Texas Health Presbyterian Hospital Denton

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 51905 Based on observation, record review, and interview, Facility B failed to comply with 42 CFR §489.24, Special responsibilities of Medicare hospitals in emergency cases. . Based on record review, facility policy review, and interviews, Facility B failed to accept an appropriate transfer for one (1) (Patient #7) of twenty-three (23) patients in need of specialized capabilities. Though Facility B had the capacity and capability to care for patients requiring gastroenterology and general surgery services, Patient #7 was denied admission due to Patient #7’s refusal of a nasogastric tube, resulting in Patient #7’s need to receive emergent treatment at another facility (Facility C). . See Tag 2411”

“ON CALL PHYSICIANS CFR(s): 489.20(r)(2) and 489.24(j)(1-2) §489.20(r)(2) [The hospital (including both the transferring and receiving hospitals), must maintain] a list of physicians who are on call for duty after the initial examination to provide further evaluation and/or treatment necessary to stabilize an individual with an emergency medical condition. §489.24(j)(1) Each hospital must maintain an on-call list of physicians on its medical staff in a manner that best meets the needs of the hospital’s patients who are receiving services required under this section in accordance with the resources available to the hospital, including the availability of on-call physicians. §489.24(j)(2)(i) The hospital must have written policies and procedures in place to respond to situations in which a particular specialty is not available or the on-call physician cannot respond because of circumstances beyond the physician’s control. §489.24(j)(2)(ii) The hospital must have written policies and procedures in place to provide that emergency services are available to meet the needs of patients with emergency medical conditions if it elects to permit on-call physicians to schedule elective surgery during the time that they are on call or to permit on-call physicians to have simultaneous on-call duties. This Standard is not met as evidenced by: 51905 Based on observation, record review, and staff interviews, Facility B failed to have written policies and procedures in place for on-call providers. Facility B also failed to provide adequate physician on-call coverage consistent with the services provided at the hospital and the resources the hospital has available, including the availability of specialists. . Findings: 1. Record review of the on-call physicians’ schedule at Facility B: A. December 2024- 7 of 31 days did not have Vascular on-call. B. December 2024- 2 of 31 days did not have Urology on-call. C. January 2025- 6 of 31 days did not have Vascular on-call. D. February 2025- 6 of 28 days did not have Vascular on-call. E. March 2025- 9 of 31 days did not have Vascular on-call. F. March 2025- 1 of 31 days did not have Urology on-call. G. April 2025- 5 of 30 days did not have Vascular on-call. H. May 2025- 6 of 31 days did not have Vascular on-call. . 2.Interview: On 05/13/2025 at 11:30 A.M, an interview was conducted with the Chief Medical Officer, Staff E reported, . “Facility B is not adequately staffed with a vascular physician.” Additionally, Staff E stated, “We use a community physician program and only have one (1) vascular surgeon. In the market, there are only two (2). It’s the same for urology; there are only three (3), and they cover several facilities. Currently, we transfer patients for placement at other facilities when we don’t have coverage.” . On 05/14/2025 at 3:54 P.M., an email conversation with the Director of Quality Management/Risk/Patient Safety (Staff K) revealed the following, . “We do not have a specific physician-on-call policy. The on-call services are tied to the on-call contract with each of the specialty groups.””

“RECIPIENT HOSPITAL RESPONSIBILITIES CFR(s): 489.24(f) A participating hospital that has specialized capabilities or facilities (including, but not limited to, facilities such as burn units, shock-trauma units, neonatal intensive care units, or (with respect to rural areas) regional referral centers, which, for purposes of this subpart, means hospitals meeting the requirements of referral centers found at §412.96 of this chapter) may not refuse to accept from a referring hospital within the boundaries of the United States an appropriate transfer of an individual who requires such specialized capabilities or facilities if the receiving hospital has the capacity to treat the individual. This requirement applies to any participating hospital with specialized capabilities, regardless of whether the hospital has a dedicated emergency department. This Standard is not met as evidenced by: 51905 Based on record review, facility policy review, and interviews, Facility B failed to accept an appropriate transfer for one (1) (Patient #7) of twenty-three (23) patients in need of specialized capabilities. Though Facility B had the capacity and capability to care for patients requiring gastroenterology and general surgery services, Patient #7 was denied admission due to Patient #7’s refusal of a nasogastric tube, resulting in Patient #7’s need to receive emergent treatment at another facility (Facility C). . Findings: 1.Medical Record Patient #7 arrived at Facility A, a free-standing emergency medical center, on 04/03/2025 at 5:30 A.M. with complaints of abdominal pain. Per Staff F, “the pain radiates to the generalized abdomen. The pain was described as aching and sharp. The symptoms are worsened with movement and position. The symptoms are not improved with antacids, food, position, or lying still. The severity of the pain was severe.” “The symptoms developed spontaneously. The was associated nausea and vomiting. The pain started at 9pm last night and then worsened by 11pm he was vomiting (vomited x2) and took Pepto Bismol at 0430 and this provided no relief. He has a history of bowel surgery as an infant.” At 6:09 A.M., Labs drawn. CBC (complete blood count) “wbc (white blood cell) mildly elevated 9.68 with left shift; otherwise normal.” Liver panel plus amylase “interpretation WNL (within normal limits). Metlyte 8 + CK (creatine kinase) “glucose 144 mildly elevated otherwise wnl.” . At 6:38 A.M., CT abdominal and pelvis with IV (intravenous) contrast completed. “1. High-grade bowel obstruction with transition point in the right lateral abdomen/distal ileum. No pneumatosis, portal venous gas, or free air. 2. Appendix not confidently identified.” . Per the Provider Treatment Notes, Staff F noted, “IV started and patient provided with 1L (liter) IV (intravenous) NS (normal saline) hydration and Toradol 30mg (milligrams) IVP (intravenous push) analgesic given as well as Levsin 0.25mg po (by mouth) antispasmodic for pain, and Zofran 8mg IVP antiemetic.” . “Discussed with patient and family who has now arrived that he will need transfer to inpatient facility with surgery services. He is agreeable to that plan. Pain is now relieved and is much improved with above meds ...” . “Discussed with surgeon on call, Staff B, who states he would like NGT (nasogastric tube) placed prior to transfer but states he will see the patient and the patient should be admitted to the hospitalist service. Discussed with patient and family who decline NGT.” “Discussed with hospitalist, Staff C, who is going to be the admitting service at [Facility B], who accepts patient in transfer to his service.” . “Patient was accepted by Admin (administration) and transfer center stated they had capacity and capability to care patient and I had secured acceptance by both the surgeon and the hospitalist on call and then transfer center called back and stated they were rescinding the acceptance at [Facility B] as the surgeon refused the patient if he was declining the NG (nasogastric) tube prior to transfer.” . “This was discussed with the patient by the nurse and patient and family then decided to go to [Facility C] instead and the transfer center was contacted there. They autoaccepted the patient to [Facility C] and the patient is agreeable to go there instead of [Facility B].” . 2.Review of the On-Call Gastroenterology and General Surgery Schedules Facility A does not have the capability to offer gastroenterology or general surgery services. Facility B had the capacity and the capability to offer gastroenterology and general surgery services. Both of the services at Facility B had available physicians at that time to care for Patient #7. Refer to On-Call attachments. . 