HospitalInspections.org

Based on observation, interview, record review and policy review, the hospital's Governing Body failed to ensure that:
- They approved appointment of Staff O as Chief Executive Officer. (A-0057)
- Nursing staff safely and accurately administered high-alert medications (drugs that bear a heightened risk of causing significant patient harm when they are used in error) to four discharged patients (#16, #18, #19 and #20), of five discharged patients reviewed with medication errors, one of which resulted in a patient's death. (A-0405)
- Nursing staff appropriately monitored one discharged patient (#17) of one discharged patient reviewed who was on ventilator (a machine that supports breathing) weaning protocol, when they did not provide continuous pulse oximetry (the percentage of oxygen in the bloodstream, a normal reading would be 95 to 100 percent) monitoring, and resulted in a negative patient outcome. (A-0395)
- Ensure that five licensed staff (Staff C, D, E, J and X) of seven licensed personnel records reviewed, were oriented and verified to be competent in the patient care they provided. The failure to ensure staff were competent resulted in an overdose of one patient (#16), and the patient died. (A-0398)
- The Chief Nursing Officer (CNO) provided adequate oversight and supervision of nursing personnel, when policies and procedures were not followed, and resulted in medication errors which involved four patients (#16, #18, #19 and #20) of five medication errors reviewed. (A-0386)
- Nursing monitored and assessed two discharged patients (#18 and #20) of two discharged patients reviewed who received fentanyl (a medication used to treat severe pain, and is a high risk drug for theft and personal use) intravenously (IV, in the vein) for changes in their urinary output, respiratory rate (RR, the number of breaths per minute, normal range for adults at rest is 12 to 20), oxygen saturation (O2 sats, oxygen saturation in the blood) and vital signs (body temperature, blood pressure, heart rate, and breathing rate), and monitored one current patient (#1) for vital signs every four hours as ordered. (A-0395)
- The Pharmacy Director (Staff Q) was made aware of medication errors that affected three discharged patients (#18, #20 and #21) of five discharged patients with medication errors reviewed (A-0508).
- The Pharmacy Director fully investigated process failures and implemented preventative measures for medication errors that affected two discharged patients (#16 and #19) of five discharged patients with medication errors reviewed, in order to reduce the likelihood of reoccurrence. (A-0508)
- Reference information was available to nursing staff when administering a high-alert medication (drugs that bear a heightened risk of causing significant patient harm when they are used in error) to one patient (#16) of three patients reviewed who experience medication errors related to the same high-alert drug. (A-0510)

These failures had the potential to adversely affect the quality of care and safety of all patients in the hospital.

The severity and cumulative effect of these systemic practices resulted in the hospital's non-compliance with 42 CFR 482.12 Condition of Participation: Governing Body.

The hospital census was 16.

Based on interview, record review, policy review of the Missouri state regulations, the hospital failed to ensure that:
- Nursing staff safely and accurately administered high-alert medications (drugs that bear a heightened risk of causing significant patient harm when they are used in error) to four discharged patients (#16, #18, #19 and #20), of five discharged patients reviewed with medication errors, one of which resulted in a patient's death. (A-0405)
- Nursing staff appropriately monitored one discharged patient (#17) of one discharged patient reviewed who was on ventilator (a machine that supports breathing) weaning protocol, when they did not provide continuous pulse oximetry (the percentage of oxygen in the bloodstream, a normal reading would be 95 to 100 percent) monitoring, and resulted in a negative patient outcome. (A-0395)
- Ensure that five licensed staff (Staff C, D, E, J and X) of seven licensed personnel records reviewed, were oriented and verified to be competent in the patient care they provided. The failure to ensure staff were competent resulted in an overdose of one patient (#16), and the patient died. (A-0398)
- The Chief Nursing Officer (CNO) provided adequate oversight and supervision of nursing personnel, when policies and procedures were not followed, and resulted in medication errors which involved four patients (#16, #18, #19 and #20) of five medication errors reviewed. (A-0386)
- Nursing monitored and assessed two discharged patients (#18 and #20) of two discharged patients reviewed who received fentanyl (a medication used to treat severe pain, and is a high risk drug for theft and personal use) intravenously (IV, in the vein) for changes in their urinary output, respiratory rate (RR, the number of breaths per minute, normal range for adults at rest is 12 to 20), oxygen saturation (O2 sats, oxygen saturation in the blood) and vital signs (body temperature, blood pressure, heart rate, and breathing rate), and monitored one current patient (#1) for vital signs every four hours as ordered. (A-0395)
- Nursing staff assessed the heart rate of one current patient (#7) of 15 current patients reviewed, and administered a medication when it should have been withheld. (A-0395)
- Nursing staff followed hospital policy when one current patient (#3) of 15 current patients reviewed, was not repositioned in bed every two hours. (A-0395)
- Nursing staff assessed the daily weights of one current patient (#1) of 15 current patients reviewed for weights. (A-0395)
- Nursing staff followed policy and provided a nursing assessment for five current patients (#1, #2, #3, #11 and #15) of 15 current patients reviewed for nursing assessments. (A-0395)
- Nursing staff removed the quality control solutions for the glucose (sugar) monitors to ensure they were not used beyond their expiration date. (A-0395)
- Nursing staff checked the crash cart (mobile cart which contains emergency medical supplies and medication) daily for functionality and adequate supply levels. (A-0395)
- They were in compliance with the state regulatory requirements under §20 CSR 2200-6.030 Intravenous (IV, in the vein) Infusion Treatment Administration by Qualified Practical Nurses, as well as failed to follow their policy when Licensed Practical Nurses (LPNs) administered IV flush (medications or solutions to maintain patency) or IV infusions without documented competency verification by the hospital to five current patients (#6, #9, #10, #14 and #32) of 10 current patients reviewed. (A-410)

The patient population of the hospital consisted of individuals that were critically ill and required ventilation and various oral and critical IV medications.

These practices resulted in a systemic failure and noncompliance with 42 CFR 482.23 Condition of Participation: Nursing Services. The hospital census was 16.

The severity and cumulative effect of these practices had the potential to place all patients at risk for their health and safety, also known as Immediate Jeopardy (IJ).

By the survey exit date, 08/05/21 at 4:00 PM, the hospital was not able to provide an acceptable plan of correction (POC) to remove the risk of harm to patients, and the IJ remained.

Based on interview, record review and policy review, the hospital failed to ensure that:
- The Pharmacy Director (Staff Q) was made aware of medication errors that affected three discharged patients (#18, #20 and #21) of five discharged patients with medication errors reviewed (A-0508).
- The Pharmacy Director fully investigated process failures and implemented preventative measures for medication errors that affected two discharged patients (#16 and #19) of five discharged patients with medication errors reviewed, in order to reduce the likelihood of reoccurrence (A-0508).
- Reference information was available to nursing staff when administering a high-alert medication (drugs that bear a heightened risk of causing significant patient harm when they are used in error) to one patient (#16) of three patients reviewed who experience medication errors related to the same high-alert drug (A-0510).

After medication errors were identified, the hospital failed to implement measures to follow their policy and ensure the Pharmacy Director was aware of and fully investigated the process failures of all medication errors as soon as reasonably possible, and failed to implement preventative measures to reduce the likelihood for recurrence, placing all patients in the hospital at risk for serious harm, injury or death.

The patient population of the hospital consisted of individuals that were critically ill and required ventilation (breathing supported by a machine) and various oral and critical intravenous (IV, in the vein) medications.

These failed practices resulted in noncompliance with 42 CFR 482.25 Condition of Participation: Pharmaceutical Services. The hospital census was 16.

Based on observation, interview, record review and policy review, the Governing Body failed to ensure the Chief Executive Officer (CEO) was responsible for management of the entire hospital including accountability for the effective oversight of staff to comply with the requirements under 42 CFR 482.12 Condition of Participation (COP): Governing Body, 42 CFR 482.23 COP: Nursing Services, and 42 CFR 482.25 COP: Pharmaceutical Services. These failures had the potential to affect the quality of care and safety of all patients. The hospital census was 16.

Findings included:

Review of the hospital-provided document titled, "Landmark Hospital Board of Managers (Governing Body) Bylaws," revised 03/2021, showed the following:
- The CEO has authority and accountability to the Board of Managers for all hospital operations and activities.
- The CEO maintains all state and federal regulatory requirements.
- The CEO assures policies and procedures are current and effectively utilized in hospital operations.
- The CEO provides leadership to promote a hospital culture that supports and sustains a highly reliable organization that is focused on patient safety and clinical quality outcomes.

