**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on record reviews, and Nurse Practitioner (NP), Physician, Pharmacist, Endocrinologist, and staff interviews, the facility failed to prevent a significant medication error related to hydrocortisone prescribed for Resident #137 (hydrocortisone tablets are a steroid medication that works by decreasing inflammation, slowing down an overactive immune system or replacing the cortisol hormone that helps the body respond to stress) when Resident #137 missed a dose of hydrocortisone on (8/29/24), received the wrong dose of hydrocortisone for two days (8/30/24 and 8/31/24) and then the medication was abruptly stopped. Abrupt cessation of hydrocortisone for adrenal insufficiency can cause an adrenal crisis, where the body experiences a sudden drop in cortisol levels and can lead to life-threatening complications such as low blood pressure. Resident #137 went 18 days without receiving hydrocortisone. Resident #137 was scheduled to be seen by the Endocrinologist on 9/19/24 for the missed doses of hydrocortisone but she was transferred to the hospital on 9/19/24 at the request of family and admitted for weakness and low blood pressure 99/79 (normal blood pressure is 120/70). This was for 1 of 9 residents reviewed for significant medication errors (Resident #137). The findings included: Review of the hospital discharge orders for Resident #137 dated 8/28/24 revealed an order hydrocortisone 10 milligrams (mg) tablet for adrenal insufficiency, (administer) 15 mg (1.5 tablets) in AM and 10 mg (1 tablet) in afternoon by mouth with food. Double or triple dose for illness for 3 days as directed (during illness, the body requires additional cortisol to regulate inflammation, blood pressure, and maintain blood volume.) Resident #137 was admitted to the facility on [DATE] with diagnoses including adrenocortical (adrenal) insufficiency. Adrenal insufficiency is a disorder in which the adrenal glands produce insufficient amounts of cortisol. A deficiency of cortisol can result in a life-threatening crisis characterized by low blood pressure. Additional diagnoses for Resident #137 included diabetes, malnutrition, high blood sodium levels, breast cancer, syncope and collapse (fainting), and abnormal gait. A physician's order transcribed from the hospital discharge summary by Unit Manager #1 dated 8/29/24 specified hydrocortisone 10mg give 1.5 tablets by mouth in the afternoon for inflammation for 3 days. The stop date for the order was 9/1/24. A physician order dated 8/30/24 for midodrine (a medication that elevates blood pressure) 10 mg every 8 hours for low blood pressure, do not give fore blood pressure over 130/80. An NP admission note written by NP #4 dated 8/30/24 was reviewed. NP #4 documented Resident #137 was to take hydrocortisone 10 mg 1.5 tablets every evening with a stop date of 9/2/24. Review of Resident #137's medication administration record (MAR) documented by Nurse #1 that on 8/29/24 Resident #137 did not receive the hydrocortisone due to the medication not being available. Further review of the MAR documented hydrocortisone 10mg 1.5 tablets was administered on 8/30/24 and 8/31/24. Review of the medication administration record for September 2024 documented Resident #137 did not receive hydrocortisone from 9/1/24 to 9/18/24. Review of the blood pressures for Resident #137 revealed the following: (normal blood pressure 120/70) - 9/1/24 117/78 at 10:00 PM - 9/3/24 97/64 at 2:00 PM; 109/58 at 10:00 PM - 9/4/24 106/75 at 2:00 PM; 104/62 at 10:00 PM - 9/5/24 97/58 at 6:00 AM; 115/56 at 2:00 PM; 96/59 at 10:00 PM - 9/6/24 93/52 at 6:00 AM; 115/56 at 10:00 PM - 9/7/24 81/61 at 6:00 AM; 112/66 at 10:00 PM - 9/8/24 118/75 at 10:00 PM - 9/9/24 101/68 at 10:00 PM - 9/10/24 76/54 at 6:00 AM - 9/12/24 109/79 at 2:00 PM - 9/13/24 104/66 at 6:00 AM; 105/76 at 10:00 PM - 9/14/24 105/72 at 6:00 AM - 9/15/24 96/56 at 10:00 PM - 9/16/24 105/68 at 6:00 AM; 102/64 at 2:00 PM; 75/54 at 10:00 PM - 9/17/24 75/54 at 6:00 AM; 91/48 at 2:00 PM; 112/71 at 10:00 PM - 9/18/24 95/65 at 6:00 AM; 95/65 at 2:00 PM; 105/55 at 10:00 PM - 9/19/24 92/61 at 6:00 AM Unit Manager #1 was interviewed on 1/8/25 at 8:47 AM. Unit Manager #1 reported she transcribed the discharge hospital orders for Resident #137 upon her admission to the facility on 8/28/24. Unit Manager #1 explained she read the hydrocortisone order to be for 3 days only and transcribed the order as she understood it. Unit Manager #1 reported she had not clarified the order with the hospital, and she had not called the Endocrinologist to ask for clarification. Unit Manager #1 reported she was not certain if the NP or the physician had reviewed the orders for Resident #137. Unit Manager #1 reported after she transcribed the hospital discharge orders, she asked Unit Manager #2 to check the orders and Unit Manager #2 did not report any transcription mistakes to her. When asked how she understood the orders for hydrocortisone, Unit Manager #1 explained she thought that the medication was to be given for only 3 days, and it didn't occur to her to call the Endocrinologist for clarification or ask the physician or NP to review the order. Unit Manager #1 reported she was not aware Resident #137 did not receive the medication on 8/29/24. Unit Manager #1 reported she was not aware she had not correctly transcribed the order for hydrocortisone. Unit Manager #2 was interviewed on 1/8/25 at 10:07 AM. Unit Manager #2 reported she reviewed Resident #137's hospital discharge orders and the orders in the electronic documentation system and she did not notice the hydrocortisone was ordered for only 3 days. Unit Manager #2 reported when she reviewed the hospital discharge orders, she thought the medication was supposed to be ordered for 3 days only and she did not notice the dose was not ordered correctly. Unit Manager #2 reported she did not call the physician, NP, or the Endocrinologist