**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on review of medical records, review of the emergency squad run report, review of hospital records, review of email communications, review of policies on Lab and Diagnostic Test Results - Clinical Protocol, Adverse Consequences and Medication Errors and Change in a Resident's Condition or Status, staff interviews, physician interview, family interview, interview with the hospital social worker, and interview with pharmacy staff, the facility failed to ensure one resident (Resident #79) was free from neglect when the facility staff failed to provide appropriate services to ensure the resident received his intravenous (IV) antibiotic as ordered for a surgical wound infected with Methicillin-resistant Staphylococcus aureus (MRSA), failed to ensure laboratory tests were completed and results reported for medication dosing, and failed to ensure accurate assessments were being completed. This resulted in Immediate Jeopardy and the potential for serious life-threatening harm, injuries and/or death, when Resident #79 was found by the transport company staff upon arriving at the facility to be confused, aphasic, and had abnormal vital signs. The resident was determined to be in an emergent situation and was taken to the emergency room at which time his body temperature was 88.9 degrees Fahrenheit (F) and wounds were noted on bilateral inner thighs, left posterior thigh and excoriated areas on the buttocks, that the facility was unaware of. Upon admission to the emergency room, the resident was diagnosed with altered mental status, septic shock, leukocytosis with multiple sources of infection: including indwelling catheter, intravenous cite red and warm, wounds on back and groin area with erythematous, urinary tract infection, hypothermia, acute renal failure, metabolic acidosis, and hyperkalemia and was admitted to critical care. This affected one (#79) of three residents (#78, #79, and #80) reviewed for change in condition. The facility census was 74. On 02/14/23 at 5:34 P.M., the Administrator, Director of Nursing (DON), Regional [NAME] President #10, Regional Nurse #500 and Campus Executive Director #50 were notified Immediate Jeopardy began on 11/20/22 when Resident #79 was admitted to the facility from the hospital with a physician order for Vancomycin that was not administered for five days (11/20/22, 11/21/22, 11/22/22, 11/23/22, 12/15/22), and on 12/21/22, he was administered the medication when it was placed on hold; then from 12/22/22 to 12/30/22 he did not receive the medication for a period of eight days. Consequently, on 12/30/22, Resident #79 was found by the Emergency Medical Technician (EMT), who was there to take him home, to be severely confused with incoherent speech and was hypotensive. He was taken emergently to the hospital resulting in the resident receiving peripheral vasoconstrictor, intravenous fluids, warming protocol, and multiple antibiotics which led to the resident being placed in the intensive care unit (ICU). Resident #79 was admitted with diagnoses including altered mental status, septic shock, leukocytosis with multiple sources of infection: including indwelling catheter, intravenous cite red and warm, wounds on back and groin area with erythematous, urinary tract infection, hypothermia, acute renal failure, metabolic acidosis, and hyperkalemia and was admitted to critical care. The Immediate Jeopardy was removed on 02/15/23, when the facility implemented the following corrective actions: • On 12/30/22 at approximately 6:30 P.M., Resident #79 was discharged from the facility. • On 02/07/23 at approximately 12:00 P.M., the DON had discussed the communication process from the pharmacy to the facility with Registered Nurse (RN) #420, Account Representative for [NAME]'s Pharmacy. They collaboratively established a contingency plan in the event the pharmacy is unable to contact the facility directly. This plan included a call to the cell phone of the DON. If unable to reach the DON, the pharmacy is to call the cell phone of the Administrator. If unable to reach the Administrator, the pharmacy is to call the cell phone of the Regional Director of Clinical Operations (RDCO) #208. • On 02/08/23 at approximately 4:30 P.M., an audit was completed by the DON of all current residents' medical records, and it was determined there were no current patients on IV antibiotics. • On 02/08/23, an audit was completed by the DON of all residents with current orders for antibiotics, to include all routes of administration, and to verify all doses were being administered as prescribed. • Beginning on 02/08/23, education was completed by the DON with all nurses regarding the company policy titled Medication Utilization and Prescribing-Clinical Protocol. • On 02/08/23 at approximately 5:00 P.M., an ad hoc Quality Assurance and Performance Improvement (QAPI) meeting was conducted with the Administrator, the DON, RDCO #208 and Medical Director (MD) #100 (via phone). A root cause analysis was conducted during this meeting with the same team members. • On 02/14/23 at 10:00 A.M., the DON, the Administrator, and RDCO #208 met in person with pharmacy representatives including Owner #440 of [NAME] Pharmacy, RN #420 Account Representative, and Pharmacist #400 to confirm an on-going communication plan is in place to monitor and address any issues or concerns. • On 02/14/23, at approximately 8:00 P.M., the DON completed an audit of all current laboratory orders to ensure they were completed as ordered. • On 02/14/23, at approximately 8:00 P.M. the DON completed the on-going audit of all residents with current orders for antibiotics, to include all routes of administration, and to verify all doses were administered as prescribed. • On 02/14/23, during the night shift, staff nurses completed a physical assessment to include vital signs and a full body skin inspection on all residents. • On 02/14/23, at approximately 9:00 P.M., the DON provided all licensed nurses in-servicing on obtaining laboratory tests and reporting results, administering medication per orders, discharge assessment, and any changes to policy and procedures, specifically education on policies titled Administering Medications, Lab and Diagnostic Test Results-Clinical Protocol, and Change in a Residents Condition or Status. • On 02/14/23 at 6:00 P.M., an ad hoc QAPI meeting was conducted with the Administrator, the DON, RDCO #208 and MD #100 (via phone). Review of the root cause analysis that had been completed on 02/08/23 was reviewed and remains unchanged. • On 02/14/23 at approximately 7:00 P.M., the Administrator initiated education to all staff regarding the facility abuse policy titled Abuse Policy and Reporting. • On 02/15/23, an audit of all residents Medication Administration Records (MAR) was conducted to ensure medications were administered as ordered. This was completed by Licensed Practical Nurse (LPN) #260. • On 02/15/23, all residents without cognitive impairment were interviewed by members of the Intradisciplinary Team (IDT) to ensure neglect was not