45847 Based on review of documentation, the Facility neglected a patient when they failed to prevent patient harm or follow current standards of safe practice [ the Facility uses American Society of Health System Pharmacists (ASHP)] by way of giving a patient with chronic kidney disease (CKD) Toradol 60mg IM to Patient #9 without reviewing Patient #9's creatinine clearance or (glomerular filtration rate) GFR level. The Findings were: Review of the client record for Patient #9 on April 20, 2022, who has documented chronic kidney disease (CKD) and is chronically taking a diuretic [which is a known contributor in volume depletion], Toradol 60mg IM was given on April 20, 2022 without reviewing his creatinine clearance or (glomerular filtration rate) GFR level. There is no documentation in Patient #9's record from April 20, 2022 of a creatinine clearance level or GFR being obtained. Record reviews of prior charts noted that Patient #9's last creatinine clearance level or GFR were obtained in November 2020. A further review of the client record for Patient #9 on April 29, 2022 revealed that Patient #9 suffered an Acute Kidney Injury (AKI) that can be correlated to the administration of the Toradol given on April 20, 2022 and the subsequent discharge medication, Indocin (an NSAID, or non-steroidal anti-inflammatory drug). The treating physician notes, in part, in the History and Physical, He [Patient #9] reports a baseline creatinine of around 2.4 (last checked April 1 at [nephrologist's] office .He [Patient #9] came here on April 20 and saw a nurse practitioner who gave him Toradol and prescription for indomethacin. He [Patient #9] took only about 5 days of the indomethacin and started feeling bad .He [Patient #9] stopped taking those medications and spoke with [his nephrologist] who wanted him to come in for lab work . The Standards utilized by this Facility are those of the American Society of Health System Pharmacists (ASHP) according to the Facility's Policy titled, Adverse Drug Reaction and Medication Errors. Per ASHP guidelines on page 533 (copy included in this packet), Ketorolac is contraindicated in patients with advanced renal impairment and in those at risk for renal failure due to volume depletion. If Cr Cl [creatinine clearance] is 10-29 mL/min, give 50% of the usual dose, and if Cr Cl is <10 mL/min, give 25% to 50% of the usual dose. An online review of ASHP guidelines on Renal Dosing Concepts, sample chapter on page 5365, which states in part, Renal function (Cr Cl and CRRT) clearance are required for dose individualization Dose reductions may be required in patients with CKD [chronic kidney disease] to avoid systemic accumulation and adverse drug events . based on the degree of reduction in Cr Cl In an interview with Staff #16 and #17 on the morning/afternoon of 01/03/2023, Staff # 16 and #17 verified that Patient #9 received the Toradol dose without the Pharmacist, Provider, or Nurse reviewing Patient #9's renal function. A further review of Patient #9's prior records shows that the last serum creatinine level or GFR level for Patient #9 prior to April 20, 2022's ED visit was from 2 years prior to the April 20, 2022's ED visit in November of 2020. The serum creatinine level was 2.59 and the GFR level was 26 at that time.

45847 Based on a review of documentation and interviews with the Facility Staff, the Facility failed to adhere to its policy regarding preventing medication errors or follow acceptable standards of practice [the Facility uses American Society of Health System Pharmacists (ASHP)] by way of giving a patient with chronic kidney disease (CKD) Toradol 60mg IM to Patient #9 without reviewing Patient #9's creatinine clearance or (glomerular filtration rate) GFR level. The Findings were: Review of the client record for Patient #9 on April 20, 2022, who has documented chronic kidney disease (CKD) and is chronically taking a diuretic [which is a known contributor in volume depletion], Toradol 60mg IM was given on April 20, 2022 without reviewing his creatinine clearance or (glomerular filtration rate) GFR level. According to the Facility's Policy titled, Adverse Drug Reaction and Medication Errors, the Facility utilizes (American Society of Health System Pharmacists) ASHP guidelines. Per ASHP guidelines on page 533 (copy included in this packet), Ketorolac is contraindicated in patients with advanced renal impairment and in those at risk for renal failure due to volume depletion. (2) If CrCl is 10-29 mL/min, give 50% of the usual dose, and if CrCl is <10 mL/min, give 25% to 50% of the usual dose. Review of the Facility's records from the Automated Pharmacy System showed that the automated Pharmacy system authorized the dose of Toradol for Patient #9 without having a current creatinine clearance or GFR level obtained. Review of an emailed Clinical Review from the Pharmacy Director/Staff #15 (the review was done on January 4, 2023 while this investigation was in progress), revealed that Staff #15 used a serum creatinine level and GFR level dated 9 days, 10 days, and 7 months after the medication error in its review. This Clinical Review also notes that ketorolac is contraindicated with GFR ? 30ml /mL/min and can contribute to acute kidney injury. In an interview with Staff #16 and #17 on the morning/afternoon of 01/03/2023, Staff # 16 and #17 were asked, What is the process with your pharmacy for verifying practitioner or physician orders for Toradol? Staff #17 replied, it is an automated system that uses an algorithm. I will print out an email in which the pharmacy completed a Clinical Review for the administration of Toradol to [Patient #9]. I received an email of the process from the pharmacy Director [Staff #15] by email. I will print it for you. It was noted that the serum creatinine level and GFR levels for Patient #9 were from after the date of his initial care [April 20, 2022]. This was pointed out to Staff #16 and #17 and both were asked how this could be possible. Staff #17 called Staff #15. Staff #17 then said, The system couldn't find a creatinine level, so it auto approved the orders without it. Staff #15 and Staff #17 were then asked, Is this a system error? Staff #17 replied, I asked [Staff #15] about that. She [Staff #15] said that they [the Facility] would be modifying the process to put a stop to auto authorization of this type in future. A further review of Patient #9's prior records shows that the last serum creatinine level or GFR level for Patient #9 prior to April 20, 2022's ED visit was from 2 years prior to the April 20, 2022's ED visit in November of 2020. The serum creatinine level was 2.59 and the GFR level was 26 at that time.