for clarification of the hydrocortisone order. NP #4 was interviewed by phone on 1/8/25 at 12:50 PM. NP #4 reported she saw Resident #137 for her admission assessment on 8/29/24. NP #4 explained she reviewed the hospital discharge orders and the orders in the electronic documentation system, but she did not notice the hydrocortisone was transcribed incorrectly. NP #4 reported hydrocortisone should not have been stopped abruptly because it would cause the body to lose an essential hormone and could cause an adrenal crisis. A pharmacist note written by Pharmacist #1 and dated 8/30/24 documented based upon the information available at the time of the review, and assuming the accuracy and completeness of such information it is my professional judgement that at such time, the resident's medication regimen contained no new irregularities . A follow-up phone interview was conducted on 1/15/25 at 1:00 PM with Pharmacist #2 and Pharmacist #3. Pharmacist #3 explained that hydrocortisone was used in adrenocortical insufficiency to replace the hormone cortisol the body made to maintain blood pressure and other functions. Pharmacist #3 reported she was unable to say if Resident #137 was affected adversely by the cessation of the hydrocortisone, as the Endocrinologist would have been responsible for managing the dosage of hydrocortisone. A physician history and physical note written by the Physician dated 9/3/24 documented hydrocortisone was to continue for adrenal insufficiency. The history and physical note did not document the hydrocortisone dose. A phone interview was conducted with the Physician on 1/8/25 at 1:03 PM. The Physician reported he had reviewed the hospital discharge orders but had not reviewed the orders transcribed into the electronic documentation system. The Physician reported the hydrocortisone was a significant medication error and the medication should not have been stopped abruptly. The admission Minimum Data Set assessment dated [DATE] assessed Resident #137 to be cognitively intact. A NP progress note dated 9/18/24 was reviewed. NP #2 documented that on 9/17/24 Resident #137's family member asked about the hydrocortisone and NP #2 documented that the hydrocortisone appeared to not be ordered. NP #2 documented she discussed Resident #137's symptoms and labs with the Endocrinologist and it appears that (Resident #137) is supposed to be on hydrocortisone 15 mg in the morning and 10 mg in the evening, which is not currently ordered. (Resident #137) received 3 days of hydrocortisone since admission to the facility (per medication administration record). The note documented the Endocrinologist ordered hydrocortisone 20 mg to be given now and 10 mg in the evening for 3 days and then 15 mg in the morning and 10 mg in the evening. The note documented the endocrinologist wanted Resident #137 to come to the office to be seen on 9/19/24. A physician order dated 9/18/24 to administer hydrocortisone 20 mg, give 1 tablet by mouth once per day for 2 days. Administer 10 mg tablet in the evening. Beginning 9/21/24 administer hydrocortisone 15 mg in the morning and 10 mg in the evening. NP #2 was interviewed on 1/8/25 at 9:40 AM. The NP reported she was not working on 8/28/24 when Resident #137 was admitted to the facility and NP #4 did the admission assessment. NP #2 reported she had reviewed Resident #137's medications (she was uncertain of the exact date) and made a call to the Endocrinologist to clarify the hydrocortisone order. NP #2 reported on 9/17/24 Resident #137's family member inquired about the hydrocortisone and NP #2 was able to talk to the Endocrinologist and received clarification of the order. NP #2 explained Resident #137 should have continued hydrocortisone and it should not have been stopped abruptly because it could cause an adrenal crisis if stopped. A follow-up phone interview was conducted with NP #2 on 1/16/25 at 10:50 AM. NP #2 clarified that the Endocrinologist had ordered hydrocortisone to be given immediately, plus gave orders for the medication for the following days. A follow-up interview was conducted by phone with the Physician on 1/15/25 at 2:48 PM and he reported the hydrocortisone dose would have been determined by the Endocrinologist, and NP #2 did the right thing by contacting the Endocrinologist for orders on 9/17/24. The Physician explained stopping hydrocortisone abruptly could cause an adrenal crisis. The Physician reported he would have expected the Unit Manager to call him, the NP, the hospital or the Endocrinologist for clarification of orders. A nursing note dated 9/19/24 at 12:15 PM documented Resident #137 was taken to her endocrinology appointment by her family member but returned to the facility without being seen by the Endocrinologist. The family member reported he was running late and was unable to get Resident #137 to the appointment on time, and he requested Resident #137 be sent to the emergency room. Hospital emergency room records dated 9/19/24 for Resident #137 documented she was admitted to the hospital for weakness and low blood pressure. Blood pressure on admission to the emergency room was 99/79. Resident #137 was a [AGE] year-old female with a past medical history significant for adrenal insufficiency. A computed tomography (CT) scan was completed on 9/19/24 and a large volume pneumoperitoneum (a condition where air or gas was in the abdominal cavity) was revealed, leading to concerns for a large bowel perforation. The decision was made with Resident #137 and her family member to undergo a laparotomy. Resident #137 was taken urgently to the operating room at 9:00 PM on 9/19/24 for lysis of adhesions, resection of the colon with a colostomy. After the surgery, Resident #137 was transferred to ICU, and she developed worsening low blood pressure. Lab results showed severe acute blood loss anemia. Resident #137 lost pulses and her abdomen was reopened in the ICU where approximately 750 