present. • Beginning on 02/15/23, the DON or designee will complete the following audits 2x/week for 4 weeks, then monthly thereafter: Antibiotic Administration, Laboratory Orders and Notifications, Medication Administration, Change of Resident Condition and Skin Integrity. Results will be reported and reviewed by the facility QAPI committee with the need for continuance evaluated and determined at that time • On 02/15/23, interviews were conducted over various shifts with LPN #200, LPN #202, LPN #280, and LPN #284 who verified they had all received the training regarding medication administration, obtaining laboratory tests, reporting laboratory test results to the pharmacy or physician, completing body audits, recognizing change of condition and abuse and neglect. Although the Immediate Jeopardy was removed on 02/15/23, the facility remained out of compliance at Severity Level 2 (no actual harm with potential for more than minimal harm that is not Immediate Jeopardy) as the facility was in the process of implementing their corrective action plan and monitoring to ensure on-going compliance. Findings include: Review of the closed medical record for Resident #79 revealed an admission date of 11/18/22 with admitting diagnoses including sepsis, MRSA in surgical wound, diabetes mellitus and neuromuscular dysfunction of bladder. The resident was discharged to the hospital on [DATE]. Review of the Minimum Data Set (MDS) assessment, dated 11/24/22, for Resident #79 revealed a brief interview for mental status (BIMS) score of 00, indicating severe impaired cognition. Resident #79 was totally dependent on staff for all care. Resident #79 did not have any pressure ulcers but had a surgical wound, had an indwelling foley catheter and was always incontinent of bowel. Review of the care plan for Resident #79 revealed the resident had potential for skin breakdown. The care plan contained individualized interventions such as treatment and preventative treatment per orders, inspect and chart skin weekly and as needed (PRN), with measurable goals. Review of the Braden scale risk assessment, dated 11/08/22, revealed Resident #79 had a score of 15, which indicated at risk for development of pressure ulcers. Review of the physician's orders for Resident #79 revealed an order dated 11/18/22 for weekly skin and body assessment per nurse and document any new negative findings in nurse's notes on day shift. A physician order dated 11/18/22 for Vancomycin (antibiotic) 1.5 gram (gm) IV solution per 1750 milliliters (ml) to be infused over 75 minutes daily for two weeks, Vancomycin trough (measures how much medication is in the blood) stat (immediately) on 11/19/22, fax results to pharmacy for dosing. A physician order dated 11/21/22 for Vancomycin IV 1 gm per 200 ml with 0.9 % Normal Saline to be infused over 75 minutes. A physician order dated 11/23/22 for laboratory tests of Complete Blood Count (CBC), Basic Metabolic Panel (BMP), Pre-Albumin and Vancomycin trough (measures how much medication is in the blood) every Friday. A physician order dated 12/03/22 for Vancomycin IV 750 milligram (mg) per150 ml, to infuse 150 ml over 75 minutes for two doses. A physician order dated 12/06/22 for Vancomycin IV 750 mg per 150 ml to be infused over 75minutes. Review of a physician ordered treatment, dated 11/18/22, revealed to change out wound vacuum to right shoulder every other day. An order dated 12/22/23 revealed to cleanse wound to back of right shoulder with normal saline then pat dry, apply calcium alginate, and cover with foam dressing, every shift. There were no physician orders to address the dressing to the Peripherally Inserted Central Catheter (PICC) intravenous line dressing. Review of the Treatment Administration Record (TAR) for Resident #79 revealed the resident received all treatments for the wound on the back as ordered. The TAR revealed weekly skin assessments were completed and no other wounds were noted. Review of the Wound Assessment Reports for Resident #79 revealed at admission on [DATE], the right shoulder surgical wound measured 6.4 centimeters (cm) by 4.20 cm by 1.5 cm. On the last assessment on 12/22/22 it measured 6.19 cm by 4.05 cm by 1.25 cm with the wound status improving. This was documented on every week and showed continued improvement. This was the only wound the facility had documentation about. Review of the Medication Administration Record (MAR) for November 2022 for Resident #79 revealed there was no evidence of the administration of the IV Vancomycin at 9:00A.M. on 11/20/22, 11/21/22, 11/22/22, 11/23/22, 12/15/22 and from 12/22/22 to 12/30/22. Interview on 02/06/23 at 3:30 P.M. with the DON revealed the pharmacy calls and informs the facility if they are to hold or administer the Vancomycin. When the DON was asked about the process of dosing Vancomycin and the missed doses from 12/20/22 to 12/30/22, he explained We follow the pharmacy's recommendations, and we only have this one document dated 12/20/22 which says to hold the dose until labs are drawn. Interview on 02/07/23 at 10:43 A.M., the DON stated he was not able to receive any further documents from pharmacy to explain why the doses were held. When asked why the doses were missed in November and December 2022, the DON did not respond to the question. The DON verified there was Vancomycin in the E-box (emergency box) which could have been accessed by the staff. The DON verified the medication Resident #79 required would have been in the E-box for the staff to be able to administer. Interview on 02/07/23 at 12:30 P.M. with Resident #79's Family Member #12 revealed Resident #79 had passed away on 01/20/23 at Miami Valley hospital. Per Family Member #12, Resident #79 was supposed to come home on [DATE] and the facility called and said he was not acting right. Family Member #12 stated she told them to send Resident #79 to the emergency room. Resident #79 was admitted for being septic due to the wounds and a urinary tract infection. Family Member #12 stated she was unaware of any other wounds other than the one on his shoulder but was told he had them on his buttocks. Resident #79 was placed in ICU and put on a lot of antibiotics, developed a rash and he was sent to Miami for the burn wound unit. Interview on 02/07/23 at 12:44 P.M. with Social Worker #300 (from the hospital) revealed the resident was admitted to the intensive care unit with sepsis and a urinary tract infection. He had multiple wounds on his buttocks, and she was not sure when these wounds were documented, but there were four extensive wounds. Interview on 02/09/23 at 10:50 A.M. with Pharmacist #400 from [NAME]'s pharmacy revealed the pharmacy had a hold on the Vancomycin and had requested a trough to be completed on 12/22/22. The pharmacy never received the trough level and no communication from the facility. The pharmacy had many problems with the facility getting trough levels when requested during this time. The facility requested for a rundown on 02/08/23 of administration and laboratory results from the pharmacy. Pharmacist #400 stated this was