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Based on record review and interview it was determined that the governing body failed to ensure appropriate oversight and coordination between the departments of emergency medicine, pharmacy services, anesthesia services, and laboratory services.

Findings include:

1. The governing body failed to ensure that emergency department medical staff provided care that conformed to current standards of practice. A trauma patient who underwent a conscious sedation procedure with propofol and morphine during a closed reduction of leg fractures in the ED had developed respiratory arrest shortly following the procedure, which was further complicated by difficult intubation attempts, and had sustained anoxic encephalopathy.

Specific reference is made to the patient referenced in MR # 1 was involved in an MVA and had open leg fractures. The trauma team did not bring the patient to the operating room (OR) and instead deferred to orthopedics when there was evidence of arterial compromise. The decision was made to reduce the fractures under conscious sedation in the ED without notifying anesthesia staff. There was no evidence that ED staff was aware of the patient's low hemoglobin (5.8), which precluded the patient from receiving the propofol in this case. Instead, the patient was administered a dose of morphine (10mg) IVP and sent to the CT. No assessment of the patient's medical condition ( presence of airway anomalies ) was made prior to the anesthesia which would make intubation difficult.

Review of MR#1 found that the patient was admitted to the emergency department by EMS and was administered sedation during a procedure (orthopedic) and was not monitored. properly. The patient received propofol, a dangerous anesthesia without precautions. The patient was transported to the CAT scan unit near the ED accompanied by a PGY-2 resident and went into a bradycardia of 36 and apnea, requiring ACLS support and emergent intubation. There was no resuscitative equipment in the CAT scan and no intubation set was transported to the CT with the patient. There was no anesthesia attending or resident with the patient in the ED. The patient was sent to the CT after having received at least 200 mg of propofol IVP and 20 mg of morphine IVP. The patient sustained a respiratory arrest in the CT on the stretcher.

At least 5 attempts were made to intubate the patient including two attempts by the anesthesia resident on call who had not been notified that a patient had been administered propofol in the ED.

Cross refer to findings noted under Emergency Services , tag #s A1100 and A1103.

2. The governing body failed to provide appropriate oversight of the pharmaceutical services in the emergency department which ensured development and implementation of policies and practices to minimize drug errors and that met the safety needs of patients. Refer to findings noted under tag # A490.

3. The governing body did not implement effective policies and practices for integration for laboratory services into the emergency department that require the prompt notification of staff or trauma team personnel of panic values and critical laboratory results. Refer to findings noted under tag # A576.

4. The governing body did not ensure accountability for the provision of anesthesia services in the emergency department to include provisions for the immediate availability of qualified anesthesia staff and safe delivery of anesthetics that have a high potential for harm to emergency trauma patients. Refer to findings noted under tag # A1000.

Based on medical record review, staff interview and other documents, it was determined that the nursing staff failed to ensure patient safety by not monitoring patients on restraints.

Findings include:

A) 1- Review of MR#3 on 12/13/11 noted an adult patient was admitted to the hospital from a nursing home on 12/7/11 after having an episode of Tonic clonic Seizure (lasting 25 minutes). Patient has a medical history of seizure disorder on anti-epileptics medication and dementia. The patient was fed via nasal gastric tube (enteral feeding) and had a Foley catheter. Patient was placed on restraints on 12/10/11 by the physician to prevent pulling on the NGT and Foley catheter. Documentation of patient ' s monitoring due to restraints was not consistently documented in the form titled " Non-Behavioral Restraint Flow Sheet " . The Restraint Flow Sheets (log) dated 12/12/11 had two sets of flow sheet with the same date and shifts but the signed initials were different. In addition, there was a flow sheet dated 12/11 which was completely checked mark for the evening shift monitoring but the initials identifying the authorized personnel was missing.

2- Review of MR#4 on 12/13/11 noted an elderly patient was admitted to the hospital on 12/5/11 due to fall at home. Patient was going down the stairs when he fell. He tried to stand up but was unable to move. Nursing progress note on 12/6/11 at 0540 noted wrist restraint applied by evening shift. Physician order was obtained; however, there was no evidence of monitoring of the patient in restraints. Monitoring flow sheet for 12/6 was not present in medical record.

a) Patient again was placed on bilateral wrist restraints on 12/9/11. Restraint Flow Sheet for the night shift was completed for monitoring; however, it was not initialed by staff at 1030 or 1100 hour.

b) On Restraint Flow Sheet dated 12/11, there was no evidence the patient was monitored every half hour from 1600-1800 hours. There was no restraint monitoring done on the evening shift (Date not documented) yet, the page was listed as page 2. The entire section of the evening shift was blank.

c) On 12/12/11, there was no monitoring documented at 1600, 2030, 2100, 2330 and 2400 hours.

