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.

STAMFORD HOSPITAL ONE HOSPITAL PLAZA STAMFORD, CT 06904 Aug. 10, 2017
VIOLATION: QAPI Tag No: A0263
The Condition of QAPI has not been met.

Based on a review of clinical records, staff interviews and a review of hospital documentation for ten of ten patients reviewed for the administration and titration of sedative medications (Patient #1, #2, #3, #4, #5, #6, #7, #8, #9 and #10), the hospital's quality assurance and performance improvement (QAPI) program failed to collect data to monitor the effectiveness and safety of services and quality of care, when there was known noncompliance with the safe administration of titratable sedative medications resulting in a finding of Immediate Jeopardy.


Based on a review of clinical records, staff interviews and a review of hospital documentation for the administration sedative medications, the hospital's QAPI program failed to collect data to monitor the effectiveness and safety of services and quality of care, when there was known noncompliance with Registered Nurses (RN) administering Propofol as a bolus which was beyond an RN's scope of practice in Connecticut resulting in a finding of Immediate Jeopardy.


Please see A273
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

1. Based on a review of clinical records, staff interviews and a review of hospital documentation for ten of ten patients reviewed for the administration and titration of sedative medications (Patient #1, #2, #3, #4, #5, #6, #7, #8, #9 and #10), the hospital's quality assurance and performance improvement (QAPI) program failed to collect data to monitor the effectiveness and safety of services and quality of care, when there was known noncompliance with the safe administration of titratable sedative medications resulting in a finding of Immediate Jeopardy. The findings included:


Review of hospital documentation identified that the hospital was cited by their accreditation body in 2015 regarding the failure to follow Propofol titration in accordance with the physician order. Although the hospital initiated and completed Propofol titration audits in December of 2015 and January of 2016, no further monitoring was conducted to ensure that Propofol was titrated in accordance with physician's orders.


Review of the Intensive Care Unit (ICU) Committee Meeting Minutes dated 4/5/16 identified the need for specific schedules for titration's of medications. The minutes identified that the Medical Director of Critical Care indicated he/she wanted to confirm practice standards and expand titration guidelines. However further review of committee minute meetings failed to reflect that titration of sedative medications was discussed further.


Interview with the Chief Nursing Officer (CNO), the Director of the ICU and the ICU Nurse Educator on 8/8/17 at 3:00 PM indicated although it was identified that the titration of sedative medications was a concern, they did not know why the administration of titratable sedatives were not tracked and/or monitored to ensure compliance after January of 2016.


Review of Quality Assurance and Performance Improvement Committee Minute Meetings dated January 2016 through June of 2017 failed to identify that the titration and/or administration of sedative medications were reviewed as a quality indicator. Interview with the Manager of Regulatory Affairs on 8/8/17 at 3:00 PM indicated he/she did not know why titratable medications were not tracked and monitored to ensure safe practice. However, the Manager of Regulatory Affairs identified that subsequent to surveyor inquiry, titratable medications would be reviewed as a part of the Quality Program.


a. Patient #1 was admitted on [DATE] with diagnosis that included stage IV [DIAGNOSES REDACTED] with lung metastasis. On 6/22/17 Patient #1's condition deteriorated requiring mechanical ventilation. Physician's orders dated 6/22/17 at 3:20 AM directed Propofol 1,000,000 micrograms (100 milliliters) intravenous (IV) to start at 5 micrograms (mcg)/kilogram (kg)/minute (min) every 5 minutes, and titrate to a Richmond Agitation Sedation Scale (RASS) score of (0 to -2). If the patient was not adequately sedated (RASS score more positive than the desired goal): Increase the dose by 5mcg/kg/min every 5 minutes until the target RASS was achieved. The orders further directed that if the RASS score was greater than 0: Increase the dose by 5mcg/kg/min, every 5 minutes until the RASS score was between 0 and -1. If the RASS score was less than -1: Decrease the rate by 5 mcg/kg/min every 5 minutes until the RASS score was between 0 and -1. Review of the nursing flow sheets identified on 6/22/17 at 5:00 AM, although the RASS score was +1 with Propofol infusing at 30 mcg/kg/min and at 6:00 AM, the RASS score was -2 and the titration was unchanged from 5:00 AM to 6:00 AM. Propofol administration was documented every hour. The Propofol was not administered according to the physician's order.