sent to the DON who informed Pharmacist #400, the DON would not pass this information on to the surveyor who asked for the information. Pharmacist #400 stated she would send the surveyor a rundown of when the pharmacy spoke to facility; Vancomycin troughs; doses the pharmacy recommended; and the lack of the facility to get back to them with a trough after 12/20/22. Pharmacist #400 stated she would forward an email from the facility they received on 02/06/23, with all the resident's laboratory values. Pharmacist #400 verified Resident #79 would have been given Vancomycin for the dates of 12/22/22 to 12/30/22, based on these trough values, if they had received them at the time the trough levels were obtained. Review of the document sent from Pharmacist #400 revealed the following breakdown of the Vancomycin laboratory orders and dosing: • On 11/18/22, order received for Vancomycin 1.5 gram (g) with instructions for trough to be obtained on 11/19/22. Vancomycin sent on evening delivery of 11/18/22. • On 11/18/22 at 8:38 P.M, on call service received call from Friendship Village Nursing Home, LPN #280 requesting a consultation. She believed that patient got a Vancomycin rash from mid shoulders to mid-thigh and won't stop scratching - bleeding from the scratching. Please note, at this time the Vancomycin had not been delivered to building. Friendship Village Nursing Home later stated they felt that this was due to the linens/hygiene. • On 11/19/22 at 2:29P.M., Pharmacist #400 was able to get in touch with LPN #284. LPN #284 stated that the Vancomycin was not administered until the morning hours of 11/19/22, which resulted in them being unable to pull a trough. At this time, pharmacy requested troughs to be obtained, so that pharmacy could appropriately and effectively dose the Vancomycin. Trough was collected on 11/19/22 at 10:50 P.M. and results were finalized on 11/20/22 at 1:07 P.M. Fax containing the trough was sent to pharmacy on 11/21/22 at 6:46 AM., with trough being 20.5. • On 11/21/22 at 1:50 P.M., Pharmacist #400 spoke with LPN #244 who confirmed trough was drawn on 11/20/22. At this time, Resident #79's weight and height were verified. Vancomycin was dosed at 1000 mg every 24 hours with extended infusion time given previous rash, though little evidence supporting a rash due to Vancomycin as patient had not been given Vancomycin at the facility. Another trough was requested on the morning of 11/22/22. Vancomycin sent to Friendship Village Nursing Home for administration on 11/21/22. • On 11/22/22, Vancomycin trough drawn at 1:00 PM and reported to the pharmacy at 5:41 PM as pending. • On 11/23/22 to 11/25/22, Vancomycin sent to Friendship Village Nursing Home by pharmacy despite no trough. On 11/23/22, bags sent for 11/24/22 and 11/25/22. On 11/25/22 bags were sent for 11/26/22, 11/27/22, and 11/28/22. • On 11/30/22, trough received at 10:12 A.M. This was the trough drawn on 11/22/22 at 1:00 P.M. Trough resulted at 4.8. Pharmacy concerned with inconsistencies in trough obtained. (Trough obtained from 11/19/22 was at 10:50 P.M., this trough obtained was at 1:00 P.M. - please note, this was with 24-hour dosing). Given the very low trough, we requested further information from the Director of Nursing, including timing of doses in relation to troughs being obtained and if the patient had received consistent doses. Nurse Account Manager attempted to contact the DON on 11/30/22, with no response. • On 12/03/22 per nurse RN #244, a trough was finally drawn on 12/02/22 at 3:30 A.M., and resulted at 20.7. DON stated the 1gm dose has been given at 9:00A.M. for at least the past three days while he worked. Based on pharmacy dispense history, he would have missed the last 3 doses since starting on 11/22/22. Pharmacist #400 requested a repeat trough on Monday, 12/05/22. It was recommended to hold the 12/03/22 dose and then start 750 mg every 24 hours for two doses until trough received. • On 12/05/22, trough level was not received despite being requested on 12/03/22. Stat trough order requested, and 750 mg dose sent to facility. • On 12/06/22, trough level obtained at 5:18 A.M. and resulted at 16.5. Pharmacist #400 instructed facility to continue 750 mg every 24 hours. • On 12/15/22, the trough level was sent to pharmacy. Collected at 7:07 A.M., reported at 11:56 A.M. and sent to pharmacy at 3:44 P.M. Trough level results at 15.4. Pharmacist #400 spoke with RN #244. RN #244 stated resident missed 12/14/22 dose and 12/15/22 dose. At this time, Pharmacist #400 advised that enough Vancomycin will be sent to get the resident through Monday but that Saturday (12/17/22) a trough level needed to be obtained. • On 12/20/22 at 11:58 A.M., the trough level was reported that was obtained on 12/19/22 at 2:21 A.M. The level was sent to the pharmacy. • On 12/20/22 at 5:04 A.M., the trough level resulted at 26.2. At this time, pharmacy called and faxed facility stating to hold Vancomycin doses and to take another trough level on Thursday (12/22/22) for further doses and instructions. • On 12/23/22, still no trough level received. Pharmacist#400 called multiple times and re-faxed request for tough levels twice with no response. Pharmacist #400 emailed the nurse account manager who then passed email along to the DON to get assistance. Pharmacist #400 email to nurse account manager: I have tried to contact FVSN (Friendship Village Skilled Nursing) via phone calls and fax multiple times to get a new trough since the last one we received on 12/19/22 that was supratherapeutic. However, I have not received any communication on this. Could you check with DON to see if a trough level is something we can get today or tomorrow? • Nurse account manager email to DON and ADON: Good morning! Could you assist with the below? Please let me know if you have any questions or concerns Pharmacy never received further troughs, response, or communication from the facility following the email on 12/23/22. Review of the email communication from RN #420 (pharmacy RN) to Friendship Village Nursing Home dated 11/28/22, revealed an onsite visit to stock Nexus and IV supplies. During the visit she met with LPN #272 to advise of the need for a trough level. Reviewed concerns regarding managing the trough levels and previous laboratory issues and timing of getting laboratory levels for Resident #79. She advised she would investigate the issue. On 11/30/22, called Friendship Village Nursing Home and advised still needed trough levels. Called and spoke to LPN #272 and she advised she would get them faxed over. Review of the American Health Associates (AHA) laboratory report sent from the pharmacy dated 12/19/22 at 11:58 A.M. for Resident #79, revealed the notes on 12/20/22 (Tuesday) holding dose, will call facility later to tell them to get another trough on Thursday, for further doses or instructions. The pharmacy called and faxed facility stating to hold vancomycin and take another trough on 12/22/22. On 12/23/22, (Friday) still no trough received at the pharmacy. The pharmacists called multiple times and refaxed request for