Review of Board of Manager meeting minutes failed to show approval of appointment of Staff O as CEO until 08/02/21, seven days after the Centers for Medicare and Medicaid Services (CMS) survey was initiated.

Additionally, the CEO, responsible for compliance with the COPs of Nursing Services and Pharmaceutical Services, failed to ensure:
- Nursing staff safely and accurately administered high-alert medications (drugs that bear a heightened risk of causing significant patient harm when they are used in error) to four discharged patients (#16, #18, #19 and #20), of five discharged patients reviewed with medication errors, one of which resulted in a patient's death. (A-0405)
- Nursing staff appropriately monitored one discharged patient (#17) of one discharged patient reviewed who was on ventilator (a machine that supports breathing) weaning protocol, when they did not provide continuous pulse oximetry (the percentage of oxygen in the bloodstream, a normal reading would be 95 to 100 percent) monitoring, and resulted in a negative patient outcome.
- Ensure that five licensed staff (Staff C, D, E, J and X) of seven licensed personnel records reviewed, were oriented and verified to be competent in the patient care they provided. The failure to ensure staff were competent resulted in an overdose of one patient (#16), and the patient died.
- The Chief Nursing Officer (CNO) provided adequate oversight and supervision of nursing personnel, when policies and procedures were not followed, and resulted in medication errors which involved four patients (#16, #18, #19 and #20) of five medication errors reviewed.
- Nursing monitored and assessed two discharged patients (#18 and #20) of two discharged patients reviewed who received fentanyl (a medication used to treat severe pain, and is a high risk drug for theft and personal use) intravenously (IV, in the vein) for changes in their urinary output, respiratory rate (RR, the number of breaths per minute, normal range for adults at rest is 12 to 20), oxygen saturation (O2 sats, oxygen saturation in the blood) and vital signs (body temperature, blood pressure, heart rate, and breathing rate), and monitored one current patient (#1) for vital signs every four hours as ordered.
- The Pharmacy Director (Staff Q) was made aware of medication errors that affected three discharged patients (#18, #20 and #21) of five discharged patients with medication errors reviewed.
- The Pharmacy Director fully investigated process failures and implemented preventative measures for medication errors that affected two discharged patients (#16 and #19) of five discharged patients with medication errors reviewed, in order to reduce the likelihood of reoccurrence.
- Reference information was available to nursing staff when administering a high-alert medication (drugs that bear a heightened risk of causing significant patient harm when they are used in error) to one patient (#16) of three patients reviewed who experience medication errors related to the same high-alert drug.

During an interview on 08/05/21 at 2:25 PM, Staff O, CEO, stated that she was responsible for the entire hospital and responsible for the oversight of the Governing Body, Nursing Services and Pharmaceutical Services.

Based on interview, record review and policy review, the hospital failed to ensure that the Chief Nursing Officer (CNO) provided adequate oversight and supervision of nursing personnel, when policies and procedures were not followed, and resulted in medication errors which involved four patients (#16, #18, #19 and #20) of five medication errors reviewed. These failures had the potential to affect the quality of care and safety of all patients who received medication by nursing personnel. The hospital census was 16.

Findings included:

1. Review of the hospital's document titled, "Chief Clinical Officer Competency," dated 06/17/20, showed that the CNO was responsible for the following:
- Ensuring that staffing standards were adequate to meet patient care needs.
- Consistently ensure that staff follow approved policies and procedures.
- Resolving problems with department managers concerning such items as staffing, utilization of facilities, equipment and supplies.
- Effectively solving problems.
- Training and educating staff as necessary and appropriate.

Review of the hospital's policy titled, "Drug Administration General," dated 04/2020, directed staff to:
- Verify drugs to be administered with the physician's order. Review the MAR to ensure that the dose was correct and that the drug was not contraindicated by allergy, sensitivity, or diagnosis.
- Read the drug label at least three times, including when picking up the drug, just prior to the administration, and just after administration.
- Before administering any drug, mentally review the five rights of drug administration for the right patient, right drug, right dose, right route, and the right time.
- Consult with a pharmacist or prescriber if there were any concerns or questions about any aspect of the drug to be administered.

Review of the hospital's undated document titled, "Fentanyl (a medication used to treat severe pain, and is a high risk drug for theft and personal use) Protocol," showed the following:
- Fentanyl maintenance dose was 25 to 100 micrograms (mcg, a measure of dosage strength)/hour.
- Fentanyl was to be initiated at a drip rate of 25 mcg/hr which was equivalent to 2.5 milliliters (ml, a measurement of liquid)/hr.
- The rate could be increased by 25 mcg/hr every 60 minutes to a soft stop maximum rate of 100 mcg/hr.
- The nurse was to document baseline vital signs (body temperature, blood pressure, heart rate, and breathing rate), oxygen saturation (oxygen saturation in the blood), cardiac monitor (noninvasive monitors of the heart that attach to the patient's chest and record heart rhythm) and any changes, the dosage given and the patient's response with each dose administered, and any changes in the patient's condition.

2. Review of patient medical records, incident reports, and hospital investigations showed the following:
- 07/16/21, Staff C, Registered Nurse (RN), along with Staff J, Nurse Manager (Charge Nurse at the time, who verified the infusion rate), began Patient #16's infusion of fentanyl at 25 milliliters per hour (ml/hr, unit of volume measurement), when the infusion should have been set at 25 micrograms per hour (mcg/hr, unit of weight measurement), resulting in an overdose of 225 mcg/hr for the time the medication was infused at that rate. The infusion rate was increased to 75 ml/hr, the patient developed low blood pressure and a slow heart rate, and cardiopulmonary resuscitation (CPR, emergency life-saving procedure performed when a person's breathing or heartbeat has stopped)/code blue (emergency situation where a patient's heart or breathing has stopped, and staff quickly respond to attempt to restore the heartbeat or breathing) was initiated, along with the administration of Narcan (a medication used to counter the effects of narcotic overdose). The patient was unable to be resuscitated and died.
- On 6/17/21, it was reported that Patient #20 received versed (medication used to help patients feel relaxed or sleep before surgery or during a procedure) at 150 mcg/hr instead of 10 mg/hr as ordered, and fentanyl at 10 mg/hr instead of 150 mcg/hr as ordered, for approximately 22 hours. The patient died six days later.
- On 05/26/21, it was documented that Patient #18 was on a fentanyl drip at 50 mcg/hr IV, and at the same time, wore a fentanyl patch dosed at 50 mcg/hr. The patient experienced an adverse drug event (ADR, unwanted or harmful reaction after the administration of a drug), and a code blue was called. The physician administered Narcan and the patient recovered. The physician documented on 06/17/21, that the patient received fentanyl 250 mcg/hr at some point during her hospitalization. Review of the medical record showed no physician's order for fentanyl 250 mcg/hr during her hospitalization. The physician and staff involved were no longer employed at the hospital, and current staff, including the CNO, had no additional information regarding Patient #18.
- On 04/26/21, a physician ordered for potassium 40 milliequivalent (mEq, chemical reaction dosage) for Patient #19, every six hours for two doses. However, the patient received potassium 40 mEq on 04/26/21 at 6:09 PM, 04/27/21 at 12:13 AM, 04/27/21 at 5:00 AM, 04/27/21 at 12:09 PM, 04/28/21 at 12:30 AM and on 04/28/21 at 5:59 AM (four extra doses), because the nurses did not check the duration against the order. The patient's potassium level elevated to six (normal range is 3.6 - 5.2) after three of the six total doses, and the patient required kayexelate (a medication that helps the body get rid of extra potassium) 30 grams (unit of measure) to lower his elevated potassium level.

Four medication errors recurred over three months, which led to negative, or potentially negative outcomes for four patients. Three of those medication errors occurred over the span of less than two months, and involved the high-alert medication fentanyl.

During an interview on 07/27/21 at 2:35 PM, Staff C, RN, stated that she could not find a preprogrammed pump for Patient #16's fentanyl infusion and began the infusion without dosage directions from the pharmacy, or access to the drug protocol. Staff C believed the medication error could happen again.

During an interview on 07/27/21 at 3:00 PM, Staff J, Nurse Manager, confirmed that staff were unable to find a preprogrammed pump for fentanyl, and when Staff C entered the infusion to run at 25 ml/hr, Staff J stated that she was not paying attention and verified the incorrect dose. Staff J believed the error could occur again.

During interviews on 07/27/21 at 1:45 PM and 07/28/21 at 10:35 AM, Staff D, CNO, stated that she determined the issues related to Patient #16's medication error included communication, the lack of pumps preprogrammed for fentanyl, and that staff didn't understand how to use the infusion pumps. Staff D stated that she provided verbal education to staff regarding how to correctly use the pumps, on communication, and to speak up if they felt they were not heard (Staff D was unable to provide documented attendance of the education provided). Additionally, Staff D was unaware that the hospital used several different types of infusion pumps.