cubic centimeters of blood were discovered. Resident #137 received several rounds of cardiopulmonary resuscitation efforts, and she died at 5:10 AM on 9/20/24. The Endocrinologist was interviewed by phone on 1/15/25 at 4:49 PM. The Endocrinologist reported she recalled talking to NP #2 and ordered Resident 137 to receive hydrocortisone 20 mg immediately. The Endocrinologist explained that stopping hydrocortisone abruptly would have caused an adrenal crisis and this crisis would have caused Resident #137 difficulties with controlling her blood pressure and caused fatigue, as well as other symptoms. The Endocrinologist explained that the adrenal crisis would not have contributed to the bleeding post-operatively. The Administrator was notified of immediate jeopardy on 1/9/25 at 10:45 AM. The facility submitted the following corrective action plan with a compliance date of 9/27/24. Address how the corrective action will be accomplished for those residents found to have been affected by the deficient practice On 08/29/24 Resident #137 was admitted to the facility. The hospital discharge summary orders for Resident #137 read: hydrocortisone 10mg tablet, (administer) 15mg (1.5 tablets) in AM and 10 mg (1 tablet) in afternoon by mouth with food, double or triple doses for illness for 3 days as directed. Resident #137 had a diagnosis of adrenal insufficiency and was prescribed hydrocortisone. The Unit Manager transcribed the order on 08/29/24: hydrocortisone 10 milligrams (mg) give 1.5 tablet by mouth in the afternoon for inflammatory for 3 days until 09/01/24. Resident #137's Medication Administration Record (MAR) was reviewed and there was no documentation of any doses of hydrocortisone administered from 09/02/24 - 09/18/24. One 20mg Hydrocortisone was administered the morning of 09/19/24. On 09/19/24, Resident #137 was transferred to the hospital, and she underwent a laparotomy for lysis of adhesions, resections of the sigmoid colon with end colostomy. Post surgery she was transferred to the Intensive Care Unit (ICU) and developed hypotension and was found to have experienced severe acute blood loss anemia and died on [DATE]. Address how the facility will identify other residents having the potential to be affected by the same deficient practice The facility recognizes that all newly admitted and readmitted residents have the potential to be affected from the prior noncompliance with significant medication errors All newly admitted and readmitted residents between 08/26/24 - 09/26/24 medication orders were audited by the Director of Nursing and or Unit Managers to ensure orders were transcribed correctly on 09/26/24. 30 residents were audited with no discrepancies noted. A quality review was completed on 09/25/24 by the Director of Nursing and or Unit Manager of current residents with a diagnosis of adrenal insufficiency and with hydrocortisone orders to ensure medication is ordered, transcribed correctly, and being given as ordered, no discrepancies noted. On 09/25/24, a quality review of current residents admitted and readmitted within the past 30 days prior to 09/25/24 was conducted by the Director of Nursing and Unit Manager to ensure all other newly admitted or readmitted patients' medications are administered per physician orders and transcribed correctly on the Medication admission Record (MAR). Address what measures will be put into place or systemic changes made to ensure the deficient practice will not recur. On 09/25/24, a Root Cause Analysis was completed by the Director of Clinical Services, and the Executive Director regarding omission of medication administration for resident #137. It was determined through root cause and analysis that the significant medication error was due to the oversight of transcribing the orders incorrectly and there was no verification conducted by a second nurse. The Director of Nursing and/or the nurse managers provided education on 9/25/24 to current nurses on the importance of transcribing all new orders from discharge summaries, verified by 2 nurses to ensure medications are transcribed and administered per physician orders to the residents. Newly hired nurses will be educated on hire during the orientation process. The Executive Director provides oversight for the education of nurses to ensure that 100% of all licensed staff were reeducated on the importance of administrating all ordered medications. Education was completed on 09/25/2024. Indicate how the facility plans to monitor its performance to make sure that solutions are sustained. The Director of Nursing and or Nurse Managers will conduct Quality Improvement Monitoring 5 times per week for 4 weeks, 1 time per week for 3 months and 1 time monthly for 3 months in clinical morning meeting to review the medication administration records of all new residents when admitted or readmitted to ensure all medications are transcribed correctly and medications are administered as ordered per physician starting 9/25/24. Upon receiving hospital discharge summaries medication orders are verified with the provider, 2 nurse verification system; 1 Nurse transcribes all orders, then 1 Nurse verifies/confirms that orders were transcribed correctly. They also review the previous days admissions during the morning meeting and verify during the meeting. On 9/25/24, when the deficient practice of transcribing orders that resulted in a significant medication error was identified the center Executive Director conducted an ADHOC Quality Assurance Performance Improvement (QAPI) meeting to determine the root cause analysis of the deficient practice. The QAPI committee put a plan of action in place to include quality improvement monitoring and the frequency of monitoring beginning on 9/26/24 to ensure medication administration orders were transcribed correctly and medications were administered as ordered. The QAPI committee included the Executive Director, Medical Director, Director