, Inpatient-Ready."

During a review of the "ED to Hospital Admission Orders" for Patient 1, dated 5/21/2020, at 12:18 p.m., the ED to Hospital Admission Orders released by Physician D and completed by LSC indicated, "Lactic Acid every three hours STAT."

During a review of a facility document titled, "Laboratory Services General Information," dated, 2/29/2020, the Laboratory Services General Information indicated, for inpatients, STAT/EXPEDITE orders are limited to tests necessary for urgent care. Lactic Acid test was shown as a test that was available for priority. This document indicated the requestor's responsibility stating, "Draw and deliver to the laboratory if routine rounds do not coincide with the specimen collection needs." This document indicated, the collection rounds for this facility were, 8 a.m., 10 a.m., 2 p.m., 6 p.m., and 10 p.m.

During a review of Patient'1's "Admit to Hospital Orders", dated 5/21/2020, authored by Physician D, the attending physician, indicated, "Diagnosis: Anemia," "Type of Admission: Observation," "Room Request: Isolation." The Admit to Hospital orders were released by Physician D on 5/21/2020, at 11:03 a.m., and completed by LSC on 5/21/2020, at 12:18 p.m.

During an observation on 6/12/2020, at 11:10 a.m., at the facility's COVID unit, all 24 rooms in this unit were observed to have doors that did not have glass windows and nursing staff will not be able to visually observe a patient from the outside. Since this COVID unit took care of patients who were either COVID positive (diagnosed COVID infection) or PUI (Person Under Investigation), doors had to remain closed as a precaution for the transmission of the infection. For a nurse who wanted to observe the patient visually, he or she would have to wear their PPE (Personal Protective Equipment) and enter the room. This unit also had the capability of monitoring patients using video monitors, where the nurses could see the patients and talk to them while the nurses are at the nursing station.

During an interview on 6/11/2020, at 1:30 p.m., with LSC, she stated she remembered that day 5/21/2020, when she admitted Patient 1. LSC stated it was a really busy shift. LSC stated Licensed Staff E (LSE) assisted her during the admission process. LSC stated that she got report from LSB and was aware of the critical lab values of Patient 1. LSC stated that LSE picked-up the PRBC from the blood bank and assisted her in the verification process and in starting the transfusion. LSC stated she stayed with the patient for at least 20 minutes after the transfusion had started to monitor for adverse reaction and to ask Patient 1 with admission assessment questions, while she was inside the room. LSC stated that her usual practice in monitoring patients undergoing blood transfusion was to stay with the patient for 15 (fifteen) minutes after the transfusion had started, if no reaction was observed, perform visual checks every 30 minutes, then hourly checks until the transfusion was completed. LSC stated Patient 1 was not confused and was not placed on a video monitoring system. LSC stated she instructed Patient 1 to use her call light if she needed assistance or if her IV (intravenous pump) beeps. LSC stated the nurses had to don and doff (wear and remove) their PPE's, and go inside a patient's room to do a visual observation on this unit. LSC stated she responded once to a call light from Patient 1's room, when she entered the room, the IV pump was beeping. LSC stated she instructed Patient 1 not to bend her left elbow because that was causing the occlusion. LSC stated that blood was transfusing well after Patient 1extended her left arm. LSC could not recall the time when she responded to Patient 1's call light as she described the situation on the COVID unit as chaotic (in a state of confusion and disorder). LSC stated that she gave report to the on-coming nurse, Licensed Staff F (LSF). LSC stated that the hand-off communication between her and the on-coming nurse, LSF, was not done at the bedside of Patient 1. When LSC was asked if a follow-up Lactic Acid blood test was performed on Patient 1 because Physician D ordered it as STAT every three hours and no follow-up test result was seen on Patient 1's record, LSC stated, LSE attempted to draw blood from Patient 1 for a follow-up Lactic Acid test but was unsuccessful. LSC stated she informed Licensed Staff G (LSG) who was doing the AAM (Advance Alert Monitoring-a statistical model the facility used to predict an individual's likelihood of deterioration) of Patient 1, that the follow-up Lactic Acid blood draw was unsuccessful.

During a review of the facility's policy and procedure (P&P) titled, "Hand-off Using Nurses Exchange (NKE)," dated 2018, the P&P indicated, "A standardized approach for hospitalized patient hand-off will be used throughout the medical centers ...Hand-off communication will include the patient and family as appropriate ...Hand-off will occur in the following situations, (# 1.4.4) Nursing Change of Shift Report i.e. Nursing Knowledge Exchange (NKE) ...Review End of Shift Report (Specific Facility Report), (# 5.2.1.8) Lines and Drains ...Additional Requirements for hand-off include: (# 5.2.6.2) At bedside, during the hand-off, the off-going staff member will introduce the patient to the oncoming staff member assuming care.

