HospitalInspections.org

Based on interview, medical record review, review of the facility's documents, and review of the facility's policies, it was determined the facility failed to provide care in a safe environment for Patient #1, who knowingly was given the wrong, increased doses, of Geodon, an antipsychotic medication, by at least two (2) Registered Nurse (RN) #1 and RN #2 (see A0144).

Patient #1 was admitted to the facility through the Emergency Department (ED) after being taken to the ED by Emergency Medical Services (EMS). He/she was observed driving on an interstate highway at a low speed, approximately twenty-five (25) miles per hour and was pulled over by law enforcement. He/she was confused, disoriented, and unable to follow commands upon arrival and was admitted with diagnoses including Hypertensive Encephalopathy, Diabetes Mellitus, Chronic Kidney Disease, Alzheimer's Disease with Dementia, and Altered Mental Status. Patient #1 was admitted to the Intensive Care Unit (ICU) on 12/29/2019 and a day later, 12/30/2019, transferred to a telemetry unit where the incorrect, increased doses of Geodon were given on 01/02/2020 and 01/03/2020.

On 01/01/2020 at 1:28 PM, the Physician ordered Geodon five (5) milligrams (mg) intramuscularly (IM) every three (3) hours as needed for agitation for Patient #1. On 01/02/2020, 7 PM to 7 AM shift, Patient #1's primary nurse was RN #1. On 01/02/2020 at 8:40 PM, the patient was given a Geodon injection for agitation by RN #3. Patient #1 might have received ten (10) mg of Geodon at this time, according to the House Administrator's written statement and interview. The Medication Administration Record (MAR) revealed he/she was given a five (5) mg dose by RN #1. On 01/03/2020 at 12:12 AM, Patient #1 received twenty (20) mg of Geodon IM for agitation by RN #4. The MAR revealed he/she was given a five (5) mg dose by RN #1. On 01/03/2020 at 4:00 AM, Patient #1 received an unknown dose (probably ten (10) mg per multiple interviews) of Geodon IM for agitation by RN #2. The MAR revealed he/she was given a five (5) mg dose by RN #1 at 4:58 AM. Therefore, with the combination of three (3) injections over an approximate eight (8) hour period, Patient #1 could have received up to forty (40) mg of Geodon instead of the combined ordered doses of fifteen (15) mg and suffered significant side effects from the increased doses.

RN #1, RN #2, RN #3, and RN #4 were suspended on 01/03/2020 after the events leading to the incident with Patient #1 were discovered. RN #1, RN #2, and RN #3 did not work again after the 7 PM to 7 AM shift on 01/02/2020 into 01/03/2020. RN #4 worked approximately three (3) hours into the next shift on 01/03/2020 at which time the facility's investigation revealed her involvement. The decision to terminate RN #1, RN #2, and RN #3 was made on 01/08/2020 with their signatures on termination forms done on 01/10/2020. RN #4 had her suspension ended on 01/09/2020 and was given a final written warning that any additional improper behavior would result in her termination. The Director of Nursing was terminated on 01/10/2020. Also, on 01/10/2020, hospital leadership led by the Chief Executive Officer (CEO) and the Senior Vice-President of Human Resources met concerning the investigation of the incident, what additional actions to take, and future mandatory facility-wide education. On 01/13/2020, one-to-one meetings between nursing leaders and the Chief Nursing Officer (CNO) occurred. These meetings discussed expectations for escalating the chain of command and following the chain of command. In addition, on 01/17/2020, a meeting was held with senior leadership which finalized four (4) topics for mandatory education which was to begin the first week of February 2020. The four (4) topics were Chain of Command, Medication Management, Patient Rights and Abuse, and Care Management. Sign-in sheets for review and discussion of policies relating to the four (4) topics revealed all of the leadership staff had completed this by 01/21/2020 and ninety-two (92) direct staff had completed this by 01/22/2020.

The failure of the facility to provide care in a safe setting due to RN #1, RN #2, RN #3, and RN #4 either giving an incorrect, increased dose of Geodon and/or failing to chart the administration or charting the incorrect dose put Patient #1 and other patients on the unit at risk of improper medication administration with subsequent side effects for the 7 PM to 7 AM shift on 01/02/2020 into 01/03/2020.

Refere to A0144

Based on interview, medical record review, review of the package insert for Geodon (an antipsychotic medication), review of facility documents, and review of the facility's policies, it was determined the facility failed to ensure it provided care in a safe environment for one (1) of ten (10) sampled patients, Patient #1. Registered Nurse (RN) #1, Patient #1's primary nurse, possibly instructed RN #2 and RN #3, and definitely instructed RN #4 to give an incorrect, increased dose of an antipsychotic medication to Patient #1 up to three (3) different times. In addition, RN #1 documented she gave the three (3) doses when she did not and documented the incorrect dose given at least two (2) times.

The findings include:

Review of the facility's policy titled, "Patient Rights and Patient Responsibilities," number 7389273, revised 12/2019, revealed the patient had the right to receive safe and appropriate medical care to the best of the organization's ability.

Review of the facility's document titled, "Patient Guide, Key Information for Your Stay, Rights and Responsibilities," undated, revealed as a patient, he/she had the right to receive safe and appropriate medical care.

Review of the facility's policy titled, "Standards of Conduct," number 7052666, revised date 10/2019, revealed violation of the facility's policies and falsification of documents could result in corrective action up to and including discharge.

Review of the package insert for Geodon, Pfizer, Distributed by Roerig, number LAB-0272-9.0, revised 01/2020, revealed it was classified as an atypical antipsychotic that when used as an intramuscular (IM) injection was indicated for acute treatment of agitation in schizophrenic patients. The insert further revealed for acute treatment of agitation, in an IM route, the dosage was ten (10) milligrams (mg) to twenty (20) mg up to a maximum dose of forty (40) mg per day. Doses of ten (10) mg could be administered every two (2) hours. Doses of twenty (20) mg could be administered every four (4) hours. In addition, the insert revealed Geodon should be avoided in patients with bradycardia or in combination with other drugs that had demonstrated QT prolongation (a heart rhythm disorder). Further review revealed rare adverse reactions were first degree atrioventricular block and bundle branch block. Geodon for IM injection was available in powder form in twenty (20) mg per single-use vials. Instruction for reconstitution was to add 1.2 milliliters of sterile water to make a one (1) milliliter injection. Therefore, each milliliter of Geodon contained twenty (20) mg, each one-half milliliter of Geodon contained ten (10) mg of Geodon, and each one-quarter milliliter contained five (5) mg of Geodon.

