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Based on interview, record review, review of the facility's policies, review of the facility's video, and review of the facility's Governing Board By-Laws, it was determined the facility failed to have a Governing Body which was effective in carrying out its responsibilities for the conduct of hospital staff for one (1) of thirteen (13) sampled patients (Patient #1).

Review of the facility's Bylaws for Baptist Healthcare System, Inc., revised 12/08/2020, Section 1.03-Responsibilities of the Board of Directors, revealed it was the responsibility of the Board of Directors to oversee the quality of care and services provided to patients.

The investigative process revealed, on 04/30/2022 between 7:00 AM and 8:00 AM, Registered Nurse (RN) #1 observed RN #2 turn down Patient #1's Oxygen Saturation (O2 Sat) Monitor (measured the oxygen level in the patient's blood) alarm to seventy-eight percent (78%) instead of the facility's Oxygen Monitoring policy requirement of at least ninety-one percent (91%). Oxygen levels less than ninety-two percent (92%) would indicate hypoxemia, a low blood oxygen level which required interventions to correct.

Review of the facility's video, dated 04/30/2022, revealed RN #2, at 7:32 AM, was outside Patient #1's room, and drew up a liquid medication into a small syringe and then entered Patient #1's room. Review of Patient #1's medication orders revealed the patient did not have any liquid medication ordered except for saline solution which was used to flush to maintain the patency of Patient #1's intravenous (IV) line. In addition, per interview with the Charge Nurse, on 08/29/2022 at 2:12 PM, RN #1 observed RN #2 give Patient #1 an IV medication at that time.

Review of Patient #1's medical record revealed, after the observed IV medication administration, Patient #1's physical condition deteriorated, and he/she became somnolent, hypoxic with a low blood oxygen level, and bradycardic with a slow heart rate. Patient #1 required interventions of oxygen, administration of an IV sedative reversal agent, and a diuretic. A chest x-ray, done on 04/30/2022 between 8:40 AM and 8:52 AM, showed aspiration pneumonia. Patient #1 expired five (5) days later of aspiration pneumonia.

Interview with the Chief Operating Officer (COO), a member of the Governing Body, on 09/02/2022 at 12:45 PM, revealed, when interviewed about the connection between the medication administration, the aspiration, and the death of Patient #1, the COO's reply was that the clinical impression listed aspiration as the cause of death. Additionally, the COO stated RN #2 was suspended, on 04/30/2022, and terminated on 05/05/2022 for failure to follow the facility's policies.

Interview with the Chief Nursing Officer (CNO), a member of the Governing Body, on 09/16/2022 at 1:50 PM, revealed the investigation did not find a process or knowledge deficit issue, but determined it was a poor judgement issue with RN #2.

Interview with the Chief Executive Officer (CEO), a member of the Governing Body, on 09/16/2022 at 2:53 PM, revealed he agreed with the processes that were followed in this case. He stated, if the processes being investigated involved the masses, he would educate the "masses".

Refer to A-0057

Based on interview, record review, review of the facility's By-laws, and review of the Chief Executive Officer's (CEO) Job Description, it was determined the CEO failed to ensure the facility provided and maintained quality patient care and failed to ensure the facility responded to an adverse quality of care incident with a systems-wide approach for one (1) of thirteen (13) sampled residents (Patient #1).

Review of Patient #1's closed medical record revealed, on 04/30/2022, Registered Nurse (RN) #2 admitted to administering some type of "magic" medication via Patient #1's intravenous (IV) line. After administration of the IV medication to Patient #1 by RN #2, Patient #1's physical condition deteriorated. Patient #1 developed aspiration pneumonia and expired five (5) days later.

Interviews from the Nursing Director of 3F, the Executive Director of Outcomes, the Chief Nursing Officer, and the Chief Executive Officer revealed the facility's analysis determined the cause of the incident was related to one (1) employee's actions and did warrant facility-wide interventions.


The findings include:

Review of the facility's "Bylaws of Baptist Healthcare System, Inc., revised 12/08/2021, revealed the Board of Directors were responsible for the oversight of quality of care and services provided to patients. The Board of Directors was also responsible for selecting and hiring a CEO, who would be the Board's direct representative in the management of the affairs of the facility.

Review of the CEO Job Description, dated 2019, revealed principal duties and responsibilities included responding to the community's needs for quality health care services by monitoring the adequacy of the facility's medical activities. Additional review revealed the CEO also ensured compliance with all regulatory agencies governing healthcare delivery.

Review of the facility's investigation revealed, on 04/30/2022, between 7:00 AM and 8:00 AM, Registered Nurse (RN) #1 observed RN #2 turn down Patient #1's Oxygen Saturation (O2 Sat) Monitor (measured the oxygen level in the patient's blood) alarm to seventy-eight percent (78%) instead of the facility's Oxygen Monitoring Policy requirement of at least ninety-one percent (91%). Oxygen levels less than ninety-two percent (92%) would indicate hypoxemia, a low blood oxygen level which required interventions to correct. Continued review revealed RN #1 stated she had observed RN #2 administer something from a syringe into Patient #1's IV line.

Review of the facility's video, dated 04/30/2022, revealed RN #2, at 7:32 AM, was outside Patient #1's room, and drew up a liquid medication into a small syringe and then entered Patient #1's room. Review of Patient #1's medication orders revealed the patient did not have any liquid medication ordered except for saline solution which was used as a flush to maintain the patency of Patient #1's intravenous (IV) line. In addition, per interview with the Charge Nurse, on 08/29/2022 at 2:12 PM, and RN #1, on 09/12/2022 at 3:00 PM, RN #1 observed RN #2 give Patient #1 an IV medication at that time.

Review of Patient #1's medical record revealed, after the observed IV medication administration, Patient #1's physical condition deteriorated, and he/she became somnolent, hypoxic with a low blood oxygen level, and bradycardic with a slow heart rate. Patient #1 required interventions of oxygen, administration of an IV sedative reversal agent, and a diuretic. A chest x-ray, done on 04/30/2022 between 8:40 AM and 8:52 AM, determined the patient had aspiration pneumonia. Patient #1 expired five (5) days later of aspiration pneumonia.

RN #2 had been arrested, was in custody at the time of the investigation, and an interview was not possible.

Interview with the Nursing Director (ND) of 3F (area of incident), on 09/02/2022 at 9:33 AM, revealed education that was pertinent to the Telemetry Unit (3F) was provided to Unit staff yearly.

Interview with the Chief Operating Officer (COO), a member of the Governing Body, on 09/02/2022 at 12:45 PM, revealed, when interviewed about the connection between the medication administration, the aspiration, and the death of Patient #1, the COO's reply was that the clinical impression listed aspiration as the cause of death. Additionally, the COO stated RN #2 was suspended, on 04/30/2022, and terminated on 05/05/2022 for failure to follow the facility's policies.

Interview with the Patient Safety Officer (PSO), on 09/12/2022 at 1:25 PM, who completed part of the facility's investigation, revealed the findings were that the 04/30/2022 incident had been an isolated incident that had not warranted unit or facility wide re-education.

Interview with RN #1, on 09/12/2022 at 3:00 PM, revealed that on 04/30/2022, she had witnessed RN #2 administer something besides saline flush into Patient #1's IV line.

Interview with the Executive Director of Outcomes, on 09/16/2022 at 1:50 PM, revealed it was her practice in situations such as the 04/30/2022 incident, to get involved when systemic issues were identified to improve a facility process. The Executive Director of Outcomes additionally revealed "they" (facility's leadership) had all felt there had been no systemic issue involved with the incident; however, if anything had been identified then she would have become involved.

Interview with the Chief Nursing Officer (CNO), a member of the Governing Body, on 09/16/2022 at 1:50 PM, revealed the investigation did not find a process or knowledge deficit issue, but determined it was a poor judgement issue with RN #2.