b. Patient #2 was admitted on [DATE] with sepsis. A physician order dated 7/4/17 at 3:50 AM directed intravenous (IV) Propofol be administered. Concentration=10,000 mcg/ml (1000 ml/100 ml bottle). Start at 5 mcg/kg/min, titrate up by 5 mcg/kg/min every 5 minutes, titrate to RASS score of 0 to -2, to a maximum continued infusion rate of 80 mcg/kg/min. If patient is not adequately sedated (RASS score more positive than desired goal) increase dose by 5 mcg/kg/min every 5 minutes until target RASS score is achieved. If the patient is more sedated than desired (RASS score more positive than desired goal) decrease rate by 5 mcg/kg/min every 5 minutes until target RASS score is achieved. The patient's RASS score was documented twice at 5 AM on 7/4/17: as -2 and -1 and decreased to -2 at 6 AM. Although review of the record identified that the Propofol was infusing at 20 mcg/kg/min at 5 AM on 7/4/17, and the RASS score was within the desired level, the propofol was decreased to 5 mcg/kg/min at 6 AM. Propofol administration was documented every hour. The Propofol was not administered according to the physician's order.



c. Patient #3 was admitted on [DATE] with acute on chronic respiratory failure. A Physician Order dated 6/19/17 at 8:40 PM directed IV Propofol be administered. Concentration=10,000 mcg/ml (1000 ml/100 ml bottle). Start at 5 mcg/kg/min, titrate up by 5 mcg/kg/min every 5 minutes, titrate to RASS score of 0 to -2, to a maximum continued infusion rate of 80 mcg/kg/min. If patient is not adequately sedated (RASS score more positive than desired goal) Increase dose by 5 mcg/kg/min every 5 minutes until target RASS score is achieved. If patient is more sedated than desired (RASS score more positive than desired goal) decrease rate by 5 mcg/kg/min every 5 minutes until target RASS score is achieved. The patient's RASS score was documented +1 at 1 AM and -1 at 2 AM on 6/23/17. However, the record indicated that the Propofol infusion was decreased from 18 mcg/kg/min to 16 mcg/kg/min from 1 AM to 2 AM on 6/23/17, rather than the titrated order of 5 mcg/kg/min. Propofol administration was documented every hour. The Propofol was not administered according to the physician's order.



d. Patient #4 was admitted on [DATE] with a hemopneumonthrorax. A Physician Order dated 6/20/17 at 4:25 AM directed IV Fentanyl be administered. Concentration 50 mcg/ml. Titrate to achieve RASS score between 0 to -1. Titrate by 2.5 mcg/hr every 0.5 hr until desired RASS score achieved to a max of 300 mcg/hr (usual dose: 25-200 mcg/hr; max 300 mcg/hr); contact MD if infusion rate exceeds the specified maximum rate. The patient's RASS score on 6/20/17 at 7 AM was -1 and at 8 AM was -2. Review of the record identified that the IV Fentanyl infusion remained at 25 mcg/hr during that period. Fentanyl administration was documented every hour. The Fentanyl was not administered according to the physician's order.



e. Patient #5 was admitted on [DATE] with Legionella pneumonia. A physician order dated 7/1/17 at 9:35 PM directed IV Propofol be administered, concentration=10,000 mcg/ml (1000 ml/100 ml bottle). Start at 5 mcg/kg/min, titrate up by 5 mcg/kg/min every 5 minutes, titrate to RASS score of 0 to -2 to a maximum continued infusion rate of 80 mcg/kg/min. If patient is not adequately sedated (RASS score more positive than desired goal), increase dose by 5 mcg/kg/min every 5 minutes until target RASS score is achieved. If patient is more sedated than desired (RASS score more positive than desired goal) decrease rate by 5 mcg/kg/min every 5 minutes until target RASS score is achieved. The patient's RASS score was the following on 7/5/17: -2 at 6 AM; -3 at 7 AM; +2 at 8 AM; +2 at 9 AM; -2 at 10 AM and -1 at 11 AM. The Propofol was infusing at 60 mcg/kg/min at 6 AM, was decreased to 50 mcg/kg/min at 7 AM and remained at 50 mcg/kg/min until 11 AM when it was decreased to 40 mcg/kg/min. Propofol administration was documented every hour. The Propofol was not administered according to the physician's order.



