The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

CHRISTUS SOUTHEAST TEXAS- ST ELIZABETH 2830 CALDER AVENUE BEAUMONT, TX 77702 Nov. 10, 2017
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on review of records and interview, the hospital failed to:

A. protect patients from being restrained for staff convenience in 2 patients (patient #1 and #2) out of 5 patients reviewed. The hospital failed to enforce existing policy and procedures established to protect patients from being restrained for staff convenience. Patients #1 and #2 were both confused after having brain bleeds. Staff placed both patients in restraints without calling the physician for orders and without attempting all available, less restrictive, interventions to reduce the risk of patient injury and prevent unnecessary restraint.

See findings in Tag A0154


B. protect patients from being restrained without physician orders in 2 patients (Patient #1 and #2) out of 5 patients reviewed. Patients #1 and #2 were placed in restraints without a valid physician order. Patient #1 died within hours after being placed in a vest restraint that had not been ordered. Patient #2 fell out of bed trying to climb over four bed rails placed up as an unordered restraint used to keep the patient from getting out of bed without assistance. Patient #2 was then placed in an unordered vest restraint to prevent him from getting out of bed.

See findings in Tag A0168



These deficient practices were determined to pose Immediate Jeopardy to patient health and safety, and placed all patients at risk for the likelihood of harm, serious injury, and possible subsequent death.
VIOLATION: USE OF RESTRAINT OR SECLUSION Tag No: A0154
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on review of record, observation, and interview, the hospital failed to protect patients from being restrained for staff convenience in 2 patients (patient #1 and #2) out of 5 patients reviewed. The hospital failed to enforce existing policy and procedures established to protect patients from being restrained for staff convenience. Patients #1 and #2 were both confused after having brain bleeds. Staff placed both patients in restraints without calling the physician for orders and without attempting all available, less restrictive, interventions to reduce the risk of patient injury and prevent unnecessary restraint.


Review of Patient #1's chart was as follows:


Patient #1 was a [AGE] year old male admitted from jail on 10-20-2017. Notes from the chart indicate he was making a phone call at the jail, lost consciousness, and may have been suffering seizure activity. He sustained lacerations (cuts) above his eye and to the back of his head. Imaging of the brain showed that he had some brain bleeding and swelling. He was placed on a ventilator and was unresponsive. Over the course of next 5 days, he became more responsive and was taken off of the ventilator on 10-25-2017. At this time, restraints were discontinued. Notes from the chart show at 8:00 pm on 10-25-2017, the patient was unrestrained. At 11:00 pm that same evening, the records indicate he was wearing a restraint vest. A restraint order for 10-25-2017 was found in the chart. The order was for bilateral wrist restraints and was signed on 10-26-2017 at 9:15 am, 5 hours and 38 minutes after the patient had been pronounced dead. A restraint order for 10-26-2017 was found in the chart. The order was for bilateral wrist restraints and was also signed on 10-26-2017 at 9:15 am, 5 hours and 38 minutes after the patient had been pronounced dead. No orders for a vest restraint were found for the days of 10-25-2017 and 10-26-2017.


An interview was conducted with Staff #12, who had been caring for the patient on the overnight shift from 10-25-2017 to the morning of 10-26-2017. Staff #12 stated he attempted bathing the patient to calm him down. He stated the patient was agitated. Staff #12 stated he had placed the restraint vest for patient safety. He was worried the patient may hurt himself by trying to get up out of bed. He stated he did not call the physician for an order. Staff #12 stated the Neuro ICU nurses do not call the physician in the middle of the night to get restraint orders. Staff #12 stated, "It's like a protocol that we just do that", referring to placing a patient in restraints and putting a form on the front of the chart for the physician to sign the next day.


Review of Patient #2's chart revealed the following:


Patient #2 was a [AGE] year old male admitted on [DATE] for a brain bleed. The patient had been on the ventilator with wrist restraints to keep him from pulling at tubes and lines. The patient was off of the ventilator on 10-22-2017 and restraints had been discontinued. On 10-29-2017, the patient was in bed in the Neuro ICU. All four rails were up. The patient was later found at 8:20 pm on his left side on the floor. The patient was placed in a restraint vest. No order was found for all four rails to be raised. An order for the restraint vest dated 10-29-2017 at 9:00 pm was found in the chart. However, the nursing staff had not initiated it as a telephone order. The physician had not signed the order until 10-31-2017 at 5:00 pm, 44 hours after the restraint had been initiated.