Review of Patient #1's medical record revealed he/she arrived at the Emergency Department (ED) on 12/29/2019 at 1:24 PM and was brought in by Emergency Medical Services (EMS) after being observed by law enforcement driving on an interstate highway at approximately twenty-five (25) miles per hour. The patient was confused, disoriented, and unable to follow commands. Patient #1 was hypertensive with a blood pressure (BP) of 219/92 millimeters of mercury (mmHg). The spouse was located and revealed the patient had a history of Alzheimer's Dementia; Chronic Kidney Disease; Diabetes, Type 2; Coronary Artery Disease (CAD); and status post Coronary Artery Bypass Graft (CABG). The patient had a stroke work-up which was negative and was admitted to the Intensive Care Unit (ICU) with a primary diagnosis of Hypertensive Encephalopathy (a disease or disorder affecting the brain). He/she was placed on a Cardene drip (a calcium channel blocker used to treat hypertension short-term). Patient #1's BP improved and the Cardene drip was discontinued on 12/30/2019 at 1:30 PM. On 12/30/2019 at 9:08 PM, the patient received a dose of Geodon 10 mg IM for agitation and combativeness which was a one-time order. On 12/30/2019, after the dose of Geodon, Patient #1 was transferred to a telemetry unit. Continued review revealed, on 12/31/2019, the patient remained agitated throughout the day, and at 6:28 PM received a one-time dose of Geodon ten (10) mg IM. On 01/01/2020 at 1:28 PM, the Physician ordered Geodon five (5) mg IM every three (3) hours as needed for agitation. This order remained in effect until it was discontinued on 01/03/2020 at 6:36 PM. From this order, the Medication Administration Record (MAR) revealed Patient #1 received Geodon five (5) mg IM for agitation on 01/01/2020 at 6:56 PM, on 01/01/2020 at 10:12 PM by RN #1, on 01/02/2020 at 8:40 PM by RN #1, on 01/03/2020 at 12:12 AM by RN #1, and on 01/03/2020 at 4:58 AM by RN #1. This was the last dose of Geodon given. Continued review revealed Patient #1 was ordered oral antipsychotics. On 12/31/2020, Patient #1 received a one-time dose of Seroquel fifty (50) mg at bedtime. This was reordered on 01/03/2020, and Patient #1 refused the fifty (50) mg dose at bedtime. On 01/01/2020 at 1:25 PM, Patient #1 was ordered Zyprexa (an antipsychotic) five (5) mg twice a day.

Continued review of Patient #1's medical record revealed, in the Physician Progress Notes, on 01/01/2020, the patient was started on Zyprexa with as needed Geodon for agitation. He also stated the spouse was unable to take the patient home, and case management was working on possible post-hospital placement in a geriatric psychiatric facility. On 01/02/2020, the Physician revealed the patient continued to be agitated, and it happened consistently throughout the night. He stated Patient #1's primary problem was agitation. On 01/03/2020, the Physician revealed the patient was doing well. He also stated the patient received high doses of Geodon the prior night and had shown no side effects. The Physician also revealed he had discussed this incident with his/her spouse and informed the spouse the patient's discharge would be delayed until the next day for monitoring. He revealed the patient was to be discharged to a geriatric psychiatric facility. Also, Nurses Notes revealed Patient #1, on 01/03/2020 at 8:00 AM, was confused but appropriate and calm; at 9:00 PM, notes reveal the patient was calm and cooperative but agitated; and on 01/04/2020 at 9:00 AM, notes reveal Patient #1 was oriented, calm, and cooperative. Review of the Discharge Summary revealed Patient #1 was medically stable and discharged on 01/04/2020 to a geriatric psychiatric unit.

Continued review of Patient #1's medical record revealed, in the Rapid Response Form for 01/02/2020 at 8:00 PM and documented by RN #3, the Rapid Response Nurse, on 01/02/2020 at 11:38 PM, Patient #1's primary nurse, RN #1 called the Rapid Response Team (RRT) for help in administering Haldol (which was an incorrect that should have been Geodon). RN #3 revealed, upon arrival to Patient #1's room on the telemetry unit, the sitter and RN #1 were with the patient who was dressed in pants, shirt, and jacket so he/she could leave the facility. The patient was confused and not oriented. RN #3 called the Charge RN, House Administrator, and Security Guard. The Security Guard, Charge RN, and sitter helped the patient stay in bed, and RN #3 administered the medication. Further review revealed the patient was resting in bed in no acute distress when she left the room. Review of the Rapid Response Form for 01/03/2020 at 4:14 AM and documented by RN #3, on 01/03/2020 at 6:37 AM, revealed upon arrival to Patient #1's room, Patient #1 was standing with the Security Guard, sitter, Primary Nurse, Charge Nurse, and House Administrator present. RN #3 stated Geodon was given as ordered, and the patient was resting in bed after the injection.

1. Review of the written statement from RN #1, on 01/03/2020, no time given, revealed Geodon five (5) mg every three (3) hours was ordered. Per the statement, at 8:00 PM, RN #3 gave five (5) mg, and at 12:00 AM, RN #4 gave twenty (20) mg. RN #4 did not know what the ordered dose was. Patient #1 was in the ICU waiting room and was very combative. Several people were trying to guide him/her back to his/her room. RN #4 was tasked with drawing up the medication and administering it. She unknowingly gave the full twenty (20) mg dose. At 4:00 AM, RN #2 gave ten (10) mg of Geodon, and at 4:15 AM, she called the Physician and got approval for a stat five (5) mg dose to cover the extra five (5) mg given at 4:00 AM. A total of thirty-five (35) mg was given over the shift when the maximum order was twenty (20) mg. RN #1's statement further revealed Patient #1 was agitated all shift. He/she was cussing and raising his/her fists, swinging at staff. Continued review of RN #1's statement revealed he/she was also a risk to him/herself because he/she was unsteady and insisted on walking the halls. He/she became combative to anyone who tried to support him/her when he/she lost his/her footing. Security was called several times throughout the night. Further review of the written statement revealed there were no episodes of sinus pauses or significant changes on his/her telemetry monitor, and he/she was on continuous monitoring throughout the night.

Review of RN #1's Notice of Corrective Action, signed 01/10/2020, revealed she was terminated because she violated the facility's Medication Management Policy and Standards of Conduct Policy by her malevolent or willful misconduct.

RN #1 was called per telephone on 01/21/2020 at 9:27 AM. She did not answer, and she did not have access to voice mail.

2. Review of the written statement from RN #2, on 01/03/2020, no time given, revealed Patient #1 at shift change was walking into other patients' rooms and was extremely combative. While nurses got the patient in bed and held his/her arm, RN #3 gave five (5) mg of Geodon. Later, around midnight, Patient #1 had gotten into the ICU waiting room and locked his/her sitter out of the room. RN #1, RN #2, and the Charge Nurse assisted the Security Guard with getting the patient into a chair while RN #4 drew up a full dose of Geodon. Unaware of Patient #1's ordered dose, RN #4 gave the patient the full dose. At that point, the staff was able to get Patient #1 back to his/her room. Further review revealed around 4:00 AM, Patient #1 became extremely combative again, and he/she with closed fists was swinging at his/her nurses. RN #2 drew up ten (10) mg of Geodon and administered it. She had already paged the Physician for additional orders; he called back immediately and said to put in a one-time dose for another five (5) mg, and to call back if more was needed. Since the as needed dose for five (5) mg and the one-time dose of five (5) mg covered the ten (10) mg that had been given, the patient did not get any additional Geodon. Patient #1 remained stable and was monitored throughout the night.
Review of RN #2's Notice of Corrective Action, signed 01/10/2020, revealed she was terminated because she violated the facility's Medication Management Policy and Standards of Conduct Policy by her malevolent or willful misconduct.