f. Patient #6 was admitted on [DATE] with seizure disorder. A physician order dated 7/1/17 at 9:35 PM directed IV Propofol be administered, concentration=10,000 mcg/ml (1000 ml/100 ml bottle). Start at 5 mcg/kg/min, titrate up by 5 mcg/kg/min every 5 minutes, titrate to RASS score of 0 to -3 to a maximum continued infusion rate of 80 mcg/kg/min. If patient is not adequately sedated (RASS score more positive than desired goal) increase dose by 5 mcg/kg/min every 5 minutes until target RASS score is achieved. If patient is more sedated than desired (RASS score more positive than desired goal) decrease rate by 5 mcg/kg/min every 5 minutes until target RASS score is achieved. The patient's RASS score was the following on 8/3/17: -2 at 2 PM; -2 at 3 PM; +2 at 3:30 PM and -2 at 4 PM. Review of the record indicated that the IV Propofol remained at 35 mcg/kg/min from 2 PM to 4 PM on 8/3/17. Propofol administration was documented every hour. The Propofol was not administered according to the physician's order.



g. Patient #7 was admitted on [DATE] after a fall who while hospitalized experienced shortness of breath with hypoxia and required mechanical ventilation. Patient #7 had diagnoses that included [DIAGNOSES REDACTED]. If the RASS score was greater than 0: increase the dose by 5 mcg/kg/min, every 5 minutes until the RASS score was between 0 and -5. The order further directed if the RASS score was less than -1: Decrease the rate by 5 mcg/kg/min every five minutes until the RASS score is between 0 and -1. Review of the nursing flow sheet identified on 8/3/17 at 8:00 AM the RASS score was -1 with Propofol infusing at 14 mcg/kg/min and at 9:00 AM the RASS score was +2 and Propofol was increased to 18 mcg/kg/min. Propofol administration was documented every hour and not administered by 5 mcg/kg/min in accordance with the physician order.



h. Patient #8 was admitted on [DATE] with a bibasilar pneumonia that resulted in acute hypoxic respiratory failure requiring mechanical ventilation. Physicians orders dated 8/3/17 directed Propofol 1,000,000 micrograms (100 milliliters) intravenous (IV) to start at 5 micrograms (mcg)/kilogram (kg)/minute (min) per order parameters. If the RASS score was greater than 0: Increase the dose by 5 mcg/kg/min, every 5 minutes until the RASS score was between 0 and -1. The order further directed if the RASS score was less than -1: Decrease the rate by 5 mcg/kg/min every five minutes until the RASS score is between 0 and -1. Review of the nursing flow sheet identified on 8/3/17 at 12:00 AM the RASS score was -1 with Propofol infusing at 25 mcg/kg/min and at 1:00 AM the RASS score remained at -1 however, Propofol was titrated to 30 mcg/kg/min. Propofol administration was documented every hour. The Propofol was not administered according to the physician's order.



i. Patient #9 was admitted on [DATE] with toxic metabolic [DIAGNOSES REDACTED] that ultimately required intubation for airway protection. Physician's orders dated 8/3/17 at 11:15 AM directed Propofol 1,000,000 micrograms (100 milliliters) intravenous (IV) to start at 5 micrograms (mcg)/kilogram (kg)/minute (min) every 5 minutes, and titrate to a RASS score of 0 to -5. If the patient was not adequately sedated (RASS score more positive than the desired goal): increase the dose by 5 mcg/kg/min every 5 minutes until the target RASS score was achieved. The orders further directed if the patient is more sedated than desired (RASS score more negative than desired goal): decrease the rate by 5 mcg/kg/min every 5 minutes until the target RASS score was achieved. Review of the nurse's notes dated 8/3/17 at 10:00 PM identified a RASS score was not documented and although Propofol was ordered at 5 mcg/kg/min and titrated in 5 mcg/kg/min increments, Propofol was infusing at 7 mcg/kg/min and at 10:56 PM the infusion was decreased to 6 mcg/kg/min absent a RASS score. Propofol administration was documented every hour. The Propofol was not administered according to the physician's order.



