Based on observation, record review, and interview, the facility failed to ensure a medication error rate of less than 5% when the facility staff made two errors out of 25 opportunities resulting in an error rate of 7.14% when staff failed to prime the insulin pens for one resident (Resident #3) during two medication pass observations. The facility census was 14. Record review of the Novolog Flexpen (name brand for insulin aspart injection - fast acting insulin) manufacturer's website, dated June 2021, instruction for use included the following: -Pull off the pen cap and wipe the rubber stopper with an alcohol swab; -Attach a new needle, push and twist the needle on until it is tight; -Check the flow in the needle with an air shot of two units. Tap the pen a few time to make any air bubbles collect at the top. Press the push button all the way in and make sure that a drop appears, if not change the needle and complete the process again; -Select the dose - Make sure the dose selector is set at 0. Turn the dose selector to select the number of units you need to inject; -Give the injection. Insert the needle into the skin. Press and hold the dose button. After the dose counter reaches 0, slowly count to six before removing the needle from the skin; -Carefully remove the needle and place it in a disposal container; -Put the cap back on the FlexPen and store at room temperature. Record review of the Lantus Solostar Pen (name brand for insulin glargine injection - long acting insulin) manufacturer's website, dated March 2020, instructions for use included the following: -Remove the pen cap with clean hands; -Wipe the pen tip (rubber seal) with an alcohol swab; -Remove the protective seal from the new needle, line the needle up straight with the pen, and screw the needle on; -Perform a safety test. Dial a test dose of two units. Hold pen with the needle pointing up and lightly tap the insulin pen so the air bubbles rise to the top of the needle. This will help get the most accurate dose. Push the injection button and ensure a drop of fluid is on the needle; -Select the dose. Make sure the window shows 0 and then select the dose; -Inject the dose. Clean skin site with an alcohol swab. Keep the pen straight, insert the needle into the skin. Press the injection button all the way down. When the number in the dose window returns to 0 while injecting, slowly count to 10 before removing. (Counting to 10 will make sure the full insulin dose is received.) Release the button and remove the needle from the skin. -Remove the needle, throw away in a sharps container, put the pen cap back on the pen and store in a safe place at room temperature. Record review of a facility document titled Insulin Pen Use, Home Care, dated 05/20/2022, showed the following: -Observe the patient preparing the insulin pen for injection; -Ensure the patient obtains the correct insulin pen and appropriate size disposable needle; -Make sure that the patient inspects the pen to confirm that it is the correct insulin and that it is not expired; -Verify the patient removed the pen cap and attaches the needle to the pen according the manufacturer's instructions; -Confirm that the patient holds the pen vertically with the needle pointing up, dials one or two units on the dosage knob, and presses the injection button until a drop of insulin appears at the tip of the needle to prime the pen; -Verify the patient dials the dosage knob to the correct dose; -Confirm the patient holds the insulin pen and inserts the needle in one quick, smooth motion into the skin at a 90-degree angle to the skin's surface; -Verify the patient steadily pushes down the injection button at the back of the pen to inject the insulin; -Ensure the patient leaves the needle in the skin for 10 seconds to prevent leakage from the injection site and then pulls the needle out of the skin; -Verify the patient removed the needles according to the manufacturer's instructions, discards the needle in a puncture resistant sharps container, and replaces the pen cap on the insulin. 1. Record review of Resident #3's face sheet (brief resident information sheet) showed the following information: -admission date of 5/27/2022; -Diagnosis included uncontrolled diabetes mellitus (disease that results in too much sugar in the blood (high blood glucose)), diabetic foot ulcer with osteomyelitis (inflammation of bone, usually due to infection), and status post transmetatarsal amputation (surgery to remove part of the foot) of foot. Record review of the resident's June 2022 physician's orders showed the following information: -An order, dated 6/3/2022, for Novolog 100 units/ml Pen (insulin aspart - short-acting, manmade version of human insulin), administer per custom blood glucose (BG) correction