An interview was conducted with Staff #9, the manager who had completed the chart review for the fall report. Staff #9 stated he was familiar with this patient. The patient had right sided weakness due to the brain bleed. Staff #9 reported the patient would push the call light but would not wait for nursing staff to assist him in getting out of bed. Staff #9 stated that was why the four rails had been raised. Staff #9 stated that the ICU had been fully staffed on the night of the fall. Staffing in the ICU is 1 nurse to 2 patients. Review of nurse staff sheets confirmed the ICU was fully staffed. Staff #9 stated that the patient room was directly in front of and in full view of the nursing station. Observation of the nursing station confirmed the patient room was in direct line of sight of the station. Staff #9 confirmed that no one witnessed the patient crawl over the rails and fall and that was why he was placed in a restraint vest after his fall. When asked if sitters could be arranged, Staff #9 stated that sitters were used rarely to keep the budget down.


A review of policy titled: "Standardized Use of Restraint and/or Seclusion", Policy Number: 3.80, Revised 04/2016 was made as follows:


Page 1 of 15
"III. POLICY STATEMENT:

...
C. The use of restraints for the prevention of falls should not be considered a routine part of fall prevention.

D. A request from a patient or family member for the application of a restraint and/or a seclusion, which they would consider beneficial, is not a sufficient basis for the use of a restraint or seclusion intervention.

E. Restraint and/or seclusion are not used as a means of coercion, discipline, or staff convenience or retaliation.

F. Restraint or seclusion is only used when less restrictive interventions are ineffective. Moreover, the hospital will use the least restrictive form of restraint or seclusion that protects the physical safety of the patient, staff, or others."



Page 5 of 15

"V. PROCESS:

...
C. Restraint and/or seclusion are used only when less restrictive, alternative interventions are ineffective. See list of alternatives below:

...
8. Family/significant other/sitter at bedside"



Page 6 of 15

"Restraint Orders: Non-violent or non self-destructive

1. LIP issues the order for use of restraints.

2. In response to an unanticipated change in patient condition that is considered an emergency, restraints may be initiated by a Registered Nurse.

3. The nurse immediately (within a few minutes) notifies a licensed independent practitioner (LIP) and requests a verbal or written order. If restraints are initiated based on a significant change in patient condition, the LIP is notified immediately.

4. A written order based on an examination by the LIP is entered into the record within 24 hours. The order must be time-limited to the next calendar day and include clinical justification, date, time and type of restraint. Standing orders/protocols or PRN (as needed) orders for restraints are prohibited."
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0168
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on review of record, observation, and interview, the hospital failed to protect patients from being restrained without physician orders in 2 patients (Patient #1 and #2) out of 5 patients reviewed. Patients #1 and #2 were placed in restraints without a valid physician order. Patient #1 died within hours after being placed in a vest restraint that had not been ordered. Patient #2 fell out of bed trying to climb over four bed rails placed up as an unordered restraint used to keep the patient from getting out of bed without assistance. Patient #2 was then placed in an unordered vest restraint to prevent him from getting out of bed.


Review of Patient #1's chart was as follows:


Patient #1 was a [AGE] year old male admitted from jail on 10-20-2017. Notes from the chart indicate he was making a phone call at the jail, lost consciousness, and may have been suffering seizure activity. He sustained lacerations (cuts) above his eye and to the back of his head. Imaging of the brain showed that he had some brain bleeding and swelling. He was placed on a ventilator and was unresponsive. Over the course of next 5 days, he became more responsive and was taken off of the ventilator on 10-25-2017. At this time, restraints were discontinued. Notes from the chart show at 8:00 pm on 10-25-2017, the patient was unrestrained. At 11:00 pm that same evening, the records indicate he was wearing a restraint vest. A restraint order for 10-25-2017 was found in the chart. The order was for bilateral wrist restraints and was signed on 10-26-2017 at 9:15 am, 5 hours and 38 minutes after the patient had been pronounced dead. A restraint order for 10-26-2017 was found in the chart. The order was for bilateral wrist restraints and was also signed on 10-26-2017 at 9:15 am, 5 hours and 38 minutes after the patient had been pronounced dead. No orders for a vest restraint were found for the days of 10-25-2017 and 10-26-2017.