j. Patient #10 was admitted on [DATE] with cervical stenosis of the spine. Patient #10 experienced neurogenic shock with an impairment of the phrenic nerve that caused diaphragmatic dysfunction that lead to hypercarbic respiratory insufficiency and cardiovascular hypotension requiring intubation. Physician's orders dated 8/4/17 directed Propofol 1,000,000 micrograms (100 milliliters) intravenous (IV) to start at 5 micrograms (mcg)/kilogram (kg)/minute (min) and to titrate as per order parameter. If the RASS score was greater than 0: Increase the dose by 5 mcg/kg/min, every 5 minutes until the RASS score was between 0 and -1. The order further directed if the RASS score was less than -1: Decrease the rate by 5 mcg/kg/min every five minutes until the RASS score is between 0 and -1. Review of the nursing flow sheet identified on 8/8/17 at 4:00 AM the RASS score was -1 with Propofol infusing at 25 mcg/kg/min and at 5:00 AM the RASS score remained at -1 however the Propofol was decreased to 20 mcg/kg/min. Propofol administration was documented every hour. The Propofol was not administered according to the physician's order.


An immediate action plan dated 8/9/17 directed that all RN's must comply with titratable medications consistent with physician orders. RN's must follow titration protocol for Propofol infusions specifically addressing: initial starting dose, titration time intervals, frequency of RASS score, documentation to reach desired RASS score, reassessment and documentation of RASS score consistent with the RASS score. Compliance with Propofol titration would be monitored through daily audits.





2. Based on a review of clinical records, staff interviews and a review of hospital documentation for the administration of sedative medications, the hospital's QAPI program failed to collect data to monitor the effectiveness and safety of services and quality of care, when there was known noncompliance with Registered Nurses (RN) administering Propofol as a bolus which was beyond an RN's scope of practice resulting in a finding of Immediate Jeopardy. The findings included:



a. Interview with RN #6 on 8/7/17 at 9:15 AM indicated he/she notified RN #2 (preceptor) and Nurse Manager #1 that between June 2017 and July 2017, bolus doses of sedative medications had been administered to patients on multiple occasions by RN's in the ICU. RN #6 identified the names of 5 patients who may have received the bolus medications. RN #6 identified that bolus doses of Propofol were not documented in the clinical record.



b. Interview with the CNO on 8/8/17 at 3:00 PM indicated that he/she was aware that RN #6 had notified RN #2 and Nurse Manager #1 that bolus doses of sedative medications were being administered by RN's. However, the hospital's investigation failed to identified that bolus doses of Propofol were administered by RN's and/or that physician's orders were not obtained and/or administration of the bolus Propofol was not documented.



c. Interviews were conducted with RN #1 (8/4/17 at 1:15 PM), RN # 2 (8/7/17 at 7:45 AM), and RN #5 (8/4/17 at 11:30 AM). RN's #1, #2 and #5 identified that when patients in the ICU were agitated, seizing or attempting to pull at medical tubes, they would administer a bolus dose of Propofol to the patient and notify the physician. RN #1, #2 and #5 indicated that the physician was responsible to place the order for the bolus dose of the Propofol. RN #1, #2 and #5 identified this practice occurred approximately once or twice a month. Further interview with RN #1, #2 and #5 indicated the dose of Propofol was at the discretion of the nurse (RN) as the amount administered was dependent on the desired level of sedation required for the particular medical condition that was occurring.


d. Although interview with RN #3 on 8/4/17 at 12:30 PM identified that bolus doses are administered by nursing (RN's) with a physician's order and documented in the electronic medication administration record, review of the clinical record failed to identify such.


e. Interview with Pharmacist #1 on 8/8/17 at 2:10 PM indicated he/she was aware that ICU nurses (RN) had administered bolus doses of Propofol during airway intubation. However, after a review of all bolus orders in the ICU for sedative medications from January of 2017 through August of 2017, Pharmacist #1 indicated a bolus dose of Propofol was never ordered by a physician and/or documented that a nurse (RN) administered the medication.


f. Review of the ICU Propofol training (with the ICU Educator) directed in part that a Propofol bolus must be administered by a physician and cannot be administered by a registered nurse (RN). Review of RN educational testing materials for analgesia medications in part, identified the State of Connecticut considered Propofol administration beyond the scope of nursing practice. Interview with the ICU Educator on 8/4/17 at 12:00 PM identified that he/she was not aware that nurses (RN)were administering bolus doses of Propofol. The ICU educator identified that nurses (RN) should not have been administering Propofol.


g. Review of the clinical records of Patients #1, #2, #3, #4, #5, #6, #7, #8, #9 and #10 failed to identify documentation that bolus Propofol was administered.


An immediate action plan dated 8/4/17 directed that Propofol bolus administration may not be administered by an RN. All RN's would receive and sign a practice alert at the beginning of each shift and prior to providing patient care.
VIOLATION: NURSING SERVICES Tag No: A0385
The Condition of Participation for Nursing services has not been met.