45847 Based on a review of documentation and interviews with the Facility Staff, the Facility failed to adhere to its policy regarding medication errors by way of not reporting a preventable event involving an administration error with serious consequences to Patient #9 to the attending physician, the hospital-wide Quality Assessment and Performance Improvement (QAPI) program, or identify systems vulnerabilities that could have prevented the drug administration. The Findings were: Review of the Facility's Medication Variances for March through May of 2022 revealed that giving Patient #9, who has documented chronic kidney disease (CKD) and is chronically taking a diuretic [diuretics are known contributors to volume depletion in all patients, not just renal patients], without reviewing his creatinine clearance or (glomerular filtration rate) GFR level was given Toradol 60mg IM and this was not reported as a medication variance. Review of the Facility's QAPI records for 2022 revealed that the medication variance which was not reported was also not reviewed by the Facility's QAPI Committee. Beginning on page 1 and ending on page 2 of the Facility's Policy titled, Adverse Drug Reaction and Medication Errors that was last revised on 10/2022, the policy stated, in part, . Policy: A. All adverse drug reactions, medication errors and near misses shall be reported and reviewed in accordance with this policy . Definition: D. Medication Error: Any preventable event that may cause or lead to inappropriate medication use or patient harm. The definition spans the entire scope of medication use. With this definition, an error does not have to reach the patient to be reportable . Procedure: A. Upon the occurrence of all actual or potential drug reactions or medication errors, the following actions should occur: 1. Notify the provider immediately for further instructions or follow-up or supportive treatment. The offending medication shall not be administered until clarification has been obtained by the provider. 2. Nursing shall monitor the patient for signs and symptoms or reactions and immediately notify physician of any unexpected changes. 3. Nursing should update the ADR and/or allergy information in the eMAR as appropriate. 4. The caregiver that observed the ADR, medication error or near miss should submit a variance through the event reporting system before the end of the shift . . Review of ADR's, Medication Errors, and Near Misses: 2. Once the variance is entered, all relevant departments shall review the risk notification report for accuracy and completeness 3. Pharmacy will trend and report all ADR's, medication errors, and near misses to the Pharmacy and Therapeutics (P&T) Committee. An annual summary will be presented to the Medical Executive Board . Review of the Facility's record from the Automated Pharmacy System showed that the automated Pharmacy system authorized the dose of Toradol for Patient #9 without having a current creatinine clearance or GFR level obtained. Review of an emailed Clinical Review from the Pharmacy Director/Staff #15 (the review was done on January 4, 2023 while this investigation was in progress), revealed that Staff #15 used a serum creatinine level and GFR level dated 9 days, 10 days, and 7 months after the medication error in its review. This Clinical Review also notes that ketorolac is contraindicated with GFR ? 30ml /mL/min and can contribute to acute kidney injury. In an interview with Staff #16 and #17 on the morning/afternoon of 01/03/2023, Staff # 16 and #17 were asked, What is the process with your pharmacy for verifying practitioner or physician orders for Toradol? Staff #17 replied, it is an automated system that uses an algorithm. I will print out an email in which the pharmacy completed a Clinical Review for the administration of Toradol to [Patient #9]. I received an email of the process from the pharmacy Director [Staff #15] by email. I will print it for you. It was noted that the serum creatinine level and GFR levels for Patient #9 were from after the date of his initial care [April 20, 2022]. This was pointed out to Staff #16 and #17 and both were asked how this could be possible. Staff #17 called Staff #15. Staff #17 then said, The system couldn't find a creatinine level, so it [the automated system] auto approved the orders without it [the serum creatinine level]. Staff #16 and Staff #17 were then asked, Is this a system error? Staff #17 replied, I asked [Staff #15] about that. She [Staff #15] said that they [the Facility] would be modifying the process to put a stop to auto authorization of this type in future. A further review of Patient #9's prior records shows that the last serum creatinine level or GFR level for Patient #9 prior to April 20, 2022's ED visit was from 2 years prior to the April 20, 2022's ED visit in November of 2020. The serum creatinine level was 2.59 and the GFR level was 26 at that time.