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Based on interview and record review, the hospital did not have an effective governing body that carried out the functions required by a governing body as evidence by:

1. The Hospital failed to identify opportunities for improvement involving medication management, nurse staffing and nursing assessment, following a Sentinel Event and RCA (root cause analysis) and ensure that preventive actions were implemented. Furthermore, the hospital failed to address these system variances. As a result, it was determined that an immediate jeopardy was present in the Neonatal Intensive Care Unit (NICU) pertaining to nurse to patient staffing. (Cross reference A tag 286 and A tag 392 #2)


2. The Hospital failed to ensure that the vecuronium (muscle relaxing anesthetic to facilitate mechanical ventilation) order set for ventilator dysynchrony (a patient's spontaneous respiratory efforts are not synchronized with the mechanical ventilator) was implemented, with clear communication and understanding to nursing and medical staff that it is a physician driven order only.
(A tag 500 #2)

3. The hospital failed to ensure that high risk medications to include Propofol and Vecuronium were administered per the physician's order by critical care nurses. (A tag 405 #'s 1, 2, 4, 5, 7, 8, 9 and A tag 500 #s 1, 2, 4, 5, 6, 8, 9)


4. The hospital failed to ensure that pharmacy staff at Hospitals A and B maintained adequate oversight and management of the medication administration process of intravenous narcotics and high risk medications. (A tag 405 #'s 3, 4, 5, 6, 7, 8, 9 and A tag 500 #'s 1, 3, 4, 5, 6, 7, 8, 9)

5. The Hospital failed to ensure oversight of nurse staffing issues and implementation of the Health System's Plan for Provision of Patient Care. (A tag 392 #'s 1-15)

6. Hospital leadership failed to ensure that an Adverse Event was reported to the required regulatory agency in a timely manner, per its own policy and procedure. (A tag 309)


On 12/13/12 at 1:00 P.M., a telephone interview was conducted with the hospital's Interim Chief Operating Office (COO) and Chief Nurse Office (CNO) (same individual). Per the CNO, prior to the Sentinel Event involving Patient 1, she was unaware that Registered Nurses (RNs) in the SICU with 1:1 assignments had been relieving each other for meals and breaks, if they thought it was "safe" to do so based on their own judgement and patient assessment. The CNO stated that she knew staffing "had been a problem" in the Neonatal Intensive Care Unit (NICU). In addition, the CNO was unaware that not all of the patient care units had developed written plans that addressed goals for patient care and staffing requirements, as required per the Health System Plan for the Provision of Patient Care, dated October 20, 2011.


The cumulative effect of these problems resulted in the facility's failure to deliver care in compliance with the Condition of Participation for Governing Body and failure to provide care to their patients in a safe environment.

Based on interview, record and document review, the hospital did not ensure that an effective quality assessment and performance improvement program (QAPI) was implemented when the hospital:


1. Failed to ensure that key opportunities for improvement were identified and preventative actions implemented, pertaining to medication management, nurse staffing, and nurse assessments following the occurrence of a Sentinel Event and Root Cause Analysis.
(A tag 286 )

2. As a result of not identifying an opportunity for improvement in nurse to patient staffing and implementing a system-wide action plan, on 12/12/12 at 7:30 P.M., a situation of Immediate Jeopardy was determined to be present concerning nurse staffing in the Neonatal Intensive Care Unit (NICU).
(A tag 286 and A tag 392 #2)


3. The hospital failed to report an Adverse Event to a regulatory agency, in accordance with it's own Sentinel Event policy and procedure.
(A tag 309)


The cumulative effect of these systemic practices and issues resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Quality Assessment and Performance Improvement.

Based on observation, interview and record review, the hospital failed to ensure that key opportunities for improvement were identified, and preventative actions implemented, following a Sentinel Event (SE, an unexpected occurrence involving the death or serious physical disability, or the risk thereof, not related to the natural course of the patient's illness or underlying condition); and a Root Cause Analysis (A process for identifying the basic and causal factor(s) that underlie variations in performance). Following the dislodgment of Patient 1's endotracheal tube in the Surgical Intensive Care Unit (SICU) of Hospital A, and subsequent anoxic brain injury, key opportunities for improvement involving medication management, nurse staffing, and nurse assessments were not identified so that potential system and process variances could be addressed. As a result of not identifying an opportunity for improvement in nurse to patient staffing and implementing a system-wide action plan, on 12/12/12 at 7:30 P.M., a situation of Immediate Jeopardy was determined to be present concerning nurse staffing in the Neonatal Intensive Care Unit (NICU). Reference A Tag 392 #2. After receipt of an acceptable plan of correction, the Immediate Jeopardy was abated on 12/12/12 at 11:38 P.M.


Findings:

On 7/2/12 at 2:00 P.M., a record review and investigation was initiated at Hospital A after the hospital reported an adverse event. Per the report, on 4/5/12, a pregnant patient (Patient 1) with a respiratory infection had an inadvertent dislodgement of an endotracheal tube which may have contributed to a hypoxic brain injury. During the incident the baby was delivered via Cesarean section at the bedside (C-section the delivery of an infant through an incision in the mother's abdomen).

On 11/6/12 at 2:30 P.M., an interview was conducted with the Sentinel Event Specialist (SES), the Director of Risk Management (DRM), the Nursing Director of Critical Care (NDCC), the Nurse Manager of the Surgical Intensive Care Unit (SICU), and the Director of Regulatory Affairs (DRA). Per the SES, the hospital had conducted an RCA concerning the dislodgement of Patient 1's endotracheal tube, emergency C-section, and subsequent anoxic brain injury. The hospital's self-identified opportunities for improvement and action plan were reviewed with the SES.

Per the SES, the hospital classified Patient 1's incident as a "delay in treatment" for the purposes of determining which areas required a detailed inquiry when conducting an RCA.

According to the hospital's policy entitled "Sentinel Event and Significant Adverse Events," dated 5/23/12, for a "treatment delay" incident, the following areas required a detailed inquiry: "staffing levels, medication management, and the physical assessment process."

The following opportunities for improvement were not identified by the hospital when it conducted the RCA:
A. Nurse Staffing and Patient Assessment: Per the SES, the hospital reviewed the nurse staffing levels in the SICU on the morning of 4/5/12. However, the hospital determined that it was "ok" for nurses in the SICU with 1:1 patient assignments to relieve each other for breaks and meals, if "based on their own nursing judgement and assessments," the individual nurses determined it was safe to do so. Patient 1's acuity score had been determined to require 1:1 nurse to patient staffing.

The hospital failed to identify and determine that the above decision was not in accordance with it's own Plan for the Provision of Patient Care, dated, 10/20/11, which stipulated the following:
Staffing would be adjusted within each department by the shift Nursing Supervisor, Leader, or designee to ensure that available staff was effectively placed to meet identified patient care needs. An acuity system was used as an instrument to quickly and appropriately predict the amount of total nursing care hours required by each patient each shift per unit. Per the plan, the purposes of a patient acuity assessment included to establish and assure acceptable performance standards relative to patient care needs, to establish staffing patterns for patient care units based on patient care needs, and to assure quality patient care using the appropriate mix of nursing personnel. Per the plan, the patient acuity instrument considered the patient's individual identified needs for direct care, psychosocial needs, and education requirements as well as indirect nursing care time. Per the plan, staffing would be sufficient at all times to ensure that RNs planned, supervised, and evaluated the care of the patients. The plan did not direct individual nurses, based on their own judgement and assessments, to make independent decisions and temporarily alter the acuity levels of their patients to accommodate break and meal reliefs.

A review of Patient 1's record revealed that on 4/5/12 at 5:25 A.M., night shift RN 3 documented that Patient 1 was on the maximum dose of Propofol at 60 micrograms/kilograms/minute (mcg/kg/min) and 100 micrograms of Fentanyl. RN 3 documented "at these settings, she is lightly sedated." RN 3 documented that Patient 1 was restrained as she was "lightly sedated, was beginning to move her arms and legs, was unaware of her surroundings, and was at risk of self extubation, pulling lines and tubes."

On 11/5/12 at 11:10 A.M., an interview was conducted with Registered Nurse (RN) 1, who was assigned to Patient 1 on the morning of 4/5/12, when the patient's endotracheal tube became dislodged. RN 1 stated that she was not aware of RN 3's assessment concerning Patient 1's sedation status. She did not recall being informed of it during the shift hand off report. RN 1 acknowledged that, when she and RN 2 independently determined it was "ok" for RN 1 to take a break and RN 2, who also had a 1:1 assignment, would cover for her, she did not have oversight of the entire SICU at the time to ensure that adequate staffing was in place to meet the needs of all patients. She was unaware of the Charge Nurse's availability, or the Resource and Trauma Nurses' availability. According to RN 1, if her patient's vital signs were "stable" and within defined parameters ordered by the physician, then it was "ok" for her to take a break and have her patient that required 1:1 monitoring, temporarily paired with another patient, as long as the other patient was "stable" too. However, RN 1 acknowledged that a critical care patient's condition could change or decline in an instant.

Per a physician's order dated, 4/3/12, a physician was to be notified if Patient 1's systolic blood pressure (top number in a blood pressure reading) was less than 100 and a diastolic pressure (bottom number in a blood pressure reading) was less than 60.

A review of Patient 1's vital signs on the morning of 4/5/12, was conducted. RN 1 took a break at approximately 9:00 A.M. on 4/5/12. Patient 1's blood pressure at 8:00 A.M. was 88/55. Patient 1's previously recorded blood pressures during the morning of 4/5/12, had been in the range of 117 to 172 over 52 to 76. There was no documentation by RN 1 concerning that blood pressure or if any actions were taken, to include physician notification. The 9:00 A.M. blood pressure was recorded as 108/51. There was no documentation by RN 1 concerning that blood pressure or if any actions were taken. Neither blood pressure was within defined parameters ordered by the physician; however, RN 1 took a break and allowed Patient 1 to be monitored by another nurse who also had a 1:1 assignment. It was during the time period when RN 1 left for a break, that Patient 1's heart rate alarm sounded and RN 4 responded to the alarm. RN 2 who was supposed to be "covering" for RN 1, had her own patient emergency and did not respond to Patient 1's alarm.

On 11/6/12 at 8:30 A.M., an interview was conducted with Medical Doctor (MD) 1, Patient 1's attending physician. MD 1 stated he was involved in the RCA analysis and review of the case concerning Patient 1. MD 1 stated that he was unaware and had not been informed to this date, of the night nurse's (RN 3) assessment concerning the adequacy of Patient 1's sedation level. In addition, he was unaware and had not been informed to this date, regarding Patient 1's blood pressures on the morning of 4/5/12, prior to RN 1 taking a break. Per MD 1, it had never been discussed or mentioned during the review. Per MD 1, he should have been informed regarding all of the above because perhaps "something was going on" with the patient that should have been addressed.

On 11/6/12 at 2:30 P.M., and on 12/13/12 at 1:00 P.M., the SES acknowledged that the hospital had failed to identify key issues that involved nurse staffing and patient assessment during it's analysis of the Sentinel Event involving Patient 1.

In addition, on 12/12/12 at 7:25 P.M., a situation of Immediate Jeopardy was determined to be present in Hospital A's Neonatal Intensive Care Unit (NICU) pertaining to nurse staffing. As a result of not identifying an opportunity for improvement in nurse to patient staffing and implementing a system-wide plan of action, the hospital failed to identify that RNs in the NICU also relieved each other for breaks and meals. Therefore, the hospital's patient classification/acuity system was not upheld at all times to ensure the safety and needs of critically ill neonate patients were met at all times.


B. Medication Management: The hospital failed to identify the following medication management issues in an effort to identify system wide variances:
Critical Care Registered Nurses (RNs) failed to implement medication policies and procedures pertaining to the administration and infusion of the high risk medications Propofol (sedative/general anesthetic drug) and Vecuronium (a paralyzing agent) for Patient 1. There was no documented evidence that Surgical Intensive Care Unit (SICU) RNs at Hospital A titrated (adjusted) the rates and dosages of Patient 1's Propofol infusion based on an appropriate physician's order. The RNs did not attempt to clarify or obtain a different order. Those RNs titrated Patient 1's Vecuronium infusion without defined titration parameters from a physician's order. A Vecuronium physician order set was implemented at Hospitals A and B without specific titration guidelines and without consistent and clear understanding of the order set implementation, by nursing and physician leadership staff.

In addition, the hospital failed to identify during the RCA that, during the emergency resuscitation of Patient 1 when she sustained a cardiac arrest, there was no documented evidence that emergency first responders, to include the patient's primary nurse RN 1, stopped the patient's Propofol (general anesthestic and sedation drug which can depress cardiac and respiratory function) and Fentanyl (narcotic pain medication which can depress respiratory function ) intravenous (IV) infusions, in an effort to improve both cardiac and respiratory function and responses.