scale five times per day; if BG is 160 milligrams(mg)/deciliter(dl) to 189 mg/dl administer 3 units; if BG 190 mg/dl to 219 mg/dl administer 6 units if BG is 220 mg/dl to 249 mg/dl administer 9 units; if BG is 250 mg/dl to 279 mg/dl administer 12 units. The order also stated to inject 1 unit Novolog per 2 gram carbs (carbohydrates), three times per day with meals and inject 1 unit Novolog per 3 gram carbs as needed with snacks; -An order, dated 6/14/22, for Lantus 100 units/ml (insulin glargine) Pen administer 56 units twice per day. During an observation on 6/29/2022, at 9:22 A.M., Registered Nurse (RN) A put on gloves, removed the cap from the Novolog FlexPen, wiped the stopper with an alcohol wipe, and put on a new needle. Without priming the pen, the RN turned the dial to the 22 indicator mark (3 units for BG 160 and 19 units for 39 gram carb breakfast). He/she entered the resident's room and used an alcohol wipe to clean the resident's abdomen. The RN injected 22 units of Novolog in the resident's abdomen. He/she returned to the medication cart, removed the needle, and entered the required information into the resident's medication administration record. During an observation on 6/30/2022, at 10:20 A.M., RN A began preparing medications for the resident. He/she took the Lantus Pen from the medication cart, removed the cap, wiped the stopper with an alcohol wipe, and put on a new needle. Without priming the pen, the RN turned the dial on the pen to the 56 indicator mark. He/she entered the resident room and administered 56 units of Lantus into the resident's abdomen. He/she returned to the medication cart, removed the needle, and entered the required information into the resident's medication administration record. During an interview on 6/30/2022, at 10:30 A.M., RN A said for insulin injections the nurse should obtain the insulin pen, check the resident name on the pen, check the expiration date, scan the pen, open the cap, wipe the insulin stopper with alcohol, prepare the dose, and administer the insulin. The RN said nurses are supposed to prime the insulin before each use with one to two units to ensure no air bubbles, but he/she was in a hurry. During an interview on 6/30/2022, at 1:10 P.M., RN B said the process for insulin administration included checking the physician orders, clean the insulin stopper with an alcohol wipe, prime needle with 2 units, then pull up the ordered dose. Take the insulin in to the room and explain to the patient. Clean the patient's skin, administer and ensure complete dose given before removing from the skin. During an interview on 6/30/2022, at 1:20 P.M., Assistant Nurse Manager, said the process for insulin administration included to prepare insulin, wipe stopper with alcohol, put on a new needle, prime the pen with 1 to 2 units, then turn to ordered dose, verify the dose with patient, clean the skin and inject the dose. During an interview on 6/30/2022, at 1:46 P.M., Administrator said that insulin is a high alert drug, staff should check blood sugar before meals, and should time insulin administration with foods. She was not familiar with insulin pens.

Based on observation, record review, and interview, the facility failed to ensure residents were free of significant medication errors when staff failed to prime insulin pens for one resident (Resident #3) during two medication pass observations. The facility had a census of 14. Record review of the Novolog Flexpen (name brand for insulin aspart injection - fast acting insulin) manufacturer's website, dated June 2021, instruction for use included the following: -Pull off the pen cap and wipe the rubber stopper with an alcohol swab; -Attach a new needle, push and twist the needle on until it is tight; -Check the flow in the needle with an air shot of two units. Tap the pen a few time to make any air bubbles collect at the top. Press the push button all the way in and make sure that a drop appears, if not change the needle and complete the process again; -Select the dose - Make sure the dose selector is set at 0. Turn the dose selector to select the number of units you need to inject; -Give the injection. Insert the needle into the skin. Press and hold the dose button. After the dose counter reaches 0, slowly count to six before removing the needle from the skin; -Carefully remove the needle and place it in a disposal container; -Put the cap back on the FlexPen and store at room temperature. Record review of the Lantus Solostar Pen (name brand for insulin glargine injection - long acting insulin) manufacturer's website, dated March 2020, instructions for use included the following: -Remove the pen cap with clean hands; -Wipe the pen tip (rubber seal) with an alcohol swab; -Remove the protective seal from the new