HospitalInspections.org

Based on interview and record review, the facility failed to develop quality indicators and implement corrective action to ensure the safety of patients receiving continuous intravenous sedation, after becoming aware the physician's orders for these patients did not include the desired level of sedation to be achieved. This failed practice resulted in the potential for undersedation leading to anxiety, unstable vital signs, and self extubation (pulling out breathing tube), or oversedation leading to prolonged ventilator (breathing machine) dependence, unstable vital signs, and death. Refer to A405 and A500.

Findings:

The facility document titled, "2015 Quality Management Program Description," was reviewed on November 17, 2015. The Performance Improvement (PI) Program was designed to monitor and improve performance of important functions, processes, and significant issues, through reporting and committee participation or oversight. The improvement functions/processes included:

a. Assessment and Care of Patients, and,

b. Medication Management/Pharmacy and Therapeutics.

The PI committee was responsible for the following:

1. Coordinating, monitoring, analyzing, and evaluating the PI activities for patients by providing a framework for measurement, assessment, and improvement;

2. Recommending appropriate studies and topics for inter-departmental or multidisciplinary quality improvement projects;

3. Recommending action for resolution of issues and/or staff education as needed;

4. Assuring communication of necessary information among departments/services when opportunities to improve care involved more than one department/service; and,

5. Monitoring performance to ensure that patient care met or exceeded legal, accreditation, licensing, and external requirements.

During an interview with the Director of Pharmacy (DOP) on November 16, 2015, at 12:20 p.m., the DOP stated physician's orders for patients receiving continuous intravenous sedation should include a target Richmond Agitation Sedation Scale (RASS), so the nursing staff would maintain the patient at a consistent and safe level of sedation. The DOP stated without the target RASS, the order was not complete.

During an interview with the DOP on November 17, 2015, at 1:45 p.m., the DOP stated during a previous medication usage evaluation (MUE) (completed in 2013 and analyzed in 2014), the pharmacy identified lack of compliance with the physician including the RASS target in the sedation order. The DOP stated the data was presented to the Critical Care and Pharmacy and Therapeutics Committees in 2014, where recommendations for improvement were made. According to the DOP, no improvement actions were developed or implemented as a result of the data presented and the recommendations made. The DOP stated they had, "not yet," done any further data collection or put corrective measures into place.

Based on observation, interview and record review, the facility failed to ensure actions taken to improve the process of following up with Emergency Department (ED) patients who had x-rays taken, when there was a discrepancy (difference) in the interpretation by the ED physician and the radiologist, were effective. This failed practice resulted in the potential for delays in patients seeking and receiving appropriate and timely follow up care.

Findings:

The facility document titled, "2015 Quality Management Program Description," was reviewed on November 17, 2015. The Performance Improvement (PI) Program was designed to monitor and improve performance of important functions, processes, and significant issues, through reporting and committee participation or oversight. The improvement functions/processes included:

a. Assessment and Care of Patients, and,

b. Continuum of Care.

The PI committee was responsible for the following:

1. Coordinating, monitoring, analyzing, and evaluating the PI activities for patients by providing a framework for measurement, assessment, and improvement;

2. Recommending appropriate studies and topics for inter-departmental or multidisciplinary quality improvement projects;

3. Monitoring performance to ensure that patient care met or exceeded legal, accreditation, licensing, and external requirements.

During a tour of the ED on November 16, 2015, at 12 noon, the communications nurse was observed reviewing her telephone messages.

During a concurrent interview with the nurse, she stated she received a message that morning from ED Physician 1, regarding the need to follow up with a patient (Patient 33), to change his instructions for follow up care. The nurse stated Patient 33 was given instructions upon discharge from the ED to follow up with an oral surgeon for evaluation of his fractured jaw. The nurse stated ED Physician 1 diagnosed Patient 33 with a jaw fracture based on his interpretation of the x-ray, but the radiologist read the x-ray as negative (no jaw fracture). The nurse stated she would call the patient to tell him the x-ray was negative and no follow up was needed.

The record for Patient 33 was reviewed. Patient 33, a 22 year old male, presented to the ED on November 13, 2015, with complaints of jaw pain. The record indicated the patient had an x-ray performed, and the results were interpreted by ED Physician 1 as a non-displaced fracture of the right mandibular angle (right jaw fracture). According to the record, based on recommendations from the ears/nose/throat (ENT) specialist, upon discharge from the ED, Patient 33 was given a prescription for pain medication and antibiotics, and told to follow up with an oral surgeon for evaluation of the fracture.

The radiology report dated November 14, 2014 (the day after the x-ray was done), indicated the radiologist interpreted the x-ray as, "No fracture demonstrated."

The radiology review section of the record indicated ED Physician 1 reviewed the radiologist's interpretation on November 16, 2015 (3 days after Patient 33 was treated in the ED), the same day he left a message for the communications nurse to follow up with the patient and tell him he did not have a fracture and did not need to follow up with an oral surgeon.

During an interview with the ED Medical Director (EDMD) on November 19, 2015, at 9:35 a.m., the EDMD stated when discrepancies existed between the ED physician's x-ray interpretation and the radiologist's x-ray interpretation, the communications nurse was informed by the ED physician, and the patient was contacted by the communications nurse. The EDMD stated there was no written time frame for this process to be completed, but his expectation was that the identification of the discrepancy, the notice to the communications nurse, and the notification of the patient, would be completed within one day (24 hours) of the x-ray. The EDMD stated he was not collecting or reviewing any data on the timeliness or effectiveness of this process. He stated he was not collecting or reviewing any data to track and trend discrepancies, by procedures or by physicians, that would identify potential opportunities for improvement.

During a concurrent interview with the Quality Management Coordinator (QMC) and the Director of Radiology (DOR) on November 19, 2015, at 9:50 a.m., they stated the existing radiology discrepancy follow-up process was developed in response to identifying a need to improve the previous process.

They explained how the current process worked.

1. X-rays done after hours (when there was no radiologist present) were interpreted by the ED physician, and the initial diagnosis and treatment were based on that interpretation;

2. The radiologist would re-read all of the ED x-rays (that were initially interpreted by the ED physician) the following day;

3. The final report by the radiologist for all, "normal," readings were sent to the inbox of the ED physician who had initially interpreted the x-ray;

4. The final report by the radiologist for all, "abnormal," readings were sent to:

a. The radiology clerk's inbox who would forward the report to the ED physician, then;

b. The radiology clerk would forward the report to the inbox for the "green doctor" (the ED physician who was responsible for reviewing the reports, reviewing the ED record, and determining whether diagnosis/treatment/follow-up instructions were appropriate);

5. The ED physician communicated discrepancies to the communications nurse; and,

6. The communications nurse would call the patient to inform the patient of the discrepancy and the need for a change in the follow-up care/instructions (if needed).

The facility policy titled, "Abnormal X-Ray Reports," was reviewed on November 19, 2015. The policy indicated a message would be sent to the ED green doctor's inbox, from radiology, regarding abnormal x-ray results. According to the policy, the ED green doctor would review the abnormal x-ray readings and notify the ED communications nurse of any new orders and appropriate follow up actions to be taken, and the nurse would notify the patient accordingly.

The facility policy titled, "Calling of Significant Findings/Discrepancy Reports," was reviewed on November 19, 2015. The policy indicated the radiologist would communicate a significant finding/discrepancy by calling the physician directly (if necessary) or clicking on the significant finding tab in the computer system (which flagged that x-ray as a significant finding/abnormal/unexpected finding in the significant finding queue). According to the policy, the x-ray file clerk would monitor the significant finding queue and send an electronic message to the appropriate physician (no time frame). If the message had not been acknowledged, a second message would be sent (no time frame). The policy indicated the x-ray file clerk would follow up in an additional five days to verify acknowledgement of the message.

