§483.35 Nursing Services
The facility must have sufficient nursing staff with the appropriate competencies and skills sets to provide nursing and related services to assure resident safety and attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, as determined by resident assessments and individual plans of care and considering the number, acuity and diagnoses of the facility's resident population in accordance with the facility assessment required at §483.71.
§483.35(a)(3) The facility must ensure that licensed nurses have the specific competencies and skill sets necessary to care for residents' needs, as identified through resident assessments, and described in the plan of care.
§483.35(a)(4) Providing care includes but is not limited to assessing, evaluating, planning and implementing resident care plans and responding to resident's needs.
§483.35(d) Proficiency of nurse aides.
The facility must ensure that nurse aides are able to demonstrate competency in skills and techniques necessary to care for residents' needs, as identified through resident assessments, and described in the plan of care.
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Observations:
Based on facility policy, clinical record review, and staff interview it was determined that the facility failed to ensure that nursing staff have the specific competencies and skill sets necessary to provide care for a resident with an insulin pump (wearable device that delivers insulin continuously to people with diabetes), and placed one resident (Resident R1) in immediate jeopardy in which health and safety were impacted.
Findings include:
Interview on 4/29/25, at 9:35 a.m. the Director of Nursing (DON) indicated "I don't think we have a policy for insulin pumps".
Review of facility policy "Competent Nursing Staff" dated 1/7/25, indicated it is the policy of the facility to provide staff with appropriate competencies and skill sets to assure resident safety and attain or maintain the highest practicable physical, mental and psychosocial well-being of each resident, as determined by resident assessments and individual plans of care.
Review of the clinical record revealed that Resident R1 was admitted to the facility on 3/25/25.
Review of Resident R1's Minimum Data Set (MDS - a periodic assessment of care needs) dated 3/30/25, indicated diagnoses of heart failure (heart doesn't pump blood as well as it should), diabetes (a long-term condition in which the body has trouble controlling blood sugar and using it for energy), and hypertension (the force of the blood against the artery walls is too high). Section C0500 a Brief Interview for Mental Status test (BIMS - is a screening test that aides in detecting cognitive impairment) indicated a score of 12 - moderately impaired cognition.
Review of Resident R1's nursing admission evaluation dated 3/25/25, indicated Section D Skin Integrity - chronic (something that lasts a long time, often three months or more) wound left foot, and right below the knee amputation (surgical removal of a limb or part of a limb) incision with staples (used to close incisions after surgery). The skin assessment failed to indicate the presence of an insulin pump.
Review of Resident R1's hospital discharge transfer orders dated 3/25/25, indicated Humalog (insulin Lispro) a rapid-acting insulin used to manage blood sugar) 100 units/milliliter injectable solution, injectable via insulin pump - average daily dose is 90 units (max dose 100 units daily).
Review of Resident R1's physician order dated 3/25/25, indicated Humulin R (insulin regular - a short acting insulin used to manage blood sugar) injection solution, inject 90 units subcutaneously (injecting a drug into the fatty tissue layer beneath the skin) one time a day for Diabetes Insulin Pump, max dose 100 units daily. Order was erroneously transcribed by LPN Employee E6.
Review of Resident R1's care plan on 4/29/25, failed to include a problem, goal, or interventions for care and management of an insulin pump.
Interview on 4/29/25, at 9:41 a.m. Registered Nurse (RN) Employee E1 indicated "No. I haven't had education on an insulin pump".
Interview on 4/29/25, at 9:44 a.m. Licensed Practical Nurse (LPN) Employee E2 indicated remembering Resident R1 having an insulin pump, but admitted she only knows about the pump because a relative of hers had one. Nobody at the facility taught her about an insulin pump. She believed the pump came with insulin already inside of it. When asked how long the pump lasted before needing changed or refilled, LPN Employee E2 indicated they last a long while and that she did not know what type of insulin pump Resident R1 had or what it looked like.
Interview on 4/29/25, at 9:51 a.m. RN Employee E3 indicated she had not received education regarding an insulin pump. Recalled Resident R1 had one because she found it beeping one day and notified the resident's nurse. Indicated the pump looked like a very tiny infusion machine.
Interview on 4/29/25, at 9:54 a.m. LPN Employee E4 indicated she had not received education regarding an insulin pump.
Interview on 4/29/25, at 9:57 a.m. LPN Employee E5 indicated not receiving training on an insulin pump, but recalls a resident downstairs had one recently. It was LPN Employee E5's first day of orientation and that's all they could recall.