During an interview on 07/28/21 at 1:20 PM, Staff M, RN, denied that he had received any of the education.

After three medication errors involving infusion pumps, the CNO failed to recognize that there were various infusion pumps used in the hospital, failed to ensure that there were an adequate number of pumps available to staff to safely administer medications to the patients, and failed to document proof that she provided education to prevent medication error reoccurrence,

2. Review of personnel files for Staff C, RN; Staff G, Licensed Practical Nurse (LPN); Staff X, Agency RN, Charge Nurse; Staff J, Nurse Manager/Charge Nurse; and Staff D, CNO, showed that none had completed the hospital's training program on IV medication administration.

During an interview on 07/29/21 at 9:45 AM and on 08/05/21 at 2:51 PM, Staff D, CNO, stated the following:
- When she was gone, no one was in charge of nursing staff.
- She was involved with investigations that involved nursing staff.
- There were no competency exams for the nursing staff.
- She had not been able to get her CNO job duties done because she always had to work on the nursing floor.
- Staff had 90 days to complete their orientation and training.
- None of the nursing staff had completed the hospital's training program for IV medication administration.
- There was nothing currently used in writing for a curriculum and training program on IV medication administration, it consisted of a demonstration and there were no sign-in sheets to document when staff attended the demonstration.

Although requested, the hospital was unable to provide education or corrective actions that were put into place to prevent medication error recurrence.

Based on observation, interview, record review and policy review, the hospital failed to ensure that nursing staff appropriately assessed and monitored patients, and the patient's environment, to provide optimal patient outcomes when:
- One discharged patient (#17) of one discharged patient reviewed who was on ventilator (a machine that supports breathing) weaning protocol, was not monitored by continuous pulse oximetry (the percentage of oxygen in the bloodstream, a normal reading would be 95 to 100 percent) monitoring and resulted in a negative patient outcome.
- Two discharged patients (#18 and #20) of two discharged patients reviewed who received fentanyl (a medication used to treat severe pain, and is a high risk drug for theft and personal use) intravenously (IV, in the vein) were not reassessed every two hours that included urinary output, respiratory rate (RR, the number of breaths per minute, normal range for adults at rest is 12 to 20), oxygen saturation (O2 sats, oxygen saturation in the blood) and vital signs (body temperature, blood pressure, heart rate, and breathing rate), and one current patient (#1) of 15 current patients reviewed was monitored for changes in vital signs every four hours as ordered.
- One current patient (#7) of 15 current patients reviewed received medication without assessment of the patient's heart rate, which would have resulted in the medication being withheld.
- One current patient (#3) of 15 current patients reviewed was not repositioned in bed every two hours.
- One current patient (#1) of 15 current patients reviewed was not monitored by daily weights.
- Five current patients (#1, #2, #3, #11 and #15) of 15 current patients reviewed did not received a nursing assessment.
- Nursing staff did not remove quality control solutions for the glucose (sugar) monitor, when they were beyond the expiration date.
- Nursing staff did not check the crash cart (mobile cart which contains emergency medical supplies and medication) daily for functionality and adequate supply levels.

These failures had the potential to affect the quality of care and endanger the safety of all patients that received care in the hospital. The hospital census was 16.

Findings included:

1. Review of the hospital's policy titled, "Mechanical Ventilator Weaning," revised 03/2021, showed that all patients in the weaning process were placed on telemetry (remote observation of a person's heart rhythm, using signals that are transmitted from the patient to a computer screen) and continuous pulse oximeter for continuous monitoring.

Review of the hospital's policy titled, "Pulse Oximetry," dated 01/2020, showed that if the monitor was used continuously, alarms must be set at 90% or as ordered by physician and staff ensured the alarm volume was at an adequate level.

Review of Patient #17's medical record showed the following:
- On 06/16//21 at 3:34 PM, the ventilator (a machine that supports breathing ) weaning interventions of the mechanical ventilation (the circulation and exchange of gases in the lungs) protocol was initiated.
- During ventilation weaning, continuous oxygen saturation (oxygen saturation in the blood) monitoring with pulse oximeter (a machine that monitors the percentage oxygen in the bloodstream, a normal reading would be 95 to 100 percent) was required.
- A code blue (emergency situation where a patient's heart or breathing has stopped, and staff quickly respond to attempt to restore the heartbeat or breathing) report dated 06/20/21, showed that Patient #17 had a cardiac rhythm of asystole (absence of heart activity) and cardiopulmonary resuscitation (CPR, emergency life-saving procedure performed when a person's breathing or heartbeat has stopped) was initiated at 8:35 PM. The patient outcome was listed as intubated (the insertion of a tube into a person's trachea for ventilation when a person is not breathing on their own) with spontaneous pulse restored.
- A Critical Care progress note dated 06/20/21 at 9:10 PM showed that Patient #17 was placed on a ventilator at 8:44 PM and that she was considered in guarded, critical condition, with potential for further decline.
- A Discharge Summary dated 06/22/21 at 2:26 PM showed that Patient #17 experienced seizure (excessive activity in the brain which causes uncontrolled jerking movements) activity, changed mental status (general changes in brain function) and required further neurological (neuro, relating to or affecting the nervous system) evaluation. The patient was transferred to an acute care facility.

Review of an undated document titled, "Landmark Hospital; Job Description; Job Title: Monitor Technician/Unit Secretary," showed that the monitor technician should always be at the monitor and should use an additional monitor technician to cover if a break or additional duties occur. The monitor technician position was cross-trained to perform unit secretary functions (primary receptionist and secretarial resource for the nursing unit) such as communications, answering call lights, and order transcription.

During interviews on 07/28/21 at 2:35 PM and 08/05/21 at 1:40 PM, Staff N, Monitor Technician, stated that:
- The responsibilities of a monitor technician were to continually monitor patients on telemetry for vital signs and heart rhythms, as well as observe those patients on video surveillance. However, monitor technicians on night shift were responsible for several duties that left the monitor station unattended for up to five minutes at a time, and the alarms for a missing pulse oximetry probe (indicating that the monitoring probe had been removed from the patient) were not always audible. During the night shift, there was one monitor technician staffed and anywhere from 15-24 patients who required telemetry monitoring.
- At approximately 8:00 PM on 06/20/21, she noticed that Patient #17 removed the tracheostomy (an opening created in the neck in order to place a tube into a person's windpipe that allows air to enter the lungs) oxygen mask and pulse oximetry probe, and when she went to reapply both, found that the pulse oximetry probe was almost broken. She reported to the nurse technician and Staff M, RN, via two-way radio, that the patient was responsive, sweating and looked a bit "gray" (indicator of low oxygen level) and attempted but was unsuccessful in locating another oximetry probe. She notified both Staff M and Staff R, Respiratory Therapist, that the patient's pulse oximetry probe needed to be replaced.
- While she entered lab orders on nearby computer (away from the monitor), she noticed Patient #17's heart rhythm showed irregularity and a low heart rate. She called for a rapid response (a changing situation that requires more staff to address the current needs of the patient), and at the same time Staff M, RN, shouted from the patient's room, and a code blue was called.

During an interview on 07/28/21 at 1:40 PM, Staff M, Registered Nurse (RN), stated that he walked by the telemetry monitor at the nurses' station just before the code blue and noticed a low heart rate for Patient #17. He entered the patient's room, returned her tracheostomy oxygen mask and called for a rapid response and then a code blue.

During an interview on 7/28/21 at 7:30 PM, Staff R, Respiratory Therapist, stated that Patient #17 had a known history of pulling at her monitor leads, pulse oximetry, and one time, removed her own tracheostomy tube.

During an interview on 08/04/21 at 10:55 AM, Staff Z, Respiratory Therapist, stated that continuous pulse oximetry monitoring of the patient was protocol during ventilator weaning, however, Patient #17 refused to keep her pulse oximetry probe on her finger and could not be redirected. On 06/20/21, during the morning hours, the patient continued to remove the pulse oximetry probe, so it was taped to her finger in an effort to deter removal, but the patient continued to remove the probe. Staff implemented "spot checking" of the oxygen saturation, which Staff Z felt was an appropriate intervention as long as the patient was checked at least every 4 hours.

During an interview on 08/03/21 at 12:00 PM, Staff W, Pulmonologist (physician focused on lung health), stated that continuous pulse oximetry was the standard of care for patients weaning from a ventilator, and he expected Patient #17 to be monitored at all times.