(There were five steps required to reach the patient: Radiologist, Radiology Clerk, ED Physician, Communications Nurse, Patient)

The QMN and the DOR stated there had not been any data collected on the effectiveness of the process since it had been changed. They stated they had never taken any action to ensure all patients with a discrepancy that required intervention were notified, and all notifications were made in a timely manner.

The DOR stated the only information that he tracked in the process was how long it took for the, "green doctor," to open the message that was sent to the inbox. He stated if the message was not opened within five days, he would receive a notice. The DOR verified an x-ray result, diagnosis, and treatment could be incorrect for up to five days without notice.

Based on observation, interview and record review, the facility failed to ensure organized nursing service was provided to all patients by failing to ensure:

1. An Intensive Care Unit (ICU) patient (Patient 1) was monitored during a MRI (magnetic resonance imaging - test that uses a magnetic field and pulses of radio wave energy to make pictures of organs and structures inside the body) procedure. Refer to A392.

2. A critical care patient (Patient 2) was monitored during a CT (computerized tomography scan - special X-ray test that produces cross-sectional images of the body using X-rays and a computer) procedure. Refer to A392.

3. The procedural sedation level for a patient (Patient 26) was assessed and reassessed according to facility policy. Refer to A395.

4. The medication order for a Midazolam (Versed - a medication used for sedation) drip contained the BRASS (Richmond Agitation Sedation Scale) target sedation level to be used for the titration of the medication for four sampled patients (Patients 5, 6, 7, and 37). Refer to A405.

5. A Propofol drip (Diprivan - a medication used for sedation) for Patient 2, and a Midazolam drip (Versed - a medication used for sedation) for Patient 5, were titrated to the level of sedation (BRASS - Richmond Agitation Sedation Scale) as ordered by the physician. Refer to A405.

6. A Midazolam (Versed - a medication used for sedation) drip order was complete for one sampled patient (Patient 5). Refer to A405.

7. Physician orders for severe pain were followed for one sampled patient (Patient 16). Refer to A405.

The cumulative effects of these systemic problems resulted in failure of the nursing department to ensure care was being provided in a safe and effective manner.

Based on interview and record review, the facility failed to ensure:

1. An Intensive Care Unit (ICU) patient (Patient 1) was monitored during a MRI (magnetic resonance imaging - test that uses a magnetic field and pulses of radio wave energy to make pictures of organs and structures inside the body) procedure. As a result staff were unaware Patient 1 had become pulseless and without respirations during the procedure until they entered the MRI room following the procedure. This may have contributed to the death of Patient 1.

2. A critical care patient (Patient 2) was monitored during a CT (computerized tomography scan - special X-ray test that produces cross-sectional images of the body using X-rays and a computer) procedure which had the potential to result in the patient's worsening condition going unrecognized.

Findings:

1. The record for Patient 1 was reviewed from October 7, 2015, through November 16, 2015. Patient 1 was admitted to the facility on September 10, 2015, with diagnoses including sepsis (whole-body inflammatory response to an infection), febrile (fever) illness, and syncopal episode (temporary loss of consciousness and posture).

Patient 1 was transferred to the Intensive Care Unit (ICU) on September 12, 2015, at 2:10 p.m., due to respiratory failure, and was intubated (breathing tube inserted) and placed on a ventilator at 3 p.m.

An order for an MRI of the brain and brain stem without contrast was ordered on September 12, 2015.

The "Care Planning Progress Note" dated September 14, 2015, indicated the following:
5:50 p.m., Patient 1 was placed on a portable, MRI compatible, ventilator and a portable cardiac/pulse oximetry monitor; and transported, via the ICU bed, to MRI accompanied by a transporter, Registered Nurse (RN) 5 and Respiratory Therapist (RT) 1.
6:05 p.m., Patient 1 was transferred from the ICU bed to a MRI compatible gurney and then placed on the MRI table in the MRI room. The cardiac/oximetry monitor was removed from the patient because the transport monitor from ICU was not "MRI compatible equipment." Patient 1 remained on the MRI compatible ventilator monitor, and was advanced into the MRI machine by the MRI Technician (MRI Tech) 1.
6:15 p.m., RT 1 was replaced by RT 2 due to the change of shift and report was exchanged. RT 2 noted Patient 1 was not on a cardiac/oximetry monitor.
6:19 p.m., the MRI was completed and RN 1, RT 2, and MRI Tech 1 entered the MRI room, at which time RT 2 heard the ventilator alarming and "cycling off," and the "ventilator circuit found to be disconnected from the ventilator side." Patient 1 was removed from the MRI chamber, and was noted to be cyanotic (blue or purple coloration of the skin due low oxygen saturation) and pulseless (no heart rate). Patient 1 was moved out of the MRI room.
6:20 p.m., cardiopulmonary resuscitation (CPR) was initiated and the "Code Blue" was activated. Patient 1 was hooked up to a cardiac monitor and an "asystole rhythm (no heart beat)" was noted.
6:24 p.m., the "Code Blue" team arrived and CPR continued to include medication administration, chest compressions and ambu bagging (hand-held device used to provide positive pressure ventilation to
patients who are not breathing).
6:35 p.m., (approximately) Patient 1's pulse returned and a blood pressure was present.
6:36 p.m., Patient 1 was transferred back to the ICU.

There was no documentation to indicate Patient 1 was monitored during the MRI procedure.

There was no indication a "Patient Resuscitation Record" was completed for Patient 1's cardiac and pulmonary arrest on September 14, 2015.

The "VS (vital signs) Pain ICU" screen dated September 14, 2015, indicated Patient 1's vital signs were taken/documented at 5:30 p.m., and not again until 6:55 p.m. (85 minutes later).

During an interview on October 9, 2015, at 9 a.m., RT 1 stated Patient 1 was placed on an MRI compatible transport ventilator. RT 1 stated she did not remember the settings (tidal volume and rate). RT 1 stated the oxygen supply tubing for the ventilator was "just long enough to reach from the wall (oxygen source) to where the patient was." RT 1 stated there was a pressure alarm on the ventilator, and if the patient was not on the ventilator or not getting air the ventilator would alarm. In addition, RT 1 stated there was a blinking light on the ventilator which indicated "green" if the ventilator was functioning and "red" if the ventilator was not functioning. RT 1 stated the alarm on the ventilator could not be heard from outside the MRI room when the door was closed or during the procedure. RT 1 stated for Patient 1, the "blinking light (red or green)" could not be seen because the ventilator was turned toward the patient (not facing the RT, RN and MRI Tech in the control area outside of the MRI room) due to the oxygen circuit length restriction. RT 1 stated she was not aware a MRI "safe" cardiac/oximetry monitor was available in order to monitor a patient during a MRI procedure. In addition, RT 1 stated September 14, 2015, was the first time she had been to MRI, and she had never been inserviced on how to care for or monitor a patient during a MRI procedure.

