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Based on facility policy, facility documents, medical record review and interview, the governing body failed to be effective in carrying out its responsibilities for the conduct of the hospital's staff and ensure incidences of fatal medication errors were thoroughly investigated and interventions developed to mitigate the risks of further fatal medication errors.

The failure of the Governing Body to mitigate risk factors associated with incidences of fatal medication errors resulted in a SERIOUS AND IMMEDIATE THREAT to the health and safety of all patients and placed them in IMMEDIATE JEOPARDY and risk of serious physical and psychological injuries.

The findings included:

1. The governing body failed to ensure incidences of fatal medication errors which were reported to the Chief Executive Officer and Chief Operating Officer were thoroughly investigated and interventions developed and implemented to ensure fatal medication errors did not recur.
Refer to A 145.

Based on hospital documents, policy review, medical record review and interview, the governing body (GB) failed to ensure incidences of fatal medication errors which were reported to the Chief Executive Officer (CEO) and Chief Operating Officer (COO)were investiaged and action plans were developed and implemented to mitigate the risks of fatal medication errors for 1 of 1 (Patient #1) patients who received a fatal medication error.

The failure of the Governing Body to ensure all incidences of fatal medication errors were thoroughly investigated and risk factors were mitigated resulted in a SERIOUS AND IMMEDIATE THREAT to the health and safety of all patients and places them in IMMEDIATE JEOPARDY and risk of serious injuries.

The findings included:

1. Review of the hospital's policy "Incident Reporting & Investigating" dated 10/24/18 and revised 1/13/19 revealed, "...It is the policy of (named hospital) that all incidents...be reported to the risk manager in a timely manner...to ensure that all incidents are properly investigated, and safety issues resolved...All incidents and injuries to patients...of the facility will be reported on the Incident Report. This report is to be completed by the person at the point of incident occurrence. The Incident Report will then be sent to the appropriate Department Manager for review and investigation of the incident. The Department Manager will investigate the incident and forward it on to the Risk Manager/administrator who will further investigate the incident and be aware of any corrective action that should take place to prevent future incidents..."

2. Medical record review for Patient #1 revealed the patient was admitted to Hospital #1's Psychiatric Geriatric unit on 12/4/2019 with a diagnoses that included Type 2 Diabetes (a disease that keeps the body from using insulin the way it should) and Dementia (a condition characterized by the impairment of at least 2 brain functions such as memory and judgement) unspecified (includes senile and pre-senile dementia) with behavioral disturbances.

Review of a physician's order dated 12/5/19 revealed Patient #1 was to receive the medication 7 units of Levemir insulin (Levimer is a long acting insulin that can affect your blood sugar for up to 24 hours) injected subcutaneous (Sub Q) in the morning.

3. Review of an Incident/Notification Report dated 12/6/19 at 11:25 AM for Patient #1 revealed Licensed Practical Nurse (LPN) #1 wrote she had administered a wrong dose of medication to Patient #1 (It was later determined in interview below that this report should have been dated 12/5/19). There was no documentation what the medication was or the dosage of the medication that was administered in error. The report documented the intervention was the patient was transferred to Hospital #2. The report documented the Director of Nursing (DON) was notified of the medication error on 12/6/19 at 11:30 AM. There was no documentation of a Supervisory review of the Incident Report, no documentation of Risk Management review of the Incident Report and no documentation the physician or family were notified of the medication error.

Review of a second Incident/Notification Report dated 12/6/19 at 7:15 AM revealed Patient #1 was found unresponsive with pinpoint pupils. Patient #1's blood sugar was checked and it was 31 (normal being 70 - 120). Patient #1 was transferred to Hospital #2 by emergency medical services (EMS). Patient #1 expired at Hospital #2 with the cause of death listed as hypoglycemia.

