HospitalInspections.org

Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.13 Patient's Rights, was out of compliance.

A-0144 - The patient has the right to receive care in a safe setting. Based on observations, interviews, and document review, the facility failed to ensure patient safety by failing to follow the manufacturer's instructions for use (IFU) for the self-releasing sensor seat belt (a seat belt that alarms when unbuckled to alert staff) for three out of three patients observed. Specifically, the facility failed to ensure the self-releasing sensor seat belt properly fit the patients and that the patients were able to remove them upon request (Patients #1, #2, and #3).

Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.21 Condition of Participation: Quality Assessment and Performance Improvement Program, was out of compliance.

A-0286 Program Scope. (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ....§482.21(c) Standard: Program Activities ... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. §482.21(e) Standard: Executive Responsibilities. The hospital ' s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. Based on interviews and document review, the facility's quality assurance and performance improvement (QAPI) program failed to ensure patient safety events were reported, investigated, and analyzed to identify causes and implement preventive measures. Specifically, the QAPI program failed to analyze the causes of patient falls and implement preventive actions to prevent recurrence. Additionally, the QAPI program failed to ensure medication events were reported, investigated, tracked, and trended for 23 of 25 unreconciled medications. These failures affected the conditions of patient rights and pharmaceutical services. (Cross-reference A-0395, and A-0494)

A-0309 Executive Responsibilities. The hospital's governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: (1) That an ongoing program for quality improvement and patient safety, including the reduction of medical errors, is defined, implemented, and maintained.(2) That the hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care and patient safety and that all improvement actions are evaluated. Based on interviews and document reviews, the facility's governing body (GB) failed to oversee the quality assurance and performance improvement (QAPI) program. Specifically, the GB did not ensure the quality department reviewed, analyzed, and investigated safety events, developed actionable corrective plans, implemented preventive measures, or tracked performance improvements in problem-prone areas such as patient falls and unreconciled medications. (Cross-reference A-0286 and A-0494)

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.23 NURSING SERVICES was out of compliance.

A-0395 RN SUPERVISION OF NURSING CARE. A registered nurse must supervise and evaluate the nursing care for each patient. Based on interviews and document review, the facility failed to ensure nursing staff evaluated patients after they fell. Specifically, the nurse failed to complete an assessment for a potential head injury to include a neurological exam in three of three medical records reviewed of patients who fell. (Patients #4, #5, and #6)

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.25 Pharmaceutical Services was out of compliance.

A- 0494 (a)(3) PHARMACY DRUG RECORDS. Current and accurate records must be kept of the receipt and distribution of all scheduled drugs. Based on document review and interviews, the facility failed to ensure safe dispensing, administration, and tracking of controlled medications in 13 of 15 medication reconciliations reviewed.

Based on observations, interviews, and document review, the facility failed to ensure patient safety by failing to follow the manufacturer's instructions for use (IFU) for the self-releasing sensor seat belt (a seat belt that alarms when unbuckled to alert staff) for three out of three patients observed. Specifically, the facility failed to ensure the self-releasing sensor seat belt properly fit the patients and that the patients were able to remove them upon request (Patients #1, #2, #3, and #4).

Findings include:

Facility policies:

The Use of Restraints policy read, a restraint is any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely.

The following are NOT considered restraints: orthopedically prescribed devices, adaptive support in response to assessed patient needs, and any device that can be easily removed intentionally by the patient in the same manner as it was applied by staff such as side rails that the patient can put down rather than climb over or wheelchair belts that can be released.

References:

The Posey HeadStaart Notification Sensor Belt for Chair IFU read, application instructions: place belt around patient at smallest part of the waist, or just above hips. Pull strap until belt is snug, but does not cause any discomfort to patient. You should be able to slide your open hand (flat) between the belt and the patient. Before leaving the patient unattended, explain the purpose for the belt. Make sure the patient understands: the need to call for assistance before exiting the chair; and how to self-release. Failure to follow these instructions could result in serious injury.

1. The facility failed to ensure patient safety by not following the manufacturer's IFU for the self-releasing sensor seat belt, resulting in an improper fit. Additionally, the facility failed to ensure patients could safely remove the self-releasing sensor seat belt.