During an interview with RT 2, on October 9, 2015, at 9:40 a.m., she stated as she clocked in for her shift she was told to relieve RT 1 in the Imaging Department. RT 2 stated this was the first time she had been to MRI, and her badge did not provide her access to the department. RT 2 stated she could see through the double glass doors as Patient 1 was being transferred from the ICU bed to the MRI compatible gurney, and then into the MRI room. RT 2 stated an MRI Technician opened the door for her and she received report from RT 1 on "all of her ICU patients." RT 2 stated she looked through the window of the MRI control room to where the patient was in the MRI room and expected to see Patient 1 on a cardiac/oximetry monitor. RT 2 stated she asked RN 5 "why is the patient not on monitors?" RT 2 stated RN 5 replied they did not monitor patients during a MRI, and the facility did not have MRI compatible equipment. RT 2 stated when the procedure was over and the door to the MRI room was unlocked, she could hear the "chirping" of the ventilator alarm as the door was being opened. RT 2 stated she "rushed to the ventilator and saw the circuit was disconnected at the ventilator site with the bacterial filter disconnected at the valve." RT 2 stated the ventilator was on a "side table" and the ventilator monitor was positioned so the alarm lights could not be seen by the staff from the MRI control room. RT 2 stated she grabbed the ambu bag and started ventilating Patient 1. RT 2 stated they resuscitated Patient 1 for 10 minutes, and then transferred the patient back to ICU.

During an interview with MRI Tech 1, on October 9, 2015, at 10:35 a.m., he stated the Imaging Department did have patient monitoring equipment available. MRI Tech 1 stated MRI Room 2 had a pulse oximeter available and MRI room 3 had a monitor which could do cardiac monitoring, pulse and oxygen saturation. MRI Tech 1 stated he told RN 5 pulse oximeter monitoring was available in the MRI room but she said "no (indicating she did not want to place Patient 1 on the MRI compatible pulse oximeter monitor)." He stated it was not unusual for the nurse not to place a critical care patient on a monitor during the MRI procedure. In addition, MRI Tech 1 stated badge access to the Imaging Department was very limited, and even the "Code Blue" team did not have access through the badging system.

During an interview with RN 5, on October 9, 2015, at 11:30 a.m., she stated she transported Patient 1 with the transporter and RT 1 to the Imaging Department on September 14, 2015, for a MRI of the brain and brain stem as ordered by the physician. RN 5 stated Patient 1 was placed on a portable ventilator and a portable cardiac/oximetry monitor. RN 5 stated MRI Tech 1 instructed her to remove the portable cardiac/oximetry monitor prior to taking the patient into the MRI room. RN 5 stated she never knew cardiac/oximetry monitoring of the patient could occur during a MRI, or there was equipment available to monitor the patient during the MRI procedure. In addition, RN 5 stated there was "no way to visualize the patient" during a MRI procedure from the MRI control room. RN 5 stated Patient 1 was off of the cardiac/oximetry monitor for approximately 15 minutes. RN 5 stated because of the way the portable ventilator was positioned, the ventilator alarm lights could not been seen from the MRI control room. RN 5 stated an RN documented the "Code Blue" but she did not get a copy of the record.

On September 18, 2015, Patient 1 was removed from the ventilator and was pronounced dead at 7:10 p.m.

During an interview with the Manager Critical Care (MCC), on November 17, 2015, at 10:45 a.m., he reviewed the record for Patient 1 and was unable to find documentation of vital signs between 5:30 p.m. and 6:55 p.m., on September 14, 2015. The MCC stated a critical care patient should receive the same standard of care when off the unit for a procedure as when the patient was located in the ICU. The MCC stated the critical care/monitoring of the patient should occur for the patient even when the patient was off of the ICU. In addition, the MCC was unable to find documentation of Patient 1's cardiopulmonary arrest and resuscitation on September 14, 2015, on the "Patient Resuscitation Record." The MCC stated the "Patient Resuscitation Record" should have been completed when Patient 1 experienced a cardiopulmonary arrest while having an MRI procedure on September 14, 2015.

The facility policy and procedure titled "Transport of Critical Care Patients To and From Other Departments for Testing and/or Procedures" revised February 2014, revealed "To ensure continuous care of critical care patients while being transported outside of ICU/CCU for tests and/or procedures. All ICU/CCU patients being transported to other departments for testing and/or procedures will be on a monitor/defibrillator and accompanied by a Registered Nurse until the patient returns to the unit. ..."

The facility policy and procedure titled "Standards of Care/Standards of Practice: Mechanical Ventilation/Artificial Airway" reviewed February 2014, revealed "... The patient will experience no mechanical ventilation/artificial airway complications. The RN and/or Respiratory Therapist will perform the following interventions when caring for the patient with mechanical ventilation/artificial airway: ... Safety measures to prevent self extubation or accidental extubation. ... Maintain patient response to ventilatory support. Monitor O2 saturation by continuous pulse oximetry. ..."

The facility policy and procedure titled "Cardiopulmonary Resuscitation, Role of Code Team Members" reviewed June 2015, revealed "... To provide an accurate chronological record of all data pertaining to the arrest and resuscitation efforts. ... There will be an accurate and chronological cardiac pulmonary report and a code blue evaluation report completed and submitted to quality for Critical Care Committee review on all Code Blues. ..."

2. On November 16, 2015, the record for Patient 2 was reviewed. Patient 2 was admitted to the facility on November 6, 2015, with diagnoses including abdominal pain, nose bleed, and respiratory distress.

On November 7, 2015, at 12:28 a.m., Patient 2 was placed on a ventilator.

Patient 2's vital signs were documented every 5 minutes starting a 1 a.m. until 1:20 a.m., with a blood pressure of 74/49 mmHg (millimeters of mercury - normal blood pressure 120/80) at 1:10 a.m. The next documented vitals signs were at 2 a.m. (40 minutes later), and were recorded every 15 minutes for several hours after this time.

The "ED (Emergency Department) Notes" dated November 7, 2015, at 1:33 a.m., indicated Patient 2 was transported to CT with a Registered Nurse and a Respiratory Therapist; and at 1:44 a.m., Patient 2 was transported to the Intensive Care Unit (ICU).

There was no documented Nursing note indicating the procedure was completed, monitoring during the procedure, and how the patient tolerated the procedure.

There was no documented Respiratory Therapy note indicating the patient's transport to CT, monitoring during the procedure, how the patient tolerated the procedure or when the patient was transported to the ICU.

During an interview with the Manager Critical Care (MCC), on November 17, 2015, at 10:45 a.m., he reviewed the record and was unable to find documentation of Patient 2's vital signs between 1:21 a.m., and 1:59 a.m., on November 7, 2015. The MCC stated when a critical care patient was transported off of a unit, the patient should receive the same standard of care as if they were on a critical care unit. The MCC stated the care for Patient 2 should continue even if the patient was off of the critical care unit to include vitals signs at least every 15 minutes and how the patient tolerated the procedure. The MCC stated the facility's current computerized documentation system did not allow the staff to document in the record while the patient was off a unit, and the staff would need to hand document the patient's vital signs/assessments and enter the information upon return to the unit.

The facility policy and procedure titled "Transport of Critical Care Patients To and From Other Departments For Testing and/or Procedures" revised February 2014, revealed "... Document in (name of facility computerized documentation system) that testing and/or procedure was completed and patient's tolerance of procedure."

Based on interview and record review the facility failed to ensure Patient 26's procedural sedation level was assessed and reassessed according to facility policy. Failure to follow the facility's procedural sedation policy had the potential for Patient 26 to be under sedated or over sedated during a procedure.

Findings:

A record review was conducted for Patient 26 on November 17, 2015. Patient 26 was admitted on November 10, 2015, with a diagnosis of worsening right second toe gangrene (loss of blood supply causing discoloration of skin).

Patient 26 had a Physician's order dated, November 11, 2015, at 10:06 a.m., for the use of interventional radiology right lower extremity angiogram ( IR-a radiologist was required to perform the test with a guide wire and X-ray to determine artery function).