3. During an interview on 1/13/2020 at 12:57 PM, LPN #1 stated she had administered Patient #1 an incorrect dose of Levemir on 12/5/19. LPN #1 stated, "...I gave him 100 units of Levemir instead of 7 units around 8:00 AM. It was transcribed wrong on the MAR by the night nurse (named LPN #2) when he was admitted the night before..."
LPN #1 stated she had discovered she had given the wrong dose that same day maybe an hour after giving the Levemir. LPN #1 stated she had told the DON and was told by the DON to fill out an incident report and turn it in to Risk Management.
LPN #1 verified she had completed an incident report but had not documented what the medication error was.

4. During an interview on 1/14/2020 at 12:20 PM the Risk Manager verified she had received an Incident Notification Report from LPN #1 on 12/6/19. She stated she was aware of a medication error but was not aware Patient #1 had received Levemir 100 units instead of 7 units as ordered on 12/5/19 until this surveyor told her. The Risk Manager verified the date of incident was dated 12/6/19 at 11:25 AM, but the incident report should have been dated 12/5/19 when the incident occurred.

5. During an interview on 1/15/19 at 10:05 AM, the DON stated she was made aware of the Levemir medication error for Patient #1 on 12/6/19. She stated Patient #1 had already been transferred to named hospital #2 on 12/6/19 when she arrived to work.

The DON stated that later that morning LPN #1 told her she thought she had given an insulin dose in error. The DON stated the LPN had given 100 units instead of 7 units. The DON stated she told LPN #1 to fill out an incident report and give it to the risk manager. The DON stated she had reported to the Chief Executive Officer, who is no longer employed at the hospital and the Chief Operation Officer.

When asked where the insulin comes from that is administered to patients the DON stated insulin is kept in stock in the facility's refrigerator and when a physician orders insulin, the nurse would go to the refrigerator stock and get the amount ordered, label the patient's name on it and administer the insulin.

When asked what process or system change had been implemented to ensure the fatal medication error did not recur, the DON stated the nurses had been educated on medication administration safety.

There was no documentation the GB, CEO, COO, Risk Manager or DON thoroughly investigated the fatal medication error, determined a root cause, examined the nursing process of dispensing and labeling medications, developed and implemented interventions to ensure the fatal medication error would not recur or implemented a monitoring process to mitigate the risk of fatal medication errors.
Refer to A 395.

Based on standards of practice, hospital policies and procedures, observation and interview, the hospital's nursing services failed to ensure the nursing services were provided in a safe and efficient manner in order to deliver quality care to its patients and avoid fatal medication errors.

The failure of the hospital's nursing services to provide safe, and efficient quality of care resulted in 1 of 1 (Patient #1) receiving a fatal dose of the medication Levemir insulin and placed all patients in a SERIOUS and IMMEDIATE THREAT and placed them in IMMEDIATE JEOPARDY and risk of serious injuries and/or death.

The findings included:

1. The hospital failed to ensure nursing standards of practice and medication policies and procedures were followed and implemented during medication administration of the drug Levemir insulin which resulted in the fatality of Patient #1.
Refer to A 395.

Based on standards of nursing practice, hospital policy, medical record review, Emergency Medical Services (EMS) trip report, incident reports and interview, the hospital's nursing service failed to provide quality oversight and evaluation of the medical needs for 1 of 1 (Patient #1) patient reviewed who received an incorrect and fatal dose of insulin.

The failure of nursing services to ensure medications were administered following standards of practice and hospital policies and procedures to prevent physical harm to patients resulted in a fatal medication error for Patient #1 and placed all in-patients of Hospital #1's psychiatric geriatric unit in a SERIOUS and IMMEDIATE THREAT to their health and safety and placed them in IMMEDIATE JEOPARDY for risk of serious injuries and/or death.

The findings included:

1. Review of the "Lippincott Manual of Nursing Practice 10th Edition" documented, "...NURSING ALERT: Unusual dosages or unfamiliar drugs should always be confirmed with the health care provider and pharmacist before administration. The nurse is ultimately accountable for the drug administered..."