RN #2 was left a voice message, on 01/21/2020 at 9:29 AM, on her telephone for the purpose of giving an interview. She did not respond by time of exit on 01/22/2020.

3. Review of RN #3's written statement, sent by email to the Director of Human Resources, on 01/08/2020 at 12:30 PM, revealed she showed RN #1 how to reconstitute Geodon on 01/02/2020 while she was making her first set of rounds. She also stated she wasted all but five (5) mg in the sharps container. RN #1 scanned the medication and selected the site of administration and amount given while RN #3 was standing with her. Patient #1 was in his/her room and was disoriented, agitated, and wanting to leave the facility and go home. He/she was pushing nurses and his/her sitter while trying to leave the room. Two (2) security guards had also come to the room. The staff held Patient #1's arm so RN #3 could safely administer the injection. After several staff left the patient's room, he/she calmed down and was lying in bed. Further review revealed RN #3 was called back to Patient #1's room around 3:30 AM on 01/03/2020. When she arrived, the room was full of people including the House Administrator, Charge Nurse, Primary Nurse, sitter, security, and other nurses from the floor. RN #3 was told she did not need to assist because there were enough staff present, so she waited in the hallway. RN #2 told RN #3 the patient received another dose of Geodon, and the Physician was being called to get orders for an additional dose. At this time, RN #3 showed the House Administrator and Charge Nurse Patient #1's cardiac strips from a few nights before when he/she had long pauses after receiving Geodon. RN #3 stated she did not believe the patient needed an additional dose of Geodon. RN #1 told RN #3 she would not administer additional doses of Geodon. As the patient was lying in bed and calm, RN #3 then left the telemetry floor.

Review of RN #3's Notice of Corrective Action, signed 01/10/2020, revealed she was terminated because of possible reckless or negligent behavior. On this form, RN #3 documented she did not give more of the medication than was prescribed by the Physician.

Interview with RN #3, on 01/21/2020 at 10:32 AM, revealed she confirmed the events as described in her written statement from 01/08/2020. In addition, RN #3 stated the injection she gave was not given through the patient's shirt. She also stated she gave the correct dose of Geodon, five (5) mg and did not ever say she gave ten (10) mg. RN #3 revealed she left the charting of the medication to RN #1 as she was Patient #1's primary nurse. In addition, she stated she was called by the Director of Human Resources later in the day of 01/03/2020, was suspended, and then later terminated. Further interview revealed RN #3 believed she had done nothing wrong, and the termination action against her was unfair.

4. Review of RN #4's written statement from 01/03/2020 at 10:57 AM via email to the Director of Human Resources revealed on 01/03/2020 around midnight she and the Charge Nurse helped the sitter for Patient #1 because he/she had gone to the ICU waiting area, and he/she would not let the sitter stay with him/her. When they arrived the patient's primary nurse and a security guard was with the patient. Then, RN #2 handed RN #4 a bag with a vial of Geodon injection in it and asked her if she would prepare the medicine for RN #1. When RN #4 asked about the dosage, RN #1 and RN #2 both said it was all of the vial, twenty (20) mg. While the other staff were holding the patient's arm, RN #1 and RN #2 said to give the whole IM injection which RN #4 did. Afterwards, RN #4 asked if RN #1 still needed to scan the medication into the record, and she said yes. After RN #1 settled the patient in his/her room, RN #4 gave RN #1 the package the Geodon came in. Further review revealed Patient #1 had been hostile throughout the night and tried to enter other patients' rooms. In the early morning of 01/03/2020, the patient was standing in the doorway of his/her room, rolled his/her fist, and acted like he/she was going to hit RN #1. RN #4 revealed she, along with other staff, helped the patient to the bed and she held his/her left hand so he/she could not grab anyone. RN #2 arrived with a prepared syringe of Geodon and gave the patient an IM injection in the right arm. Further review revealed after the injection, RN #4 released the patient's hand and exited the room.

Review of RN #4's Notice of Corrective Action, signed 01/10/2020, revealed she was given a final written warning with suspension from 01/03/2020 to 01/09/2020 for possible unintended human behavior by violating the facility's Medication Management policy and Standards of Conduct policy.

Interview with RN #4, on 01/20/2020 at 4:45 PM, revealed she confirmed all the events from her written statement from 01/03/2020. She also revealed she had been suspended from 01/03/2020 to 01/09/2020 and then given a final written warning which she signed on 01/10/2020.

5. Review of RN #5's written statement from an Incident Report filed 01/03/2020 at 12:43 PM, revealed she was the primary nurse for Patient #1 on the 7 AM to 7 PM shift on 01/03/2020 and took over the patient's care from RN #1. RN #5 stated during report from RN #1 that RN #1 reported the patient had Geodon five (5) mg ordered but twenty (20) mg came in the vial, so Patient #1 was given more than five (5) mg each of the three (3) times she had given the medication on her shift. RN #1 told RN #5 the first time she gave five (5) mg; the second time she gave twenty (20) mg; and the third time she gave ten (10) mg. RN #1 then told RN #5 to keep an eye on Patient #1 because he/she had experienced a 3.2 second pause on the heart monitor during this hospitalization. When RN #5 looked at the MAR she discovered that only five (5) mg was charted for each dose given.

Interview with RN #5, on 01/20/2020 at 2:30 PM, revealed she confirmed the events that happened on 01/03/2020 per Incident Report that she filed. In addition, when she looked at Patient #1's heart monitor strip she discovered everything was normal. The House Administrator from the previous shift told RN #5 she was aware of the situation with the increased doses of Geodon being given. The Physician was at the nurses station and RN #5 informed him of the incident. The patient's planned discharge was canceled for another day of monitoring. A security guard remained with the patient until the family arrived around mid-afternoon. RN #5 stated Patient #1 remained alert and oriented all shift.