In addition, Patient 26 had a physician's order dated, November 11, 2015, at 3:45 p.m. The order indicated, fentanyl (pain reliever/sedative) 50 micrograms (mcgs), intravenous 1 milliliter (ml) (2 doses), 1 (ml) = 50 mcg... Volume 2 ml... Titrate to desired effect by repeating doses every 5-15 minutes as needed. The order further indicated, "Administration instructions: for procedural sedation. Doses to be given as needed per physician request (during) intra-procedure."

Patient 26's Medication Administration Record (MAR) indicated Patient 26 received 25 mcg of fentanyl at 3:53 p.m. by Registered Nurse (RN) 1 and another dose of 25 mcg of fentanyl given by RN 2 at 4:31 p.m. Review of the procedural nursing documentation between 3:45 p.m. and 4:35 p.m., did not include a completed PASS (Procedural & Anesthetic Scoring System-assessment and reassessment of a patient during a procedure in which sedation/pain reliever is used) as per facility policy.

Review of the facility policy titled, "Procedural Sedation by Non-Anesthesia Personnel," revised June 2014, defined the PASS scoring system as follows:

"Procedure and Anesthesia Scoring System (PASS)

Recovery/Level of Sedation

Consciousness
Awake and alert, turns towards voice = 2
Arousable but drifts back to sleep = 1
Unresponsive (except to painful/repeated stimulus) = 0

Activity
Appropriate for age or development = 2
Weak for age or development = 1
No voluntary movement = 0

Circulation
Stable blood pressure (Bp) with 15 % of presedation level = 2
Bp with 30% of presedation level =1
Bp 30% higher or lower than presedation level =0

Respiration
Able to cough, breathe deeply or cry = 2
Dyspnea (shortness of breath) or limited breathing = 1
Apnea (lack of respirations) obstructed breathing requires assistance to maintain airway = 0

Oxygen saturation (percentage of oxygen intake)
Room air: oxygen saturation greater than 95% = 2
Needs supplemental oxygen to maintain oxygen saturation level greater than 95% = 1
Oxygen saturation less than 95% with oxygen supplementation = 0

Readiness for discharge
Pain
None or mild = 2
Moderate or severe pain controlled with intravenous analgesics (pain medication) = 1
Persistent severe pain = 0

Emetic (anti-nausea/vomiting medication)
None or mild nausea with no vomiting = 2
Transient (intermittent) vomiting or retching = 1
Persistent moderate to severe nausea and vomiting = 0"

A review of Patient 26's procedural sedation documentation indicated RN 1 and RN 2 did not document any PASS scores on Patient 26 during a procedure which required sedation and/or pain reliever.

An interview was conducted with the Director of Radiology (DOR) on November 18, 2015, at 9:30 a.m. The DOR stated, "Nurses should have completed a PASS score if the nurses used sedation."

An interview was conducted with RN 1 on November 18, 2015, at 9:40 a.m. Nurse 1 stated, "PASS should be completed with the use of sedation."

A review of the facility policy,"Procedural Sedation by Non-Anesthesia Personnel," revised June 2014 further indicated, "Moderate and deeply sedated patients shall be subject to ongoing observation by a person with demonstrated competence in the identification of respiratory failure and other potential complications...Each patient shall be assessed at least every 15 minutes as to their level of consciousness, adequacy of ventilation, and ability to maintain a patent airway with intact protective reflexes. A PASS score for "Level of Sedation" shall be documented at the time of these assessments. These assessments should be performed by a physician, dentist, podiatrist, physician assistant, or appropriately trained nurse."

25937

4. On November 18, 2015, at 9:05 a.m., the electronic medical record for Patient 16 was reviewed with Registered Nurse (RN) 10. Patient 16 was admitted to the facility on November 9, 2015, with diagnoses that included anemia (low red blood cells) and hematuria (blood in the urine).

The physician's orders, dated November 9, 2015, indicated to give Norco (a pain medication) every four hours as need for moderate pain (4-6), or morphine (another pain medication) every four hours as needed for severe pain (7-10).

In a concurrent interview, RN 10 stated the pain assessment of the patient was based on the patient's stated pain level on a scale of 1-10. He stated normally it was considered mild pain for a pain scale of 1-3, moderate pain for a pain scale of 4-6, and severe pain for a pain scale of 7-10. RN 10 stated he also considered the patient's acceptable pain level to determine if the pain was mild, moderate, or severe.

The pain assessment flowsheet, dated November 15, 2015, at 3:06 a.m., indicated Patient 16 complained of sharp, continuous pain in the abdomen at a pain scale of eight (8), with an acceptable pain level of two (2). Interventions included medication of the patient.

The medication administration record indicated Norco was given to Patient 16 on November 15, 2015, at 3:06 a.m.

RN 10 stated he did not know why Norco (for moderate pain) was given instead of Morphine (for severe pain). RN 10 stated because Patient 16's stated pain was eight (8), and his acceptable level was two (2), then the morphine should have been administered as ordered for severe pain (7-10).

The policy and procedure titled, "Medication Administration Documentation with Bar Coding," dated July 2015, was reviewed. The policy indicated, "Medication will be administered according to the Six (6) Rights of Medication Administration." These rights included, "Right medication... Right reason."



28294

Based on interview and record review, the facility failed to ensure:

1. The medication order for a Midazolam drip (Versed - a medication used for sedation) drip contained the RASS (Richmond Agitation Sedation Scale) target sedation level to be used for the titration of the medication for four sampled patients (Patients 5, 6, 7, and 37). This resulted in the nursing staff determining the patients' targeted sedation level and titrating the medication drip to their determined sedation level.

2. A Propofol drip (Diprivan - a medication used for sedation) for Patient 2, and a Midazolam drip (Versed - a medication used for sedation) for Patient 5, were titrated to the level of sedation (RASS - Richmond Agitation Sedation Scale) as ordered by the physician. This resulted in the patients being under or over sedated based on the physician's order.

3. A Midazolam drip (Versed - a medication used for sedation) order was complete for one sampled patient (Patient 5). This resulted in Patient 5 receiving a Versed drip for greater than 20 hours before the order was corrected and made complete.

4. Physician orders for severe pain were followed for one sampled patient (Patient 16). Patient 16 complained of severe pain, however he was medicated for moderate pain instead. This resulted in Patient 16's pain not being managed per physician order.

Findings:

Richmond Agitation Sedation Scale (RASS) is a validated and reliable method to assess patients' level of sedation in the ICU. Used in the setting of mechanically ventilated patients in the ICU to avoid over and under sedation. Based on a +4 to -5 scale which ranks agitation and the possibility for sedation:
+4 - Combative;
+3 - Very Agitated;
+2 - Agitated;
+1 - Restless;
0 - Alert and Calm;
-1 - Drowsy;
-2 - Light Sedation;
-3 - Moderate Sedation;
-4 - Deep Sedation; and
-5 - Unarousable Sedation.

1a. On November 16, 2015, the record for Patient 5 was reviewed. Patient 5 was admitted to the facility
Intensive Care Unit (ICU) on November 15, 2015, with diagnoses including aspiration pneumonia.

Patient 5 was placed on a ventilator and an order was written for Intravenous (IV - medication administered directly into a vein) Midazolam at a rate of 2 milligrams (mg) per hour with instructions to "Titrate to 8 mg/hr as needed for sedation."

There was no indication of the sedation level/RASS target the physician wanted achieved for Patient 5's sedation level.