On 11/5/12 at 8:30 A.M., an interview was conducted with RN 4, who was the first RN to respond to Patient 1's bradycardia (low heart rate) alarm and bring the crash cart to the room. Per RN 4, when she responded to Patient 1's alarm, the patient's heart rate was 30. RN 4 "was not aware" of Patient 1's Propofol or Fentanyl infusions.

On 11/5/12 at 11:10 A.M., an interview was conducted with RN 1. Per RN 1, as she was returning from her break she saw RN 4 bring the crash cart to Patient 1's room. RN 1 entered the room with Respiratory Therapist (RT) 2. RN 1 stated the patient's heart rate was low and she looked "dusky." RN 1 stated she assessed the airway with RT 1. RN 1 listened for breath sounds. Per RN 1, "I don't know what happened with the Propofol and Fentanyl, I didn't turn them off."

On 11/6/12 at 8:30 A.M., an interview was conducted with MD 1. MD 1 confirmed that during a code situation, drugs such as Propofol and Fentanyl should have been discontinued.

On 11/6/12 at 2:30 P.M. an interview was conducted with the SES. Per the SES, the hospital had not identified any medication management issues that were a "root cause" of Patient 1's event. While the above listed medication management issues may not have been "root causes" surrounding Patient 1's event, the required intense analysis of the medication management process during the RCA, should have identified those variances in the medication management process in an effort to enhance system wide patient safety concerning the administration of high risk medications.

Based on observation, interview and record review, the hospital leadership failed to ensure that its Sentinel Event (SE, an unexpected occurrence involving death or serious physical disability, or the risk thereof, not related to the natural course of the patient's illness or underlying condition) policy and procedure was implemented. Following the dislodgment of Patient 1's endotracheal tube in the Surgical Intensive Care Unit (SICU) of Hospital A, and subsequent anoxic brain injury, the hospital failed to report the Sentinel Event to the California Department of Public Health (CDPH) in a timely manner, per the hospital's own policy and procedure.


Findings:

1. On 7/2/12 at 2:00 P.M., a record review and investigation was initiated at Hospital A after the hospital reported an adverse event. Per the report, on 4/5/12, a pregnant patient (Patient 1) with a respiratory infection had an inadvertent dislodgement of an endotracheal tube which may have contributed to a hypoxic brain injury. During the incident the baby was delivered via Cesarean section at the bedside (C-section the delivery of an infant through an incision in the mother's abdomen). Patient 1 was discharged from the hospital on 5/15/12. The hospital reported the adverse event to CDPH on 7/2/12, almost 3 months after the occurrence of the adverse event, and approximately 6 weeks after the patient was discharged from the hospital.

On 10/9/12 at 3:00 P.M., a record review was conducted at the long term acute care facility to which Patient 1 had initially been transferred. Per a neurologist's consult note dated 5/19/12, Patient 1 had suffered a significant anoxic brain injury and was in a vegetative, minimally conscious state. Per the note, "given her current neurologic signs and the information available, it is unlikely that the patient will ever make any meaningful recovery to an independent neurologic state. She will likely remain in dependent care for the rest of her life."

On 11/6/12 at 2:30 P.M., an interview was conducted with the Sentinel Event Specialist (SES), the Director of Risk Management (DRM), the Nursing Director of Critical Care (NDCC), the Nurse Manager of the Surgical Intensive Care Unit (SICU), and the Director of Regulatory Affairs (DRA). Per the SES, the hospital had conducted an RCA concerning the dislodgement of Patient 1's endotracheal tube, emergency C-section, and subsequent anoxic brain injury. Per the SES, the hospital classified Patient 1's incident as a "delay in treatment" for the purposes of determining which areas required a detailed inquiry when conducting an RCA.

On 12/12/12 at 4:10 P.M., a joint interview was conducted with the Chief Medical Officer (CMO), the Director of Regulatory Affairs (DRA), the Critical Care Medical Director (CCMD), the Resuscitation Medical Director, the Chief of Staff, the Anesthesia Program Director, and the Medical Director of Respiratory Services. The CMO acknowledged that the hospital considered the event that involved Patient 1 to be a Sentinel Event. The CMO confirmed that multiple opportunities for improvement were identified that involved medical and nursing staff performance, Code Blue response policies and procedures, and communication failures. According to the CCMD, a critical care fellow's (physician in training) performance and response during the resuscitation of Patient 1 was "substandard."

According to the hospital's policy entitled "Sentinel Event and Significant Adverse Events," dated 5/23/12, a Sentinel Event was defined as "an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof, not related to the natural course of the patient's illness or underlying condition. Per the policy, a "serious injury or disability was defined as a, "physical impairment that substantially limited one or more of the major life activities of an individual, or the loss of bodily function, if the impairment or loss lasted more that 7 days or was still present at the time of discharge from an inpatient health care facility..." Per the policy, the Regulatory Affairs department was reponsible for notifying the CDPH of a "reportable Adverse Event." The policy listed 28 reportable, by State law, Adverse Events. The 28th reportable event was defined as "an adverse event or series of adverse events that causes the death or serious disability of a patient, personnel, or visitor."

Patient 1 sustained a serious disability in the form of a hypoxic brain injury that severely impacted her function and was still present at the time of her discharge on 5/15/12, as a result of a series of adverse events or hospital system/procedural failures.

According to the Sentinel Event policy, the hospital was required to report the adverse event to the CDPH no later than 5 days after the adverse event was detected. The hospital did not report the event to the CDPH until 7/2/12, which was almost 3 months after the event. At the time of Patient 1's discharge on 5/15/12, her neurological function remained severely compromised due to the hypoxic injury, and the hospital failed to report the event to the CDPH at that time.

Based on observation, interview, record and document review, Nursing Leadership did not provide adequate oversight, to establish and maintain safe and effective care of patients, when Nursing Leadership:

Findings:

1. Failed to ensure that nursing practice pertaining to the administration of intravenous narcotics and the high risk medications Propofol and Vecuronium was safe and administered per policy and/or physician's orders.
(A tag 405 #'s 1, 2, 3, 4, 5, 6, 7 and A tag 500 #'s 1, 2, 3, 4, 5, 6, 7)

2. Failed to ensure that the patient acuity system/protocol and nurse-to-patient ratios were consistently implemented per hospital policy. As a result, a situation of Immediate Jeopardy was determined to be present in the Neonatal Intensive Care Unit (NICU).
(A tag 392 #1, 2, 9, 10, 15, 16)

3. Failed to ensure that written staffing plans were developed for each patient care area/department per the hospital's Plan for the Provision of Patient Care
(A tag 392 #s 2, 3, 6, 8, 13, 14 )

4. Failed to ensure that RNs consistently completed a patient acuity scoring tool.
(A tag 392 #s 5, 7, 11, 12)

5. Failed to ensure that medications were administered per physician orders.
(A tag 405 #s 1, 2, 3, 4, 5, 6, 7 )

6. Failed to ensure that Registered Nurses informed a physician of a critical care patient's status.
(A tag 396 )


The cumulative effect of these systemic practices and issues resulted in the failure of the hospital to deliver statutorily mandated compliance with the Condition of Participation for Nursing Services.

Based on observation, interview, record and document review, the hospital failed to ensure that its Plan for the Provision of Patient Care was implemented at all times, to include breaks and meal relief, to ensure the safe and effective care of patients and the immediate availability of a registered nurse to meet patient needs. The facility's patient classification system was not maintained at all times at Hospital A in the Surgical Intensive Care Unit (SICU) and the Neonatal Intensive Care Unit (NICU). A critical care Registered Nurse (RN) and a Charge Nurse in the SICU were not immediately available to respond to Patient 1, when the patient's endotracheal (breathing) tube became dislodged. Patient 1 experienced a hypoxic brain injury as a result of the incident. Written staffing plans to address the individual needs of a patient care unit and its patient population were not developed for all units, to include the SICU and NICU at Hospital A. RNs at Hospitals A and B failed to consistently complete a patient acuity scoring tool which helped determine the appropriate staffing levels required to meet all patients needs.

Findings:

1. On 7/2/12 at 2:00 P.M., a record review and investigation was initiated at Hospital A after the hospital reported an adverse event. Per the report, on 4/5/12, a pregnant patient (Patient 1) with a respiratory infection had an inadvertent dislodgement of an endotracheal tube which may have contributed to a hypoxic brain injury. During the incident, the baby was delivered via Cesarean section at the bedside (C-section the delivery of an infant throught an incision in the mother's abdomen).

Patient 1 was admitted to Hospital A on 4/3/12, due to shortness of breath and fevers, per a History and Physical (H&P) dated 4/3/12. Additional diagnoses included high blood pressure and morbid obesity. Patient 1 was also pregnant, at 26 weeks gestation. On 4/3/12, the patient's respiratory status declined which necessitated intubation (breathing tube inserted via the mouth) and mechanical ventilation (breathing machine). Patient 1 was transferred out of the OB (obstetrics) unit to the SICU, on that same date. Per a physician's note, dated 4/5/12 at 5:30 A.M., Patient 1 was in acute respiratory distress with multilobar pneumonia (lung infection) and had acute renal failure.


Per nursing and physician progress notes, on 4/5/12, Patient 1 remained intubated and was on a continuous Propofol (sedative and general anesthestic) infusion for sedation; and a continuous Fentanyl (narcotic) infusion for pain control. Intravenous antibiotics were also administered. Bilateral soft wrist restraints were applied to prevent her from pulling at lines and tubes. The endotracheal tube was secured with cloth tape at 22 centimeters (cm.) ( a measurement used to denote location/placement of the tube). Patient 1 was in a single bed room. The patient was on contact isolation with droplet precautions (infection control precautions to prevent the spread of infection), so the door to Patient 1's room was kept closed.


The hospital's Plan for the Provision of Patient Care, dated 10/20/11, was reviewed. Per the plan, staffing would be adjusted within each department by the shift Nursing Supervisor, Leader, or designee to ensure that available staff was effectively placed to meet identified patient care needs. An acuity system was used as an instrument to quickly and appropriately predict the amount of total nursing care hours required by each patient each shift per unit. Per the plan, the purposes of a patient acuity assessment included to establish and assure acceptable performance standards relative to patient care needs, to establish staffing patterns for patient care units based on patient care needs, and to assure quality patient care using the appropriate mix of nursing personnel. Per the plan, the patient acuity instrument considered the patient's individual identified needs for direct care, psychosocial needs, and education rerquirements as well as indirect nursing care time. Per the plan, staffing would be sufficient at all times to ensure that RNs planned, supervised, and evaluated the care of the patients.


On 4/5/12 at 5:25 A.M., night shift RN 3 documented that Patient 1 was on the maximum dose of Propofol at 60 micrograms/kilograms/minute (mcg/kg/min) and 100 micrograms of Fentanyl. RN 3 documented "at these settings, she is lightly sedated." RN 3 documented that Patient 1 was restrained as she was "lightly sedated, was beginning to move her arms and legs, was unaware of her surroundings, and was at risk of self extubation, pulling lines and tubes."

On 10/3/12 an interview was conducted with the SICU Nurse Manager (NM). The NM described the following nurse staffing situation in the SICU on the morning of 4/5/12, at approximately 9:00 A.M. The NM was on vacation. The two Assistant NMs were in a meeting on-site. The "Resource RN" (who normally provided breaks and assisted in patient care) was given a patient assignment due to an emergent admission to the SICU. Two trauma nurses were in the trauma room attending to 2 patients. The SICU Charge Nurse (CN) was assisting with an intubation in the trauma room. The trauma room was an extension of the SICU, however, it was a separate area and the rest of the SICU could not be monitored or visualized from the trauma room. The remainder of nurses had patient assignments in the unit. RN 1 was assigned to Patient 1. Patient 1's acuity score was 29.7, per the hospital's GRASP acuity tool, which made her a 1:1 assignment (1 nurse with 1 patient only). Per the SICU NM, patients with an acuity score of 17.7 were 1:2 (1 nurse with 2 patients).

Per the SICU NM, on 4/5/12, at approximately 9:00 A.M. (exact time could not be ascertained), RN 1 decided to take a morning break and asked RN 2 to cover her patient assignment, Patient 1.

RN 2's patient also had an acuity score of 29.7 which made him a 1:1 nursing assignment. RN 2's patient's diagnoses included a massive brain hemorrhage. RN 2's patient had a ventriculostomy drain (a tube inserted into the brain to relieve pressure) in place and was on continuous intravenous infusions to maintain his hemodynamic status, per a medical record review. RN 2's patient was in the room next to Patient 1; however, Patient 1 could not be visualized from inside of RN 2's patient's room. RN 2 agreed to cover for RN 1, which meant she was now responsible for monitoring 2 patients and the 1:1 nurse to patient assignments, based on acuity scores and previously determined patient needs, was no longer in place for either patient.

