CRITICAL
(J)
📢 Someone Reported This
A family member, employee, or ombudsman was alarmed enough to file a formal complaint
Immediate Jeopardy (IJ) - the most serious Medicare violation
Free from Abuse/Neglect
(Tag F0600)
Someone could have died · This affected 1 resident
Based on record review, interviews, hospital record review, hospice record review, facility documentation and policy review, the facility failed to ensure one (Resident #1) of five residents reviewed ...
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Based on record review, interviews, hospital record review, hospice record review, facility documentation and policy review, the facility failed to ensure one (Resident #1) of five residents reviewed for insulin administration was free from neglect as evidenced by neglecting to give insulin per physician orders, neglecting to notify the provider immediately after an insulin overdose, and neglecting to monitor the resident after a medication error.
Resident #1 had Diabetes Mellitus Type II and had physician orders for Levemir U-100 (long-acting) insulin, 5 units (u) to be given one time daily at 9:00 a.m. He also had orders for Novolog 100 unit (u)/milliliter (ml) (short-acting) insulin to be given per a sliding scale (based on blood glucose measurement) before each meal and at bedtime.
On 3/12/23 at 5:20 a.m. Staff A, Registered Nurse (RN) checked Resident #1's blood glucose level and charted it was 327. Per the sliding scale, this called for the administration of 12u of Novolog. The nurse neglected to check the medication label on the insulin vial and instead administered 12u of Levemir insulin to Resident #1. Staff A, RN did not notify the physician of this medication error immediately and she proceeded to administer Resident #1 12u of Novolog insulin.
Staff A, RN did not notify a provider of the medication error until after finishing her shift, at 7:15 a.m., approximately 2 hours after the resident was administered an overdose of insulin. The Nurse Practitioner told the nurse to monitor the resident closely and have Glucagon (a medication that raises blood glucose levels and is used to treat hypoglycemia) ready if needed.
A late entry progress note written recorded on 3/12/23 at 7:36 p.m. by Staff A, RN showed she checked the blood glucose level of Resident #1 approximately 1 hour after the insulin overdose and the reading was 84. The next documented blood glucose level was not until approximately 11:45 a.m. when the resident was found to be unresponsive by Staff B, RN with a blood glucose level of 58.
During an interview with Staff B, RN on 4/5/23 at 2:50 p.m., she confirmed she took over care of Resident #1 at 7:00 a.m. She said she had to give her other assigned residents their medications, but she stuck her head in the room of Resident #1 a couple of times and he was sleeping but arousable.
There was no documentation showing Resident #1 had vital signs or blood glucose monitored from approximately 6:20 a.m. until 11:45 a.m.
Resident #1 was sent to the hospital where he was found to be hypoglycemic (having blood glucose levels less than 70 milligrams (mg)/deciliter(dL)) and having seizure like activity secondary (caused by) to hypoglycemia. The resident was intubated (had a breathing tube placed down the throat into the windpipe to allow a machine to assist with breathing,) placed on life support, and admitted to the Intensive Care Unit. He was later transferred to an in-patient Hospice, where he passed away on 3/27/23.
This failure created a situation that resulted in a worsened condition and death to Resident #1 and resulted in the determination of Immediate Jeopardy beginning on 3/12/23. After surveyor review and verification, it was determined the actions implemented by the facility achieved compliance on 3/17/23.
The findings of Immediate Jeopardy were determined to be corrected on 3/17/23.
Findings included:
A review of Resident #1's medical record showed an admission date of 1/18/23 with diagnoses that included Type II Diabetes Mellitus without complications, Neurocognitive disorder with Lewy bodies, and Metabolic encephalopathy (primary.)
A review of Resident #1's Minimum Data Set (MDS) Five Day Assessment Section C, Cognitive Patterns, showed the resident had a Brief Interview for Mental Status Score (BIMS) score of 99, indicating he was unable to complete the interview. The assessment showed the resident had short- and long-term memory problems and his cognitive skills for daily decision making was severely impaired. Section I, Active Diagnoses showed the resident had Diabetes Mellitus and Non-Alzheimer's Dementia but did not have a seizure disorder or epilepsy. The MDS was dated 3/10/23.
A review of Resident #1's physician orders related to diabetes revealed:
-1/18/23 Insulin aspart (Novolog) 100 unit (u)/milliliter (ml) (70-30) per sliding scale:
If blood sugar is less than 70, call MD.
If blood sugar is 141-180, give 3 units.
If blood sugar is 181-220, give 5 units.
If blood sugar Is 221-260, give 8 units.
If blood sugar is 261-300, give 10 units.
If blood sugar is 301-350, give 12 units.
If blood sugar is greater than 350, give 14 units.
Subcutaneous. Before meals and at bedtime.
6:00 a.m., 11:15 a.m., 5:00 p.m., 9:00 p.m.
-1/18/23 Levemir U-100 Insulin solution; 100 u/ml; amt: 5 units subcutaneous 1 time daily. Give 5 units subcutaneous once per day for Type II Diabetes Mellitus without complications. Once in morning, 9:00 a.m.
-1/18/23 Glucagon (HCL) Emergency Kit. 1 milligram (mg) IM (intramuscular) injection as directed PRN (as needed) for hypoglycemia.
-3/6/23 Side Effects: Hyperglycemia/Insulin Medication Use. Observe resident closely for side effects: confusion, sweating, SOB (shortness of breath), fruity breath, weakness, fatigue, increased thirst, increased urination, shakiness, pale skin, lethargy. Every shift: Days 7:00 a.m.-7:00 p.m. Nights 7:00 p.m.-7:00 a.m.
-3/6/23 Side Effects: Monitor resident for s/s (signs/symptoms) of hypoglycemia. Monitor for shaking/trembling, fast heart rate, increased hunger, sweating, confusion/difficulty concentrating, dizziness. Every shift: Days 7:00 a.m.-7:00 p.m. Nights 7:00 p.m.-7:00 a.m.
A review of Resident #1's Medication Administration Record (MAR) showed the residents blood glucose levels and insulin administered were as follows:
3/11/23 6:00 a.m. blood glucose was 212 milligram (mg)/deciliter (dL) with 5 units of Novolog insulin administered per sliding scale order.
3/11/23 between 7:00-11:00 a.m. Levemir U-100, 5 units was administered as ordered.
3/11/23 11:15 a.m. blood glucose was 99 mg/dL with no Novolog insulin administered per sliding scale order.
3/11/23 5:00 p.m. blood glucose was 114 mg/dL with no Novolog insulin administered per sliding scale order.
3/12/23 6:00 a.m. blood glucose was 327 mg/dL with 12 units of Novolog insulin administered per sliding scale. (Documented on 3/12/23 at 5:20 a.m.)
3/12/23 11:15 a.m. blood glucose was 58 mg/dL with no Novolog insulin administered per sliding scale order. (Documented on 3/12/23 at 1:01 p.m.)
A review of Resident #1's medical record revealed the following care plan:
Category: Health Related Complications
Resident #1 has a diagnosis of Diabetes and is at risk for unstable blood glucose as evidenced by hyperglycemia with signs and symptoms of increased thirst, headaches, blurred vision, increased urination, fatigue, weight loss, blood sugars >180 mg/dl and hypoglycemia with signs and symptoms of shakiness, dizziness, sweating, intense hunger, irritability, anxiety, decreased level of consciousness, headache.
Interventions include blood glucose monitoring as ordered, document non-compliance of diet recommendations, medications as ordered, notify MD with significant changes in signs and symptoms, and observe for/report signs and symptoms of hypoglycemia: shakiness, dizziness, sweating, intense hunger, irritability, anxiety, decreased level of consciousness, headache.
Created 1/18/23.
A review of Resident #1's medication record showed the following progress notes:
A Nursing Note dated 3/12/23 5:45 a.m. (Recorded as late entry on 3/12/23 at 7:36 p.m.) showed Resident's BS [blood sugar] at 0545 am med pass recorded 327. Both Levemir 12u and Novolog 12 units given. Levemir order is for 5u to be given between 7-11 a.m. Rechecked in 1 hour and BS 84. Medication error and BS levels reported to on call nurse manager [Staff C, Licensed Practical Nurse (LPN)/Unit Manager (UM)] and ARNP for Medical Director. Received order to hold am dose of Levemir, monitor resident and have glucagon on standby if needed. New orders and BS checks reported to oncoming nurse [Staff B, Registered Nurse (RN).] Resident is awake and alert without s/s [signs and symptoms] of hypoglycemia. Dietary trays on hall and trays passing at this time. The Nursing note was entered by Staff A, Registered Nurse (RN).
A Nursing Note dated 3/12/23 1:20 p.m. showed Client observed in bed resting with eyes closed. Blood glucose checked: 58. Rechecked to verify BG [Blood Glucose]: 56, 52. Glucagon 1g injected subq [subcutaneously]. Client breathing was regular at 14 respirations per min [minute]. Sternal rub performed and patient continued to be unresponsive. Pupils pinpoint and BG dropped to 38. Another nurse called 911 while I stayed with the patient. Blood pressure measured manually: BP 70/30 pulse 66. The reading was lower than in the early AM which was 116/60 pulse 70. BG went up to 68 and then back down to 54. Paramedics arrived at 12:55 and patient left at 1300. Client was cool to touch and unresponsive when the paramedics arrived but continued to have steady respiration at 14 bpm. MD notified at 1300 gave ok to send to ER for eval and tx [treatment], and family notified at 1305. The Nursing Note was entered by Staff B, RN.
A review of the facility documentation, dated 3/12/23, described the medication error as Nurse mistakenly administered Levemir 12U instead of Novolog 12U, nurse administered Novolog 12U after realizing she gave Levemir 12U. After administering both insulins, nurse contacted MD on call. It showed the correct order was sliding scale Novolog 12u. The type of error was listed as incorrect dose and incorrect medication. The report showed the resident became hypotensive and hypoglycemic around 12:45, resident was unresponsive but maintained respirations and heart rate. The immediate interventions were described as Glucagon 1g injected subq as ordered. Res [resident] blood sugar rechecked. Resident remained unresponsive. 911 activated and res transported to ER [emergency room] via stretcher around 12:55. The report shows the following blood sugar levels:
3/12/23 5:15 a.m. Blood sugar 327 mg/dL
3/12/23 12:04 p.m. Blood sugar 58 mg/dL
A phone interview was conducted with Staff A, RN on 4/10/23 at 8:48 a.m. She confirmed she was taking care of Resident #1 the morning of 3/12/23 and made a medication error. She said the resident had been on her wing for a while and she was familiar with him. She said the resident was confused but could converse, saying hello and talking some. She said he did not always recognize family; he was incontinent and needed full care. She added the resident was able to self-propel in his wheelchair with his feet once he had help getting up.