Patient 5 was started on a Midazolam drip at 2 mg/hr on November 15, 2015, at 8:41 p.m., and had a RASS score of "+2 Agitated."

On November 15 to November 16, 2015, Patient 5's RASS score was either +2 or -2 between 8:41 p.m., and 4 a.m., and the Midazolam drip was increased to 3 mg/hr on November 16, 2015, at 4 a.m.

The order for the "Desired Richmond Agitation Sedation Scale (RASS) Target Score?" was written on November 16, 2015, at 11:47 a.m., for "-2 Light Sedation."

During an interview with Registered Nurse (RN) 3, on November 16, 2015, at 11:30 a.m., she reviewed the record and was unable to find documentation of a RASS target score. RN 3 stated a RASS target score was needed in order to titrate the Midazolam drip to the desired level of sedation for the patient. RN 3 stated Patient 5 should have had an ordered RASS target so the nurse could titrate the Midazolam drip based on the physician's order for the patient's level of sedation.

b. On November 16, 2015, the record for Patient 6 was reviewed. Patient 6 was admitted to the facility on November 10, 2015, with diagnoses including bowel obstruction and respiratory distress.

Patient 6 was placed on a ventilator and an order was written for Midazolam at a rate of 2 mg/hr on November 11, 2015, at 6 p.m., discontinued by the pharmacist at 6:21 p.m., and re-written at 6:30 p.m. by the pharmacist with the only change to the order being "Double Check Required."

The Midazolam order indicated:
"DOUBLE CHECK REQUIRED"
"Start after initial bolus orders completed and patient has achieved RASS target. Begin infusion at ordered dose and adjust infusion rate as follows:
- If RASS greater than TARGET: see order for midazolam (VERSED) IV (Breakthrough RASS greater than or equal to one level above target) and increase infusion rate by 1 MG/HR every one hour until RASS = TARGET.
- If RASS = TARGET for 8 hours: decrease infusion by 0.25 MG/HR every 4 hours.
- If RASS less than TARGET for 2 hours: decrease infusion by 0.5 MG/HR every 2 hours until RASS = TARGET.
Call physician for midazolam infusion rate = 10 MG/HR or breakthrough midazolam dose = 10 MG and RASS target not achieved."

There was no indication of the sedation level/RASS target the physician wanted to achieve for Patient 6's sedation level.

Patient 6 was started on a Midazolam drip at 2 mg/hr on November 11, 2015, at 8 p.m., and at 8:30 p.m., had a RASS score of "-2 Light Sedation" with the Midazolam drip rate being increased to 5 mg/hr.

Patient 6's RASS score remained at a "-2 Light Sedation," and the Midazolam drip rate was increased to 6 mg/hr at 9 p.m.; and 8 mg/hr on November 12, 2015, at 12 a.m.

On November 12, 2015, at 8 a.m., Patient 6's RASS score was "-1 Drowsy," and the Midazolam drip rate was increased to 10 mg/hr at 8:30 a.m. The next documented RASS score was "-2 Light Sedation" at 12 p.m. (four hours later).

Patient 6's RASS score remained at a "-2 Light Sedation," and the Midazolam drip rate was decreased to 8 mg/hr on November 13, 2015, at 10 a.m. (22 hours later).

On November 13, 2015, at 12 p.m., Patient 6's RASS score was "-2 Light Sedation," and the Midazolam drip rate was decreased to 2 mg/hr at 2:04 p.m., with the next documented RASS score of "-2 Light Sedation" at 7:45 p.m. (7 hours and 45 minutes after the previous RASS score).

Patient 6's RASS score remained at "-2 Light Sedation" from November 13, 2015, at 7:45 p.m., until November 15, 2015, at 11:15 p.m., with the exception of November 14, 2015, at 10 a.m., when the RASS score was "+1 Restless."

The Midazolam drip rate was decreased to 1 mg/hr on November 14, 2015, at 11 a.m.; and increased to 2 mg/hr at 6:30 p.m.; and increased to 4 mg/hr at 8 p.m., with the RASS score remaining at "-2 Light Sedation."

On November 15, 2015, at 2 p.m., Patient 6's RASS score was "-1 Drowsy" and the Midazolam drip rate was 5 mg/hr.

The order for the "Desired Richmond Agitation Sedation Scale (RASS) Target Score" was written on November 16, 2015, at 2:17 p.m., for a target sedation level of "-1 Drowsy" (4 days and 20 hours after the order/administration for the Midazolam drip for sedation had been written).

c. On November 16, 2015, the record for Patient 7 was reviewed. Patient 7 was admitted to the facility on August 31, 2015, with diagnoses including respiratory failure and encephalopathy (disease, damage or malfunction of the brain).

Patient 7 was placed on a ventilator and an order was written for Midazolam at a rate of 2 mg/hr on September 7, 2015, at 7:15 p.m., and was discontinued on September 10, 2015, at 11:17 a.m.

The order indicated:
"DOUBLE CHECK REQUIRED"
"Start after initial bolus orders completed and patient has achieved RASS target. Begin infusion at ordered dose and adjust infusion rate as follows:
- If RASS greater than TARGET: see order for midazolam (VERSED) IV (Breakthrough RASS greater than or equal to one level above target) and increase infusion rate by 1 MG/HR every one hour until RASS = TARGET.
- If RASS = TARGET for 8 hours: decrease infusion by 0.25 MG/HR every 4 hours.
- If RASS less than TARGET for 2 hours: decrease infusion by 0.5 MG/HR every 2 hours until RASS = TARGET.
Call physician for midazolam infusion rate = 10 MG/HR or breakthrough midazolam dose = 10 MG and RASS target not achieved."

There was no indication of the sedation level/RASS target the physician wanted achieved for Patient 7's sedation level.

Patient 7's RASS score on September 7, 2015, at 8 p.m., was "-3 Moderate Sedation," and was placed on a Midazolam drip at a rate of 1 mg/hr at 9:29 p.m.

Patient 7's RASS score remained "-3 Moderate Sedation," and on September 8, 2015, at 8 a.m., the Midazolam drip was discontinued.

d. The record for Patient 37 was reviewed on November 18, 2015. Patient 37 was admitted to the facility on November 14, 2015, with a diagnosis of sepsis (total body infection).

On November 16, 2015, Patient 37 was placed on a ventilator and an order was written for Midazolam at a rate of 0.5 mg/hr.

The order indicated:
"DOUBLE CHECK REQUIRED"
"Start after initial bolus orders completed and patient has achieved RASS target. Begin infusion at ordered dose and adjust infusion rate as follows:
- If RASS greater than TARGET: see order for midazolam (VERSED) IV (Breakthrough RASS greater than or equal to one level above target) and increase infusion rate by 1 MG/HR every one hour until RASS = TARGET.
- If RASS = TARGET for 8 hours: decrease infusion by 0.25 MG/HR every 4 hours.
- If RASS less than TARGET for 2 hours: decrease infusion by 0.5 MG/HR every 2 hours until RASS = TARGET.
Call physician for midazolam infusion rate = 10 MG/HR or breakthrough midazolam dose = 10 MG and RASS target not achieved."

There was no order for, or indication of, the sedation level/RASS target the physician wanted achieved for Patient 37's sedation level.

During an interview with the Manager Critical Care (MCC), on November 17, 2015, at 10:30 a.m., he reviewed the records for Patients 5, 6, and 7, and was unable to find documentation of a RASS target being ordered when the Midazolam drip was ordered for the patients. The MCC stated the Midazolam orders were incomplete without the RASS target, and the nurse/pharmacist should have obtained a RASS target in order to complete the order and to know what sedation level the medication should be titrated to.