Review of Patient #17's physician's progress notes by Staff V, Physician, showed that on 06/20/21 at 9:10 PM, (after the code blue) the patient was in critical condition with potential for further decline with guarded condition.

During a interviews on 07/27/21 at 10:40 AM, 08/04/21 at 11:40 AM, and 08/05/21 at 2:51 PM, Staff D, Chief Nursing Officer (CNO), stated that monitor technicians received orientation and training which outlined that they were not to leave the telemetry monitoring area unless another staff member monitored telemetry patients in their absence. However, on the night of 06/20/21, at the time immediately prior to Patient #17's code blue, video surveillance of the nursing station showed that the monitor technician appeared to be positioned approximately three feet away from the telemetry monitors at another computer.

During interviews on 08/03/21 at 9:15 AM and 08/05/21 at 12:00 PM, Staff T, Monitor Technician, stated that she had expressed concern to her leadership staff a week prior to 06/20/21, regarding the lack of a monitoring at the monitoring station.

2. Review of the hospital's policy titled, "Assessment/Reassessment-Care Planning," reviewed 09/2020, showed that reassessments of those patients on a critical drip were to be reassessed every two hours. Patients receiving a Fentanyl drip would be reassessed for urinary output, respiratory rate, O2 sats, and vital signs and documented in the electronic medication administration record (eMAR). All patients with a critical drip would have a reassessment completed every two hours and documented in the electronic medical record (EMR). The primary nurse would follow the protocol and notification to the provider as stated with in each protocol.

Review of Patient #18's medical record showed the following:
- She was a 28 year-old-female who had undergone treatment for a blood clot for six weeks.
- Review of the MAR indicated that she was on a fentanyl drip from 05/23/21 at 11:12 AM until 05/25/21 at 3:08 PM.
- The patient's vital signs were not consistently recorded every two hours from the time the Fentanyl infusion began on 05/23/21 until it was stopped on 05/25/21.
- The patient's urinary output was not consistently recorded every two hours from the time the Fentanyl infusion began on 05/23/21 until it was stopped on 05/25/21. The patient's urinary output was only documented two times during a 50 hour (approximate) infusion (25 opportunities to document urinary output).

Review of Patient #20's medical record showed the following:
- He was a 53-year-old male admitted on 06/14/21 with respiratory failure.
- Review of the MAR indicated that he was on a Fentanyl drip from 06/14/21 at 4:00 PM until 06/23/21 at 5:19 PM.
- The patient's vital signs were not consistently recorded every two hours from the time the fentanyl infusion began on 06/17/21 until it was stopped on 06/23/21.
- The patient's urinary output was not consistently recorded every two hours from the time the fentanyl infusion began on 06/17/21 until it was stopped on 06/23/21. The patient's urinary output was only documented 12 times during a 144 hour (approximate) infusion (72 opportunities to document urinary output).

Review of Patient #1's medical record showed a physician's order dated 07/15/21 at 6:01 PM, to obtain vital signs every four hours. Review of nursing flow sheets dated 07/16/21 from 12:00 AM through 07/26/2021 at 12:00 AM, showed vital signs were not documented every four hours as ordered. On 07/18/21 there were no vital signs documented for the day, and on 07/22/21, there was only one set of vital signs documented for the day.

3. Review of Patient #7's medical record showed a physician's order for Amiodarone 200 milligrams (mg, a measure of dosage strength) daily and medication withheld if the patient's heart rate assessed at less than 55. Patient #7's vital signs on 07/27/21 at 8:01 AM showed a heart rate of 54.

Observation on 07/27/21 at 8:15 AM, showed Staff B, administered medications for Patient #7, which included Amiodarone (medication used to treat certain types of serious [possibly fatal] irregular heartbeat arrhythmias [a condition in which the heart beats with an irregular or abnormal rhythm] and to restore normal heart rhythm and maintain a regular, steady heartbeat). Staff B administered the medication without assessment of the patient's heart rate.

4. Review of the hospital's policy titled, "Clinical Practice Guidelines," revised 07/2021, showed that patients unable to turn or move themselves adequately would be turned and repositioned every two hours to help ensure skin integrity (to be without breakdown).

Review of Patient #3's medical record showed:
- The patient was admitted 07/23/21 at 5:45 PM.
- The patient was bedfast (confined to bed) and unable to reposition herself.
- The patient had two pressure wounds; one located on her coccyx (tailbone area) and one on her foot.
- Nursing assessment dated 07/25/21 at 8:28 PM, included interventions to turn and reposition the patient every two hours.
- Patient #3's positions were documented in the nursing assessment flowsheets on 07/24/21 at 9:35 PM and 07/25/21 at 8:58 PM, as "In Bed" without distinction as to positioned on back, right side or left side.
- Nursing assessment flowsheets from 07/23/21 at 12:00 AM through 07/26/21 at 12:00 AM, showed no additional documentation that the patient was repositioned or turned.

5. Review of the hospital's policy titled, "Clinical Practice Guidelines," revised 07/2021, showed that patient weights were assessed and documented on the nursing flow sheet by 6:00 AM.

Review of Patient #1's medical record showed:
- The patient was admitted on 07/15/21.
- On 07/16/2021 at 11:33 AM, a physician's order to obtain daily weights was entered.
- Nursing flowsheets from 07/16/21 at 12:00 AM through 07/26/21 at 12:00 AM, showed no weights were documented for nine out of 10 days.

During an interview on 07/27/21 at 11:23 AM, Staff J, Nurse Manager, stated that she would expect patients to be weighed as ordered by a physician.

6. Review of the hospital's policy titled, "Clinical Practice Guidelines," revised 07/2021, showed that every patient received a complete assessment at the beginning of each shift, and assessments were documented in the nursing flow sheet.

Review of the following patients' medical records showed no day shift nursing assessments documented for:
- Patient #1 on 08/02/21 and 08/03/21;
- Patient #2 on 08/02/21;
- Patient #3 on 08/02/21;
- Patient #11 on 08/02/21; and
- Patient #15 on 08/02/21.

7. Review of the hospital's policy titled, "Glucose Testing, Whole Blood," effective 03/13/21, showed that control solutions expired 90 days after opened or until the expiration date, whichever date came first.

Observation on 07/27/21 at 11:25 AM, showed the daily control solutions for the glucose testing monitors were labeled, "Opened 04/15/21, Expired 7/15/21."

8. Though requested, the hospital failed to provide a policy regarding daily checks of the emergency crash cart.

Review of the hospital-provided document titled, "Landmark Hospital of Joplin Crash Cart Checklist," dated 07/2021, showed that the crash cart was not documented as checked during the 7:00 AM shifts on 07/16/21, 07/17/21, 07/19/21, 07/20/21 and 07/26/21.

During an interview on 07/27/21 at 11:00 AM, Staff D, CNO, stated that the emergency crash carts were checked every shift, every day to insure that equipment was operational, the lock was intact, and emergency supplies were readily available.






44536

Based on interview, record review and policy review, the hospital failed to ensure that five licensed staff (Staff C, D, E, J and X) of seven licensed personnel records reviewed, were oriented and verified to be competent in the patient care they provided. The failure to ensure staff were competent resulted in an overdose of one patient (#16), and the patient died. This failed practice had the potential to affect all patients who received nursing care. There were 25 licensed staff contracted by agency who provided care to patients in the hospital. The hospital census was 16.

Findings included:

1. Review of the hospital's policy titled, "Clinical Competencies," reviewed 10/2020, showed that all hospital employees were responsible for the assessment, treatment or care of patients, must be competent to perform these tasks in order to deliver quality patient care. All departments will have a process for determining staff competency at the time of hire and for assessing and documenting continued competency. Nursing Administration will have the authority and responsibility for ensuring the ongoing assessment of nursing staff competency.

Review of the hospital's document titled, "New Employee Orientation," reviewed on 02/2020, showed that all newly hired employees were required to complete General Hospital Orientation (GHO) within 60 days of their start date. Failure to complete GHO within 60 days of employment for any reason may result in termination. All orientation records, including orientation checklists, must be complete at the time of the 90 day evaluation.

Review of the hospital's investigation of a medication error, showed that on 07/16/21, Staff J, Registered Nurse (RN), Nurse Manager (Charge Nurse at the time the error was made), inaccurately verified Patient #16's fentanyl (a medication used to treat severe pain) intravenous (IV, in the vein) infusion rate, and when the medication was administered, it resulted in an overdose of fentanyl, and the patient died.

Review on 07/29/21 at 9:45 AM, of the personnel file for Staff J, showed that she had not completed the curriculum and training program for IV medication administration.