2. Review of the standards of practice, Can a Registered Nurse Dispense Medications, found at www.registerednurses.org revealed, "Dispensing of medication can be described as preparing, packaging, labeling and then providing the medication to a patient or their representative to be taken... The 2019 Lawbook for Pharmacy... dispense... means and refers to the furnishing of drugs or devices directly to a patient by a physician, dentist, optometrist, podiatrist, or veterinarian, or by a certified nurse midwife... There is no reference to registered nurse or licensed nurse for the act of dispensing...".

3. Review of the hospital's policy High Alert/Risk Medications dated 12/8/19 revealed, "...A list of high alert/risk medications shall be maintained and special precautions shall be used throughout the medication use process to reduce the risk of errors related to ordering and prescribing, transcribing, preparation, storage, distribution and administration ...high-alert/risk categories... Insulin, subcutaneous... High-alert/risk medications are drugs that have an increased risk of causing significant harm to a patient when used in error... to reduce the overall risk of errors of high-risk medications... Double-check processes shall be implemented, used and maintained. During the Admission Medication Reconciliation Process. During transcriptions from the Admission Medication Reconciliation to the MAR [Medication Administration Record]. Prior to administering the medication to the patient and with any dosage change..."

4. Medical record review for Patient #1 revealed the patient was admitted to the hospital's Psychiatric Geriatric unit on 12/4/2019 with diagnoses which included Type 2 Diabetes (a disease that keeps the body from using insulin the way it should) and unspecified Dementia (a condition characterized by impairment of at least two brain functions, such as memory loss and judgement) with behavioral disturbances (behavioral abnormalities are common and include symptoms such as depression, anxiety psychosis, agitation, aggression, dis-inhibition, and sleep disturbances).

The Nursing Admission Assessment dated 12/4/19 at 8:10 PM revealed Patient #1 was confused, disoriented, weak, ambulatory with assistance of a wheelchair and required total assistance and constant 1:1 (one caregiver to one patient) supervision for behavioral disturbances and immediate assistance to complete self-care tasks.

Review of a hand written Medication Administration Record (MAR) dated 12/4/19 revealed LPN #2 transcribed for Patient #1 to receive "Levemir insulin (long acting insulin that can effect the blood sugar for up to 24 hours after the injection is given) 100 units/milliliters (mls) subcutaneous (SQ) every morning. There was no documentation of the amount of Levimer insulin Patient #1 was to receive each morning.

Review of the pharmacy printed MAR dated December 2019 revealed an order for Levemir insulin 100 units/ml and to administer 7 units SQ every morning.

On the nursing handwritten MAR by the date 12/5/19, Licensed Practical Nurse (LPN) #1 signed her initials as administering Levemir insulin to Patient #1 at 8:00 AM. There was no documentation of the amount of insulin Patient #1 received.

On the Pharmacy printed MAR by the date 12/5/19, LPN #1 signed her initials as the nurse who administered Levemir to Patient #1. There was no documentation on this MAR of the amount of insulin that was administered to the patient.

Review of the Nursing Flowsheet dated 12/5/19 revealed Licensed Practical Nurse (LPN) #4 documented the following about Patient #1:
At 8:15 AM the patient was resting in bed.
At 11:30 AM, "...pt. resting in bed. This nurse continues to attempt to awaken pt. Pt wakes up and is verbal but falls back to sleep..."
At 11:40 AM Patient #1 was placed in a wheelchair and taken to the dayroom.

Review of the Psychiatric Technician (Psych Tech) #1 observation form dated 12/5/19 revealed Patient #1's level of observation was 1:1 with every (q) 15 minutes documentation of location and behavior as follows:
From 7:00 AM to 11:15 AM Patient #1 was observed in his room sleeping. There was no documentation the patient ate breakfast.
From 11:30 AM to 11:45 AM Patient #1 was observed in the dining room sleeping and calm. The Psych Tech documented the patient ate 75% of the lunch meal.
From 12:00 PM to 12:30 PM Patient #1 was observed in the dayroom sleeping and actively engaged. There was no documentation what the patient was actively engaged in doing while sleeping.
From 12:45 PM to 2:45 PM Patient #1 was observed in the dayroom sleeping and calm.
There was no documentation from 3:00 PM to 10:45 PM what the patient was doing and no documentation the patient during this time. There was no documentation the patient voided from 7:00 AM on 12/5/19 to 7:45 AM 12/6/19 when the patient was transferred out to Hospital #2.
LPN #1 and Registered Nurse (RN) #3 signed the form as accurate.