The facility pre-printed order set titled "Sedation-Analgesia Orders" dated November 5, 2014, revealed "... Patient must be intubated and on ventilator if receiving continuous infusion sedation. ... Choose initial RASS TARGET: sedation range using the Richmond Agitation-Sedation Scale (RASS). This can be modified by a later order. ... Nursing Orders - Richmond Agitation Scale (RASS) Target. Note: A RASS Target is REQUIRED with Sedation Medication Orders. Monitor Patient, Richmond Agitation Sedation Scale (RASS). Comment: Monitor and record with each set of vitals. Desired RASS target score ______. ..."

2a. On November 16, 2015, the record for Patient 2 was reviewed. Patient 2 was admitted to the facility on November 6, 2015, with diagnoses including abdominal pain and respiratory distress.

Patient 2 was placed on a ventilator and an order was written for Propofol 5 micrograms (mcg) per kilogram (kg) per minute or a rate of 3.13 milliliters (ml) per hour (hr).

The Propofol order indicated:
"DOUBLE CHECK REQUIRED"
"Start at 5 mcg/kg/min dose. Increase by 5 mcg/kg/min every 5 minutes to a maximum of 100 mcg/kg/min until RASS TARGET is achieved. Once RASS TARGET is achieved, check RASS every 1 hour (OR PER LOCAL POLICY) and adjust propofol dose as follows:
- If RASS less than TARGET: decrease propofol by 5 mcg/kg/min every 5 minutes until RASS TARGET is achieved.
- If RASS greater than TARGET: increase propofol by 5 mcg/kg/min every 5 minutes to a maximum of 100 mcg//kg/min until RASS TARGET is achieved.
- Call physician for Propofol at maximum dose and RASS target not achieved.
- Notify physician to re-evaluate sedation regimen after 72 hours of propofol infusion to consider alternative sedation medications.
- Stop propofol before extubation.
- Change tubing and bottle every 12 hours."

The order for the "Desired Richmond Agitation Sedation Scale (RASS) Target Score?" was written and revised twice as follows:
- November 7, 2015, at 12:33 a.m., indicated "-4 Deep Sedation;"
- November 7, 2015, at 2:08 a.m., indicated "-3 Moderated Sedation;" and
- November 8, 2015, at 2:17 p.m., indicated "-2 Light Sedation."

The Propofol drip order was initiated on November 7, 2015, at 12:51 a.m., and was increased to 50 mcg/kg/min at 2:35 a.m., at which time Patient 2 had a RASS score of "-3 Moderate Sedation."

On November 8, 2015, at 3:50 p.m., the Propofol drip was at 25 mcg/kg/min, and the RASS score was "-3 Moderate Sedation (There was no indication the Propofol drip rate was decreased when the RASS score was less than the ordered target.)."

On November 10, 2015, the RASS score was "-2 Light Sedation" at 12 p.m., and the Propofol drip was turned off at 12:41 p.m.

On November 10, 2015, the record indicated the following times for RASS scores with no documentation to indicate Propofol was administered:
1:39 p.m., the RASS score was "+2 Agitated."
3 p.m., the RASS score was "+1 Restless."
3:45 p.m., the RASS score was "-1 Drowsy."

At 4:44 p.m., the RASS score was "-3 Moderate Sedation," and the Propofol drip was at 50 mcg/kg/min At 7 p.m., the Propofol drip was decreased to 40 mcg/kg/min and again increased to 50 mcg/kg/min at 8:48 p.m., with the RASS score remaining at "-3 Moderate Sedation."

The Propofol drip, per physician's order, was to be titrated to a RASS target score of "-2 Light Sedation."

b. On November 16, 2015, the record for Patient 5 was reviewed. Patient 5 was admitted to the facility Intensive Care Unit (ICU) on November 15, 2015, with diagnoses including aspiration pneumonia.

Patient 5 was placed on a ventilator and an order was written for Intravenous (IV - medication administered directly into a vein) Midazolam at a rate of 2 milligrams (mg) per hour with instructions to "Titrate to 8 mg/her as needed for sedation."

Patient 5 was started on a Midazolam drip at 2 mg/hr on November 15, 2015, at 8:41 p.m., and had a RASS score of "+2 Agitated."

On November 15 to November 16, 2015, Patient 5's RASS score was either +2 or -2 between 8:41 p.m., and 4 a.m., and the Midazolam drip was increased to 3 mg/hr on November 16, 2015, at 4 a.m.

The order for the "Desired Richmond Agitation Sedation Scale (RASS) Target Score?" was written on November 16, 2015, at 11:47 a.m., for "-2 Light Sedation."

The Midazolam drip order was updated/revised on November 16, 2015, at 5:30 p.m., and indicated:
"DOUBLE CHECK REQUIRED"
"Start after initial bolus orders completed and patient has achieved RASS target. Begin infusion at ordered dose and adjust infusion rate as follows:
- If RASS greater than TARGET: see order for midazolam (VERSED) IV (Breakthrough RASS greater than or equal to one level above target) and increase infusion rate by 1 MG/HR every one hour until RASS = TARGET.
- If RASS = TARGET for 8 hours: decrease infusion by 0.25 MG/HR every 4 hours.
- If RASS less than TARGET for 2 hours: decrease infusion by 0.5 MG/HR every 2 hours until RASS = TARGET.
Call physician for midazolam infusion rate = 10 MG/HR or breakthrough midazolam dose = 10 MG and RASS target not achieved."

On November 17, 2015, the RASS score and Midazolam drip rates were as follows:
- At 12 p.m., RASS score of "-2 Light Sedation" and the Midazolam drip was at 2 mg/hr.
- At 1 p.m., RASS score of "+3 Very Agitated" and the Midazolam drip was at 4 mg/hr (increased by 2 mg/hr in one hour).
- At 1:30 p.m., no RASS score indicated and the Midazolam drip was at 6 mg/hr (increased by 2 mg/hr in 30 minutes).
- At 2 p.m., RASS score of "+3 Very Agitated" and the Midazolam drip was at 10 mg/hr (increased by 4 mg/hr in 30 minutes).
- At 3 p.m., RASS score of "-2 Light Sedation" and the Midazolam drip was at 10 mg/hr.

There was no "breakthrough" order for Midazolam.

There was no documented indication an order was obtained to increase the Midazolam by more than 1 mg/hr.

There was no documented indication the physician was notified when the Midazolam drip was increased to 10 mg/hr.

During an interview with Registered Nurse (RN) 4, on November 18, 2015, at 10:25 a.m., he reviewed the record and verified the Midazolam drip was not increased by 1 mg/hr as ordered by the physician for a RASS greater than target. RN 4 stated the Midazolam drip rate was increased based on nursing "experience," and that it was a "common practice to increase the Versed at whatever rate is needed based on the patient's status without a physician's order." RN 4 stated the Versed for Patient 5 was increased based on "nursing experience and judgement." RN 4 stated a "breakthrough" order was not obtained.

The facility policy and procedure titled "Medication Administration Documentation with Bar Coding" revised July 2015, revealed "... The patient can expect to receive medications according to the following principles and procedures: Medications will be administered according to the Six (6) Rights of Medication Administration." These rights included right dose and right time.

3. On November 16, 2015, the record for Patient 5 was reviewed. Patient 5 was admitted to the facility Intensive Care Unit (ICU) on November 15, 2015, with diagnoses including aspiration pneumonia.