During an interview on 07/29/21 at 9:45 AM, Staff D, Chief Nursing Officer (CNO), verified that Staff J had been employed since 04/2021, and had not completed her curriculum and training program for IV medication administration.

Review on 07/29/21 at 10:35 AM, of the personnel file for Staff C, RN, showed an employment start date of 05/25/21, and the document titled, "General Hospital Orientation," was not completed.

During an interview on 07/29/21 at 10:35 AM, Staff S, Regional Human Resources Director, stated that Staff C had not completed her required GHO training, and verified that she had been employed for more than 60 days.

Review on 07/29/21 at 10:25 AM, of the personnel file for Staff D, CNO, showed that she had not completed the curriculum and training program for IV medication administration.

During an interview on 07/29/21 at 9:45 AM, Staff D, verified that she had not completed the curriculum and training program for IV medication administration, and had been employed for over one year.

Review on 07/29/21 at 9:45 AM, of the personnel file for Staff E, Licensed Practical Nurse (LPN), showed 12 undated Competency Checklists sheets. She had been an employee for four years.

During an interview on 07/29/21 at 10:35 AM, Staff S, Regional Human Resources Director, stated that Staff E's competency checklist should have been dated, as there was no way to verify when her orientation was completed without a date.

2. Review of the hospital's undated document titled, "Agency Nurse Orientation," showed it did not include competency checklists or verification of competencies to ensure a nurse was able to provide competent care to the patients in which he or she provided care.

Review of the hospital-provided document titled, "Employee Roster - Agency," dated 07/26/21, showed that there were 25 agency nursing staff contracted to provide patient care within the hospital.

Review of the personnel file for Staff X, Agency RN, showed a charge nurse staffing contract dated 07/16/21 through 08/21/21. A document titled, "Competency Checklist - Clinical Contract Personnel," showed competencies were not completed.

During an interview on 08/03/21 at 9:35 AM, Staff X, Charge Nurse, stated that on her first day, she was paired with another nurse and they had a patient assignment of nine patients, and she was instructed that she had to take four of the nine patients. When she explained that she didn't have computerized documentation access or training, had not been oriented to the unit, did not have access to secured areas, and did not feel comfortable taking a patient assignment, the Chief Nursing Officer (CNO) was contacted and informed that she had refused to take a patient assignment. She stated that as a new employee, "you don't come in and get a 'sit-down orientation' at this hospital." The majority of nursing staff were agency staff, and were new, and when questioned if she believed that she received an adequate orientation, she replied, "Absolutely not."

Based on interview, record review and policy review, the hospital failed to ensure nursing staff safely and accurately administered high-alert medications (drugs that bear a heightened risk of causing significant patient harm when they are used in error) to four discharged patients (#16, #18, #19 and #20), of five discharged patients reviewed with medication errors, one of which resulted in a patient's death. These failed practices placed all patients who received medications in the hospital at risk for serious harm, injury, or death.

After the medication errors were identified, staff failed to implement measures to ensure they did not reoccur.

The patient population of the hospital consisted of individuals that were critically ill and required ventilation (a machine that supports breathing) and various oral and critical intravenous (IV, in the vein) medications. The hospital census was 16.

Findings included:

1. Review of the hospital's policy titled, "Drug Administration General," dated 04/2020, directed staff to:
- Verify drugs to be administered with the physician's order.
- Review the Medication Administration Record (MAR) to ensure that the dose was correct.
- Before administering any drug, mentally review the five rights of drug administration for the right patient, right drug, right dose, right route, and the right time.
- Consult with a pharmacist or prescriber if there were any concerns or questions about any aspect of the drug to be administered.

Review of the hospital's policy titled, "Nursing Standards of Patient Care," reviewed 02/2020, showed that:
- The nurse was ultimately responsible for the accurate transcription of orders.
- The patient's medication would be documented with the appropriate time, route, dose and injection site by the administering nurse who would initial and sign their name in the appropriate space on the MAR.
- Verbal or telephone orders should be kept to a strict minimum. The order would be read back and verified prior to executing the orders.

Review of the hospital's policy titled, "Verbal and Telephone Orders," reviewed 02/2020, showed that:
- Verbal communication of medication orders was limited to urgent situations in which immediate written or electronic communication was not feasible.
- Verbal orders, when allowed, would be immediately written down by the recipient, read back by the recipient, and confirmed or corrected by the prescriber. The order must be written before it was read back.
- For medication orders, both parties would express doses of medication by unit of weight, for example milligram (mg, a measure of dosage strength), grams (g, a unit of dosage strength), milliequivalents (mEq, a unit of measure), millimoles (mMol, a unit of measure).
- Verbal medication orders should include the date and time the order was received, the patient name, the medication name, dosage form, strength or concentration, dose frequency, route, quantity and or duration, name of the prescriber and the signature of order recipient.

Review of the hospitals policy titled, "Performance Improvement Adverse (Untoward) Drug Reactions," reviewed 06/2021, showed that an adverse drug reaction was defined as any undesired, unintended, excessive, or exaggerated effect (including medication errors) of a drug administered to a patient within the hospital, and that the pharmacist, in collaboration with appropriate hospital staff, should conduct an intensive analysis of each and every significant adverse drug reaction as soon as possible. The purpose of the analysis should be to identify all possible factors which may have contributed to the occurrence and then develop corrective procedures designed to prevent reoccurrence.

2. Review of Patient #16's medical record showed the following:
- Patient #16 was a 63-year-old male admitted on 06/30/21, from another hospital, for Covid-19 (highly contagious, and sometimes fatal virus) pneumonia.
- On 07/16/21 at 6:58 AM, the nursing assessment documentation indicated Patient #16 was alert and oriented to person, place, and time, behavior was appropriate, he moved his arms and legs, pupils were appropriate, speech was intelligible, reflexes were good, lungs were clear, respirations (inhalation and exhalation of air; breathing) were 40 breaths per minute (normal is 12 to 20 breaths per minute) and regular, with bi-level positive airway pressure (Bi-PAP, a non-invasive machine that pressurizes room air to help a person to take in oxygen and exhale carbon dioxide, used to treat lung disease and respiratory weakness) on 100%, his heart rate exceeded 100 beats per minute at times (normal is 60 to 100).
- At 3:06 PM, Staff C, Registered Nurse, (RN), placed a verbal physician's order electronically in the computer system for IV fentanyl 50 micrograms (mcg, a measure of dosage strength)/milliliters (ml, a measurement of liquid), with the pharmacy to specify the rate and dose. The order indicated it was read back and verified by the nurse.
- At 3:07 PM, Staff Q, Pharmacy Director, accepted the electronic order, and the medication was available for patient administration at 3:09 PM.
- The MAR, dated 07/16/21 at 12:00 AM through 07/16/21 at 5:30 PM, showed no documentation that the drug fentanyl was administered.
- On 07/16/21 at 4:40 PM, a code blue (emergency situation where a patient's heart or breathing has stopped, and staff quickly respond to attempt to restore the heartbeat or breathing) was documented for Patient #16, indicating he was unresponsive with no pulse, respirations (inhalation and exhalation of air; breathing), or blood pressure. He was given Narcan (a medication used to counter the effects of a narcotic overdose) at 4:44 PM, 4:52 PM, 4:56 PM and 5:10 PM, but attempts to resuscitate the patient were unsuccessful, and the patient died at 5:26 PM.

During an interview on 07/28/21 at 9:50 AM, Staff P, Physician, confirmed that her order to Staff C, RN, was for fentanyl 25 mcg (per hour).

During an interview on 07/28/21 at 9:05 AM, Staff Q, Pharmacy Director, stated that Staff C, RN, took an incomplete verbal order from a physician for the fentanyl administration, and that verbal orders were the reason for several medication-related issues in the hospital.

Review of a medication infusion label provided by Staff Q, Pharmacy Director, for the fentanyl administered to Patient #16 on 07/16/21, showed fentanyl, a high-alert medication that required two nurses verify the dose, with a concentration of 10 mcg/ml to be administered per protocol. It did not indicate the rate at which the drug was to be infused.

Review of the hospital's document titled, "Incident Report Summary 2021," showed that on 07/16/21, a physician ordered fentanyl IV 25 mcg (per hour); however, the IV pump was set to infuse at 25 ml (per hour - an overdose of 225 mcg/hour for the time the medication was infused at that rate).