3.Review of Transfer Center Communications Audio 1: 04/03/2025 Facility A Staff F Patient #7 Transfer Request Recording “ED Physician Staff F, called the transfer center RN Staff G, requesting a transfer for Patient #7. “Staff verified Patient #7’s name and date of birth. Patient arrived at Facility A, at 5:36 A.M with “severe abdominal pain and vomiting” per ED Physician Staff F. Patient #7 was diagnosed with a “small bowel obstruction.” Per ED Physician Staff F, it was a “high grade obstruction.” “ED Physician Staff F stated that they were requesting a bed in “Med-Surg,” (a medical/surgical unit). Per ED Physician Staff F, Patient #7 “needs surgery and that’s it.” ED Physician Staff F stated, “I think just as long as we have a surgery consult, we’re good.” “Staff verified Patient #7’s past medical history, including bowel surgery as a child. “Staff F reported labs were within normal limits, with the exception of a white blood cell count (WBC) of 9.2. “RN Staff G called the nursing supervisor of Facility B, Nursing Supervisor, Staff H, to verify capacity and capability. Per Nursing Supervisor Staff H, “surgery on-call today,” Staff B. Nursing Supervisor Staff H advised to “see what he says and let [her] know.” “RN Staff G then relayed the message, “we did get approval, no conditions, she just wants me to reach out to the general surgeon.” “ED Physician Staff F asked if “it’s just going to go to the hospitalist, or maybe Staff B will take him.” . Audio 2: 04/03/2025 Facility B Staff B Consult and Admit “RN Staff G connected Surgeon Staff B to ED Physician Staff F for a doctor-to-doctor consult. ED Physician Staff F gave Surgeon Staff B report on Patient #7. “Surgeon Staff B stated, “he needs an NGT (nasogastric tube) before transfer. He’s at a high aspiration risk. He needs to have an NGT tube. And if he does, we can admit him to medical unit.” . Audio 3: 04/03/2025 Facility B Staff C Consult and Admit “Hospitalist, Staff C, called for a doctor-to-doctor consult. Per Hospitalist Staff C, “we can accept the patient, but I need to make sure the surgeon is on-call.” RN Staff G, updated Hospitalist Staff C stating that Surgeon Staff B has been consulted and would like an NGT before transfer. “Hospitalist Staff C asked ED Physician Staff F is an NGT was placed to which EdD Physician Staff F stated, “no, the patient is declining it.” “Hospitalist Staff C states “As long as the surgeon is accepted, I am okay too. We can accept the patient to med-surg.” . Audio 4: 04/03/2025 Facility B Staff B NGT Notification of Contingency “Per Surgeon Staff B, “the transfer is contingent, I need to make sure that this guy has an NG tube for transfer, because we have had patient’s that would aspirate on route, let me make that clear. They need to keep that patient until he’s stabilized, but a NG tube is needed for stabilization for transfer.” . Audio 5: 04/03/2025 Facility B Staff B Notification of NGT Refusal “Per RN Staff G, the patient is refusing the NGT, because he is not vomiting. Staff Surgeon B stated, “it doesn’t matter, he needs to have an NG tube, it’s part of the agreement for transfer, there’s no negotiating.” “It is part of the management.” . Audio 6: 04/03/2025 Facility A Staff F Notification of Denial “RN Staff G relayed to ED Physician Staff F that Surgeon Staff B says the patient must have an NGT that it is non-negotiable as part of his agreement to take the patient, and that without it, he will not be able to accept the patient. “RN Staff G stated, “would you like me to reroute the patient to a different facility?” ED Physician Staff F stated, “I suppose we’re going to have to, because the patient is declining our procedure, and we have to have informed consent to do a procedure on a patient.” . 4.Interview An interview was conducted on 05/13/2025 at 11:50 A.M. with Surgeon Staff B. When asked about high-grade small bowel obstructions, Staff B stated, “ ...there is a block severe enough that it causes a traffic jam and proximally backs up.” “ ...depending on their (the patient’s) medical history, the risk could be high.” Per Staff B, “an NG (nasogastric) tube is placed for decompression in resuscitation for preventable risk of throwing up bile and stomach acid. This can lead to a septic response, which can lead to severe complications. The NG (nasogastric) tube helps mitigate those risks.” When asked about Patient #7, Staff B stated, “This patient was appropriate for a medical unit admission.” . An interview was conducted on 05/15/2025 at 10:45 A.M. with Surgeon Staff B. When asked if he was aware of a transferring patient’s financial status prior to acceptance, Staff B replied, “Never. A patient’s financial status is never considered when evaluating or accepting a transfer. Decisions are based solely on medical necessity.” When asked how many patients with small bowel obstructions he has cared for, Staff B replied, “I have frequently managed and operated on hundreds of patients with small bowel obstructions, have personally placed numerous NGTs (nasogastric tubes), and have also seen and managed sequela of preventable aspiration complications.” Staff B was asked if a patient presented to the emergency department and refused a nasogastric tube, would they still receive care, Staff B replied, “Yes. All patients are entitled to receive a medical exam and necessary treatment regardless of whether they accept every recommended intervention and also deserve proper counseling.””

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 33589 BASED ON observation, record review, and interview, the facility nursing service failed to ensure an organized nursing service that provides 24-hour nursing services: ~ Failed to supervise and evaluate 1 of 1 patient’s (Patient #1’s) care on 7/08/2024 when the discharge teaching RN (Personnel #10) administered 5 times the prescribed Insulin into Patient #1’s 24-hour TPN (Total Parental Nutrition) infusion bag. Personnel #10 administered 100 units into the bag instead of the 20 units that was prescribed. Patient #1 had to be emergently readmitted on 7/09/2024 for a life-threatening blood sugar; AND ~ Failed to implement immediate action on 7/09/2024 to prevent further insulin overdoses from occurring, after being informed of Personnel #10’s actions with Patient #1. Cross Reference: A0394; A0398; and A0405 ~ Failed to ensure a valid and current licensure for each nurse providing patient care (that is, hospital employee, contract, lease, other agreement, or volunteer), citing 1 of 1 contract nurse (Personnel #10). Cross Reference: A0395 ~ Failed to ensure all nurses who provide services (that is, hospital employee, contract, lease, other agreement, or volunteer) have adequate supervision, evaluation, and adhere to the policies and procedures, citing 1 of 1 contract nurse (Personnel #10) on 7/08/2024. Cross Reference: A0395 ~ Failed to ensure all drugs and biologicals were administered by, or under supervision of, nursing or other personnel (that is, hospital employee, contract, lease, other agreement, or volunteer) in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures, citing 1 of 1 patient’s (Patient #1’s) 7/08/2024 discharge teaching RN (Personnel #10) administered 5 times the prescribed Insulin into Patient #1’s 24-hour TPN (Total Parenteral Nutrition) infusion bag. Personnel #10 administered 100 units into the bag instead of the 20 units that was prescribed. Patient #1 had to be emergently readmitted on 7/09/2024 for a life-threatening blood sugar. Cross Reference: A0395”

“LICENSURE OF NURSING STAFF CFR(s): 482.23(b)(2) The nursing service must have a procedure in place to ensure that hospital nursing personnel for whom current licensure is required have a valid and current licensure. This Standard is not met as evidenced by: 33589 BASED ON record review and interview, Nursing failed to ensure a valid, and current licensure for each nurse providing patient care (that is, hospital employee, contract, lease, other agreement, or volunteer), citing 1 of 1 contract nurse (Personnel #10) file did not reflect verification of a valid, and current licensure. FINDINGS The THR (Texas Health Resources) file for Personnel #10 included, “Contract Labor/Professional Vendor Services Personal Data sheet...Effective Date: 3/09/2020...Job Title: Clinical Liaison...Contact with patients: Yes Contact with THR Staff: Yes...Criminal Search...Drug/Immunity/Lab Testing...2019 Flu Shot.” The THR/THDN (Texas Health Denton) file for Personnel #10 did not evidence Texas Health Denton’s verification of licensure, a job description, orientation, or any initial and ongoing competencies. During a record review and interview on 08/08/2024 at 1:55 PM, Personnel #1 confirmed the provided Personnel #10’s file did not reflect Texas Health Denton (THDN) completed a verification of nurse licensure, a job description, orientation, or any initial and ongoing competencies. Personnel #1 stated he could not find a policy for contractor license verification. The THR 3/13/2024 effective “Clinical Competency Management” policy required, “establish the organization’s process for defining, assessing, maintaining, demonstrating, and improving the clinical competency of all staff members...Clinical competencies should be assessed and documented during onboarding and on an ongoing basis... Initial clinical competency validation through observation of daily work...Competency Assessment - The act of verification, demonstration or proof of one’s skill or knowledge through various assessment methods...” The THR 8/16/2012 effective “Clinical Education and Training” policy required, “Employees who provide patient care should receive an Orientation to their role as required by regulatory bodies and reflecting evidence-based best practice guidelines. Orientation is provided at the time of the employee’s date of hire, upon role change, and transfer to another clinical department. Orientation should include assessment and validation of the employee’s Competency prior to the employee functioning independently...Orientation should be provided prior to the employee functioning independently...Competency - An expected level of performance that integrates knowledge, skills, abilities and judgment...Orientation - The educational process of introducing individuals who are new to the organization or department to the philosophy, goals, policies, procedures, role expectations and other factors needed to function in a specific work setting...””

