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1 BROOKDALE PLAZA

BROOKLYN, NY 11212

ANESTHESIA SERVICES

Tag No.: A1000

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.

USE OF RESTRAINT OR SECLUSION

Tag No.: A0154

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.

PATIENT SAFETY

Tag No.: A0286

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.

INTEGRATION OF EMERGENCY SERVICES

Tag No.: 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.