During a review of "Inpatient Nursing Notes" for Patient 1 dated, 5/21/2020, at 12:51 p.m., documented by LSG, the Inpatient Nursing note indicated, AAM initiated on 5/21/2020, at 12:30 p.m., "REASON FOR CALL", Severe weakness, low hemoglobin, high glucose, increasing lactate. ASSESSMENT SUMMARY/SITUATION:
"84 Y female just settled into hospital room from ED. VSS (vital signs stable) at this time, will wait for redo of labs. Per Physician D, transfuse patient and do post transfusion lactate and hgb/hct (hemoglobin and hematocrit- blood tests related to the red blood cells)."

During a review of Patient 1's "ED to Hospital Admission, All Administrations of PRBC", dated 5/21/2020, this document indicated, "New Bag-Blood: 60ml/hr, action time 5/21/2020, at 1:26 p.m., recorded time 5/21/2020, at 1:28 p.m." LSC and LSE signed off on this documented entry. Another entry indicated, "Rate Change-Blood: 150 ml/hr, action time 5/21/2020, at 1:48 p.m., recorded time 5/21/2020, at 1:49 p.m.", this entry was documented by LSC. The next entry indicated, "Stopped: 0 ml/hr, action time 5/21/2020, at 5:09 p.m., recorded time 5:09 p.m.", this entry was documented by LSF. This facility document indicated on 5/21/2020, from 1:26 p.m. to 5:09 p.m., three hours and forty three minutes after the blood transfusion was started and discovered to be occluded, Patient 1 had only received 75 ml (milliliters) of the 300 ml bag of PRBC.


During an interview on 6/15/2020, at 11:39 a.m., with LSF, she stated she received report from day shift nurse LSC. LSF stated Patient 1 was alert and oriented and was not on a video monitor in her room. LSF confirmed that the hand-off communication with LSC did not occur at the Patient 1's bedside because the facility was trying to conserve their PPE's. LSF stated that after receiving report from LSC regarding Patient 1, another patient assigned to her, (LSF), became unstable and she spent about an hour stabilizing that patient. LSF stated after she stabilized her other patient, she entered Patient 1's room and discovered that the IV site had occluded and Patient 1 had only received 75 ml of the blood transfusion. LSF stated she informed Assistant Nurse Manager H (ANMH) and received orders from Physician I for a new unit of PRBC for transfusion. LSF stated the laboratory was aware and will prepare the blood product. LSF stated when she was getting ready to start the process of getting a new bag of one (1) unit PRBC, ANMH informed her that she needed to go on her break. LSF stated she told ANMH that Patient 1's blood transfusion had already been delayed and she had to start it. LSF stated ANMH told her that he will not sign for any missed breaks if she did not take her break as scheduled. LSF stated that the blood transfusion was not re-started and when she came back from her break, she again was attempting to start the process for blood transfusion when ANMH informed her that Patient 1's COVID test came back negative, and Patient 1 needed to be transferred to a non-Covid unit. LSF stated that ANMH told her that he will "hound" her until Patient 1 was transferred. LSF stated, "There was no reason to transfer the patient (Patient 1) right away." LSF stated resource nurses who were RN's (Registered Nurses), who were assigned on the COVID unit, were being sent by ANMH to other hospital units to perform other tasks and were not available when the primary nurses needed assistance at the COVID unit. ANMH was not available for interview during this investigation process. LSF stated Patient 1 was under her care from 3 p.m. to 6:35 p.m., on 5/21/2020.

During a review of "Inpatient Nursing Note" for Patient 1, dated 5/21/2020, at 5:21 p.m., the Inpatient Nursing Note authored by LSF, indicated, "Came into room and I.V. occluded, pt. (patient) stated that she heard I.V. pump beeping but did not call. Per I.V. pump blood only infused 75 ml. Blood bank contacted to prepare new unit. ANM (ANMH) notified. Physician I informed-new unit will be ordered, lab preparing."

During a review of the facility's policy and procedure (P&P) titled, "Blood Administration NCAL (Northern California) Regional Policy," dated 5/22/19, the P&P indicated, the purpose of this P&P was to ensure consistent and effective practice for the management of patients receiving blood products, with the expected outcome that the patient will be safely transfused in a timely manner and that any adverse reactions will be minimized ...Transfusion should be started upon receipt of the blood product from the Blood Bank...The maximum amount of time for a unit of blood or blood component to be transfused is four (4) hours from the time it was issued from Blood Bank...Continue to assess the patient during the transfusion, including visual observation, with further assessment including vital signs, as needed.