Patient 5 was placed on a ventilator and an order was written, on November 15, 2015, at 8:30 p.m., and verified by a pharmacist at 8:37 p.m., for Intravenous (IV - medication administered directly into a vein) Midazolam at a rate of 2 milligrams (mg) per hour with instructions to "Titrate to 8 mg/hr as needed for sedation."

There was no indication of the sedation level/RASS target the physician wanted achieved for Patient 5's sedation level.

There was no indication of the frequency or rate at which the titration should occur.

Patient 5 was started on a Midazolam drip at 2 mg/hr on November 15, 2015, at 8:41 p.m., and had a RASS score of "+2 Agitated."

On November 15 to November 16, 2015, Patient 5's RASS score was either +2 or -2 between 8:41 p.m., and 4 a.m., and the Midazolam drip was increased to 3 mg/hr on November 16, 2015, at 4 a.m.

The order for the "Desired Richmond Agitation Sedation Scale (RASS) Target Score" was written on November 16, 2015, at 11:47 a.m., for "-2 Light Sedation."

On November 16, 2015, at 12 p.m., Patient 5's RASS score was "-2 Light Sedation" and the Midazolam drip was at 3 mg/hr with an increase to 6 mg/hr, at 12:50 p.m., with the RASS score remaining "-2 Light Sedation."

During an interview with the Manager Critical Care (MCC), on November 17, 2015, at 10:30 a.m., he reviewed the record and was unable to find documentation of a complete order for the Midazolam drip. The MCC stated the order needed a RASS target, and a frequency or rate at which the titration should occur. The MCC stated if the physician used the order set, or the pharmacist corrected the order to follow the order set, the order would have been correct. In addition, the MCC stated an order would also need to be placed for the RASS target which was a different computer screen than the medication order set.

The facility policy and procedure titled "Medication Orders: Specific Requirements" reviewed December 2014, revealed "... Titration Orders: When writing orders to titrate a medication dose, the physician must include the following information: Under what conditions or parameters the dose is to be titrated. The frequency or rate at which titration should occur. The maximum dose of the medication. ..."

Based on interview and record review, the facility failed to control and distribute medications in a safe manner to protect the patients by failing to ensure:

1. The medication order for a Midazolam (Versed - a medication used for sedation) drip contained the RASS (Richmond Agitation Sedation Scale) target sedation level to be used for the titration of the medication for four sampled patients (Patients 5, 6, 7, and 37). This resulted in the nursing staff determining the patients' targeted sedation level and titrating the medication drip to their determined sedation level.

2. A Midazolam (Versed - a medication used for sedation) drip order was complete for one sampled patient (Patient 5). This resulted in Patient 5 receiving a Versed drip for greater than 20 hours before the order was corrected and made complete.

Findings:

Richmond Agitation Sedation Scale (RASS) is a validated and reliable method to assess patients' level of sedation in the ICU. Used in the setting of mechanically ventilated patients in the ICU to avoid over and under sedation. Based on a +4 to -5 scale which ranks agitation and the possibility for sedation:
+4 - Combative;
+3 - Very Agitated;
+2 - Agitated;
+1 - Restless;
0 - Alert and Calm;
-1 - Drowsy;
-2 - Light Sedation;
-3 - Moderate Sedation;
-4 - Deep Sedation; and
-5 - Unarousable Sedation.

1a. On November 16, 2015, the record for Patient 5 was reviewed. Patient 5 was admitted to the facility
Intensive Care Unit (ICU) on November 15, 2015, with diagnoses including aspiration pneumonia.

Patient 5 was placed on a ventilator and an order was written for Intravenous (IV - medication administered directly into a vein) Midazolam at a rate of 2 milligrams (mg) per hour with instructions to "Titrate to 8 mg/hr as needed for sedation."

There was no indication of the sedation level/RASS target the physician wanted achieved for Patient 5's sedation level.

Patient 5 was started on a Midazolam drip at 2 mg/hr on November 15, 2015, at 8:41 p.m. Patient d had a RASS score of "+2 Agitated."

On November 15 to November 16, 2015, Patient 5's RASS score was either +2 or -2 between 8:41 p.m., and 4 a.m., and the Midazolam drip was increased to 3 mg/hr on November 16, 2015, at 4 a.m.

During an interview with Registered Nurse (RN) 3, on November 16, 2015, at 11:30 a.m., she reviewed the record and was unable to find documentation of a RASS target score. RN 3 stated a RASS target score was needed in order to titrate the Midazolam drip to the desired level of sedation for the patient. RN 3 stated Patient 5 should have had an ordered RASS target so the nurse could titrate the Midazolam drip based on the physician's order for the patient's level of sedation.

b. On November 16, 2015, the record for Patient 6 was reviewed. Patient 6 was admitted to the facility on November 10, 2015, with diagnoses including bowel obstruction and respiratory distress.

Patient 6 was placed on a ventilator and an order was written for Midazolam at a rate of 2 mg/hr on November 11, 2015, at 6 p.m., discontinued by the pharmacist at 6:21 p.m., and re-written at 6:30 p.m. by the pharmacist with the only change to the order being "Double Check Required."

The Midazolam order indicated:
"DOUBLE CHECK REQUIRED"
"Start after initial bolus orders completed and patient has achieved RASS target. Begin infusion at ordered dose and adjust infusion rate as follows:
- If RASS greater than TARGET: see order for midazolam (VERSED) IV (Breakthrough RASS greater than or equal to one level above target) and increase infusion rate by 1 MG/HR every one hour until RASS = TARGET.
- If RASS = TARGET for 8 hours: decrease infusion by 0.25 MG/HR every 4 hours.
- If RASS less than TARGET for 2 hours: decrease infusion by 0.5 MG/HR every 2 hours until RASS = TARGET.
Call physician for midazolam infusion rate = 10 MG/HR or breakthrough midazolam dose = 10 MG and RASS target not achieved."

There was no indication of the sedation level/RASS target the physician wanted achieved for Patient 6's sedation level.

There was no indication the pharmacist recognized the Midazolam drip order was missing the RASS target when the pharmacist re-wrote the order on November 11, 2015, at 6:30 p.m.

Patient 6 was started on a Midazolam drip at 2 mg/hr on November 11, 2015, at 8 p.m., and at 8:30 p.m., had a RASS score of "-2 Light Sedation" with the Midazolam drip rate being increased to 5 mg/hr.

Patient 6's RASS score remained at a "-2 Light Sedation," and the Midazolam drip rate was increased to 6 mg/hr at 9 p.m.; and 8 mg/hr on November 12, 2015, at 12 a.m.

On November 12, 2015, at 8 a.m., Patient 6's RASS score was "-1 Drowsy," and the Midazolam drip rate was increased to 10 mg/hr at 8:30 a.m. The next documented RASS score was "-2 Light Sedation" at 12 p.m. (four hours later).

Patient 6's RASS score remained at a "-2 Light Sedation," and the Midazolam drip rate was decreased to 8 mg/hr on November 13, 2015, at 10 a.m. (22 hours later).

On November 13, 2015, at 12 p.m., Patient 6's RASS score was "-2 Light Sedation," and the Midazolam drip rate was decreased to 2 mg/hr at 2:04 p.m., with the next documented RASS score of "-2 Light Sedation" at 7:45 p.m. (7 hours and 45 minutes after the previous RASS score).

Patient 6's RASS score remained at "-2 Light Sedation" from November 13, 2015, at 7:45 p.m., until November 15, 2015, at 11:15 p.m., with the exception of November 14, 2015, at 10 a.m., when the RASS score was "+1 Restless."