laboratory test twice, with no response and emailed facility. The call to the facility was made multiple times and faxed, with no response. The pharmacist emailed nurse account manager at facility, who passed along the email to the DON to get assistance. The email from the pharmacist stated I have tried to contact FVSN (Friendship Village Nursing Home) via phone calls and fax multiple times to get a new trough, since that last one we received on 12/19/22 was supratherapeutic. However, I have not received any communication on this. Could you check with the DON to see if trough is something we can get tomorrow? The pharmacy never received further troughs, response or communication from the facility following the email sent on 12/23/22. Review of Resident #79's Discharge summary, dated [DATE], included a vital signs section which listed a pulse of 64 beats per minute (bpm) and respirations at eight per minute were obtained on 12/30/22 at 2:20 A.M. The blood pressure (BP) on the form was documented as obtained on 11/18/22 and identified the BP to be 137/87 millimeters of mercury (mmHg). No temperature was listed on the form. This was signed by Licensed Social Worker #600, LPN #272 with a notation of verbal education given to spouse on 12/30/22 at 11:55 A.M. The record contained no evidence any of the resident's vital signs were obtained after 2:20 A.M. on 12/30/22. Review of the progress note for Resident #79 dated 12/30/22 at 6:45 P.M., revealed the resident was scheduled to be discharged home with his wife. The EMT arrived and expressed concerns about getting him safely into the apartment. Resident #79 was disoriented, confused, and unable to respond to them. This nurse spoke with the wife, and she would like him sent to the hospital. Review of the Patient Care Report dated 12/30/22 at 6:06 P.M., revealed the EMT documented the resident's BP was 72/46 mmHg, pulse 66 bpm, respirations 20, and oxygen level was 92% on room air. At 6:16 P.M., BP was 74/44 mmHg, pulse 63 bpm, respirations 20, and oxygen level was 92% on room air. Upon arrival on scene Resident #79 was severely confused with incoherent speech. Resident #79's stroke scale positive with unequal grip, facial droppage and aphasia. Report from nursing home staff is this is not normal for Resident #79. EMT crew advised nursing home staff that for the safety of Resident #79 and well-being, transport to emergency room would be best. Given Resident #79's status and vitals, decision made to upgrade run from non-emergent to emergent. Review of the hospital report dated 12/30/22 at 6:42 P.M., revealed Resident #79 arrived from the nursing home with midline insertion site and right upper extremity noted to be red. It appears infected where the midline IV dressing had not been changed since 12/24/22 per dressing sticker. Resident #79 is yelling and screaming, not saying words, or answering questions. Resident #79's vital signs were: BP 142/78 mmHg, temperature 88.9 degrees F, and pulse was 44 bpm. A consult with internal medicine revealed the ill appearing elderly man presently from Friendship Village. Based on Resident #79's appearance, report from EMT, and an old bandage from PICC line, there is concerns for neglect at the Extended Care Facility (ECF). Resident #79 is hypothermic (low body temperature) and bradycardic (slow heart rate). The hospital was initiating warming protocol. Blood pressure was marginal but improving with IV fluids. Blood Pressure was 92/61, temperature was 91.8 F, respirations were nine. Treated with antibiotics due to thickness of his urine. Resident #79 is hyperkalemic (elevated potassium level) which is likely to be contributing to his bradycardia dysrhythmia. Resident #79's medical condition was assessed as severe deterioration that posed to be life threatening which required critical care to be rendered. Resident #79's diagnoses included septic shock, urinary tract infection, hypothermic, acute renal failure, metabolic acidosis, and leukocytosis with multiple sources of infection from indwelling urinary catheter; PICC line was warm and red; wounds on back and groin with erythematous in multiple areas and was recently hospitalized for MRSA abscess requiring debridement and Vancomycin. Resident #79's urine was described as chocolate milk colored urine. Review of the pictures of the wounds taken in the emergency room revealed two posterior left thigh open wounds. The upper wound measuring approximately 2 cm by 1 cm, right lower wound approximately 2 cm by 2 cm and both appear to have slough. The anterior right inner thigh measuring approximately 6 cm by 0.5 cm appears to have slough. The left anterior inner thigh had a wound measuring approximately 4 cm by 0.5 cm with red serous drainage. The buttocks were observed to be bright red with blood and bowel noted on the depends. Interview on 02/07/23 at 2:01 P.M. with Medical Director (MD) #100, revealed when Resident #79 was seen in the emergency room, he was in septic shock. MD #100 stated his body temperature was 88 degrees F and his pulse was around 50. Review of the nursing document titled Skin Inspection Report for Resident #79 revealed the assessments were completed on 11/18/22 which identified skin as not intact-existing (area was previously present). On 11/25/22 and 12/02/22 the assessment identified skin as intact. On 12/09/22, 12/16/22, and 12/23/22 the report identified skin as not intact-existing and on 12/30/22 the assessment continued to identify the resident's skin to be not intact-existing area. There was not a time listed on the 12/30/22 inspection identifying when the assessment was completed. None of the skin inspection reports identified any description of the non-intact skin. Interview on 02/09/23 at 3:45 P.M. with Regional Nurse #500 verified she only had knowledge of Resident #79 having the wound on the shoulder. The facility was not aware of any other wound on the resident. When asked to look at facility skin assessments, Regional Nurse #500 stated what she gave for wounds was all they had. Regional Nurse #500 explained the only thing the skin assessment has is a check off box which states either Skin intact, Skin not intact - existing or Skin not intact new. Regional Nurse #500 verified the skin reports reviewed only had Skin not intact-existing and Skin Intact marked. Interview on 02/13/23 at 1:30 P.M. with STNA #300 revealed she was the primary aide for the rehabilitation unit where Resident #79 was located. STNA #300 verified she was applying cream to the buttocks of resident due to redness and she did not recall any open wound on him. Resident #79 did not refuse any type of care for her during his stay. Interview on 02/13/23 at 4:15 P.M. with RDCO #208 stated the facility bears their responsibility for this occurring but the pharmacy needs to bear their own responsibility by not contacting upper management in the facility about the missing Vancomycin troughs. RDCO #208 stated LPN #242 who took care of Resident #79 was fired due to lack of assessments of the resident. Review of the policy titled Change in a Resident's Condition