Interview with the Chief Executive Officer (CEO), on 09/16/2022 at 2:53 PM, revealed he was over the operations at the facility, and at the end of the day, he was responsible. He stated he had been informed of the situation with Patient #1 and actions being taken, and would provide input if needed. He further stated that he agreed with processes that were being followed in this case. He stated, if the processes being investigated involved the masses, the would educate the masses. He stated he was very proud of the nurses and the staff involved and how they handled it. The CEO stated he had confidence that staff would report actual/suspected concerns.

Based on interviews and record reviews it was determined the facility failed to ensure patients received care in a safe setting and were free from chemical restraints for one (1) of thirteen (13) sampled patients (Patient #1).

Review of the facility's policy titled, "Patient Rights and Responsibilities", number VIII:1a, revised 06/2021, revealed patients had the right to receive care in a safe setting. Continued review revealed patients had the right to be free from restraints and seclusion, of any form, that was not medically necessary or used as a means of coercion, discipline, convenience or retaliation.

The investigative process revealed, on 04/30/2022 between 7:00 AM and 8:00 AM, Registered Nurse (RN) #2 was observed by RN #1 to turn down Patient #1's Oxygen Saturation (O2 Sat) Monitor (measured the oxygen level in the patient's blood) alarm to seventy-eight percent (78%) instead of the facility's Oxygen Monitoring Policy requirement of at least ninety-one percent (91%,) (less than ninety-two percent {92%} would indicate hypoxemia, a low blood oxygen level which required interventions to correct).

Review of the facility's video, dated 04/30/2022 at 7:32 AM, revealed RN #2, who was outside Patient #1's room, aspirated liquid medication from a small medication vial into a small syringe and entered Patient #1's room.

However, per Patient #1's medical record, he/she did not have any intravenous (IV) medications ordered at that time, which would have been the route of administration for the medication from the syringe. RN #1 observed RN #2 administer an IV medication to Patient #1. When RN #1 asked RN #2 about the IV medication that she had administered to Patient #1, RN #2 replied that it was something "magic". Interview with Physician #1 revealed, on 04/30/2022, time unknown, RN #2 had requested that she order a medication for Patient #1's agitation, but Physician #1 declined.

After administration of the IV medication to Patient #1 (by RN #2) his/her physical condition deteriorated. It was suspected the IV medication that RN #2 administered was Ativan, an anti-anxiety medication and benzodiazepine, that was not ordered for Patient #1. The medication was ordered for another patient. Prior to the IV drug administration, Patient #1 was alert, confused but responsive, and his/her vital signs were stable (VSS). RN #1 checked on Patient #1 again, prior to 8:00 AM, and the patient was drowsy, with labored breathing, hypoxic (low O2 saturation) and had a slow heart rate. Patient #1's immediate treatment included Oxygen delivered through a non-rebreather mask (allowed for a higher concentration of Oxygen to be administered) and Romazicon IV (a sedative reversal agent). Patient #1 developed aspiration pneumonia and expired five (5) days later.

Interview with the Chief Operating Officer (COO), on 09/02/2022 at 12:45 PM, revealed, when interviewed related to the medication administration, the aspiration, and the death of Patient #1, the COO's reply was that the clinical impression listed aspiration as the cause of death. Additionally, the COO stated RN #2 was suspended on 04/30/2022 and terminated on 05/05/2022 for failure to follow the facility's policies.

Refer to A-0144 and A-0160

Based on interview, record review, review of the facility's video, review of the facility's incident report, and review of the facility's policies, it was determined the facility failed to ensure patients received care in a safe setting for one (1) of thirteen (13) sampled patients (Patient #1).

On 04/30/2022 Registered Nurse (RN) #2, an on-coming nurse for the 7:00 AM to 7:00 PM shift, was observed by RN #1, at least twice, between 7:00 AM and 8:00 AM, to turn down Patient #1's Oxygen (O2) Saturation Monitor alarm (measured the amount of Oxygen in a patient's blood) to seventy-eight percent (78%). Per interview with the Charge Nurse, on 08/29/2022 at 2:12 PM, and review of the facility's Oxygen Therapy Policy, the alarm should be set at ninety-one percent (91%), unless ordered otherwise by a Physician, to notify staff if the patient had an abnormally low blood oxygen level, and interventions were required.

Registered Nurse (RN) #2, per the facility's video, dated 04/30/2022 at 7:32 AM, was outside Patient #1's room. She aspirated liquid medication from a small medication vial into a small syringe and entered Patient #1's room. However, Patient #1 did not have any intravenous (IV) medications ordered at that time, which would have been the route of administration for the medication from the syringe. Review of the Medication Administration Record (MAR) for Patient #1 revealed he/she was not administered any IV medication.

Record review revealed RN #1 checked on Patient #1 again, prior to 8:00 AM, and the patient's condition had deteriorated. Patient #1 was drowsy, with labored breathing, hypoxic (low O2 saturation) and a slow heart rate. Patient #1 had to be treated by applying a non-rebreather mask (allows for a higher concentration of Oxygen to be administered) and Romazicon (a sedative reversal agent). Patient #1 developed pneumonia and died five (5) days later.

The findings include:

Review of the document, "Your Rights and Responsibilities as a Hospital Patient", revised 06/06/2022, that was given to all patients and their representative(s) upon presenting to the facility, revealed patients had the right to receive care in a safe setting. Continued review revealed patients had the right to be free from restraints and seclusion, of any form, that were not medically necessary or used as a means of coercion, discipline, convenience or retaliation.

Review of the facility's policy titled, "Medication Administration III-A-1", revised 07/2021, revealed medications were administered upon the receipt of a valid medication order by a Physician. Further review revealed the practitioner, who was to administer the medication, was to ensure the medication was correct, in-date, had the correct dose, the correct dosage form, and at the correct time. The policy stated barcode verification was used to ensure the medication's identity, strength and form, as well as the correct patient and time of administration. Per the policy, barcode verification triggered documentation of the administration in the electronic medical record (EMR) or the medication administration record (MAR).

The facility failed to provide a requested copy of the Controlled Substances Policy.

Review of the facility's policy titled, "Management of Oxygen Therapy and Titration", number III-B55, revised 11/30/2021, revealed a written order for Oxygen therapy was needed, and the monitoring threshold was to set at ninety-one percent (91%) unless otherwise ordered by the Physician.

Review of the facility's policy titled, "Just Culture", number 11169.4, revised and effective 09/01/2021, revealed its purpose was: 1) to confirm the facility's strong commitment to maintaining a "just culture"; 2) to set clear expectations for staff and leaders as it related to safe practices and reporting any safety concerns; 3) to ensure open and honest communication in the event of an error; and 4) to establish criteria and guidelines for determining appropriate action(s) to be taken if there was an error in judgement.

Review of Patient #1's Emergency Department (ED) clinical record revealed the patient presented to the ED, on 04/28/2022 at 11:00 PM, after he/she had sustained a fall at home. Continued review of Patient #1's ED clinical record revealed his/her O2 sats (94%-96%) were within normal limits (WNL), oxygen was not ordered, and he/she was alert and oriented to person, place, and time. Radiologic results revealed a left posterior scalp hematoma, no cranial fractures, or intracranial hematomas. A chest x-ray (CXR) resulted retrocardiac opacity that might reflect atelectasis (complete or partial lung collapse) or pneumonia. Further review revealed the white blood cell count (WBC) was elevated at 11.33 (normal 3.40-10.80), indicating an infection; and Sodium was high at 146 (normal 136-145), indicating dehydration.
Per the record, The facility admitted Patient #1 to a telemetry unit (where the patient's heart and the O2 sat level were monitored), on 04/28/2022, for further work-up, related to the test results. Admitting diagnoses were Multiple Falls, Dehydration, and Hypernatremia (high blood sodium level).