6. Review of the House Administrator's (HA) written statement from 01/04/2020 at 2:18 AM via email to the Director of Human Resources revealed on 01/03/2020 at approximately 4:20 AM she arrived at Patient #1's room. The patient was standing in the doorway with many staff members present. The patient was very agitated, waving his/her fists and demanding he/she leave the facility. RN #1 stated the patient had Geodon 5 mg IM every three (3) hours as needed for agitation ordered, and this had been given at 4:00 AM. The HA repeated this back to RN #1, and she confirmed what had been said. At that time RN #2 stated the dose was more like twenty (20) mg and laughed. RN #1 again stated the patient had received only five (5) mg. The HA asked RN #2 to call the Physician to see if he wanted to order anything else. RN #2 came back and said the Physician had ordered an additional five (5) mg, and we were waiting on it to be sent to the floor from pharmacy. The HA went to the nurses station where RN #3 showed her telemetry strips from 12/31/2019 to 01/01/2020 with pauses, and the patient had received a one-time order for Geodon on 12/31/2019 around 6:30 PM. The HA stated she knew Geodon could cause pauses because of prolonging the QT interval, so she told RN #3 to tell RN #1 not to give the additional five (5) mg of Geodon. The HA looked at the MAR and saw five (5) mg doses had been documented by RN #1 at 8:40 PM on 01/02/2020, 12:12 AM on 01/03/2020, and 4:58 AM on 01/03/2020. Further review revealed the HA called RN #1 to clarify since she had told the HA she gave five (5) mg at 4:00 AM. RN #1 stated the 4:00 AM dose was really ten (10) mg and scanned it for 4:58 AM to cover the additional medication given at 4:00 AM. The HA informed RN #1 Physician orders did not work that way, and she would follow up with RN #1. When the HA talked with RN #1 again, she was told the patient received twenty (20) mg each dose given, and RN #1 did not administer any of the doses, she only scanned them into the MAR. The HA talked with RN #4 who had been identified as the nurse who gave the 12:12 AM injection. RN #4 stated she had given the whole vial because she was told to prepare the medication and give it. RN #4 revealed she did not know what the ordered dose was. When the HA told RN #4 what the ordered dose was, she was visibly upset. Also, the HA talked with RN #1 and RN #2. RN #2 was loudly saying that RN #1 would not get into trouble because she did not administer any of the doses given. RN #1 and RN #2 were told to go to the Director of Nursing's (DON) office and give a statement. The HA called RN #3 who confirmed giving the 8:40 PM 01/02/2020 dose. RN #3 stated she thought she gave ten (10) mg. When asked if she knew the order was for five (5) mg, RN #3 stated yes, and she had wasted some of the medication. When asked if she thought she had given ten (10) mg or less, RN #3 stated she probably gave ten (10) mg. RN #3 was asked to write a statement and send it to her manager or the DON.

Interview with the HA, on 01/21/2020 at 10:10 AM, revealed she confirmed the incident as related in the email sent to the Director of Human Resources on 01/04/2020. In addition, the HA stated there were several other people present on the telephone call with RN #3, and they confirmed RN #3 stated twice she thought she gave Patient #1 ten (10) mg of Geodon instead of five (5) mg.

7. Review of Patient #1's meeting notes between the patient's sitter and the Director of Human Resources, on 01/07/2020 at 3:30 PM, revealed Patient #1 used a lot of bad language and was belligerent. She also revealed RN #3 gave the patient an IM injection through his shirt sleeve. The sitter then stated she didn't hear staff use any profanity directed toward Patient #1.

Interview with Patient #1's sitter, on 01/20/2020 at 4:15 PM, revealed the patient had been very belligerent during the 7 PM to 7 AM shift from 01/02/2020 into 01/03/2020. She stated she confirmed the events as related by other staff but believed having so many staff around caused his/her behavior to escalate. She also stated she did not hear or witness any verbal abuse directed toward the patient.

8. Review of Patient #1's meeting notes between the Charge Nurse (CN) and the Director of Human Resources, on 01/06/2020 at 10:00 AM, revealed the patient's first injection was given by RN #3; the second by RN #4; and the third by RN #2. For the third injection, the HA requested RN #1 call the Physician for another medication because she believed the Geodon was not working. The CN revealed she did not know who prepared the Geodon or the dose that was given. She also stated she thought the patient's sitter was afraid of him/her.

Interview with the CN, on 01/21/2020 at 11:16 AM, revealed she worked the 7 PM to 7 AM shift 01/02/2020 going into 01/03/2020. She stated she was present when the 8:40 PM dose of Geodon was give to Patient #1 by RN #3. She revealed once the injection was given, the patient became calm. For the 12:12 AM dose of Geodon, the CN revealed she was also present, and RN #4 gave the medication. For the 04:00 AM dose of Geodon, the CN stated she was present, Patient #1 was trying to hit RN #1, and RN #2 gave the medication. She also revealed none of the injections were given through the patient's sleeve. The CN stated she did not witness or hear any verbal abuse directed toward the patient, and if she had she would have immediately removed the staff member from patient care and immediately notified the HA for further action. In addition, the CN stated since the incident, there had been floor-wide teaching with emphasis on resources available in emergency situations and de-escalation techniques.

Interview with the Chief Medical Officer (CMO), on 01/22/2020 at 9:25 AM, revealed he was first made aware of the incident with Patient #1 by the DON on 01/03/2020 between 1:00 and 2:00 PM. Then, that day, he met with the Chief Nursing Officer (CNO), DON, and Director of Human Resources. The CMO further revealed he was kept abreast as the investigation progressed. He also stated it was decided to delay the discharge of Patient #1 until the next day so he/she could be monitored. Later in the day of 01/03/2020, the CMO met with Patient #1's Physician, who was aware of the situation, about having full disclosure with the family after they arrived. The CMO stated he spent several hours trying to work through the situation on 01/03/2020, and it was his understanding the staff involved had been suspended earlier in the day.

Interview with Patient #1's Physician, on 01/22/2020 at 9:46 AM, revealed he knew Patient #1 very well, and the patient had Sundowner's Syndrome and Dementia. Consequently, he/she would become very aggressive and agitated, usually in the PM, and then would greatly improve in the AM. The Physician stated he was made aware of the increased doses of Geodon being given the AM of 01/03/2020 while on the floor making rounds. He stated he ordered the patient's discharge to be delayed a day for continued monitoring. The Physician revealed the telemetry strips did not have any pauses, and he was not concerned about a prolonged QT interval. He did say he would be more concerned about heart block but this would be a rare side effect. The Physician stated he met later in the day with the patient's family and disclosed the incident to them. He revealed Patient #1 was discharged the next day and did not suffer any adverse effects from the increased doses of Geodon he/she received.

Interview with the Nurse Manager (NM) of the Telemetry Unit, on 01/21/2020 at 12:43 PM, revealed RN #1, RN #2, and RN #4 were assigned to the Orthopedics Unit and would float to telemetry periodically depending on the census in orthopedics. She stated she did not perform their performance evaluations but communicated with their direct supervisor closely. The NM stated she knew of no previous problems with RN #1, RN #2, or RN #4. She revealed all patients on telemetry were monitored, except by Physician order not to be monitored. Staff on the unit had been specially trained to monitor, and there was continuous monitoring. The RN checked all strips three (3) times per shift when they were printed. The NM reported the patient to nurse ratio ranged between 4:1 and 6:1, depending on the acuity of the patients. She also revealed she had done 1:1 conversations with staff about topics concerning this incident. The NM stated the facility was in the process of additional education about medication administration, handling out-of-control patients and dementia patients, and use of restraints.

Interview with the CNO, on 01/17/2020 at 3:10 PM, revealed she had been in her position since 12/2019. The decision was made to replace the DON before 01/10/2020 because the CNO was interested in improving the culture of safety in the facility. Changes that had been implemented recently included a weekly meeting with the leadership group, a daily meeting with the house managers, daily check-in with the CNO with safety concerns, better exchange of information, and increased expectations and increased accountability with leadership and house managers.