A. Observations

i. On 12/3/24 at 11:23 a.m., observations were conducted in the North patient unit. Observations revealed Patient #1 being transferred from the bed to the wheelchair with the assistance of charge nurse (RN) #6 and rehabilitation nursing technician (Tech) #7. Tech #7 repositioned the patient in the wheelchair and applied the self-releasing sensor seat belt, leaving approximately a six-inch gap between the patient's abdomen and the belt.

a. At 11:33 a.m., upon request of Surveyor A, Patient #1 could not remove the self-releasing sensor seat belt on three separate occasions.

ii. On 12/3/24 at 1:54 p.m., observations were conducted in the North patient unit. Observations revealed Patient #2 in their wheelchair in their room wearing a self-releasing sensor seat belt. Further observations revealed approximately a six-inch gap between the patient's abdomen and the belt.

iii. On 12/3/24 at 2:00 p.m., observations were conducted in the therapy gym. Observations revealed Patient #3 was observed receiving therapy in their wheelchair while wearing a self-releasing sensor seat belt.

a. At 2:00 p.m., upon request of Surveyor A, Patient #3 could not remove the self-releasing sensor seat belt on three separate occasions.

B. Document Review

i. A live medical record review for Patient #1 was completed on 12/12/24 with chief nursing officer (CNO) #3. The medical record revealed Patient #1 was admitted to the rehabilitation hospital on 11/29/24 for deconditioning (physical decline caused by prolonged inactivity or reduced activity) and lack of activities of daily living (ADL) independence (basic tasks for independent living, like eating, dressing, bathing, and using the toilet) with a diagnosis of Alzheimer's (a brain disorder that effects memory and thinking skills). Further review of the medical record revealed, on 11/30/24 at 12:18 p.m., occupational therapist (OT) #8 stated Patient #1 was unable to remove the self-releasing sensor seat belt. Additionally, on 12/2/24 at 4:36 p.m., speech language pathologist (SLP) #9 stated the patient had severe memory, orientation, and problem-solving deficits.

During the live medical record review, CNO #3 stated it was the staff's responsibility to ensure the patients could remove the self-releasing sensor seat belt. CNO #3 stated if the patients were unable to remove the self-releasing sensor seat belt due to physical or mental deficits, it was considered a restraint.

ii. A live medical record review for Patient #3 was completed on 12/12/24 with CNO #3. The medical record revealed Patient #3 was admitted to the rehabilitation hospital on 11/27/24 for generalized weakness. Further review of the medical record revealed the patient removed the self-releasing seatbelt on 11/28/24 at 11:00 a.m. and on 12/3/24 at 8:00 a.m. However, CNO #3 was unable to locate documentation the staff assessed the patient's ability to remove the self-releasing sensor seat belt for five days, from 11/28/24 to 12/3/24. CNO #3 stated that staff should have assessed the patient's ability to remove the self-releasing sensor seat belt at least once per shift and documented the outcome in the medical record.

iii. A live medical record review for Patient #4 was completed on 12/12/24 with chief nursing officer (CNO) #3. The medical record revealed Patient #4 was admitted to the rehabilitation hospital on 11/14/24 after an acute hospitalization for multiple falls at home. Further review of the medical record revealed, on 11/20/24 at 9:00 a.m., Patient #4 was found in a prone position (a patient lying face down on their stomach) with the wheelchair self-releasing seat belt still attached and the wheelchair on top of the patient. Further review of the medical record revealed that staff did not perform a neurological exam at the time of the fall or before notifying the provider, despite the fall being unwitnessed and the mechanism of injury.

C. Interviews

i. On 12/3/24 at 1:35 p.m., an interview was conducted with Tech #7. Tech #7 stated the self-releasing sensor seat belt needed a 2-3 finger-width gap between the patient and the self-releasing sensor seat belt. Tech #7 stated the patient could slide out of their chair and fall if the self-releasing sensor seat belt was too loose. Tech #7 stated they had never seen or asked Patient #1 to undo their self-releasing sensor seat belt. Tech #7 stated there were no risks to the patient if they could not remove the self-releasing sensor seat belt.

This was in contrast to the Use of Restraints policy which read, a restraint was any manual method, physical or mechanical device, material, or equipment that immobilized or reduced a patient's ability to move their arms, legs, body, or head freely.