Based on a clinical record review, staff interviews, and a review of facility documentation for ten of ten patients reviewed for the administration and titration of sedative medications (Patient #1, #2, #3, #4, #5, #6, #7, #8, #9 and #10), the hospital failed to ensure that Registered Nurses (RN's) in the Intensive Care Unit (ICU) followed physician's orders resulting in a finding of Immediate Jeopardy.


Based on a clinical record review, staff interviews, and a review of facility documentation for the administration of of bolus sedative medications, the hospital failed to take action when there was known noncompliance with (RN) administering Propofol as a bolus which was beyond an RN's scope of practice resulting in a finding of Immediate Jeopardy.


Please see A405
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


1. Based on a clinical record review, staff interviews, and a review of facility documentation for ten of ten patients reviewed for the administration and titration of sedative medications (Patient #1, #2, #3, #4, #5, #6, #7, #8, #9 and #10), the hospital failed to ensure that Intensive Care Unit (ICU) RN's followed physician's orders resulting in a finding of Immediate Jeopardy. The findings included:



a. Patient #1 was admitted on [DATE] with diagnosis that included stage IV [DIAGNOSES REDACTED] with lung metastasis. On 6/22/17 Patient #1's condition deteriorated requiring mechanical ventilation. Physician's orders dated 6/22/17 at 3:20 AM directed Propofol 1,000,000 micrograms (100 milliliters) intravenous (IV) to start at 5 micrograms (mcg)/kilogram (kg)/minute (min) every 5 minutes, and titrate to a Richmond Agitation Sedation Scale (RASS) score of (0 to -2). If the patient was not adequately sedated (RASS score more positive than the desired goal): Increase the dose by 5mcg/kg/min every 5 minutes until the target RASS was achieved. The orders further directed that if the RASS score was greater than 0: Increase the dose by 5mcg/kg/min, every 5 minutes until the RASS score was between 0 and -1. If the RASS score was less than -1: Decrease the rate by 5 mcg/kg/min every 5 minutes until the RASS score was between 0 and -1. Review of the nursing flow sheets identified on 6/22/17 at 5:00 AM, although the RASS score was +1 with Propofol infusing at 30 mcg/kg/min and at 6:00 AM, the RASS score was -2 and the titration was unchanged from 5:00 AM to 6:00 AM. Propofol administration was documented every hour. The Propofol was not administered according to the physician's order.


b. Patient #2 was admitted on [DATE] with sepsis. A physician order dated 7/4/17 at 3:50 AM directed intravenous (IV) Propofol be administered. Concentration=10,000 mcg/ml (1000 ml/100 ml bottle). Start at 5 mcg/kg/min, titrate up by 5 mcg/kg/min every 5 minutes, titrate to RASS score of 0 to -2, to a maximum continued infusion rate of 80 mcg/kg/min. If patient is not adequately sedated (RASS score more positive than desired goal) increase dose by 5 mcg/kg/min every 5 minutes until target RASS score is achieved. If the patient is more sedated than desired (RASS score more positive than desired goal) decrease rate by 5 mcg/kg/min every 5 minutes until target RASS score is achieved. The patient's RASS score was documented twice at 5 AM on 7/4/17: as -2 and -1 and decreased to -2 at 6 AM. Although review of the record identified that the Propofol was infusing at 20 mcg/kg/min at 5 AM on 7/4/17, and the RASS score was within the desired level, the propofol was decreased to 5 mcg/kg/min at 6 AM. Propofol administration was documented every hour. The Propofol was not administered according to the physician's order.



c. Patient #3 was admitted on [DATE] with acute on chronic respiratory failure. A Physician Order dated 6/19/17 at 8:40 PM directed IV Propofol be administered. Concentration=10,000 mcg/ml (1000 ml/100 ml bottle). Start at 5 mcg/kg/min, titrate up by 5 mcg/kg/min every 5 minutes, titrate to RASS score of 0 to -2, to a maximum continued infusion rate of 80 mcg/kg/min. If patient is not adequately sedated (RASS score more positive than desired goal) Increase dose by 5 mcg/kg/min every 5 minutes until target RASS score is achieved. If patient is more sedated than desired (RASS score more positive than desired goal) decrease rate by 5 mcg/kg/min every 5 minutes until target RASS score is achieved. The patient's RASS score was documented +1 at 1 AM and -1 at 2 AM on 6/23/17. However, the record indicated that the Propofol infusion was decreased from 18 mcg/kg/min to 16 mcg/kg/min from 1 AM to 2 AM on 6/23/17, rather than the titrated order of 5 mcg/kg/min. Propofol administration was documented every hour. The Propofol was not administered according to the physician's order.