Review of the SAFE report (the facility's incident report that drove investigations), dated 05/02/2022, revealed RN #1, on 04/30/2022 at approximately 8:30 AM, reported her concerns to the unit Charge Nurse (CN) that Patient #1 had been given something that was causing his/her physical decline. Continued review of the SAFE report revealed RN #1 reported she was concerned because she had observed RN #2 administer a "suspicious" IV medication to Patient #1 between 7:30 AM and 8:00 AM. Further review revealed Patient #1 did not have any IV medications ordered at that time.

Additional review of the SAFE report, dated 05/02/2022, concerning Patient #1, revealed when RN #1 questioned RN #2 about what she had given Patient #1, all RN #2 would say was that it was "magic". It was documented in the SAFE report that prior to the administration of the IV liquid, Patient #1 had received his/her morning medications, from RN #2, at 8:04 AM (per review of the MAR) that included Buspar (anti-anxiety agent) 30 milligrams (mg) by mouth (PO); Xanax 0.5 mg (anti-anxiety agent) PO; and Zoloft (anti-depressant) 25 mg PO. RN #2 did not mention any IV administration other than flushing the IV line with saline solution. It was noted in the SAFE report that prior to the administration of the unknown IV liquid, Patient #1 was alert, confused but responsive, and vitals signs were stable (VSS). Per the report, at approximately 7:30 AM to 8:00 AM, RN #1 decided to check on Patient #1 again, prior to leaving her shift. It was documented in the SAFE report that Patient #1 was found to be somnolent (drowsy), hypoxic (low O2 saturation) and bradycardic (heart rate less than sixty (60) beats per minute). Continued review revealed Physician #1 believed Patient #1 had aspirated the food and morning pills given at 8:04 AM by RN #2. Further review revealed Patient #1 was treated by applying a non-rebreather mask (allows for a higher concentration of Oxygen to be administered) and Romazicon (a sedative reversal agent). It was documented in the SAFE report that Patient #1's responsiveness improved, and he/she began pulling at the monitor lines.

Review of the facility's video, dated 04/30/2022, revealed on 04/30/2022 at 7:21 AM, RN #2 (alleged perpetrator) came onto the floor, stopped in front of Patient #1's (alleged victim) room, and entered and exited his/her room; at 7:22:22 AM, RN #2 entered the medication (med) room; and at 7:24:57 AM, several nurses (RN #2 was still in the med room) entered Patient #1's room (per staff interview, Patient #1's chair/bed alarm was sounding. Continued review revealed at 7:30:37 AM, RN #2 exited the med room; at 7:31:50 AM, RN #2 entered Patient #1's room (it could not be determined if anything was in her hands); and at 7:32:06 AM, RN #2 exited Patient #1's room, talking to the dayshift Patient Care Technician (PCT). Additional review revealed at 7:32:12 AM, RN #2 had a pre-packaged saline flush (already prepared syringe) for the IV in her scrub pants' right leg side pocket (per interview, the only saline flush available) and was standing outside Patient #1's room with a small vial in her left hand and aspirated (drew) a liquid medication into a small syringe; Patient #1 did not have any IV meds ordered at that time. Continued review revealed at 7:32:37 AM, RN #2 entered Patient #1's room; at 7:32:50 AM, RN #2 exited Patient #1's room and exited the frame. Further review revealed at 7:33:34 AM, RN #2 entered the frame with soft wrist restraints in hand, entered Patient #1's room and closed the door; Patient #1 did not have soft wrist restraints ordered. Continued review revealed at 8:15:45 AM, RN #2 exited Patient #1's room and was out of the frame. At 8:32:55 AM, RN #2 entered the frame with O2 tubing and entered Patient #1's room (her exit could not be seen on the video). Additional review revealed at 8:46 AM, RN #2 entered Patient Room S-320. Per the video, at 8:40 AM to 8:52 AM, the Charge Nurse (CN), along with other staff, entered Patient #1's room and were in and out. A portable chest x-ray machine (CXR) entered and exited the room. At 8:55:57 AM, RN #2 exited Patient Room S-320. Further review revealed at 8:56:55 AM, Physician #1 had arrived and was conversing with the CN and RN #2 and then entered Patient #1's room; and at 9:00 AM, the video ended.

Continued review of Patient #1's medical record, after the incident, revealed Physician #1 ordered Patient #1 to receive Lasix 40 mg IV (a diuretic), an Albuterol Duo-Neb breathing treatment, Romazicon (sedative reversal agent) 0.2 mg IV, and a one-hundred (100%) non-rebreather mask, which was used to deliver seventy (70) to one-hundred (100) percent oxygen.

RN #2 had been arrested, was in custody at the time of the investigation, and an interview was not possible.

Interview with RN #1, on 09/12/2022 at 3:00 PM, revealed she worked from 7:00 PM on 04/29/2022 to the morning of 04/30/2022. She stated around 7:30 AM to 8:00 AM, she observed Patient #1's Oxygen Monitor alarm was turned down and alarming, after RN #2 started working on 04/30/2022 on the 7:00 AM to 7:00 PM shift. She stated she turned it back up to ninety-one percent (91%) and observed RN #2 turn it back down below policy requirements. RN #1 also stated she set the alarm to be monitored at the Nurse's station, and RN #2 removed the monitoring capability at the Nurse's station. Additional interview revealed, on the morning of 04/30/2022, she had witnessed RN #2 administer something besides saline flush into Patient #1's IV line.

Interview with the Patient Safety Officer (PSO), on 08/29/2022 at 10:35 AM, revealed she completed a piece of the investigation surrounding Patient #1. She stated a drug screen was not completed for Patient #1 because he/she took a benzodiazepine (Xanax) routinely at home, prior to this admission, and the test result would have shown a positive result, regardless of whether or not the patient was given an additional,unordered benzodiazepine. She also stated that Human Resources (HR) took the lead on the investigation because it had been determined by Leadership that it was a personnel issue and not an abuse issue.

Interview with the CN, on 08/29/2022 at 2:12 PM, revealed she was the 7:00 AM to 7:00 PM Charge Nurse (CN) the morning of 04/30/2022. She stated RN #1 came to her at approximately 8:00 AM or 8:30 AM, on 04/30/2022, with concerns that she had observed RN #2 administer Patient #1 something in his/her IV and then flush the line. Continued interview revealed when RN #1 asked RN #2 what she had given Patient #1, all RN #2 would say was it was something "magic". She stated she went to assess Patient #1, and he/she was lethargic with labored breathing. Continued interview revealed RN #2 told her she had administered Patient #1's morning medications that included Buspar 30 milligrams (mg) by mouth (PO), Xanax 0.5 mg PO, and Zoloft 25 mg PO. She stated RN #2 did not mention any IV administration other than flushing the IV line with saline. Further, the CN stated Patient #1's O2 Monitor alarm was turned down to seventy-eight (78%) instead of the ninety-one percent (91%) per the facility's policy requirement. She stated she questioned RN #2 again about what she had given Patient #1, and RN #2 again stated his/her morning medications. The CN stated she contacted Respiratory Therapy (RT) and the Physician (Physician #1). She stated RT responded, and Patient #1 was given a breathing treatment and put on a 100% non-rebreather mask. She stated Physician #1 ordered Lasix IV to be given. The CN also stated she realized that Patient #2 had an order for an IV sedative medication (Ativan, a benzodiazepine). She stated, when she checked the dispensing system (Omnicell), it indicated that RN #2 had signed out an Ativan 2 mg vial for Patient #2, at 7:24 AM on 04/30/2022. She stated it was documented that RN #2 had given Patient #2 the 0.25 mg Ativan IV at 8:49 AM. The CN stated it was the supposition that RN #2 had given Patient #1 the 0.25 mg of IV Ativan that had been signed out for Patient #2, which would account for Patient #1's somnolence and subsequent aspiration of pills and food.