According to the SICU NM, shortly after RN 1 left for a break, RN 2's patient's intracranial pressure (ICP) went up. According to RN 2's note, on 4/5/12, at approximately 9:00 A.M., the patient's ICP increased from 14 to 23-26 (normal is 7-15). RN 2 was focused on her own patient's needs which included calling the neuro critical care physician team to the patient's bedside.

According to the SICU NM, after RN 1 left for a break, and while RN 2 was taking care of her own patient's emergent needs, RN 4, who had a 2 patient assignment in another room, heard an alarm sounding. RN 4 left her patients' room, and went to the nurses' station to see whose alarm was sounding. RN 4 saw that it was Patient 1's heart rate alarm. RN 4 went to Patient 1's room and saw that the patient's heart rate was 30 (Patient 1's previously recorded heart rates had been in the range of 98-114, per the SICU nursing flowsheet). RN 4 left the room, got the crash cart, stated "I need some help," and went back to Patient 1's room. Per the SICU NM, as RN 4 was bringing the crash cart, RN 1 returned from her break. According to the SICU NM, the appropriate placement of Patient 1's endotracheal tube came into question, and the RNs and respiratory therapist first responders to Patient 1's room implemented cardiopulmonary resusitation measures and attempted to re-establish an airway for Patient 1. RN 2 did not respond to Patient 1's emergency as she was attending to her own patient's emergent condition with an increased ICP.

On 10/3/12 at 10:30 A.M., an interview was conducted with the Director of Regulatory Affairs (DRA). Per the DRA, the hospital was unable to establish an exact timeline of the events surrounding Patient 1's emergency. Per the DRA, the cardiac monitor strips that would have automatically printed out when Patient 1's heart rate and blood pressures were not within the assigned alarm parameters, and would have helped to determine a more exact time that the patient's status was compromised, had been "lost" and were unavailable for review. The DRA presented a timeline document that the hospital attempted to create based on available data and staff interviews that were conducted following the event. Per the timeline, RN 4 responded to Patient 1's alarm sometime between 9:14 A.M. and 9:17 A.M. Per the timeline, Patient 1's ventilator was alarming for approximately 2-3 minutes, prior to personnel response.

Per the timeline, at 9:25 A.M. (approximately 8-11 minutes after initial response), a decision was made by the first responders to call an overhead Code Blue as Patient 1's oxygenation and hemodynamic status had not improved. The hospital Code Blue team arrived and MD 1 assessed Patient 1's airway and determined that she required re-intubation. Per the Code Blue record, re-intubation was completed at 9:40 A.M. Following re-intubation, breath sounds and a heart rate were re-established. At approximately 9:30 A.M., an obstetrical team arrived at Patient 1's beside and a decision was made to deliver Patient 1's baby via C-section at the bedside in the SICU. Per an Operating Room Record, a viable infant was delivered at 9:35 A.M. Per a physican's note dated 4/5/12, the baby did not have spontaneous cry and was floppy. The baby's initial heart rate was zero. Emergent resuscitative interventions were implemented and the baby was transferred to the Neonatal Intensive Care Unit (NICU).

On 11/5/12 at 8:15 A.M., an interview was conducted with RN 4, who was the first person to respond to Patient 1's alarm. Per RN 4, she heard an alarm sounding for a time period that was "longer than usual," so she left her room to investigate the alarm source. RN 4 stated that she was unaware where the Charge Nurse was. She was unaware that the 2 trauma nurses were unavailable due to traumas. She was unware that the resource nurse was also unavailable. Per RN 4, when she went to Patient 1's room, the door was closed and the curtain was pulled. The entrance to Patient 1's room was a sliding glass door, so when the curtain was pulled as well, Patient 1 was not visible from the outside of the room. RN 4 initally did not know who Patient 1's RN was.

On 11/5/12 at 10:00 A.M., an interview was conducted with the RN who was the SICU Charge Nurse (CN) on 4/5/12. Per the SICU CN, she was unaware that Patient 1 had suffered a cardiac arrest until a technician came into the trauma room and told her. She was unsure of the time, but she left the trauma room at that point and came to Patient 1's room. The CN acknowledged that the condition or status of a patient in the critical care unit can change in an instant. CNs routinely assisted in the trauma room when needed. Per the CN, she never wanted to take the additional admission that morning which took away the resource nurse for break coverage and overall additional help. Per the CN, she told the house supervisor that it would be "unsafe" for her to take the admission. Per the CN, she was told by the house supervisor that she had to take the additional admission. According to the CN, the SICU was "not always compliant" with mandated staffing requirements. Per the CN, she "didn't have a chance to call anyone else for assistance in overseeing the unit because "everything ocurred simultaneously."

On 11/5/12 at 11:10 A.M., an interview was conducted with RN 1. Per RN 1 it was acceptable for nurses with 1:1 assignments to relieve each other for breaks if, based on their own nursing judgement and assessments, their patients were "stable " and if the patient was a "neighbor" (close in proxmity). According to RN 1, she made the decision to take a break without approval from, or a discussion with, the Charge Nurse. According to RN 1, "we have a break RN if we have staffing for it." RN 1 acknowledged that, when she determined it was "ok" for her to take a break, she was unaware that the 2 trauma nurses were busy, she was unaware that the resource nurse had taken a patient assignment, and she was unaware that the Charge Nurse was also busy in the trauma room. RN 1 acknowledged that she did not have oversight of the entire SICU, and the needs of the unit at that moment in time, when she and RN 2 decided that it was acceptable for RN 1 to take a break, and have RN 2 cover her own patient, as well as Patient 1, who were both 1:1 assignments.

Per a Discharge Summary note, dated 5/15/12, Patient 1 was transferred to a long term acute care facility. Discharge diagnoses included hypoxic ischemic encephalopathy (a condition when the brain is deprived of adequate oxygen supply). Per the Discharge Summary, the physician could not be certain of Patient 1's prognosis at the time of discharge.

On 10/9/12 at 3:00 P.M., a record review was conducted at the long term acute care facility to which Patient 1 had initially been transferred. Per a neurologist's consult note dated 5/19/12, Patient 1 had suffered a significant anoxic brain injury and was in a vegetative, minimally conscious state. Per the note, "given her current neurologic signs and the information available, it is unlikely that the patient will ever make any meaningful recovery to an independent neurologic state. She will likely remain in dependent care for the rest of her life."

On the morning of 4/5/12, the SICU at Hospital A failed to ensure that its Plan for the Provision of Patient Care was implemented at all times to ensure safe and effective care for Patient 1, and to ensure the immediate availability of an RN to meet Patient 1's needs when her condition became seriously compromised. The facility's patient classification system was not upheld by RNs 1 and 2, who each had predetermined 1:1 patient assignments, but decided that it was acceptable to temporarily change that acuity to 1:2 in order to take a break. When Patient 1's condition became compromised due to a dislodged endotracheal tube and alarms were sounding, her assigned RN had taken a break and was not immediately available. RN 2 who had her own 1:1 assignment had agreed to "cover" for RN 1, but her own patient had an emergency and she was not immediately available to respond to those alarms and Patient 1's emergent needs. The Charge Nurse was not immediately available to respond to Patient 1's alarms or needs because she was in the trauma room and had not made provisions for additional coverage or resources to manage, staff, and maintain oversight of the SICU.


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2. On 12/12/12, at 2:20 P.M., a general tour of Hospital A's Neonatal Intensive Care Unit (NICU) was conducted with the Director of Quality. The NICU on the 2nd Floor was comprised of the "A Nursery," "C Nursery," "D Nursery," and Infant Special Care nursery located on the 4th Floor. The 2nd Floor NICU was licensed for 40 patient beds and the Infant Special Care Nursery on the 4th Floor was licensed for 9 patient beds. The NICU's total census for 12/12/12, was 42 neonatal patients. The NICU's "A Nursery" had 16 neonatal patients.
The hospital's patient classification system indicated that neonatal patients in the "A Nursery" required a nurse-to-patient ratio of 1:1 (1 RN with 1 patient) or 1:2 (1 RN with 2 patients) to meet the needs of the critically ill neonates. The "C Nursery" had 12 neonatal patients, their patient classification system indicated that they required a nurse-to-patient ratio of 1:2 or 1:3. The "D Nursery" had 6 neonatal patients, their patient classification system indicated that they required a nurse-to-patient ratio of 1:3. The Infant Special Care nursery on the 4th Floor had 8 neonatal patients, their patient classification system indicated that they required nurse-to-patient ratio of 1:2 or 1:3.

An interview with the Charge Nurse (CN 26) and the NICU Manager was conducted on 12/12/12 at 2:30 P.M. CN 26 stated that the "break nurses" provided break and meal relief for the RNs. She stated that they had two break nurses for the day shift on 12/12/12. Break nurses were also assigned to assist with procedures on the unit (i.e. peripherally inserted central catheter, also known as PICC line placements). The NICU manager stated that they did not have a written staffing plan which addressed the individual needs of their unit, described the different nurses (i.e. charge nurse and break nurse) required for the unit to function, in order to meet the needs of the patient population they served.

The hospital's Plan for the Provision of Patient Care, dated 10/20/11, was reviewed. Per the plan, staffing would be adjusted within each department by the shift Nursing Supervisor, Leader, or designee to ensure that available staff was effectively placed to meet identified patient care needs. An acuity system was used as an instrument to quickly and appropriately predict the amount of total nursing care hours required by each patient each shift per unit. Per the plan, the purposes of a patient acuity assessment included to establish and assure acceptable performance standards relative to patient care needs, to establish staffing patterns for patient care units based on patient care needs, and to assure quality patient care using the appropriate mix of nursing personnel. Per the plan, the patient acuity instrument considered the patient's individual identified needs for direct care, psychosocial needs, and education requirements as well as indirect nursing care time. Per the plan, staffing would be sufficient at all times to ensure that RNs planned, supervised, and evaluated the care of the patients.

A review of the NICU's Unit Secretary Report (a sheet that contained all the neonates and their Registered Nurses for the shift), dated 12/12/12, was conducted. The following RNs patient assignments were confirmed:

RN 28 was assigned Patient 28 and Patient 29
RN 29 was assigned Patient 30 and Patient 31
RN 30 was assigned Patient 32 and Patient 33

A review of the NICU GRASP sheets, dated 12/12/12, indicated that Patient 28, Patient 29, Patient 30, Patient 31, Patient 32 and Patient 33 had an acuity score of 13.3. According to the hospital's patient classification system, these neonatal patients required nursing care to include one RN to 2 neonatal patients at all times to meet the needs of the critically ill neonates.

On 12/12/12 at 3:00 P.M., a private interview was conducted with Registered Nurse (RN 27). RN 27 stated that the staffing was "not safe nor was it appropriate." She stated that the NICU was "already out of ratio due to the high census and it's been crazy." She explained that the break and meal reliefs were not conducted by the break nurse because the break nurse was involved with procedures more often than not. She further explained that the NICU RNs covered each others breaks and meal reliefs. She acknowledged that the hospital's patient classification system was not upheld when neonatal/patient assignments requiring 1 RN to 2 neonatal patients became 1 RN with 3 neonatal patients to as many as 4 neonates when the RNs relieved each others breaks and meals.

On 12/12/12 at 3:38 P.M., a private interview was conducted with RN 28. RN 28 stated that she had her break and meal relief on 12/12/12. She stated that the NICU RNs paired up with each other in order to go on their breaks and meals. She explained that the NICU usually had one break nurse but she was involved with procedures which often made her unavailable to relieve staff for their breaks and meals. RN 28 stated that covering each others breaks and meals "works for us" and this practice was "what we're use to." She stated that she paired up with RN 29 who had a patient assignment that consisted of 2 neonates on 12/12/12. She acknowledged that both their patient assignments required 1 RN for 2 neonates but when they relieved each other for breaks and meals, their patient assignments became 1 RN with 4 critically ill neonates.

On 12/12/12, beginning at 3:50 P.M., general observations were conducted. Patient 28, Patient 29, Patient 30, Patient 31, Patient 32 and Patient 33 were critically ill neonates in the "A Nursery." The care of the critically ill neonates included respiratory assistance (i.e. on a ventilator or a nasal CPAP device) (CPAP - continuous positive airway pressure, a respiratory treatment that delivers slightly pressurized air during the breathing cycle), tube feedings, central line infusions of neonatal parenteral nutrition, the use of isolettes (an incubator for premature infants that provides controlled temperature and humidity), radiant warmers and giraffe beds (specially designed, high-tech warming isolette for critically ill newborns).