The following were not considered restraints: orthopedically prescribed devices, adaptive supports used in response to assessed patient needs, and devices that patients could easily remove in the same way staff applied them, such as side rails the patient could lower rather than climb over or wheelchair belts the patient could release.
This was also in contrast to the Posey HeadStart Notification Sensor Belt for Chair IFU which read, the user placed the belt around the patient at the smallest part of the waist or just above the hips and pulled the strap until the belt was snug but did not cause any discomfort. They ensured an open hand could slide flat between the belt and the patient. Before leaving the patient unattended, they explained the belt's purpose and confirmed the patient understood the need to call for assistance before exiting the chair and how to self-release. Failure to follow these instructions could have resulted in serious injury.

ii. On 12/3/24 at 1:12 p.m., an interview was conducted with OT #11. OT #11 stated they were in charge of OT #8's training. OT #11 stated they reviewed and co-signed OT #8's medical records. OT #11 stated that OT #8 charted Patient #1 could not remove the self-releasing sensor seat belt during the admission OT evaluation. OT #11 stated the patient should not have had a self-releasing sensor seat belt if they were unable to remove it. OT #11 stated this would have been considered a restraint. OT #11 stated the patient should have had a pressure pad alarm for safety. OT #11 stated if the patient attempted to stand with a self-releasing sensor seat belt still attached, they could fall or slide down in the chair and strangulate themselves.

iii. On 12/3/24 at 1:27 p.m., an interview was conducted with therapy director (Director) #12. Director #12 stated Patient #1's admission OT evaluation in the medical record stated the patient could not remove their self-releasing sensor seat belt. Director #12 stated the OT should not have placed the patient in a self-releasing sensor seat belt; instead, the OT should have placed the patient on a pressure pad alarm for safety. Director #12 stated if a patient was unable to remove the self-releasing sensor seat belt it would be considered a restraint.

iv. On 12/12/24 at 12:33 p.m., an interview was conducted with CNO #3. CNO #3 stated staff were responsible for assessing and documenting the patient's ability to remove the self-releasing sensor seat belt. CNO #3 stated if the patient could not remove the self-releasing sensor seat belt, it was considered a restraint. CNO #3 stated it was important to ensure the self-releasing sensor seat belt fit properly. CNO #3 stated that if the self-releasing sensor seat belt was too loose, the patient could slide down in the wheelchair, suffocate, and die.

Based on interviews and document review, the facility's quality assurance and performance improvement (QAPI) program failed to ensure patient safety events were reported, investigated, and analyzed to identify causes and implement preventive measures. Specifically, the QAPI program failed to analyze the causes of patient falls and implement preventive actions to prevent recurrence. Additionally, the QAPI program failed to ensure medication events were reported, investigated, tracked, and trended for 23 of 25 unreconciled medications. These failures affected the conditions of patient rights and pharmaceutical services. (Cross-reference A-0395, and A-0494)

Findings include:

The Performance Improvement & Safety Plan read, the ultimate responsibility for the implementation and operation of this Plan is the hospital CEO. The Safety Committee, Quality Council, Medical Executive Committee (MEC), and Governing Body will provide interdisciplinary input and oversight related to patient safety. Organizational performance activities and projects are judged and prioritized based on their impact on our customers. The activities and projects should address the patients' priorities and recognize them as a part of the healthcare team. The objective of the performance improvement dashboard (Quality Dashboard) is to document and communicate the activities of the Quality Program. The Quality Dashboard will be completed monthly, and outliers will be reported to the Quality Council, MEC, and governing body at least quarterly.

The Risk Management Plan read, the Chief Executive Officer (CEO) is responsible for the overall Risk Management and Performance Improvement & Safety plans and the establishment of the Quality Council/Committee. The Quality Council/Committee has delegated the task of oversight over the adverse event reporting system and investigation of adverse events to the Director of Quality/Risk (DQR). The Quality/Risk Department develops, implements, and coordinates a systematic organization-wide program. The quality program will include investigating and analyzing the frequency and causes of adverse incidents (patient safety events), the development of appropriate measures to minimize the risk of adverse incidents to patients and others, and the development, implementation, and ongoing evaluation of procedures, protocols, and systems. The appropriate department or service will be required to review the actual or potential problem, determine the root cause and a resolution plan, or follow any action requested by the Quality Council. Problem resolution will consist of corrective action(s) and identify the appropriate action(s) and measures to be implemented to address the identified problem(s) associated with adverse incidents. A corrective action plan should be a SMART (Specific, Measurable, Achievable, Relevant, and Time-bound) plan, and the action plan will be readily understood and outline a clear link to the vulnerabilities identified. The Quality Council and Medical Staff Executive Committee shall establish the policies and procedures to ensure the Risk Management Program is integrated and coordinated.