An interview was conducted with Staff #12, who had been caring for the patient on the overnight shift from 10-25-2017 to the morning of 10-26-2017. Staff #12 stated he attempted bathing the patient to calm him down. He stated the patient was agitated. Staff #12 stated he had placed the restraint vest for patient safety. He was worried the patient may hurt himself by trying to get up out of bed. He stated he did not call the physician for an order. Staff #12 stated the Neuro ICU nurses do not call the physician in the middle of the night to get restraint orders. Staff #12 stated, "It's like a protocol that we just do that", referring to placing a patient in restraints and putting a form on the front of the chart for the physician to sign the next day.


Review of Patient #2's chart revealed the following:


Patient #2 was a [AGE] year old male admitted on [DATE] for a brain bleed. The patient had been on the ventilator with wrist restraints to keep him from pulling at tubes and lines. The patient was off of the ventilator on 10-22-2017 and restraints had been discontinued. On 10-29-2017, the patient was in bed in the Neuro ICU. All four rails were up. The patient was later found at 8:20 pm on his left side on the floor. The patient was placed in a restraint vest. No order was found for all four rails to be raised. An order for the restraint vest dated 10-29-2017 at 9:00 pm was found in the chart. However, the nursing staff had not initiated it as a telephone order. The physician had not signed the order until 10-31-2017 at 5:00 pm, 44 hours after the restraint had been initiated.



An interview was conducted with Staff #9, the manager who had completed the chart review for the fall report. Staff #9 stated he was familiar with this patient. The patient had right sided weakness due to the brain bleed. Staff #9 reported the patient would push the call light but would not wait for nursing staff to assist him in getting out of bed. Staff #9 stated that was why the four rails had been raised. Staff #9 stated that the ICU had been fully staffed on the night of the fall. Staffing in the ICU is 1 nurse to 2 patients. Review of nurse staff sheets confirmed the ICU was fully staffed. Staff #9 stated that the patient room was directly in front of and in full view of the nursing station. Observation of the nursing station confirmed the patient room was in direct line of sight of the station. Staff #9 confirmed that no one witnessed the patient crawl over the rails and fall and that was why he was placed in a restraint vest after his fall. When asked if sitters could be arranged, Staff #9 stated that sitters were used rarely to keep the budget down.


A review of policy titled: "Standardized Use of Restraint and/or Seclusion", Policy Number: 3.80, Revised 04/2016 was made as follows:


Page 1 of 15
"III. POLICY STATEMENT:

...
C. The use of restraints for the prevention of falls should not be considered a routine part of fall prevention.

D. A request from a patient or family member for the application of a restraint and/or a seclusion, which they would consider beneficial, is not a sufficient basis for the use of a restraint or seclusion intervention.

E. Restraint and/or seclusion are not used as a means of coercion, discipline, or staff convenience or retaliation.

F. Restraint or seclusion is only used when less restrictive interventions are ineffective. Moreover, the hospital will use the least restrictive form of restraint or seclusion that protects the physical safety of the patient, staff, or others."



Page 5 of 15

"V. PROCESS:

...
C. Restraint and/or seclusion are used only when less restrictive, alternative interventions are ineffective. See list of alternatives below:

...
8. Family/significant other/sitter at bedside"


Page 6 of 15

"Restraint Orders: Non-violent or non self-destructive

1. LIP issues the order for use of restraints.

2. In response to an unanticipated change in patient condition that is considered an emergency, restraints may be initiated by a Registered Nurse.

3. The nurse immediately (within a few minutes) notifies a licensed independent practitioner (LIP) and requests a verbal or written order. If restraints are initiated based on a significant change in patient condition, the LIP is notified immediately.

4. A written order based on an examination by the LIP is entered into the record within 24 hours. The order must be time-limited to the next calendar day and include clinical justification, date, time and type of restraint. Standing orders/protocols or PRN (as needed) orders for restraints are prohibited."
VIOLATION: NURSING SERVICES Tag No: A0385
Based on review of records and interview, the nursing staff failed to administer controlled substances (Fentanyl) in a safe manner per physician orders/protocols in 5 patients (Patient #'s 1, 3, 5, 6, and 12) out of 11 patients reviewed. Nursing staff were administering bolus (a single dose given at once) doses of Fentanyl and titrating (changing the rate up or down based on patient condition) Fentanyl without physician orders to do so.