Based on document review , the facility's departmental performance improvement review failed to ensure effective oversight and supervision of the care rendered in the emergency department.

Findings include:

The hospital failed to identify and take action for the systemic issues and multiple factors that contributed to an adverse patient event in the emergency department.

Specific reference is made to MR #1 for a patient who sustained an anoxic brain injury following the administration of propofol used an anesthetic during the closed reduction of leg fractures in the emergency department on 8/6/11.

Review of the quality improvement incident report for the patient referenced in MR #1 on 12/13/11 determined it was incomplete and did not address the underlying systemic issues associated with this adverse event. The investigation did not include:

-Validated interviews of the staff were missing, including the nurse and physicians who were directly involved in the patient's care, in the emergency department preceding this event. At interview with the facility's administrative staff on 12/12/11, the nurse involved in this incident was terminated and was not available for interview. It was revealed this nurse was also directly involved in a subsequent incident of a pediatric death following an overdose of a child who was administered an adult dosage of intravenous antibiotic.

- The investigation concluded that the patient received one dose of propofol and two doses of morphine but did not consider the fact that a third dose of propofol had been removed from the Omnicell machine at the same time the last morphine dose had been administered at 8:04 AM. There was no investigation of the missing dose of propofol that was removed at the same time of the morphine at 8:04 AM on 8/6/11.

- The facility's quality review was limited to the removal of propofol from the Omnicell but did not correct the fundamental problems with the availability of lethal doses of certain medications, which permits the staff to remove multiple doses of potentially harmful drugs for the same patient.

-Although there is some reference in the report to the amount of time that the orthopedic fellow took to reduce the fracture, there is no correlation between that time and the time that the morphine was administered. During the survey, the facility did not make the orthopedic fellow available for interview and the facility failed to produce any evidence that this fellow had been interviewed by the hospital to give his account of the event. There was no reference in any QA regarding other reasons for the large amounts of propofol removed from the onmicell .

Review of QA submitted to the survey team referred to a notation that the orthopedic fellow commenced the reduction at 7:30 AM . The ER attending administered Morphine 10 IVP and Propofol 200mg over a " few " minutes. Another Morphine 10 MG IVP was given during the reduction. It is stated in additional QA that the " procedure " took about 10 minutes (7:40 PM ) to complete. At 7:22 AM another propofol was removed from the omnicell (200 mg IV) . There is no QA or investigation as to whether this second dose of propofol was administered. There is no reference as to the timing of the second morphine (8:04AM), which does not correspond to the time in the QA when the procedure was underway (7:40 am).

There is no investigation as to why the 8:04 AM entries on the Omnicell have both propofol and morphine being removed from the Omnicell simultaneously.

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Based on medical record review, staff interview and other documents, it was determined the Nursing staff failed to implement the facilities policy for pressure ulcer management to ensure that patients receive care in a safe setting.

Findings include:

A) 1-Review of MR# 2 on 12/13/11 noted an elderly patient was admitted to the hospital on 10/21/11 from a nursing home due to acute respiratory failure. The patient is respirator dependent and has a pressure ulcer stage IV in the sacrum. Documentation of treatment of pressure ulcer from 10/21-10/24/11 was not found.
Patient Admission Database performed by nursing was done on 10/25/11 which noted a Braden score of 11 (high risk). The nurse noted the patient having a Stage III sacral pressure ulcer not a stage IV as per the nursing home document titled " Physician Order Activity Detail Report " and Emergency Department Record. The treatment for the pressure ulcer was not noted in the form titled " Weekly Pressure Ulcer Progress Assessment Update " or in the nursing progress notes until 11/11/11. Patient sacral pressure ulcer increased in size from 9cmx7cmx.5cm on 10/25 to 10cmx12cmx5cm on 11/24/11. This pressure ulcer was debrided on 12/1/11. Patient developed an additional pressure ulcer on 12/1/11 located on the left knee stage II.

2- Review of Nursing Form titled " Weekly Pressure Ulcer Progress Assessment Update " revealed untimely pressure ulcer assessment. Patient ' s pressure ulcer assessments were not done consistently as per facility policy. Time lapse between assessments varied from 5 days to 11 days. Patient ' s pressure ulcer assessments was noted on 10/25, 10/31, 11/11, 11/16, 11/24 and 12/1. Pressure ulcer assessment should be done weekly.