The Electronic Event Reporting policy defined actual (adverse) events as events that occurred and reached the patient or individual. An unsafe condition is when the circumstances present at the hospital could cause adverse events. The policy's purpose is to establish guidelines for reporting adverse incidents/events and document certain events at the hospital in a system that provides a confidential mechanism of identification, tracking, trending, and follow-up of all such events. The Risk Management program is based upon the ability of the program to promptly obtain important facts and details of the circumstances surrounding an (adverse) event within a reasonable time frame of when the event occurred. To this end, an event report is to be completed for every occurrence which meets the following definition: any happening not consistent with the routine care or operation of the facility or the desired routine care of the patient and/or operation of the facility, which places our patients and visitors at increased risk for harm. An events report should document events relating to patients, visitors, volunteers, or other persons involved in any adverse event. The Quality Committee has delegated the task of investigating adverse events to the Director of Quality Risk (DQR). An adverse event report must be completed in a timely manner and be entered as close in real time to the event as possible.

The Fall Prevention Program read, the fall team is responsible for: analyzing data and trending information and making recommendations to the Medical Executive Committee (MEC) and Governing Body (GB) on ways to improve patient safety and decrease falls in the hospital; investigating and making recommendations to hospital leaders on products and services available to reduce risk of harm from falls; monitoring compliance with the fall prevention program and recommending appropriate actions when needed. The purpose of tracking and trending is to evaluate the effectiveness of the fall program and to identify opportunities for improvement. The interdisciplinary fall team will review all falls and tracking/trending information on a regular basis to evaluate the effectiveness of the current fall prevention protocol. Relevant reports and results of all hospital improvement activities, to include fall tracking and trending data, will be reported to the Quality and/or Safety Committees and the Medical Executive Committee no less than quarterly, according to the rules and regulations of the hospital.

The Medication Diversion Prevention policy read, the pharmacy department will monitor the timeliness and justifications provided by nursing when resolving discrepancies. If the Director of Pharmacy (DOP) or pharmacist designee discovers a pattern of discrepancies that remain unresolved in an untimely manner, the DOP or pharmacist designee will notify the CNO along with specific report information.

National guidelines:

According to the American Society of Health-System Pharmacists (ASHP) Guidelines on Preventing Diversion of Controlled Substances, which was provided by the facility on 12/10/24, it is imperative that there is a detailed and thorough approach to investigating and reporting suspected diversion. Incomplete investigations and follow-up can have serious patient care implications. Any unresolved medication discrepancy should be considered a possible diversion and escalated to an investigation. Facilities should have a process to resolve controlled substance (CS) discrepancies and specify when medication discrepancies must be resolved. CS discrepancies should be reported and resolved as soon as possible upon discovery, preferably no later than the end of the work shift. Discrepancies that cannot be resolved ("unresolvable discrepancies") are jointly reviewed by pharmacy and patient care leadership, with resolution within 24 to 72 hours.

The organizational oversight and accountability section read the policies and procedures should include processes for medication diversion efforts, address prevention control, diversion detection, incident investigation, and reporting procedures, such as documenting and monitoring medication trend reports, quality improvement efforts and their outcomes, compliance with existing procedures, and action plans. Medication incidents should be collated, reviewed, and analyzed to identify further opportunities for improvement. Surveillance data should be trended and acted upon, corrective actions implemented, and a resolution of identified issues verified.

1. The QAPI program failed to review and analyze the causative factors of patient falls and implement preventive actions to prevent recurrence. (Cross-reference A-0395)

A. Document Review

i. A review of the Quality Dashboard revealed between 6/2024 and 11/2024, the facility failed to meet its target patient fall rate of 5.7 in June, July, September, October, and November.

a. In June of 2024, the fall rate was 11.7.

b. In July of 2024, the fall rate was 10.34.

c. In September of 2024, the fall rate was 7.03.

d. In October of 2024, the fall rate was 10.86.

e. In November of 2024, the fall rate was 6.01.

ii. A review of the Fall Measures Action Plans provided by the facility on 12/14/24 revealed the action plans lacked corrective actions with clear measures to address the prevention of patient falls. Additionally, upon request, the facility could not provide evidence of the implemented preventative measures or how the effectiveness of the action plans and fall interventions were evaluated.