During a concurrent interview and document review on 6/16/2020, at 2:11 pm., with LSG, she stated she worked as the RRT RN (Rapid Response Team Registered Nurse) on 5/21/2020. LSG stated that her role involved rounding on different units of the facility. LSG stated that she saw a resource RN from the COVID unit assisting with other tasks in different units like performing COVID testing, or helping with proning (means putting a patient in the prone position, or "flat on their belly with their chest and face down, rather than on their back) at the ICU (Intensive Care Unit). LSG stated that proning was time consuming and would take the resource nurses away from the COVID unit where they were scheduled to work. LSG reviewed the afternoon shift staffing schedule for 5/21/2020, and LSG explained how the staffing schedule showed that the COVID unit was adequately staffed, but in reality, LSG stated, the resource RN's were being pulled out of the unit to perform other tasks in other units. LSG stated staff had filed grievances regarding this practice but management did not listen. LSG stated that the facility's acuity system (system that identifies the amount of nursing care needed for each patient on a unit based on the level of intensity, nursing care and tasks for each patient) was not working and she, (LSG), and other nursing staff voiced their concerns to the management. LSG stated that this staffing issue was an ongoing problem and a concern for the safe delivery of patient care. LSG was asked about the process of monitoring a patient undergoing blood transfusion and what was expected of the nurse doing the blood transfusion, LSG stated that her process was to stay with the patient for fifteen minutes after the infusion had started to check for adverse reaction, periodically perform visual checks on the patient every 30 minutes, then every hour until the infusion was completed.

During a review of Patient 1's "Default Flowsheet Data", dated 5/21/2020, the Default Flowsheet Data indicated, Patient 1's vital signs were taken at the COVID unit on 5/21/2020, at, 12:19 p.m., 1:44 p.m., and 5:13 pm. The Safety Interventions which checked for patient safety, side rails, call light within reach, patient rounds, precautions, and isolation status were checked on 5/21/2020, at 1 pm., and the next safety check was documented on 5/21/2020, at 5 p.m. This facility document indicated on 5/21/2020, no safety intervention checks were documented for four hours, between 1 p.m., and 5 p.m.

During an interview on 6/17/2020, at 12:17 p.m., with Department Manager J, Department Manager J stated, his expectation as a Manager was that an hourly rounding was happening on all hospital units of the facility. Department Manager J stated during the hand-off communication from the incoming and outgoing primary nurses, at least one of the nurses should be at the patient's bedside.

During an interview on 6/12/2020, at 11:20 a.m., with Department Manager J, at the facility's COVID unit, regarding prioritizing break time and performing nursing procedures, Department Manager J stated his expectation was that the nursing procedures that needed to be done would take priority over the scheduled breaks of the nurses.

During a review of Patient 1's "Inpatient Nursing Notes", dated 5/21/2020, at 6:31 p.m., authored by LSF, the Inpatient Nursing Notes indicated, "Called and gave report to Licensed Staff K (LSK) RN, endorsed need of starting 1 U (unit) PRBC and golytely (laxative solution that stimulates bowel movements) bowel prep (preparation). Lactic acid needs drawn-called lab to do on third floor and RN informed as well."

During an interview on 6/11/2020, at 4 p.m., with LSK, she stated she was getting report from LSF when Patient 1 was already being wheeled to her unit. LSK stated Patient 1 was brought into her room and Patient 1 requested to use the bathroom. LSK stated Patient 1 ambulated independently to the restroom using a walker. LSK stated she asked Patient Care Technician L (PCTL) to stay with Patient 1. LSK stated she had not done any assessments yet on Patient 1, when she collapsed on her bed after coming out of the restroom. LSK stated it all happened within five minutes after Patient 1 was transferred to her care.

During a review of Patient 1's "Inpatient Nursing Note" authored by LSK, dated, 5/21/2020, at 8:31 p.m., the Inpatient Nursing Note indicated, "Patient (Patient 1) arrives to this floor via bed, brought by two ANM's at 1841 (6:41 p.m.), upon arrival patient requested to use the BR (bathroom), patient ambulates to the BR and as returning back to bed, patient appeared diaphoretic (sweating), and stated, "She is not dizzy", when documenting staff (LSK) asked if she is ok. Patient stated she is not and able to state her name. VSS (Vital Signs Stable), BS (Blood Sugar) 242, BP (Blood Pressure) 75/35 and PR (Pulse Rate) 63/min, Rounder and ANM called, RRT (Rapid Response Team) called, patient became unresponsive, BP 60/36 and O2 (Oxygen) sat (saturation) 75 on 4 l/min (liters per minute), Physician M and Physician N at bedside, code blue (medical emergency) initiated, primary nurse at bedside, blood transfusion started per orders. RRT and other code members at bedside performed ACLS (Advanced Cardiovascular Life Support). Patient was pronounced at 1938 (7:38 p.m.) by Physician M and Son was also notified by Physician M."

During a review of Patient 1's "Code Blue Record for Adult and Pediatric", dated 5/21/2020, the Code Blue Record for Adult and Pediatric indicated, Code Blue was recognized at 1845 (6:45 p.m.), witnessed by LSK. Reason for code blue: Respiratory Arrest. At 1853 (6:53 p.m.), Patient 1 was intubated (inserted a tube into a person or a body part, especially the trachea (windpipe) for ventilation) by Physician O. At 1902 (7:02 p.m.), CPR (Cardiopulmonary Resuscitation) was started. At 1908 (7:08 p.m.), CPR was stopped, code blue resolved. Patient 1 was revived.