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 33589 BASED ON observation, record review, and interview, Nursing failed to supervise and evaluate each patient’s care, citing - 1 of 1 patient’s (Patient #1’s) 7/08/2024 discharge teaching RN (Personnel #10) administered 5 times the prescribed Insulin into Patient #1’s 24-hour TPN (Total Parental Nutrition) infusion bag. Personnel #10 administered 100 units into the bag instead of the 20 units that was prescribed. Patient #1 had to be emergently readmitted on 7/09/2024 for a life-threatening blood sugar; AND - Nursing failed to implement immediate action on 7/09/2024 to prevent further insulin overdoses from occurring, after being informed of Personnel #10’s actions with Patient #1. FINDINGS Although the Investigation and Analysis process began on 7/12/2024 and multiple Texas Health Resource System (THR/THRC) meetings occurred since, Texas Heath Presbyterian Denton (THDN) and Texas Heath Resource System did not produce evidence during the 2-day survey of any implemented immediate actions to prevent the next patient discharged on TPN with insulin from suffering an insulin overdose. Patient #1 returned to the Emergency Department (ED) 7/09/2024 within 24 hours of discharge on 7/08/2024 with a blood sugar (BS/BG/BSG) at home of 23 and required hospital readmission. The admission diagnosis was Insulin Overdose. Patient #1’s record reflected, ~ “7/09/2024 ED Triage note: 16:39 (4:39 PM) EMS (Ambulance) Report - hypoglycemia (low blood sugar) at home, pt (patient) is chemo (chemotherapy) pt. and does tube feeds at home and mix (TPN bag) had 100 units insulin instead of 20 units, EMS arrival poc bsg (Point of care Blood Glucose) 22, 200 cc (cubic centimeter) D 10 (Dextrose 10) en route... ~ ED Nurse Note: 16:46 (4:46 PM) Family reports that company that mixes tube feeds put 100 units Humulin R in tube feeds instead of 20 units Humulin R... ~ ED Provider note: Chief Complaint: Low blood sugar symptomatic...5:20 PM 74 y.o. (year old) male, with a h/o (history) diabetes and tongue cancer currently compliant with TPN, who presents to the ED via EMS for accidental insulin overdose onset 14:30 (2:30 PM) today. Patient was given 100 units of Humalog, which was much greater than his prescribed...accompanied by family who reports diaphoresis, flushed faced, and temporary altered mental status which has resolved upon arrival of EMS and glucose administration. Per EMS: Blood glucose was 22 upon EMS arrival. This was improved to 93 upon arrival (at ED), with 200 ml (milliliters) D 10 given en route...17:00 (5:00 PM) IV D50 (Intravenous Dextrose 50) drip infusion initiated at this time...Final diagnoses: Insulin overdose, accidental... ~ 7/10/2024 Care Transition Management (CTM) Note: 13:39 (1:39 PM) Referral initiated...THR Infusion (THMS/ProHealth/CarePath) will send a different rep out to do a re-teach on the insulin additive and confirm that dosing and procedure is correct...Transition Plan: Met with patient and spouse. Pt just discharged two days ago on TPN and home IV abx (Intravenous Antibiotics). Pt readmitted with extremely low blood sugar, wife reports there was incorrect dosing on the insulin additive in his TPN bag. Pt and spouse are somewhat distressed/distraught over the incident. CTM offered reassurance. Contacted Patient Advocate and advised her of situation, she will follow up with pt/spouse as soon as able. THR Infusion will send someone out early afternoon, wife will bring home TPN supplies up for teaching... ~ Clinical Nutrition Note 14:37 (2:37 PM) Pt known from past admits- readmit today after d/c (discharge) 2 days d/t (due to) low BS d/t (due to) accidental incorrect administration of insulin dose in TPN...” Patient #1’s 7/08/2024 record reflected, ~ “TPN Adult Order 07/08/24 1117 Frequency: Routine TPN-2100 07/08/24 2100 - 24 hours (Mg/Milligrams; g/grams; ml/milliliters or cc; mEq/milliequivalent) Mixture Ingredients Medication Ordered Dose amino acids 10 % 100 g dextrose 70 % 340 g CLINOLIPID 20% 55 g sodium acetate 190 mEq potassium acetate 20 mEq potassium phosphate 25 mmol calcium gluconate 4 mEq magnesium sulfate 14 mEq MVI-12 With Vit K 10 mL trace elements adult 1 mL Insulin regular 25 units folic acid (Folvite) 1 mg thiamine 100 mg sterile water 68.957 mL The 7/07/2024 TPN Adult Order required 20 units of Insulin. ~ Care Transition Manager Note reflected 14:48 (2:48 PM) TPN (Intravenous feeding) by THR Infusion...Transition Plan: Personnel #10 from THR infusion done teaching at the bedside, spoke to patient and spouse ready to discharge today, no needs at this time. CTM called (named) Home Health informed them TPN started at 2:30 PM today. ~ Physician Discharge Summary...11:27 AM Active Problems: Benign prostatic hyperplasia...Dysphagia..Immunocompromised state due to drug therapy...Palliative care encounter...Gallbladder dilatation...From prior progress note Problem list/Plan: 1. Abdominal pain POA (Present on Admission): improving; currently on TPN 2. Metastatic lung cancer with tongue cancer POA: follow-up with Oncology 3. Anemia of malignancy POA: monitor CBC (blood counts) 4. Paroxysmal atrial fibrillation POA: continue current medical management 5. Hyponatremia POA: monitor sodium level 6. Acquired hypothyroidism POA: currently on IV Synthroid 7. Acute Metabolic Acidosis nPOA (not Present on Admission): monitor labs -treat underlying issues 8. ABN LFTS (abnormal liver function tests) nPOA: checked US x2 (ultrasound) HIDA scan (hepatobiliary iminodiacetic acid/imaging procedure used to diagnose problems of the liver, gallbladder, and bile ducts) also somewhat questionable abnormal -general surgeon consulted -no plan for surgery as of right now 9. Hypokalemia POA: monitor replete as needed 10. Bacteremia not POA: consulted ID (Infectious Disease) -on broad-spectrum antibiotics -monitor closely -source might be gallbladder or abdominal wall cellulitis versus other 11. Abdominal wall cellulitis not POA: follow-up with ID -wound care -IV antibiotics...Discharge Procedure Orders Regular Diet; Order Comments: NPO (Nothing by mouth); with TPN...” There was no documentation on 7/08/2024 by Personnel #10 for teaching/education of the caregiver of the signs and symptoms of hypoglycemia or to not stop the TPN abruptly. There was no documentation on 7/08/2024 by Personnel #10 for administering (measuring/drawing up/injecting/mixing/hanging) the TPN infusion bag with Insulin. There was no documentation on 7/08/2024 of Personnel #10 verifying the TPN prescription AND having a licensed nurse/Pharmacist/or Physician verify/double check/second person (dual sign off) review the Insulin dose prior to administration. The 7/10/2024 Reliability Learning tool entered by Personnel #5 reflected, “Event 7/09/2024 1300 (1:00 PM) Dose incorrect...serious harm: yes...description: discharged home on TPN and antibiotics. His TPN (was to) included 20 units of regular insulin that was added to the bag during the teach by our nurse liaison Personnel #10. The dose was prescribed and labeled to be given as 20 units, (Personnel #10) was also told 20 units verbally when he left (THMS) with the medication. The patient’s spouse called and asked me what the dose was, and I told her 20 units which is 0.2 (ml) on the syringe. She said that when she watched the video it showed (Personnel #10) drawing back 1 ml, the entire syringe...A few hours later the home health nurse (name unknown) came to change the TPN and the patient became very sweaty and lightheaded, she checked his blood sugars, and they were 19, 20, and 23. EMS was called, and the patient was started on D50 to correct. He was then taken to the hospital (THDN) and admitted. Patient recovered and is being discharged back home 7/10. I called Personnel #10 after learning what happened to the patient and asked what dose was and he said 20 units, I asked how far back he drew the syringe, and he said the entire amount, I then explained that it is 100 units, and that 0.2 ml would have been 20 units. He said thank you and that he didn’t know...7/11/2024 Personnel #20...escalated to contracted company; (THDN) nursing not involved in TPN preparation...7/12/2024...Based on RN response, as documented in the original narrative, there is an education and knowledge-based deficiency...7/12/2024 Description: Medication error cause emergency intervention...” The THR file for Personnel #10 included, “Contract