Review of the 12/6/19 Nursing Flowsheet for Patient #1 revealed RN #2 documented at 7:15 AM, "...Psych tech notified RN staff that patient was not responding appropriately-mid sternal rubs with unresponsiveness. Pin-point pupils noted bilaterally. Glucometer check revealed level of 31 ...". Emergency Medical Service (EMS) was notified.

Review of the EMS report dated 12/6/19 at 7:21 AM revealed when EMS arrived Patient #1 was found lying in the bed unresponsive, but breathing. EMS documented, "...Staff reported they had found him in bed and checked his sugar [blood glucose level] and it was 31 [normal being 70 - 120]. Staff gave glucose rectally PTA [prior to arrival] they advised us that the patient is a diabetic and the last time anyone had saw him eat anything was at 8:00 last night [this however was not documented in any of the nursing or Psych Tech notes]. Pt did not respond to the treatment and remained unresponsive...We checked his BGL [blood glucose level] and it was 73...We attempted 5 IV [Intravenous] sticks but were unsuccessful..."
EMS administered 1 milligram of Glucagon (liquid sugar) intramuscular (IM) to Patient #1.
Patient #1 did not respond and remained unresponsive during transport to Hospital #2.

Review of Hospital #2's emergency department (ED) note dated 12/6/19 revealed Patient #1 arrived by EMS with symptoms of Hypoglycemia and, "the onset was unknown". Patient was, "drowsy, moans with tactile stimulations, pupils sluggish...". The ED physician documented Patient #1 had been discharged from Hospital #2 two days ago Urinary Tract Infection (UTI)/Bacteremia.

Patient #1 was admitted to the Intensive Care Unit (ICU) with diagnoses that included Drug Induced Encephalopathy, Hypoglycemia and Dementia.

Review of Hospital #2's physician's progress note dated 12/12/19 revealed Patient #1's encephalopathy, "could be to prolonged hypoglycemia".

On 12/13/19 the physician documented, "...etiology of encephalopathy is believed to be hypoglycemia..."

On 1/7/2020 Patient #1 expired at Hospital #2. The physician documented the cause of death was, "hypoglycemia, urinary tract infection and bacteremia".

5. Review of an Incident/Notification Report dated 12/6/19 11:25 AM for Patient #1 revealed Licensed Practical Nurse (LPN) #1 wrote she had administered a wrong dose of medication to Patient #1. There was no documentation what the medication was or the dosage of the medication that was administered in error. The report documented the intervention was the patient was transferred to Hospital #2. The report documented the Director of Nursing (DON) was notified on the medication error on 12/6/19 at 11:30 AM. There was no documentation of the LPN's Supervisory review of the Incident Report, no documentation of Risk Management review of the Incident Report and no documentation the physician or family were notified of the medication error.

Review of a second Incident/Notification Report dated 12/6/19 at 7:15 AM revealed Patient #1 was found unresponsive with pinpoint pupils. Patient #1's blood sugar was checked and it was 31 (normal being 70 - 120). Patient #1 was transferred to Hospital #2 by emergency medical services (EMS). Patient #1 expired at Hospital #2 with the cause of death listed as hypoglycemia.