Staff A, RN said during her shift running from 3/11/23 7:00 p.m. to 3/12/23 7:00 a.m., the resident had stayed up very late, until 2:00 a.m. She said he did not want to stay in bed and was restless. She said there was no increased confusion, the resident was at his baseline. She said he had a history of falls, so she got him up to a wheelchair for a couple of hours, then put him back to bed.
Staff A, RN said when insulin comes from the pharmacy, the vial is in the insulin box with a label on it and it is in a plastic bag that also has a label. Those bags are placed in the medication cart. She said when she pulled the bag out of the drawer, she read the bag, name, and checked everything. She confirmed she did not check the label on the box, she only checked the bag. After she administered the first insulin based on the sliding scale, she came back to the cart to put the vial in the box and bag, she realized she had given the wrong insulin. Staff A, RN said she gave the resident 12u of Levemir long-acting insulin instead of Novolog short-acting insulin. She said she panicked and stated, in my mind his blood sugar was still 327. The long acting was not going to bring down his blood sugar now. She said she went ahead and administered the Novolog within a couple of minutes of the Levemir. Staff A, RN said it was 5:30 a.m. and she could not call the doctor yet as she thought it was too early. She said, that is my error, I gave both. She said right after change of shift, approximately 7:15 a.m., she called and talked to the Nurse Practitioner (NP) for the Medical Director and the on-call manager, Staff C, LPN/UM
Staff A, RN said the NP told her to monitor the resident closely, hold the morning dose of Levemir and have Glucagon on hand.
An interview was conducted with Staff C, LPN/UM. on 4/17/23 at 12:29 p.m. Staff C, LPN/UM confirmed she was the on-call manager on 3/12/23. She said Staff A, RN called her about 7:20 a.m. and informed her she gave the wrong insulin to Resident #1. Staff C, LPN/UM said she asked Staff A, RN if she had talked to the doctor and Staff A, RN told her no. She said she told Staff A, RN to contact the doctor and follow his orders. She said Staff A, RN only told her she gave the resident long-acting insulin. She said she was not told the resident was also given short-acting insulin at the same time. Staff C, LPN/UM said she then received a call about 2:30 p.m. from Staff B, RN (the nurse caring for Resident #1 on the day shift 3/12/23) saying Resident #1's blood sugar had dropped. Staff B, RN asked her if she was aware of the extra insulin and Staff C, LPN/UM told her she was not aware. Staff B, RN notified her they gave Resident #1 Glucagon, and he was sent to the hospital. Staff C, LPN/UM said she notified the Director of Nursing (DON), and the DON notified the administrator. Staff C, LPN/UM said around 5:00 p.m. the day the error was made (3/12/23) she, along with other management, came in and began doing medication cart audits.
During an interview with the DON on 4/18/23 at 4:31 p.m. she confirmed she came to the facility on 3/12/23 to complete medication cart audits with Staff C, LPN/UM.
An interview was conducted with Staff B, RN on 4/5/23 at 2:50 p.m. She said she came on shift at 6:45 a.m. on 3/12/23 and received shift report from Staff A, RN between 7:00-7:15 a.m. She said Staff A, RN informed her she gave Resident #1 both long-acting and short-acting insulin that morning. She said Staff A, RN had not called the doctor at that point. Staff B, RN said Staff A, RN called the provider for the first time after she gave her report, approximately 7:15 a.m. She said Staff A, RN told her the NP gave orders to monitor the resident and have glucagon ready. Staff B, RN said she found out later that day Staff A, RN did not inform the NP she gave both the long and short-acting insulin; she only told her about the incorrect dose of Levemir. Staff B, RN said she checked Resident #1's blood glucose level between 8:30-9:00 a.m. and it was in the 90's. She said she did not document the blood glucose check in the resident's medical record because there was no place to enter it. Staff B, RN did say she could have documented it under vitals, but she did not think about that at the time. She said right before lunch trays came out, which is around 12, she rechecked Resident #1s' blood glucose and it was 58. She said she had another nurse (Staff D, LPN) come in and they verified again, it was 56 then 52. Staff B, RN said she administered Glucagon to the resident then checked his blood glucose again. She said it was then 38, so they called 911. She said she continually checked blood glucose levels until paramedics arrived. She said he went up to 68 then dropped back down in the 50's. When asked about monitoring the resident between 9:00 a.m. and 11:45 a.m., she said she was giving all of her other residents their medication. She said she looked in the room a couple of times and the resident was sleeping. She said he was snoring but arousable. A review of records did not reveal any documentation showing Resident #1 was assessed or monitored from 9:00 a.m. until 11:45 a.m.
An interview was conducted with Staff D, LPN on 4/18/23 at 1:50 p.m. Staff D, LPN stated I did not know [Resident #1] very well but I do know he was very confused and a fall risk, very impulsive. That day he was sent out I helped the nurse. She came to me and said she checked his sugar [blood glucose] and it was low. She said she couldn't get him to take anything by mouth and I told her well give him the sugar s*** (expletive) [glucagon] we have in our medication carts, so she did that, and she came to me and said it's even lower now and I don't know what to do. I told her you need to call 911 and get them here. They couldn't even bring him back either. He was breathing and his heart was beating but he was just unresponsive.
An interview was conducted with Staff E, Nurse Practitioner (NP) on 4/12/23 at 8:42 a.m. The NP stated she does not physically go to this facility and did not know this resident, but she was covering on-call the morning of 3/12/23. She said she does not recall exactly when the nurse called or what she told her specifically. She said she was told Resident #1 had received the wrong dose of insulin and had gotten double what he should have. The NP said she told the nurse to have Glucagon ready to go, monitor the resident and if his blood glucose drops low and you cannot get him out of it, to call her back. The NP said she never heard anything else from the facility.
She said Staff A, RN just told her she gave too much insulin; she did not get into details. She said she does not believe Staff A, RN mentioned giving both insulins at the same time. She said she does not remember if she gave specific monitoring parameters, but her standard with low or high blood sugar is they should be checked at least every 2 hours. When asked if it was okay that the resident's blood glucose level was only checked between 8:30/9:00 a.m. then again at 11:45/12:00 p.m. she said, absolutely not. The NP said she did not have any notes related to this call.
An interview was conducted with the Regional Consultant Pharmacist on 4/17/23 at 10:33 a.m. She said the onset of action for Levemir is between 3-4 hours after administration and the duration of action can range from 5/6 hours up to 18 hours depending on body weight and other factors specific to the resident. She said the onset of action for Novolog is around 12-18 minutes and the duration of action is between 3-7 hours depending on body weight, age, and other factors specific to the resident. The pharmacist said around 3-4 hours after both insulins were administered to the resident would have most likely been the point, they were at the highest effect together and the blood sugar could drop low. The pharmacist said 12u of Levemir is not an unusual dose, however because insulin is so dependent, for Resident #1 individually it may have been. She said typically the Novolog and Levemir are not administered at the same time, there would be some spacing. The pharmacist said in the incidence of an insulin overdose, the resident's blood glucose should be checked every 15 minutes and if it is below 70, interventions should have been implemented, such as giving Glucagon or IV glucose. She said the onset of Glucagon is 5-20 minutes and most protocols show that if Glucagon is given and the blood glucose is still below 70 you proceed to the next step, in this case send resident to the hospital.
The pharmacist said the consultant pharmacist that visited the facility had not identified anything unusual in the facility regarding insulins or other medications. The pharmacist had previously conducted medication cart audits and did not find any issues.
An interview was conducted with the facility Medical Director on 4/10/23 at 11:43 a.m. He said the nurse gave Resident #1 12u of rapid acting insulin and 12u or long-acting insulin. He confirmed he was not called that morning. He said the NP told the nurse to monitor the resident and have Glucagon ready. The doctor said he not did have any notes showing he saw Resident #1 and stated, It is very weird. (The Medical Director and NHA both confirmed there was no documentation to show the resident was seen in the facility by a primary provider.)
The doctor said when a medication error is made the nurse should let the provider and their immediate supervisor know right then. He said he or the on-call should have been called that morning when the error happened.
A review of the local Fire Rescue Patient Care Report showed the 911 call for Resident #1 was received on 3/12/23 at 12:38 p.m. Emergency Medical Services (EMS) arrived at the patient at 12:50 p.m. The reports showed the chief complaint for Resident #1 was Diabetic-Hypoglycemia and the primary symptom was altered mental status. The resident's blood glucose was 48 and his blood pressure was 119/68 at 12:56 p.m. The Fire Rescue Narrative note showed found 77 yom [year old male] lying in his hospital bed. Pt [patient] responded to painful stimuli, Pt equal chest rise and fall, ABC's [airway, breathing, circulation] intact, skin WNL [within normal limits,] lung sounds clear, and perrl [pupils equal, round, reactive to light.] Staff stated pt was assessed and BGL [blood glucose level] was 39. Staff stated they gave 1g of Glucagon with no improvement leading them to call [Fire rescue.] Pt was carried to the stretcher and secured with all appropriate straps, rails x 2 and semi-Fowlers [position] for pt comfort and safety. Pt. further assessed and vitals WNL. Pt. BGL 48. Pt IV established and 250ml of D10 [Dextrose 10% solution] given with an improved response. Staff stated pt has Lewy Body dementia and only has a verbal response as his baseline. Pt continued to improve throughout the entire call. Pt transported to [local hospital] per request. Pt monitored enroute with no notable changes. Fire Rescue arrived at the hospital at 1:13 p.m. on 3/12/23.