During a review of "All Administrations of PRBC" for Patient 1, dated 5/21/2020, the All Administrations of PRBC indicated, "New Bag-Blood: 150 ml/hr, action time, 5/21/2020, at 1900 (7 p.m.). Recorded time 5/21/2020, at 1911 (7:11 p.m.). Documented by LSK and dually signed off with Licensed Staff P (LSP).

During a review of Patient 1's "Orders, From Admission Onwards," dated, 5/21/2020, at 7 p.m., indicated, attending Physician D ordered, "Transfer for Level of Care Need", diagnosis: Anemia, LOC (Loss of Consciousness), Shock, respiratory failure, intubation, mechanical ventilation (a treatment to help a person breathe when they find it difficult or are unable to breathe on their own). Level of Care: ICU (Intensive Care Unit).

During a review of Patient 1's "Code Blue Record for Adult and Pediatric", dated 5/21/2020, the Code Blue Record for Adult and Pediatric indicated, "At 1913 (7:13 p.m.), CPR was restarted, Patient 1 had no pulse. At 1922 (7:22 p.m.), MTP (Massive Transfusion Protocol- In cases of severe, ongoing, life- threatening hemorrhage (blood loss), the facility's MTP may be initiated by the treating physician. Refer to the facility's MTP) was called. At 1924 (7:24 p.m.), the blood products arrived. At 1927 (7:27 p.m.) continue with CPR, Patient 1 had no pulse. At 1730 FFP (Fresh Frozen Plasma is indicated for patients with coagulopathy (a condition in which the blood's ability to coagulate (form clots) is impaired) two packs started. At 1935 (7:35 p.m.) Vasopressin (medication that raises blood pressure by narrowing blood vessels) started, 100 units/250 ml. At 1938 (7:38 p.m.), CPR stopped, MD called expiration time by Physician M.

During a review of the facility's "Massive Transfusion Protocol" (MTP), last approved on 12/19, the MTP indicated:
1.0 Protocol Statement

1.1 Critically ill or injured patients identified with severe hemorrhagic shock (is a life-threatening condition involving insufficient blood flow to the body tissues) require immediate blood product resuscitation while concurrent actions are performed to control the source of hemorrhage.
1.2 Blood products for patients with hemorrhagic shock will be obtained through an immediate process and transfused aggressively in an effort to restore and maintain circulating blood volume, appropriate coagulation, and oxygenation of tissues.
1.3 MTP should be implemented when massive transfusion (> (over) 6 units of PRBC's over 1 hour) is anticipated. MTP should not be implemented as a means to retrieve blood products emergently or more rapidly, and a full MTP is not reasonably anticipated.

2.0 Protocol Purpose

2.1 To rapidly restore blood volume and treat coagulopathy in patients with hemorrhagic shock using a 1:1:1 ratio of PRBC: FFP: Platelets (a small colorless disk-shaped cell fragment without a nucleus, found in large numbers in blood and involved in clotting).
2.2 To outline the procedure for the safe and immediate transport and administration of blood and blood components during a "Massive Transfusion Protocol" (MTP).
2.3 To outline the responsibilities for staff and physicians involved in the transfusion process.

During a review of "Physicians Progress Notes" for Patient 1, dated 5/21/2020, at 7:54 p.m., authored by Physician M, the Physicians Progress Notes indicated, "Responded to overhead rapid response. Patient (Patient 1) reportedly became unresponsive and pulseless after walking to the bathroom moments prior. Standard ACLS was initiated. Blood transfusion was started as well. Due to her hemoglobin of 6.0, MTP was called subsequently. Patient initially regained pulse but became pulseless again after a few minutes. ACLS was re-initiated. Code was called after a total of 38 minutes. Patient (Patient 1) was pronounced (time of death) at 7:38 p.m."

During an interview with on 6/16/2020, at 3 p.m., with Physician M, Physician M was asked to clarify his progress note, dated 5/21/2020, at 7:54 p.m., where it stated, "Due to hemoglobin of 6.0, MTP was called subsequently", Physician M was asked, "Does this mean that a hemoglobin of 6 (six) an indication to call MTP? Physician M stated, "No." Physician M stated that MTP was actually suggested to him by another physician, Physician O, who was also in the room during this medical emergency.