or Status, dated April 2014, revealed our facility shall promptly notify the resident, his or her attending Physician, and representative, consistent with his or her authority of changes in the resident's medical or mental condition and or status. Review of the policy titled Lab and Diagnostic Test Results - Clinical Protocol, dated September 2012, revealed the staff will process test requisitions and arrange for tests, a nurse will review all results and will identify the urgency of communicating with the attending physician based on physician request, the seriousness of abnormality, and the individual's current condition. Review of the facility policy titled Abuse Prevention/Reporting Policy and Procedure, last updated 05/09/18 revealed every resident has the right to be free from mistreatment, neglect, and misappropriation of property. Neglect was defined as the failure of the facility, its employees or service providers to provide goods and services necessary to avoid physical harm, pain, mental anguish, or emotional distress. This represents non-compliance related to Master Complaint Number OH00139489, Complaint Number OH00139264, and Complaint Number OH00139095.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observations, review of medical records, review of the emergency squad run report, review of hospital records, review of email communications, review of policies on Lab and Diagnostic Test Results - Clinical Protocol, Adverse Consequences and Medication Errors and BD Auto Shield Duo Safety Pen Needles, staff interviews, physician interview, and interview with pharmacy staff, the facility failed to ensure one resident (Resident #79) was free from significant medication errors when Resident #79 was admitted to the facility with diagnosis of sepsis with Methicillin-Resistant Staphylococcus Aureus?(MRSA) in a surgical wound and was not administered the intravenous (IV) antibiotic medication as ordered and failed to ensure laboratory tests were completed and results reported to the pharmacy for dosing of the IV antibiotic. This resulted in Immediate Jeopardy and the potential for serious life-threatening harm, injuries and/or death, when Resident #79 was found by the transport company staff upon arriving at the facility, to be confused, aphasic, and had abnormal vital signs. The resident was determined to be in an emergent situation and was taken to the emergency room at which time his body temperature was 88.9 degrees Fahrenheit(F) and he was subsequently taken to the Intensive Care Unit (ICU) for septic shock. Upon admission to emergency room, the resident was diagnosed with altered mental status, septic shock, leukocytosis with multiple sources of infection: including indwelling catheter, intravenous cite red and warm, wounds on back and groin area with erythematous, urinary tract infection, hypothermia, acute renal failure, metabolic acidosis, and hyperkalemia and was admitted to critical care. Additionally, the facility failed to ensure insulin medications, administered via Flex Pen, were primed prior to dialing up the ordered dose for two residents (#48 and #72) resulting in the residents not receiving the correct amount of medication as ordered by the physician that placed these residents at potential risk for more than minimal harm that is not Immediate Jeopardy. This affected two (#48 and #72) of five residents reviewed for medication administration. The facility census was 74. On 02/14/23 at 5:34 P.M., the Administrator, Director of Nursing (DON), Regional [NAME] President #10, Regional Nurse #500 and Campus Executive Director #50 were notified Immediate Jeopardy began on 11/20/22 when Resident #79 was admitted to the facility from the hospital with a physician order for Vancomycin that was not administered not administered for five days (11/20/22, 11/21/22, 11/22/22, 11/23/22, 12/15/22), and on 12/21/22, he was administered the medication when it was placed on hold; then from 12/22/22 to 12/30/22 he did not receive the medication for a period of eight days. Consequently, on 12/30/22, Resident #79 was found by the Emergency Medical Team (EMT), who was there to take him home, to be severely confused with incoherent speech and was hypotensive. He was taken emergently to the hospital resulting in the resident receiving peripheral vasoconstrictor, intravenous fluids, warming protocol, and multiple antibiotics which lead to the resident being placed in the ICU. Resident #79 was admitted with diagnoses including altered mental status, septic shock, leukocytosis with multiple sources of infection: including indwelling catheter, intravenous cite red and warm, wounds on back and groin area with erythematous, urinary tract infection, hypothermia, acute renal failure, metabolic acidosis, and hyperkalemia and was admitted to critical care. The Immediate Jeopardy was removed on 02/15/23 when the facility implemented the following corrective actions: • On 12/30/22 at approximately 6:30 P.M., Resident #79 was discharged from the facility. • On 02/07/23 at approximately 12:00 P.M., the DON, had discussed the communication process from the pharmacy to the facility with Registered Nurse (RN) #420, Account Representative for [NAME]'s Pharmacy. They collaboratively established a contingency plan in the event the pharmacy is unable to contact the facility directly. This plan included a call to the cell phone of the DON. If unable to reach the DON, the pharmacy is to call the cell phone of the Administrator. If unable to reach the Administrator, the pharmacy is to call the cell phone of the Regional Director of Clinical Operations (RDCO) #208. • On 02/08/23 at approximately 4:30 P.M., an audit was completed by the DON of all current residents' medical records, and it was determined that there were no current patients on IV antibiotics. • On 02/08/23, an audit was completed by the DON of all residents with current orders for antibiotics, to include all routes of administration, and to verify all doses were being administered as prescribed. • Beginning on 02/08/23, education was completed by DON, with all nurses regarding the company policy titled Medication Utilization and Prescribing-Clinical Protocol. • On 02/08/23 at approximately 5:00 P.M., an ad hoc Quality Assurance and Performance Improvement (QAPI) meeting was conducted with the Administrator, the DON, RDCO #208 and Medical Director (MD) #100 (via phone). A root cause analysis for medication errors was conducted during this meeting with the same team members. • On 02/14/23 at 10:00 A.M., the DON, the Administrator, and RDCO #208 met in person with pharmacy representatives including Owner #440 of [NAME] Pharmacy, RN #420 Account Representative and Pharmacist #400 to confirm an on-going communication plan is in place to monitor and address any issues or concerns. • On 02/14/23 at approximately 8:00 P.M., the DON completed an audit of all current laboratory orders to ensure they were completed as ordered. • On 02/14/23 at approximately 8:00 P.M., the DON completed the on-going audit of all residents with current orders for