A review of hospital records, dated 3/12/23, for Resident #1 showed the Chief Complaint as From [facility]: Pt found to be hypoglycemic this morning, given 1 g of glucagon by staff, pt blood sugar in the 40's for EMS given 250ml of D10. Pt hx: dementia. The History or Present Illness revealed Patient presents to the emergency department acutely altered. Patient presents from [facility] with report from EMS indicated the patient was hypoglycemic. He was given glucagon, but this did not improve his blood sugar. When EMS arrived his blood sugar was in the 40s. They subsequently gave D10. He was unresponsive for them the entirety of their time with the patient. I subsequently called patient's emergency contact, [family member.] She states the patient does have Lewy body dementia. However, normally is not unresponsive and is alert. Patient does arrive with a DO NOT RESUSCITATE order and I specifically clarified with the [family member] if he would want to be intubated [have a breathing tube placed down the throat into the windpipe to allow a machine to assist with breathing.] She thinks that that [sic] would be in accordance with his wishes and he would be amenable to intubation. She does not know of any seizure history, which I asked because the patient did have rhythmic eye movements and contracted positioning that made me concerned for possible seizures. I did also call the facility and discussed with the nurse taking care of him. She does confirm that patient is normally able to push himself around in wheelchair and is typically alert. She does state that this morning was an acute change for patient. Patient was unresponsive for her the entire time as well. Patient on arrival unresponsive and unable to answer any questions for me. The record also revealed the resident had recurrent episodes of hypoglycemia on arrival and was again given D50 and a D10 drip was started. Despite the correction of the hypoglycemia, the patient continued to be altered. There was a strong suspicion for possible seizure in the setting of rhythmic movements of the eyes and contracted positioning. The patient was hypothermic on arrival and a forced air warming blanket was used. An intubation was performed and completed without any hypoxia.
A continued review of hospital records showed an assessment performed on Resident #1 on 3/12/23 at 1:40 p.m. The assessment showed the resident's level of consciousness as obtunded, meaning he had a lessened interest in the environment and slowed response to stimulation. The Coma Scale showed Resident #1 has no eye-opening response and no verbal response. The resident did have a motor response of flexion withdrawal. His overall coma score was a 6.
According to the Centre for Neuro Skills, the Glasgow Coma Scale provides an assessment of coma and impaired consciousness. The total scores were explained as follows: 90% less than or equal to 8 are in a coma, greater than or equal to 9 not in coma, 8 is the critical score, 9-12= moderate severity, and greater than or equal to 13=minor injury. (Accessed on 4/20/23 at https://www.neuroskills.com/education-and-resources/glasgow-coma-scale/)
The hospital records, dated 3/12/23 showed after reexamination in the emergency room Resident #1 was found to have a urinary tract infection which could potentially be contributory but does not truthfully explain why the patient was seizing. Following intubation and paralysis wearing off, patient without further rhythmic activity of his eyes and no longer posturing his upper extremities leading me to believe that his seizure likely is stopped. Patient was admitted to the Intensive Care Unit.
The hospital Discharge Summary, dated 3/20/23, showed Patient was weaned off sedation, however patient was not waking up and minimally responsive. Therefore, he remained intubated due to concerns of ability to protect airway. Palliative care consulted. Patient was discharged to inpatient hospice facility pending bed availability. The discharge diagnoses included acute hypoxic respiratory failure, requiring mechanical ventilation, acute encephalopathy, likely multifactorial secondary to hypoglycemia, UTI (Urinary tract infection,) possible seizure with underlying Lew body dementia. Low suspicion of meningitis and possible seizure secondary to hypoglycemia. The patient's overall prognosis is terminal with no meaningful recovery.
A review of the in-patient Hospice record showed the resident arrived to their facility on 3/20/23 at 1:30 p.m. He was non-responsive to spoken name, his eyes were wide open with no track, and his facial features were relaxed. A hospice note dated 3/20/23 at 4:58 p.m. showed Provider ordering ME [medical examiner] Reportable Death: Patient has been deemed ME case per [medical doctor] for reported medical error of inappropriate insulin at a nursing facility leading to profound hypoglycemia. The record revealed Resident #1's time of death at 12:16 p.m. on 3/27/23.
An interview was conducted on 4/17/23 at 12:17 p.m. with a family member of Resident #1. The family member confirmed the resident passed away at the in-patient Hospice facility but was unable to discuss any further details at the time.
A facility policy titled Abuse, Neglect, Exploitation, Mistreatment, Misappropriation of Property, and Injury of Unknown Source Prevention (ANEMMI), undated, was reviewed. The policy showed the following:
Intent: The facility will develop and operationalize policies and procedures for screening and training employees, protection of residents and for the prevention, identification, investigation, and reporting of abuse, neglect, mistreatment, and misappropriation of property; to include the use of physical or chemical restraints. The purpose is to assure that the facility is doing all that is within its control to prevent occurrences and protect its residents.
Procedure:
I. Screening:
-Screen potential employees for a history of abuse, neglect, or mistreating residents. This includes attempting to obtain information from previous employers and/or current employers and checking with the appropriate licensing boards and registries.
-The facility must not employ or otherwise engage individuals who:
i. Have been found guilty of abuse, neglect, exploitation, misappropriation of property, or mistreatment by a court of law;
ii. Have had a finding entered into the State nurse aide registry concerning abuse, neglect, exploitation, mistreatment or residents or misappropriation of their property; or
iii. Have a disciplinary action in effect against his or her professional license by a state licensure body as a result of a finding of abuse, neglect, exploitation, mistreatment of residents or misappropriation of resident property.
-The facility will report to the State nurse aide registry or licensing authorities any knowledge it has of actions by a court of law against an employee, which would indicate unfitness for service as a nurse aide or other facility staff.
II. Training:
-Train employees, through orientation and on-going sessions on issues related to abuse prohibition practices such as:
*Prohibiting and preventing all forms of abuse, neglect, misappropriation of resident property, and exploitation;
*Appropriate interventions to deal with aggressive and/or catastrophic reactions of residents;
*Recognizing signs of abuse, neglect, exploitation, and misappropriation of resident property, such as physical or psychosocial indicators;
*Reporting abuse, neglect, exploitation, and misappropriation of resident property, including injuries of unknown sources, and to whom and when staff and others must report their knowledge related to any alleged violation without fear of reprisal;
*Understanding behavioral symptoms of residents that may increase the risk of abuse and neglect and how to respond. These symptoms, include, but are not limited to, the following:
1. Aggressive and/or catastrophic reactions of residents;
2. Wandering or elopement-type behaviors;
3. Resistance to care;
4. Outbursts or yelling out; and
5. Difficulty in adjusting to new routines or staff.
*How to recognize signs of burnout, frustration and stress that may lead to abuse;
*In addition to the freedom from abuse, neglect, and exploitation requirements in § 483.12, facilities must also provide training to their staff that at a minimum educates staff on:
1. § 483.95(c) Activities that constitute abuse, neglect, exploitation, and misappropriation of resident property as set forth at § 483.12.
2. § 493.95(c) Procedures for reporting incidents of abuse, neglect, exploitation, or the misappropriation of resident property.
3. §493.95(c) Dementia management and resident abuse prevention.
III. Prevention:
-Provide residents, families, and staff information on how and to whom they may report concerns, incidents, and grievances without the fear of retribution; and provide feedback regarding the concerns that have been expressed.
-Ensuring the health and safety of each resident with regard to visitors such as family members or resident representatives, friends, or other individuals subject to the resident's right to deny or withdraw consent at any time and to reasonable clinical and safety restrictions;
-Identifying, correcting, and intervening in situations in which abuse, neglect, exploitation, and/or misappropriation of resident property is more likely to occur. This includes the implementation of policies that address the deployment of trained and qualified, registered, licensed, and certified staff on each shift in sufficient numbers to meet the needs of the residents, and assure that the staff assigned have knowledge of the individual residents' care needs and behavioral symptoms, if any.
-Assuring that residents are free from neglect by having the structures and processes to provide needed care and services to all residents, which includes, but is not limited to, the provision of a facility assessment to determine what resources are necessary to care for its residents competently;
[TRUNCATED]
CRITICAL
(J)
📢 Someone Reported This
A family member, employee, or ombudsman was alarmed enough to file a formal complaint
Immediate Jeopardy (IJ) - the most serious Medicare violation
Deficiency F0726
(Tag F0726)
Someone could have died · This affected 1 resident
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on record review, interviews, hospital record review, hospice record review, facility documentation and policy review, the...
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**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on record review, interviews, hospital record review, hospice record review, facility documentation and policy review, the facility failed to provide competent staff, which ensured residents reviewed for insulin administration received medication as ordered and follow-up monitoring occurred after a medication error. The facility failed to ensure one (Resident #1) of five residents were assessed and monitored for approximately five hours following identification of an insulin medication error and failed to notify the provider of a medication error in a timely manner as evidenced by a lapse of approximately two hours after the medication error occurred.
This failure created a situation that resulted in a worsened condition and death to Resident #1 and resulted in the determination of Immediate Jeopardy beginning on 3/12/23. After surveyor review and verification, it was determined the actions implemented by the facility achieved compliance on 3/17/23.
Findings included:
Reference citation F600
A review of Resident #1's medical record showed an admission date of 1/18/23 with diagnoses that included Type II Diabetes Mellitus without complications, Neurocognitive disorder with Lewy bodies, and Metabolic encephalopathy (primary.)
A review of Resident #1's Minimum Data Set (MDS) Five Day Assessment Section C, Cognitive Patterns, showed the resident had a Brief Interview for Mental Status Score (BIMS) score of 99, indicating he was unable to complete the interview. The assessment also showed the resident had short- and long-term memory problems and his cognitive skills for daily decision making was severely impaired. Section I, Active Diagnoses showed the resident had Diabetes Mellitus and Non-Alzheimer's Dementia but did not have a seizure disorder or epilepsy. The MDS was dated 3/10/23.
A review of Resident #1's physician orders related to diabetes revealed:
-1/18/23 Insulin aspart (Novolog) 100 unit (u)/milliliter (ml) (70-30) per sliding scale:
If blood sugar is less than 70, call MD.
If blood sugar is 141-180, give 3 units.
If blood sugar is 181-220, give 5 units.
If blood sugar Is 221-260, give 8 units.
If blood sugar is 261-300, give 10 units.
If blood sugar is 301-350, give 12 units.
If blood sugar is greater than 350, give 14 units.
Subcutaneous. Before meals and at bedtime.
6:00 a.m., 11:15 a.m., 5:00 p.m., 9:00 p.m.
-1/18/23 Levemir U-100 Insulin solution; 100 u/ml; amt: 5 units subcutaneous 1 time daily. Give 5 units subcutaneous once per day for Type II Diabetes Mellitus without complications. Once in morning, 9:00 a.m.
-1/18/23 Glucagon (HCL) Emergency Kit. 1 milligram (mg) IM (intramuscular) injection as directed PRN (as needed) for hypoglycemia.
-3/6/23 Side Effects: Hyperglycemia/Insulin Medication Use. Observe resident closely for side effects: confusion, sweating, SOB (shortness of breath), fruity breath, weakness, fatigue, increased thirst, increased urination, shakiness, pale skin, lethargy. Every shift: Days 7:00 a.m.-7:00 p.m. Nights 7:00 p.m.-7:00 a.m.