Labor/Professional Vendor Services Personal Data sheet...Effective Date: 3/09/2020...Job Title: Clinical Liaison...Contact with patients: Yes Contact with THR Staff: Yes...Criminal Search...Drug/Immunity/Lab Testing...2019 Flu Shot.” The THR/THDN file for Personnel #10 did not evidence Texas Health Denton completed a verification of licensure, a job description, orientation, or any initial and ongoing competencies. The 7/23/2024 email from Personnel #7 to Personnel #6, #8, and #9 reflected, “10:27 AM...We have not done any remediation trainings with Personnel #10. To my knowledge he has not been restricted from any type of patient...” There was no evidence of re-education or counseling of Personnel #10 (or colleagues) after Patient #1’s 7/09/2024 ED event provided during the onsite survey. The 5/13/2019 effective THMS to THDN Expectation Document (contract) required, “set forth mutual expectations of the IV preparation services...Contacts Personnel #7 (THMS) and #9 (THDN)...THDN’s TPN orders will be sent to THMS via Care Connect...cut-off times for THMS to receive orders...TPN orders 1:00 PM...THMS agrees to follow THMS’ Standard Operating Procedures, use only qualified employees who possess appropriate product knowledge and demonstrate understanding of procedures, aseptic techniques, and process controls in connection with the performance of IV services for THDN...” The 3/01/2016 effective Business Associate Agreement between THR and ProHealth Pharmacy Solutions required, “HIPAA...PHI...” security (Health Insurance Portability and Accountability Act / Protected Health Information). The 3 Amendments to the Home Infusion Support Services Agreement between THR and ProHealth Pharmacy Services/PPS required, “PPS shall facilitate the referral/discharge process for home infusion patients through on-site clinical liaisons located in agreed upon locations within THR medical facilities. These liaisons shall receive referral information and transfer it to PPS patient care center...coordinate nursing services for home infusion patients referred for home infusion as required...liaisons shall be awarded access to THR hospitals to facilitate and assist in home infusion patient discharge to THR services...so service coordination between hospital and home infusion is seamless...” The 3 amendments were effective 3/01/2019, 2/01/2020, and 3/12/2024. The 8/08/2024 email from Personnel #6 to Personnel #3 stated, “background on the contractual status of ProHealth and THRC...As set forth in the contract, ProHealth Pharmacy Solutions is the current legal corporate entity contracted with THRC. ProHealth was acquired several years ago by a CarepathRX parent company, and is now owned by CarepathRX Services, LLC, but the contracts held by ProHealth have not been assigned to, or assumed by, another entity ...Being in the Carepath group of companies, ProHealth may be referred to from time to time as Carepath...ProHealth is the actual and correct legal contraction party for the THRC agreement...” The provided contracts did not provide authorization for Personnel #10 to administer medication onsite at Texas Health Denton (THDN). During record review and interview on 8/07/2024 at 1:10 PM, Personnel #1 and #2 were present. Personnel #2 navigated the record and confirmed the findings. Personnel #2 stated Patient #1 had an admitted on 7/09 to 7/10; and 6/26 to 7/8. The 7/09/2024 ED record stated, “previously discharged 7/08/2024” Admitted to IMC (Intermediate Care) for an “Insulin Overdose.” Personnel #2 was asked for documentation of the patient teaching of how to put Insulin into the TPN bag prior to discharge on 7/08/2024. Personnel #2 showed Personnel #4’s note that stated, “7/08/2024 at 14:48 which reflected TPN by THR Infusion (THMS)...Transition Plan: Personnel #10 from THR infusion done teaching at the bedside, spoke to patient and spouse ready to discharge today, no needs at this time. CTM called Trio Home Health informed them TPN started at 2:30 PM today.” Personnel #2 was asked who THR Infusion was. Personnel #2 stated Texas Health Medical Support (THMS). Personnel #2 was shown Personnel #10’s business card that showed THMS and asked if this was the same place. Personnel #2 stated yes. Personnel #2 was asked for documentation by Personnel #10. Personnel #2 stated he would not document in our system. Personnel #2 was asked if there was a second nurse verification/review of the amount of insulin added to the bag during the teaching. Personnel #2 stated I don’t see that documented. Personnel #2 was asked if the teaching bag was hung/administered for the patient. Personnel #2 stated based on documentation it was. Personnel #2 confirmed the patient received TPN while admitted and the teaching and last ordered TPN bags were not documented in the MAR (Medication Administration Record). We (THDN) did not provide it. It would not have been documented in our record. Personnel #2 was asked if a nurse giving insulin should have a second nurse verify the dose. Personnel #2 sated yes. Also, our nurses do not add medications into the TPN bags. That is only done by the pharmacy here. During an interview on 8/07/2024 at 2:06 PM, (Personnel #1 and #2 were present) Personnel #3 was asked about immediate actions implemented after the insulin overdose. Personnel #3 stated we may need to bring Personnel #7 and #8 in to answer that. Personnel #8 was brought into a Teams call. Personnel #8 was asked about immediate actions. Personnel #8 discussed the investigation has been complicated with the nurse being a contract versus an employee. Personnel #7 is over the (THMS) Texas Health infusion group and Carepath. We are currently developing action items to define the whole process. Personnel #7 was added to the call. Personnel #7 was asked about the immediate actions for the incident and a list of other patients for Personnel #10. Personnel #7 stated we can get a list of patients Denton requested service for, but we don’t file those requests by the liaison who provides the service. We are working on that now. We are not tracking who services each patient. The nurses are contract employees for Carepath. Personnel #18 is the Carepath leader and Personnel #7’s supervisor. I reached out to her and asked them for a list like that (Personnel #7’s patients). Personnel #3 asked/stated what was the leader’s response. Personnel #7 stated Personnel #18’s initial response was get info and discuss it, then answer back. Personnel #7 was asked what occurred with the nurse. Personnel #7 stated we did not clarify education or disciplinary action. Personnel #7 was asked about PEER Review of the nurse. Personnel #7 stated I don’t think that has been answered. Personnel #7 was asked if THMS has a PEER Review process. Personnel #7 stated no, we do not. Personnel #7 was asked about the name on the business card is THMS not Carepath. Personnel #7 stated the personnel cost for Carepath is a pass-through charge for us (THMS). When he is at the facility, he is representing us (THMS). During an observation of the “7/08/2024 THMS training video” on 8/07/2024 ending at 4:45 PM, the video showed Personnel #10 teaching the wife to draw up and add Insulin to a TPN infusion bag. The insulin teaching began at 2:14 of the video. Personnel #10 verbalized the 20 units dose then drew up 1 ml of Insulin (video timing 3:24) and injected 1 ml into the TPN bag (ending 4:04). Personnel #10 clearly hesitated (2:31) when he looked at the front and back of the syringe package before drawing a full syringe of Insulin and injecting a full syringe of insulin. The wife questioned the amount he drew, and he stated it again. The wife questioned him trying to make since of what he was saying versus doing. Personnel#10’s name tag said ProHealth Pharmacy Solution, Contractor, Registered Nurse. Reference: The syringe was a TB (tuberculosis syringe) labeled in milliliters (ml) versus an insulin syringe which would have been labeled in units. One syringe was 1 milliliter. One milliliter of Insulin equals 100 units of Insulin. The prescribed 20 units dose would have been 0.2 milliliters in the TB syringe. (Picture may not be visible.) Personnel #10 did not follow the policy that required a second nurse’s (witness/dual sign off) verification of the amount of Insulin drawn up prior to injecting the Insulin into the TPN bag. Personnel #10 did not follow the policy that required