On 12/12/12, at 5:30 P.M., an interview was conducted with RN 29. RN 29 stated that she had a break and meal relief on 12/12/12. She stated that RN 28 took care of one of her neonatal patients and RN 30 took care of the other neonate. She acknowledged that NICU RNs' practice was to cover each other for breaks and meals. She acknowledged that when she left for her break and meal, her patient assignment did not meet the predetermined patient classification score which was the hospital's method of ensuring that there was adequate staff present at all times, to meet the needs of the critically ill neonates.

On 12/12/12 at 5:45 P.M., an interview was conducted with RN 30. RN 30 acknowledged that in the NICU, the usual practice was that the RNs covered for each other during breaks and meals. She stated that the break nurse was often involved with a procedure on the unit therefore, in order for the RNs to have a break and meal, they paired up with one another. She explained that their patient assignments were to consist of 1 RN with 2 neonatal patients which were determined by the hospital's patient classification system. However, she acknowledged that NICU RNs did not implement their own patient classification system during breaks and meals, as patient assignments became 1 RN with 3 neonatal patients to as many as 4 critically ill neonates during these times.

A discussion and interview was held with the NICU Manager and Director of Woman and Infant Services (DWIS) on 12/12/12 at 6:25 P.M. NICU Manager and DWIS stated that they were aware that NICU RNs with "stable" neonatal patients may leave their patients with another RN in their room for breaks. The NICU Manager acknowledged that staffing was very important when caring for critically ill neonates as their condition may change from stable to full decompensation. They were both asked if they were aware of the Sentinel Event (SE, an unexpected occurrence involving death or serious physical disability, or the risk thereof, not related to the natural course of the patient's illness or underlying condition) that occurred in the adult surgical intensive care unit (SICU) related to critical care RNs relieving each other for breaks and not upholding the hospital's patient classification system at all times? They both confirmed their knowledge of the SE. The NICU Manager stated that what happened in the SICU did not apply to their unit because it only involved the care of 1:1 patients. She stated that their critically ill neonates who required 1:1 nursing care were maintained at all times. However, the NICU Manager was unable to provide documented evidence to demonstrate that the hospital's patient classification system was upheld at all times, to include breaks and meals in accordance with it's own system-wide plan for the provision of patient care (i.e. break logs). She acknowledged that the NICU did not have a process nor a system in place to ensure that documented evidence was completed and collected.

On 12/12/12 at 7:25 P.M., a situation of Immediate Jeopardy was determined to be present in the NICU. A meeting was held with the Director of Regulatory, Director of Woman and Infant Services, NICU Manager and the Accreditation and Licensing Principal Consultant, to inform them of the immediate jeopardy. After receipt of an acceptable corrective action plan, the immediate jeopardy was abated on 12/12/12 at 11:38 P.M.

Multiple record reviews were conducted on 12/13/12 beginning at 2:30 P.M. It was confirmed that Patient 28, Patient 29, Patient 30, Patient 31, Patient 32 and Patient 33 all had diagnoses to include prematurity and respiratory distress. Therefore, their patient acuity scores did require 1 RN to 2 neonates to meet the needs of these critically ill neonatal patients.

An interview with RN 31 was conducted on 12/14/12 at 8:30 A.M. RN 31 stated that for a "solid 2 years," the NICU RNs have been covering each others' break and meal reliefs. She stated that the NICU was not compliant with the hospital's provision of patient care to include meeting nurse-to-patient staffing ratios at all times to include breaks and meals. She described the staffing situation on a really busy day in the NICU was "horrific" and "unsafe."

3. On 7/2/12 at 2:00 P.M., a record review and investigation was initiated at Hospital A after the hospital reported an adverse event. Per the report, on 4/5/12, a pregnant patient (Patient 1) with a respiratory infection had an inadvertent dislodgement of an endotracheal tube which may have contributed to a hypoxic brain injury. During the incident the baby was delivered via Cesarean section (C-section the delivery of an infant throught an incision in the mother's abdomen).

Patient 1 was admitted to Hospital A on 4/3/12, due to shortness of breath and fevers, per a History and Physical (H&P) dated 4/3/12. Additional diagnoses included high blood pressure and morbid obesity. Patient 1 was also pregnant, at 26 weeks gestation. On 4/3/12, the patient's respiratory status declined which necessitated intubation (breathing tube inserted via the mouth) and mechanical ventilation (breathing machine). Patient 1 was transferred out of the OB (obstetrics) unit to the SICU, on that same date. Per a physician's note, dated 4/5/12 at 5:30 A.M., Patient 1 was in acute respiratory distress with multilobar pneumonia (lung infection) and had acute renal failure.


Per nursing and physician progress notes, on 4/5/12, Patient 1 remained intubated and was on a continuous Propofol (sedative and general anesthestic) infusion for sedation; and a continuous Fentanyl (narcotic) infusion for pain control. Intravenous antibiotics were also administered. Bilateral soft wrist restraints were applied to prevent her from pulling at lines and tubes. The endotracheal tube was secured with cloth tape at 22 centimeters (cm.) ( a measurement used to denote location/placement of the tube). Patient 1 was in a single bed room. The patient was on contact isolation with droplet precautions (infection control precautions to prevent the spread of infection), so the door to Patient 1's room was kept closed.


On 4/5/12 at 5:25 A.M., night shift RN 3 documented that Patient 1 was on the maximum dose of Propofol at 60 micrograms/kilograms/minute (mcg/kg/min) and 100 micrograms of Fentanyl. RN 3 documented "at these settings, she is lightly sedated." RN 3 documented that Patient 1 was restrained as she was "lightly sedated," was beginning to move her arms and legs, was unaware of her surroundings, and was at risk of self extubation, pulling lines and tubes."

On 10/3/12, an interview was conducted with the SICU Nurse Manager (NM). The NM described the following nurse staffing situation in the SICU on the morning of 4/5/12 at approximately 9:00 A.M. The NM was on vacation. The two Assistant NMs were in a meeting on site. The "Resource RN" (who normally provided breaks and assisted in patient care) was given a patient assignment due to an emergent admission to the SICU. Two trauma nurses were in the trauma room attending to two patients. The SICU Charge Nurse (CN) was assisting with an intubation in the trauma room. The trauma room was an extension of the SICU; however, it was a separate area and the rest of the SICU could not be monitored or visualized from the trauma room. The remainder of nurses had patient assignments in the unit. RN 1 was assigned to Patient 1. Patient 1's acuity score was 29.7, per the hospital's GRASP acuity tool, which made her a 1:1 assignment (1 nurse with 1 patient only). Per the SICU NM, patients with an acuity score of 17.7 were 1:2 (1 nurse with 2 patients).

Per the SICU NM, on 4/5/12 at approximately 9:00 A.M. (exact time could not be ascertained), RN 1 decided to take a morning break and asked RN 2 to cover her patient assignment, Patient 1.

RN 2's patient also had an acuity score of 29.7 which made him a 1:1 nursing assignment. RN 2's patient's diagnoses included a massive brain hemorrhage. RN 2's patient had a ventriculostomy drain (a tube inserted into the brain to relieve pressure) in place and was on continuous intravenous infusions to maintain his hemodynamic status, per a medical record review. RN 2's patient was in the room next to Patient 1; however, Patient 1 could not be visualized from inside of RN 2's patient's room. RN 2 agreed to cover for RN 1, which meant she was now responsible for monitoring two patients and the 1:1 nurse to patient assignments, based on acuity scores and previously determined patient needs, was no longer in place for either patient.

According to the SICU NM, shortly after RN 1 left for a break, RN 2's patient's intracranial pressure (ICP) went up. According to RN 2's note, on 4/5/12 at approximately 9:00 A.M., the patients ICP increased from 14 to 23-26 (normal is 7-15). RN 2 was focused on her own patient's needs which included calling the neuro critical care physician team to the patient's bedside.

According to the SICU NM, after RN 1 left for a break, and while RN 2 was taking care of her own patient's emergent needs, RN 4, who had a 2 patient assignment in another room, heard an alarm sounding. RN 4 left her patients' room, and went to the nurses' station to see whose alarm was sounding. RN 4 saw that it was Patient 1's heart rate alarm. RN 4 went to Patient 1's room and saw that the patient's heart rate was 30 (Patient 1's previously recorded heart rates had been in the range of 98-114, per the SICU nursing flowsheet). RN 4 left the room, got the crash cart, stated "I need some help," and went back to Patient 1's room. Per the SICU NM, as RN 4 was bringing the crash cart, RN 1 returned from her break. According to the SICU NM, the appropriate placement of Patient 1's endotracheal tube came into question, and the RNs and respiratory therapist first responders to Patient 1's room implemented cardiopulmonary resusitation measures and attempted to reestablish an airway for Patient 1. RN 2 did not respond to Patient 1's emergency as she was attending to her own patient's emergent condition with an increased ICP.

On 10/3/12 at 10:30 A.M., an interview was conducted with the Director of Regulatory Affairs (DRA). Per the DRA, the hospital was unable to establish an exact timeline of the events surrounding Patient 1's emergency. Per the DRA, the cardiac monitor strips that would have automatically printed out when Patient 1's heart rate and blood pressures were not within the assigned alarm parameters, and would have helped to determine a more exact time that the patient's status was compromised, had been "lost" and were unavailable for review. The DRA presented a timeline document that the hospital attempted to create based on available data and staff interviews that were conducted following the event. Per the timeline, RN 4 responded to Patient 1's alarm sometime between 9:14 A.M. and 9:17 A.M. Per the timeline, Patient 1's ventilator was alarming for an approximately a 2-3 minute period, prior to personnel response.

Per the timeline, at 9:25 A.M. (approximately 8-11 minutes after initial response), a decision was made by the first responders to call an overhead Code Blue as Patient 1's oxygenation and hemodynamic status had not improved. The hospital Code Blue team arrived and MD 1 assessed Patient 1's airway and determined that she

Based on interview and record review, Hospital A failed to ensure that Critical Care Registered Nurses revised the plan of care, for 1 of 37 sampled patients (1), based on their own assessments of the patient's condition and status. RNs in the Surgical Intensive Care Unit (SICU) failed to notify Patient 1's physician regarding the adequacy of the patient's sedation level or blood pressures that were not within ordered parameters.

Findings:

On 7/2/12 at 2:00 P.M., a record review and investigation was initiated at Hospital A after the hospital reported an adverse event. Per the report, on 4/5/12, a pregnant patient (Patient 1) with a respiratory infection had an inadvertent dislodgement of an endotracheal tube which may have contributed to a hypoxic brain injury. During the incident, the baby was delivered via Cesarean section at the bedside (C-section the delivery of an infant through an incision in the mother's abdomen).

Patient 1 was admitted to Hospital A on 4/3/12, due to shortness of breath and fevers, per a History and Physical (H&P) dated 4/3/12. Additional diagnoses included high blood pressure and morbid obesity. Patient 1 was also pregnant at 26 weeks gestation. On 4/3/12, the patient's respiratory status declined, which necessitated intubation (breathing tube inserted via the mouth) and mechanical ventilation (breathing machine). Patient 1 was transferred out of the OB (obstetrics) unit to the SICU, on that same date. Per a physician's note, dated 4/5/12 at 5:30 A.M., Patient 1 was in acute respiratory distress with multilobar pneumonia (lung infection) and had acute renal failure.


Per nursing and physician progress notes, on 4/5/12, Patient 1 remained intubated and was on a continuous Propofol (sedative and general anesthetic) infusion for sedation; and a continuous Fentanyl (narcotic) infusion for pain control. Intravenous antibiotics were also administered. Bilateral soft wrist restraints were applied to prevent her from pulling at lines and tubes. The endotracheal tube was secured with cloth tape at 22 centimeters (cm.) ( a measurement used to denote location/placement of the tube). The patient was on contact isolation with droplet precautions (infection control precautions to prevent the spread of infection).

On 4/3/12 at 8:27 P.M., Medical Doctor (MD) 2 ordered the administration of a continuous Propofol infusion. Per the order, the Propofol was to be started at 10 micrograms (mcg) per kilogram per minute (mcg/kg/min). RNs were to titrate the infusion rate by 5 mcg. every 5 minutes to achieve a target RASS score of negative 2 (-2). (RASS score: Richmond Agitation-Sedation Scale; A numerical score, ranging from +4 (very combative) to -5 (unarousable) assigned to a patient which relies on patient behavior and movement to determine the level of sedation). A RASS score of -2 indicated "light sedation," when the patient briefly awakened to voice, with eye opening and contact less than 10 seconds.


On 4/5/12 at 5:25 A.M., night shift RN 3 documented that Patient 1 was on the maximum dose of Propofol at 60 micrograms/kilograms/minute (mcg/kg/min) and 100 micrograms of Fentanyl. RN 3 documented "at these settings, she is lightly sedated." RN 3 documented that Patient 1 was restrained as she was "lightly sedated, was beginning to move her arms and legs, was unaware of her surroundings, and was at risk of self extubation, pulling lines and tubes." There was no documentation that RN 3 notified the patient's physician about the adequacy of the patient's sedation level.