Review of the hospital's document titled, "Mini Root Cause Analysis (RCA, a tool to help study events where patient harm or undesired outcomes occurred in order to find the root cause): Incorrect Fentanyl Rate," dated 07/21/21, showed that on 07/16/21:
- Patient #16 was moved to a higher observation room, intubated (the insertion of a tube into a person's trachea for ventilation when a person is not breathing on their own), and placed on a ventilator.
- Staff P, Physician, verbally ordered a fentanyl drip at 25, and when Staff C, RN, asked the physician to clarify, stating "25 mls," Staff P nodded, and she assumed the physician nodded in agreement.
- Staff C checked five infusion pumps, and fentanyl was not preprogrammed into the pumps (drug specific programs to ensure dosages are correctly administered, and made to prevent over and under dosing, especially for high-risk drugs).
- Staff C began the fentanyl drip on a non-programmed pump at the rate of 25 ml/hr, and Staff J, Nurse Manager (Charge Nurse at the time of the incident), verified the dosage was correct.
- Patient #16 continued to be restless and the drip rate was increased to 75 ml/hr (an overdose of 675 to 725 mcg/hour for the time the medication was infused at that rate).
- When Staff Q, Pharmacy Director, was notified that the fentanyl drip was infusing at 75 ml/hr, he asked staff to stop the infusion.
- Patient #16 developed low blood pressure and a slow heart rate, and cardiopulmonary resuscitation (CPR, emergency life-saving procedure performed when a person's breathing or heartbeat has stopped)/code blue was initiated at 4:40 PM.
- Factors identified that contributed to the medication error included that the IV pumps were not preprogrammed with fentanyl and that staff were confused by the pump. A fentanyl protocol, which referenced the standard concentration for fentanyl, and clearly stated the dose was to be started at 25 mcg/hr, was available on staff computers. However, nursing staff were not aware of the location of the protocols, and monitor technicians were the only staff who could print off the protocols from the computers. Additionally, the nurse did not use closed loop communication to verify the physician's order, and there was no verbal confirmation by the physician of the fentanyl order dosage.

Review of the hospital's undated document titled, "Fentanyl Protocol," showed the following:
- Fentanyl maintenance dose was 25 to 100 mcg/hr.
- Fentanyl was to be initiated at a drip rate of 25 mcg/hr, which was equivalent to 2.5 ml/hr.
- The rate could be increased by 25 mcg/hr every 60 minutes to a rate of 100 mcg/hr.
- The nurse was to document the dosage given and the patient's response with each dose administered and any changes in the patient's condition.

During an interview on 07/27/21 at 2:35 PM, Staff C, RN, stated that she took over care for Patient #16 after he was intubated. Staff P, Physician, gave a verbal order for fentanyl to Staff J, Nurse Manager (Charge Nurse at the time of the incident). She, along with Staff D, Chief Nursing Officer (CNO), tried to program the pumps with the fentanyl infusion. There were no directions on the fentanyl IV infusion bag. She asked Staff P, Physician, twice, if she wanted the fentanyl to start at 25 ml/hr and the physician nodded her head yes. The pump was not preprogrammed for fentanyl, so she pushed the button for "no drug selected" on the pump, and began the infusion at 25 ml/hr. She had no other choice than to use the "no drug selected" option on the pump to infuse the fentanyl. Staff J double-checked the pump and confirmed it was infusing at the correct rate. Staff C stated that she had used the "no drug selected" approximately three times since she started working at the hospital three months ago, she did not have access to the drug protocol to determine how the drug should be infused, and she felt that the medication error could happen again.

During an interview on 07/27/21 at 3:00 PM, Staff J, Nurse Manager, stated that she was the Charge Nurse working when Patient #16 was intubated. Staff P, Physician, gave Staff C, RN, a verbal order for fentanyl, but no one was able to find a preprogrammed pump. Staff C decided to enter "no drug selected" into the pump used to infuse the fentanyl. Staff J verified that the pump was set to 25 ml/hr and that it was correct. She made the mistake because did not pay close enough attention, and felt that the same mistake could happen again.

During interviews on 07/27/21 at 1:45 PM and 07/28/21 at 10:35 AM, Staff D, CNO, stated that she determined the issues related to Patient #16's medication error included communication, the lack of pumps preprogrammed for fentanyl, and that staff didn't understand how to use the infusion pumps. Staff D admitted that she did not realize there were several different types of pumps used in the hospital. She provided verbal education to staff regarding how to correctly use the pumps, communication, and to speak up if they felt they were not heard.

During an interview on 07/28/21 at 1:20 PM, Staff M, RN, denied that he had received any of the education.

Although requested, the hospital was unable to provide documentation of education that was provided to staff after the event to ensure the medication error did not reoccur.

Review of the personnel files for Staff C, RN; Staff J, Nurse Manager (Charge Nurse at the time of the incident); and Staff D, CNO, showed that none of them had completed the hospital's training program on IV medication administration. The personnel files indicated that Staff J and Staff D were both employed by the hospital for longer than 90 days.

During an interview on 07/29/21 at 9:45 AM, Staff D, CNO, stated the following:
- Staff had 90 days to complete their orientation and training.
- None of the nursing staff had completed the hospital's training program for IV medication administration.
- Their IV medication administration training consisted of a demonstration only.

3. Review of Patient #18's medical record showed that she was a 28-year-old female who had undergone six weeks of treatment for a blood clot. The patient's MAR indicated that on 05/25/21, the patient was to receive fentanyl 50 mcg/hr IV and a fentanyl patch (adhesive patch placed on the skin, releasing a slow dose of medication through the skin) 50 mcg/hr. The physician's discharge summary dated 06/17/21, indicated that the patient received 250 mcg/hr at some point during her hospitalization.

Although requested, the hospital failed to provide any medical record documentation related to the IV fentanyl administration of 250 mcg/hr.

Review of the hospital's document titled, "Confidential Incident Report," dated 05/25/21, showed that two pumps in the intensive care unit (ICU, a unit where critically ill patients are cared for) would not allow staff to enter the patient's weight and drug (fentanyl) to be infused. Five staff members attempted to program the pump for the infusion and were unsuccessful. Insufficient training was identified as a contributing factor to the event.

The incident report did not indicate the actual drug involved, or the error that was made, but was provided by hospital administration to correlate with the "Incident Report Summary 2021," dated 05/26/21.

Review of the hospital's document titled, "Incident Report Summary 2021," dated 05/26/21, indicated that Patient #18 was on a fentanyl drip, had an adverse drug event, and a code blue was called. The physician administered Narcan twice, and the patient's vital signs returned to normal limits.

Review of the hospital's document titled, "Mini RCA: Narcotic overdose with reversal with Narcan," dated 06/01/21, showed the overdose was identified as a "no error" event, and opportunities for improvement did not include failures on the part of the hospital or staff.

During an interview on 07/28/21 at 9:05 AM, Staff Q, Pharmacy Director, stated that he was not aware of the incident report which involved Patient #18. He believed the event was related to the infusion pump, identified the event as an adverse reaction, and did not identify any responsibility for the event within the pharmacy.

4. Review of Patient #19's medical record showed the following:
- He was a 71-year-old male admitted on 03/12/21, with Covid-19 pneumonia.
- On 04/26/21 at 1:47 PM, there was a physician's order for Potassium (medication used to treat and prevent low levels of potassium [a mineral needed for your body to function properly]) 40 mEq to be given orally every six hours for a total of two doses.
- The discharge medication list showed that Patient #19 received a total of six doses of Potassium 40 mEqs through his percutaneous endoscopic gastrostomy (PEG, a tube inserted through a person's abdomen directly into the stomach to provide a means of feeding when oral intake is not possible) tube from 04/26/21 at 6:09 PM through 04/28/21 at 5:59 AM.

Review of the hospital's document titled, "Confidential Incident Report," dated 04/26/21, showed the following:
- There was an order on 04/26/21, for two doses of Potassium 40 mEq per the patients PEG tube every six hours, in response to a low blood potassium level of 3.5 (normal levels are 3.5 to 5.0 mEq/L).
- The pharmacist failed to enter the duration of the two doses, and the patient received an additional four doses.
- After three of the six doses, Patient #19's potassium level was elevated at 6.0.
- The patient received an additional three doses prior to the pharmacist discovering the error.
- Kayexalate (a medication that helps the body get rid of extra potassium) 30 grams was ordered.
- The section for follow-up indicated the need for staff education/training and a staff action plan.
- Reviewers notes indicated there would be education to the pharmacists to pay special attention to all new potassium orders. The pharmacist was then responsible to place a duration in the proper amount of doses equal to the provider's request. Education had been provided to staff about reading the eMAR and placing a comment in the comment section such as dose one of two, dose two of two, and communicate between nurses.

Although requested, the hospital failed to provide documentation of education provided to staff after the event to ensure the medication error did not reoccur.