nurses to document clinical care including medication administration and patient/family teaching. During an interview on 08/07/2024 ending at 4:45 PM, Personnel #1, and #2 were present. Personnel #2 stated Personnel #16 has confirmed yes, there should have been a 2 person check on the Insulin. During an interview on 8/07/2024 at 4:57 PM, Personnel #3 entered the conference room. Personnel #1 and #2 were present. Personnel #3 discussed the response after the 7/10/2024 knowledge of the Insulin Overdose. Personnel #3 stated the report came through 7/10/2024 for THMS. We (THDN) were not involved until later. He was not our employee. They did an immediate SBAR notice on 7/12/2024 that said put the bill on hold and do a review. This only went to THMS, not us, as we were not involved yet. THMS was handling it before then. I was not privy to what (THMS) the system pharmacy was doing with this vendor. The nurse was a contract nurse, not even THMS employee. We were added 7/18/2024 when they (THMS and THR System) realized the instruction and medication happened onsite here (THDN). Personnel #3 was asked the SBAR did not say to stop using the THMS service for patients. Personnel #3 stated it did not. We spoke about actions at the 8/02 meeting. Discussion on not using the service (THMS) for this purpose until implementation of remediation could be completed. At the 8/07 meeting today, I reiterated that action. After the meeting, I spoke directly to Personnel #17 and said no Denton patient uses the service (THMS) for infusions without going through me. Personnel #3 had Personnel #8 join via Teams call. Personnel #3 asked Personnel #8 Prior to today there have been no definitive action plans. Personnel #8 stated right now we need to figure out what that will look like. Personnel #3 asked Personnel #8 - Personnel #6 and #7 did not have a plan for Denton. Personnel #8 stated that is correct. Personnel #8 left the Teams call. During an interview on 8/07/2024 ending at 5:49 PM, Personnel #3 was asked from 7/10/2024 to today 8/07/2024 Denton has no evidence of action by THR/THMS/ProHealth/Carepath with Personnel #10 and Denton did not stop using THMS. Personnel #3 stated correct. During a record review and interview on 08/08/2024 at 1:55 PM, Personnel #1 confirmed the provided Personnel #10’s file did not reflect Texas Health Denton (THDN) completed a verification of nurse licensure, a job description, orientation, or any initial or ongoing competencies. Personnel #1 stated he could not find a policy for contractor license verification. During an interview on 08/08/2024 at 4:10 PM, Personnel #3 was asked if they decided whether the THMS RN had authorization to administer the medications. Personnel #3 stated I have not seen in the contracts that they have authorization here. The Texas Health Resources’ (THR System) 7/20/2023 effective, “High Alert Medications for the Adult Patient” policy required, “Purpose 2.1. To identify High-Alert Medications and establish practices to prevent and reduce adverse drug events...4.1.3. The hospital has in place interventions deemed appropriate for each High-Alert Medication. Interventions intended to mitigate potential for harm with High-Alert Medications include but are not limited to: a. education of staff and patients/family b. co-signatures by two licensed clinical personnel (Dual Sign-Off)...e. reduction of bedside mixing (IV admixture by a nurse) f. utilization of premixed medications...4.2. Dual Sign-Offs 4.2.1. The Medication Administration Record (MAR) entries for High-Alert Medications found in Attachment “A” are to be co-signed by two licensed clinical personnel within the scope of their practice, examples: Registered Nurse (RN), pharmacist, or physicians. 4.2.2. The Dual Sign-Off process is done by each participating licensed care provider without interruption to obtain proper validation. Both parties will independently visualize and confirm the validation process. The Dual Sign-Off process is carried out as set forth in Attachment “B”...4.2.4. All medications are to be administered appropriately. a. When the medication is administered by a mechanical pump/syringe delivery device (examples: Alaris pump or PCA pump), the device settings are incorporated into the verification/Dual Sign-Off process...8.1. Attachment A - High-Alert Medications Requiring Dual Sign-Off...Attachment A High-Alert Medications...I - Insulin (excludes insulin U-100 concentration administered subcutaneous)...Attachment B Steps in Performing a Dual Sign-Off for a High-Alert Medication 1. Medication Preparation...All High Alert medications, excluding products that are U-100 concentration to be given subcutaneously, all other insulin administrations, including intravenous administration, should have dual sign off performed...Right Medication, Right Time, Right Dose, & Right Route: Ensure that you are meeting these 4 administration requirements by looking at the e-MAR screen to assure that there is no alert. All alerts will be addressed prior to administration of the medication...viii. Confirm any associated lab values for the high-risk medications. ix. If the drug to be administered is Insulin, the most recent blood glucose level, insulin type and dose will be verified prior to administration. x. Open medications or draw up medications at the bedside. xi. Request a 2nd licensed clinical personnel who has the authority to administer APINCH medications and has adequate access in CareConnect One to independently verify the five (5) administration requirements. xii. The 2nd appropriate licensed personnel will physically verify the medication for the dual sign-off. xiii. Administer the medication. xiv. Document medication administration independently. The Texas Health Presbyterian Hospital Denton’s (THDN) March 2023 last reviewed, “Parenteral Nutrition (PN/TPN) Interdisciplinary Management” policy Approved By: Pharmacy & Therapeutics Committee required, “...2.1 Purpose: To guide in the appropriate ordering, preparing, administering and monitoring of Parenteral Nutrition (PN/TPN) therapy...4.13 Prior to administration, a nurse must verify the composition of the PN/TPN...4.20 Medications should never be added to the PN/TPN...6.3...Pharmacy will compound the PN/TPN...Nursing Service - for administering therapy after the composition and flow rate have been checked, monitoring therapy and reporting any adverse reactions to the physician...This policy represents the collaborative effort of the Texas Health system entities to determine and direct the recommended practice for the care anticipated under this policy and includes the input of clinical subject matter specialists. As no policy or published procedure can anticipate every clinical and/or medical presentation, this policy is a guideline and is not intended as a substitute for the clinician’s clinical judgment and/or experience.” The Texas Health Resource (THR System) 3/13/2024 effective, “Clinical Competency Management” policy required, “Purpose: 2.1 To establish the organization’s process for defining, assessing, maintaining, demonstrating, and improving the clinical competency of all staff members. 3.0 Policy Statement(s): 3.1 This policy communicates the process for identification, management, and documentation of clinical competencies during onboarding and on an ongoing basis. 4.0 Policy Guidance: 4.1 Clinical competencies should be assessed and documented during onboarding and on an ongoing basis. 4.2 Clinical competencies should be reviewed annually and updated as indicated...4.4.1 Initial clinical competency validation through observation of daily work...” The Texas Health Resource (THR System) 9/12/2023 last reviewed, “Clinical Education and Training” policy required, “3.1 Employees who provide patient care should receive an Orientation to their role as required by regulatory bodies and reflecting evidence-based best practice guidelines. Orientation is provided at the time of the employee’s date of hire, upon role change, and transfer to another clinical department. Orientation should include assessment and validation of the employee’s Competency prior to the employee functioning independently.” The Texas Health Resource (THR System) 12/12/2023 effective, “Cause Analysis” policy required, “2.0 Purpose: 2.1 To provide guidance for performing cause analysis that will result in identification of sustainable process improvements and corrective actions to prevent recurrence of an event(s)...4.12 Immediate/Remedial Corrective Action - A fix designed to restore the product, service, or system to an acceptable condition typically taken immediately after discovery and designed to mitigate immediate risk; may be implemented without necessarily addressing the cause of the event...””