Per a physician's order dated 4/3/12, a physician was to be notified for a systolic (top number in a blood pressure reading) blood pressure less than 100 and a diastolic pressure (bottom number in a blood pressure reading) less than 60.

On 4/5/12 at 8:00 A.M., RN 1 documented that Patient 1's blood pressure reading via an arterial line (blood pressure monitored via a catheter inserted into an artery) was 88/55. There was no additional documentation by RN 1 pertaining to that blood pressure or that she verified the reading via another method. There was no documentation that a physician was notified.

On 4/5/12 at 9:00 A.M., RN 1 documented that Patient 1's blood pressure was 108/51. There was no additional documentation regarding the blood pressure reading or notification of the patient's physician.

On 11/6/12 at 8:30 A.M., an interview was conducted with Medical Doctor (MD) 1, Patient 1's attending physician. MD 1 stated that he was unaware and had not been informed to this date, of the night nurse's (RN 3) assessment concerning the adequacy of Patient 1's sedation level. In addition, he was unaware and had not been informed to this date regarding Patient 1's blood pressures on the morning of 4/5/12, prior to RN 1 taking a break. Per MD 1, he should have been informed regarding all of the above because perhaps "something was going on" with the patient that should have been addressed. MD 1 stated that perhaps Patient 1's sedation level was not adequate and it should have been reevaluated.

Based on interview and record review, Hospitals A and B failed to ensure that Critical Care Registered Nurses (RNs) implemented medication policies and procedures, pertaining to the administration and continuous infusion of narcotics and the high risk medications Propofol (sedative/general anesthetic drug) and Vecuronium (a paralyzing agent), for 8 of 47 sampled patients (1, 16, 21, 26, 27, 48, 49, 52,). There was no documented evidence that Surgical Intensive Care Unit (SICU) RNs at Hospital A titrated (adjusted) the rates and dosages of Patient 1's Propofol infusion based on an appropriate physician's order. The RNs did not attempt to clarify or obtain a different order. In addition, those RNs titrated Patient 1's Vecuronium infusion without defined titration parameters from a physician's order. Patient 26's continuous infusion of Propofol was titrated up not in accordance with the physician's order. There was no documented evidence in Patient 27's medical record that a verbal order was given by the physician to decrease his continuous infusion of Dilaudid (narcotic pain medication). The failure of RNs to implement medication policies and procedures and physician orders increased the potential for patient harm.

Findings:

1. Per a record review on 10/3/12 at 10:15 A.M. Patient 1 was admitted to Hospital A on 4/3/12, due to shortness of breath and fevers, per a History and Physical (H&P) dated 4/3/12. Additional diagnoses included high blood pressure. Patient 1 was also pregnant, at 26 weeks gestation. On 4/3/12, the patient's respiratory status declined which necessitated intubation (breathing tube inserted via the mouth) and mechanical ventilation (breathing machine). Patient 1 was transferred out of the OB (obstetrics) unit to the SICU, on that same date.

On 4/3/12 at 8:27 P.M., Medical Doctor (MD) 2 ordered the administration of a continuous Propofol infusion. Per the order, the Propofol was to be started at 10 micrograms (mcg) per kilogram per minute (mcg/kg/min). RNs were to titrate the infusion rate by 5 mcg. every 5 minutes to achieve a target RASS score of negative 2 (-2). (RASS score: Richmond Agitation-Sedation Scale; A numerical score, ranging from +4 (very combative) to -5 (unarousable) assigned to a patient which relies on patient behavior and movement to determine the level of sedation). The maximum rate was 60 mcg/kg/min. The RASS score was to be checked hourly, and if the RASS score was greater than (>) or equal to (=) 2 levels below the goal, the Propofol rate was to be decreased by 10 mcg/kg/min. every 10 minutes until the RASS was at goal (-2).

According to the above order, the RNs would have to rely on Patient 1's movements in order to adjust the rate or dosage.

On 4/3/12 at 8:36 P.M., shortly after MD 2 ordered the Propofol infusion, MD 2 ordered the continous IV infusion of Vecuronium so that Patient 1 would be paralyzed and not be able to breathe out of synchrony (simultaneously) with the ventilator.

A review of the hospital's policy entitled "High Risk Medications," dated 10/8/12 was conducted. The policy defined a high risk medication as one that had the potential to cause severe life-threatening side effects, and/or required special monitoring. Both Propofol and Vecuronium were listed as high risk medications.

A review of the hospital's policy entitled "Medication Preparation, Labeling and Administration," dated 4/21/11 was reviewed. Per the policy, medication orders were to reviewed prior to being administered.

A review of the hospital's policy entitled "Patient Treatment and Medication Orders," dated 4/19/12, was reviewed. Per the policy, RNs were to monitor the specific parameters prescribed for titrating the medication orders for increasing or decreasing the dose based upon the patient's status.

A review of nurses notes, from 4/3/12 through 4/4/12 at 6:37 P.M., when the Vecuronium was discontinued, was conducted. During that time span, the SICU RNs documented that Patient 1's RASS scores were "-5," or unarousable, as the patient was paralyzed from the Vecuronium.

On 4/4/12 at 5:47 P.M., RN 7 documented that the propofol drip was "titrated up" for an increased heart rate and blood pressure; however, the propofol order did not provide those titration parameters.

On 12/12/12 at 7:30 A.M., an interview was conducted with RN 6 who initiated Patient 1's Propofol and Vecuronium infusions. RN 6 stated that she was titrating the drips (infusions) to stabilize the patient's blood pressure which was very labile. RN 6 was asked if a Propofol order that instructed adjustments to be made based on a RASS score was appropriate for Patient 1, given the fact that the patient was also being administered the paralytic agent, Vecuronium. RN 6 stated that it was not an appropriate Propofol order. RN 6 stated that MD 2 had ordered the Vecuronium drip, after the Propofol drip was started, and she did not go back and check the order to see if MD 2 provided a new order for the Propofol. RN 6 acknowledged that the Propofol order did not provide titration parameters based on the patient's blood pressure, and that she did not clarify or obtain a new order, once the patient was placed on Vecuronium.

On 12/12/12 at 8:00 A.M., an interview was conducted with RN 7. RN 7 stated that if a patient was on a paralytic agent, such as Vecuronium, a RASS score could not be obtained; therefore, a Propofol order based on a RASS score would not be appropriate. RN 7 confirmed that she titrated Patient 1's Propofol infusion based on the patient's blood pressure which was not consistent with the physician's order.

On 12/12/12 at 8:20 A.M., an interview was conducted with the Nursing Director of Critical Care (NDCC) and the SICU Nurse Manager (NM). Both the NDCC and the SICU NM acknowledged that the critical care RNs did not have an order to titrate the patient's Propofol infusion based on blood pressure or heart rate. Both acknowledged that RNs 6 and 7 should have clarified and obtained a new order for Propofol, since Patient 1 was paralyzed which rendered the RASS score unusable.

2. Per a record review conducted on 10/3/12 at 10:15 A.M., Patient 1 was admitted to Hospital A on 4/3/12, due to shortness of breath and fevers, per a History and Physical (H&P) dated 4/3/12. Additional diagnoses included high blood pressure. Patient 1 was also pregnant, at 26 weeks gestation. On 4/3/12, the patient's respiratory status declined which necessitated intubation (breathing tube inserted via the mouth) and mechanical ventilation (breathing machine). Patient 1 was transferred out of the OB (obstetrics) unit to the SICU, on that same date.


A review of the hospital's policy entitled "High Risk Medications," dated 10/8/12, was conducted. The policy defined a high risk medication as one that had the potential to cause severe life-threatening side effects, and/or required special monitoring. Vecuronium was listed as a high risk medication.

A review of the hospital's policy entitled "Patient Treatment and Medication Orders," dated 4/19/12, was reviewed. Per the policy, RNs were to monitor the specific parameters prescribed for titrating the medication orders for increasing or decreasing the dose based upon the patient's status. Per the policy, variable orders which were not titrated by a practitioner were to have specific lab results or physiologic parameter outcomes and titration instructions. Per the policy, medication orders titrated to a specific subjective end point were not acceptable.

On 4/3/12 at 8:36 P.M., MD 2 ordered the continous IV infusion of Vecuronium so that Patient 1 would be paralyzed and not be able to breathe out of synchrony (simultaneously) with the ventilator. The order was prescribed as "start at 1 milligram (mg)/hour. Goal: ventilator synchrony. Max (maximum) rate: 15 mg/hr." The order did not provide specific titration guidelines or objective endpoints regarding "ventilator synchrony."


On 4/3/12 at 9:00 P.M., RN 6 documented that Patient 1 was on Vecuronium and no "train of four" (a method of monitoring the degree or effectiveness of a neuromuscular blockade drug) had been ordered per the Medicine team. RN 6 documented that the Vecuronium was being titrated to the patient's respiratory rate set on the ventilator.

On 12/12/12 at 7:30 A.M., an interview was conducted with RN 6. RN 6 stated that she requested MD 2 to order the Vecuronium based on the "train of four" parameters which was what she was accustomed to. RN 6 stated it was the SICU's policy and protocol to titrate a Vecuronium drip to the train of four order set and not to ventilator synchronization. According to RN 6 the train of four protocol provided specific titration guidelines, but she was unable to get an order from MD 2 for that.

A review of Patient 1's Vecuronium Medication Administration Record, revealed that between 4/3/12 at 9:00 P.M. and 4/4/12 at 7:10 A.M., RN 6 adjusted the patient's Vecuronium infusion rate/dosage 4 times in the absence of specific parameters or guidelines. Between 4/4/12 at 8:00 A.M. and 4/4/12 at 4:53 P.M., RN 7 adjusted the infusion twice without specific guidelines or additional orders from a physician.

On 12/12/12 at 8:30 A.M., a joint interview was conducted with the Nursing Director of Critical Care (NDCC) and the SICU Nurse Manager (NM). Both stated that the SICU RNs were accustomed to titrating a Vecuronium drip based on the "train of four" physician order set.

On 12/12/12 at 9:00 A.M., a joint interview was conducted with the Director of Pharmacy (DOP), a Critical Care Pharmacist (CCP), and the Pharmacy Manager (PM). Per the CCP, the Vecuronium order set for ventilator synchrony was intended to be physician driven, and if the dose required titration or adjustment, the physician was supposed to initiate a new order.

On 12/12/12 at 1:00 P.M., an interview as conducted with a Critical Care Clinical Nurse Specialist (CNS). The CNS was considered to be an expert in clinical practice. The CNS stated that she was unaware of a Vecuronium order set for ventilator synchrony and did not know when it had been implemented.

On 12/12/12 at 1:30 P.M., an interview was conducted with the NDCC. Per the NDCC, RN 6 should have implemented the hospital's chain of command policy, when she was unable to obtain a Vecuronium order that she was comfortable with and competent in administering. The NDCC acknowledged that there were no specific guidelines or objective endpoints in the Vecuronium ventilator synchrony order set, which was required per hospital policy.



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3. On 12/10/12, Patient 16 was admitted to the Intensive Care Unit (ICU) of Hospital B for treatment of an altered level of consciousness possible due to the ingestion of isopropyl alcohol (a type of alcohol found in antifreeze and rubbing alcohol). A review of Patient 16's medical record was conducted on 12/11/12 at 11:10 A.M. According to a physician's order, dated, 12/10/12, Patient 16 was to receive a continuous intravenous (IV) infusion of Fentanyl (a narcotic analgesic). The physician's order for IV Fentanyl contained specific instructions for administration. Instructions: "Target Pain Score: <4. Start at 25 mcg./hr (micrograms per hour). Titrate by 12.5 mcg/hr every hour if > = 2 boluses/hr x 2 consecutive hours. Max rate 100 mcg/hr. If RASS (Richmond Agitation-Sedation Score) at goal and pain controlled, decrease fentanyl rate by 12.5 mcg/hr. Concentration = 10 mcg/mL (micrograms per milliliter).

A review of Patient 16's Medication Administration Record (MAR) indicated that the IV Fentanyl infusion was started at 25 mcg/hr on 12/10/12 at 11:37 P.M. At 2:00 A.M., on 12/11/12, his Registered Nurse (RN 16) increased the Fentanyl infusion rate to 37.5 mcg/hr. At 3:30 A. M, Patient 16's pain score was 0. The target pain score was < 4. And, his RASS was -3. The target RASS was -2. At 5:00 A.M., RN 16 increased the Fentanyl infusion rate, again, to 50 mcg/hr. However, there was no documentation in Patient 16's medical record indicating why the Fentanyl infusion rate was increased twice. There was no documentation in the MAR that two boluses of Fentanyl had been administered to justify increasing the Fentanyl infusion rate.