See findings in Tag A0405


These deficient practices were determined to pose Immediate Jeopardy to patient health and safety, and placed all patients at risk for the likelihood of harm, serious injury, and possible subsequent death.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
Based on review of records and interview, the nursing staff failed to administer controlled substances (Fentanyl) in a safe manner per physician orders/protocols in 5 patients (Patient #'s 1, 3, 5, 6, and 12) out of 11 patients reviewed. Nursing staff were administering bolus (a single dose given at once) doses of Fentanyl and titrating (changing the rate up or down based on patient condition) Fentanyl without physician orders to do so.


Patient #1

An order was placed on 10-22-2017 for a Fentanyl drip to be given intravenously (IV) as directed at a rate of 50 micrograms (mcg) per hour. No other Fentanyl order was found for patient #1.

The Medication Administration Record (MAR) was documented that the Fentanyl drip was running at a rate of 5 milliliters per hour (equivalent to 50 mcg per hour) from 10/22/2017 through 10/25/2017. No documentation was found of any variance from this rate, to include bolus (a single dose given at once) injections.

Review of the Controlled Drug Administration Record (CDAR) showed that:

1. on 10/22/17, the Fentanyl drip was initiated at the ordered rate with a 4 hour limit of 200 mcg.

2. on 10-23-2017 at 10:00 pm, the CDAR records indicate the patient received a 50 mcg bolus. Four hours later at 2:00 am and again at 6:00 am, the records indicate the patient received 50 mcg boluses.

3. on 10-24-2017 at 10:00 pm, the patient received a 100 mcg bolus. Four hours later on 10-25-2017 at 2:00 am, the patient received another 50 mcg bolus.

4. on 10-25-2017 at 2:00 pm, the patient received a 100 mcg bolus.

5. on 10-25-2017 at 4:30 pm the patient received an 80 mcg bolus.

6. on 10-25-2017 at 6:00 pm the patient was given another 100 mcg bolus.

Review of the patient record showed that the patient began experiencing respiratory distress and decreased level of consciousness. Around 2:00 am, the physician was notified, all narcotics were held, and Narcan was administered. The record reflects that the patient condition did not improve upon Narcan administration. The patient was pronounced dead on 10-26-2017 at 3:37 am.


Patient #3

An order was placed on 11-1-2017 for a Fentanyl drip to be given intravenously (IV) as directed at a rate of 100 micrograms (mcg) per hour. No other Fentanyl order was found for patient #3.

The Medication Administration Record (MAR) was documented that the Fentanyl drip was running at a rate of 10 milliliters per hour (equivalent to 100 mcg per hour) from 11/1/2017 through 11/9/2017. No documentation was found of any variance from this rate, to include bolus (a single dose given at once) injections.

Review of the Controlled Drug Administration Record (CDAR) showed that:

1. on 11/1/17, the Fentanyl drip was initiated at the ordered rate with a 4 hour limit of 400 mcg.

2. on 11-2-2017 at 10:00 am, the record shows the patient received a 100 mcg bolus.

3. on 11-2-2017 at 6:00 pm, the record shows the patient received a 50 mcg bolus.

4. on 11-3-2017 at 7:00 pm, the record shows the patient received a 50 mcg bolus. On 11-7-2017 at 2:00 am, the record shows the patient received a 50 mcg bolus.


Patient #5

An order was placed on 10-26-2017 for a Fentanyl drip to be given intravenously (IV) as directed at a rate of 50 micrograms (mcg) per hour. No other Fentanyl drip orders were found for patient #5.

The Medication Administration Record (MAR) was documented that the Fentanyl drip was running at a rate of 5 milliliters per hour (equivalent to 50 mcg per hour) from 10/26/2017 through 11/4/2017. On 11/4/2017, the rate was documented as 20 milliliters per hour (equivalent to 200 mcg per hour). No documentation was found of an order to titrate (change the rate based on patient condition) or to include bolus (a single dose given at once) injections.

Review of the Controlled Drug Administration Record (CDAR) showed that:

1. on 10/27/17, the Fentanyl drip was initiated at the ordered rate with a 4 hour limit of 200 mcg. The record showed that the patient received a 100 mcg bolus on 10-27-2017 at 10:00 am, a 50 mcg bolus on 10-27-2017 at 6:00 pm, a 50 mcg bolus on 10-27-2017 at 10:00 pm, and again at midnight.