needle, line the needle up straight with the pen, and screw the needle on; -Perform a safety test. Dial a test dose of two units. Hold pen with the needle pointing up and lightly tap the insulin pen so the air bubbles rise to the top of the needle. This will help get the most accurate dose. Push the injection button and ensure a drop of fluid is on the needle; -Select the dose. Make sure the window shows 0 and then select the dose; -Inject the dose. Clean skin site with an alcohol swab. Keep the pen straight, insert the needle into the skin. Press the injection button all the way down. When the number in the dose window returns to 0 while injecting, slowly count to 10 before removing. (Counting to 10 will make sure the full insulin dose is received.) Release the button and remove the needle from the skin. -Remove the needle, throw away in a sharps container, put the pen cap back on the pen and store in a safe place at room temperature. Record review of a facility document titled Insulin Pen Use, Home Care, dated 05/20/2022, showed the following: -Observe the patient preparing the insulin pen for injection; -Ensure the patient obtains the correct insulin pen and appropriate size disposable needle; -Make sure that the patient inspects the pen to confirm that it is the correct insulin and that it is not expired; -Verify the patient removed the pen cap and attaches the needle to the pen according the manufacturer's instructions; -Confirm that the patient holds the pen vertically with the needle pointing up, dials one or two units on the dosage knob, and presses the injection button until a drop of insulin appears at the tip of the needle to prime the pen; -Verify the patient dials the dosage knob to the correct dose; -Confirm the patient holds the insulin pen and inserts the needle in one quick, smooth motion into the skin at a 90-degree angle to the skin's surface; -Verify the patient steadily pushes down the injection button at the back of the pen to inject the insulin; -Ensure the patient leaves the needle in the skin for 10 seconds to prevent leakage from the injection site and then pulls the needle out of the skin; -Verify the patient removed the needles according to the manufacturer's instructions, discards the needle in a puncture resistant sharps container, and replaces the pen cap on the insulin. 1. Record review of Resident #3's face sheet (brief resident information sheet) showed the following information: -admission date of 5/27/2022; -Diagnosis included uncontrolled diabetes mellitus (disease that results in too much sugar in the blood (high blood glucose)), diabetic foot ulcer with osteomyelitis (inflammation of bone, usually due to infection), and status post transmetatarsal amputation (surgery to remove part of the foot) of foot. Record review of the resident's June 2022 physician's orders showed the following information: -An order, dated 6/3/2022, for Novolog 100 units/ml Pen (insulin aspart - short-acting, manmade version of human insulin), administer per custom blood glucose (BG) correction scale five times per day; if BG is 160 milligrams(mg)/deciliter(dl) to 189 mg/dl administer 3 units; if BG 190 mg/dl to 219 mg/dl administer 6 units if BG is 220 mg/dl to 249 mg/dl administer 9 units; if BG is 250 mg/dl to 279 mg/dl administer 12 units. The order also stated to inject 1 unit Novolog per 2 gram carbs (carbohydrates), three times per day with meals and inject 1 unit Novolog per 3 gram carbs as needed with snacks; -An order, dated 6/14/22, for Lantus 100 units/ml (insulin glargine) Pen administer 56 units twice per day. During an observation on 6/29/2022, at 9:22 A.M., Registered Nurse (RN) A put on gloves, removed the cap from the Novolog FlexPen, wiped the stopper with an alcohol wipe, and put on a new needle. Without priming the pen, the RN turned the dial to the 22 indicator mark (3 units for BG 160 and 19 units for 39 gram carb breakfast). He/she entered the resident's room and used an alcohol wipe to clean the resident's abdomen. The RN injected 22 units of Novolog in the resident's abdomen. He/she returned to the medication cart, removed the needle, and entered the required information into the resident's medication administration record. During an observation on 6/30/2022, at 10:20 A.M., RN A began preparing medications for the resident. He/she took the Lantus Pen from the medication cart, removed the cap, wiped the stopper with an alcohol wipe, and put on a new needle. Without priming the pen, the RN turned the dial on the pen to the 56 indicator mark. He/she entered the resident room and administered 56 units of Lantus into the resident's abdomen. He/she returned to the medication cart, removed the needle, and entered the required information into the resident's medication