of Nursing, the Manager of Social Services, a Unit Manager, Wound Care Nurse, and two floor Nurses. The results of the quality monitoring will be brought to the Quality Assurance Performance Improvement meeting monthly to ensure ongoing compliance for 4 months. Quality Improvement schedule will be modified based on findings of the monitoring. The Center Executive Director alleges compliance on 9/27/24. The corrective action plan was validated on 1/9/25. Education for all nurses was reviewed, and interviews were conducted with the Unit Managers and the staff nurses to confirm receipt of the education. Initial audits of new admissions from 8/26/24 to 9/26/24 were reviewed and no significant medication errors were identified. Quality reviews of current residents and new admissions were reviewed, and no issues were identified. Morning meeting and QAPI meeting notes were reviewed with the DON and Administrator. The immediate jeopardy removal date of 9/27/24 and the compliance date of 9/27/24 was validated.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on resident observation, record review, and interviews with the nursing staff, Nurse Practitioner (NP), and Medical Director, the facility failed to administer pain medication prior to completing 50 wound dressing changes during the previous 34 days for a resident with a Stage 4 pressure ulcer and severe cognitive impairment. This occurred for 1 of 2 residents (Resident #16) reviewed for pressure ulcers. Resident #16's Stage 4 pressure ulcer on her left heel required scheduled wound dressing changes; the frequency of these dressing changes increased from once daily to twice a day on 6/22/23. At that time, Resident #16 had an order for an opioid pain medication to be administered twice daily. However, the frequency of this pain medication (med) was reduced with instructions to administer only one dose of the opioid pain medication every 24 hours as needed for heel/leg pain (Start Date 6/23/23). The order also included a notation to give the pain medication 60 minutes prior to dressing changes. Staff interviews revealed Resident #16 would frequently holler out and kick during wound dressing changes and she would sometimes yell so loudly during wound care that she could be heard out in the hallway (even with the door closed). Nursing staff described the resident's level of pain during dressing changes as, off the scale and severe. Immediate Jeopardy began on 6/23/23 when Resident #16's medication orders were reduced to once daily dosing and no longer coincided with the frequency of the resident's wound dressing changes provided twice a day. Immediate Jeopardy was removed as of 8/9/2023 when the facility implemented an acceptable allegation of Immediate Jeopardy removal. The facility remains out of compliance at a scope and severity level E (no actual harm with potential for more than minimal harm that is not immediate jeopardy) for the facility to continue staff education and ensure monitoring systems put into place are effective. The findings included: Resident #16 was admitted to the facility on [DATE]. Her cumulative diagnoses included diabetes, peripheral vascular disease, hemiplegia (paralysis on one side of the body) and hemiparesis (partial weakness on one side of the body) following unspecified cerebrovascular disease, a history of gout, chronic pain syndrome, Alzheimer's disease, and dementia. The resident's physician's orders included the following, in part: --325 mg acetaminophen to be given as two tablets by mouth every 6 hours as needed for pain (Start Date 5/25/23). --Left heel: Clean with ¼ strength Dakins (a solution used to prevent and treat skin and tissue infections), pack with gauze soaked with Dakins, covered by a dry dressing every day and evening shift (Start Date 6/22/23). --50 milligrams (mg) tramadol (an opioid pain medication) to be given as one tablet by mouth every 24 hours as needed for heel/leg pain. Give 60 minutes prior to dressing changes (Start Date 6/23/23). Tramadol is a controlled substance medication. A review of Resident #16's electronic medical record (EMR) included a progress note dated 6/28/23 and authored by the Nurse Practitioner (NP) who helped to care for the resident. The History of Present Illness noted, .She has a left heel unstageable pressure ulcer under treatment. The wound MD is closely following it for treatment interventions and the wound nurse is following it for daily drsg [dressing] changes . Resident #16's most recent Minimum Data Set (MDS) was a significant change assessment dated [DATE]. The MDS reported the resident had severely impaired cognition. Resident #16 required extensive assistance for bed mobility, transfers, dressing, toileting, and personal hygiene. She was totally dependent on staff for eating. The resident was reported to be incontinent of bladder and bowel. The MDS indicated Resident #16 had one unhealed Stage 4 pressure ulcer. The assessment reported the resident received as needed (PRN) medication for pain, which included an opioid pain medication on 1 out of 7 days during the look back period. A Wound Evaluation and Management Summary dated 7/6/23 revealed Resident #16 was seen for follow-up by the facility's Wound Care Physician #1 for an assessment and evaluation. The resident was reported to have a Stage 4 pressure wound (full thickness) of the left heel of greater than 88 days duration. The size of the wound was measured as 6.4 centimeters (cm) length by 5.8 cm width by 1.8 cm depth. The wound was reported to have deteriorated due to the generalized decline of the patient. Resident #16 was also followed by Wound Care Physician #1 on 7/13/23 and 7/20/23. The Wound Evaluation and Management Summary from the 7/20/23 visit indicated the size of resident's Stage 4 pressure wound (full thickness) of the left heel was measured as 7.4 cm in length by 5.7 cm width by 1.7 cm depth. The wound progress was reported