antibiotics, to include all routes of administration, and to verify all doses were administered as prescribed. • On 02/14/23, at approximately 9:00 P.M., the DON provided all licensed nurses in-servicing on obtaining laboratory tests and reporting results, administering medication per orders, and any changes to policy and procedures, specifically education on policies titled Administering Medications, and Lab and Diagnostic Test Results-Clinical Protocol. • On 02/14/23 at 6:00 P.M., an ad hoc QAPI meeting was conducted with the Administrator, the DON, RDCO #208 and MD #100 (via phone). Review of the root cause analysis for medication errors that had been completed on 02/08/23 was reviewed and remains unchanged. • On 02/15/23, an audit of all resident Medication Administration Records (MAR) was conducted for antibiotics and laboratory tests being completed. This was completed by Licensed Practical Nurse (LPN) #260. • Beginning on 02/15/23, the DON or designee will complete the following audits 2x/week for 4 weeks, then monthly thereafter. Results will be reported and reviewed by the facility QAPI committee with the need for continuance evaluated and determined at that time: Antibiotic Administration; Laboratory Orders and Notifications, and Medication Administration. • On 02/15/23, interviews were conducted over various shifts with LPNs #200, #202, #280, and #284 who verified they had all received the training regarding medication administration, obtaining laboratory tests, and reporting laboratory test results to the pharmacy or physician. Although the Immediate Jeopardy was removed on 02/15/23, the facility remained out of compliance at Severity Level 2 (no actual harm with potential for more than minimal harm that is not Immediate Jeopardy) as the facility was in the process of implementing their corrective action plan and monitoring to ensure on-going compliance. Findings include: 1) Review of the closed medical record for Resident #79 revealed an admission date of 11/18/22 with admitting diagnoses including sepsis, MRSA in surgical wound, diabetes mellitus and neuromuscular dysfunction of bladder. The resident was discharged to the hospital on [DATE]. Review of the Minimum Data Set (MDS) assessment dated [DATE] for Resident #79 revealed a brief interview for mental status (BIMS) score of 00 indicating severe impaired cognition. Resident #79 was totally dependent on staff for all care. Review of the physician's orders for Resident #79 revealed an order dated 11/18/22 for weekly skin and body assessment per nurse and document any new negative findings in nurse's notes on day shift. A physician order dated 11/18/22 for Vancomycin (antibiotic) 1.5-gram (gm) IV solution per 1750 milliliters (ml) to be infused over 75 minutes daily for two weeks, Vancomycin trough (measures how much medication is in the blood) stat (immediately) on 11/19/22, fax results to pharmacy for dosing. A physician order dated 11/21/22 for Vancomycin IV 1 gm per 200 ml with 0.9 % Normal Saline to be infused over 75 minutes. A physician order dated 11/23/22 for Vancomycin trough every Friday. A physician order dated 12/03/22 for Vancomycin IV 750 milligram (mg) per 150 ml, to infuse 150 ml over 75 minutes for two doses. A physician order dated 12/06/22 for Vancomycin IV 750 mg per 150 ml to be infused over 75minutes. Review of the MAR for November 2022 for Resident #79 revealed there was no evidence of the administration of the Vancomycin at 9:00A.M. on 11/20/22, 11/21/22, 11/22/22, 11/23/22, 12/15/22 and from 12/22/22 to 12/30/22. There was no indication as to why the medications was not administered. Review of the American Health Associates (AHA) laboratory test for Resident #79 revealed a Vancomycin trough result dated 12/23/22 of 20.2 micrograms per milliliter (mcg/mL) with a normal range of 10 mcg/mL to 20 mcg/mL. Vancomycin trough result on 12/26/22 was 19.0 mcg/mL and on 12/30/22 was 19.6 mcg/mL. There was no evidence these results were sent to the pharmacy for dosing. Review of the nurse's progress notes on 12/28/22 at 3:15 P.M., revealed the nurse spoke to pharmacy person in reference to Vancomycin current order of Vancomycin IV 750 mg per 150 ml to be infused over 75minutes. This writer was advised Vancomycin still on hold. Pharmacy needs trough results, then pharmacy can send out Vancomycin. Interview on 02/06/23 at 3:30 P.M. with the DON revealed the pharmacy calls and informs the facility if they are to hold or administer the Vancomycin. When the DON was asked about the process of dosing Vancomycin and the missed doses for 12/20/22 to 12/30/22, he explained We follow the pharmacy's recommendations, and we only have this one document dated 12/20/22 which says to hold the dose until labs are drawn. Interview on 02/09/23 at 10:50 A.M. with Pharmacists #400 from [NAME]'s pharmacy revealed the pharmacy had a hold on the Vancomycin and had requested a trough to be completed on 12/22/22. The pharmacy never received the trough level and there was no communication from the facility. The pharmacy had many problems with the facility obtaining trough levels when requested by the pharmacy during this time. The facility requested a rundown on 02/08/23 of administration and laboratory results from the pharmacy. Pharmacist #400 stated this was sent to the DON who informed Pharmacist #400, the DON would not pass this information on to the surveyor who asked for the information. Pharmacist #400 stated she would send the surveyor a rundown of when the pharmacy spoke to facility; the Vancomycin troughs; the doses the pharmacy recommended; and the lack of the facility to get back to them with a trough after 12/20/22. Pharmacist #400 stated she would forward an email from the facility they received on 02/06/23, with all the resident's laboratory values. Pharmacist #400 verified Resident #79 would have been given Vancomycin for the dates of 12/22/22 to 12/30/22, based on these trough values, if they had received them at the time the trough levels were obtained. Review of the document sent from the Pharmacist #400 revealed the following breakdown of the Vancomycin laboratory orders and dosing: • On 11/18/22, order received for Vancomycin 1.5 gram (g) with instructions for trough to be obtained on 11/19/22. Vancomycin sent on evening delivery of 11/18/22. • On 11/18/22 at 8:38 P.M, on call service received call from Friendship Village Nursing Home, LPN #280 requesting a consultation. She believed that patient got a Vancomycin rash from mid shoulders to mid-thigh and won't stop scratching - bleeding from the scratching. Please note, at this time the Vancomycin had not been delivered to building. Friendship Village Nursing Home later stated they felt that this was due to the linens/hygiene. • On 11/19/22 at 2:29P.M., Pharmacist #400 was able to get in touch with LPN #284. LPN #284 stated that the Vancomycin was not administered until the morning hours of 11/19/22, which resulted in them being unable to pull a trough. At this time, pharmacy requested troughs to be obtained, so that pharmacy could appropriately and