6. During an interview on 1/13/2020 at 12:57 PM, LPN #1 stated she had given Patient #1 an incorrect dose of Levemir on 12/5/19. LPN #1 stated, "...I gave him 100 units of Levemir instead of 7 units around 8:00 AM. It was transcribed wrong on the MAR by the night nurse [named LPN #2] when he was admitted the night before..."
LPN #1 stated she had discovered she had given the wrong dose that day "maybe an hour after giving it [the Levemir insulin].
LPN #1 stated she had told the DON, and was told by the DON to fill out an incident report and to turn it in to Risk Management.
LPN #1 verified she had completed an incident report but had not documented what the dose or the medication.
LPN #1 stated she had not notified the physician or family of the medication error.
When asked why she had initialed Levemir insulin as being administered on 2 different MARs, LPN #1 stated she had documented on the written MAR and then the pharmacy generated MAR came up and she signed her initials on that as well.
LPN #1 stated she had only given the Levemir one time on 12/5/19 at 8:00 AM. S
LPN #1 stated Patient #1 didn't receive the AM dose of Levimer insulin on 12/6/19.
LPN #1 stated she did not know what happened to the Levemir insulin after she had administered the wrong dose.

7. During a telephone interview on 1/15/2020 at 8:53 AM, LPN #2 verified she had incorrectly transcribed the Levemir insulin order on the MAR for Patient #1. LPN #2 stated, "...I was in orientation, another nurse [named LPN #3] was writing on the medication admission papers. I transcribed that onto the MAR, since I was in orientation that nurse was supposed to check behind me and make sure there were no errors. Basically I transcribed wrong...".
LPN #2 stated she gave the written MAR back to the nurse (LPN #3) but she was unaware if the nurse had checked behind her for accuracy. LPN #2 stated she was hired in November 2019.

8. During a telephone interview on 1/15/2020 at 9:30 AM, LPN #3 stated she did not remember if she was orienting another nurse on 12/4/19. LPN #3 stated she had not gone back to review the MAR that LPN #2 had transcribed on 12/4/19. LPN #3 stated the hospital was short staffed and she had been pulled to work on the floor as a tech.

9. During an interview on 1/14/2020 at 10:40 AM, Psych Tech #1 verified Patient #1 was sleeping and did not eat breakfast or mid-morning snack on 12/5/19. Psych Tech #1 stated she was told by LPN #4 to keep Patient #1 in bed. Psych Tech #1 stated Patient #1 had not voided during her shift. Psych Tech #1 stated she could not remember if she had notified the nurse the patient had not voided, but stated the nurse had signed off her documentation.

10. During an interview on 1/15/2020 at 10:05 AM, the DON stated she had been made aware of the insulin mediation error for Patient #1 on 12/6/19 after the patient had been transferred to the hospital. The DON stated, "...On the 6th [12/6/19] I arrived after he [Patient #1] had already been transferred to the hospital [Hospital #2]. Later that morning [named LPN #1] stated she thought she had made an insulin error. [Named LPN #1] stated she had given 100 units instead of 7 units. I told her to fill out an incident report and give it to the risk manager. I told [named Chief Executive Officer (CEO)] and [named Chief Operating Officer (COO)]. I looked at the MAR and it was handwritten. I did not see a preprinted MAR...".
The DON stated she had not checked the Levemir insulin Flexpen that had been used to administer the Levemir to Patient #1 stating, "...I'm not sure if it was sent back to pharmacy or if it was disposed of. I'm not sure what the protocol is for returning insulin to pharmacy or disposing of insulin...".
The DON verified there was no documentation Patient #1's physican or family had been notified of the medication error. The DON stated she did not know if the EMS or if Hospital #2 had been made aware that Patient #1 had received Levemir 100 units instead of 7 units the day before (12/5/19).
When asked what system or process changes had been put into place since the incidence of administering 100 units of instead of 7 units of insulins and the DON stated, the DON stated the nurses had been educated on medication administration safety.

11. During an interview on 1/14/2020 at 12:20 PM, when asked about the Acute Care Patient Observation Forms the Risk Manager stated she reviewed the forms on each shift 3 times a week. The Risk Manager stated she was not aware the forms were incomplete for Patient #1.