Based on interview, medical record review, review of the facility's documents, and review of the facility's policies, it was determined the facility failed to provide safe medication administration for Patient #1, who knowingly was given the wrong, increased doses, of Geodon, an antipsychotic medication, by at least two (2) Registered Nurses (RN) #1 and RN #2 (see A0405).

Patient #1 was admitted to the facility through the Emergency Department (ED) after being taken to the ED by Emergency Medical Services (EMS). He/she was observed driving on an interstate highway at a low speed, approximately twenty-five (25) miles per hour and was pulled over by law enforcement. He/she was confused, disoriented, and unable to follow commands upon arrival and was admitted with diagnoses including Hypertensive Encephalopathy, Diabetes Mellitus, Chronic Kidney Disease, Alzheimer's Disease with Dementia, and Altered Mental Status. Patient #1 was admitted to the Intensive Care Unit (ICU) on 12/29/2019 and a day later, 12/30/2019, transferred to a telemetry unit where the incorrect, increased doses of Geodon were given on 01/02/2020 and 01/03/2020.

On 01/01/2020 at 1:28 PM, the Physician ordered Geodon five (5) milligrams (mg) intramuscularly (IM) every three (3) hours as needed for agitation for Patient #1. On 01/02/2020, on the 7 PM to 7 AM shift, Patient #1's primary nurse was RN #1. On 01/02/2020 at 8:40 PM, the patient was given a Geodon injection for agitation by RN #3. Patient #1 might have received ten (10) mg of Geodon at this time, according to the House Administrator's written statement and interview. The Medication Administration Record (MAR) revealed he/she was given a five (5) mg dose by RN #1. On 01/03/2020 at 12:12 AM, Patient #1 received twenty (20) mg of Geodon IM for agitation by RN #4. The MAR revealed he/she was given a five (5) mg dose by RN #1. On 01/03/2020 at 4:00 AM, Patient #1 received an unknown dose (probably ten (10) mg per multiple interviews) of Geodon IM for agitation by RN #2. The MAR revealed he/she was given a five (5) mg dose by RN #1 at 4:58 AM. Therefore, with the combination of three (3) injections over an approximate eight (8) hour period, Patient #1 could have received up to forty (40) mg of Geodon instead of the combined ordered doses of fifteen (15) mg and suffered significant side effects from the increased doses.

RN #1, RN #2, RN #3, and RN #4 were suspended on 01/03/2020 after the events leading to the incident with Patient #1 were discovered. RN #1, RN #2, and RN #3 did not work again after the 7 PM to 7 AM shift on 01/02/2020 into 01/03/2020. RN #4 worked approximately three (3) hours into the next shift on 01/03/2020 at which time the facility's investigation revealed her involvement. The decision to terminate RN #1, RN #2, and RN #3 was made on 01/08/2020 with the final terminations signed on 01/10/2020. RN #4 had her suspension ended on 01/09/2020 and was given a final written warning that any additional improper behavior would result in her termination. The Director of Nursing was terminated on 01/10/2020. Also, on 01/10/2020, hospital leadership led by the Chief Executive Officer (CEO) and the Senior Vice-President of Human Resources met concerning the investigation of the incident, what additional actions to take, and future mandatory facility-wide education. On 01/13/2020, one-to-one meetings between nursing leaders and the Chief Nursing Officer (CNO) occurred. These meetings discussed expectations for escalating the chain of command and following the chain of command. In addition, on 01/17/2020, a meeting was held with senior leadership which finalized four (4) topics for mandatory education which was to begin the first week of February 2020. The four (4) topics were Chain of Command, Medication Management, Patient Rights and Abuse, and Care Management. Sign-in sheets for review and discussion of policies relating to the four (4) topics revealed all of the leadership staff had completed this by 01/21/2020 and ninety-two (92) direct staff had completed this by 01/22/2020.

The failure of the facility to provide safe administration of medications due to RN #1, RN #2, RN #3, and RN #4 either giving an incorrect, increased dose of Geodon and/or failing to chart the administration or charting the incorrect dose put Patient #1 and other patients on the unit at risk of improper medication administration with subsequent side effects for the 7 PM to 7 AM shift on 01/02/2020 into 01/03/2020.

Refere to A0405

Based on interview, medical record review, review of the package insert for Geodon (an antipsychotic medication), review of facility documents, and review of the facility's policies, it was determined the facility failed to ensure safe and correct medication administration was performed for one (1) of ten (10) sampled patients, Patient #1. Registered Nurse (RN) #1, Patient #1's primary nurse, possibly instructed RN #2 and RN #3, and definitely instructed RN #4 to give an incorrect, increased dose of an antipsychotic medication to Patient #1 up to three (3) different times. In addition, RN #1 documented she gave the three (3) doses when she did not and documented the incorrect dose given at least two (2) times.

The findings include:

Review of the facility's policy titled, "Medication Management," number 6992644, revised date 11/2019, revealed medications were administered in accordance with the orders of a licensed independent practitioner who was responsible for the patient's care. Further review revealed the nurse was to stop and consider the six (6) rights of administration before giving any medication which included giving the right dose with the right documentation of the administration on the patient's medication administration record (MAR).

Review of the facility's policy titled, "Standards of Conduct," number 7052666, revised date 10/2019, revealed violation of the facility's policies and falsification of documents could result in corrective action up to and including discharge.

Review of the package insert for Geodon, Pfizer, Distributed by Roerig, number LAB-0272-9.0, revised 01/2020, revealed it was classified as an atypical antipsychotic that when used as an intramuscular (IM) injection was indicated for acute treatment of agitation in schizophrenic patients. The insert further revealed for acute treatment of agitation, in an IM route, the dosage was ten (10) milligrams (mg) to twenty (20) mg up to a maximum dose of forty (40) mg per day. Doses of ten (10) mg could be administered every two (2) hours. Doses of twenty (20) mg could be administered every four (4) hours. In addition, the insert revealed Geodon should be avoided in patients with bradycardia or in combination with other drugs that had demonstrated QT prolongation. Further review revealed rare adverse reactions were first degree atrioventricular block and bundle branch block. Geodon for IM injection was available in powder form in twenty (20) mg per single-use vials. Instruction for reconstitution was to add 1.2 milliliters of sterile water to make a one (1) milliliter injection. Therefore, each milliliter of Geodon contained twenty (20) mg, each one-half milliliter of Geodon contained ten (10) mg of Geodon, and each one-quarter milliliter contained five (5) mg of Geodon.