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 33589 BASED ON observation, record review, and interview, the Director of Nursing Services failed to ensure all nurses who provide services (that is, hospital employee, contract, lease, other agreement, or volunteer) have adequate supervision, evaluation, and adhere to the policies and procedures, citing 1 of 1 contract nurse (Personnel #10) did not have adequate supervision, evaluation, and adhere to the policies and procedures. FINDINGS During an observation of the “7/08/2024 THMS training video” on 8/07/2024 ending at 4:45 PM, the video showed Personnel #10 teaching the wife to draw/add Insulin to a TPN infusion bag. The insulin teaching began at 2:14 of the video. Personnel #10 verbalized the 20 units dose then drew up 1 ml of Insulin (3:24) and injected 1 ml into the TPN bag (ending 4:04). Personnel #10 clearly hesitated (2:31) when he looked at the syringe (front and back) before drawing a full syringe of Insulin and injecting a full syringe of insulin. The wife questioned the amount he drew, and he stated it again. The wife questioned him trying to make since of what he was saying versus doing. Personnel#10’s name tag said ProHealth Pharmacy Solution, Contractor, Registered Nurse. Personnel #10 did not follow the policy that required a second nurse’s (witness/dual sign off) verification of the amount of Insulin drawn up prior to injecting the Insulin into the TPN bag. Personnel #10 did not follow the policy that required nurses to document clinical care including medication administration and patient/family teaching. The THR file for Personnel #10 included, “Contract Labor/Professional Vendor Services Personal Data sheet...Effective Date: 3/09/2020...Job Title: Clinical Liaison...Contact with patients: Yes Contact with THR Staff: Yes...Criminal Search...Drug/Immunity/Lab Testing...2019 Flu Shot.” The 7/23/2024 email from Personnel #7 to Personnel #6, #8, and #9 reflected, “10:27 AM...We have not done any remediation trainings (sp) with Personnel #10. To my knowledge he has not been restricted from any type of patient...” There was no evidence of re-education or counseling of Personnel #10 (or colleagues) after Patient #1’s 7/09/2024 ED event provided during the onsite survey. During an interview on 08/07/2024 ending at 4:45 PM, Personnel #1, and #2 were present. Personnel #2 stated Personnel #16 has confirmed yes, there should have been a 2 person check on the Insulin. During a record review and interview on 08/08/2024 at 1:55 PM, Personnel #1 confirmed the provided Personnel #10’s file did not reflect Texas Health Denton (THDN) completed a verification of nurse licensure, a job description, orientation, or any initial and ongoing competencies. During an interview on 08/08/2024 at 4:10 PM, Personnel #3 was asked if they decided whether the THMS RN had authorization to administer the medications. Personnel #3 stated I have not seen in the contracts that they have authorization here. The provided contracts did not provide authorization for Personnel #10 to administer medication onsite at Texas Health Denton (THDN). The 8/08/2024 email from Personnel #6 to Personnel #3 stated, “background on the contractual status of ProHealth and THRC...As set forth in the contract, ProHealth Pharmacy Solutions is the current legal corporate entity contracted with THRC. ProHealth was acquired several years ago by a CarepathRX parent company, and is now owned by CarepathRX Services, LLC, but the contracts held by ProHealth have not been assigned to, or assumed by, another entity...Being in the Carepath group of companies, ProHealth may be referred to from time to time as Carepath...ProHealth is the actual and correct legal contraction party for the THRC agreement...” The Texas Health Resources’ (THR System) 7/20/2023 effective, “High Alert Medications for the Adult Patient” policy required, “If the drug to be administered is Insulin, the most recent blood glucose level, insulin type and dose will be verified prior to administration. x. Open medications or draw up medications at the bedside. xi. Request a 2nd licensed clinical personnel who has the authority to administer APINCH medications and has adequate access in CareConnect One to independently verify the five (5) administration requirements. xii. The 2nd appropriate licensed personnel will physically verify the medication for the dual sign-off. xiii. Administer the medication. xiv. Document medication administration independently.” The Texas Health Presbyterian Hospital Denton’s (THDN) March 2023 last reviewed, “Parenteral Nutrition (PN/TPN) Interdisciplinary Management” policy Approved By: Pharmacy & Therapeutics Committee required, “...2.1 Purpose: To guide in the appropriate ordering, preparing, administering and monitoring of Parenteral Nutrition (PN/TPN) therapy...4.13 Prior to administration, a nurse must verify the composition of the PN/TPN...4.20 Medications should never be added to the PN/TPN...6.3...Pharmacy will compound the PN/TPN...Nursing Service - for administering therapy after the composition and flow rate have been checked, monitoring therapy and reporting any adverse reactions to the physician...” The Texas Health Resource (THR System) 3/13/2024 effective, “Clinical Competency Management” policy required, “Purpose: 2.1 To establish the organization’s process for defining, assessing, maintaining, demonstrating, and improving the clinical competency of all staff members. 3.0 Policy Statement(s): 3.1 This policy communicates the process for identification, management, and documentation of clinical competencies during onboarding and on an ongoing basis. 4.0 Policy Guidance: 4.1 Clinical competencies should be assessed and documented during onboarding and on an ongoing basis. 4.2 Clinical competencies should be reviewed annually and updated as indicated...4.4.1 Initial clinical competency validation through observation of daily work...” The Texas Health Resource (THR System) 9/12/2023 last reviewed, “Clinical Education and Training” policy required, “3.1 Employees who provide patient care should receive an Orientation to their role as required by regulatory bodies and reflecting evidence-based best practice guidelines. Orientation is provided at the time of the employee’s date of hire, upon role change, and transfer to another clinical department. Orientation should include assessment and validation of the employee’s Competency prior to the employee functioning independently.” The 5/13/2019 effective THMS to THDN Expectation Document (contract) required, “set forth mutual expectations of the IV preparation services...Contacts Personnel #7 (THMS) and #9 (THDN)...THDN’s TPN orders will be sent to THMS via Care Connect...cut-off times for THMS to receive orders...TPN orders 1:00 PM...THMS agrees to follow THMS’ Standard Operating Procedures, use only qualified employees who possess appropriate product knowledge and demonstrate understanding of procedures, aseptic techniques, and process controls in connection with the performance of IV services for THDN...” The 3/01/2016 effective Business Associate Agreement between THR and ProHealth Pharmacy Solutions required, “HIPAA...PHI...” security. (Health Insurance Portability and Accountability Act / Protected Health Information) The 3 Amendments to the Home Infusion Support Services Agreement between THR and ProHealth Pharmacy Services/PPS required, “PPS shall facilitate the referral/discharge process for home infusion patients through on-site clinical liaisons located in agreed upon locations within THR medical facilities. These liaisons shall receive referral information and transfer it to PPS patient care center...coordinate nursing services for home infusion patients referred for home infusion as required...liaisons shall be awarded access to THR hospitals to facilitate and assist in home infusion patient discharge to THR services...so service coordination between hospital and home infusion is seamless...” The 3 amendments were effective 3/01/2019, 2/01/2020, and 3/12/2024.”