-3/6/23 Side Effects: Monitor resident for s/s (signs/symptoms) of hypoglycemia. Monitor for shaking/trembling, fast heart rate, increased hunger, sweating, confusion/difficulty concentrating, dizziness. Every shift: Days 7:00 a.m.-7:00 p.m. Nights 7:00 p.m.-7:00 a.m.
A review of Resident #1's Medication Administration Record (MAR) showed the residents blood glucose levels and insulin administered were as follows:
3/11/23 6:00 a.m. blood glucose was 212 milligram (mg)/deciliter (dL) with 5 units of Novolog insulin administered per sliding scale order.
3/11/23 between 7:00-11:00 a.m. Levemir U-100, 5 units was administered as ordered.
3/11/23 11:15 a.m. blood glucose was 99 mg/dL with no Novolog insulin administered per sliding scale order.
3/11/23 5:00 p.m. blood glucose was 114 mg/dL with no Novolog insulin administered per sliding scale order.
3/12/23 6:00 a.m. blood glucose was 327 mg/dL with 12 units of Novolog insulin administered per sliding scale. (Documented on 3/12/23 at 5:20 a.m.)
3/12/23 11:15 a.m. blood glucose was 58 mg/dL with no Novolog insulin administered per sliding scale order. (Documented on 3/12/23 at 1:01 p.m.)
A review of Resident #1's medical record revealed the following care plan:
Category: Health Related Complications
Resident #1 has a diagnosis of Diabetes and is at risk for unstable blood glucose as evidenced by hyperglycemia with signs and symptoms of increased thirst, headaches, blurred vision, increased urination, fatigue, weight loss, blood sugars >180 mg/dl and hypoglycemia with signs and symptoms of shakiness, dizziness, sweating, intense hunger, irritability, anxiety, decreased level of consciousness, headache.
Interventions include blood glucose monitoring as ordered, document non-compliance of diet recommendations, medications as ordered, notify MD with significant changes in signs and symptoms, and observe for/report signs and symptoms of hypoglycemia: shakiness, dizziness, sweating, intense hunger, irritability, anxiety, decreased level of consciousness, headache.
Created 1/18/23.
A review of Resident #1's medication record showed the following progress notes:
A Nursing Note dated 3/12/23 5:45 a.m. (Recorded as late entry on 3/12/23 at 7:36 p.m.) showed Resident's BS [blood sugar] at 0545 am med pass recorded 327. Both Levemir 12u and Novolog 12 units given. Levemir order is for 5u to be given between 7-11 a.m. Rechecked in 1 hour and BS 84. Medication error and BS levels reported to on call nurse manager [Staff C, Licensed Practical Nurse (LPN)/Unit Manager (UM)] and ARNP for Medical Director. Received order to hold am dose of Levemir, monitor resident and have glucagon on standby if needed. New orders and BS checks reported to oncoming nurse [Staff B, Registered Nurse (RN).] Resident is awake and alert without s/s [signs and symptoms] of hypoglycemia. Dietary trays on hall and trays passing at this time. The Nursing note was entered by Staff A, Registered Nurse (RN).
A Nursing Note dated 3/12/23 1:20 p.m. showed Client observed in bed resting with eyes closed. Blood glucose checked: 58. Rechecked to verify BG [Blood Glucose]: 56, 52. Glucagon 1g injected subq [subcutaneously]. Client breathing was regular at 14 respirations per min [minute]. Sternal rub performed and patient continued to be unresponsive. Pupils pinpoint and BG dropped to 38. Another nurse called 911 while I stayed with the patient. Blood pressure measured manually: BP 70/30 pulse 66. The reading was lower than in the early AM which was 116/60 pulse 70. BG went up to 68 and then back down to 54. Paramedics arrived at 12:55 and patient left at 1300. Client was cool to touch and unresponsive when the paramedics arrived but continued to have steady respiration at 14 bpm. MD notified at 1300 gave ok to send to ER for eval and tx [treatment], and family notified at 1305. The Nursing Note was entered by Staff B, RN.
A review of the facility documentation, dated 3/12/23, described the medication error as Nurse mistakenly administered Levemir 12U instead of Novolog 12U, nurse administered Novolog 12U after realizing she gave Levemir 12U. After administering both insulins, nurse contacted MD on call. It showed the correct order was sliding scale Novolog 12u. The type of error was listed as incorrect dose and incorrect medication. The report showed the resident became hypotensive and hypoglycemic around 12:45 p.m., resident was unresponsive but maintained respirations and heart rate. The immediate interventions were described as Glucagon 1g injected subq as ordered. Res [resident] blood sugar rechecked. Resident remained unresponsive. 911 activated and res transported to ER [emergency room] via stretcher around 12:55. The report shows the following blood sugar levels:
3/12/23 5:15 a.m. Blood sugar 327 mg/dL
3/12/23 12:04 p.m. Blood sugar 58 mg/dL
A phone interview was conducted with Staff A, RN on 4/10/23 at 8:48 a.m. She confirmed she was taking care of Resident #1 the morning of 3/12/23 and made a medication error. She said the resident had been on her wing for a while and she was familiar with him. She said the resident was confused but could converse, saying hello and talking some. She said he did not always recognize family; he was incontinent and needed full care. She added the resident was able to self-propel in his wheelchair with his feet once he had help getting up.
Staff A, RN said during her shift running from 3/11/23 7:00 p.m. to 3/12/23 7:00 a.m., the resident had stayed up very late, until 2:00 a.m. She said he did not want to stay in bed and was restless. She said there was no increased confusion, the resident was at his baseline. She said he had a history of falls, so she got him up to a wheelchair for a couple of hours, then put him back to bed.
Staff A, RN said when insulin comes from the pharmacy, the vial is in the insulin box with a label on it and it is in a plastic bag that also has a label. Those bags are placed in the medication cart. She said when she pulled the bag out of the drawer, she read the bag, name, and checked everything. She confirmed she did not check the label on the box, she only checked the bag. After she administered the first insulin based on the sliding scale, she came back to the cart to put the vial in the box and bag, she realized she had given the wrong insulin. Staff A, RN said she gave the resident 12u of Levemir long-acting insulin instead of Novolog short-acting insulin. She said she panicked and stated, in my mind his blood sugar was still 327. The long acting was not going to bring down his blood sugar now. She said she went ahead and administered the Novolog within a couple of minutes of the Levemir. Staff A, RN said it was 5:30 a.m. and she could not call the doctor yet as she thought it was too early. She said, that is my error, I gave both. She said right after change of shift, approximately 7:15 a.m., she called and talked to the Nurse Practitioner (NP) for the Medical Director and the on-call manager, Staff C, LPN/UM
Staff A, RN said the NP told her to monitor the resident closely, hold the morning dose of Levemir and have Glucagon on hand.
An interview was conducted with Staff C, LPN/UM. on 4/17/23 at 12:29 p.m. Staff C, LPN/UM confirmed she was the on-call manager on 3/12/23. She said Staff A, RN called her about 7:20 a.m. and informed her she gave the wrong insulin to Resident #1. Staff C, LPN/UM said she asked Staff A, RN if she had talked to the doctor and Staff A, RN told her no. She said she told Staff A, RN to contact the doctor and follow his orders. She said Staff A, RN only told her she gave the resident long-acting insulin. She said she was not told the resident was also given short-acting insulin at the same time. Staff C, LPN/UM said she then received a call about 2:30 p.m. from Staff B, RN (the nurse caring for Resident #1 on the day shift 3/12/23) saying Resident #1's blood sugar had dropped. Staff B, RN asked her if she was aware of the extra insulin and Staff C, LPN/UM told her she was not aware. Staff B, RN notified her they gave Resident #1 Glucagon, and he was sent to the hospital. Staff C, LPN/UM said she notified the Director of Nursing (DON), and the DON notified the administrator. Staff C, LPN/UM said around 5:00 p.m. the day the error was made (3/12/23) she, along with other management, came in and began doing medication cart audits.
During an interview with the DON on 4/18/23 at 4:31 p.m. she confirmed she came to the facility on 3/12/23 to complete medication cart audits with Staff C, LPN/UM.
An interview was conducted with Staff B, RN on 4/5/23 at 2:50 p.m. She said she came on shift at 6:45 on 3/12/23 and received shift report from Staff A, RN between 7:00-7:15 a.m. She said Staff A, RN informed her she gave Resident #1 both long-acting and short-acting insulin that morning. She said Staff A, RN had not called the doctor at that point. Staff B, RN said Staff A, RN called the provider for the first time after she gave her report, approximately 7:15 a.m. She said Staff A, RN told her the NP gave orders to monitor the resident and have glucagon ready. Staff B, RN said she found out later that day Staff A, RN did not inform the NP she gave both the long and short-acting insulin; she only told her about the incorrect dose of Levemir. Staff B, RN said she checked Resident #1's blood glucose level between 8:30-9:00 a.m. and it was in the 90's. She said she did not document the blood glucose check in the resident's medical record because there was no place to enter it. Staff B, RN did say she could have documented it under vitals, but she did not think about that at the time. She said right before lunch trays came out, which is around 12, she rechecked Resident #1s' blood glucose and it was 58. She said she had another nurse (Staff D, LPN) come in and they verified again, it was 56 then 52. Staff B, RN said she administered Glucagon to the resident then checked his blood glucose again. She said it was then 38, so they called 911. She said she continually checked blood glucose levels until paramedics arrived. She said he went up to 68 then dropped back down in the 50's. When asked about monitoring the resident between 9:00 a.m. and 11:45 a.m., she said she was giving all of her other residents their medication. She said she looked in the room a couple of times and the resident was sleeping. She said he was snoring but arousable. A review of records did not reveal any documentation showing Resident #1 was assessed or monitored from 9:00 a.m. until 11:45 a.m.
An interview was conducted with Staff D, LPN on 4/18/23 at 1:50 p.m. Staff D, LPN stated I did not know [Resident #1] very well but I do know he was very confused and a fall risk, very impulsive. That day he was sent out I helped the nurse. She came to me and said she checked his sugar [blood glucose] and it was low. She said she couldn't get him to take anything by mouth and I told her well give him the sugar s*** (expletive) [glucagon] we have in our medication carts, so she did that, and she came to me and said it's even lower now and I don't know what to do. I told her you need to call 911 and get them here. They couldn't even bring him back either. He was breathing and his heart was beating but he was just unresponsive.