2. on 11-1-2017 at 4:00 pm, the rate was increased to 150 mcg per hour with a 50 mcg bolus. The rate was titrated up and down between 100 mcg and 150 mcg until 11-4-2017 at 3:30 am when it was set at 200 mcg per hour and remained there until the drip was discontinued on 11-8-2017. During those four days, the patient received 4 additional 50 mcg boluses and two additional 100 mcg boluses.


Patient #6

An order was placed on 11-5-2017 for a Fentanyl drip to be given intravenously (IV) as directed at a rate of 25 micrograms (mcg) per hour. No other Fentanyl order was found for patient #6.

The Medication Administration Record (MAR) was documented that the Fentanyl drip was running at a rate of 2.5 milliliters per hour (equivalent to 25 mcg per hour) from 11/5/2017 through 11/9/2017. No documentation was found of any variance from this rate, to include bolus (a single dose given at once) injections.

Review of the Controlled Drug Administration Record (CDAR) showed that on 11/5/17, the Fentanyl drip was initiated at the ordered rate with a 4 hour limit of 100 mcg. On 11-7-2017 at 6:00 am, the CDAR showed that the patient was given a 100 mcg bolus of Fentanyl. The total 4 hour dose documented was 220 mcg. This total was 20 mcg over the recorded 4 hour dose given and the 100 mcg dose given, without an explanation. This exceeded the 4 hour limit by 120 mcg without a physician order.

The records between 11-7-2017 at 8:00 am and 11-8-2017 at 10:00 am were not found in the record. On 11-8-2017 at 10:00 am, the CDAR reflects that the rate was increased from 25 mcg an hour to 100 mcg per hour with a 4 hour limit of 400 mcg. No order was found for the increase. The Fentanyl drip remained at that rate until it was discontinued on 11-9-2017.



Patient #12

An order was placed on 10-4-2017 for a Fentanyl drip to be given intravenously (IV) as directed at a starting rate of 25 micrograms (mcg) per hour. The rate was ordered to be adjusted every hour by 25 mcg per hour for keep pain less than 4 on the pain scale. No other Fentanyl order was found for patient #4.

Review of the Controlled Drug Administration Record (CDAR) indicted on the Fentanyl drip was started 10-4-2017 at 5:30 pm. At 6:00 pm the continuous rate was recorded at 150 mcg per hour, 100 mcg higher than the titration rate allowed. In addition to the increased continuous rate, the record showed the patient had been given a 100 mcg bolus. On 10-5-2017 the patient received a 50 mcg bolus at 2:00 pm and 25 mcg bolus at 6:00 pm. On 10-10-2017 the record showed the patient received a 4 mcg bolus at 10:00 pm.



On 11-9-2017 an interview was conducted with Staff #15 in the Medical Intensive Care Unit (MICU). Staff #15 stated that when a bolus of Fentanyl is needed for a patient, the medication is removed from the bag of medication that is currently hanging and administered. Staff #15 stated that when ampoules (individual doses) of Fentanyl are given, it is during a procedure such as intubation or surgery.

On 11-10-2017, an interview was conducted with Staff #10. Staff #10 stated that the Fentanyl drip she was managing was "per protocol". Staff #10 was not able to locate the protocol in the patient orders or in the intranet where hospital protocols are located.



An interview was conducted with Staff #11, Pharmacy Director. Staff #11 stated he did not know information from the Fentanyl order set that had been used prior to computerized physician order entry (CPOE) was not in the electronic orders. Staff #11 was able to locate a paper copy of a Fentanyl order set that had been used prior to CPOE. Staff #11 stated this was the protocol that nursing staff were referring to. Staff #11 confirmed that the information on the paper order was not in the electronic order. Staff #11 confirmed that without this information in CPOE, the orders were incomplete.
VIOLATION: Condition of Participation: Pharmaceutical Se Tag No: A0489
Based on review of records, observation, and interview, the pharmacy failed to ensure effective oversight of pharmaceutical servicesin the hospital in that Fentanyl was not ordered, administered, and monitored in a safe manner in 5 patients (Patient #'s 1, 3, 5, 6, and 12) out of 11 patients reviewed. The pharmacist failed to reconcile the physician orders and the Controlled Drug Administration Record (CDAR) to ensure the medication were given in accordance with the physician orders.