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 33589 BASED ON observation, record review, and interview, the facility failed to ensure all drugs and biologicals were administered by, or under supervision of, nursing or other personnel (that is, hospital employee, contract, lease, other agreement, or volunteer) in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures, citing 1 of 1 patient’s (Patient #1’s) 7/08/2024 discharge teaching RN (Personnel #10) administered 5 times the prescribed Insulin into Patient #1’s 24-hour TPN (Total Parenteral Nutrition) infusion bag. Personnel #10 administered 100 units into the bag instead of the 20 units that was prescribed. Patient #1 had to be emergently readmitted on 7/09/2024 for a life-threatening blood sugar. FINDINGS Patient #1 returned to the Emergency Department (ED) 7/09/2024 within 24 hours of discharge on 7/08/2024 with a blood sugar (BS/BG/BSG) at home of 23 and required hospital readmission. The admission diagnosis was Insulin Overdose. ~ 7/10/2024 Care Transition Management (CTM) Note: 13:39 (1:39 PM) Referral initiated...THR Infusion will send a different rep out to do a re-teach on the insulin additive and confirm that dosing and procedure is correct...Transition Plan: Met with patient and spouse. Pt just discharged two days ago on TPN and home IV abx (Intravenous Antibiotics). Pt readmitted with extremely low blood sugar, wife reports there was incorrect dosing on the insulin additive in his TPN bag. Patient #1’s 7/08/2024 record reflected, The 7/08/2024 TPN Adult Order required 25 units of Insulin. The 7/07/2024 TPN Adult Order required 20 units of Insulin. ~Care Transition Manager Note reflected 14:48 (2:48 PM) TPN (Total Parental Nutrition/Intravenous feeding) by THR Infusion...Transition Plan: (Personnel #10 )from THR infusion done teaching at the bedside, spoke to patient and spouse ready to discharge today, no needs at this time. CTM called (named) Home Health informed them TPN started at 2:30 PM today. There was no documentation on 7/08/2024 by Personnel #10 for teaching/education of the caregiver of the signs and symptoms of hypoglycemia or not stopping the TPN abruptly. There was no documentation on 7/08/2024 by Personnel #10 for administering (measuring/drawing up/injecting/mixing/hanging) the TPN infusion bag with Insulin. There was no documentation on 7/08/2024 of Personnel #10 verifying the TPN prescription AND having a licensed nurse/Pharmacist/or Physician verify/double check/second person (dual sign off) review the Insulin dose prior to administration. The Texas Health Resources (THR)/Texas Health Denton (THDN) file for Personnel #10 did not evidence Texas Health Denton completed a verification of licensure, a job description, orientation, or any initial and ongoing competencies. The provided contracts did not provide authorization for Personnel #10 to administer medication onsite at Texas Health Denton (THDN). During record review and interview on 8/07/2024 at 1:10 PM, Personnel #1 and #2 were present. Personnel #2 navigated the record and confirmed the findings. Personnel #2 stated Patient #1 had an admitted on 7/09 to 7/10; and 6/26 to 7/8. The 7/09/2024 ED record stated, “previously discharged 7/08/2024” Admitted to IMC (Intermediate Care) for an “Insulin Overdose.” Personnel #2 was asked for documentation of the patient teaching of how to put Insulin into the TPN bag prior to discharge on 7/08/2024. Personnel #2 showed Personnel #4’s note that stated, “7/08/2024 at 14:48 which reflected TPN by THR Infusion (THMS)...Transition Plan: Personnel #10 from THR infusion done teaching at the bedside, spoke to patient and spouse ready to discharge today, no needs at this time. CTM called Trio Home Health informed them TPN started at 2:30 PM today.” Personnel #2 was asked who THR Infusion was. Personnel #2 stated Texas Health Medical Support (THMS). Personnel #2 was shown Personnel #10’s business card that showed THMS and asked if this was the same place. Personnel #2 stated yes. Personnel #2 was asked for documentation by Personnel #10. Personnel #2 stated he would not document in our system. Personnel #2 was asked if there was a second nurse verification/review of the amount of insulin added to the bag during the teaching. Personnel #2 stated I don’t see that documented. Personnel #2 was asked if the teaching bag was hung/administered for the patient. Personnel #2 stated based on documentation it was. Personnel #2 confirmed the patient received TPN while admitted and the teaching and last ordered TPN bags were not documented in the MAR (Medication Administration Record). We (THDN) did not provide it. It would not have been documented in our record. Personnel #2 was asked if a nurse giving insulin should have a second nurse verify the dose. Personnel #2 sated yes. Also, our nurses do not add medications into the TPN bags. That is only done by the pharmacy here. During an observation of the “7/08/2024 THMS training video” on 8/07/2024 ending at 4:45 PM, the video showed Personnel #10 teaching the wife to draw/add Insulin to a TPN infusion bag. The insulin teaching began at 2:14 of the video. Personnel #10 verbalized the 20 units dose then drew up 1 ml of Insulin (3:24) and injected 1 ml into the TPN bag (ending 4:04). Personnel #10 clearly hesitated (2:31) when he looked at the syringe (front and back) before drawing a full syringe of Insulin and injecting a full syringe of insulin. The wife questioned the amount he drew, and he stated it again. The wife questioned him trying to make since of what he was saying versus doing. Personnel#10’s name tag said ProHealth Pharmacy Solution, Contractor, Registered Nurse. Personnel #10 did not follow the policy that required a second nurse’s (witness/dual sign off) verification of the amount of Insulin drawn up prior to injecting the Insulin into the TPN bag. Personnel #10 did not follow the policy that required nurses to document clinical care including medication administration and patient/family teaching. During an interview on 08/07/2024 ending at 4:45 PM, Personnel #1, and #2 were present. Personnel #2 stated Personnel #16 has confirmed yes, there should have been a 2 person check on the Insulin. During a record review and interview on 08/08/2024 at 1:55 PM, Personnel #1 confirmed the provided Personnel #10’s file did not reflect Texas Health Denton (THDN) completed a verification of nurse licensure, a job description, orientation, or any initial and ongoing competencies. Personnel #1 stated he could not find a policy for contractor license verification. During an interview on 08/08/2024 at 4:10 PM, Personnel #3 was asked if they decided whether the THMS RN had authorization to administer the medications. Personnel #3 stated I have not seen in the contracts that they have authorization here. The 8/08/2024 email from Personnel #6 to Personnel #3 stated, “background on the contractual status of ProHealth and THRC...As set forth in the contract, ProHealth Pharmacy Solutions is the current legal corporate entity contracted with THRC. ProHealth was acquired several years ago by a CarepathRX parent company, and is now owned by CarepathRX Services, LLC, but the contracts held by ProHealth have not been assigned to, or assumed by, another entity...Being in the Carepath group of companies, ProHealth may be referred to from time to time as Carepath...ProHealth is the actual and correct legal contraction party for the THRC agreement...” The Texas Health Resources’ (THR System) 7/20/2023 effective, “High Alert Medications for the Adult Patient” policy required, “If the drug to be administered is Insulin, the most recent blood glucose level, insulin type and dose will be verified prior to administration. x. Open