Telephonic interview on 4/29/25, at 10:12 a.m. LPN Employee E6 indicated she only picked up one shift at this facility. Recalled an admission that night during her shift of 7:00 p.m. - 7:00 a.m. When asked if she was familiar with insulin pumps, she indicated not having experience with one or receiving education on it. Recalled she arrived to work at 7:00 p.m. for her first shift at the facility and they told her she had a new admission. She remembered calling the "On Call" doctor who said someone will come in and see the new admission in the morning. She indicated she transcribed the orders from the hospital discharge transfer orders. She indicated she did not receive any training at the facility, had to pass her medications and do the admission on her own. She indicated she was not aware she entered the incorrect insulin type and that she was not aware she wrote the insulin to be injected subcutaneously in error, rather than to refill the pump.
Review of Resident R1's progress note dated 3/31/25, at 12:03 p.m. indicated resident was wearing an insulin pump. Resident was ordered to be given 90 units Humulin insulin to refill insulin pump; but the nurse administered Humulin 90 units subcutaneously in error and was transferred to the hospital where he was diagnosed with hypoglycemia and accidental insulin overdose.
Review of LPN Employee E6's employee file failed to include evidence of orientation to the facility,
Interview on 4/29/25, at 2:00 p.m. the Director of Nursing confirmed LPN Employee E6, and the facility nursing staff were not trained on insulin pumps. Confirmed LPN Employee E6 was not trained on facility processes, admission process, transcribing physician orders from hospital discharge papers, transcribed the incorrect insulin type in the admission orders, and this resulted in a negative resident outcome.
On 4/29/25, at 2:03 p.m., the Nursing Home Administrator (NHA) and Director of Nursing (DON) were made aware that Immediate Jeopardy (IJ) existed, NHA was provided the IJ Template, that placed one resident (Resident R1) in immediate jeopardy in which health and safety were impacted, and a corrective action plan was requested.
On 4/29/25, at 4:01 p.m., an acceptable Corrective Action Plan was received which included the following interventions:
Immediate Action:
Resident was sent out to the hospital for evaluation regarding insulin medication error and returned to the facility in stable condition. Resident R1 has been discharged from the facility with no plans to return.
The root cause of the event was that the facility failed to educate licensed staff on insulin pump usage, admission process, and transcribing physician orders from hospital discharge paperwork.
Residents:
-Residents will be audited by the DON or designee to identify specialty equipment by 4/29/25. If specialty equipment is identified, the staff will obtain physician orders. Care plans will be updated to include specialty equipment (if applicable) by 4/29/25.
-Admission assessments for residents admitted from 3/25/25, to present will be audited for special equipment specifically insulin pumps and/or continuous glucose monitors by the DON or designee by 4/29/25.
-Physician orders from discharge paperwork for residents admitted from 3/25/25, to present will be audited for accuracy by DON or designee by 4/29/25.
System Correction:
-Pre-admission resident screening will be conducted by the Admissions Director (AD) or designee to identify any special equipment. Special equipment needs will be communicated to the nursing team prior to resident admission. AD will be educated on this process by the NHA or designee by 4/29/25.
Licensed nursing staff (including agency) will be educated on the following:
-Pre-admission resident screening will be conducted by the AD or designee to identify any special equipment. Special equipment needs will be communicated to the nursing team prior to resident admission.
-Assessing residents upon admission for special equipment including insulin pumps/continuous glucose monitors (CGM's).
-Obtaining physician orders for specialty equipment.
-Accurate order transcription and admission red lining processes (a process to double check accuracy of orders).
-Care plan updates on specialty equipment (insulin pumps/CGM's).
-The DON or designee will educate licensed nursing staff (including agency) on updated processes by 4/30/25, or before the start of their next scheduled shift.
-Facility policy on medication administration updated and reviewed to include specialty equipment, obtaining physician orders, and updating care plans.
Monitoring:
-Audits of new resident admission assessments will be conducted by the DON or designee weekly for four weeks, monthly for two months to ensure assessments, redlining, and orders are completed and accurate. Findings of audits will be submitted through facility Quality Assurance and Performance Improvement (QAPI) program. Next QAPI meeting scheduled for 5/1/25.