An interview was conducted with Staff E, Nurse Practitioner (NP) on 4/12/23 at 8:42 a.m. The NP stated she does not physically go to this facility and did not know this resident, but she was covering on-call the morning of 3/12/23. She said she does not recall exactly when the nurse called or what she told her specifically. She said she was told Resident #1 had received the wrong dose of insulin and had gotten double what he should have. The NP said she told the nurse to have Glucagon ready to go, monitor the resident and if his blood glucose drops low and you cannot get him out of it, to call her back. The NP said she never heard anything else from the facility.
She said Staff A, RN just told her she gave too much insulin; she did not get into details. She said she does not believe Staff A, RN mentioned giving both insulins at the same time. She said she does not remember if she gave specific monitoring parameters, but her standard with low or high blood sugar is they should be checked at least every 2 hours. When asked if it was okay that the resident's blood glucose level was only checked between 8:30/9:00 a.m. then again at 11:45/12:00 p.m. she said, absolutely not. The NP said she did not have any notes related to this call.
An interview was conducted with the Regional Consultant Pharmacist on 4/17/23 at 10:33 a.m. She said the onset of action for Levemir is between 3-4 hours after administration and the duration of action can range from 5/6 hours up to 18 hours depending on body weight and other factors specific to the resident. She said the onset of action for Novolog is around 12-18 minutes and the duration of action is between 3-7 hours depending on body weight, age, and other factors specific to the resident. The pharmacist said around 3-4 hours after both insulins were administered to the resident would have most likely been the point, they were at the highest effect together and the blood sugar could drop low. The pharmacist said 12u of Levemir is not an unusual dose, however because insulin is so dependent, for Resident #1 individually it may have been. She said typically the Novolog and Levemir are not administered at the same time, there would be some spacing. The pharmacist said in the incidence of an insulin overdose, the resident's blood glucose should be checked every 15 minutes and if it is below 70, interventions should have been implemented, such as giving Glucagon or IV glucose. She said the onset of Glucagon is 5-20 minutes and most protocols show that if Glucagon is given and the blood glucose is still below 70 you proceed to the next step, in this case send resident to the hospital.
The pharmacist said the consultant pharmacist that visited the facility had not identified anything unusual in the facility regarding insulins or other medications. The pharmacist had previously conducted medication cart audits and did not find any issues.
An interview was conducted with the facility Medical Director on 4/10/23 at 11:43 a.m. He said the nurse gave Resident #1 12u of rapid acting insulin and 12u or long-acting insulin. He confirmed he was not called that morning. He said the NP told the nurse to monitor the resident and have Glucagon ready. The doctor said he did not have any notes showing he saw Resident #1 and stated, It is very weird. (The Medical Director and NHA both confirmed there was no documentation to show the resident was seen in the facility by a primary provider.)
The doctor said when a medication error is made the nurse should let the provider and their immediate supervisor know right then. He said he or the on-call should have been called that morning when the error happened.
A review of the local Fire Rescue Patient Care Report showed the 911 call for Resident #1 was received on 3/12/23 at 12:38 p.m. Emergency Medical Services (EMS) arrived at the patient at 12:50 p.m. The reports showed the chief complaint for Resident #1 was Diabetic-Hypoglycemia and the primary symptom was altered mental status. The resident's blood glucose was 48 and his blood pressure was 119/68 at 12:56 p.m. The Fire Rescue Narrative note showed found 77 yom [year old male] lying in his hospital bed. Pt [patient] responded to painful stimuli, Pt equal chest rise and fall, ABC's [airway, breathing, circulation] intact, skin WNL [within normal limits,] lung sounds clear, and perrl [pupils equal, round, reactive to light.] Staff stated pt was assessed and BGL [blood glucose level] was 39. Staff stated they gave 1g of Glucagon with no improvement leading them to call [Fire rescue.] Pt was carried to the stretcher and secured with all appropriate straps, rails x 2 and semi-Fowlers [position] for pt comfort and safety. Pt. further assessed and vitals WNL. Pt. BGL 48. Pt IV established and 250ml of D10 [Dextrose 10% solution] given with an improved response. Staff stated pt has Lewy Body dementia and only has a verbal response as his baseline. Pt continued to improve throughout the entire call. Pt transported to [local hospital] per request. Pt monitored enroute with no notable changes. Fire Rescue arrived at the hospital at 1:13 p.m. on 3/12/23.
A review of hospital records, dated 3/12/23, for Resident #1 showed the Chief Complaint as From [facility]: Pt found to be hypoglycemic this morning, given 1 g of glucagon by staff, pt blood sugar in the 40's for EMS given 250ml of D10. Pt hx: dementia. The History or Present Illness revealed Patient presents to the emergency department acutely altered. Patient presents from [facility] with report from EMS indicated the patient was hypoglycemic. He was given glucagon, but this did not improve his blood sugar. When EMS arrived his blood sugar was in the 40s. They subsequently gave D10. He was unresponsive for them the entirety of their time with the patient. I subsequently called patient's emergency contact, [family member.] She states the patient does have Lewy body dementia. However, normally is not unresponsive and is alert. Patient does arrive with a DO NOT RESUSCITATE order and I specifically clarified with the [family member] if he would want to be intubated [have a breathing tube placed down the throat into the windpipe to allow a machine to assist with breathing.] She thinks that that [sic] would be in accordance with his wishes and he would be amenable to intubation. She does not know of any seizure history, which I asked because the patient did have rhythmic eye movements and contracted positioning that made me concerned for possible seizures. I did also call the facility and discussed with the nurse taking care of him. She does confirm that patient is normally able to push himself around in wheelchair and is typically alert. She does state that this morning was an acute change for patient. Patient was unresponsive for her the entire time as well. Patient on arrival unresponsive and unable to answer any questions for me. The record also revealed the resident had recurrent episodes of hypoglycemia on arrival and was again given D50 and a D10 drip was started. Despite the correction of the hypoglycemia, the patient continued to be altered. There was a strong suspicion for possible seizure in the setting of rhythmic movements of the eyes and contracted positioning. The patient was hypothermic on arrival and a forced air warming blanket was used. An intubation was performed and completed without any hypoxia.
A continued review of hospital records showed an assessment performed on Resident #1 on 3/12/23 at 1:40 p.m. The assessment showed the resident's level of consciousness as obtunded, meaning he had a lessened interest in the environment and slowed response to stimulation. The Coma Scale showed Resident #1 has no eye-opening response and no verbal response. The resident did have a motor response of flexion withdrawal. His overall coma score was a 6.
According to the Centre for Neuro Skills, the Glasgow Coma Scale provides an assessment of coma and impaired consciousness. The total scores were explained as follows: 90% less than or equal to 8 are in a coma, greater than or equal to 9 not in coma, 8 is the critical score, 9-12= moderate severity, and greater than or equal to 13=minor injury. (Accessed on 4/20/23 at https://www.neuroskills.com/education-and-resources/glasgow-coma-scale/)
The hospital records, dated 3/12/23 showed after reexamination in the emergency room Resident #1 was found to have a urinary tract infection which could potentially be contributory but does not truthfully explain why the patient was seizing. Following intubation and paralysis wearing off, patient without further rhythmic activity of his eyes and no longer posturing his upper extremities leading me to believe that his seizure likely is stopped. Patient was admitted to the Intensive Care Unit.
The hospital Discharge Summary, dated 3/20/23, showed Patient was weaned off sedation, however patient was not waking up and minimally responsive. Therefore, he remained intubated due to concerns of ability to protect airway. Palliative care consulted. Patient was discharged to inpatient hospice facility pending bed availability. The discharge diagnoses included acute hypoxic respiratory failure, requiring mechanical ventilation, acute encephalopathy, likely multifactorial secondary to hypoglycemia, UTI (Urinary tract infection,) possible seizure with underlying Lew body dementia. Low suspicion of meningitis and possible seizure secondary to hypoglycemia. The patient's overall prognosis is terminal with no meaningful recovery.
A review of the in-patient Hospice record showed the resident arrived to their facility on 3/20/23 at 1:30 p.m. He was non-responsive to spoken name, his eyes were wide open with no track, and his facial features were relaxed. A hospice note dated 3/20/23 at 4:58 p.m. showed Provider ordering ME [medical examiner] Reportable Death: Patient has been deemed ME case per [medical doctor] for reported medical error of inappropriate insulin at a nursing facility leading to profound hypoglycemia. The record revealed Resident #1's time of death at 12:16 p.m. on 3/27/23.
An interview was conducted on 4/17/23 at 12:17 p.m. with a family member of Resident #1. The family member confirmed the resident passed away at the in-patient Hospice facility but was unable to discuss any further details at the time.
A facility policy titled Administration of Drugs, dated April 2022, was reviewed. The following showed the following:
Policy
Drugs will be administered in a timely manner and as prescribed by the resident's attending physician or the Center's Medical Director.
2. Drugs must be administered in accordance with the written orders of the attending physician.
3. All current drugs and dosage schedules must be recorded on the resident's Electronic Medication Administration Record (eMAR).
7. Drugs may not be set up in advance and must be administered within one (1) hour before or after their prescribed time.
11. When PRN drugs are administered, the nurse should record:
a. The date and time administered inside eMAR displays;
b. Any complaints or symptoms for which the drug was administered; and
c. Any results achieved from administering the drug and the time such results were observed.
13. The nurse should enter an explanatory note in the progress notes for eMAR when drugs are withheld, refused, or given other than at scheduled times. The physician should be notified of drugs that are withheld and or repeated refusal of drugs.
15. Prior to administering the resident's drug, the nurse should compare the drug and dosage schedule on the resident's eMAR with the drug label.
A facility policy titled Diabetes Care-Insulin Administration, dated April 2022 was reviewed. The policy showed the following:
Policy
Special precautions should be followed when administering insulin.
Policy Interpretation and Implementation
1. Special precautions should be followed in the administration of insulin.
2. Insulin dosage should be drawn only by personnel licensed to administer such drug and must be administered by the person drawing the injection.
3. The type of insulin, dosage requirements, strength, and method of administration should be verified to assure that it corresponds with the order on the medication sheet and the physician's order.
4. Any discrepancies should be reported to the Charge Nurse or designee.
5. The resident's physician should be notified of any discrepancies or adverse drug reactions.
A facility policy titled Medication Errors and Adverse Reactions, undated, was reviewed. The policy showed the following:
Policy
Drug errors and adverse drug reactions should be reported to the resident's attending physician.