Interview, with the HR Business Partner that completed the Human Resources segment of the investigation, on 08/29/2022 at 2:43 PM, revealed she was notified of the incident, on Saturday, 04/30/2022, and started the investigation on Monday, 05/02/2022. She stated the results of the facility's investigation was that RN #2 was suspended and terminated for failure to follow components of three (3) policies. These were for Medication Administration, by-passing the scanning process; O2 Monitoring, setting the monitor alarm at seventy-eight percent (78%) instead of ninety-one (91%); and Controlled Substances, having medications drawn up longer than one (1) hour prior to administration. She stated, at no time during the investigation, was there any credible evidence that Patient #1 had been abused. She stated RN #2 had not followed the facility's policies.

Interview with the Regional Vice President of HR, on 08/30/2022 at 1:24 PM, revealed she had been the Administrator on Call (AOC) on 04/30/2022. She stated she was notified of the incident, but another employee, the Nursing Director on Call (NDOC-no longer at the facility) did the preliminary investigation, on 04/30/2022, and she (VP HR) had more of a support role during this time. She stated, after the incident with Patient #1, RN #2 was allowed to remain on the floor and complete documentation in a patient care setting instead of being monitored in an area away from patient care because there was no credible evidence to suggest it was anything other than a policy violation.

Interview with the Nursing Director (ND) of 3F (area of incident), on 09/02/2022 at 9:33 AM, revealed she had been notified of the incident by RN #1 via phone and by the NDOC. She stated that she did not have any part in the investigation. She stated education that was pertinent to the Telemetry Unit (3F) was provided to Unit staff yearly.

Interview with the Chief Operating Officer (COO), also a member of the Governing Body, on 09/02/2022 at 12:45 PM, revealed his involvement with the incident was that he had an extensive conversation with Patient #1's daughter, via phone, on 05/06/2022 at 10:40 AM. The COO stated the family had a right to disclosure of the significant event that affected Patient #1, which was the suspected administration of unordered IV Ativan by RN #2. He stated medication error disclosure to patients/families was on a case-by-case basis. He stated he felt that medication administered without a Physician's Order warranted disclosure.

Continued interview with the COO, on 09/02/2022 at 12:45 PM, revealed Patient #1's daughter had asked the questions, "Why did this happen? Was it a mistake?" He stated his answer to the daughter was that the facility did not receive much cooperation from RN #2 and did not have the answers to those questions. He stated, based on the information gathered during the investigation, the Kentucky Board of Nursing (KBN) was the best entity to report the lapse in Nursing Standards of Care by RN #2. Further, he stated there was a culture of Patient Safety at the facility. When asked about the medication administration, the aspiration, and the death of Patient #1, the COO's reply was that the clinical impression listed aspiration as the cause of death.

Interview with the Chief Nursing Officer (CNO), on 09/16/2022 at 1:50 PM, revealed the process when there was a reported incident, was to have a SAFE report completed, and she was notified of data and investigation results. The CNO stated she did not actually conduct any investigations herself, and the facility's "JUST Culture" was how these situations were investigated. She stated the investigation did not find a process or knowledge deficit issue, but determined it was a poor judgement issue with RN #2. She stated on 04/30/2022, the House Supervisor and Administrator On Call notified her of the incident. The CNO stated the Nurse involved (RN #2) did not cooperate with the investigation. She stated "JUST Culture" empowered staff to speak up. She stated the fact that this was detected was the best evidence these safety practices were in place. Continued interview revealed during HR's discussion of the incident, on 05/05/2022, it was determined it was a poor decision instead of lack of education because of her five (5) years of experience and an employee file that was clear, regarding these issues.

Interview with the Chief Executive Officer (CEO), on 09/16/2022 at 2:53 PM, revealed he was over the operations at the facility, and at the end of the day, he was responsible. He stated he had been informed of the situation with Patient #1 and actions being taken, and would provide input if needed. He further stated that he agreed with processes that were being followed in this case. He stated, if the processes being investigated involved the masses, the would educate the masses. The CEO stated he was very proud of the nurses and the staff involved and how they handled it. He stated "JUST Culture" allowed the night shift nurse (RN #1) to come forward with her concerns with this incident. The CEO stated he had confidence that staff would report actual/suspected concerns.

Based on interview; record review; review of the facility's incident report; review of the facility's video; review of the Food and Drug Administration website, https://accessdate.fda.gov; and review of the facility's policies, it was determined the facility failed to ensure patients were free from chemical restraints for one (1) of thirteen (13) sampled patients (Patient #1).

Per the facility's video, on 04/30/2022, Registered Nurse (RN) #2 administered an intravenous (IV) medication to Patient #1, who had no IV medications ordered. In addition, the medication administered to Patient #1 was suspected to be Ativan, a benzodiazepine, that was ordered for another patient.

Patient #1 experienced a physical decline after this and required a sedative reversal agent, among other interventions, to be given to counteract the medication's effects. However, Patient #1 developed aspiration pneumonia and expired five (5) days later.

The findings include:

Review of the facility's policy titled, "Patient Rights and Responsibilities", number VIII:1a, revised 06/2021, revealed patients had the right to be free from restraints and seclusion, of any form, that was not medically necessary or used as a means of coercion, discipline, convenience, or retaliation.

Review of the Food and Drug Administration website, https://accessdate.fda.gov, revealed Ativan (lorazepam was the generic form) was a benzodiazepine and had multiple uses, such as a sedative for pre-operative procedures or to control anxiety.
Further review revealed extreme caution must be used when administering Ativan Injection/IV to elderly patients, very ill patients, or to patients with limited pulmonary reserve because of the possibility that hypoventilation could occur.
In addition, Ativan administration in persons over age sixty-five (65) might be associated with a greater incidence of central nervous system depression and more
respiratory depression. Another adverse effect reported was bradycardia, and overdosage of benzodiazepines was usually manifested by varying degrees of central nervous-system depression, ranging from drowsiness to coma. It stated, in mild cases, symptoms included drowsiness, mental confusion, and lethargy. In more serious examples, symptoms might include ataxia, hypotonia, hypotension, hypnosis, stages one (1) to three (3) coma, and, very rarely, death. Per the website, the benzodiazepine antagonist flumazenil (Romazicon) might be used in hospitalized patients as an adjunct for proper management of a benzodiazepine overdose. In addition, the website stated Ativan must never be used without individualization of the dosage particularly when used with other medications capable of producing central-nervous-system depression.

Review of Patient #1's Emergency Department (ED) clinical record revealed the patient presented to the ED, on 04/28/2022 at 11:00 PM, after he/she had sustained a fall at home. The facility admitted Patient #1 to a telemetry unit (where the patient's heart and the O2 sat level was monitored), on 04/28/2022, for further work-up, related to the test results. Admitting diagnoses were Multiple Falls, Dehydration, and Hypernatremia (high blood sodium level).

Review of the SAFE report (the facility's incident report), dated 05/02/2022, revealed Registered Nurse (RN) #1, on 04/30/2022 at approximately 8:30 AM, reported her concerns to the unit Charge Nurse (CN) that Patient #1 had been given something that was causing his/her physical decline. Continued review of the SAFE report revealed RN #1 reported she was concerned because she had observed RN #2 administer a "suspicious" intravenous (IV) medication to Patient #1. Further review revealed Patient #1 did not have any IV medications ordered at that time.