administration record. During an interview on 6/30/2022, at 10:30 A.M., RN A said for insulin injections the nurse should obtain the insulin pen, check the resident name on the pen, check the expiration date, scan the pen, open the cap, wipe the insulin stopper with alcohol, prepare the dose, and administer the insulin. The RN said nurses are supposed to prime the insulin before each use with one to two units to ensure no air bubbles, but he/she was in a hurry. During an interview on 6/30/2022, at 1:10 P.M., RN B said the process for insulin administration included checking the physician orders, clean the insulin stopper with an alcohol wipe, prime needle with 2 units, then pull up the ordered dose. Take the insulin in to the room and explain to the patient. Clean the patient's skin, administer and ensure complete dose given before removing from the skin. During an interview on 6/30/2022, at 1:20 P.M., Assistant Nurse Manager, said the process for insulin administration included to prepare insulin, wipe stopper with alcohol, put on a new needle, prime the pen with 1 to 2 units, then turn to ordered dose, verify the dose with patient, clean the skin and inject the dose. During an interview on 6/30/2022, at 1:46 P.M., Administrator said that insulin is a high alert drug, staff should check blood sugar before meals, and should time insulin administration with foods. She was not familiar with insulin pens.

Based on interview and record review, the facility staff failed to ensure 100% of staff had been fully vaccinated for COVID-19 (a highly contagious virus that causes serious illness or death), or granted a qualifying exemption when one staff (Employee C) had not received the full primary vaccination series as of the start of the survey on 6/28/2022. The facility census was 14. Record review of the facility policy entitled Universal COVID-19 Vaccination (undated) showed the following information: -Vaccination is known to reduce the instance and severity of COVID-19 illness in the workplace. The facility has adopted this policy on mandatory vaccination to safeguard employees, providers, and patients from the hazards of COVID-19; -The facility requires all staff to be fully vaccinated for COVID-19 unless an exemption from this policy has been granted as an accommodation. Regardless of clinical responsibility or patient contact, the policy and procedures apply to covered workforce members, which includes employees, licensed practitioners, and individuals who provide care, treatment, or other services for the facility or its patients; -Individuals who fail to comply with policy requirements will not be allowed to work or provide services and will be subject to disciplinary measures, up to and including termination of employment, contracted services, or medical staff membership. Record review of the Centers for Disease Control and Prevention (CDC) Stay Up to Date with Your COVID-19 Vaccines, dated 06/24/2022, showed the following: - A person is considered full after two week after receiving the final dose of the primary series; -The primary series is two doses given three to eight weeks apart. 1. Record review of the facility's undated COVID-19 Vaccination Status - TCU Staff showed the following: -Total staff of 27; -Staff partially vaccinated: 0; -Staff fully vaccinated: 27; -Staff with medical exemptions: 0; -Staff with non-medical exemptions: 0. Record review of the facility's COVID-19 resident outbreak documentation showed no residents tested positive for COVID-19 for the past four weeks. Record review of Employee C's COVID-19 Vaccination Record Card showed the following: -The first dose COVID-19 two-step vaccination dose was administered 1/25/2022. (The card did not show documentation of a the second dose.) Record review of Employee C's facility COVID-19 Immunization Record showed the following information: -Employee received the first dose of a two dose COVID-19 vaccine series on 1/25/2022. (The record did not show the second dose was provided prior to the survey start on 6/28/2022.) During an interview on 6/30/2022, at 10:35 A.M., Employee C confirmed receiving the first dose of the COVID-19 vaccine on 1/25/2022. The employee said he/she did not like how he/she felt after receiving the first dose of the COVID-19 vaccine, so did not pursue obtaining the second dose. The employee said he/she had not requested or been granted an exemption from the mandatory vaccinations. During an interview on 6/30/2022, at 11:40 A.M., the Assistant Nurse Manager (ANM) said she was not aware that Employee C was not up to date on COVID vaccines. The employee health department of the facility's system tracked all COVID vaccinations. Employee C should not have worked if they were not in compliance with the facility policy.