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 38015 Based on record review and interview, the facility failed to ensure that medications for the treatment of pain were reassessed in accordance with hospital policies and accepted standards of practice. This failure resulted in 3 of 4 patients (Patient #2, #4, and Patient #6) being administered a pain medication and not having a reassessment of the effectiveness of the medication. Record review of the medication administration record of Patient #2 showed morphine 2mg was given on 3/6/17 at 2:25 AM for leg pain. There was not reassessment of the pain to determine the effectiveness of the morphine. Record review of the medication administration record of Patient #4 showed morphine 2mg was given on 5/14/19 at 5:45 AM for abdominal pain. There was no reassessment of the pain to determine the effectiveness of the morphine. Record review of the medication administration record of Patient #6 showed Norco 5/325mg was given on 5/13/19 at 7:57 AM. There was no reassessment of the pain to determine the effectiveness of the Norco. In an interview with Staff #55 on 5/14/19 at 10:00 AM, Staff #55 stated that pain is to be reassessed to determine the effectiveness of a pain medication. Record review of the policy, Pain Assessment and Reassessment, Management, and Documentation, last reviewed 7/2017, showed: Patients have the right to appropriate assessment and management of pain . Pain will be reassessed after a pain intervention is performed. When administering non-PCA pain medications. Pain reassessment will be done within an hour of administering pain medications . RN.LVN responsible for . reviewing and documenting effectiveness of pain medication . Record review of recommendations for improving the quality of acute and cancer pain management by D. [NAME] and C. Miaskowski of the American Pain Society Quality of Care Task Force [2005; 165(14):1574-1580] showed: The American Pain Society published the most current guidelines in 2005 for improving the management of acute pain . The 5 most current guidelines include prompt recognition and treatment of pain, involvement of patients in the pain management plan, improvement of treatment patterns, reassessment and adjustment of the pain management plan as needed, and monitoring processes and outcomes of pain management.

37490 Based on interview and record review, in 1 of 1 credentialing file reviewed, the facility failed to follow Medical Staff Services policy titled: Practitioner Health and Wellness. Once receiving notification of physician condition, there was no written request to investigate submitted to Peer Review Committee. Findings include: Chief nursing officer (ID# 51) and Director of Medical Staff Services (ID# 83) on 1/2/2016 at 12:41 stated that there is no documentation in February or March meeting minutes for peer review, medical executive committee, or Board of Trustee meeting regarding reported condition physician (ID# 54), nor is there a written request to investigate. Record review of credentialing file for physician (ID# 54) revealed a letter dated 2/20/2015 from health care provider (ID# 84) regarding the medical condition of physician (ID#54). This letter expressed presenting symptoms, treatment and medical studies conducted. In the conclusion of this letter, it is stated that physician (ID#54) does not currently demonstrate disabling symptoms of Parkinson's disease and should be able to continue functioning in his practice. Record review of facility policy for the department of medical staff services titled: Practitioner Health and Wellness (no date on policy) revealed the following information: Policy: 1. Any individual who has clinical privileges must maintain physical and mental health status sufficient to carry out those privileges in a safe manner. 2. Reports or concerns about impairment must be investigated and acted upon in a timely manner and in accordance with state and federal law, including, but not limited to, the Americans with Disabilities Act (ADA). Definition: b. Physical illness or condition, including but limited to those illnesses or conditions that would adversely affect cognitive, motor, or perceptive skills, including deterioration through the aging process. Procedure: Self reporting-Application process 1. During the application process, all applicants must report information about their ability to perform the clinical privileges they are requesting. Each medical staff member or other individual with clinical privileges is responsible for reporting any change in his/her abilities that might possibly affect the quality of patient care rendered by him/her as related to the performance of his/her clinical privileges and/or medical staff duties. Such reports should be made immediately upon the individual becoming aware of the change. 2. A written report must be given to the Chief Executive officer, the Chief of Staff, the Chairperson of the individual's medical staff department, and/or the chairperson of the credentials committee. The recipient of this letter shall submit it, along with a written request to investigate, to the Peer Review Committee.