3-The patient ' s Nutrition Reassessments performed by Dietitians noted that the patient ' s weight was not available. These reassessment were done on 11/7, 11/13, 11/18, 11/25, 12/5 and 12/10/11. The patient ' s weight was the same on all Nutrition Reassessment Notes. Blood albumin status was not available after 10/26 for the Dietitian to assess protein status of the patient for wound healing and prevention of protein malnutrition.
4- Patient ' s history and physical exam documented by the physician was not found in the medical record. The Unit Nurse Manager and the Director of Nursing were unable to provide the document.

Based on record review and interview, it was evident that the hospital and pharmacy department failed to formulate and implement policies and procedures to guide clinical staff regarding practices that minimize risk for potential drug errors, in order to meet the safety needs of patients.

Findings include:

It was evident that the pharmacy failed to formulate and implement policies and procedures to govern the clinical activities of medical and nursing staff .

Review of MR#1 and pharmacy omnicell printout report on 12/12/11 found that a lethal dose of propofol was removed from the omnicell machine in the ED under 1 patient's name. Specifically, 600 mg of the propofol was removed over 1 hour by the same nurse for the same patient.. Since the pharmacy has permitted the ED to have an omnicell machine with no pharmacy oversight, the nurse was able to access three(3) 200 mg. vials of propofol for the same patient over 1 hour period. The pharmacy has no record as to the disposition of the drug vials and failed to conduct an investigation of the event.

Review of the Medication Reconciliation for the patient in MR#1 found that the patient's name was associated with a total of 30mg of Morphine. IVP in the ED .

At interview with the Pharmacy Director and the Nursing Services Director on 12/12/11, it was stated that as the nurse was terminated and refused to answer phone calls, the facility relied on hearsay from a union delegate that 1 of the vials was seen under ED tables not accessible for removal.

Review of the omnicell records finds that there is no record of disposition for any of the propofol vials for that period.

Based on record review it was evident that the facility failed to ensure the provision of adequate laboratory services to meet patient needs in the emergency department.

Findings include:

The facility did not ensure that the clinical laboratory services were integrated into emergency services.

Review of MR#1 found that ED staff were not notified of a panic value (hematocrit: 17.1 hemoglobin: 5.8) in a trauma team patient.

The record shows a result for HgB of 5.8 and a HCT of 17.1 was evident at 7:02 AM on 8/6/11. There was no evidence in the medical record that the staff considered this data prior to the performance of a closed reduction under anesthesia in the ED without the presence and consultation by ED staff. There was no evidence of medical or anesthesia clearance prior to the initiation of the procedure.

Review of the facility's QAPI report on 12/12/11 shows the lab staff attempted to call the ED to relate the message of emergency laboratory panic values, but it was reported that no staff answered the telephone.

Based on record review and interview, it was determined the hospital did not ensure the provision of anesthesia services in the emergency department for the immediate availability of qualified anesthesia staff and supervision of the safe delivery of anesthetics that have a high potential for harm to emergency trauma patients.

Findings include:

The hospital failed to ensure accountability for the provision of safe anesthesia services delivered to a patient in the emergency department. The hospital also failed to conduct a focused review of anesthesia care in the matter of an adverse event occurring in the course of anesthesia in the Emergency Department.

1. Review of MR# 1 on 12/12/11 found that the patient received propofol and morphine in the ED to implement conscious sedation in a trauma patient. The patient went into deep anesthesia while in the CT. The patient required emergent intubation and resuscitation and multiple attempts (at least 5 attempts) at intubation were required in this patient. Even though the patient was noted to have been ventilated with a bag-valve device prior to the successful intubation, there was clinical evidence that the patient developed anoxic encephalopathy as a result of improper application of the device during the arrest and unsuccessful intubation attempts.

There was no evidence that the anesthesia staff who was on-call in the facility during this event were notified that a patient in the ED had been under anesthesia and coded.


2. It was evident that the anesthesia department did not ensure that the use of anesthetic agents in areas other than the OR and procedure rooms ( e.g. emergency department) were administered in a safe manner.

Findings include:

Review of MR#1 on 12/12/11 found that the patient who was a trauma team was administered propofol in the ED by the attending for the purpose of providing conscious sedation for emergent closed reduction of a fracture where there was arterial compromise.

Review of facility policy and procedure for moderate sedation does not refer to propofol. Additionally, there was no evidence of NPO status or ASA status . The patient's low HGB (5.8) was not known to the ED staff but was in the system for review. No " tackles box " was taken to CT as required by policy.

The patient received 200 mg. of propofol and 20 mg of morphine IVP over a 55 minute period. After the administration of the second dose of morphine 10 mg. IVP the patient was transferred to CT in the company of a PGY - 2 surgical resident.