Review of Patient #1's medical record revealed he/she arrived at the Emergency Department (ED) on 12/29/2019 at 1:24 PM and was brought in by Emergency Medical Services (EMS) after being observed by law enforcement driving on an interstate highway at approximately twenty-five (25) miles per hour. The patient was confused, disoriented, and unable to follow commands. Patient #1 was hypertensive with a blood pressure (BP) of 219/92 millimeters of mercury (mmHg). The spouse was located and revealed the patient had a history of Alzheimer's Dementia; Chronic Kidney Disease; Diabetes, Type 2; Coronary Artery Disease (CAD); and status post Coronary Artery Bypass Graft (CABG). The patient had a stroke work-up which was negative and was admitted to the Intensive Care Unit (ICU) with a primary diagnosis of Hypertensive Encephalopathy. He/she was placed on a Cardene drip (a calcium channel blocker used to treat hypertension short-term). Patient #1's BP improved and the Cardene drip was discontinued on 12/30/2019 at 1:30 PM. On 12/30/2019 at 9:08 PM, the patient received a dose of Geodon 10 mg IM for agitation and combativeness which was a one-time order. On 12/30/2019, after the dose of Geodon, Patient #1 was transferred to a telemetry unit. Continued review revealed, on 12/31/2019, the patient remained agitated throughout the day, and at 6:28 PM received a one-time dose of Geodon ten (10) mg IM. On 01/01/2020 at 1:28 PM, the Physician ordered Geodon five (5) mg IM every three (3) hours as needed for agitation. This order remained in effect until it was discontinued on 01/03/2020 at 6:36 PM. From this order, the Medication Administration Record (MAR) revealed Patient #1 received Geodon five (5) mg IM for agitation on 01/01/2020 at 6:56 PM, on 01/01/2020 at 10:12 PM by RN #1, on 01/02/2020 at 8:40 PM by RN #1, on 01/03/2020 at 12:12 AM by RN #1, and on 01/03/2020 at 4:58 AM by RN #1. This was the last dose of Geodon given. Continued review revealed Patient #1 was ordered oral antipsychotics. On 12/31/2020, Patient #1 received a one-time dose of Seroquel fifty (50) mg at bedtime. This was reordered on 01/03/2020, and Patient #1 refused the fifty (50) mg dose at bedtime. On 01/01/2020 at 1:25 PM, Patient #1 was ordered Zyprexa (an antipsychotic) five (5) mg twice a day.

Continued review of Patient #1's medical record revealed, in the Physician Progress Notes, on 01/01/2020, the patient was started on Zyprexa with as needed Geodon for agitation. He also stated the spouse was unable to take the patient home, and case management was working on possible post-hospital placement in a geriatric psychiatric facility. On 01/02/2020, the Physician revealed the patient continued to be agitated, and it happened consistently throughout the night. He stated Patient #1's primary problem was agitation. On 01/03/2020, the Physician revealed the patient was doing well. He also stated the patient received high doses of Geodon the prior night and had shown no side effects. The Physician also revealed he had discussed this incident with his/her spouse and informed the spouse the patient's discharge would be delayed until the next day for monitoring. He revealed the patient was to be discharged to a geriatric psychiatric facility. Also, Nurses Notes revealed Patient #1, on 01/03/2020 at 8:00 AM, was confused but appropriate and calm; at 9:00 PM, notes reveal the patient was calm and cooperative but agitated; and on 01/04/2020 at 9:00 AM, notes reveal Patient #1 was oriented, calm, and cooperative. Review of the Discharge Summary revealed Patient #1 was medically stable and discharged on 01/04/2020 to a geriatric psychiatric unit.

Continued review of Patient #1's medical record revealed, in the Rapid Response Form for 01/02/2020 at 8:00 PM and documented by RN #3, the Rapid Response Nurse, on 01/02/2020 at 11:38 PM, Patient #1's primary nurse, RN #1 called the Rapid Response Team (RRT) for help in administering Haldol (incorrect, should have been Geodon). RN #3 revealed, upon arrival to Patient #1's room on the telemetry unit, the sitter and RN #1 were with the patient who was dressed in pants, shirt, and jacket so he/she could leave the facility. The patient was confused and not oriented. RN #3 called the Charge RN, House Administrator, and Security Guard. The Security Guard, Charge RN, and sitter helped the patient stay in bed, and RN #3 administered the medication. Further review revealed the patient was resting in bed in no acute distress when she left the room. Review of the Rapid Response Form for 01/03/2020 at 4:14 AM and documented by RN #3, on 01/03/2020 at 6:37 AM, revealed upon arrival to Patient #1's room, Patient #1 was standing with the Security Guard, sitter, Primary Nurse, Charge Nurse, and House Administrator present. RN #3 stated Geodon was given as ordered, and the patient was resting in bed after the injection.

1. Review of the written statement from RN #1, on 01/03/2020, no time given, revealed Geodon five (5) mg every three (3) hours was ordered. Per the statement, at 8:00 PM, RN #3 gave five (5) mg, and at 12:00 AM, RN #4 gave twenty (20) mg. RN #4 did not know what the ordered dose was. Patient #1 was in the ICU waiting room and was very combative. Several people were trying to guide him/her back to his/her room. RN #4 was tasked with drawing up the medication and administering it. She unknowingly gave the full twenty (20) mg dose. At 4:00 AM, RN #2 gave ten (10) mg of Geodon, and at 4:15 AM, she called the Physician and got approval for a stat five (5) mg dose to cover the extra five (5) mg given at 4:00 AM. A total of thirty-five mg was given over the shift when the maximum order was twenty (20) mg. RN #1's statement further revealed Patient #1 was agitated all shift. He/she was cussing and raising his/her fists, swinging at staff. He/she was also a risk to him/herself because he/she was unsteady and insisted on walking the halls. He/she became combative to anyone who tried to support him/her when he/she lost his/her footing. Further review of the statement revealed Security was called several times throughout the night. There were no episodes of sinus pauses or significant changes on his/her telemetry monitor, and he/she was on continuous monitoring throughout the night.

Review of RN #1's Notice of Corrective Action, signed 01/10/2020, revealed she was terminated because she violated the facility's Medication Management Policy and Standards of Conduct Policy by her malevolent or willful misconduct.

RN #1 was called per telephone on 01/21/2020 at 9:27 AM. She did not answer, and she did not have access to voice mail.

2. Review of the written statement from RN #2, on 01/03/2020, no time given, revealed Patient #1 at shift change was walking into other patients' rooms and was extremely combative. While nurses got the patient in bed and held his/her arm, RN #3 gave five (5) mg of Geodon. Later, around midnight, Patient #1 had gotten into the ICU waiting room and locked his/her sitter out of the room. RN #1, RN #2, and the Charge Nurse assisted the Security Guard with getting the patient into a chair while RN #4 drew up a full dose of Geodon. Unaware of Patient #1's ordered dose, RN #4 gave the patient the full dose. At that point, the staff was able to get Patient #1 back to his/her room. Further review revealed around 4:00 AM, Patient #1 became extremely combative again, and he/she with closed fists was swinging at his/her nurses. RN #2 drew up ten (10) mg of Geodon and administered it. She had already paged the Physician for additional orders; he called back immediately and said to put in a one-time dose for another five (5) mg, and to call back if more was needed. Since the as needed dose for five (5) mg and the one-time dose of five (5) mg covered the ten (10) mg that had been given, the patient did not get any additional Geodon. Patient #1 remained stable and was monitored throughout the night.