as Exacerbated due to generalized decline of patient. The Additional Wound Detail note read: progressive necrosis of plantar foot wound noted. Do not think that this wound will heal, and if it does, it will mean over 2 years of dressing changes and pain from wound. Will check with family to see if they would consider a below knee amputation to give healed wound, less pain over time and decrease need for daily dressing changes for the foreseeable future. The resident's most recent care plan (last date of review completed on 7/20/23) included the following areas of focus: --Resident has Activities of Daily Living (ADL) self-care performance deficits related (in part) to weakness, debility, and residual left hemiparesis for old cerebrovascular accident (CVA or stroke), Alzheimer's disease, and dementia. A notation within this area of focus (dated 7/4/23) reported the resident had a significant change in condition with deterioration of a pressure wound to her left heel. --Resident has actual skin breakdown/cellulitis with potential for further impaired skin integrity related to incontinence, a history of diabetes, and impaired mobility. An undated notation within this area of focus documented, medication for pain prior [to] dressing changes as ordered and deterioration. The planned interventions included providing treatment(s) to the resident's left heel as ordered and continuing treatment via the wound physician. The resident's physician's orders included the following, in part: --Left heel: Clean with ¼ strength Dakins, pack with gauze soaked with Dakins, covered by an ABD pad (a highly absorbent, non-woven material that [NAME] moisture away from the wound) with dry dressing every day and evening shift (Start Date 7/25/23). --250 mg cephalexin (an antibiotic) to be given as 1 tablet by mouth every 12 hours for left heel cellulitis times 14 days (Start Date 7/26/23). Resident #16 continued to be followed by Wound Care Physician #1 on 7/27/23. The Wound Evaluation and Management Summary from the 7/27/23 visit indicated the size of resident's Stage 4 pressure wound (full thickness) of the left heel was measured as 7.6 cm in length by 5.6 cm width by 1.9 cm depth. The wound progress was reported as not improved. On 8/2/23, Resident #16 was seen by Wound Care Physician #2 (a provider covering for Wound Care Physician #1). The Wound Evaluation and Management Summary from the 8/2/23 visit indicated the size of resident's Stage 4 pressure wound (full thickness) of the left heel was measured as 9.2 cm in length by 6.7 cm width by 1.9 cm depth. The wound progress was again reported as not improved. Wound Care Physician #1 was not available for an interview. An observation of Resident #16's wound care was scheduled with the facility's Wound Care Nurse for the morning of 8/3/23. On 8/3/23 at 7:45 AM, the Wound Care Nurse cautioned that although Resident #16 would frequently holler out and kick during the wound dressing changes, she would have to continue to complete her wound care. The nurse stated she typically needed to have another staff member in the room to help hold the resident during the wound dressing change. The Wound Care Nurse confirmed Resident #16 had been premedicated for pain. On 8/3/23 at 7:57 AM, Nurse Aide (NA) #1 and the Wound Care Nurse were accompanied to Resident #16's room for her wound dressing change. Both the nurse and NA were observed as they washed their hands and donned clean gloves. The Wound Care Nurse explained to Resident #16 what they were planning to do. The resident gave permission for the wound dressing change and observation of the wound care at that time. Resident #16 was repositioned onto her right side; the NA supported her with one hand while gently holding her other hand. As the Wound Care Nurse removed the wound's outer dressing and gauze packing the wound, the resident moaned and called out in pain. She also appeared to try and move her leg away as the wound was re-packed and dressed; the Wound Care Nurse requested the NA attempt to hold her foot and leg still. As the resident exhibited these obvious signs of pain, NA #1 was observed as he rubbed the resident's back and leg to help soothe her. At the conclusion of the wound care, both NA #1 and the Wound Care Nurse agreed the resident did relatively well during this dressing change. NA #1 explained that sometimes he could hear the resident yell so loudly during wound care that she could be heard out in the hallway (even with her door closed). A review of the resident's EMR included her July 2023 and August 2023 Treatment Administration Records (TARs). The TARs from 7/1/23 to 8/3/23 indicated the resident's wound dressing was scheduled to be changed every day and every evening shift (twice daily). A review of Resident #16's Controlled Medication Utilization Record (a declining inventory sheet) revealed from 7/1/23 to the morning of 8/3/23, only 17 doses of tramadol had been withdrawn from the inventory dispensed for this resident. One dose of tramadol was withdrawn from Resident #16's inventory on each of the following dates: --7/2/23 at 12:19 PM --7/3/23 at 10:00 AM --7/5/23 at 10:00 PM --7/9/23 at 9:00 PM --7/12/23 at 9:00 PM --7/13/23 at 10:00 AM --7/14/23 at 10:00 AM --7/17/23 at 11:00 AM --7/22/23 at 10:00 AM --7/23/23 at 11:00 AM --7/24/23 at 10:00 AM --7/25/23 at 11:05 AM --7/26/23 at 12:06 PM --7/27/23 at 9:00 AM --7/28/23 at 10:00 AM --7/31/23 at 10:30 AM --8/3/23 at 6:07 AM A review of the resident's Medication Administration Record (MAR) from July 2023 and August 2023 revealed from 7/1/23 to the morning of 8/3/23, only 4 doses (two tablets) of 325 mg PRN acetaminophen was administered to Resident #16 on the following dates: --7/3/23 at 10:08 PM --7/6/23 at 10:42 AM --7/19/23 at 5:52 AM --7/20/23 at 5:49 AM An interview was conducted with the Wound Care Nurse on 8/3/23 at 2:00 PM. Upon inquiry, the Wound Care Nurse reported she completed the facility's