During a review of "Discharge Summary" for Patient 1, dated 5/22/2020, at 7:19 a.m., the Discharge Summary authored by Physician D indicated, "Date of Admission: 5/21/2020." "Date of Death: 5/21/2020." Reason for Hospital Admission (Admitting Diagnosis): Anemia
Hospital Course and Significant Findings: "84-year-old woman who presented with fatigue, weakness, patient with long-standing history of iron deficiency anemia, patient with previous GI (Gastro-intestinal) work-up revealing diverticulosis. Upon presentation patient did not report symptoms of active GI bleeding, patient did not report hematemesis (vomiting of blood), melena (blood in bowel movements), or rectal bleeding. Patient was noted to be anemic on presentation with hemoglobin of 6 (six), transfusion was ordered, and GI was consulted. As patient was hemodynamically stable (It means that the person's heart is pumping blood at a stable rate, and there is a good circulation of blood in the body) and without signs of overt (obvious) bleeding, she was admitted to the floor on telemetry (The telemetry unit is an area of a hospital where special machines are used to help staff closely monitor patients). GI recommended bowel prep the evening of admission in anticipation for both EGD (Esophagogastroduodenoscopy (EGD) is a test to examine the lining of the esophagus (a muscular tube connecting the throat (pharynx) with the stomach), stomach, and first part of the small intestine (the duodenum) and colonoscopy (an exam used to detect changes or abnormalities in the large intestine (colon) and rectum) the following day. Later that evening patient (Patient 1) was found ambulating back to bed and sustained loss of consciousness, rapid response and code blue was activated, patient sustained cardiac arrest and was unable to be resuscitated."

During a review of Patient 1's "Death Note," dated, 5/22/2020, at 9:28 a.m., authored by Physician D, the Death Note indicated, "Immediate Cause of Death: Cardiac Arrest...Due to Anemia...Due to iron deficiency..."

Based on observations, interviews, and record reviews, the facility failed to adhere to its policy and procedure on blood administration when the facility staff did not administer one (1) unit of PRBC (Packed Red Blood Cells- also known as packed cells, are red blood cells that have been separated for blood transfusion) as ordered, and in a safe and timely manner to Patient 1, who presented to the Emergency Department (ED) with severe anemia and a critical level of Hemoglobin (a red protein responsible for transporting oxygen in the blood). This failure resulted in Patient 1 not receiving the blood transfusion as ordered STAT(immediately or without delay) by the physician which caused Patient 1 to die of Cardiac Arrest (sudden loss of cardiac function when the heart abruptly stops beating) due to Anemia (Anemia is a condition in which you lack enough healthy red blood cells to carry adequate oxygen to your body's tissues) and Iron Deficiency (A condition where a lack of iron in the body leading to anemia).

Findings:

During a review of the "ED Provider Note" for Patient 1, dated 5/21/2020, at 10:31 a.m., the ED Provider Note indicated, Patient 1 was an elderly female with a past medical history including diabetes, chronic kidney disease, hyperlipidemia (an abnormally high concentration of fats or lipids in the blood), hypertension, anemia, diverticulosis (the condition of having multiple pouches (diverticula) in the large intestines that are not inflamed). The ED provider note indicated, Patient 1's chief complaints were weakness and shortness of breath. The ED provider notes indicated, Patient 1 had her blood drawn for multiple diagnostic tests on 5/21/2020, at 9:40 a.m. Patient 1 had two lab results that came back with critical values. Patient 1's hemoglobin (a red protein responsible for transporting oxygen in the blood) was 6 g/dl (grams per deciliter), where the reference range for the facility's laboratory was 11.5-15 g/dl. Patient 1's Lactic Acid was 2.2 mmol/L (millimoles/liter), where the reference range was 0.5-1.9 mmol/L. Patient 1's course at the ED indicated, "Hemoglobin 6 (six) , likely explains sx (symptoms)," ..."Plan to transfuse." ..."Dark stool, guaiac+ (a positive test result indicates that abnormal, occult (hidden) bleeding was occurring somewhere in the digestive tract)." ..." "Starting with one unit PRBC (Packed Red Blood Cells- also known as packed cells, are red blood cells that have been separated for blood transfusion)."

During a review of a facility document titled, "Laboratory Services General Information", dated 2/29/2020, the Laboratory Services General Information indicated, critical values are considered life threatening and require prompt physician attention.

During a review of Patient 1's "ED to Hospital Admission Orders", dated 5/21/2020, the ED to Hospital admission orders indicated, on 5/21/2020, at 9:59 a.m., Physician A ordered, "Prepare PRBC (Packed Red Blood Cells), 1 (one) unit STAT". Reason for Transfusion: "Rapid, Ongoing Blood Loss."

During an interview on 6/11/2020, at 2:05 p.m., with Licensed Staff B (LSB), LSB stated, his understanding of STAT orders that it had to be carried out immediately or within an hour. LSB stated that Patient 1 was symptomatic for COVID-19 (Coronavirus Disease of 2019) and was tested at the Emergency Department. LSB also stated that he was giving report to Licensed Staff C (LSC) at the COVID Unit, when the blood bank called to inform him that the 1 unit of PRBC was ready for pick-up. LSB stated that the volume of one (1) unit of PRBC was 300 ml.

During an interview on 6/16/2020, at 1:01 p.m., with Physician A, Physician A stated, "All my orders at the ED are STAT orders." Physician A stated he expected stat orders for blood transfusion to be given at least within the hour when blood product becomes available from the blood bank.