See findings in Tag A0500


These deficient practices were determined to pose Immediate Jeopardy to patient health and safety, and placed all patients at risk for the likelihood of harm, serious injury, and possible subsequent death.
VIOLATION: DELIVERY OF DRUGS Tag No: A0500
Based on review of records, observation, and interview, the pharmacy failed to ensure that Fentanyl was ordered, administered, and monitored in a safe manner in 5 patients (Patient #'s 1, 3, 5, 6, and 12) out of 11 patients reviewed. Pharmacy failed to review and reconcile the physician orders with the Controlled Drug Administration Record (CDAR) to ensure the medication was given in accordance with the physician order.


Patient #1

An order was placed on 10-22-2017 for a Fentanyl drip to be given intravenously (IV) as directed at a rate of 50 micrograms (mcg) per hour. No other Fentanyl order was found for patient #1.

The Medication Administration Record (MAR) was documented that the Fentanyl drip was running at a rate of 5 milliliters per hour (equivalent to 50 mcg per hour) from 10/22/2017 through 10/25/2017. No documentation was found of any variance from this rate, to include bolus (a single dose given at once) injections.

Review of the CDAR showed that on 10/22/17, the Fentanyl drip was initiated at the ordered rate with a 4 hour limit of 200 mcg. On 10-23-2017 at 10:00 pm, the CDAR records indicate the patient received a 50 mcg bolus. Four hours later at 2:00 am and again at 6:00 am, the records indicate the patient received 50 mcg boluses. On 10-24-2017 at 10:00 pm, the patient received a 100 mcg bolus. Four hours later on 10-25-2017 at 2:00 am, the patient received another 50 mcg bolus. On 10-25-2017 at 2:00 pm, the patient received a 100 mcg bolus. On 10-25-2017 at 4:30 pm the patient received an 80 mcg bolus. On 10-25-2017 at 6:00 pm the patient was given another 100 mcg bolus. Review of the patient record showed that the patient began experiencing respiratory distress and decreased level of consciousness. Around 2:00 am, the physician was notified, all narcotics were held, and Narcan was administered. The record reflects that the patient condition did not improve upon Narcan administration. The patient was pronounced dead on 10-26-2017 at 3:37 am.


Patient #3

An order was placed on 11-1-2017 for a Fentanyl drip to be given intravenously (IV) as directed at a rate of 100 micrograms (mcg) per hour. No other Fentanyl order was found for patient #3.

The Medication Administration Record (MAR) was documented that the Fentanyl drip was running at a rate of 10 milliliters per hour (equivalent to 100 mcg per hour) from 11/1/2017 through 11/9/2017. No documentation was found of any variance from this rate, to include bolus (a single dose given at once) injections.

Review of the Controlled Drug Administration Record (CDAR) showed that on 11/1/17, the Fentanyl drip was initiated at the ordered rate with a 4 hour limit of 400 mcg. On 11-2-2017 at 10:00 am, the record shows the patient received a 100 mcg bolus. On 11-2-2017 at 6:00 pm, the record shows the patient received a 50 mcg bolus. On 11-3-2017 at 7:00 pm, the record shows the patient received a 50 mcg bolus. On 11-7-2017 at 2:00 am, the record shows the patient received a 50 mcg bolus.


Patient #5

An order was placed on 10-26-2017 for a Fentanyl drip to be given intravenously (IV) as directed at a rate of 50 micrograms (mcg) per hour. No other Fentanyl drip orders were found for patient #5.

The Medication Administration Record (MAR) was documented that the Fentanyl drip was running at a rate of 5 milliliters per hour (equivalent to 50 mcg per hour) from 10/26/2017 through 11/4/2017. On 11/4/2017, the rate was documented as 20 milliliters per hour (equivalent to 200 mcg per hour). No documentation was found of an order to change the rate or to include bolus (a single dose given at once) injections.