Additional review of the SAFE report concerning Patient #1, dated 05/02/2022, revealed when RN #1 questioned RN #2 about what she had given Patient #1, all RN #2 would say was that it was "magic". Per the report, it was noted, prior to the administration of the unknown IV liquid, Patient #1 was alert, confused but responsive, and vital signs were stable (VSS). At approximately 7:30 AM to 8:00 AM, RN #1 decided to check on Patient #1 again, prior to leaving her shift. The report stated Patient #1 was found to be drowsy, hypoxic (low O2 saturation), and bradycardic (slow heart rate).

Review of the facility's video, dated 04/30/2022 at 7:32:12 AM, revealed RN #2, who was outside Patient #1's room, aspirated liquid medication from a small medication vial into a small syringe and entered Patient #1's room. However, Patient #1 did not have any intravenous (IV) medications ordered at that time, which would have been the route of administration for the medication from the syringe. Further review revealed at 7:33:34 AM, RN #2 entered the frame with soft wrist restraints in hand, entered Patient #1's room again and closed the door; Patient #1 did not have soft wrist restraints ordered.

RN #2 had been arrested, was in custody at the time of the investigation, and an interview was not possible.

Interview with the Charge Nurse (CN), on 08/29/2022 at 2:12 PM, revealed she was the 7:00 AM to 7:00 PM Charge Nurse the morning of 04/30/2022. She stated RN #1 came to her at approximately 8:00 AM or 8:30 AM, on 04/30/2022, with concerns that she had observed RN #2 administer Patient #1 something in his/her IV and then flush the line. Continued interview revealed when RN #1 asked RN #2 what she had given Patient #1, all RN #2 would say was it was something "magic". She stated she went to assess Patient #1, and he/she was lethargic with labored breathing. She stated RN #2 told her RN #2 had administered Patient #1's morning medications that included Buspar 30 milligrams (mg) by mouth (PO), Xanax 0.5 mg PO, and Zoloft 25 mg PO. She stated RN #2 did not mention any IV administration other than flushing the IV line with saline. She stated she questioned RN #2 again about what she had given Patient #1, and RN #2 again stated his/her morning medications. The CN stated she contacted Respiratory Therapy (RT) and the Physician (Physician #1). She stated RT responded, and Patient #1 was given a breathing treatment and put on a 100% non-rebreather mask. She stated Physician #1 ordered Lasix IV to be given. The CN also stated she realized that Patient #2 had an order for an IV sedative medication (Ativan, a benzodiazepine). She stated, when she checked the dispensing system (Omnicell), it indicated that RN #2 had signed out an Ativan 2 mg vial for Patient #2, at 7:24 AM on 04/30/2022, and it was documented that RN #2 had given Patient #2 the 0.25 mg Ativan IV at 8:49 AM. The CN stated it was the supposition that RN #2 had given Patient #1 the 0.25 mg of IV Ativan that had been signed out for Patient #2, which would account for Patient #1's somnolence and subsequent aspiration of pills and food.

Continued review of Patient #1's medical record, after the incident, revealed Physician #1 ordered Patient #1 to receive Lasix 40 mg IV (a diuretic), an Albuterol Duo-Neb breathing treatment, Romazicon (sedative reversal agent) 0.2 mg IV, and a one-hundred (100%) non-rebreather mask, which was used to deliver seventy (70) to one-hundred (100) percent oxygen.

Interview with the Chief Operating Officer (COO), on 09/02/2022 at 12:45 PM, revealed his involvement with the incident was that he had an extensive conversation with Patient #1's daughter, via phone, on 05/06/2022 at 10:40 AM. The COO stated the family had a right to disclosure of the significant event that affected Patient #1, which was the suspected administration of unordered IV Ativan by RN #2. He stated medication error disclosure to patients/families was on a case-by-case basis. He stated he felt that medication administered without a Physician's Order warranted disclosure.

Interview with Physician #1, on 09/02/2022 at 2:14 PM, revealed RN #2 had requested a medication for agitation for Patient #1, on 04/30/2022, (she could not remember the time), but she denied the request. She stated Patient #1 was very elderly, which would indicate that diversionary activities should be tried first. She also stated Haldol was the medication she used for agitation, not Ativan, and would only order such medication after assessing the patient.

Interview with RN #1, on 09/12/2022 at 3:00 PM, revealed that on 04/30/2022, she had witnessed RN #2 administer something besides saline flush into Patient #1's IV line.

Based on observation, interview, facility incident report, facility policies and review of the facility's Governing Board By-Laws, it was determined the facility failed to have an effective Quality Assessment Process Improvement (QAPI) program in place to track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that included feedback and learning throughout the hospital and failed to ensure patients had the right to care in a safe setting, for one (1) of thirteen (13) sampled patients (Patient #1).

Review of the facility's investigative process (incident report) revealed, on 04/30/2022 between 7:00 AM to 8:00 AM, Registered Nurse (RN) #2 was observed to turn down Patient #1's oxygen saturation (O2 Sat) monitor (device which measures the oxygen level in a patient's blood) threshold to seventy-eight percent (78 %). However, the facility's Oxygen Monitoring policy revealed the requirement was for O2 Sats to be at least ninety-one percent (91%).

Observation of the facility's video, dated 04/30/2022, revealed RN #2 was observed outside Patient #1's room aspirating (drawing up) a liquid medication into a small syringe and then entered Patient #1's room. Review of Patient #1's medication orders revealed he/she did not have any liquid medications ordered except for saline solution flush to maintain the patency of Patient #1's intravenous (IV) line. Continued observation of the facility's video revealed RN #2 also entered Patient #1's room at that time with soft wrist restraints; however, Patient #1 did not have Physician's Orders for any type of restraints. Another RN (RN #1) observed RN #2 administer an IV medication to Patient #1, and when asked about the IV medication, RN #2 stated the medication was something "magic." Patient #1's physical condition deteriorated after the IV medication was administered to him/her, and when RN #1 checked on the patient he/she was drowsy, hypoxic (low O2 saturation level), with labored breathing and a slow heart rate. Patient #1 developed aspiration pneumonia and expired five (5) days later.

The findings include:

Review of the facility's Bylaws, revised 12/08/2020, Section 1.03-Responsibilities of the Board of Directors, revealed it was the responsibility of the facility's Board of Directors to oversee the quality of care and services provided to patients. Continued review of the Bylaws, Section 8.01-Medical Staff Organization and Governance, revealed the Medical staff were to be appointed by the Administrative Board and organized in such a manner as to provide for and maintain quality patient care.

Review of the facility's policy titled, "Patient Rights and Responsibilities", number VIII:1a, revised 06/2021, revealed patients had the right to receive care in a safe setting. Continued review revealed patients had the right to be free from restraints and seclusion, of any form, that was not medically necessary or used as a means of coercion, discipline, convenience or retaliation. Additional review revealed patients were to be free from restraints and seclusion, of any form, that were not medically necessary or were used as a means of coercion, discipline, convenience or retaliation.

Review of the facility's policy titled, "Medication Administration III-A-1", revised 07/2021, revealed medications were administered upon the receipt of a valid medication order by a Physician.

Review of the facility's policy titled, "Just Culture", number 11169.4, revised and effective 09/01/2021, revealed its purpose was: to confirm the facility's strong commitment to maintaining a "just culture"; to set clear expectations for staff and leaders as it related to safe practices and reporting any safety concerns; and to ensure open and honest communication in the event of an error. Continued review of the policy revealed its purpose additionally included to establish criteria and guidelines for determining appropriate action(s) to be taken if there was an error in judgement on the part of a staff member.

Interview with the Chief Operating Officer (COO), on 09/02/2022 at 12:45 PM, revealed RN #2 was suspended on 04/30/2022 and terminated on 05/05/2022. Continued interview revealed RN #2 was terminated for failure to follow the facility's policies and Nursing Standards of Care related to medication administration, bypassing the medication scanning process, and lowering the patient's Oxygen monitor threshold to 78% so it would not alarm.