medications or draw up medications at the bedside. xi. Request a 2nd licensed clinical personnel who has the authority to administer APINCH medications and has adequate access in CareConnect One to independently verify the five (5) administration requirements. xii. The 2nd appropriate licensed personnel will physically verify the medication for the dual sign-off. xiii. Administer the medication. xiv. Document medication administration independently.” The Texas Health Denton’s (THDN) March 2023 last reviewed, “Parenteral Nutrition (PN/TPN) Interdisciplinary Management” policy Approved By: Pharmacy & Therapeutics Committee required, “...2.1 Purpose: To guide in the appropriate ordering, preparing, administering and monitoring of Parenteral Nutrition (PN/TPN) therapy...4.13 Prior to administration, a nurse must verify the composition of the PN/TPN...4.20 Medications should never be added to the PN/TPN...6.3...Pharmacy will compound the PN/TPN...Nursing Service - for administering therapy after the composition and flow rate have been checked, monitoring therapy and reporting any adverse reactions to the physician...” The Texas Health Resource (THR System) 3/13/2024 effective, “Clinical Competency Management” policy required, “Purpose: 2.1 To establish the organization’s process for defining, assessing, maintaining, demonstrating, and improving the clinical competency of all staff members. 3.0 Policy Statement(s): 3.1 This policy communicates the process for identification, management, and documentation of clinical competencies during onboarding and on an ongoing basis. 4.0 Policy Guidance: 4.1 Clinical competencies should be assessed and documented during onboarding and on an ongoing basis. 4.2 Clinical competencies should be reviewed annually and updated as indicated...4.4.1 Initial clinical competency validation through observation of daily work...” The Texas Health Resource (THR System) 9/12/2023 last reviewed, “Clinical Education and Training” policy required, “3.1 Employees who provide patient care should receive an Orientation to their role as required by regulatory bodies and reflecting evidence-based best practice guidelines. Orientation is provided at the time of the employee’s date of hire, upon role change, and transfer to another clinical department. Orientation should include assessment and validation of the employee’s Competency prior to the employee functioning independently.” The 5/13/2019 effective Texas Health Medical Support (THMS) to THDN Expectation Document (contract) required, “set forth mutual expectations of the IV preparation services...Contacts Personnel #7 (THMS) and #9 (THDN)...THDN’s TPN orders will be sent to THMS via Care Connect...cut-off times for THMS to receive orders...TPN orders 1:00 PM...THMS agrees to follow THMS’ Standard Operating Procedures, use only qualified employees who possess appropriate product knowledge and demonstrate understanding of procedures, aseptic techniques, and process controls in connection with the performance of IV services for THDN...” The 3/01/2016 effective Business Associate Agreement between THR and ProHealth Pharmacy Solutions required, “HIPAA...PHI...” security. (Health Insurance Portability and Accountability Act / Protected Health Information) The 3 Amendments to the Home Infusion Support Services Agreement between THR and ProHealth Pharmacy Services/PPS required, “PPS shall facilitate the referral/discharge process for home infusion patients through on-site clinical liaisons located in agreed upon locations within THR medical facilities. These liaisons shall receive referral information and transfer it to PPS patient care center...coordinate nursing services for home infusion patients referred for home infusion as required...liaisons shall be awarded access to THR hospitals to facilitate and assist in home infusion patient discharge to THR services...so service coordination between hospital and home infusion is seamless...” The 3 amendments were effective 3/01/2019, 2/01/2020, and 3/12/2024.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 33579 Based on Record Review and Interview the hospital failed 1 of 1 Patient (Pateint #1) by failing the patient to receive care in a safe setting. Patient #1 was admitted to the hospital after being with another provider for 2 days and medical clearance was required. Patient #1 was diagnosed with Type 1 diabetes mellitus with hyperglycemia. Patient #1 admits to consuming multiple sodas and attempting to increase blood sugar. Upon arrival to the emergency department blood sugar level was 1600. Findings Include: During Record Review of the hospital Clinical Progress Note on 02/11/2024 at 1128 Patient #1 was assessed and determined to be a High Risk for Suicide Ideation, although Patient #1 denied all suicidial ideation in completion of the Crisis Evaluation Assessment. The Behavioral Health Crisis Clinician has completed there assessment and reviewed the findings with the attending physician. The Patient has been recommended for transfer to inpatient behavior healthier care at the conclusion of the assessment the patient was not medically cleared per the attending physician. During Interview with Hospital Staff #1 at 1:45 PM on 02/22/2024, it was reported by Staff #1, “This Patient was deemed to be a High-Risk Suicide, we should have gotten her a Involuntary EDO. Patient #1 vesiculated back and forth.” During Interview Staff #1 on 02/22/2024 at 2:00 PM Patient #1 signed out of the hospital Against Medical Advice, and walked approximately a quarter of a mile onto the freeway and was struck and killed on the Southbound Side of I-35 by U-Haul truck. During Interview with Hospital Staff #4 at 4:30PM on 02/22/2024 it was reported, “The Patient requested to leave the hospital Against Medical Advice (AMA). Patient #1 signed to leave and stated wished to return to...[original provider}. The hospital felt Patient #1 was oriented x4 and reported that they do not transport Patients who request and are discharged AMA. The Patient requested directions to get back to {original provider}, which is “less than a mile away.” We felt if we transported Patient #1, Patient would continue not to be accepted. If she entered on own accord Patient #1 would be accepted as a walk-in.” “In review of bingmaps.com mental health facility is 1.6 miles away opposite of the direction Patient #1 walked and takes 30minutes to walk.” During Interview on 02/22/2024 at 4:45 PM Staff #4 and Staff #11 reported “Patient #1 signed the AMA, attempts to encourage not to discharge were unsuccessful, but Patient #1 requested direction to get to mental health facility, and directions were provided verbally and hand written. “ Policy The Texas Health Presbyterian Policy Assessment, Reassessment, and Documentation Policy 10/2022, “The Registered Nurse (RN) is responsible for patient assessment, reassessment and the coordination of patient care. The Texas Presbyterian Hospital - Denton Policy on “Abuse, Neglect, and Sexual Exploitation of Patients while in the hospital, 08/2022, ‘An employee, medical staff member, advanced practice professional (‘APP’), allied health professional (‘AHP’), or volunteer who reasonably believes a patient has been Abused, Neglected, or Sexually Exploited while the patient is in the hospital shall promptly report it in accordance with this policy . The Texas Presbyterian Hospital-Denton Policy on “Patient Rights and Responsibilities, 11/2020, “It is the Policy of each Texas Health member facility that every patient has the right to care, treatment, and services within the Facility capacity and capabilities as they may change from time to time, within the Facility mission, and in compliance with federal and state laws, and regulations. “”