During a review of the "ED Nursing Notes" for Patient 1, dated 5/21/2020, at 11:24 a.m., authored by LSB, the note indicated, "Report called to Licensed Nurse C (LSC) to include MD DX (Medical Doctor's Diagnosis), patient history and assessment, doctor's orders, labs (laboratory tests) done with critical values, medications given, tests done, and pending orders (Blood bank called-ready for pick-up). Floor to initiate transfusion. Patient transferred to a room by ED Transport."

During a review of a facility laboratory record titled, "Results History" for Patient 1, the Results History indicated, on 5/21/2020, at 11:57 a.m., "Units of Packed Red Blood Cells available, Inpatient-Ready."

During a review of Patient'1's "Admit to Hospital Orders", dated 5/21/2020, authored by Physician D, the attending physician, indicated, "Diagnosis: Anemia," "Type of Admission: Observation," "Room Request: Isolation." The Admit to Hospital orders were released by Physician D on 5/21/2020, at 11:03 a.m., and completed by LSC on 5/21/2020, at 12:18 p.m.

During an observation on 6/12/2020, at 11:10 a.m., at the facility's COVID unit, all 24 rooms in this unit were observed to have doors that did not have glass windows and nursing staff will not be able to visually observe a patient from the outside. Since this COVID unit took care of patients who were either COVID positive (diagnosed COVID infection) or PUI (Person Under Investigation), doors had to remain closed as a precaution for the transmission of the infection. For a nurse who wanted to observe the patient visually, he or she would have to wear their PPE (Personal Protective Equipment) and enter the room. This unit also had the capability of monitoring patients using video monitors, where the nurses could see the patients and talk to them while the nurses are at the nursing station.

During an interview on 6/12/2020, at 1:30 p.m., with LSC, she stated she remembered that day 5/21/2020, when she admitted Patient 1. LSC stated it was a really busy shift. LSC stated she was assisted by Licensed Staff E (LSE) during the admission process. LSC stated that she got report from LSB and was aware of the critical lab values of Patient 1. LSC stated that LSE picked-up the PRBC from the blood bank and assisted her in the verification process and in starting the transfusion. LSC stated she stayed with the patient for at least 20 minutes after the transfusion had started to monitor for adverse reaction and to ask Patient 1 with admission assessment questions, while she was inside the room. LSC stated that her usual practice in monitoring patients undergoing blood transfusion was to stay with the patient for 15 (fifteen) minutes after the transfusion had started, if no reaction was observed, perform visual checks every 30 minutes, then hourly checks until the transfusion was completed. LSC stated Patient 1 was not confused and was not placed on a video monitoring system. LSC stated she instructed Patient 1 to use her call light if she needed assistance or if her IV (intravenous pump) beeps. LSC stated the nurses had to don and doff (wear and remove) their PPE's, and go inside a patient's room to do a visual observation on this unit. LSC stated she responded once to a call light from Patient 1's room, when she entered the room, the IV pump was beeping. LSC stated she instructed Patient 1 not to bend her left elbow because that was causing the occlusion. LSC stated that blood was transfusing well after Patient 1extended her left arm. LSC stated she could not recall the time when she responded to Patient 1's call light and she described the situation on the COVID unit at that time as chaotic (in a state of confusion and disorder). LSC stated that she gave report to the on-coming nurse, Licensed Staff F (LSF). LSC stated that the hand-off communication between her and the on-coming nurse, LSF, was not done at the bedside of Patient 1.

During a review of a facility laboratory record titled, "Dispense Packing List," dated 5/21/2020, at 1:12 p.m., the Dispense Packing List indicated, LSE was the courier who accepted the blood product (1 unit PRBC) from the laboratory on 5/21/2020, at 1:12 p.m.

During a review of Patient 1's "ED to Hospital Admission, All Administrations of PRBC", dated 5/21/2020, this document indicated, "New Bag-Blood: 60ml/hr, action time 5/21/2020, at 1:26 p.m., recorded time 5/21/2020, at 1:28 p.m." LSC and LSE signed off on this documented entry. Another entry indicated, "Rate Change-Blood: 150 ml/hr, action time 5/21/2020, at 1:48 p.m., recorded time 5/21/2020, at 1:49 p.m.", this entry was documented by LSC. The next entry indicated, "Stopped: 0 ml/hr, action time 5/21/2020, at 5:09 p.m., recorded time 5:09 p.m.", this entry was documented by LSF. This facility document indicated on 5/21/2020, from 1:26 p.m., to 5:09 p.m., three hours and forty three minutes after the blood transfusion was started and discovered that it had occluded, Patient 1 had only received 75 ml (milliliters) of the PRBC.