The Midazolam drip rate was decreased to 1 mg/hr on November 14, 2015, at 11 a.m.; and increased to 2 mg/hr at 6:30 p.m.; and increased to 4 mg/hr at 8 p.m., with the RASS score remaining at "-2 Light Sedation."

On November 15, 2015, at 2 p.m., Patient 6's RASS score was "-1 Drowsy" and the Midazolam drip rate was 5 mg/hr.

The order for the "Desired Richmond Agitation Sedation Scale (RASS) Target Score" was written on November 16, 2015, at 2:17 p.m., for a target sedation level of "-1 Drowsy" (4 days and 20 hours after the order/administration for the Midazolam drip for sedation was written).

c. On November 16, 2015, the record for Patient 7 was reviewed. Patient 7 was admitted to the facility on August 31, 2015, with diagnoses including respiratory failure and encephalopathy (disease, damage or malfunction of the brain).

Patient 7 was placed on a ventilator and an order was written for Midazolam at a rate of 2 mg/hr on September 7, 2015, at 7:11 p.m., and was reviewed by a pharmacist.

The Midazolam drip order was discontinued on September 10, 2015, at 11:17 a.m.

The order indicated:
"DOUBLE CHECK REQUIRED"
"Start after initial bolus orders completed and patient has achieved RASS target. Begin infusion at ordered dose and adjust infusion rate as follows:
- If RASS greater than TARGET: see order for midazolam (VERSED) IV (Breakthrough RASS greater than or equal to one level above target) and increase infusion rate by 1 MG/HR every one hour until RASS = TARGET.
- If RASS = TARGET for 8 hours: decrease infusion by 0.25 MG/HR every 4 hours.
- If RASS less than TARGET for 2 hours: decrease infusion by 0.5 MG/HR every 2 hours until RASS = TARGET.
Call physician for midazolam infusion rate = 10 MG/HR or breakthrough midazolam dose = 10 MG and RASS target not achieved."

There was no indication of the sedation level/RASS target the physician wanted achieved for Patient 7's sedation level.

There was no indication the pharmacist recognized the Midazolam drip order was missing the RASS target when the pharmacist reviewed the order on September 7, 2015, at 7:11 p.m.

Patient 7's RASS score on September 7, 2015, at 8 p.m., was "-3 Moderate Sedation," and was placed on a Midazolam drip at a rate of 1 mg/hr at 9:29 p.m.

Patient 7's RASS score remained "-3 Moderate Sedation," and on September 8, 2015, at 8 a.m., the Midazolam drip was discontinued.

d. The record for Patient 37 was reviewed on November 18, 2015. Patient 37 was admitted to the facility on November 14, 2015, with a diagnosis of sepsis (total body infection).

On November 16, 2015, Patient 37 was placed on a ventilator and an order was written for Midazolam at a rate of 0.5 mg/hr.

The order indicated:
"DOUBLE CHECK REQUIRED"
"Start after initial bolus orders completed and patient has achieved RASS target. Begin infusion at ordered dose and adjust infusion rate as follows:
- If RASS greater than TARGET: see order for midazolam (VERSED) IV (Breakthrough RASS greater than or equal to one level above target) and increase infusion rate by 1 MG/HR every one hour until RASS = TARGET.
- If RASS = TARGET for 8 hours: decrease infusion by 0.25 MG/HR every 4 hours.
- If RASS less than TARGET for 2 hours: decrease infusion by 0.5 MG/HR every 2 hours until RASS = TARGET.
Call physician for midazolam infusion rate = 10 MG/HR or breakthrough midazolam dose = 10 MG and RASS target not achieved."

There was no order for, or indication of, the sedation level/RASS target the physician wanted achieved for Patient 37's sedation level.

During an interview with the Director of Pharmacy (DOP) on November 16, 2015, at 12:20 p.m., the DOP stated physician's orders for patients receiving continuous intravenous sedation should include a target Richmond Agitation Sedation Scale (RASS), so the nursing staff would maintain the patient at a consistent and safe level of sedation. The DOP stated without the target RASS, the order was not complete.

During an interview with the Manager Critical Care (MCC), on November 17, 2015, at 10:30 a.m., he reviewed the records for Patients 5, 6, and 7, and was unable to find documentation of a RASS target being ordered when the Midazolam drip was ordered for the patients. The MCC stated the Midazolam orders were incomplete without the RASS target, and the nurse/pharmacist should have obtained a RASS target in order to complete the order and to know what sedation level the medication should be titrated to.

The facility pre-printed order set titled "Sedation-Analgesia Orders" dated November 5, 2014, revealed "... Patient must be intubated and on ventilator if receiving continuous infusion sedation. ... Choose initial RASS TARGET: sedation range using the Richmond Agitation-Sedation Scale (RASS). This can be modified by a later order. ... Nursing Orders - Richmond Agitation Scale (RASS) Target. Note: A RASS Target is REQUIRED with Sedation Medication Orders. Monitor Patient, Richmond Agitation Sedation Scale (RASS). Comment: Monitor and record with each set of vitals. Desired RASS target score ______. ..."

2. On November 16, 2015, the record for Patient 5 was reviewed. Patient 5 was admitted to the facility Intensive Care Unit (ICU) on November 15, 2015, with diagnoses including aspiration pneumonia.

Patient 5 was placed on a ventilator and an order was written, on November 15, 2015, at 8:30 p.m., and verified by a pharmacist at 8:37 p.m., for Intravenous (IV - medication administered directly into a vein) Midazolam at a rate of 2 milligrams (mg) per hour with instructions to "Titrate to 8 mg/hr as needed for sedation."

There was no indication of the sedation level/RASS target the physician wanted achieved for Patient 5's sedation level.

There was no indication of the frequency or rate at which the titration should occur.

There was no indication the pharmacist recognized the Midazolam drip order was missing the RASS target, or the frequency or rate at which the titration should occur, when the pharmacist reviewed the order on November 15, 2015, at 8:37 p.m.

Patient 5 was started on a Midazolam drip at 2 mg/hr on November 15, 2015, at 8:41 p.m., and had a RASS score of "+2 Agitated."

On November 15 to November 16, 2015, Patient 5's RASS score was either +2 or -2 between 8:41 p.m., and 4 a.m., and the Midazolam drip was increased to 3 mg/hr on November 16, 2015, at 4 a.m.

During an interview with the Manager Critical Care (MCC), on November 17, 2015, at 10:30 a.m., he reviewed the record and was unable to find documentation of a complete order for the Midazolam drip. The MCC stated the order needed a RASS target, and a frequency or rate at which the titration should occur. The MCC stated if the physician used the order set, or the pharmacist corrected the order to follow the order set, the order would have been correct. In addition, the MCC stated an order would also need to be placed for the RASS target which was a different computer screen than the medication order set.

During an interview with the Inpatient Pharmacy Supervisor (IPS), on November 17, 2015, at 1:50 p.m., he reviewed the record and was unable to find documentation of a complete order for the Midazolam drip ordered on November 15, 2015, at 8:30 p.m. The IPS stated the order needed a RASS target, and a frequency or rate at which the titration should occur. The IPS stated the pharmacist should have corrected the order when he reviewed the order on November 15, 2015, at 8:37 p.m.

The facility policy and procedure titled "Medication Orders: Specific Requirements" reviewed December 2014, revealed "... Titration Orders: When writing orders to titrate a medication dose, the physician must include the following information: Under what conditions or parameters the dose is to be titrated. The frequency or rate at which titration should occur. The maximum dose of the medication. ..."