During an interview on 07/28/21 at 9:05 AM, Staff Q, Pharmacy Director, stated that he initiated the incident report related to Patient #19 receiving additional doses of potassium. When the physician entered the electronic medication order into the computer, he entered how many doses of potassium should be administered in the comments section of the order. The comments were not visible to the nurses during administration unless they took an additional step and searched for comments embedded within the order. After reviewing the incident report, he put in a request with Information Technology (IT) for the ability to add specific duration and doses, but they were not able to fix the issue. Staff Q admitted that because they failed to fix the issue, the medication error could occur again.

During an interview on 07/27/21 at 4:00 PM, Staff A, Quality Management Director (DQM), stated that no root cause analysis was done for this incident report because she did not feel it was warranted.

5. Review of Patient #20's medical record showed that he was a 53-year-old male admitted on 06/14/21, with respiratory failure (condition in which not enough oxygen passes from the lungs into the blood) and ventilator weaning as tolerated. He required high doses of sedating medications while on the ventilator. He was pronounced dead on 06/23/21 at 5:19 PM.

Review of the hospital's document titled, "Incident Report Summary 2021," dated 06/17/21, showed Patient #20 received Versed (medication used to help patients feel relaxed or sleep before surgery or during a procedure) and fentanyl drips running at incorrect rates.

Although requested, the hospital failed to provide nursing documentation from Patient #20's medical record related to the incident report or medication error.

Review of the hospital's document titled, "Confidential Incident Report," dated 06/17/2,1 showed the following:
- Patient #20's Versed was running at 150 mcg/hr instead of 10 mg/hr as ordered.
- Fentanyl was running at 10 mg/hr instead of 150 mcg/hr as ordered.
- Patient #20 received the incorrect medication dosages for "probably" 22 - 23 hours.
- The error was caused by inattentiveness, and indicated that staff who were involved would be coached.

Although requested, the hospital failed to provide documentation of education that was provided to staff after the event to ensure the medication error did not reoccur.

During interviews on 07/28/21 at 9:05 AM and 06/03/21 at 11:41 AM, Staff Q, Pharmacy Director, stated that he was never informed of, or reviewed, the incident report related to Patient #20. He stated that this medication error was impossible and could not have happened.

During an interview on 07/27/21 at 4:00 PM, Staff A, DQM, stated that there was no RCA done related to Patient #20 receiving the wrong doses of fentanyl and Versed.

Although requested, the hospital failed to provide documentation to show that corrective actions were implemented after the recognition of these medication errors, to ensure safe medication administration practices and prevent medication error recurrence.

Based on observation, interview, record review, policy review and review of Missouri state regulations, the hospital failed to be in compliance with the state regulatory requirements under §20 CSR 2200-6.030 Intravenous (IV, in the vein) Infusion Treatment Administration by Qualified Practical Nurses, as well as failed to follow their policy when Licensed Practical Nurses (LPNs) administered IV flush (medications or solutions to maintain patency) or IV infusions without documented competency verification by the hospital, to five current patients (#6, #9, #10, #14 and #32) of 10 current patients reviewed. This failed practice placed all patients with IV access at risk for their health and safety. The hospital census was 16.

Findings included:

1. Review of the hospital's policy titled, "Drug Administration General," dated 04/2020, showed that drugs should be administered by, or given under the supervision of, appropriately licensed personnel who are legally qualified to administer drugs as designated by the medical staff, their bylaws, and their rules/regulations.

Review of §20 CSR 2200-6.030 Intravenous Infusion Treatment Administration by Qualified Practical Nurses showed that IV-certified LPNs who have documented competency verification by the individual's employer may maintain the patency of "locked" peripheral (a catheter that begins and terminates in a vein in an extremity [i.e., arm, hand, leg, or foot] or in a vein in the scalp) and central venous catheters (long, thin, flexible tube placed in a large vein that allows multiple fluids to be given and blood to be drawn) with saline (salt water solution) and/or heparin (a medication used as a blood thinner or to prevent blood clots from forming) flush solutions.

Observation on 08/03/21 at 9:50 AM, showed Staff G, LPN, administered a heparin IV flush and a saline flush to Patient #10, through a midline catheter (an IV catheter that is inserted into a vein near the bend of the arm and advanced three to 12 inches into the upper arm).

Review of the medication administration records (MAR) for Patients #6, #10, #14 and #32, dated 08/03/21 from 12:00 AM to 4:00 PM, showed that Staff G, LPN, administered one heparin IV flush to Patient #10 and IV saline flushes to Patients #6, #10, #14 and #32.

Review of the personnel file for Staff G, LPN, showed a document titled, "Step-Down and Medical Surgical Orientation Skills Checklist," dated 06/25/21, showed she had not completed competencies in IV infusion and medication administration, or assessment of IV infusion site complications.

2. Review of the MAR for Patient #9, dated 08/03/21 from 12:00 AM to 4:00 PM, showed that Staff E, LPN, administered one heparin IV flush, one IV saline flush and one dose of IV infused Meropenem (a medication used to treat severe infections) to Patient #9.

Review of the personnel file for Staff E, LPN, showed no competency verification for IV medications. She had been an employee for four years.

During an interview on 07/29/21 at 9:45 AM and on 08/05/21 at 2:51 PM, Staff D, Chief Nursing Officer, stated the following:
- Staff had 90 days to complete their orientation and training.
- None of the nursing staff had completed the hospital's training program for IV medication administration.
- There were no competency exams for the nursing staff.




39841

Based on interview, record review and policy review, the hospital failed to ensure that the Pharmacy Director (Staff Q) was made aware of medication errors that affected three discharged patients (#18, #20 and #21) of five discharged patients with medication errors reviewed. The hospital also failed to ensure that the Pharmacy Director fully investigated process failures and implemented preventative measures for medication errors that affected two discharged patients (#16 and #19) of five discharged patients with medication errors reviewed, in order to reduce the likelihood of reoccurrence. This had the potential to affect the safety and quality of care for all patients. The hospital census was 16.

Findings included:

1. Review of the hospital's policy titled, "Performance Improvement Medication Errors," reviewed 06/2021, showed the following:
- The Director of Pharmacy should participate in the hospital's Quality Assurance Program which documents and assesses medication errors to determine cause and an appropriate response as part of a mission to improve the quality of the medication use processes and prevent medication errors.
- The Director of Pharmacy should report and review medication errors in accordance with this policy, the hospital's policy, and state law.
- Pharmacy intervention to prevent medication errors should be appropriately documented and reported to the appropriate committee on a routine basis.
- Pharmacists should devote careful attention to the dispensing processes to ensure that errors were not introduced at that point in the medication process.
- The Director of Pharmacy will be responsible for assessing internal medication errors. The Director of Pharmacy should investigate causes of the internal medication errors and develop methods for decreasing occurrence.
- The Director of Pharmacy should collaborate with other hospital staff in investigating all medication errors. An investigation of each medication error should commence as soon as it was reasonably possible.
- A medication error was defined as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication was in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems including prescribing; order communication; product labeling; packaging; compounding; dispensing; administrations; education; monitoring and use.
- Examples of medication errors include, but were not limited to wrong patient; wrong drug; wrong dosage form; contraindicated drug; drug allergy; expired drug; wrong dose; wrong route; wrong date or time; extra dose; omission of a dose; wrong rate of administration; physician error in prescribing.

Review of an incident report related to Patient #16, showed that on 07/16/21, a physician ordered fentanyl (medication used to treat severe pain), in the vein (IV) at 25 micrograms (mcg, unit of weight measurement); however, the IV pump was set for 25 milliliters (ml, unit of volume measurement).

This error created an overdose of 225 mcg/hour for the time the medication was infused at that rate.

Review of Patient #16's medical record showed that the fentanyl IV was ordered verbally by Staff P, Physician, electronically entered as an order by Staff C, Registered Nurse (RN), and electronically signed by the physician. The order indicated the infusion rate and dose would be as directed by the pharmacy. Staff Q, Pharmacy Director, accepted the electronic order and dispensed the medication.

Review of the fentanyl label provided by Staff Q, Pharmacy Director, for the fentanyl administered to Patient #16, showed that it did not include the infusion rate. The label indicated it was a high-alert medication (drugs that bear a heightened risk of causing significant patient harm when they are used in error) that required two nurses check the dose.