During a review Patient 1's "Default Flowsheet Data", dated 5/21/2020, the Default Flowsheet Data indicated, Patient 1's vital signs were taken at the COVID unit on 5/21/2020, at, 12:19 p.m., 1:44 p.m., and 5:13 pm. The Safety Interventions which checked for patient safety, side rails, call light within reach, patient rounds, precautions, and isolation status were checked on 5/21/2020, at 1 p.m., and the next safety check was documented on 5/21/2020, at 5 p.m. This facility document indicated on 5/21/2020, no safety intervention checks were documented for four hours, between 1 p.m., and 5 p.m.

During an interview on 6/15/2020, at 11:39 a.m., with LSF, she stated she received report from day shift nurse LSC. LSF stated Patient 1 was alert and oriented and was not on a video monitor in her room. LSF confirmed that the hand-off communication with LSC did not occur at the Patient 1's bedside because the facility was trying to conserve their PPE's. LSF stated that after receiving report from LSC regarding Patient 1, another patient assigned to her, (LSF), became unstable and she spent about an hour stabilizing that patient. LSF stated after she stabilized her other patient, she entered Patient 1's room and discovered that the IV site had occluded and Patient 1 had only received 75 ml of the blood transfusion. LSF stated she informed Assistant Nurse Manager H (ANMH) and received orders from Physician I for a new unit of PRBC for transfusion. LSF stated the laboratory was aware and will prepare the blood product. LSF stated when she was getting ready to start the process of getting a new bag of 1 unit PRBC, ANMH informed her that she needed to go on her break. LSF stated she told ANMH that Patient 1's blood transfusion had already been delayed and she had to start it. LSF stated ANMH told her that he will not sign for any missed breaks if she did not take her break as scheduled. LSF stated that the blood transfusion was not re-started and when she came back from her break, she again was attempting to start the process for blood transfusion when ANMH informed her that Patient 1's COVID test came back negative, and Patient 1 needed to be transferred to a non-COVID unit. LSF stated that ANMH told her that he will "hound" her until Patient 1 was transferred. LSF stated, "There was no reason to transfer the patient (Patient 1) right away." LSF stated resource nurses who were RN's (Registered Nurses), who were assigned on the COVID unit, were being sent by ANMH to other hospital units to perform other tasks and were not available when the primary nurses needed assistance at the COVID unit. ANMH was not available for interview during this investigation process. LSF stated Patient 1 was under her care from 3 p.m. to 6:35 p.m., on 5/21/2020.

During a review of "Inpatient Nursing Note" for Patient 1, dated 5/21/2020, at 5:21 p.m., the Inpatient Nursing Note authored by LSF, indicated, "Came into room and I.V. occluded, pt. (patient) stated that she heard I.V. pump beeping but did not call. Per I.V. pump blood only infused 75 ml. Blood bank contacted to prepare new unit. ANM (ANMH) notified. Physician I informed-new unit will be ordered, lab preparing."

During a review of Patient 1's "Inpatient Nursing Notes", dated 5/21/2020, at 6:31 p.m., authored by LSF, the Inpatient Nursing Notes indicated, "Called and gave report to Licensed Staff K (LSK) RN, endorsed need of starting 1 U (unit) PRBC and golytely (laxative solution that stimulates bowel movements) bowel prep (preparation). Lactic acid needs drawn-called lab to do on third floor and RN informed as well."

During an interview on 6/12/2020, at 11:20 a.m., with Department Manager J, at the facility's COVID unit, regarding prioritizing break time and performing nursing procedures, Department Manager J stated his expectation was that the nursing procedures that needed to be done would take priority over the scheduled breaks of the nurses.

During a concurrent interview and document review on 6/16/2020, at 2:11 pm., with LSG, she stated she worked as the RRT RN (Rapid Response Team Registered Nurse) on 5/21/2020. LSG stated that her role involved rounding on different units of the facility. LSG stated that she saw a resource RN from the COVID unit assisting with other tasks in different units like performing COVID testing, or helping with proning (means putting a patient in the prone position, or "flat on their belly with their chest and face down, rather than on their back) at the ICU (Intensive Care Unit). LSG stated that proning was time consuming and would take the resource nurses away from the COVID unit where they were scheduled to work. LSG reviewed the afternoon shift staffing schedule for 5/21/2020, and LSG explained how the staffing schedule showed that the COVID unit appeared adequately staffed, but in reality, LSG stated, the resource RN's were being pulled out of the unit to perform other tasks in other units. LSG stated staff had filed grievances regarding this practice but management did not listen. LSG stated that the facility's acuity system (system that identifies the amount of nursing care needed for each patient on a unit based on the level of intensity, nursing care and tasks for each patient) was not working and she, (LSG), and other nursing staff voiced their concerns to the management. LSG stated that this staffing issue was an ongoing problem and a concern for the safe delivery of patient care. LSG was asked about the process of monitoring a patient undergoing blood transfusion and what was expected of the nurse doing the blood transfusion, LSG stated that her process was to stay with the patient for fifteen minutes after the infusion had started to check for adverse reaction, periodically perform visual checks on the patient every 30 minutes, then every hour until the infusion was completed.