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 37490 Based on interview and record review, the facility failed to report 1 of 2 preventable adverse events ([NAME]) to the Texas Health Care Safety Network (TxHSN) and to complete a root cause analysis (RCA) for 1 of 3 adverse events reviewed. Findings include: Interview with Chief Nursing Officer ( ID# 51) on 11/1/2016 at 2:20 PM revealed that adverse event (wrong surgical procedure) performed 3/11/15, involving patient (ID# 3) was not reported to the state as required and that it should have been. Interview with Chief Nursing Officer (ID# 51) on 11/2/2016 at 9:35 AM revealed that in regard to adverse advent (wrong surgical procedure) that occurred with patient (ID# 3) on 3/11/2015, there was no incident report generated when the facility was notified. There was no documentation of a root cause analysis (RCA) performed regarding the event. There was an investigation performed, but no documentation to review that shows the investigation process. Record review of Texas Department of State Health Services Facility-Specific Healthcare Safety Report of preventable adverse events reported from January 2015-July 2015 for [NAME] Regional Medical Center reveled the following information. Preventable Adverse Events ([NAME]) Events related to patient care: Total Number of 1 Patient death or severe harm associated with a fall in the healthcare facility that caused a broken bone. Record review of the Texas Department of State Health Services 3 Tier Phase -In Implementation for Preventable Adverse Events ([NAME]) revealed the following information: First Tier [NAME] Reporting Beginning January 1, 2015 1. Surgeries or invasive procedures involving a surgery on the wrong patient, wrong procedure. 10. Patient death or severe harm associated with a fall in a healthcare facility resulting in fracture, dislocation, intracranial injury, crushing injury, burn or other injury. Record review of facility policy titled Event Reporting: Patient and Non-Patient dated 01/2012 revealed the following information: Purpose: -To provide a record of events and documentation of the facts -To provide a base for further investigation with a focus on a patient safety and environmental safety processes and systems, and the corrective measures needed to prevent recurrence and sustain improvement -To collect data for statistical analysis -To fulfill regulatory requirements for reporting events -to alert Risk Management to potential claim situations Policy: -Adverse events, errors, unexpected events, variances, incidents, and near misses involving patients will promptly reported online in the Meditech Risk Management Patient Notification System even if the event seems insignificant at the time. -Event reports are intended to provide a record of the event and document the facts - Event reporting is an important part of the Hospital-wide focus on safety and performance improvement. - Event reporting is a system of notification to Hospital leadership of actual or potential risks and patient safety issues/concerns. -Events reports should be completed during the shift the event occurs or is discovered to have occurred. Supervisor, Manager and Director Review responsibilities: 2. Service leaders are responsible for prompt (within 72 hours) initial review of all information entered by the employee and for conducting an investigation to determine root cause and follow-up to ensure resolution of identified issues/concerns. 4. Results of investigations should be shared with the staff with a focus on process and systems design and redesign and outcome, and the corrective measures needed to prevent recurrence and sustain improvement.

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** 35028 Based on interview and record review, the facility failed to ensure that one of six sampled patients (Patient #1) fully participated in her discharge plan of care. The facility failed to: ? Verify and discuss family contact information, ? Assess and evaluate family support options, and ? Provide safe travel arrangements to return home. Findings include: TX 00209790 Record review of intake # 00209790 revealed statements by Patient #1 in which she described a fall at home on 05/13/14, followed by a call to 911 and transportation to the hospital. After tests were run, she was returned home in a cab despite her protest of the discharge and request for further treatment. Record review of Patient #1's Emergency Department (ED) record dated 05/15/14 revealed an [AGE] year old who arrived by ambulance at 4:15 PM with complaints of back pain and generalized weakness following a fall at home. Record review of Patient #1's x-ray of pelvis and bilateral hips and computed tomography of the left hip dated 05/15/14 showed degenerative changes with no fracture. Record review of the Nursing Notes dated 05/15/14 at 7:30 PM revealed that Patient #1 was discharged home in a cab. Further review of the Nursing Notes failed to reveal documentation that staff attempted to contact her family at any time during this ED visit. Interview on 02/11/15 at 03:00 PM with the Chief Nursing Officer (#52) revealed acknowledgements that Patient #1's disposition home should have been handled differently. There should have been family involvement in the discharge plan and a different mode of transportation should have been provided for her. Interviews on 02/11/15 at 10:55 AM with ED Registered Nurses (#53, #54 and #61): all three stated that in this situation, Patient #1's family should have been contacted and the patient should not have been sent home alone in a cab. Review of the facility policy titled Patient Rights and Responsibilities/Provisions for the Disabled dated 08/2012 reads, 1. The Patient has the right to: . (b) Reasonable safety insofar as the hospital practices . are concerned . (f) Be involved in care planning and treatment . (j) Have a family member or representative of his choice . notified promptly of his admission to the hospital.