An interview was conducted with the RN Manager of the ICU on 12/11/12, at 1:50 P.M. The RN Manager acknowledged that there was no documented evidence in Patient 16's medical record to indicate why the Fentanyl IV infusion was increased by 12.5 mcg at 3:30 A.M. and increased another 12.5 mcg at 5:00 A.M. The RN Manager also acknowledged that the two Fentanyl dosage increases were not in accordance with the physician's order.

On 12/12/12 at 7:50 A.M., an interview was conducted with RN 16. RN 16 stated that he increased Patient 16's Fentanyl infusion dose by 12.5 mcg/hr twice because of his episodes of restlessness. RN 16 acknowledged that he did not get a physician's order for the increased dosage nor did he document Patient 16's episodes of restlessness in the medical record.

4 . Patient 21 was admitted to Hospital B on 8/15/12, for surgical treatment of Stage 4 Colon Cancer. Post-operatively, Patient 21 was transferred to the Intensive Care Unit (ICU). A review of Patient 21's medical record was conducted on 12/12/12, at 4:00 P.M. According to a physician's order, dated 9/5/12, Patient 21 was to receive a continuous intravenous infusion of Vecuronium (muscle relaxing anesthetic to facilitate mechanical ventilation). The physician's order for IV Vercuronium contained specific instructions for administration. Instructions: "Start at 2 mg/hr (milligrams per hour). Goal: Titrate per Train of Four Protocol (TOF - a test for measuring the level of neuromuscular blockade). Goal TOF 2/4. If TOF > 1/4, bolus per separate bolus order and increase drip by 1 mg/hr. Recheck TOF in 1 hour. If TOF 0/4, decrease drip by 1 mg/hr. If TOF 1/4, no change..."

A review of Patient 21's medication administration record (MAR) indicated that the Vecuronium IV infusion was started on 9/5/12 at 2 mg/hr. At 1:00 P.M. on 9/11/12, Registered Nurse (RN 21) decreased the Vecuronium infusion rate to 1 mg/hr. Patient 21's TOF, at that time, was 2/4. The physician's order specifically indicated to decrease the Vecuronium by 1 mg/hr if the TOF = 0/4.

An interview was conducted with RN 21 on 12/13/12, at 1:10 P.M. RN 21 remembered that Patient 21 was receiving Vecuronium because he was on a mechanical ventilator. RN 21 stated that on 9/11/12, at 1:00 P.M. she was at the patient's beside with his physician (MD 21). RN 21 was talking to MD 21 about giving Patient 21 a "sedation vacation." According to RN 21, MD 21 agreed with her to decrease the Vecuronium. However, there was no documented evidence in Patient 21's medical record that MD 21 had written an order to decrease the Vecuronium. RN 21 acknowledged that "her error was that she did not make certain that MD 21 wrote an order giving specific instructions regarding decreasing the Vecuronium IV infusion."

A review of the hospital's policy entitled "Medication Preparation, Labeling and Administration," dated 4/21/11 was reviewed. Per the policy, medication orders were to be reviewed prior to being administered.




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5. A review of Patient 26's medical record was conducted on 12/12/12, at 8:52 A.M. Patient 26 was admitted to Hospital A on 12/6/12, due to shortness of breath per the History and Physical, dated 12/6/12.

According to a Physician's Order dated 12/9/12 at 5:26 A.M., the administration of a continuous infusion of Propofol was ordered. Per the order, the Propofol was to be started at 10 micrograms (mcg) per kilogram per minute (mcg/kg/min). RNs were to titrate the infusion rate by 5 mcg. every 5 minutes to achieve a target RASS score of negative 2 (-2). (RASS score: Richmond Agitation- Sedation Scale: a numerical score, ranging from +4 (very combative) to -5 (unarousable) assigned to a patient which relies on patient behavior and movement to determine the level of sedation). The maximum rate was 60 mcg/kg/min. If the RASS score was greater than (>) or equal to (=) 2 levels below the goal, the Propofol rate was to be decreased by 10 mcg/kg/min. every 10 minutes until the RASS was at goal (-2).

An interview and joint record review was conducted with Administrative Nurse (AN 26) on 12/12/12 at 9:25 A.M. AN 26 acknowledged that Patient 26's continuous infusion of Propofol was titrated up (increased) from 10 mcg/kg/min on 12/9/12 at 8:00 P.M. to 20 mcg/kg/min on 12/9/12 at 10:00 P.M., which was an increase of 10 mcg (increment) instead of 5 mcg. She agreed that the titration of Patient 26's Propofol infusion was not in accordance with the physician's order.

A review of the hospital's policy entitled "High Risk Medications," dated 10/8/12 was conducted. The policy defined a high risk medication as one that had the potential to cause severe life-threatening side effects, and/or required special monitoring. Propofol was listed as a high risk medication.

A review of the hospital's policy entitled "Patient Treatment and Medication Orders," dated 4/19/12, was reviewed. Per the policy, RNs were to monitor the specific parameters prescribed for titrating the medication orders for increasing or decreasing the dose based upon the patient's status.

An interview with the Clinical Nurse Specialist (CNS 26) was conducted on 12/12/12 at 9:35 A.M. CNS 26 acknowledged that the RN did not titrate Patient 26's Propofol infusion in accordance with the physician's order.

6. A review of Patient 27's medical record was conducted on 12/12/12 at 10:55 A.M. Patient 27 was admitted to Hospital A on 11/16/12 due to burns on 50% of his total body surface area (TBSA) per a Progress Note, dated 12/11/12. Per the same Progress Note, one of the treatment plans for Patient 27 included the continuous infusion of Dilaudid for pain management.

According to a Physician's Order dated 12/4/12 at 4:51 P.M., the continuous infusion of Dilaudid (Hydromorphone 100 mg (milligrams) in sodium chloride 0.9% 100 ml (milliliter) infusion) was to be administered to Patient 27. Per the order, Dilaudid was to be started at 4 mg/hr (per hour). RNs were to titrate by 0.2 mg/hr every 2 hours if target pain score was not achieved. The target pain score was less than (<) 4. If pain was controlled, decrease hydromorphone by 0.1 mg/hr.

An interview and joint record review with Registered Nurse (RN 26) was conducted on 12/12/12 at 11:02 A.M. According to Patient 27's Sedation and Analgesia Overview, dated 12/11/12 at 8:46 A.M., the continuous infusion of Dilaudid was decreased from 4 mg/hr to 3 mg/hr and Patient 27's pain score was zero (no pain). RN 26 stated that a verbal order was given by the physician to decrease the Dilaudid infusion rate however, she acknowledged that there was no documented evidence in Patient 27's medical record to show that a verbal order was given or obtained from the physician. She acknowledged that physician's order should have been in Patient 27's medical record in accordance with the hospital's policy.

A review of the hospital's policy entitled "Patient Treatment and Medication Orders," dated 4/19/12, was reviewed. Per the policy, when verbal or telephone orders are given by the prescriber, the order must be documented promptly, including time, date, the authorizing provider name, and full signature and title of the person accepting the order.

An interview with the Burn Intensive Care Unit Manager (BICUM) was conducted on 12/12/12 at 11:20 A.M. The BICUM acknowledged that when Patient 27's Dilaudid infusion rate was decreased, there should have been a physician's order in the medical record in accordance with the hospital's policy.





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7. A review of Patient 48's medical record was conducted on 12/11/12 at 2:30 P.M. Patient 48 was admitted to the hospital on 12/10/12, for altered level of consciousness per the History and Physical (H&P) dated 12/10/12. The physician's order dated 12/10/12 at 10:33 P.M. specified that a Propofol (A sedative/anesthetic medication) continuous infusion was to be initiated at 10 mcg/kg/min. A review of Patient 48's MAR was conducted on 12/11/12, at 2:31 P.M. Documentation by the RN indicated that the Propofol infusion was initiated at 15 mcg/kg/min at 10 P.M. on 12/10/12.

A review of the hospital's policy titled "Patient Treatment and Medication Orders" was conducted on 12/11/12 at 3:30 P.M. The policy specified under nurse service responsibilities that "review each patient recorded each shift to see that all orders are appropriately recorded, signed, complied with, and countersignatures obtained, if necessary. Verify that all medication orders are accurately transcribed on the Medication administration record (MAR/eMAR)."

An interview with the clinical nurse specialist for SICU was conducted on 12/11/12, at 3:30 P.M. she stated that the hospital was aware that there is a problem with the propofol orders not matching the nursing documentation of what was given. She stated that at times the physician may give a verbal order and then not enter the order in the computer, or the nurse does not document the change as a verbal order. She acknowledged that the nurses should be ensuring that if the physician does not enter the new order in the computer that the RN's should be entering it as a verbal order.


8. Patient 49's medical record was reviewed on 12/11/12, at 2:35 P.M. Patient 49 was admitted on 12/10/12, with a diagnoses of intracranial bleed per the H&P dated 12/10/12. The physician's order dated 12/10/12 at 2:45 P.M., specified that Propofol continuous infusion was to be initiated at 10 mcg/kg/min and titrate by 5 mcg/kg/min every 5 minutes until target RASS score achieved. Patient 49's MAR indicated that the RN documented on 12/10/12, at 2:34 P.M. that Propofol was initiated at 40 mcg/kg/min, further documentation indicated that 1 minute later on 12/10/12 at 2:35 P.M. propofol was administered at 60 mcg/kg/min.

A review of the hospital's policy titled "Patient Treatment and Medication Orders" was conducted on 12/11/12 at 3:30 P.M. The policy specified under nurse service responsibilities that "review each patient recorded each shift to see that all orders are appropriately recorded, signed, complied with, and countersignatures obtained, if necessary. Verify that all medication orders are accurately transcribed on the Medication administration record (MAR/eMAR)."

An interview with the clinical nurse specialist for SICU was conducted on 12/11/12, at 3:30 P.M. she stated that the hospital was aware that there is a problem with the propofol orders not matching the nursing documentation of what was given. She stated that at times the physician may give a verbal order and then not enter the order in the computer, or the nurse does not document the change as a verbal order. She acknowledged that the nurses should be ensuring that if the physician does not enter the new order in the computer that the RN's should be entering it as a verbal order.


9. Patient 52's medical record was reviewed on 12/11/12, at 2:45 P.M. Patient 52 was admitted on 12/9/12, with a diagnoses of Pulmonary Hypertension per the H&P dated 12/9/12. Per the physician's order dated 12/10/12, at 2:30 P.M., Propofol continuous infusion was to be initiated at 10 mcg/kg/min. Patient 52's MAR indicated that the RN documented that Propofol was initiated at 50 mcg/kg/min on 12/10/12 at 2:30 P.M.

A review of the hospital's policy titled "Patient Treatment and Medication Orders" was conducted on 12/11/12 at 3:30 P.M. The policy specified under nurse service responsibilities that "review each patient recorded each shift to see that all orders are appropriately recorded, signed, complied with, and countersignatures obtained, if necessary. Verify that all medication orders are accurately transcribed on the Medication administration record (MAR/eMAR)."

An interview with the clinical nurse specialist for SICU was conducted on 12/11/12, at 3:30 P.M. she stated that the hospital was aware that there is a problem with the propofol orders not matching the nursing documentation of what was given. She stated that at times the physician may give a verbal order and then not enter the order in the computer, or the nurse does not document the change as a verbal order. She acknowledged that the nurses should be ensuring that if the physician does not enter the new order in the computer that the RN's should be entering it as a verbal order.

Based on interview and record review, the hospital failed to ensure that drugs were provided in a safe and effective manner in accordance with accepted professional practices as evidenced by:

1. The hospital failed to ensure that pharmacy staff at Hospitals A and B maintained adequate oversight and management of the medication administration process of intravenous narcotics and high risk medications in critical care units in accordance with hospital policies and physician's orders.
(A tag 405 #'s 1, 2, 3, 4, 5, 6, 7, 8, 9 and A tag 500 # 1, 2, 3, 4, 5, 6, 7, 8, 9)

2. The hospital failed to ensure that a Vecuronium physician order set was implemented at Hospitals A and B with specific titration guidelines and with consistent and clear understanding of the order set implementation, by nursing and physician leadership staff.
(A tag 500 # 2)

3. The hospital failed to ensure that Surgical Intensive Care Unit (SICU) RNs at Hospital A titrated (adjusted) the rates and dosages of Patient 1's Propofol(sedative/general anesthetic drug) infusion based on an appropriate physician's order. The RNs or pharmacy staff did not identify or clarify the inappropriateness of the order, or obtain a different order. In addition, those RNs titrated Patient 1's Vecuronium (a paralyzing agent) infusion without defined titration parameters from a physician's order.
(A tag 405 #s 1,2 and A tag 500 #'s 1,2 )

4. Hospital A failed to ensure that Critical Care Registered Nurses (RNs) implemented medication policies and procedures pertaining to the administration and continuous infusion of narcotics and high risk medications Propofol (sedative/general anesthetic drug)
(A tag 405 #'s 1, 3, 5, 6, 7, 8, 9 and A tag 500 #'s 1, 3, 5, 6, 7, 8 9)

5. The hospital failed to ensure that an adequate Policy and Procedure was developed related to the administration of medications by nurses in accordance with the physician's order.
(A tag 500 # 3, 4)

The cumulative effect of these systemic problems resulted in the facility's failure to deliver care in compliance with the Condition of Participation for pharmaceutical Services and failure to provide care to their patients in a safe environment.