Policy Interpretation and Implementation
1. Adverse drug reactions and drug errors with adverse clinical consequences should be reported to the resident's attending physician or physician designee.
2. Nursing services should implement and follow the physician's orders. The resident's condition should be closely observed for seventy-two (72) hours or as may be directed.
3. A detailed account of the incident should be recorded on a medication error report.
4. Documentation of the residence condition and response to treatment should be recorded during the observation period.
5. The Medical Director and Director of Nursing Services should be informed of all drug errors and adverse reactions.
6. If the reaction is allergic in nature, the chart will be labeled to inform all parties of the drug that the resident is allergic to.
A facility job description titled Registered Nurse, dated 8/16/19 was reviewed. The job description listed the following:
Overview
Under the direction of the Director of Nursing, supervises the nursing personnel and the day-to-day nursing activities of the facility during an assigned tour of duty. Such supervision must be in accordance with accepted professional standards and current federal, state and local regulations to ensure the highest degree of quality care is always maintained.
Responsibilities:
-Monitor the daily delivery of nursing care and nursing staff performance as they deliver nursing care to the patients/residents in accordance with established policies and procedures
-Identify problems or potential problems in the delivery of nursing care to residents and implement corrective action immediately
-Oversee the nursing care to patients/residents to ensure safe, efficient and customer-oriented services are delivered at all times.
-Visit resident on report daily in order to observe and evaluate each resident's physical and emotional status
-Provide direct nursing care as necessary
-Ensure the staff refer to the resident's care plan prior to administering care to the resident
-Assist the staff nurses in monitoring seriously ill resident
-Ensure that all nurses on your shift comply with the written procedures for the administration, storage and control of medications and supplies
-Monitor medication passes and treatments to ensure compliance with physician orders and facility policy
-Review medication administration records (MAR) for completeness of information, accuracy in the transcription of physician orders
-Report all accident and incidents to Supervisor immediately upon occurrence
-Conduct all activities within established safety, security and infection control procedures and guidelines Conducts all activities within established corporate compliance policies and procedures
-Ensure residents safety in accordance with resident safety program.
An article titled Hypoglycemia (Nursing,) dated January 2023, was reviewed. The article showed the following:
Nursing Diagnosis
According to the North American Nursing Diagnosis Association International 9 ([NAME]-I), the nursing diagnosis of risk for unstable blood glucose level poses many additional risks and additional nursing diagnoses for the patient. The nurse's responsibility is to diagnose human responses within the nurse's scope and level of competency. It is vital that critical thinking is used to identify and understand the risk factors of unstable blood glucose levels, particularly low levels for the sake of this topic, and the accompanying signs and symptoms upon presentation of the patient.
Medical Management
Identification of a hypoglycemic patient is critical due to potential adverse effects including coma and/or death. Severe hypoglycemia can be treated with intravenous (IV) dextrose followed by infusion of glucose. For conscious patients able to take oral (PO) medications, readily absorbable carbohydrate sources (such as fruit juice) should be given. For patients unable to take oral agents, a 1-mg intramuscular (IM) injection of glucagon can be administered. Once the patient is more awake, a complex carbohydrate food source should be given to the patient to achieve sustained euglycemia. More frequent blood glucose monitoring should occur to rule out further drops in blood sugar.
Nursing Management
Nursing management of hypoglycemic episodes may consist of pharmacologic and non-pharmacologic actions. Immediate and frequent glucose monitoring is vital for any patient presenting with symptoms of unstable blood glucose, particularly with hypoglycemia.
Risk Management
Patient safety remains the priority in any event. The nurse should monitor the patient closely during and following a hypoglycemic episode. It is important to avoid leaving the patient unattended, due to the risks of worsening s[TRUNCATED]
CRITICAL
(J)
📢 Someone Reported This
A family member, employee, or ombudsman was alarmed enough to file a formal complaint
Immediate Jeopardy (IJ) - the most serious Medicare violation
Deficiency F0760
(Tag F0760)
Someone could have died · This affected 1 resident
Based on record review, interviews, hospital record review, hospice record review, facility documentation and policy review the facility failed to ensure one (Resident #1) of five residents reviewed f...
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Based on record review, interviews, hospital record review, hospice record review, facility documentation and policy review the facility failed to ensure one (Resident #1) of five residents reviewed for insulin administration was free from a significant medication error as evidenced by the wrong dose and wrong type of insulin being administered a diabetic resident.
This failure created a situation that resulted in a worsened condition and death to Resident #1 and resulted in the determination of Immediate Jeopardy beginning on 3/12/23. After surveyor review and verification, it was determined the actions implemented by the facility achieved compliance on 3/17/23.
Findings included:
Reference citation F600
A review of Resident #1's medical record showed an admission date of 1/18/23 with diagnoses that included Type II Diabetes Mellitus without complications, Neurocognitive disorder with Lewy bodies, and Metabolic encephalopathy (primary.)
A review of Resident #1's Minimum Data Set (MDS) Five Day Assessment Section C, Cognitive Patterns, showed the resident had a Brief Interview for Mental Status Score (BIMS) score of 99, indicating he was unable to complete the interview. The assessment also showed the resident had short- and long-term memory problems and his cognitive skills for daily decision making was severely impaired. Section I, Active Diagnoses showed the resident had Diabetes Mellitus and Non-Alzheimer's Dementia but did not have a seizure disorder or epilepsy. The MDS was dated 3/10/23.
A review of Resident #1's physician orders related to diabetes revealed:
-1/18/23 Insulin aspart (Novolog) 100 unit (u)/milliliter (ml) (70-30) per sliding scale:
If blood sugar is less than 70, call MD.
If blood sugar is 141-180, give 3 units.
If blood sugar is 181-220, give 5 units.
If blood sugar Is 221-260, give 8 units.
If blood sugar is 261-300, give 10 units.
If blood sugar is 301-350, give 12 units.
If blood sugar is greater than 350, give 14 units.
Subcutaneous. Before meals and at bedtime.
6:00 a.m., 11:15 a.m., 5:00 p.m., 9:00 p.m.
-1/18/23 Levemir U-100 Insulin solution; 100 u/ml; amt: 5 units subcutaneous 1 time daily. Give 5 units subcutaneous once per day for Type II Diabetes Mellitus without complications. Once in morning, 9:00 a.m.
-1/18/23 Glucagon (HCL) Emergency Kit. 1 milligram (mg) IM (intramuscular) injection as directed PRN (as needed) for hypoglycemia.
-3/6/23 Side Effects: Hyperglycemia/Insulin Medication Use. Observe resident closely for side effects: confusion, sweating, SOB (shortness of breath), fruity breath, weakness, fatigue, increased thirst, increased urination, shakiness, pale skin, lethargy. Every shift: Days 7:00 a.m.-7:00 p.m. Nights 7:00 p.m.-7:00 a.m.
-3/6/23 Side Effects: Monitor resident for s/s (signs/symptoms) of hypoglycemia. Monitor for shaking/trembling, fast heart rate, increased hunger, sweating, confusion/difficulty concentrating, dizziness. Every shift: Days 7:00 a.m.-7:00 p.m. Nights 7:00 p.m.-7:00 a.m.
A review of Resident #1's Medication Administration Record (MAR) showed the residents blood glucose levels and insulin administered were as follows:
3/11/23 6:00 a.m. blood glucose was 212 milligram (mg)/deciliter (dL) with 5 units of Novolog insulin administered per sliding scale order.
3/11/23 between 7:00-11:00 a.m. Levemir U-100, 5 units was administered as ordered.
3/11/23 11:15 a.m. blood glucose was 99 mg/dL with no Novolog insulin administered per sliding scale order.
3/11/23 5:00 p.m. blood glucose was 114 mg/dL with no Novolog insulin administered per sliding scale order.
3/12/23 6:00 a.m. blood glucose was 327 mg/dL with 12 units of Novolog insulin administered per sliding scale. (Documented on 3/12/23 at 5:20 a.m.)
3/12/23 11:15 a.m. blood glucose was 58 mg/dL with no Novolog insulin administered per sliding scale order. (Documented on 3/12/23 at 1:01 p.m.)
A review of Resident #1's medical record revealed the following care plan:
Category: Health Related Complications
Resident #1 has a diagnosis of Diabetes and is at risk for unstable blood glucose as evidenced by hyperglycemia with signs and symptoms of increased thirst, headaches, blurred vision, increased urination, fatigue, weight loss, blood sugars >180 mg/dl and hypoglycemia with signs and symptoms of shakiness, dizziness, sweating, intense hunger, irritability, anxiety, decreased level of consciousness, headache.
Interventions include blood glucose monitoring as ordered, document non-compliance of diet recommendations, medications as ordered, notify MD with significant changes in signs and symptoms, and observe for/report signs and symptoms of hypoglycemia: shakiness, dizziness, sweating, intense hunger, irritability, anxiety, decreased level of consciousness, headache.
Created 1/18/23.
A review of Resident #1's medication record showed the following progress notes:
A Nursing Note dated 3/12/23 5:45 a.m. (Recorded as late entry on 3/12/23 at 7:36 p.m.) showed Resident's BS [blood sugar] at 0545 am med pass recorded 327. Both Levemir 12u and Novolog 12 units given. Levemir order is for 5u to be given between 7-11 a.m. Rechecked in 1 hour and BS 84. Medication error and BS levels reported to on call nurse manager [Staff C, Licensed Practical Nurse (LPN)/Unit Manager (UM)] and ARNP for Medical Director. Received order to hold am dose of Levemir, monitor resident and have glucagon on standby if needed. New orders and BS checks reported to oncoming nurse [Staff B, Registered Nurse (RN).] Resident is awake and alert without s/s [signs and symptoms] of hypoglycemia. Dietary trays on hall and trays passing at this time. The Nursing note was entered by Staff A, Registered Nurse (RN).
A Nursing Note dated 3/12/23 1:20 p.m. showed Client observed in bed resting with eyes closed. Blood glucose checked: 58. Rechecked to verify BG [Blood Glucose]: 56, 52. Glucagon 1g injected subq [subcutaneously]. Client breathing was regular at 14 respirations per min [minute]. Sternal rub performed and patient continued to be unresponsive. Pupils pinpoint and BG dropped to 38. Another nurse called 911 while I stayed with the patient. Blood pressure measured manually: BP 70/30 pulse 66. The reading was lower than in the early AM which was 116/60 pulse 70. BG went up to 68 and then back down to 54. Paramedics arrived at 12:55 and patient left at 1300. Client was cool to touch and unresponsive when the paramedics arrived but continued to have steady respiration at 14 bpm. MD notified at 1300 gave ok to send to ER for eval and tx [treatment], and family notified at 1305. The Nursing Note was entered by Staff B, RN.