The patient went into respiratory arrest and a profound bradycardia in the CT suite while on the ED stretcher. There was no intubation kit in the CT as well as none on the stretcher. The only intervention was transport back to the trauma area and oxygenation.

The patient required at least 5 attempts at endotracheal intubation prior to the anesthesia service's successful attempt.

There was no evidence that the ED exercised proper supervision of the patient where the patient had received propofol and morphine proximal to transport to the CT. The patient evidenced a progression to deep anesthesia in the CT. The patient's hematocrit was 17.1 and hemoglobin was 5.8, and the ED medical staff had no knowledge of this for proper clearance.

Based on record review and interview it was evident that the hospital failed to provide effective coordination of care and trauma services to an emergency patient that conformed to current standards of practice.

Findings include:

Review of the record of a patient referenced in MR#1 on 12/12/11 found that the ED failed to provide trauma services to a patient that conformed to current standards of emergency practice. In addition, the hospital did not develop procedures to ensure the appropriate monitoring of trauma patients who require anesthetic medications that represent a high risk for complication during the course of conscious sedation procedures conducted outside of the operating room in the emergency department.

The facility is a level 1 trauma center and the patient referenced in MR#1 was in an MVA on 8/6/11 with open fractures of the leg. There was advanced notification by EMS. The trauma team was called. The ED deferred to the orthopedic service in not transporting the patient to the OR for reduction when there was clinical evidence of arterial compromise.

Instead, there were attempts at closed reduction utilizing propofol and morphine IVP for "conscious sedation. " There was no evidence that the ED checked a panic value of hemoglobin of 5.8 . The patient, however received a second dose of morphine minutes prior to being transported to the CT without any intubation kit in the company of a resident.

The record shows a result for HgB of 5.8 and a HCT of 17.1 was evident at 7:02 AM on 8/6/11. There was no evidence in the medical record that the staff considered this data prior to the performance of a closed reduction under anesthesia in the ED without the presence and consultation by ED staff. There was no evidence of medical or anesthesia clearance prior to the initiation of the procedure. There was no evidence that any ED staff had attempted to determine the status of the laboratory results.

Review of Omnicell records (medication dispensation machine) corresponding to MR #1 on 12/12/11 found that the following medications were removed:
At 7:01 AM on 8/6/11 , 1 unit cefazolin sodium 1 GM inj was removed.

The following medications were removed from Omnicell by the same RN:
At 7:13 AM on 8/6/11, 1 unit of morphine sulfate 5 mg/1 ml 1 ML inj was removed from Omnicell by the nurse.
At 7:13 AM on 8/6/11, another entry for 1 unit of morphine sulfate 5 mg/1 ml 1 ML inj was removed from Omnicell by the nurse.
At 7:14 AM on 8/6/11, an entry for 1 unit of propofol 10 mg/1 ml , 20 ML inj was removed from Omnicell by the nurse.
At 7:16 AM on 8/6/11, an entry for 2 gentamicin sulfate 40 mg/1ml 2mg INJ was removed from Omnicell by the nurse.
At 7:22 AM on 8/6/11, another entry for 1 unit of propofol 10 mg/1 ml , 20 ML inj was removed from Omnicell by the nurse.
At 8:04 AM on 8/6/11, an entry for 1 unit of morphine sulfate 10 mg/1 ml 1 ML vial was removed from Omnicell by the nurse.
At 8:04 AM on 8/6/11, an entry for 1 unit of propofol 10 mg/1 ml , 20 ML inj was removed from Omnicell by the nurse.

The orders on the record do not correspond to the record of medication removal from the Omnicell machine.

According to review of MR#1 and comparison to the Omnicell pharmacy report in the ED, it was found the same RN removed 3 vials of Propofol 200 mg under the patient's name over a period of 50 minutes. Further review finds that the medical record reports that the patient was administered Propofol 200 mg IVP and morphine 10mg IVP by the ED attending.

The nursing notes report that after the patient went into cardiac arrest the ED, the MD entered the computer at 10:03 am and charted in the medical orders section that he administered this drug in a different sequence. Specifically, at 10:03 AM , the MD noted, "propofol 40 mg were given Q20 secs until induction total used 200 mgs".

Review of omnicell record identifies that the nurse removed 200 mg. of Propofol concurrently with a total of Morphine 10 mg. IVP at 7:13 and 7:14 AM. Eight (8) minutes later at 7:22 AM, the same nurse removed 200 mg of propofol from the omnicell but there is no record of any administration of it in the patient record . A third episode of removal of 200 mg of propofol and morphine 10 MG was noted at 8:04 AM (this third propofol dose was removed 42 minutes following the removal of the second propofol dose).