Review of the Controlled Drug Administration Record (CDAR) showed that on 10/27/17, the Fentanyl drip was initiated at the ordered rate with a 4 hour limit of 200 mcg. The record showed that the patient received a 100 mcg bolus on 10-27-2017 at 10:00 am, a 50 mcg bolus on 10-27-2017 at 6:00 pm, a 50 mcg bolus on 10-27-2017 at 10:00 pm, and again at midnight. On 11-1-2017 at 4:00 pm, the rate was increased to 150 mcg per hour with a 50 mcg bolus. The rate was titrated up and down between 100 mcg and 150 mcg until 11-4-2017 at 3:30 am when it was set at 200 mcg per hour and remained there until the drip was discontinued on 11-8-2017. During those four days, the patient received 4 additional 50 mcg boluses and two additional 100 mcg boluses.


Patient #6

An order was placed on 11-5-2017 for a Fentanyl drip to be given intravenously (IV) as directed at a rate of 25 micrograms (mcg) per hour. No other Fentanyl order was found for patient #6.

The Medication Administration Record (MAR) was documented that the Fentanyl drip was running at a rate of 2.5 milliliters per hour (equivalent to 25 mcg per hour) from 11/5/2017 through 11/9/2017. No documentation was found of any variance from this rate, to include bolus (a single dose given at once) injections.

Review of the Controlled Drug Administration Record (CDAR) showed that on 11/5/17, the Fentanyl drip was initiated at the ordered rate with a 4 hour limit of 100 mcg. On 11-7-2017 at 6:00 am, the CDAR showed that the patient was given a 100 mcg bolus of Fentanyl. The total 4 hour dose documented was 220 mcg. This total was 20 mcg over the recorded 4 hour dose given and the 100 mcg dose given, without an explanation. This exceeded the 4 hour limit by 120 mcg without a physician order.

The records between 11-7-2017 at 8:00 am and 11-8-2017 at 10:00 am were not found in the record. On 11-8-2017 at 10:00 am, the CDAR reflects that the rate was increased from 25 mcg an hour to 100 mcg per hour with a 4 hour limit of 400 mcg. No order was found for the increase. The Fentanyl drip remained at that rate until it was discontinued on 11-9-2017.



Patient #12

An order was placed on 10-4-2017 for a Fentanyl drip to be given intravenously (IV) as directed at a starting rate of 25 micrograms (mcg) per hour. The rate was ordered to be adjusted every hour by 25 mcg per hour for keep pain less than 4 on the pain scale. No other Fentanyl order was found for patient #4.

Review of the Controlled Drug Administration Record (CDAR) indicted on the Fentanyl drip was started 10-4-2017 at 5:30 pm. At 6:00 pm the continuous rate was recorded at 150 mcg per hour, 100 mcg higher than the titration rate allowed. In addition to the increased continuous rate, the record showed the patient had been given a 100 mcg bolus. On 10-5-2017 the patient received a 50 mcg bolus at 2:00 pm and 25 mcg bolus at 6:00 pm. On 10-10-2017 the record showed the patient received a 4 mcg bolus at 10:00 pm.



Interview was conducted with Staff #11, Pharmacy Director. Staff #11 stated that pharmacy reviews the CDAR and the orders to ensure the medication is given per orders. Staff #11 stated that there was an approved protocol for the Fentanyl drips that allowed for bolus injections based on specific criteria. The protocol also allowed for nursing staff to titrate the medication (change the rate up or down) based on specific criteria. Staff #11 was not able to provide a copy of the approved protocol. No protocol was found in the patient records or in the computer system.


Staff #11 stated that nursing staff were not able to give a bolus injection by removing Fentanyl from the patient's existing bag of medication. Fentanyl would have to be given through the IV pump settings for a bolus or a separate order would have to be written, requiring the nurse to remove a separate dose of Fentanyl from the medication dispense machine. When Staff #11 was told nursing could remove the medication from the existing bag, a tour of the Medical Intensive Care Unit (MICU) was made to observe the pumps in use.


Staff #10 was observed in the MICU accessing the pump settings for the medication Fentanyl for Patient #3. It was observed that there was not a setting to provide a bolus of medication through the pump. Staff #10 confirmed that if a separate dose of Fentanyl was not removed from the medication dispense machine with a separate order for a bolus, the Fentanyl bolus was removed from the existing bag and injected into the IV tubing between the pump and patient. This would not be accounted for in the pump totals, but would be written on the CDAR. Staff #10 was not able to locate a protocol that allowed for a bolus of medication to be given.


During the tour, Staff #11 confirmed that he was not aware that this was how Fentanyl was being given to the patients.