Interview on 4/30/25, at 10:50 a.m. RN Employee E6 indicated she wasn't familiar with insulin pumps prior to receiving training, and that Resident R1's insulin pump was beeping and she asked him what it was. Resident R1 (with a BIMS of 12) educated RN Employee E6 on the insulin pump. RN Employee E6 drew up the insulin and Resident R1 showed RN Employee E6 how to fill the pump with the insulin.
Telephonic interview on 4/30/25, at 11:29 a.m. LPN Employee E7 verified she received education on insulin pumps, facility processes, admission process and transcribing physician orders from hospital discharge papers.
Telephonic interview on 4/30/25, at 11:37 a.m. LPN Employee E8 verified she received education on insulin pumps, facility processes, admission process and transcribing physician orders from hospital discharge papers.
Review of the Abatement plan on 4/30/25, indicated:
-Resident R1 was sent out to the hospital and later returned. Has since discharged home status post physical and occupational therapy and wound care.
-The root cause of the event was listed as the facility failed to educate licensed staff on insulin pump usage, admission process, and transcribing physician orders from hospital discharge paperwork.
-The DON completed a house audit on 84 of 84 residents in house for specialty equipment needs. No new residents identified.
-New Admissions (20 residents) assessed for special equipment since 3/25/25, completed.
-New Admissions (20 residents) physician order audit for accuracy and no discrepancies found.
-AD was in-serviced on pre-admission screening for special equipment prior to acceptance to facility including, life vest, insulin pump, CGM's, pacemakers, etc.
-Facility policy updated to include specialty equipment having physician orders and care plans reflective of equipment.
-Facility professional nurses 27 of 27 received education.
-Agency professional nurses 17 of 17 received education.
Total professional staff 44.
-Interviewed nine of nine professional staff in house on 4/30/25, who verified they received training.
-Six professional nurses confirmed via phone on 4/30/25, 11:39 a.m.
-Total of 15 verified receiving education.
-Audit forms completed per plan, next QAPI, May 1, 2025.
-No additional equipment needs were identified through the abatement process.
The Immediate Jeopardy was lifted on 4/30/25, at 12:03 p.m. when the action plan was verified.
During an interview on 4/29/25, at 2:03 p.m. the NHA and DON confirmed that the facility failed to ensure that nursing staff have the specific competencies, and skill sets necessary to provide care for a resident with an insulin pump, and placed one resident (Resident R1) in immediate jeopardy in which health and safety were impacted.
28 Pa. Code: 201.14(a) Responsibility of Licensee.
28 Pa. Code: 211.10(d) Resident care policies.
28 Pa. Code: 211.12 (d)(5) Nursing Services.
| | Plan of Correction - To be completed: 05/29/2025
1. Resident was sent out to the hospital for evaluation regarding insulin medication error and returned to facility in stable condition. Resident has been discharged from the facility with no plans to return.
2. A whole house audit was completed by DON or designee to identify residents with specialty equipment on 4-29-25. If specialty equipment was identified, staff obtained physician orders and care plans updated.
3. A whole house audit of admission assessments for residents admitted from 3/25/25 to present was audited for special equipment (specifically insulin pumps and/or continuous glucose monitors by DON or designee by 4-29-25.
4. Physician orders from discharge paperwork for residents admitted from 3/25/25 to present was audited for accuracy by DON or designee by 4-29-25.
5. Licensed staff will be educated on updated admission assessments, obtaining physician orders, accurate order transcription, admission redlining process, and care plan updates for specialty equipment. This will be provided by DON or designee.
6. A directed in-service presented by AAE consulting will take place on 5/27/25 to educate licensed staff on this occurrence and best practice. The program is: Competent nursing staff.
7. Admissions director was educated by NHA on a pre-admission screening process on 4-29-25. Special equipment needs will be communicated to the nursing team prior to resident admission.
8. The facility policy on medication administration was updated and reviewed to include specialty equipment, obtaining physician orders, and updated care plans. The facility policy includes that the facility does not utilize insulin pumps. The facility does not accept residents with insulin pumps. If the resident has a CGM, they can choose to use it however per facility policy, orders will be obtained for blood glucose checks.
9. To ensure competent nursing staff, onboarding of new nurses will include orientation by the DON that reviews the facility resident admission process, redlining, care plans, and specialty equipment.
10. Audits of new resident admission assessments will be conducted by DON or designee weekly x 4 weeks, then monthly x 2 months to ensure admission assessments, redlining, care plans, and orders are completed and accurate.
11. Findings of audits will be submitted through facility QAPI program for monitoring.
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