While the second morphine dose of 10mg IVP was ordered, and the facility staff stated at interview that it was administered, this medication was removed from the Omnicell at the same time as a third vial of propofol 200 MG was taken concurrently from the Omnicell at 8:04 AM.

There is no record of the disposition of the 8:04 AM propofol dose. In addition, there is no written documentation to support that the patient actually received the subsequent dose of morphine that was taken from Omnicell at 8:04 AM.

Review of the sedation/ anesthesia record for MR#1 found that the RN documented propofol " " " (representing ditto) dose at 7:13 am, Propofol 120 mg at 7:14 am and propofol 80 mg, written at 7:15 am and 7:17 am. This 7:15 am and 7:17 am entry noted "propofol" as 80 mg IVP, giving by the physician (name noted)". This entry written for 80 mg was written in bold print and was superimposed over another number. This entry documented for 80 mg of propofol was written over an original number of 120 mg.

The surveyor noted from the record that the initial dose of propofol was administered with morphine between 7:13 AM and 7:17 AM.

At 50 minutes later, a second dose of morphine was administered as ordered but the propofol 200mg IV is recorded as being removed concurrently with the morphine at 8:04 AM.

Review of the ED record for medical orders found that the morphine 10 MG IVP and propofol 200 mg were ordered and noted as given at 7:13 AM. A second order for morphine 10 MG IVP was noted at 9:54 AM (after the patient's respiratory arrest) but was not given at that time, according to interview of the ED Medical Director and review of QA documents on 12/12/11.

There was no evidence that the ED attending or the trauma team assessed that the administration of the second morphine 10 mg. removed at 8:04 AM represented a deeper sedation, bordering on anesthesia. There is no evidence that the trauma team checked the labs to determine if it was safe to put the patient under general anesthesia in any area other than the OR with strict anesthesia supervision. There was no assessment by the trauma team or the ED medical staff of the potential need for endotracheal intubation, in that the patient received a larger dose of medications than could be safely administered to a non-ventilated patient.

After this medication, which was administered at 8:04 AM, the patient was transported to the CT at 8:25 AM without any intubation setup. At 8:30 AM, the patient went into respiratory arrest and a profound bradycardia. Heart rate was noted of 32. At approximately 8:32 AM. a code was called in the ED. Multiple unsuccessful attempts at intubation were carried out without concurrent ventilatory support and the patient sustained anoxic brain injury.

Review of the record found no evidence of a procedure note written for the closed reduction of the fractures by the orthopedic staff in the ED. At interview with the ED Medical Director on 12/12/11, it was stated that Registered Nurses are permitted to administer IV push propofol.

Cross refer to findings noted under tag # A1103.

Based on record review and interview, it was evident that the hospital did not formulate and implement procedures or practices to promote integration of activities between clinical staff and departments to achieve effective coordination of care provided to emergency trauma patients.

Findings include:

It was evident that the ED did not formulate and implement a policy addressing STAT verbal orders in the ED by multiple practitioners during trauma teams and other emergencies. Specific reference is made to the lack of structured policy and oversight of the management of trauma teams during emergent matters that require time-sensitive coordination of care and effective communications between multiple practitioners at the same time in the emergency department, in order to maintain patient safety.

It was determined there was no policy regarding verbal orders applicable to the emergency department.

Review of MR#1 on 12/12/11 found that the patient was a driver in an MVA and was made a trauma team on arrival. There is evidence that the patient was seen by orthopedics and an attempt was made to reduce fractures that were causing arterial compromise. There is evidence that propofol 200 mg and Morphine 10mg were administered prior to the reduction.

Review of the record (QA) finds that a second dose of Morphine 10 mg. IVP was administered during the reduction. The reduction took 10 minutes. It was not clear who ordered that second dose. There is no record of that Morphine on the omnicell. There is, however a propofol 200 mg removed corresponding to that time. The facility management reports that they have no record of that propofol but they have been advised by a " union steward " that the vial " fell " under a table.

Specifically, the omnicell record notes another propofol 200 mg being removed from the omnicell corresponding to that time. This entry is at 7:22 am, 8 minutes after 7:14 am when the initial dose of propofol is recorded in the omnicell and in the record.

No policy regarding multiple medication orders and verbal orders issued by other disciplines in a trauma team is found. In addition, there is no specific policy that describes the integration of activities performed by staff from different departments and coordination of staff responsibility during a trauma.