d. Patient #4 was admitted on [DATE] with a hemopneumonthrorax. A Physician Order dated 6/20/17 at 4:25 AM directed IV Fentanyl be administered. Concentration 50 mcg/ml. Titrate to achieve RASS score between 0 to -1. Titrate by 2.5 mcg/hr every 0.5 hr until desired RASS score achieved to a max of 300 mcg/hr (usual dose: 25-200 mcg/hr; max 300 mcg/hr); contact MD if infusion rate exceeds the specified maximum rate. The patient's RASS score on 6/20/17 at 7 AM was -1 and at 8 AM was -2. Review of the record identified that the IV Fentanyl infusion remained at 25 mcg/hr during that period. Fentanyl administration was documented every hour. The Fentanyl was not administered according to the physician's order.



e. Patient #5 was admitted on [DATE] with Legionella pneumonia. A physician order dated 7/1/17 at 9:35 PM directed IV Propofol be administered, concentration=10,000 mcg/ml (1000 ml/100 ml bottle). Start at 5 mcg/kg/min, titrate up by 5 mcg/kg/min every 5 minutes, titrate to RASS score of 0 to -2 to a maximum continued infusion rate of 80 mcg/kg/min. If patient is not adequately sedated (RASS score more positive than desired goal), increase dose by 5 mcg/kg/min every 5 minutes until target RASS score is achieved. If patient is more sedated than desired (RASS score more positive than desired goal) decrease rate by 5 mcg/kg/min every 5 minutes until target RASS score is achieved. The patient's RASS score was the following on 7/5/17: -2 at 6 AM; -3 at 7 AM; +2 at 8 AM; +2 at 9 AM; -2 at 10 AM and -1 at 11 AM. The Propofol was infusing at 60 mcg/kg/min at 6 AM, was decreased to 50 mcg/kg/min at 7 AM and remained at 50 mcg/kg/min until 11 AM when it was decreased to 40 mcg/kg/min. Propofol administration was documented every hour. The Propofol was not administered according to the physician's order.



f. Patient #6 was admitted on [DATE] with seizure disorder. A physician order dated 7/1/17 at 9:35 PM directed IV Propofol be administered, concentration=10,000 mcg/ml (1000 ml/100 ml bottle). Start at 5 mcg/kg/min, titrate up by 5 mcg/kg/min every 5 minutes, titrate to RASS score of 0 to -3 to a maximum continued infusion rate of 80 mcg/kg/min. If patient is not adequately sedated (RASS score more positive than desired goal) increase dose by 5 mcg/kg/min every 5 minutes until target RASS score is achieved. If patient is more sedated than desired (RASS score more positive than desired goal) decrease rate by 5 mcg/kg/min every 5 minutes until target RASS score is achieved. The patient's RASS score was the following on 8/3/17: -2 at 2 PM; -2 at 3 PM; +2 at 3:30 PM and -2 at 4 PM. Review of the record indicated that the IV Propofol remained at 35 mcg/kg/min from 2 PM to 4 PM on 8/3/17. Propofol administration was documented every hour. The Propofol was not administered according to the physician's order.



g. Patient #7 was admitted on [DATE] after a fall who while hospitalized experienced shortness of breath with hypoxia and required mechanical ventilation. Patient #7 had diagnoses that included [DIAGNOSES REDACTED]. If the RASS score was greater than 0: increase the dose by 5 mcg/kg/min, every 5 minutes until the RASS score was between 0 and -5. The order further directed if the RASS score was less than -1: Decrease the rate by 5 mcg/kg/min every five minutes until the RASS score is between 0 and -1. Review of the nursing flow sheet identified on 8/3/17 at 8:00 AM the RASS score was -1 with Propofol infusing at 14 mcg/kg/min and at 9:00 AM the RASS score was +2 and Propofol was increased to 18 mcg/kg/min. Propofol administration was documented every hour and not administered by 5 mcg/kg/min in accordance with the physician order.