Interview with Physician #1, on 09/02/2022 at 2:14 PM, revealed RN #2 had requested a medication for Patient #1 on 04/30/2022 for agitation; however, the Physician denied the RN's request. Continued interview revealed at ninety-seven (97) years of age, "you" would try diversionary activities first prior to medication. Further interview revealed Haldol (an antipsychotic medication) was the medication the Physician used, not Ativan (an anti-anxiety medication) and would only order such a medication after assessing the patient.

Interview, on 09/12/2022 at 1:25 PM, with the Patient Safety Officer (PSO), who completed part of the facility's investigation, revealed a root cause analysis (RCA) was conducted, regarding the 04/30/2022 incident, to identify any opportunities for process improvement. The PSO stated the findings were that the incident was an isolated incident that did not warrant unit or facility wide re-education.

Interview with the Executive Director of Outcomes, on 09/13/2022 at 1:25 PM, revealed she had been notified of the incident on 04/30/2022. However, she did not have any involvement in the facility's investigation.

The State Survey Agency (SSA) Surveyor requested to review the facility's Root Cause Analysis; however, the facility denied the request and did not answer direct questions regarding the RCA.

Interview, on 09/16/2022 at 1:50 PM, with the Chief Nursing Officer (CNO) revealed the facility's process was for an incident report to be completed and for her to be notified of the data and investigation results. Per the CNO, she did not actually conduct any of the investigation herself, and it was "JUST culture" for how "we" evaluate these situations. Continued interview revealed "JUST culture" empowered staff to speak up and that was how those things were trended when reports would not "pick it up". The CNO stated "we" did not find a process or knowledge deficit issue, it was a "poor judgement issue" by the RN. According to the CNO, on 04/30/2022, the House Supervisor and Administrator on Call notified her of the incident, and the nurse (RN #2) involved had not cooperated with the facility's investigation. Further interview revealed the fact that the incident was detected was the best evidence the facility's safety practices were in place. The CNO further stated during the facility's Human Resources (HR) discussion on 05/05/2022, it was determined it was a poor decision instead of lack of education because of RN #2's five (5) years of nursing experience and her not having had such issues previously. In addition, the CNO revealed RN #2 had a "clean" personnel record.

Interview, on 09/16/2022 at 1:50 PM, with the Executive Director of Outcomes revealed she had not received further updates after initial notification of the 04/30/2022 incident. Continued interview revealed her job description encompassed overseeing performance data for the hospital, getting specifics to types of registries, and overseeing infection control for the facility. Further interview revealed it was her practice in situations such as the 04/30/2022 event, to get involved when systemic issues were identified to improve a facility process. The Executive Director of Outcomes additionally stated "they" (facility's leadership) had all felt there had been no systemic issue involved with the incident; however, if anything had been identified then she would have become involved.

Interview, on 09/16/2022 at 2:53 PM, with the Chief Executive Officer (CEO) revealed he was over the operations of the facility, and at the "end of the day" was responsible. The CEO stated the facility's regulatory, risk, and quality personnel reported to him. Continued interview revealed he had "much" confidence in the facility's risk management processes and was informed of the output from councils. Per the CEO he had an "open-door policy", and the facility was a good facility and "We do things the right way." He stated he had been informed of the 04/30/2022 situation and the actions being taken, had given input if needed, and agreed with the processes being followed in this case. According to the CEO, if the processes being investigated involved the masses, "we" educate the masses. He stated, "I'm very proud of the nurses and the staff involved" and how they handled the incident. Further interview revealed the "JUST" culture allowed a night shift nurse to come forward with her concerns regarding the incident. Further interview revealed the data was analyzed for trending to make sure there were no problems, and incident reports were looked at for issues. In addition, the CEO stated the facility had support processes and he had confidence staff would report.

Refer to A-286

Based on interview, review of the facility's incident report, facility policies and review of the facility's Governing Board By-Laws, it was determined the facility failed to have an effective Quality Assessment Process Improvement (QAPI) program in place to track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that included feedback and learning throughout the hospital and ensure patient safety, for one (1) of thirteen (13) sampled patients (Patient #1).

Review of the facility's 04/30/2022 investigative process (incident report) information and video revealed, on 04/30/2022, between 7:00 AM to 8:00 AM, Registered Nurse (RN) #2 turned down Patient #1's oxygen saturation (O2 Sat) monitor's (measured the oxygen level in the patient's blood) threshold to seventy-eight percent (78%) instead of the facility's policy on Oxygen Monitoring requirement of maintaining the threshold at least ninety-one percent (91%).

Review of the facility's video, dated 04/30/2022, revealed RN #2 working outside Patient #1's room aspirating (drawing up) a liquid medication into a small syringe. Continued observation revealed RN #2 then entered Patient #1's room with the syringe and soft wrist restraints on her person. However, review of Patient #1's medical record revealed the patient had no liquid medication ordered except for a saline solution flush to maintain the patency of Patient #1's intravenous (IV) line. In addition, further medical record review revealed Patient #1 had no Physician's Orders for any type of restraints. RN #1 observed RN #2 administer an IV medication to Patient #1, and when asked about the IV medication, RN #2 stated the medication was something "magic." Patient #1's physical condition deteriorated after the IV medication was administered to him/her. When RN #1 checked on the patient he/she was drowsy, hypoxic (low O2 saturation level), with labored breathing and a slow heart rate. Patient #1 developed aspiration pneumonia and expired five (5) days later.

The findings include:

Review of the facility's Bylaws revised 12/08/2020, revealed Section 1.03-Responsibilities of the Board of Directors, noted it was the Board of Directors' responsibility to oversee the quality of care and services provided to patients. In addition, review of the Section 8.01-Medical Staff Organization and Governance of the Bylaws, revealed medical staff were to be appointed by the Administrative Board and organized in such a manner as to provide for and maintain quality patient care.

Review of the facility's policy titled, "Patient Rights and Responsibilities", number VIII:1a, revised 06/2021, revealed patients had the right to receive care in a safe setting. Continued review revealed patients had the right, and were to be free from restraints and, seclusion of any form, that was not medically necessary or was used as a means of coercion, discipline, convenience or retaliation.

Review of the facility's policy titled, "Management of Oxygen Therapy and Titration", number III-B55, revised 11/30/2021, revealed the monitoring threshold was to be set at ninety-one percent (91%) unless otherwise ordered by the Physician for patients who had oxygen administration orders.

Review of the facility's policy titled, "Just Culture", number 11169.4, revised and effective 09/01/2021, revealed its purpose was: to confirm the facility's strong commitment to maintaining a "just culture"; to set clear expectations for staff and leaders as it related to safe practices and reporting any safety concerns; and to ensure open and honest communication in the event of an error. Continued review of the policy revealed its purpose additionally included to establish criteria and guidelines for determining appropriate action(s) to be taken if there was an error in judgement on the part of a staff member.

Review of the facility's policy titled, "Medication Administration III-A-1", revised 07/2021, revealed medications were administered upon receipt of a valid medication order by a Physician. Continued review revealed the "practitioner" was to ensure the medication to be administered was: the correct medication; in-date; the correct dose; the correct dosage form; and, was administered at the correct time for the medication. Per policy review, barcode verification was used to ensure the medication's identity, strength and form, as well as the correct patient and time of administration. Further policy review revealed the barcode verification triggered documentation of the administration of a medication in the electronic medical record (EMR) or on the Medication Administration Record (MAR).

Interview, on 09/02/2022 at 12:45 PM, with the Chief Operating Officer revealed the facility suspended RN #2, on 04/30/2022, after the incident, and terminated the nurse on 05/05/2022. Per the Chief Operating Officer (COO), the facility terminated RN #2 for failure to follow its policies and the Nursing Standards of Care related to medication administration. Further interview revealed RN #2 was also terminated for bypassing the facility's medication scanning process, and for lowering Patient #1's oxygen monitor threshold to 78% so it would not alarm.