A review of the facility documentation, dated 3/12/23, described the medication error as Nurse mistakenly administered Levemir 12U instead of Novolog 12U, nurse administered Novolog 12U after realizing she gave Levemir 12U. After administering both insulins, nurse contacted MD on call. It showed the correct order was sliding scale Novolog 12u. The type of error was listed as incorrect dose and incorrect medication. The report showed the resident became hypotensive and hypoglycemic around 12:45, resident was unresponsive but maintained respirations and heart rate. The immediate interventions were described as Glucagon 1g injected subq as ordered. Res [resident] blood sugar rechecked. Resident remained unresponsive. 911 activated and res transported to ER [emergency room] via stretcher around 12:55. The report shows the following blood sugar levels:
3/12/23 5:15 a.m. Blood sugar 327 mg/dL
3/12/23 12:04 p.m. Blood sugar 58 mg/dL
A phone interview was conducted with Staff A, RN on 4/10/23 at 8:48 a.m. She confirmed she was taking care of Resident #1 the morning of 3/12/23 and made a medication error. She said the resident had been on her wing for a while and she was familiar with him. She said the resident was confused but could converse, saying hello and talking some. She said he did not always recognize family; he was incontinent and needed full care. She added the resident was able to self-propel in his wheelchair with his feet once he had help getting up.
Staff A, RN said during her shift running from 3/11/23 7:00 p.m. to 3/12/23 7:00 a.m., the resident had stayed up very late, until 2:00 a.m. She said he did not want to stay in bed and was restless. She said there was no increased confusion, the resident was at his baseline. She said he had a history of falls, so she got him up to a wheelchair for a couple of hours, then put him back to bed.
Staff A, RN said when insulin comes from the pharmacy, the vial is in the insulin box with a label on it and it is in a plastic bag that also has a label. Those bags are placed in the medication cart. She said when she pulled the bag out of the drawer, she read the bag, name, and checked everything. She confirmed she did not check the label on the box, she only checked the bag. After she administered the first insulin based on the sliding scale, she came back to the cart to put the vial in the box and bag, she realized she had given the wrong insulin. Staff A, RN said she gave the resident 12u of Levemir long-acting insulin instead of Novolog short-acting insulin. She said she panicked and stated, in my mind his blood sugar was still 327. The long acting was not going to bring down his blood sugar now. She said she went ahead and administered the Novolog within a couple of minutes of the Levemir. Staff A, RN said it was 5:30 a.m. and she could not call the doctor yet as she thought it was too early. She said, that is my error, I gave both. She said right after change of shift, approximately 7:15 a.m., she called and talked to the Nurse Practitioner (NP) for the Medical Director and the on-call manager, Staff C, LPN/UM
Staff A, RN said the NP told her to monitor the resident closely, hold the morning dose of Levemir and have Glucagon on hand.
An interview was conducted with Staff C, LPN/UM. on 4/17/23 at 12:29 p.m. Staff C, LPN/UM confirmed she was the on-call manager on 3/12/23. She said Staff A, RN called her about 7:20 a.m. and informed her she gave the wrong insulin to Resident #1. Staff C, LPN/UM said she asked Staff A, RN if she had talked to the doctor and Staff A, RN told her no. She said she told Staff A, RN to contact the doctor and follow his orders. She said Staff A, RN only told her she gave the resident long-acting insulin. She said she was not told the resident was also given short-acting insulin at the same time. Staff C, LPN/UM said she then received a call about 2:30 p.m. from Staff B, RN (the nurse caring for Resident #1 on the day shift 3/12/23) saying Resident #1's blood sugar had dropped. Staff B, RN asked her if she was aware of the extra insulin and Staff C, LPN/UM told her she was not aware. Staff B, RN notified her they gave Resident #1 Glucagon, and he was sent to the hospital. Staff C, LPN/UM said she notified the Director of Nursing (DON), and the DON notified the administrator. Staff C, LPN/UM said around 5:00 p.m. the day the error was made (3/12/23) she, along with other management, came in and began doing medication cart audits.
During an interview with the DON on 4/18/23 at 4:31 p.m. she confirmed she came to the facility on 3/12/23 to complete medication cart audits with Staff C, LPN/UM.
An interview was conducted with Staff B, RN on 4/5/23 at 2:50 p.m. She said she came on shift at 6:45 on 3/12/23 and received shift report from Staff A, RN between 7:00-7:15 a.m. She said Staff A, RN informed her she gave Resident #1 both long-acting and short-acting insulin that morning. She said Staff A, RN had not called the doctor at that point. Staff B, RN said Staff A, RN called the provider for the first time after she gave her report, approximately 7:15 a.m. She said Staff A, RN told her the NP gave orders to monitor the resident and have glucagon ready. Staff B, RN said she found out later that day Staff A, RN did not inform the NP she gave both the long and short-acting insulin; she only told her about the incorrect dose of Levemir. Staff B, RN said she checked Resident #1's blood glucose level between 8:30-9:00 a.m. and it was in the 90's. She said she did not document the blood glucose check in the resident's medical record because there was no place to enter it. B, RN did say she could have documented it under vitals, but she did not think about that at the time. She said right before lunch trays came out, which is around 12, she rechecked Resident #1s' blood glucose and it was 58. She said she had another nurse (Staff D, LPN) come in and they verified again, it was 56 then 52. Staff B, RN said she administered Glucagon to the resident then checked his blood glucose again. She said it was then 38, so they called 911. She said she continually checked blood glucose levels until paramedics arrived. She said he went up to 68 then dropped back down in the 50's. When asked about monitoring the resident between 9:00 a.m. and 11:45 a.m., she said she was giving all of her other residents their medication. She said she looked in the room a couple of times and the resident was sleeping. She said he was snoring but arousable. A review of records did not reveal any documentation showing Resident #1 was assessed or monitored from 9:00 a.m. until 11:45 a.m.
An interview was conducted with Staff D, LPN on 4/18/23 at 1:50 p.m. Staff D, LPN stated I did not know [Resident #1] very well but I do know he was very confused and a fall risk, very impulsive. That day he was sent out I helped the nurse. She came to me and said she checked his sugar [blood glucose] and it was low. She said she couldn't get him to take anything by mouth and I told her well give him the sugar s*** (expletive) [glucagon] we have in our medication carts, so she did that, and she came to me and said it's even lower now and I don't know what to do. I told her you need to call 911 and get them here. They couldn't even bring him back either. He was breathing and his heart was beating but he was just unresponsive.
An interview was conducted with Staff E, Nurse Practitioner (NP) on 4/12/23 at 8:42 a.m. The NP stated she does not physically go to this facility and did not know this resident, but she was covering on-call the morning of 3/12/23. She said she does not recall exactly when the nurse called or what she told her specifically. She said she was told Resident #1 had received the wrong dose of insulin and had gotten double what he should have. The NP said she told the nurse to have Glucagon ready to go, monitor the resident and if his blood glucose drops low and you cannot get him out of it, to call her back. The NP said she never heard anything else from the facility.
She said Staff A, RN just told her she gave too much insulin; she did not get into details. She said she does not believe Staff A, RN mentioned giving both insulins at the same time. She said she does not remember if she gave specific monitoring parameters, but her standard with low or high blood sugar is they should be checked at least every 2 hours. When asked if it was okay that the resident's blood glucose level was only checked between 8:30/9:00 a.m. then again at 11:45/12:00 p.m. she said, absolutely not. The NP said she did not have any notes related to this call.
An interview was conducted with the Regional Consultant Pharmacist on 4/17/23 at 10:33 a.m. She said the onset of action for Levemir is between 3-4 hours after administration and the duration of action can range from 5/6 hours up to 18 hours depending on body weight and other factors specific to the resident. She said the onset of action for Novolog is around 12-18 minutes and the duration of action is between 3-7 hours depending on body weight, age, and other factors specific to the resident. The pharmacist said around 3-4 hours after both insulins were administered to the resident would have most likely been the point, they were at the highest effect together and the blood sugar could drop low. The pharmacist said 12u of Levemir is not an unusual dose, however because insulin is so dependent, for Resident #1 individually it may have been. She said typically the Novolog and Levemir are not administered at the same time, there would be some spacing. The pharmacist said in the incidence of an insulin overdose, the resident's blood glucose should be checked every 15 minutes and if it is below 70, interventions should have been implemented, such as giving Glucagon or IV glucose. She said the onset of Glucagon is 5-20 minutes and most protocols show that if Glucagon is given and the blood glucose is still below 70 you proceed to the next step, in this case send resident to the hospital.
The pharmacist said the consultant pharmacist that visited the facility had not identified anything unusual in the facility regarding insulins or other medications. The pharmacist had previously conducted medication cart audits and did not find any issues.
An interview was conducted with the facility Medical Director on 4/10/23 at 11:43 a.m. He said the nurse gave Resident #1 12u of rapid acting insulin and 12u or long-acting insulin. He confirmed he was not called that morning. He said the NP told the nurse to monitor the resident and have Glucagon ready. The doctor said he did not have any notes showing he saw Resident #1 and stated, It is very weird. (The Medical Director and NHA both confirmed there was no documentation to show the resident was seen in the facility by a primary provider.)
The doctor said when a medication error is made the nurse should let the provider and their immediate supervisor know right then. He said he or the on-call should have been called that morning when the error happened.
A review of the local Fire Rescue Patient Care Report showed the 911 call for Resident #1 was received on 3/12/23 at 12:38 p.m. Emergency Medical Services (EMS) arrived at the patient at 12:50 p.m. The reports showed the chief complaint for Resident #1 was Diabetic-Hypoglycemia and the primary symptom was altered mental status. The resident's blood glucose was 48 and his blood pressure was 119/68 at 12:56 p.m. The Fire Rescue Narrative note showed found 77 yom [year old male] lying in his hospital bed. Pt [patient] responded to painful stimuli, Pt equal chest rise and fall, ABC's [airway, breathing, circulation] intact, skin WNL [within normal limits,] lung sounds clear, and perrl [pupils equal, round, reactive to light.] Staff stated pt was assessed and BGL [blood glucose level] was 39. Staff stated they gave 1g of Glucagon with no improvement leading them to call [Fire rescue.] Pt was carried to the stretcher and secured with all appropriate straps, rails x 2 and semi-Fowlers [position] for pt comfort and safety. Pt. further assessed and vitals WNL. Pt. BGL 48. Pt IV established and 250ml of D10 [Dextrose 10% solution] given with an improved response. Staff stated pt has Lewy Body dementia and only has a verbal response as his baseline. Pt continued to improve throughout the entire call. Pt transported to [local hospital] per request. Pt monitored enroute with no notable changes. Fire Rescue arrived at the hospital at 1:13 p.m. on 3/12/23.