Based on interview, record, and document review, the hospital failed to ensure that pharmacy staff at Hospitals A and B maintained adequate oversight and management of the medication administration process of intravenous narcotics and high risk medications in critical care units, to ensure that those medications were administered safely, and in accordance with hospital policies and physician orders, for 8 of 32 sampled patients (1, 16, 21, 26, 27, 48, 49, 52). There was no documented evidence that Surgical Intensive Care Unit (SICU) RNs at Hospital A titrated (adjusted) the rates and dosages of Patient 1's Propofol (sedative/general anesthetic drug) infusion based on an appropriate physician's order. The RNs or pharmacy staff did not identify or clarify the inappropriateness of the order, or obtain a different order. In addition, those RNs titrated Patient 1's Vecuronium (a paralyzing agent) infusion without defined titration parameters from a physician's order. A Vecuronium physician order set was implemented at Hospitals A and B without specific titration guidelines and without consistent and clear understanding of the order set implementation, by nursing and physician leadership staff. An RN in the critical care unit at Hospital B failed to administer a Fentanyl (narcotic) intravenous infusion in accordance with the physician's order. The failure of RNs to implement medication policies and procedures and physician orders increased the potential for patient harm.


Findings:

1. Per a record review on 10/3/12 at 10:15 A.M., Patient 1 was admitted to Hospital A on 4/3/12, due to shortness of breath and fevers, per a History and Physical (H&P) dated 4/3/12. Additional diagnoses included high blood pressure. Patient 1 was also pregnant, at 26 weeks gestation. On 4/3/12, the patient's respiratory status declined which necessitated intubation (breathing tube inserted via the mouth) and mechanical ventilation (breathing machine). Patient 1 was transferred out of the OB (obstetrics) unit to the SICU, on that same date.

On 4/3/12 at 8:27 P.M., Medical Doctor (MD) 2 ordered the administration of a continuous Propofol infusion. Per the order, the Propofol was to be started at 10 micrograms (mcg) per kilogram per minute (mcg/kg/min). RNs were to titrate the infusion rate by 5 mcg. every 5 minutes to achieve a target RASS score of negative 2 (-2). (RASS score: Richmond Agitation-Sedation Scale; A numerical score, ranging from +4 (very combative) to -5 (unarousable) assigned to a patient which relies on patient behavior and movement to determine the level of sedation). The maximum rate was 60 mcg/kg/min. The RASS score was to be checked hourly, and if the RASS score was greater than (>) or equal to (=) 2 levels below the goal, the Propofol rate was to be decreased by 10 mcg/kg/min. every 10 minutes until the RASS was at goal (-2).

According to the above order, the RNs would have to rely on Patient 1's movements in order to adjust the rate or dosage.

On 4/3/12 at 8:36 P.M., shortly after MD 2 ordered the Propofol infusion, MD 2 ordered the continous IV infusion of Vecuronium so that Patient 1 would be paralyzed and not be able to breathe out of synchrony (simultaneously) with the ventilator.

A review of the hospital's policy entitled "High Risk Medications," dated 10/8/12, was conducted. The policy defined a high risk medication as one that had the potential to cause severe life-threatening side effects, and/or required special monitoring. Both Propofol and Vecuronium were listed as high risk medications.

A review of the hospital's policy entitled "Medication Preparation, Labeling and Administration," dated 4/21/11, was reviewed. Per the policy, medication orders were to reviewed prior to being administered. Pharmacist responsibilities also included reviewing each inpatient medication order for appropriateness before verifying it.

A review of the hospital's policy entitled "Patient Treatment and Medication Orders," dated 4/19/12, was reviewed. Per the policy, RNs were to monitor the specific parameters prescribed for titrating the medication orders for increasing or decreasing the dose based upon the patient's status.

A review of nurses notes from 4/3/12 through 4/4/12, at 6:37 P.M., when the Vecuronium was discontinued, was conducted. During that time span, the SICU RNs documented that Patient 1's RASS scores were "-5", or unarousable, as the patient was paralyzed from the Vecuronium.

On 4/4/12 at 5:47 P.M., RN 7 documented that the propofol drip was "titrated up" for an increased heart rate and blood pressure; however, the propofol order did not provide those titration parameters.

On 12/12/12 at 7:30 A.M., an interview was conducted with RN 6 who initiated Patient 1's Propofol and Vecuronium infusions. RN 6 stated that she was titrating the drips (infusions) to stabilize the patient's blood pressure which was very labile. RN 6 stated that MD 2 had ordered the Vecuronium drip after the Propofol drip was started, RN 6 did not go back and check the order to see if MD 2 provided a new order with different titration parameters for the Propofol, once Vecuronium was ordered. RN 6 acknowledged that the Propofol order did not provide titration parameters based on the patient's blood pressure, and that she did not clarify or obtain a new order, once the patient was placed on Vecuronium.

On 12/12/12 at 8:00 A.M., an interview was conducted with RN 7. RN 7 also confirmed that she titrated Patient 1's Propofol infusion based on the patient's blood pressure which was not consistent with the physician's order.


On 10/3/12 at 3:00 P.M., an interview was conducted with Critical Care Pharmacist (CCP) 2. Per CCP 2, the physicians Propofol order to titrate the dose based on the patient's RASS score was not appropriate once the Vecuronium infusion was ordered and started. The physician should have ordered the Propofol to be titrated based on physiological parameters such as blood pressure or heart rate. CCP 2 acknowledged that pharmacy staff did not identify this issue with the order or seek clarification and/or obtain a new order from the physician.


2. Per a record review conducted on 10/3/12, at 10:15 A.M. Patient 1 was admitted to Hospital A on 4/3/12, due to shortness of breath and fevers, per a History and Physical (H&P) dated 4/3/12. Additional diagnoses included high blood pressure. Patient 1 was also pregnant, at 26 weeks gestation. On 4/3/12, the patient's respiratory status declined which necessitated intubation (breathing tube inserted via the mouth) and mechanical ventilation (breathing machine). Patient 1 was transferred out of the OB (obstetrics) unit to the SICU, on that same date.


A review of the hospital's policy entitled "High Risk Medications," dated 10/8/12, was conducted. The policy defined a high risk medication as one that had the potential to cause severe life-threatening side effects, and/or required special monitoring. Vecuronium was listed as a high risk medication.

A review of the hospital's policy entitled "Patient Treatment and Medication Orders," dated 4/19/12, was reviewed. Per the policy, RNs were to monitor the specific parameters prescribed for titrating the medication orders for increasing or decreasing the dose based upon the patient's status. Per the policy, variable orders which were not titrated by a practitioner were to have specific lab results or physiologic parameter outcomes and titration instructions. Per the policy, medication orders titrated to a specific subjective end point were not acceptable.

On 4/3/12 at 8:36 P.M., MD 2 ordered the continous IV infusion of Vecuronium so that Patient 1 would be paralyzed and not be able to breathe out of synchrony (simultaneously) with the ventilator. The order was prescribed as "start at 1 milligram (mg)/hour. Goal: ventilator synchrony. Max (maximum) rate: 15 mg/hr." The order did not provide specific titration guidelines or objective endpoints regarding "ventilator synchrony."


On 4/3/12 at 9:00 P.M., RN 6 documented that Patient 1 was on Vecuronium and no "train of four" (a method of monitoring the degree or effectiveness of a neuromuscular blockade drug) had been ordered per the Medicine team. RN 6 documented that the Vecuronium was being titrated to the patient's respiratory rate set on the ventilator.

On 12/12/12 at 7:30 A.M., an interview was conducted with RN 6. RN 6 stated that she requested MD 2 to order the Vecuronium based on the "train of four" parameters which was what she was accustomed to. RN 6 stated it was the SICU's policy and protocol to titrate a Vecuronium drip to the train of four order set, and not to ventilator synchronization. According to RN 6 the train of four protocol provided specific titration guidelines, but she was unable to get an order from MD 2 for that.

A review of Patient 1's Vecuronium Medication Administration Record, revealed that between 4/3/12 at 9:00 P.M. and 4/4/12 at 7:10 A.M., RN 6 adjusted the patient's Vecuronium infusion rate/dosage 4 times in the absence of specific parameters or guidelines. Between 4/4/12 at 8:00 A.M. and 4/4/12 at 4:53 P.M., RN 7 adjusted the infusion twice without specific guidelines or additional orders from a physician.

On 12/12/12 at 8:30 A.M., a joint interview was conducted with the Nursing Director of Critical Care (NDCC) and the SICU Nurse Manager (NM). Both confirmed that the SICU RNs were accustomed to titrating a Vecuronium drip based on the "train of four" physician order set, not ventilator synchrony.


On 12/12/12 at 9:00 A.M., a joint interview was conducted with the Director of Pharmacy (DOP), a Critical Care Pharmacist (CCP), and the Pharmacy Manager (PM). Per the CCP, the Vecuronium order set for ventilator synchrony was intended to be physician driven, and if the dose required titration or adjustment, the physician was supposed to initiate a new order. Per the DOP, the Vecuronium order set for ventilator synchrony had been in place for two years.


On 12/12/12 at 4:10 P.M., a joint interview was conducted with members of Medical Staff leadership to include the Medical Directors of Respiratory Services, Critical Care, and the Professor of Medicine, Chief of Staff. The Chief of Staff confirmed that the Vecuronium physician order set should be physician driven and provide specific titration guidelines. However, the Medical Director of Respiratory Services stated that the nurses were "competent" to titrate the Vecuronium to "ventilator synchrony."


On 12/12/12 at 1:00 P.M., an interview was conducted with a Critical Care Clinical Nurse Specialist (CNS), an expert in clinical practice for the Critical Care Units. The CNS stated that she was unaware of a Vecuronium order set for ventilator synchrony and did not know when it had been implemented. The CNS stated that it didn't seem as though an interdisciplinary and collaberative approach was taken when the Vecuronium order set was developed and implemented. Per the CNS, if such an approach had been taken, an educational plan could have been developed and nurse competencies validated to ensure the safe administration and titration of Vecuronium, in accordance with the ventilator synchrony order.


On 12/12/12 at 3:00 P.M., an interview was conducted with the DOP. The DOP acknowledged that detailed information concerning the Vecuronium order set for ventilator synchrony was not disseminated well amongst the physician and nursing staff to ensure the safe and effective administration of a Vecuronium infusion.



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3. On 12/10/12, Patient 16 was admitted to the Intensive Care Unit (ICU) of Hospital B for treatment of an altered level of consciousness possible due to the ingestion of isopropyl alcohol (a type of alcohol found in antifreeze and rubbing alcohol). A review of Patient 16's medical record was conducted on 12/11/12 at 11:10 A.M. According to a physician's order, dated, 12/10/12, Patient 16 was to receive a continuous intravenous (IV) infusion of Fentanyl (a narcotic analgesic). The physician's order for IV Fentanyl contained specific instructions for administration. Instructions: "Target Pain Score: <4. Start at 25 mcg./hr (micrograms per hour). Titrate by 12.5 mcg/hr every hour if > = 2 boluses/hr x 2 consecutive hours. Max rate 100 mcg/hr. If RASS (Richmond Agitation-Sedation Score) at goal and pain controlled, decrease fentanyl rate by 12.5 mcg/hr. Concentration = 10 mcg/mL (micrograms per milliliter).

A review of Patient 16's Medication Administration Record (MAR) indicated that the IV Fentanyl infusion was started at 25 mcg/hr on 12/10/12, at 11:37 P.M. At 2:00 A.M., on 12/11/12, his Registered Nurse (RN 16) increased the Fentanyl infusion rate to 37.5 mcg/hr. At 3:30 A. M, Patient 16's pain score was 0. The target pain score was < 4. And, his RASS was -3. The target RASS was -2. At 5:00 A.M., RN 16 increased the Fentanyl infusion rate, again, to 50 mcg/hr. However, there was no documentation in Patient 16's medical record indicating why the Fentanyl infusion rate was increased twice. There was no documentation in the MAR that two boluses of Fentanyl had been administered to justfy increasing the Fentanyl infusion rate.