During an interview on 6/11/2020, at 4 p.m., with LSK, she stated she was getting report from LSF when Patient 1 was already being wheeled to her unit. LSK stated Patient 1 was brought into her room and she requested assistance to use the bathroom. LSK stated Patient 1 ambulated independently to the restroom using a walker. LSK stated she asked PCTL (Patient Care Technician L) to stay with Patient 1. LSK stated she had not done any assessments yet on Patient 1, when she collapsed on her bed after coming out of the restroom. LSK stated it all happened within five minutes after Patient 1 was transferred to her care.

During a review of Patient 1's "Inpatient Nursing Note" authored by LSK, dated, 5/21/2020, at 8:31 p.m., the Inpatient Nursing Note indicated, "Patient (Patient 1) arrives to this floor via bed, brought by two ANM's at 1841 (6:41 p.m.), upon arrival patient requested to use the BR (bathroom), patient ambulates to the BR and as returning back to bed, patient appeared diaphoretic (sweating), and stated, "She is not dizzy", when documenting staff (LSK) asked if she is ok. Patient stated she is not and able to state her name. VSS (Vital Signs Stable), BS (Blood Sugar) 242, BP (Blood Pressure) 75/35 and PR (Pulse Rate) 63/min, Rounder and ANM called, RRT (Rapid Response Team) called, patient became unresponsive, BP 60/36 and O2 (Oxygen) sat (saturation) 75 on 4 l/min (liters per minute), Physician M and Physician N at bedside, code blue (medical emergency) initiated, primary nurse at bedside, blood transfusion started per orders. RRT and other code members at bedside performed ACLS (Advanced Cardiovascular Life Support). Patient was pronounced at 1938 (7:38 p.m.) by Physician M. and Son was also notified by Physician M."

During a review of Patient 1's "Code Blue Record for Adult and Pediatric", dated 5/21/2020, indicated, Code Blue was recognized at 1845 (6:45 p.m.), witnessed by LSK. Reason for code blue: Respiratory Arrest. At 1853 (6:53 p.m.), Patient 1 was intubated (inserted a tube into a person or a body part, especially the trachea (windpipe) for ventilation) by Physician O. At 1902 (7:02 p.m.), CPR (Cardiopulmonary Resuscitation) was started. At 1908 (7:08 p.m.), CPR was stopped, code blue resolved. Patient 1 was revived.

During a review of "All Administrations of PRBC" for Patient 1, dated 5/21/2020, the All Administrations of PRBC indicated, "New Bag-Blood: 150 ml/hr, action time, 5/21/2020, at 1900 (7 p.m.). Recorded time 5/21/2020, at 1911 (7:11 p.m.). Documented by LSK and dually signed off with Licensed Staff P (LSP).

During a review of Patient 1's "Orders, From Admission Onwards," dated, 5/21/2020, at 7 p.m., indicated, attending Physician D ordered, "Transfer for Level of Care Need", diagnosis: Anemia, LOC (Loss of Consciousness), Shock, respiratory failure, intubation, mechanical ventilation. Level of Care: ICU (Intensive Care Unit).

During a review of Patient 1's "Code Blue Record for Adult and Pediatric", dated 5/21/2020, the Code Blue Record for Adult and Pediatric indicated, "At 1913 (7:13 p.m.), CPR was restarted, Patient 1 had no pulse. At 1922 (7:22 p.m.), MTP (Massive Transfusion Protocol- In cases of severe, ongoing, life- threatening hemorrhage (blood loss), the facility's MTP may be initiated by the treating physician...) was called. At 1924 (7:24 p.m.), the blood products arrived. At 1927 (7:27 p.m.) continue with CPR, Patient 1 had no pulse. At 1730 FFP (Fresh Frozen Plasma is indicated for patients with coagulopathy (a condition in which the blood's ability to coagulate (form clots) is impaired) two packs started. At 1935 (7:35 p.m.) Vasopressin (medication that raises blood pressure by narrowing blood vessels) started 100 units/250 ml. At 1938 (7:38 p.m.), CPR stopped, MD called expiration time by Physician M.

During a review of Patient 1's "Death Note," dated, 5/22/2020, at 9:28 a.m., authored by Physician D, the Death Note indicated, "Immediate Cause of Death: Cardiac Arrest...Due to Anemia...Due to iron deficiency..."

During a review of the facility's policy and procedure (P&P) titled, "Blood Administration NCAL (Northern California) Regional Policy," dated 5/22/19, the P&P indicated, the purpose of this P&P was "...To ensure consistent and effective practice for the management of patients receiving blood products, with the expected outcome that the patient will be safely transfused in a timely manner and that any adverse reactions will be minimized ...Transfusion should be started upon receipt of the blood product from the Blood Bank...The maximum amount of time for a unit of blood or blood component to be transfused is four (4) hours from the time it was issued from Blood Bank...Continue to assess the patient during the transfusion, including visual observation, with further assessment including vital signs, as needed."