h. Patient #8 was admitted on [DATE] with a bibasilar pneumonia that resulted in acute hypoxic respiratory failure requiring mechanical ventilation. Physicians orders dated 8/3/17 directed Propofol 1,000,000 micrograms (100 milliliters) intravenous (IV) to start at 5 micrograms (mcg)/kilogram (kg)/minute (min) per order parameters. If the RASS score was greater than 0: Increase the dose by 5 mcg/kg/min, every 5 minutes until the RASS score was between 0 and -1. The order further directed if the RASS score was less than -1: Decrease the rate by 5 mcg/kg/min every five minutes until the RASS score is between 0 and -1. Review of the nursing flow sheet identified on 8/3/17 at 12:00 AM the RASS score was -1 with Propofol infusing at 25 mcg/kg/min and at 1:00 AM the RASS score remained at -1 however, Propofol was titrated to 30 mcg/kg/min. Propofol administration was documented every hour. The Propofol was not administered according to the physician's order.



i. Patient #9 was admitted on [DATE] with toxic metabolic [DIAGNOSES REDACTED] that ultimately required intubation for airway protection. Physician's orders dated 8/3/17 at 11:15 AM directed Propofol 1,000,000 micrograms (100 milliliters) intravenous (IV) to start at 5 micrograms (mcg)/kilogram (kg)/minute (min) every 5 minutes, and titrate to a RASS score of 0 to -5. If the patient was not adequately sedated (RASS score more positive than the desired goal): increase the dose by 5 mcg/kg/min every 5 minutes until the target RASS score was achieved. The orders further directed if the patient is more sedated than desired (RASS score more negative than desired goal): decrease the rate by 5 mcg/kg/min every 5 minutes until the target RASS score was achieved. Review of the nurse's notes dated 8/3/17 at 10:00 PM identified a RASS score was not documented and although Propofol was ordered at 5 mcg/kg/min and titrated in 5 mcg/kg/min increments, Propofol was infusing at 7 mcg/kg/min and at 10:56 PM the infusion was decreased to 6 mcg/kg/min absent a RASS score. Propofol administration was documented every hour. The Propofol was not administered according to the physician's order.



j. Patient #10 was admitted on [DATE] with cervical stenosis of the spine. Patient #10 experienced neurogenic shock with an impairment of the phrenic nerve that caused diaphragmatic dysfunction that lead to hypercarbic respiratory insufficiency and cardiovascular hypotension requiring intubation. Physician's orders dated 8/4/17 directed Propofol 1,000,000 micrograms (100 milliliters) intravenous (IV) to start at 5 micrograms (mcg)/kilogram (kg)/minute (min) and to titrate as per order parameter. If the RASS score was greater than 0: Increase the dose by 5 mcg/kg/min, every 5 minutes until the RASS score was between 0 and -1. The order further directed if the RASS score was less than -1: Decrease the rate by 5 mcg/kg/min every five minutes until the RASS score is between 0 and -1. Review of the nursing flow sheet identified on 8/8/17 at 4:00 AM the RASS score was -1 with Propofol infusing at 25 mcg/kg/min and at 5:00 AM the RASS score remained at -1 however the Propofol was decreased to 20 mcg/kg/min. Propofol administration was documented every hour. The Propofol was not administered according to the physician's order.

Review of hospital documentation identified that the hospital was cited by their accreditation body in 2015 regarding the failure to follow Propofol titration in accordance with the physician order. Although the hospital initiated and completed Propofol titration audits in December of 2015 and January of 2016, no further monitoring was conducted to ensure that Propofol was titrated in accordance with physician's orders.


Review of the ICU Committee Meeting Minutes dated 4/5/16 indicated an accreditation and licensing body identified the need for specific schedules for titration's of medications. The Medical Director of Critical Care indicated he wanted to confirm practice standards and expand titration guidelines however further review of committee minute meetings failed to reflect that titration of sedative medications was discussed further.



Interview with the Chief Nursing Officer (CNO), the Director of the ICU and the ICU Nurse Educator on 8/8/17 at 3:00 PM indicated although it was identified that the titration of sedative medications was a concern, they did not know why the administration of titratable sedatives were not tracked and/or monitored to ensure compliance after January of 2016.

Interview with the Manager of Regulatory Affairs on 8/8/17 at 3:00 PM indicated he/she did not know why titratable medications were not tracked and monitored to ensure safe practice.