effectively dose the Vancomycin. Trough was collected on 11/19/22 at 10:50 P.M. and results were finalized on 11/20/22 at 1:07 P.M. Fax containing the trough was sent to pharmacy on 11/21/22 at 6:46 AM., with trough being 20.5. • On 11/21/22 at 1:50 P.M., Pharmacist #400 spoke with LPN #244 who confirmed trough was drawn on 11/20/22. At this time, Resident #79's weight and height were verified. Vancomycin was dosed at 1000 mg every 24 hours with extended infusion time given previous rash, though little evidence supporting a rash due to Vancomycin as patient had not been given Vancomycin at the facility. Another trough was requested on the morning of 11/22/22. Vancomycin sent to Friendship Village Nursing Home for administration on 11/21/22. • On 11/22/22, Vancomycin trough drawn at 1:00 PM and reported to the pharmacy at 5:41 PM as 'pending'. • On 11/23/22 to 11/25/22, Vancomycin sent to Friendship Village Nursing Home by pharmacy despite no trough. On 11/23/22, bags sent for 11/24/22 and 11/25/22. On 11/25/22, bags sent for 11/26/22, 11/27/22, and 11/28/22. • On 11/30/22, trough received at 10:12 A.M. This was the trough drawn on 11/22/22 at 1:00 P.M. Trough resulted at 4.8. Pharmacy concerned with inconsistencies in trough obtained. (Trough obtained from 11/19/22 was at 10:50 P.M., this trough obtained was at 1:00 P.M. - please note, this was with 24-hour dosing). Given the very low trough, we requested further information from the Director of Nursing, including timing of doses in relation to troughs being obtained and if the patient had received consistent doses. Nurse Account Manager attempted to contact the DON on 11/30/22, with no response. • On 12/03/22 per nurse RN #244, a trough was finally drawn on 12/02/22 at 3:30 A.M., and resulted at 20.7. DON stated that the 1g dose has been given at 9:00A.M., for at least the past three days while he worked. Based on pharmacy dispense history, he would have missed the last 3 doses since starting on 11/22/22. Pharmacist #400 requested a repeat trough on Monday, 12/05/22. It was recommended to hold the 12/03/22 dose and then start 750 mg every 24 hours for two doses until trough received. • On 12/05/22, trough level was not received despite being requested on 12/03/22. Stat trough order requested, and 750 mg dose sent to facility. • On 12/06/22, trough level obtained at 5:18 A.M. and resulted at 16.5. Pharmacist #400 instructed facility to continue 750 mg every 24 hours. • On 12/15/22, the trough level was sent to pharmacy. Collected at 7:07 A.M., reported at 11:56 A.M. and sent to pharmacy at 3:44 P.M. Trough level results at 15.4. Pharmacist #400 spoke with RN #244. RN #244 stated resident missed 12/14/22 dose and 12/15/22 dose. At this time, Pharmacist #400 advised that enough Vancomycin will be sent to get the resident through Monday but that Saturday (12/17/22) a trough level needed to be obtained. • On 12/20/22 at 11:58 A.M., the trough level was reported that was obtained on 12/19/22 at 2:21 A.M. The level was sent to the pharmacy. • On 12/20/22 at 5:04 A.M., the trough level resulted at 26.2. At this time, pharmacy called and faxed facility stating to hold Vancomycin doses and to take another trough level on Thursday (12/22/22) for further doses and instructions. • On 12/23/22, still no trough level received. Pharmacist#400 called multiple times and re-faxed request for tough levels twice with no response. Pharmacist #400 emailed the nurse account manager who then passed email along to the DON to get assistance. Pharmacist #400 email to nurse account manager: I have tried to contact FVSN (Friendship Village Skilled Nursing) via phone calls and fax multiple times to get a new trough since the last one we received on 12/19/22 that was supratherapeutic. However, I have not received any communication on this. Could you check with DON to see if a trough level is something we can get today or tomorrow? • Nurse account manager email to DON and ADON: Good morning! Could you assist with the below? Please let me know if you have any questions or concerns Pharmacy never received further troughs, response, or communication from the facility following the email on 12/23/22. Review of the email communication from RN #420 (pharmacy RN) to Friendship Village Nursing Home dated 11/28/22, revealed an onsite visit to stock Nexus and IV supplies. During the visit she met with LPN #272 to advise of the need for a trough level. Reviewed concerns regarding managing the trough levels and previous laboratory issues and timing of getting laboratory levels for Resident #79. She advised she would investigate the issue. On 11/30/22, called Friendship Village Nursing Home and advised still needed trough levels. Called and spoke to LPN #272 and she advised she would get them faxed over. Review of the American Health Associates (AHA) laboratory report sent from the pharmacy dated 12/19/22 at 11:58 A.M., for Resident #79 revealed the notes on 12/20/22 (Tuesday) holding dose, will call facility later to tell them to get another trough on Thursday, for further doses or instructions. The pharmacy called and faxed facility stating to hold vancomycin and take another trough on 12/22/22. On 12/23/22, (Friday) still no trough received at the pharmacy. The pharmacists called multiple times and refaxed request for laboratory test twice, with no response and emailed facility. The call to the facility was made multiple times and faxed, with no response. The pharmacist emailed nurse account manager at facility, who passed along the email to the DON to get assistance. The email from the pharmacist stated I have tried to contact FVSN (Friendship Village Nursing Home) via phone calls and fax multiple times to get a new trough, since that last one, we received on 12/19/22 was supratherapeutic. However, I have not received any communication on this. Could you check with the DON to see if trough is something we can get tomorrow? The pharmacy never received further troughs, response or communication from the facility following the email sent on 12/23/22. Review of the progress note for Resident #79 dated 12/30/22 at 6:45 P.M., revealed the resident was scheduled to be discharged home with his wife. The EMT arrived and expressed concerns about getting him safely into the apartment. Resident #79 was disoriented, confused, and unable to respond to them. This nurse spoke with the wife, and she would like him sent to the hospital. Review of the Patient Care Report dated 12/30/22 at 6:06 P.M., revealed the EMT documented the blood pressure (BP) was 72/46 mmHg, pulse 66 beats per minute (bpm), respirations 20, and oxygen level was 92% on room air. At 6:16 P.M., BP was 74/44 mmHg, pulse 63 bpm, respirations 20, and oxygen level was 92% on room air. Upon arrival on scene Resident #79 was severely confused with incoherent speech. Resident #79's stroke scale positive with unequal grip, facial droppage and aphasia. Report from nursing home staff is this is not normal for Resident #79. EMT crew advised nursing home staff that for the safety of Resident #79 and well-being, transport to