Review of RN #2's Notice of Corrective Action, signed 01/10/2020, revealed she was terminated because she violated the facility's Medication Management Policy and Standards of Conduct Policy by her malevolent or willful misconduct.

RN #2 was left a voice message, on 01/21/2020 at 9:29 AM, on her telephone for the purpose of giving an interview. She did not respond by time of exit on 01/22/2020.

3. Review of RN #3's written statement, sent by email to the Director of Human Resources, on 01/08/2020 at 12:30 PM, revealed she showed RN #1 how to reconstitute Geodon on 01/02/2020 while she was making her first set of rounds. She also stated she wasted all but five (5) mg in the sharps container. RN #1 scanned the medication and selected the site of administration and amount given while RN #3 was standing with her. Patient #1 was in his/her room and was disoriented, agitated, and wanting to leave the facility and go home. He/she was pushing nurses and his/her sitter while trying to leave the room. Two (2) security guards had also come to the room. The staff held Patient #1's arm so RN #3 could safely administer the injection. After several staff left the patient's room, he/she calmed down and was lying in bed. Further review revealed RN #3 was called back to Patient #1's room around 3:30 AM on 01/03/2020. When she arrived, the room was full of people including the House Administrator, Charge Nurse, Primary Nurse, sitter, security, and other nurses from the floor. RN #3 was told she did not need to assist because there was enough staff present, so she waited in the hallway. RN #2 told RN #3 the patient received another dose of Geodon, and the Physician was being called to get orders for an additional dose. At this time, RN #3 showed the House Administrator and Charge Nurse Patient #1's cardiac strips from a few nights before when he/she had long pauses after receiving Geodon. RN #3 stated she did not believe the patient needed an additional dose of Geodon. RN #1 told RN #3 she would not administer additional doses of Geodon. As the patient was lying in bed and calm, RN #3 then left the telemetry floor.

Review of RN #3's Notice of Corrective Action, signed 01/10/2020, revealed she was terminated because of possible reckless or negligent behavior. On this form, RN #3 documented she did not give more of the medication than was prescribed by the Physician.

Interview with RN #3, on 01/21/2020 at 10:32 AM, revealed she confirmed the events as described in her written statement from 01/08/2020. In addition, RN #3 stated the injection she gave was not given through the patient's shirt. She also stated she gave the correct dose of Geodon, five (5) mg and did not ever say she gave ten (10) mg. RN #3 revealed she left the charting of the medication to RN #1 as she was Patient #1's primary nurse. In addition, she stated she was called by the Director of Human Resources later in the day of 01/03/2020, was suspended, and then later terminated. Further interview revealed RN #3 believed she had done nothing wrong, and the termination action against her was unfair.

4. Review of RN #4's written statement from 01/03/2020 at 10:57 AM via email to the Director of Human Resources revealed on 01/03/2020 around midnight she and the Charge Nurse helped the sitter for Patient #1 because he/she had gone to the ICU waiting area, and he/she would not let the sitter stay with him/her. When they arrived, the patient's primary nurse and a security guard was with the patient. Then, RN #2 handed RN #4 a bag with a vial of Geodon injection in it and asked her if she would prepare the medicine for RN #1. When RN #4 asked about the dosage, RN #1 and RN #2 both said it was all of the vial, twenty (20) mg. While the other staff were holding the patient's arm, RN #1 and RN #2 said to give the whole IM injection which RN #4 did. Afterwards, RN #4 asked if RN #1 still needed to scan the medication into the record, and she said yes. After RN #1 settled the patient in his/her room, RN #4 gave RN #1 the package the Geodon came in. Further review revealed Patient #1 had been hostile throughout the night and tried to enter other patients' rooms. In the early morning of 01/03/2020, the patient was standing in the doorway of his/her room, rolled his/her fist, and acted like he/she was going to hit RN #1. RN #4 revealed she, along with other staff, helped the patient to the bed and she held his/her left hand so he/she could not grab anyone. RN #2 arrived with a prepared syringe of Geodon and gave the patient an IM injection in the right arm. Further review revealed after the injection, RN #4 released the patient's hand and exited the room.

Review of RN #4's Notice of Corrective Action, signed 01/10/2020, revealed she was given a final written warning with suspension from 01/03/2020 to 01/09/2020 for possible unintended human behavior by violating the facility's Medication Management policy and Standards of Conduct policy.

Interview with RN #4, on 01/20/2020 at 4:45 PM, revealed she confirmed all the events from her written statement from 01/03/2020. She also revealed she had been suspended from 01/03/2020 to 01/09/2020 and then given a final written warning which she signed on 01/10/2020.

5. Review of RN #5's written statement from an Incident Report filed 01/03/2020 at 12:43 PM, revealed she was the primary nurse for Patient #1 on the 7 AM to 7 PM shift on 01/03/2020 and took over the patient's care from RN #1. RN #5 stated during report from RN #1 that RN #1 reported the patient had Geodon five (5) mg ordered but twenty (20) mg came in the vial, so he/she was given more each of the three (3) times she had given the medication on her shift. RN #1 told RN #5 the first time she gave five (5) mg; the second time she gave twenty (20) mg; and the third time she gave ten (10) mg. RN #1 then told RN #5 to keep an eye on Patient #1 because he/she had experienced a 3.2 second pause on the heart monitor during this hospitalization. When RN #5 looked at the MAR she discovered that only five (5) mg was charted for each dose given.

Interview with RN #5, on 01/20/2020 at 2:30 PM, revealed she confirmed the events that happened on 01/03/2020 per Incident Report that she filed. In addition, when she looked at Patient #1's heart monitor strip, she discovered everything was normal. The House Administrator from the previous shift told RN #5 she was aware of the situation with the increased doses of Geodon being given. The Physician was at the nurses station and RN #5 informed him of the incident. The patient's planned discharge was canceled for another day of monitoring. A security guard remained with the patient until the family arrived around mid-afternoon. RN #5 stated Patient #1 remained alert and oriented all shift.