Review of the ICU Propofol training with the Educator of the Intensive Care Unit on 8/8/17 directed in part that Propofol would be initiated at 5 mcg/kg/min. for 5 minutes. The level of sedation would be measured by a RASS score. After the initiation of the medication titration would proceed at 5 mcg/kg every 5 minutes until the RASS was between 0 and -1. If the RASS score was greater than 0: increase the dose by 5 mcg/kg/min every 5 min. until the RASS score was between 0 and -1. If the RASS score was less than -1: decrease the rate by 5 mcg/kg/min every 5 minutes until the RASS score was between 0 and -1. The Nurse Educator of the ICU indicated that staff were trained regarding the titration of medications and he/she could not identify why the staff were not following the physician order for titration.



An immediate action plan dated 8/4/17 directed that a physician's order must be obtained if any deviation from the order was made for the titration of sedative medications. All registered nurses (RN's) would receive and sign a practice alert at the beginning of each shift and prior to providing patient care.


An addendum to the plan of correction dated 8/9/17 identified that RN's must follow titration protocol for Propofol infusions specifically addressing: initial starting dose, titration time intervals, frequency of RASS score documentation to reach desired RASS score and reassessment and documentation of RASS score consistent with the physician order. Compliance with Propofol titration would be monitored through daily audits.







2. Based on a clinical record review, staff interviews, and a review of facility documentation for the administration of bolus sedative medications, the hospital failed to take action when there was known noncompliance with Registered Nurses (RN) administering Propofol as a bolus which was beyond an RN's scope of practice resulting in a finding of Immediate Jeopardy. The findings included:


a. Interview with RN #6 on 8/7/17 at 9:15 AM indicated he/she notified RN #2 (preceptor) and Nurse Manager #1 that between June 2017 and July 2017, bolus doses of sedative medications had been administered to patients on multiple occasions by RN's in the ICU. RN #6 identified the names of 5 patients who may have received the bolus medications. RN #6 identified that bolus doses of Propofol were not documented in the clinical record.



b. Interview with the CNO on 8/8/17 at 3:00 PM indicated that he/she was aware that RN #6 had notified RN #2 and Nurse Manager #1 that bolus doses of sedative medications were being administered by RN's. However, the hospital's investigation failed to identified that bolus doses of Propofol were administered by RN's and/or that physician's orders were not obtained and/or administration of the bolus Propofol was not documented.



c. Interviews were conducted with RN #1 (8/4/17 at 1:15 PM), RN # 2 (8/7/17 at 7:45 AM), and RN #5 (8/4/17 at 11:30 AM). RN's #1, #2 and #5 identified that when patients in the ICU were agitated, seizing or attempting to pull at medical tubes, they would administer a bolus dose of Propofol to the patient and notify the physician. RN #1, #2 and #5 indicated that the physician was responsible to place the order for the bolus dose of the Propofol. RN #1, #2 and #5 identified this practice occurred approximately once or twice a month. Further interview with RN #1, #2 and #5 indicated the dose of Propofol was at the discretion of the nurse (RN) as the amount administered was dependent on the desired level of sedation required for the particular medical condition that was occurring.


d. Although interview with RN #3 on 8/4/17 at 12:30 PM identified that bolus doses are administered by nursing (RN's) with a physician's order and documented in the electronic medication administration record, review of the clinical record failed to identify such.


e. Interview with Pharmacist #1 on 8/8/17 at 2:10 PM indicated he/she was aware that ICU nurses (RN) had administered bolus doses of Propofol during airway intubation. However, after a review of all bolus orders in the ICU for sedative medications from January of 2017 through August of 2017, Pharmacist #1 indicated a bolus dose of Propofol was never ordered by a physician and/or documented that a nurse (RN) administered the medication.


f. Review of the ICU Propofol training (with the ICU Educator) directed in part that a Propofol bolus must be administered by a physician and cannot be administered by a registered nurse (RN). Review of RN educational testing materials for analgesia medications in part, identified the State of Connecticut considered Propofol administration beyond the scope of nursing practice. Interview with the ICU Educator on 8/4/17 at 12:00 PM identified that he/she was not aware that nurses (RN)were administering bolus doses of Propofol. The ICU educator identified that nurses (RN) should not have been administering Propofol.



An immediate action plan dated 8/4/17 directed that Propofol bolus administration may not be administered by an RN. All RN's would receive and sign a practice alert at the beginning of each shift and prior to providing patient care.