Interview, on 09/02/2022, at 2:14 PM, with Physician #1 revealed she had been contacted by RN #2 regarding a request for a medication for agitation for Patient #1 on 04/30/2022. However, continued interview revealed the Physician stated she denied RN #2's request for the medication. Per the Physician, at ninety-seven (97) years of age, diversionary activities should be tried first. The Physician further stated she used Haldol (antipsychotic medication) medication, and not the requested Ativan (anxiety medication). In addition, Physician #1 stated she would only order such a medication after assessing the patient.

Interview, on 09/12/2022 at 1:25 PM, with the Patient Safety Officer (PSO), who completed part of the facility's investigation, revealed a root cause analysis (RCA) was conducted for the 04/30/2022 incident to identify any opportunities for process improvement. However, further interview revealed the findings were that the 04/30/2022 incident had been an isolated incident that had not warranted unit or facility wide re-education.

The State Survey Agency (SSA) Surveyor requested to review the facility's Root Cause Analysis documentation; however, the request was denied. In addition, the facility did not answer direct questions regarding their RCA.

Interview, on 09/13/2022, at 1:25 PM, with the Executive Director of Outcomes, revealed she had been notified of the incident on 04/30/2022, but she had no involvement in the facility's investigation.

Interview, on 09/16/2022 at 1:50 PM, with the Chief Nursing Officer (CNO) revealed the facility's process was to complete an incident report, and for her to be notified of the data and investigation results. Per the CNO, she did not actually conduct any of the investigation herself. According to the CNO, the facility did not find a process or knowledge deficit issue after the investigation, and determined it was a poor judgement issue on the part of RN #2. She stated that on 04/30/2022, she was notified of the incident by the House Supervisor and Administrator on Call. Interview revealed the Nurse (RN #2) involved had not cooperated with the facility's investigation. Continued interview revealed the "JUST culture" was how the facility evaluated "these situations". Further interview revealed the facility's "JUST culture" empowered staff to speak up and that was how such things were trended when reports did not pick it up. The CNO further stated the fact that the incident was detected was the best evidence the safety practices were in place. In addition, the CNO revealed, on 05/05/2022, during the Human Resources (HR) discussion it was determined the 04/30/2022 incident had been a poor decision on the part of RN #2, instead of a lack of education because of her five (5) years of experience as a nurse and as she had not had those issues previously and had a "clean" personnel record.

Interview, on 09/16/2022 at 1:50 PM, with the Executive Director of Outcomes revealed she had not received further updates after receiving the initial notification of the 04/30/2022 incident. Per the Executive Director of Outcomes, her job description encompassed overseeing the facility's performance data, getting the specifics for the types of registries, and overseeing the infection control program for the facility. Interview further revealed it was her practice in situations such as this, to get involved when systemic issues were identified and to improve a process. In addition, she stated "they" (the facility's leadership) had all felt no systemic issue was involved related to the incident. The Executive Director of Outcomes further revealed if anything had been identified, she would have gotten involved.

Interview, on 09/16/2022 at 2:53 PM, with the Chief Executive Officer (CEO) revealed he was over operations of the facility, and at the end of the day, he was responsible. Per the CEO, the facility's regulatory, risk, and quality personnel reported to him. He stated he had "much" confidence in the facility's risk management processes and he was informed of the output from the councils, and he had an "open-door policy". According to the CEO, he had been informed of the 04/30/2022 situation and of the actions being taken. Continued interview revealed the CEO had given input if needed on the situation and he agreed with the processes being followed in the case. Continued interview revealed if the processes being investigated involved the masses, "we" educate the masses. The CEO stated he was "very proud of the nurses and the staff involved" and how they handled the situation. Further interview revealed the "JUST" culture had allowed a night shift nurse to come forward with her concerns regarding the 04/30/2022 incident. The CEO stated, "We are a good facility and we do things the right way." In addition, the CEO further revealed the data was analyzed for trending to make sure there were no problems and to look at incident reports for issues. Interview revealed he supported processes and had confidence that staff would report.

Based on interview, record review, review of the facility's incident report, review of the facility's job descriptions, and review of the facility's policies, it was determined the nursing staff failed to provide patients with quality care, a safe environment, and failed to ensure staff followed the facility's policies and procedures. This failure affected one (1) of thirteen (13) sampled patients (Patient #1).

Review of the facility's policy, "Patient Rights and Responsibilities", number VIII:1a, revised 06/2021, revealed patients had the right to receive care in a safe setting.

Review of the facility's policy titled, "Medication Administration III-A-1", revised 07/2021, revealed medications were administered upon the receipt of a valid medication order by a Physician. Further review revealed the practitioner was to ensure the medication was correct, in-date, correct dose, correct dosage form and correct time to administer the medication. Barcode verification was used to ensure the medication's identity, strength and form as well as the correct patient and time of administration. Per the policy, barcode verification triggered documentation of the administration in the electronic medical record (EMR) or the medication administration record (MAR).

Review of the facility's policy titled, "Just Culture", number 11169.4, revised and effective 09/01/2021, revealed the purpose was to 1) confirm the facility's strong commitment to maintaining a "just culture"; 2) set clear expectations for staff and leaders as it related to safe practices and reporting any safety concerns; 3) ensure open and honest communication in the event of an error; and 4) establish criteria and guidelines for determining appropriate action(s) to be taken if there was an error in judgement.

Review of facility's job descriptions for Registered Nurses, Charge Nurses, and the Chief Nursing Officer revealed those positions were responsible for providing patients with quality care, a safe environment, and following the facility's policies and procedures.

Review of the facility's video revealed, on 04/30/2022 at 7:32 AM, RN #2 stood outside Patient #1's room, aspirated (drew) liquid medication from a small vial into a small syringe and entered Patient #1's room. Interview with RN #1, on 09/12/2022 at 3:00 PM, revealed on the morning of 04/30/2022, she witnessed RN #2 administer something besides saline flush into Patient #1's IV line. However, review of Patient #1's medical record revealed he/she had no IV medication ordered at this time.

Review of the facility's incident report and timeline of events concerning Patient #1 revealed, approximately thirty (30) minutes after RN #2 entered Patient #1's room with the IV medication, the patient became somnolent, drowsy, and in respiratory distress with Oxygen saturation levels of seventy-eight percent (78%). Treatment included, according to Patient #1's medical record, Romazicon IV, a sedative reversal agent. Further review of Patient #1's medical record revealed the patient expired five (5) days later from aspiration pneumonia.

Interview with the Charge Nurse, on 08/29/2022 at 2:12 PM, and Chief Operating Officer, on 09/02/2022 at 12:45 PM, revealed they both stated a medication error occurred by RN #2 giving an unordered IV medication to Patient #1. They stated the supposition that RN #2 administered Ativan IV (sedative, anti-anxiety agent, benzodiazepine), a medication ordered for another patient, Patient #2, to Patient #1.

Refer to A-0405

Based on interview, record review, review of the facility's incident report, review of the facility's video, and review of the facility's policies, it was determined the facility failed to ensure medications were administered according to the orders of the Physician responsible for the patient's care and accepted standards of practice for one (1) of thirteen (13) sampled patients, Patient #1.

Registered Nurse (RN) #2, per the facility's video, dated 04/30/2022 at 7:32 AM, was outside Patient #1's room. She aspirated liquid medication from a small medication vial into a small syringe and entered Patient #1's room. However, Patient #1 did not have any intravenous (IV) medications ordered at that time, which would have been the route of administration for the medication from the syringe. Review of the medication administration record (MAR) for Patient #1 revealed he/she was not administered any IV medication. However, per interview, RN #1 observed RN #2 administer an IV medication to Patient #1.