emergency room would be best. Given Resident #79's status and vitals, decision made to upgrade run from non-emergent to emergent. Review of the hospital report dated 12/30/22 at 6:42 P.M., revealed Resident #79 arrived from the nursing home with midline insertion site and right upper extremity noted to be red. It appears infected where the midline IV dressing had not been changed since 12/24/22 per dressing sticker. Resident #79 is yelling and screaming, not saying words, or answering questions. Resident #79's vital signs were: BP 142/78 mmHg, temperature 88.9 degrees F, and pulse was 44 bpm. A consult with internal medicine revealed the ill appearing elderly man presently from Friendship Village. Based on Resident #79's appearance, report from EMT, and an old bandage from PICC line, there is concerns for neglect at the Extended Care Facility (ECF). Resident #79 is hypothermic (low body temperature) and bradycardic (slow heart rate). The hospital was initiating warming protocol. Blood pressure was marginal but improving with IV fluids. Blood Pressure was 92/61, temperature was 91.8 F, respirations were nine. Treated with antibiotics due to thickness of his urine. Resident #79 is hyperkalemic (elevated potassium level) which is likely to be contributing to his bradycardia dysrhythmia. Resident #79's medical condition was assessed as severe deterioration that posed to be life threatening which required critical care to be rendered. Resident #79's diagnoses included septic shock, urinary tract infection, hypothermic, acute renal failure, metabolic acidosis, and leukocytosis with multiple sources of infection from indwelling urinary catheter; PICC line was warm and red; wounds on back and groin with erythematous in multiple areas and was recently hospitalized for MRSA abscess requiring debridement and Vancomycin. Resident #79's urine was described as chocolate milk colored urine. Interview on 02/07/23 at 2:01 P.M., with Medical Director (MD) #100, revealed when Resident #79 was seen in the emergency room, he was in septic shock. MD #100 stated his body temperature was 88 degrees F and his pulse was around 50 bpm. Interview on 02/07/23 at 10:43 A.M. with the DON he stated he was not able to receive any further documents from pharmacy to explain why the doses were held. When asked why the doses were missed in November and December 2022, he did not respond to the question. He verified there was Vancomycin in the E-box (emergency box) which could have been accessed by the staff. The DON verified the medication Resident #79 required would have been in the E-box for the staff to be able to administer. Interview on 02/13/23 at 4:15 P.M. with RDCO #208 stated the facility bears their responsibility for this occurring but the pharmacy needs to bear their own responsibility by not contacting upper management in the facility about the missing Vancomycin troughs. 2) Review of the medical record for Resident #48 revealed an admission date of 04/04/18 with a diagnosis of diabetes mellitus. Review of the MDS assessment for Resident #48 dated 01/09/23, revealed she had moderate impaired cognition and received insulin seven days a week. Review of the plan of care for Resident #48 revealed a plan for potential for hypoglycemia or hyperglycemia with an intervention which included administer insulin as ordered. Review of the physician's order for Resident #48 revealed an order dated 03/09/22, for Lantus 100 unit per ml vial, to give eight units subcutaneously in the morning. Observation of medication administration on 02/01/23 at 8:45 A.M. with LPN #200, revealed he took the Lantus 100 unit per ml out of the cart for Resident #48. LPN #200 cleansed the end with alcohol pad with a gloved hand, then proceeded to dial up eight units of Lantus. LPN #200 did not prime the needle with two units of insulin. Interview on 02/01/23 at 10:20 A.M. with LPN#200 verified he did not prime the needle for Resident #48 due to the needle is already primed. 3) Review of the medical record for Resident #72 revealed an admission date of 05/24/18 with a diagnosis including diabetes mellitus. Review of the MDS assessment for Resident #72 dated 01/11/23, revealed she had moderate impaired cognition and received insulin seven days a week. Review of the plan of care for Resident #72 revealed a plan for diabetes with an intervention which included administer insulin as ordered. Review of the physician's orders for Resident #72 revealed an order for Basaglar insulin 100 unit per ml Kwik pen, to give 25 units subcutaneous daily. Observation on 02/01/23 at 10:15 A.M. revealed LPN #200 pulled Resident #72's Basaglar insulin 100 unit per ml out of the medication cart. LPN #200 cleaned the end of pen with gloved hand then dialed up 25 units of the Basaglar insulin. Before entering the room, the surveyor asked LPN #200 if he needed to prime the pen prior to dialing up the 25 units and LPN #200 explained he did not need to prime the needle because it was already primed. LPN #200 proceeded to give the 25 units of Basaglar insulin. Interview on 02/01/23 at 10:25 A.M. with RDCO #208 verified the needles for the flex pens are not pre-primed and need to be primed with two units prior to dialing up the dose per physician's order. She will call the doctor and inform him of the residents who did not receive their full dose and see if the doctor wants the two units given to these residents. Observation on 02/01/23 at 10:35 A.M. with Clinical Team Manger (CTM) #204 of the insulin needle containers which are used for flex pens verified it did not indicate the needles were a pre-primed insulin needle. CTM #204 opened the box and the instructions inside indicated to dial up two units and push down then put in the dose of insulin required by the physician. Review of the undated form titled BD Auto Shield Duo Safety Pen Needles revealed the instructions for use in section one to check if the pen needle is attached correctly then dial two units, point the pen up and press the thumb button. If liquid does not appear at the needle tip, repeat this step as recommended by the pen instructions. If liquids still do not appear, change the needle, and repeat the above steps. To performing the injection, dial the prescribed dose on the pen. Review of the policy titled Adverse Consequences and Medication Errors, dated April 2014, revealed a medication error is defined as the preparation or administration of drugs or biological which is not in accordance with physician's order or manufacturer's specifications such as wrong dose or failure to follow manufacturer's instructions. Review of the policy titled Lab and Diagnostic Test Results - Clinical Protocol, dated September 2019 revealed the staff will process test requisitions and arrange for tests, a nurse will review all results and will identify the urgency of communicating with the attending physician based on physician request, the seriousness of abnormality, and the individual's current condition. This represents non-compliance found with Master Complaint Number OH00139489 and Complaint Number OH0039424.