A review of hospital records, dated 3/12/23, for Resident #1 showed the Chief Complaint as From [facility]: Pt found to be hypoglycemic this morning, given 1 g of glucagon by staff, pt blood sugar in the 40's for EMS given 250ml of D10. Pt hx: dementia. The History or Present Illness revealed Patient presents to the emergency department acutely altered. Patient presents from [facility] with report from EMS indicated the patient was hypoglycemic. He was given glucagon, but this did not improve his blood sugar. When EMS arrived his blood sugar was in the 40s. They subsequently gave D10. He was unresponsive for them the entirety of their time with the patient. I subsequently called patient's emergency contact, [family member.] She states the patient does have Lewy body dementia. However, normally is not unresponsive and is alert. Patient does arrive with a DO NOT RESUSCITATE order and I specifically clarified with the [family member] if he would want to be intubated [have a breathing tube placed down the throat into the windpipe to allow a machine to assist with breathing.] She thinks that that [sic] would be in accordance with his wishes and he would be amenable to intubation. She does not know of any seizure history, which I asked because the patient did have rhythmic eye movements and contracted positioning that made me concerned for possible seizures. I did also call the facility and discussed with the nurse taking care of him. She does confirm that patient is normally able to push himself around in wheelchair and is typically alert. She does state that this morning was an acute change for patient. Patient was unresponsive for her the entire time as well. Patient on arrival unresponsive and unable to answer any questions for me. The record also revealed the resident had recurrent episodes of hypoglycemia on arrival and was again given D50 and a D10 drip was started. Despite the correction of the hypoglycemia, the patient continued to be altered. There was a strong suspicion for possible seizure in the setting of rhythmic movements of the eyes and contracted positioning. The patient was hypothermic on arrival and a forced air warming blanket was used. An intubation was performed and completed without any hypoxia.
A continued review of hospital records showed an assessment performed on Resident #1 on 3/12/23 at 1:40 p.m. The assessment showed the resident's level of consciousness as obtunded, meaning he had a lessened interest in the environment and slowed response to stimulation. The Coma Scale showed Resident #1 has no eye-opening response and no verbal response. The resident did have a motor response of flexion withdrawal. His overall coma score was a 6.
According to the Centre for Neuro Skills, the Glasgow Coma Scale provides an assessment of coma and impaired consciousness. The total scores were explained as follows: 90% less than or equal to 8 are in a coma, greater than or equal to 9 not in coma, 8 is the critical score, 9-12= moderate severity, and greater than or equal to 13=minor injury. (Accessed on 4/20/23 at https://www.neuroskills.com/education-and-resources/glasgow-coma-scale/)
The hospital records, dated 3/12/23 showed after reexamination in the emergency room Resident #1 was found to have a urinary tract infection which could potentially be contributory but does not truthfully explain why the patient was seizing. Following intubation and paralysis wearing off, patient without further rhythmic activity of his eyes and no longer posturing his upper extremities leading me to believe that his seizure likely is stopped. Patient was admitted to the Intensive Care Unit.
The hospital Discharge Summary, dated 3/20/23, showed Patient was weaned off sedation, however patient was not waking up and minimally responsive. Therefore, he remained intubated due to concerns of ability to protect airway. Palliative care consulted. Patient was discharged to inpatient hospice facility pending bed availability. The discharge diagnoses included acute hypoxic respiratory failure, requiring mechanical ventilation, acute encephalopathy, likely multifactorial secondary to hypoglycemia, UTI (Urinary tract infection,) possible seizure with underlying Lew body dementia. Low suspicion of meningitis and possible seizure secondary to hypoglycemia. The patient's overall prognosis is terminal with no meaningful recovery.
A review of the in-patient Hospice record showed the resident arrived to their facility on 3/20/23 at 1:30 p.m. He was non-responsive to spoken name, his eyes were wide open with no track, and his facial features were relaxed. A hospice note dated 3/20/23 at 4:58 p.m. showed Provider ordering ME [medical examiner] Reportable Death: Patient has been deemed ME case per [medical doctor] for reported medical error of inappropriate insulin at a nursing facility leading to profound hypoglycemia. The record revealed Resident #1's time of death at 12:16 p.m. on 3/27/23.
An interview was conducted on 4/17/23 at 12:17 p.m. with a family member of Resident #1. The family member confirmed the resident passed away at the in-patient Hospice facility but was unable to discuss any further details at the time.
A facility policy titled Administration of Drugs, dated April 2022, was reviewed. The following showed the following:
Policy
Drugs will be administered in a timely manner and as prescribed by the resident's attending physician or the Center's Medical Director.
2. Drugs must be administered in accordance with the written orders of the attending physician.
3. All current drugs and dosage schedules must be recorded on the resident's Electronic Medication Administration Record (eMAR).
7. Drugs may not be set up in advance and must be administered within one (1) hour before or after their prescribed time.
11. When PRN drugs are administered, the nurse should record:
a. The date and time administered inside eMAR displays;
b. Any complaints or symptoms for which the drug was administered; and
c. Any results achieved from administering the drug and the time such results were observed.
13. The nurse should enter an explanatory note in the progress notes for eMAR when drugs are withheld, refused, or given other than at scheduled times. The physician should be notified of drugs that are withheld and or repeated refusal of drugs.
15. Prior to administering the resident's drug, the nurse should compare the drug and dosage schedule on the resident's eMAR with the drug label.
A facility policy titled Diabetes Care-Insulin Administration, dated April 2022 was reviewed. The policy showed the following:
Policy
Special precautions should be followed when administering insulin.
Policy Interpretation and Implementation
1. Special precautions should be followed in the administration of insulin.
2. Insulin dosage should be drawn only by personnel licensed to administer such drug and must be administered by the person drawing the injection.
3. The type of insulin, dosage requirements, strength, and method of administration should be verified to assure that it corresponds with the order on the medication sheet and the physician's order.
4. Any discrepancies should be reported to the Charge Nurse or designee.
5. The resident's physician should be notified of any discrepancies or adverse drug reactions.
A facility policy titled Medication Errors and Adverse Reactions, undated, was reviewed. The policy showed the following:
Policy
Drug errors and adverse drug reactions should be reported to the resident's attending physician.
Policy Interpretation and Implementation
1. Adverse drug reactions and drug errors with adverse clinical consequences should be reported to the resident's attending physician or physician designee.
2. Nursing services should implement and follow the physician's orders. The resident's condition should be closely observed for seventy-two (72) hours or as may be directed.
3. A detailed account of the incident should be recorded on a medication error report.
4. Documentation of the residence condition and response to treatment should be recorded during the observation period.
5. The Medical Director and Director of Nursing Services should be informed of all drug errors and adverse reactions.
6. If the reaction is allergic in nature, the chart will be labeled to inform all parties of the drug that the resident is allergic to.
A facility job description titled Registered Nurse, dated 8/16/19 was reviewed. The job description listed the following:
Overview
Under the direction of the Director of Nursing, supervises the nursing personnel and the day-to-day nursing activities of the facility during an assigned tour of duty. Such supervision must be in accordance with accepted professional standards and current federal, state and local regulations to ensure the highest degree of quality care is always maintained.
Responsibilities:
-Monitor the daily delivery of nursing care and nursing staff performance as they deliver nursing care to the patients/residents in accordance with established policies and procedures
-Identify problems or potential problems in the delivery of nursing care to residents and implement corrective action immediately
-Oversee the nursing care to patients/residents to ensure safe, efficient and customer-oriented services are delivered at all times.
-Visit resident on report daily in order to observe and evaluate each resident's physical and emotional status
-Provide direct nursing care as necessary
-Ensure the staff refer to the resident's care plan prior to administering care to the resident
-Assist the staff nurses in monitoring seriously ill resident
-Ensure that all nurses on your shift comply with the written procedures for the administration, storage and control of medications and supplies
-Monitor medication passes and treatments to ensure compliance with physician orders and facility policy
-Review medication administration records (MAR) for completeness of information, accuracy in the transcription of physician orders
-Report all accident and incidents to Supervisor immediately upon occurrence
-Conduct all activities within established safety, security and infection control procedures and guidelines Conducts all activities within established corporate compliance policies and procedures
-Ensure residents safety in accordance with resident safety program.
According to the Food and Drug Administration Levemir injection label, Levemir is a long-acting (up to 24-hour duration of action) human insulin analog used to improve glycemic control in adults and children with diabetes mellitus.
Warnings and Precautions included:
-Dose adjustment and monitoring: Monitor blood glucose in all patients treated with insulin. Insulin regiments should be modified cautiously and only under medical supervision.
-Hypoglycemia is the most common adverse reaction to insulin therapy and may be life-threatening.
5.3 Hypoglycemia
Hypoglycemia is the most common adverse reaction of insulin therapy, including LEVEMIR. The risk of hypoglycemia increases with intensive glycemic control. Patients must be educated to recognize and manage hypoglycemia. Severe hypoglycemia can lead to unconsciousness or convulsions and may result in temporary or permanent impairment of brain function or death. Severe hypoglycemia requiring the assistance of another person or parental glucose infusion, or glucagon administration has been observed in clinical trials with insulin, including trials with LEVEMIR.
8.5 Geriatric Use
In elderly patients with diabetes, the initial dosing, dose increments and maintenance dosage should be conservative to avoid hypoglycemia.
10. Overdosage
An excess of insulin relative to food intake, energy expenditure, or both may lead to severe and sometimes prolonged and life-threatening hypoglycemia. Mild episodes of hypoglycemia usually can be treated with oral glucose. Adjustments in drug dosage, meal patterns or exercise may be needed.
More severe episode with coma, seizure, or neurological impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose.
(Accessed on 4/21/23 at https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021536s037lbl.pdf)
Facility immediate actions to correct deficient practice and remove the Immediate Jeopardy included:
On 3/12/2023:
The DON/designee completed cart audit of all insulin to ensure all insulin is labeled and stored appropriately.
The physician and family notified and Medication error.
Statements were obtained from Staff who were worki[TRUNCATED]