wound dressing changes on Monday through Friday's day shift while the hall nurses completed the wound care during the evening shifts and on weekends. When asked about the pre-medication for Resident #16, the nurse stated she always checked with the hall nurse to be sure the resident had received her pain medication prior to doing her dressing change. When the results of Resident #16's Controlled Medication Utilization Record were shared, the Wound Care Nurse stated from now on she would need to verify the resident had been pre-medicated before proceeding with a dressing change instead of just asking the nurse about it. At that time, the nurse confirmed the resident's orders for tramadol included only one dose every 24 hours. The Wound Care Nurse reported Resident #16's pain meds had been reduced by the NP some time ago because twice daily dosing sedated her too much. The nurse reported Resident #16 did very well with the dressing change today and NA #1 had even commented to her about it. She reported the resident usually exhibited three (3) times the behaviors related to pain during dressing changes that were observed earlier that morning (on 8/3/23). When repeating what NA #1 said about the resident sometimes yelling out so loud in pain that she could be heard out in the hallway, the nurse acknowledged this statement was true. A telephone interview was conducted on 8/7/23 at 2:22 PM with Nurse #8. Nurse #8 was identified by her initials on Resident #16's July 2023 TAR as having completed the resident's evening wound dressing changes on 7/2/23, 7/5/23, and 7/12/23. Nurse #8 was also identified as having withdrawn one dose of tramadol for Resident #16 on 7/5/22 at 10:00 PM and on 7/12/22 at 9:00 PM. When asked if she could recall whether the tramadol was given to the resident as pre-medication prior to the dressing changes on those evenings, the nurse thought they likely were because she typically completed dressing changes after her medication pass was done. When asked about the resident's level of pain during the evening dressing changes, the nurse stated, for sure, she had discomfort with the dressing changes. The nurse stated she had not worked with the resident in the last 3 weeks or so but when she did, Resident #16 would occasionally cry out in pain when she completed the dressing changes. A telephone interview was conducted on 8/7/23 at 2:37 PM with Nurse #4. Nurse #4 was identified by her initials on Resident #16's July 2023 TAR as having completed evening wound dressing changes for the resident on 7/9/23, 7/17/23, and 7/23/23. The nurse recalled that the resident initially received her pain medication (tramadol) twice daily to help cover her pain with the twice daily dressing changes. However, the pain medication was later reduced to once daily. The nurse reported it was difficult to know what to do because the order for pain medication indicated it was to be given one hour before a dressing change, but the dressing changes were done twice daily. The nurse stated she would give the resident her pain medication in the morning and acetaminophen later as well. When asked about the resident's level of pain experienced during the evening dressing changes, Nurse #4 stated, It was off the scale. The nurse described her pain as severe and reported Resident #16 would holler out and try to move her feet away. Nurse #4 reported she would always give the resident chewing gum after her dressing change as a reward because she knew the resident enjoyed it. A telephone interview was conducted on 8/7/23 at 3:59 PM with Nurse #9. Nurse #9 was identified by her initials on Resident #16's July 2023 TAR as having completed evening wound dressing changes for the resident on 7/3/23, 7/8/23, 7/10/23, 7/13/23, 7/14/23, 7/22/23 7/27/23, and 7/31/23. Upon inquiry, Nurse #9 was asked how Resident #16 tolerated her dressing changes. The nurse stated, Most of the time, she doesn't like it. She flinches. Nurse #9 added that the resident might call out Ow at times and would also try to move her leg some. When asked if she could estimate the resident's level of pain exhibited, the nurse stated it varied but was probably a 5 (on a scale of 0 to 10, with 0 indicative of no pain). She stated, I try to do it [the dressing change] as easy as I can. Upon further inquiry, the nurse reported removing and replacing the packing from Resident #16's wound tended to be the most painful part of the dressing change for her. Nurse #9 stated she has given the resident PRN acetaminophen quite a few times in the past to help with the pain. When asked why she did not give the acetaminophen to the resident every time she had to do a dressing change, the nurse stated it would have been because someone else had probably given it to her. An interview was conducted on 8/3/23 at 3:55 PM with the facility's Director of Nursing (DON). During the interview, the DON was shown Resident #16's TARs (which documented dressing changes were scheduled to be completed twice daily), along with her order for 50 mg tramadol to be given as one tablet by mouth every 24 hours as needed for heel/leg pain to be given 60 minutes prior to dressing changes. When asked about the discrepancy in the frequency of the wound care and pre-medication orders, the DON recalled that at some point in time Resident #16's pain medication had been reduced due to sedation. The DON reported the order for the pain medication should have been written differently and added to the resident's TAR to ensure the resident was always pre-medicated prior to her dressing changes. A telephone interview was conducted on 8/4/23 at 9:27 AM with the facility's Administrator, DON, and Wound Care Nurse. During the interview, the Wound Care Nurse reported she had received a verbal order from Wound Care Physician #1 some time ago for the frequency of the dressing changes for Resident #16 to be completed twice daily (instead of once a day). Upon