6. Review of the House Administrator's (HA) written statement from 01/04/2020 at 2:18 AM via email to the Director of Human Resources revealed on 01/03/2020 at approximately 4:20 AM she arrived at Patient #1's room. The patient was standing in the doorway with many staff members present. The patient was very agitated, waving his/her fists and demanding he/she leave the facility. RN #1 stated the patient had Geodon 5 mg IM every three (3) hours as needed for agitation ordered, and this had been given at 4:00 AM. The HA repeated this back to RN #1, and she confirmed what had been said. At that time RN #2 stated the dose was more like twenty (20) mg and laughed. RN #1 again stated the patient had received only five (5) mg. The HA asked RN #2 to call the Physician to see if he wanted to order anything else. RN #2 came back and said the Physician had ordered an additional five (5) mg, and we were waiting on it to be sent to the floor from pharmacy. The HA went to the nurses station where RN #3 showed her telemetry strips from 12/31/2019 to 01/01/2020 with pauses, and the patient had received a one-time order for Geodon on 12/31/2019 around 6:30 PM. The HA stated she knew Geodon could cause pauses because of prolonging the QT interval, so she told RN #3 to tell RN #1 not to give the additional five (5) mg of Geodon. The HA looked at the MAR and saw five (5) mg doses had been documented by RN #1 at 8:40 PM on 01/02/2020, 12:12 AM on 01/03/2020, and 4:58 AM on 01/03/2020. Further review revealed the HA called RN #1 to clarify since she had told the HA she gave five (5) mg at 4:00 AM. RN #1 stated the 4:00 AM dose was really ten (10) mg and scanned it for 4:58 AM to cover the additional medication given at 4:00 AM. The HA informed RN #1 Physician orders did not work that way, and she would follow up with RN #1. When the HA talked with RN #1 again, she was told the patient received twenty (20) mg each dose given, and RN #1 did not administer any of the doses, she only scanned them into the MAR. The HA talked with RN #4 who had been identified as the nurse who gave the 12:12 AM injection. RN #4 stated she had given the whole vial because she was told to prepare the medication and give it. RN #4 revealed she did not know what the ordered dose was. When the HA told RN #4 what the ordered dose was, she was visibly upset. Also, the HA talked with RN #1 and RN #2. RN #2 was loudly saying that RN #1 would not get into trouble because she did not administer any of the doses given. RN #1 and RN #2 were told to go to the Director of Nursing's (DON) office and give a statement. The HA called RN #3 who confirmed giving the 8:40 PM 01/02/2020 dose. RN #3 stated she thought she gave ten (10) mg. When asked if she knew the order was for five (5) mg, RN #3 stated yes, and she had wasted some of the medication. When asked if she thought she had given ten (10) mg or less, RN #3 stated she probably gave ten (10) mg. RN #3 was asked to write a statement and send it to her manager or the DON.

Interview with the HA, on 01/21/2020 at 10:10 AM, revealed she confirmed the incident as related in the email sent to the Director of Human Resources on 01/04/2020. In addition, the HA stated there were several other people present on the telephone call with RN #3, and they confirmed RN #3 stated twice she thought she gave Patient #1 ten (10) mg of Geodon instead of five (5) mg.

7. Review of Patient #1's meeting notes between the patient's sitter and the Director of Human Resources, on 01/07/2020 at 3:30 PM, revealed Patient #1 used a lot of bad language and was belligerent. She also revealed RN #3 gave the patient an IM injection through his shirt sleeve. The sitter then stated she didn't hear staff use any profanity directed toward Patient #1.

Interview with Patient #1's sitter, on 01/20/2020 at 4:15 PM, revealed the patient had been very belligerent during the 7 PM to 7 AM shift from 01/02/2020 into 01/03/2020. She stated she confirmed the events as related by other staff but believed having so many staff around caused his/her behavior to escalate. She also stated she did not hear or witness any verbal abuse directed toward the patient.

8. Review of Patient #1's meeting notes between the Charge Nurse (CN) and the Director of Human Resources, on 01/06/2020 at 10:00 AM, revealed the patient's first injection was given by RN #3; the second by RN #4; and the third by RN #2. For the third injection, the HA requested RN #1 call the Physician for another medication because she believed the Geodon was not working. The CN revealed she did not know who prepared the Geodon or the dose that was given. She also stated she thought the patient's sitter was afraid of him/her.

Interview with the CN, on 01/21/2020 at 11:16 AM, revealed she worked the 7 PM to 7 AM shift 01/02/2020 going into 01/03/2020. She stated she was present when the 8:40 PM dose of Geodon was give to Patient #1 by RN #3. She revealed once the injection was given, the patient became calm. For the 12:12 AM dose of Geodon, the CN revealed she was also present, and RN #4 gave the medication. For the 04:00 AM dose of Geodon, the CN stated she was present, Patient #1 was trying to hit RN #1, and RN #2 gave the medication. She also revealed none of the injections were given through the patient's sleeve. The CN stated she did not witness or hear any verbal abuse directed toward the patient, and if she had she would have immediately removed the staff member from patient care and immediately notified the HA for further action. In addition, the CN stated since the incident there had been floor-wide teaching with emphasis on resources available in emergency situations and de-escalation techniques.

Interview with the Chief Medical Officer (CMO), on 01/22/2020 at 9:25 AM, revealed he was first made aware of the incident with Patient #1 by the DON on 01/03/2020 between 1:00 and 2:00 PM. Then, that day, he met with the Chief Nursing Officer (CNO), DON, and Director of Human Resources. The CMO further revealed he was kept abreast as the investigation progressed. He also stated it was decided to delay the discharge of Patient #1 until the next day so he/she could be monitored. Later in the day of 01/03/2020, the CMO met with Patient #1's Physician, who was aware of the situation, about having full disclosure with the family after they arrived. The CMO stated he spent several hours trying to work through the situation on 01/03/2020, and it was his understanding the staff involved had been suspended earlier in the day.

Interview with Patient #1's Physician, on 01/22/2020 at 9:46 AM, revealed he knew Patient #1 very well, and the patient had Sundowner's Syndrome and Dementia. Consequently, he/she would become very aggressive and agitated, usually in the PM, and then would greatly improve in the AM. The Physician stated he was made aware of the increased doses of Geodon being given the AM of 01/03/2020 while on the floor making rounds. He stated he ordered the patient's discharge to be delayed a day for continued monitoring. The Physician revealed the telemetry strips did not have any pauses, and he was not concerned about a prolonged QT interval. He did say he would be more concerned about heart block but this would be a rare side effect. The Physician stated he met later in the day with the patient's family and disclosed the incident to them. He revealed Patient #1 was discharged the next day and did not suffer any adverse effects from the increased doses of Geodon he/she received.

Interview with the Nurse Manager (NM) of the Telemetry Unit, on 01/21/2020 at 12:43 PM, revealed RN #1, RN #2, and RN #4 were assigned to the Orthopedics Unit and would float to telemetry periodically depending on the census in orthopedics. She stated she did not perform their performance evaluations but communicated with their direct supervisor closely. The NM stated she knew of no previous problems with RN #1, RN #2, or RN #4. She revealed all patients on telemetry were monitored, except by Physician order not to be monitored. Staff on the unit had been specially trained to monitor, and there was continuous monitoring. The RN checked all strips three (3) times per shift when they were printed. The NM reported the patient to nurse ratio ranged between 4:1 and 6:1, depending on the acuity of the patients. She also revealed she had done 1:1 conversations with staff about topics concerning this incident. The NM stated the facility was in the process of additional education about medication administration, handling out-of-control patients and dementia patients, and use of restraints.

Interview with the CNO, on 01/17/2020 at 3:10 PM, revealed she had been in her position since 12/2019. The decision was made to replace the DON before 01/10/2020 because the CNO was interested in improving the culture of safety in the facility. Changes that had been implemented recently included a weekly meeting with the leadership group, a daily meeting with the house managers, daily check-in with the CNO with safety concerns, better exchange of information, and increased expectations and increased accountability with leadership and house managers.