An interview was conducted with the RN Manager of the ICU on 12/11/12, at 1:50 P.M. The RN Manager acknowledged that there was no documented evidence in Patient 16's medical record to indicate why the Fentanyl IV infusion was increased by 12.5 mcg at 3:30 A.M. and increased another 12.5 mcg at 5:00 A.M. The RN Manager also acknowledged that the two Fentanyl dosage increases were not in accordance with the physician's order.

On 12/12/12, at 7:50 A.M., an interview was conducted with RN 16. RN 16 stated that he increased Patient 16's Fentanyl infusion dose by 12.5 mcg/hr twice because of his episodes of restlessness. RN 16 acknowledged that he did not get a physician's order for the increased dosage nor did he document Patient 16's episodes of restlessness in the medical record.

The hospital was unable to provide a policy and procedure that addressed the administration of medications in accordance with a physician's order.

4 . Patient 21 was admitted to Hospital B on 8/15/12, for surgical treatment of Stage 4 Colon Cancer. Post-operatively, Patient 21 was transferred to the Intensive Care Unit (ICU). A review of Patient 21's medical record was conducted on 12/12/12, at 4:00 P.M. According to a physician's order, dated 9/5/12, Patient 21 was to receive a continuous intravenous infusion of Vecuronium (muscle relaxing anesthetic to facilitate mechanical ventilation). The physician's order for IV Vercuronium contained specific instructions for administration. Instructions: "Start at 2 mg/hr (milligrams per hour). Goal: Titrate per Train of Four Protocol (TOF - a test for measuring the level of neuromuscular blockade). Goal TOF 2/4. If TOF > 1/4, bolus per separate bolus order and increase drip by 1 mg/hr. Recheck TOF in 1 hour. If TOF 0/4, decrease drip by 1 mg/hr. If TOF 1/4, no change..."

A review of Patient 21's medication administration record (MAR) indicated that the Vecuronium IV infusion was started on 9/5/12 at 2 mg/hr. At 1:00 P.M. on 9/11/12, Registered Nurse (RN 21) decreased the Vecuronium infusion rate to 1 mg/hr. Patient 21's TOF, at that time, was 2/4. The physician's order specifically indicated to decrease the Vecuronium by 1 mg/hr if the TOF = 0/4.

An interview was conducted with RN 21 on 12/13/12, at 1:10 P.M. RN 21 remembered that Patient 21 was receiving Vecuronium because he was on a mechanical ventilator. RN 21 stated that on 9/11/12 at 1:00 P.M., she was at the patient's beside with his physician (MD 21). RN 21 was talking to MD 21 about giving Patient 21 a "sedation vacation." According to RN 21, MD 21 agreed with her to decrease the Vecuronium. However, there was documented evidence in Patient 21's medical record that MD 21 had written an order to decrease the Vecuronium. RN 21 acknowledged that "her error was that she did not make certain that MD 21 wrote an order giving specific instructions regarding decreasing the Vecuronium IV infusion."

The hospital was unable to provide a policy and procedure that addressed the administration of medications in accordance with a physician's order.




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5. A review of Patient 26 was conducted on 12/12/12 at 8:52 A.M. Patient 26 was admitted to Hospital A on 12/6/12 due to shortness of breath per the History and Physical, dated 12/6/12.

According to a Physician's Order dated 12/9/12 at 5:26 A.M., the administration of a continuous infusion of Propofol was ordered. Per the order, the Propofol was to be started at 10 micrograms (mcg) per kilogram per minute (mcg/kg/min). RNs were to titrate the infusion rate by 5 mcg. every 5 minutes to achieve a target RASS score of negative 2 (-2). (RASS score: Richmond Agitation- Sedation Scale: a numerical score, ranging from +4 (very combative) to -5 (unarousable) assigned to a patient which relies on patient behavior and movement to determine the level of sedation). The maximum rate was 60 mcg/kg/min. If the RASS score was greater than (>) or equal to (=) 2 levels below the goal, the Propofol rate was to be decreased by 10 mcg/kg/min. every 10 minutes until the RASS was at goal (-2).

An interview and joint record review was conducted with Administrative Nurse (AN 26) on 12/12/12 at 9:25 A.M. AN 26 acknowledged that Patient 26's continuous infusion of Propofol was titrated up (increased) from 10 mcg/kg/min on 12/9/12 at 8:00 P.M. to 20 mcg/kg/min on 12/9/12 at 10:00 P.M. which was not in accordance with the physician's order.

A review of the hospital's policy entitled "High Risk Medications", dated 10/8/12 was conducted. The policy defined a high risk medication as one that had the potential to cause severe life-threatening side effects, and/or required special monitoring. Propofol was listed as a high risk medication.

A review of the hospital's policy entitled "Patient Treatment and Medication Orders," dated 4/19/12, was reviewed. Per the policy, RNs were to monitor the specific parameters prescribed for titrating the medication orders for increasing or decreasing the dose based upon the patient's status.

An interview with the Clinical Nurse Specialist (CNS 26) was conducted on 12/12/12 at 9:35 A.M. CNS 26 acknowledged that the RN did not titrate Patient 26's Propofol infusion in accordance with the physician's order. She stated that RNs should have been following the hospital's policy and titrating continuous infusions of medications in accordance with the physician's order.

An interview with pharmacist 26 was conducted on 12/12/12 at 11:15 A.M. Pharmacist 26 stated that it was the pharmacy staff's responsibility to ensure that all medications had physician's orders, physician's orders were complete and that the administration of medications were in accordance with the orders.

6. A review of Patient 27's medical record was conducted on 12/12/12 at 10:55 A.M. Patient 27 was admitted to Hospital A on 11/16/12 due to burns on 50% of his total body surface area (TBSA) per a Progress Note, dated 12/11/12. Per the same Progress Note, one of the treatment plans for Patient 27 included the continuous infusion of Dilaudid for pain management.

According to a Physician's Order dated 12/4/12 at 4:51 P.M., the continuous infusion of Dilaudid (Hydromorphone 100 mg (milligrams) in sodium chloride 0.9% 100 ml (milliliter) infusion) was to be administered to Patient 27. Per the order, Dilaudid was to be started at 4 mg/hr (per hour). RNs were to titrate by 0.2 mg/hr every 2 hours if target pain score was not achieved. The target pain score was less than (<) 4. If pain was controlled, decrease hydromorphone by 0.1 mg/hr.

An interview and joint record review with Registered Nurse (RN 26) was conducted on 12/12/12 at 11:02 A.M. According to Patient 27's Sedation and Analgesia Overview, dated 12/11/12 at 8:46 A.M., the continuous infusion of Dilaudid was decreased from 4 mg/hr to 3 mg/hr and Patient 27's pain score was zero (no pain). RN 26 stated that a verbal order was given by the physician to decrease the Dilaudid infusion rate however, she acknowledged that there was no documented evidence in Patient 27's medical record to show that a verbal order was given or obtained from the physician. She acknowledged that physician's order should have been in Patient 27's medical record in accordance with the hospital's policy.

A review of the hospital's policy entitled "Patient Treatment and Medication Orders," dated 4/19/12, was reviewed. Per the policy, when verbal or telephone orders are given by the prescriber, the order must be documented promptly, including time, date, the authorizing provider name, and full signature and title of the person accepting the order. According to the same policy, "For medication orders, the read back must include the patient's name, drug name, dose, route, frequency and purpose to be sure of complete and correct understanding."

An interview with pharmacist 26 was conducted on 12/12/12 at 11:15 A.M. Pharmacist 26 stated that it was the pharmacy staff's responsibility to ensure that all medications had physician's orders, physician's orders were complete and that the administration of medications were in accordance with the orders. He acknowledged that a physician's order should have been in Patient 27's medical record when his Dilaudid infusion rate was decreased.

An interview with the Burn Intensive Care Unit Manager (BICUM) was conducted on 12/12/12 at 11:20 A.M. The BICUM acknowledged that when Patient 27's Dilaudid infusion rate was decreased, there should have been a physician's order with titration guidelines or a clear order from the prescriber for the medication administration change found in the medical record in accordance with the hospital's policy.



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7. A review of Patient 48's medical record was conducted on 12/11/12, at 2:30 P.M. Patient 48 was admitted to the hospital on 12/10/12, for altered level of consciousness, per the H&P dated 12/10/12. The physician's order dated 12/10/12, at 10:33 P.M. specified that a Propofol continuous infusion was to be initiated at 10 mcg/kg/min. A review of Patient 48's MAR was conducted on 12/11/12, at 2:31 P.M. Documentation by the RN indicated that the Propofol infusion was initiated at 15 mcg/kg/min at 10 P.M. on 12/10/12.

A review of the hospital's policy titled "Patient Treatment and Medication Orders" was conducted on 12/11/12 at 3:30 P.M. The policy specified under nurse service responsibilities that "review each patient recorded each shift to see that all orders are appropriately recorded, signed, complied with, and countersignatures obtained, if necessary. Verify that all medication orders are accurately transcribed on the Medication administration record (MAR/eMAR)."

An interview with the clinical nurse specialist for SICU was conducted on 12/11/12 at 3:30 P.M. she stated that the hospital was aware that there is a problem with the propofol orders not matching the nursing documentation of what was given. She stated that at times the physician may give a verbal order and then not put the order in or the nurse does not document the change as a verbal order. She acknowledged that the nurses should be ensuring that if the physician does not put in the new order that they should be entering it as a verbal order.

An interview with the Critical Care Pharmacist was conducted on 11/6/12 at 10:50 A.M. He stated that the hospital pharmacists do not currently perform a retrospective chart review to verify that what the RN documeted as the initating dose for Propofol matched what was documeted in the physician's order.


8. Patient 49's medical record was reviewed on 12/11/12 at 2:35 P.M. Patient 49 was admitted on 12/10/12 with a diagnoses of intracranial bleed per the H&P dated 12/10/12. The physician's order dated 12/10/12 at 2:45 P.M. specified that Propofol continuous infusion was to be initiated at 10 mcg/kg/min and titrate by 5 mcg/kg/min every 5 minutes until target RASS score achieved. Patient 49's MAR indicated that the RN documented on 12/10/12 at 2:34 P.M. that Propofol was initiated at 40 mcg/kg/min, further documentation indicated that 1 minute later on 12/10/12 at 2:35 P.M. propofol was administered at 60 mcg/kg/min.

A review of the hospital's policy titled "Patient Treatment and Medication Orders" was conducted on 12/11/12 at 3:30 P.M. The policy specified under nurse service responsibilities that "review each patient recorded each shift to see that all orders are appropriately recorded, signed, complied with, and countersignatures obtained, if necessary. Verify that all medication orders are accurately transcribed on the Medication administration record (MAR/eMAR)."

An interview with the clinical nurse specialist for SICU was conducted on 12/11/12 at 3:30 P.M. she stated that the hospital was aware that there is a problem with the propofol orders not matching the nursing documentation of what was given. She stated that at times the physician may give a verbal order and then not put the order in or the nurse does not document the change as a verbal order. She acknowledged that the nurses should be ensuring that if the physician does not put in the new order that they should be entering it as a verbal order.

An interview with the Critical Care Pharmacist was conducted on 11/6/12 at 10:50 A.M. He stated that the hospital pharmacists do not currently perform a retrospective chart review to verify that what the RN documeted as the initating dose for Propofol matched what was documeted in the physician's order.


9. Patient 52's medical record was reviewed on 12/11/12 at 2:45 P.M. Patient 52 was admitted on 12/9/12 with a diagnoses of Pulmonary Hypertension per the H&P dated 12/9/12. Per the physician's order dated 12/10/12 at 2:30 P.M., Propofol continuous infusion was to be initiated at 10 mcg/kg/min. Patient 52's MAR indicated that the RN documented that Propofol was initiated at 50 mcg/kg/min on 12/10/12 at 2:30 P.M.

A review of the hospital's policy titled "Patient Treatment and Medication Orders" was conducted on 12/11/12 at 3:30 P.M. The policy specified under nurse service responsibilities that "review each patient recorded each shift to see that all orders are appropriately recorded, signed, complied with, and countersignatures obtained, if necessary. Verify that all medication orders are accurately transcribed on the Medication administration record (MAR/eMAR)."

An interview with the clinical nurse specialist for SICU was conducted on 12/11/12 at 3:30 P.M. she stated that the hospital was aware that there is a problem with the propofol orders not matching the nursing documentation of what was given. She stated that at times the physician may give a verbal order and then not put the order in or the nurse does not document the change as a verbal order. She acknowledged that the nurses should be ensuring that if the physician does not put in the new order that they should be entering it as a verbal order.

An interview with the Critical Care Pharmacist was conducted on 11/6/12 at 10:50 A.M. He stated that the hospital pharmacists do not currently perform a retrospective chart review to verify that what the RN documeted as the initating dose for Propofol matched what was documeted in the physician's order.