review of the resident's medical record, the Wound Care Nurse reported the verbal order for twice daily dressing changes was received on 6/22/23 due to the large amount of drainage the resident had from her wound. The DON reported Resident #16's pain management was addressed last evening (8/3/23) with new orders written by the facility's Medical Director. A telephone interview was conducted on 8/4/23 at 8:00 AM with the resident's NP and her Clinical Services Manager. During the interview, the NP was informed that Resident #16's wound dressing change for the Stage 4 pressure ulcer on her left heel was observed on the morning of 8/3/23. Although the Wound Care Nurse and NA both reported the resident was less vocal and less resistant to the wound care than usual, the resident was observed to exhibit obvious signs of pain even after being pre-medicated. When the NP was asked if she was aware of the resident having pain with the dressing changes, the NP stated Resident #16 was at a point where she needed to have a portion of her limb amputated. She stated until then, the resident would have pain there. She added, no amount of pain med will take care of that pain. When asked if the NP intended for Resident #16 to be pre-medicated with a dose of tramadol prior to each dressing change, the NP replied, Correct that's for the first wound [first dressing change]. The NP reported at one point, she tried to schedule an opioid pain medication twice daily but that was too much for this resident. The NP stated, She was truly lethargic with twice a day dosing. Upon further inquiry, the NP reported she did not know until yesterday (8/3/23) that the resident was getting a dressing change twice a day. She stated, My intentions were daily if they were doing it [dressing changes] daily and [that she be] pre-medicated before [the wound care]. When asked if the NP was aware the resident was not always being pre-medicated for dressing changes, she responded by saying, No, I wanted her to be pre-medicated before the dressing changes daily. The NP stated Resident #16 did have medication orders for PRN acetaminophen and the NP would encourage administration of it in addition to the tramadol to help with the pain. An interview was conducted on 8/2/23 at 2:14 PM with the facility's Medical Director (who is also a Medical Doctor or MD). During the interview, the MD reported Resident #16's wound would not heal at this point due to the lack of circulation to her limb. He stated a surgical consult was requested and amputation of her lower leg was recommended. He reported Resident #16's family needed to decide as to whether the amputation would be done. A follow-up telephone interview was conducted on 8/4/23 at 9:40 AM with the facility's Medical Director. During the interview, the MD reported although the resident was under another provider's service, he was the physician for all residents in the building. The observation of Resident #16's wound dressing change on 8/3/23 and staff interviews were discussed, along with the resident's medication records which revealed she was not routinely pre-medicated for the dressing changes scheduled each day. When asked, the MD reported twice daily dressing changes would not deter a wound from healing and would only help. The MD recalled Resident #16's NP had shared that the resident's pain medication was previously cut back due to oversedation. However, the MD reported that yesterday (8/3/23), he went ahead and changed her medication regimen. The MD stated he trusted the changes would help the resident's level of comfort going forward and he would follow-up with her as needed. The Administrator was notified of immediate jeopardy on 8/8/2023. The facility provided the following immediate jeopardy removal plan: Credible Allegation of Immediate Jeopardy Removal F-697 o Identify those recipients who have suffered, or are likely to suffer, a serious adverse outcome as a result of the noncompliance; and Based on observations, record reviews, and State Surveyor and staff interviews, the facility failed to provide pain management for a resident with severe cognitive impairment, who had a Stage 4 pressure ulcer of her heel (Resident #16). Resident #16 has been assessed by the Wound Care nurse on 08/03/23 and pain medication was administered. Regional Director of Clinical Services, along with Executive Director notified medical director regarding pain management and new orders received for additional pain medication and hospice consult, and transcribed to the Medication Administration Record, Resident #16's responsible party was notified of new orders to include medication changes. Resident #16's Plan of Care has been updated on 08/03/2023 by the Minimum Data Set Nurse to reflect resident's problem, goal, and interventions. Current Facility Residents with wounds have the potential to be affected. a. Current Residents with wounds (12) had Pain Assessments completed by a Licensed Nurse on 8/08/23 using a Pain Assessment to determine those that are at risk for pain. a.i. Current residents with wounds (12) were reviewed to ensure current orders included pain management. These Residents had interventions put into place by a Licensed Nurse and their Plans of care were updated on 08/08/23. b. Current Residents with wounds (12) had orders for pain management received for wound care prior to treatment. Pain Evaluations were performed by a Licensed Nurse on 08/08/23 to ensure that pain management has been addressed for residents with wounds and appropriate interventions are in place. b.i. These affected Residents had interventions put into place by a Licensed Nurse and their Plans of care were updated, accordingly on 8/08/23. The residents and/or Responsible Party was notified of changes made with current orders to include pain medications and plan of care. The Facility has a contract with a Certified Wound Company with Physicians who makes rounds