Review of the hospital's investigation into the cause of the fentanyl error showed that Staff C, RN, began the fentanyl drip on a pump at the rate of 25 ml/hr, and not the correct dose of 25 mcg per hour. Staff J, Nurse Manager (Charge Nurse at the time of the incident), verified the dosage was correct. During the infusion, the dose was increased to 75 ml/hr. The patient developed low blood pressure and a slow heart rate, and cardiopulmonary resuscitation (CPR, emergency life-saving procedure performed when a person's breathing or heartbeat has stopped)/code blue (emergency situation where a patient's heart or breathing has stopped, and staff quickly respond to attempt to restore the heartbeat or breathing) was initiated along with the administration of Narcan (a medication used to counter the effects of narcotic overdose). The patient was unable to be resuscitated and died. Contributing factors identified by the hospital included that the IV pump used was not preprogrammed for fentanyl dosages, staff were confused by the pump, staff were not aware of the location of fentanyl infusion protocols, and communication failures with the physician's order.

During an interview on 07/27/21 at 2:35 PM, Staff C, RN, stated that she tried to find a pump that was preprogrammed to infuse fentanyl, but when a preprogrammed pump could not be found, she and Staff D, Chief Nursing Officer (CNO), attempted to program the pump. There were no directions on the fentanyl bag for the infusion, and she did not have access to the fentanyl protocol, so she started the fentanyl at 25 ml/hr, and Staff J confirmed the rate was correct. Staff C felt that this medication error could happen again.

During an interview on 07/27/21 at 3:00 PM, Staff J, Nurse Manager, stated that she verified that the IV pump was set to 25 ml/hr and that the fentanyl infusion was correct. She made the mistake because she was not paying enough attention, and felt that this same mistake could happen again.

During an interview on 07/28/21 at 9:05 AM, Staff Q, Pharmacy Director, stated that verbal orders were the reason for several medication-related issues in the hospital, and added that he had nothing to do with medication errors related to the IV infusion pumps.

There was no indication that the pharmacy director implemented measures to ensure that this medication error did not reoccur, even though he was aware that verbal orders were a contributing factor for this error, as well as others.

2. Review of an incident report dated 05/26/21, showed that Patient #18 was on a fentanyl drip, had an adverse drug event (ADR, unwanted or harmful reaction after the administration of a drug), and a code blue was called. The physician administered Narcan and the patient recovered.

Review of Patient #18's medication administration record (MAR) indicated that on 05/25/21, the patient was to receive fentanyl 50 mcg/hr IV and a fentanyl patch 50 mcg/hr.

Review of the hospital's investigation into the ADR showed that the patient had a fentanyl drip and fentanyl patch in place at the same time, and Narcan was required to reverse the overdose. There were no failures recognized on the part of the hospital or staff, and the ADR was considered a "no error" event.

During an interview on 07/28/21 at 9:05 AM, Staff Q, Pharmacy Director, stated that he was not aware of the incident report, identified the event as an adverse reaction related to an infusion pump, and not a responsibility of the pharmacy.

3. Review of an incident report dated 04/26/21, showed that Patient #19 had received four doses of Potassium after it was discontinued. The duration of the dosage was not entered on the electronic MAR and the nurses did not check the duration against the order. The patient's potassium level in his blood was 6, (normal range is 3.6 - 5.2) after three doses (of the six doses administered) and the patient required the administration of Kayexelate (a medication that helps the body get rid of extra potassium).

Review of the hospital's investigation into the medication error showed that the pharmacist failed to enter the drug administration duration of only two doses into the MAR, and the patient received an additional four doses.

During an interview on 07/28/21 at 9:05 AM, Staff Q, Pharmacy Director, stated that he had entered how many doses of Potassium should be administered in the comments section of the order, but the comments were not visible to the nurses during administration unless they took an additional step and searched for comments embedded within the order. After reviewing the incident report he put in a request with Information Technology (IT) to correct the issue, but they were unable to find a resolution, and because of this, Staff Q admitted that the medication error could occur again.

There was no indication that the pharmacy director attempted additional measures to correct the identified error, even through he admitted that the error could happen again.

4. Review of an incident reports dated 06/17/21, showed that Patient #20 received Versed (medication used to help patients feel relaxed or sleep before surgery or during a procedure) and fentanyl infusions, running at incorrect rates. The patient's versed was running at 150 mcg/hr instead of 10 mg/hr as ordered, and fentanyl was running at 10 mg/hr instead of 150 mcg/hr as ordered. The patient received the incorrect medication dosages for "probably" 22 - 23 hours. It was determined that there was no harm to the patient (the patient was on a ventilator [machine that supports breathing]) and contributing factors included staff inattentiveness.

During interviews on 07/28/21 at 9:05 AM and 06/03/21 at 11:41 AM, Staff Q, Pharmacy Director, stated that he was never informed of or reviewed the incident report, and believed that the medication error could not have happened.

5. Review of an incident report dated 01/08/21, showed that Patient #21 had received fentanyl by mistake.

During an interview on 07/28/21 at 9:05 AM, Staff Q, Pharmacy Director,stated that he was not informed of the medication error but should have been, since it involved a medication. He added that since the fentanyl count was correct for 01/08/21, he felt that the incident report needed no further attention.

During an interview on 08/03/21 at 2:30 PM, Staff Q, Pharmacy Director, stated that he was not notified of all medication errors, only if they were directly related to a pharmacological (a branch of medical science that deals with the discovery, chemistry, effects, uses and manufacture of drugs) issue. Staff Q then reviewed and read aloud a portion of the hospital's pharmacy policy that indicated that the Director of Pharmacy should collaborate with other hospital staff in investigating all medication errors and that an investigation of each medication error should commence as soon as it was reasonably possible. Staff Q further stated that he believed that his attendance of the Risk Management meetings fulfilled the policy requirement.


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Based on interview and record review, the hospital failed to provide reference information to nursing staff when administering a high alert medication (drugs that bear a heightened risk of causing significant patient harm when they are used in error) to one patient (#16) of three patients reviewed who experience medication errors related to the same high risk drug. This failure had the potential to affect the quality of care and safety of all patients. The hospital census was 16.

Findings included:

1. Although requested, the hospital failed to provide a policy related to ensuring staff had access to reference material for drug therapy.

Review of an incident report related to Patient #16, showed that on 07/16/21, a physician ordered fentanyl (medication used to treat severe pain), in the vein (IV) at 25 micrograms (mcg, unit of weight measurement); however, the IV pump was set for 25 milliliters (ml, unit of volume measurement).

This error created an overdose of 225 mcg/hour for the time the medication was infused at that rate.

Review of the fentanyl label provided by Staff Q, Pharmacy Director, for the fentanyl administered to Patient #16, showed that it did not include the infusion rate. The label indicated it was a high alert medication that required two nurses check the dose.

Review of the hospital's investigation of the fentanyl error showed that Staff C, Registered Nurse (RN), began the fentanyl drip on a pump at the rate of 25 ml/hr, and not the correct dose of 25 mcg per hour. Staff J, Nurse Manager (Charge Nurse at the time of the incident), verified the dosage was correct. During the infusion, the dose was increased to 75 ml/hr. The patient developed low blood pressure and a slow heart rate, and cardiopulmonary resuscitation (CPR, emergency life-saving procedure performed when a person's breathing or heartbeat has stopped)/code blue (emergency situation where a patient's heart or breathing has stopped, and staff quickly respond to attempt to restore the heartbeat or breathing) was initiated along with the administration of Narcan (a medication used to counter the effects of narcotic overdose. The patient was unable to be resuscitated and died. The investigation showed that a fentanyl protocol was available to staff on hospital computers, and included the starting dose for fentanyl at 25 mcg/hr, which could be increased by 25 mcg/hr every 60 minutes; however, nursing staff were not aware of the location of the fentanyl protocols and monitor technicians were the only staff who could print the protocols from the computers.

During an interview on 07/27/21 at 2:35 PM, Staff C, RN, stated that there was no infusion rate on the fentanyl bag, and she did not have access to the fentanyl protocol, so she started the fentanyl at 25 ml/hr, and Staff J confirmed the rate was correct. Staff C felt that this medication error could happen again.

During an interview 07/28/21 at 1:20 PM, Staff M, RN, stated that the fentanyl protocol used to be in a binder, but administration took them away, and the protocols must be printed from the computer. Because of this, Staff M stated that he kept a copy of the protocols in his locker so he could access to them when he needed them.

During an interview on 07/28/21 at 10:35 AM, Staff D, Chief Nursing Officer (CNO), stated that she took the printed medication protocols away because staff were using outdated protocols, and the protocols used now were on the computer and must be printed off by a monitor technician.

During an interview on 07/28/21 at 9:05 AM, Staff Q, Pharmacy Director, stated that he had nothing to do with medication errors related to IV infusion pumps.