RN #1 checked on Patient #1 again, prior to 8:00 AM, and the patient's condition had deteriorated. Patient #1 was drowsy, with labored breathing, hypoxic (low O2 saturation) and had a fast heart rate. Patient #1's treatment included applying a non-rebreather mask with one-hundred percent (100%) oxygen delivery and Romazicon (a sedative reversal agent). Patient #1 developed pneumonia and died five (5) days later.

The findings include:

Review of the facility's policy titled, "Medication Administration III-A-1", revised 07/2021, revealed medications were administered upon the receipt of a valid medication order by a Physician. Further review revealed the practitioner, who was to administer the medication, was to ensure the medication was correct, in-date, had the correct dose, had the correct dosage form, and had the correct time. The policy stated barcode verification was used to ensure the medication identity, strength and form, as well as the correct patient and time of administration. Per the policy, barcode verification triggered documentation of the administration in the electronic medical record (EMR) or the medication administration record (MAR).

Review of Patient #1's Emergency Department (ED) clinical record revealed the patient presented to the ED, on 04/28/2022 at 11:00 PM, after he/she had sustained a fall at home. The facility admitted Patient #1 to a telemetry unit (where the patient's heart and the O2 sat level was monitored), on 04/28/2022, for further work-up, related to the test results. Admitting diagnoses were Multiple Falls, Dehydration, and Hypernatremia (high blood sodium level).

Review of the SAFE report (the facility's incident report), dated 05/02/2022, revealed Registered Nurse (RN) #1, on 04/30/2022 at approximately 8:30 AM, reported her concerns to the unit Charge Nurse (CN) that Patient #1 had been given something that was causing his/her physical decline. Continued review of the SAFE report revealed RN #1 reported she was concerned because she had observed RN #2 administer a "suspicious" intravenous (IV) medication to Patient #1. Further review revealed Patient #1 did not have any IV medications ordered at that time.

Additional review of the SAFE report concerning Patient #1, dated 05/02/2022, revealed when RN #1 questioned RN #2 about what she had given Patient #1, all RN #2 would say was that it was "magic". Per the report, it was noted, prior to the administration of the unknown IV liquid, Patient #1 was alert, confused but responsive, and vital signs were stable (VSS). At approximately 7:30 AM to 8:00 AM, RN #1 decided to check on Patient #1 again, prior to leaving her shift. The report stated Patient #1 was found to be drowsy, hypoxic (low O2 saturation), and bradycardic (a slow heart rate of less than sixty (60) beats per minute.

Per the facility's video, dated 04/30/2022 at 7:32 AM, Registered Nurse (RN) #2 was outside Patient #1's room. RN #2 aspirated liquid medication from a small medication vial into a small syringe and entered Patient #1's room. However, per Patient #1's medical record, he/she did not have any intravenous (IV) medications ordered to be given that morning, and the medication administration record (MAR) did not show any IV medication was given.

Continued review of Patient #1's medical record, after the incident, revealed Physician #1 ordered Patient #1 to receive Lasix 40 mg IV (a diuretic), an Albuterol Duo-Neb breathing treatment, Romazicon (sedative reversal agent) 0.2 mg IV, and a one-hundred (100%) non-rebreather mask, which was used to deliver seventy (70) to one-hundred (100) percent oxygen.

RN #2 had been arrested, was in custody at the time of the investigation, and an interview was not possible.

Interview with the CN, on 08/29/2022 at 2:12 PM, revealed she was the 7:00 AM to 7:00 PM Charge Nurse (CN) the morning of 04/30/2022. She stated RN #1 came to her at approximately 8:00 AM or 8:30 AM, on 04/30/2022, with concerns that she had observed RN #2 administer Patient #1 something in his/her IV and then flush the line. Continued interview revealed when RN #1 asked RN #2 what she had given Patient #1, all RN #2 would say was it was something "magic". She stated she went to assess Patient #1, and he/she was lethargic with labored breathing. She stated RN #2 told her RN #2 had administered Patient #1's morning medications that included Buspar 30 milligrams (mg) by mouth (PO), Xanax 0.5 mg PO, and Zoloft 25 mg PO. She stated RN #2 did not mention any IV administration other than flushing the IV line with saline. She stated she questioned RN #2 again about what had been given Patient #1, and RN #2 again stated his/her morning medications. The CN stated she contacted Respiratory Therapy (RT) and the Physician (Physician #1). She stated RT responded, and Patient #1 was given a breathing treatment and put on a 100% non-rebreather mask. She stated Physician #1 ordered Lasix IV to be given. The CN also stated she realized that Patient #2 had an order for an IV sedative medication (Ativan, a benzodiazepine). She stated, when she checked the dispensing system (Omnicell), it indicated that RN #2 had signed out an Ativan 2 mg vial for Patient #2, at 7:24 AM on 04/30/2022, and it was documented that RN #2 had given Patient #2 the 0.25 mg Ativan IV at 8:49 AM. The CN stated it was the supposition that RN #2 had given Patient #1 the 0.25 mg of IV Ativan that had been signed out for Patient #2, which would account for Patient #1's somnolence and subsequent aspiration of pills and food.

Interview with the Chief Operating Officer (COO), also a member of the Governing Body, on 09/02/2022 at 12:45 PM, revealed his involvement with the incident was that he had an extensive conversation with Patient #1's daughter, via phone, on 05/06/2022 at 10:40 AM. The COO stated the family had a right to disclosure of the significant event that affected Patient #1, which was the suspected administration of unordered IV Ativan by RN #2. He stated medication error disclosure to patients/families was on a case-by-case basis. He stated he felt that medication administered without a Physician's order warranted disclosure.

Continued interview with the COO, on 09/02/2022 at 12:45 PM, revealed Patient #1's daughter had asked the questions, "Why did this happen? Was it a mistake?" He stated his answer to the daughter was that the facility did not receive much cooperation from RN #2 and did not have the answers to those questions. He stated, based on the information gathered during the investigation, the Kentucky Board of Nursing (KBN) was the best entity to report the lapse in Nursing Standards of Care by RN #2. Further, he stated there was a culture of Patient Safety at the facility. When asked to connect the dots between the medication administration, the aspiration, and the death of Patient #1, the COO's reply was that the clinical impression listed aspiration as the cause of death.

Interview with Physician #1, on 09/02/2022 at 2:14 PM, revealed RN #2 had requested a medication for agitation for Patient #1, on 04/30/2022, (she could not remember the time), but she denied the request. She stated Patient #1 was very elderly, which would indicate that diversionary activities should be tried first. She also stated Haldol was the medication she used for agitation, not Ativan, and would only order such medication after assessing the patient.

Interview with RN #1, on 09/12/2022 at 3:00 PM, revealed, on the morning of 04/30/2022, she had witnessed RN #2 administer something besides saline flush into Patient #1's IV line.

Interview with the Chief Nursing Officer (CNO), on 09/16/2022 at 1:50 PM, revealed the process when there was a reported incident, was to have a SAFE report completed, and she was notified of data and investigation results. She stated the investigation did not find a process or knowledge deficit issue, but determined it was a poor judgement issue with RN #2. She stated on 04/30/2022, the House Supervisor and Administrator On Call notified her of the incident. She stated the Nurse involved (RN #2) did not cooperate with the investigation. She stated "JUST Culture" empowered staff to speak up. She stated the fact that this was detected was the best evidence these safety practices were in place. She stated during HR's discussion of the incident, on 05/05/2022, it was determined it was a poor decision instead of lack of education because of her five (5) years of experience and an employee file that was clear, regarding these issues.

Interview with the Chief Executive Officer (CEO), on 09/16/2022 at 2:53 PM, revealed he was over the operations at the facility, and at the end of the day, he was responsible. He stated he had been informed of the situation with Patient #1 and actions being taken, and would provide input if needed.