weekly for consultation, assessment, and treatment orders. The Certified Wound Physician is available by phone and via telehealth for consultation, assessment and treatment orders. Current Certified Wound Physician and Wound Care Nurse will be re-educated by Regional Director of Clinical Services on 08/08/2023 related to assessing pain before, during and after wound care is provided. Physician will be included in updating resident's plan of care to include pharmacological and non-pharmacological pain interventions are being offered prior to wound care management. Resident's that have dementia or other cognitive impairment will be medicated per nonverbal pain cues and assessment. Regional Director of Clinical Services also educated Wound Care Nurse on 08/08/2023, to provide a copy of the Certified Wound Physician notes and orders to the primary care provider (Nurse Practitioner or Medical Director) weekly. o Specify the action the entity will take to alter the process or system failure to prevent a serious adverse outcome from occurring or recurring, and when the action will be complete. On 08/08/2023, the Director of Nursing conducted education with the Nurse Manager/Wound Care Nurse to ensure the following Licensed Nursing Staff will assess pain before, during and after wound care is provided, to verify that pharmacological pain interventions are offered prior to wound care management, will communicate with wound care provider of any pain management changes, pain medications are to be administered as per physician orders for residents with documentation in the medical record, according to the plan of care. Wound care education will be provided by the Nurse Manager during orientation for newly hired nurses and ongoing. On 08/08/2023, the Director of Nursing conducted education with the Nurse Manager/Wound Care Nurse to ensure the Nurse Aides were provided education related to reporting pain to the nurse based on the request or observation of the patient according to the plan of care. Current Certified Wound Physician and Wound Care Nurse will be re-educated by Regional Director of Clinical Services on 08/08/2023 related to assessing pain before, during and after wound care is provided. Physician will be included in updating resident's plan of care to include pharmacological and non-pharmacological pain interventions are being offered prior to wound care management. Regional Director of Clinical Services also educated Wound Care Nurse to provide a copy of the Certified Wound Physician notes and orders to the primary care provider (Nurse Practitioner or Medical Director). On 08/08/2023, the Director of Nursing and/or Nurse Manager conducted re-education with Licensed Nursing Staff to ensure the following: a. Licensed Nursing Staff - assess pain before, during and after wound care is provided. b. Licensed Nursing Staff- education provided on how to anticipate needs and assess pain for residents that are cognitively impaired. c. Licensed Nursing staff - education provided to verify that pharmacological pain interventions are offered prior to wound care management. d. Licensed Nursing staff - will communicate with resident's primary care provider to notify of any signs and symptoms of pain and to request any pain medication. e. Licensed Nursing staff - will communicate with wound care provider of any pain management changes. Wound care education will be provided by the Nurse Manager during orientation for newly hired nurses and ongoing f. Licensed Nursing Staff- pain medications are to be administered as per physician orders for residents with documentation in the medical record, according to the plan of care. g. Starting on 08/08/2023 Nurse Aides were provided education related to reporting pain to the nurse based on the request or observation of the patient according to the plan of care. h. Staff not educated prior to 08/08/2023 will be educated prior to working their next shift. The Executive Director will validate the staff education was completed prior to the staff member working their next shift i. Certified Wound Physician received education by the Regional Director of Clinical Services on 08/08/2023 related to assessing pain before, during and after wound care is provided according to the plan of care. j. Newly hired nursing staff will be educated by the Nurse Manager during the orientation period going forward. The Executive Director is responsible for the implementation of this credible allegation F-697 Abatement Plan for removal of Immediate Jeopardy Transitional Health Services of Kannapolis (8/09/2023) Dated alleged Immediate Jeopardy removal: 08/09/23. The validation of the credible allegation conducted on 08/10/23 included licensed and certified nurse staff completed in-service education related to pain assessment of verbal and nonverbal residents prior to wound care, during wound care and post wound care. Random nurse staff were interviewed and explained the policy related identification of signs and symptoms of pain and proper reporting to the physician and Responsible Party of pain medication effectiveness. The nurse management staff began audits to monitor pain assessments for residents residing in the facility on 08/08/23. Resident care plans were reviewed and updated on 08/08/23 to reflect current pain management goals and interventions related to pain management during wound care. Resident #16 was observed asleep in bed. The wound care nurse revealed that she had performed wound care as ordered the morning of 08/10/23 and Resident #16 had received her scheduled pain medication as ordered 30 minutes prior to her wound care and Resident #16 tolerated her wound care with no verbal or nonverbal signs or symptoms of pain. Interviews were conducted with alert and oriented residents that received wound care and pain management provided during wound care with no concerns identified. Immediate Jeopardy removal date effective 08/09/23.