This was in contrast to the Risk Management Plan, which stated corrective action plans would be Specific, Measurable, Achievable, Relevant, and Time-bound (SMART) and include clear, actionable measures to address the identified problem.

iii. The Fall Prevention Committee meeting minutes from June 2024 through November 2024 were reviewed. The meeting minutes revealed no evidence the Committee had investigated or reviewed the effectiveness of fall prevention measures to identify opportunities for improvement despite increased patient falls.

This was in contrast to the Fall Prevention Program, which stated the fall prevention committee analyzed patient fall events to identify trends and recommended and implemented improvement activities to reduce patient falls.

B. Interviews with leadership revealed insufficient quality oversight, inadequate analysis of patient fall events, and a failure to implement interventions to prevent recurrence.

i. On 12/10/24 at 5:48 p.m., surveyors requested an interview with the director of quality and risk (DQR) #15 for 12/11/24. On 12/11/24 at 2:46 p.m., surveyors were informed that DQR #15 had resigned effective immediately, and DQR #10, who worked at a separate location, had joined the survey.

ii. On 12/11/24 at 2:46 p.m., an interview was conducted with chief executive officer (CEO) #1. CEO #1 stated quality activities related to patient fall events were overseen and managed by DQR #15 before they resigned. CEO #1 stated that DQR #15 reviewed all patient safety events, ensured the event had been investigated, and any preventative measures needed had been implemented and documented before the event was closed.

However, upon request, the facility was unable to provide evidence DQR #15 had ensured patient fall events were investigated, follow-up actions conducted, or preventative measures related to patient fall events implemented and performed before DQR #15 resigned.

This was in contrast to the Risk Management Plan, which stated the DQR oversaw patient safety event reports and investigations, analyzed their causes and assessed their impact on patient safety.

a. On 12/11/24 at 2:50 p.m., an interview was conducted with DQR #10. DQR #10 stated patient falls were a performance indicator monitored, tracked, and trended by the quality program. DQR #10 further stated the quality program delegated the review, investigation, tracking, and trending of patient fall events to the Fall Prevention Committee. DQR #10 also stated the Fall Prevention Committee meeting minutes contained the follow-up, education provided, and preventative measures implemented due to a patient fall event.

The interview with DQR #10 contrasted with the Fall Prevention Committee meeting minutes, which contained no evidence the Fall Prevention Committee had identified process improvements to prevent the recurrence of falls or assessed the effectiveness of the fall prevention measures implemented for patients despite increased patient falls at the facility.

2. Staff failed to report unreconciled medication events. Additionally, the facility could not provide evidence the unreconciled medications had not been diverted or that the medication event had been investigated. (Cross-reference A-0409)

A. Document review

i. A review of the Unreconciled Medication report provided by the facility on 12/3/24 revealed between 8/23/24 and 11/25/24, multiple medications were withdrawn from the Pyxis (an automated medication dispensing system) without documentation the medication was administered, wasted or returned to the pharmacy (unreconciled). Furthermore, a patient safety event was either not entered or entered more than 72 hours after the fact.

a. Examples of unreconciled medications with no patient safety event:

i. On 11/24/24 and 11/25/24, one 5 mg tablet of oxycodone (a narcotic pain medication) and one 325 mg tablet of acetaminophen-hydrocodone (a narcotic medication).

ii. On 10/30/24, one 325 mg tablet of acetaminophen-hydrocodone.

iii. On 10/19/24 and 11/19/24, one 150 mg pregabalin capsule (a controlled medication used to treat nerve pain).

iv. On 10/18/24, one 10 mg tablet of oxycodone.

v. On 10/12/24, one 50 mg tablet of tramadol (a narcotic pain medication).

b. Examples of unreconciled medications with patient safety events entered more than 72 hours after the event occurred:

i. On 8/23/24, one 5 mg tablet of oxycodone. A patient safety event was entered on 9/10/24, 18 days later.

ii. On 8/30/24, one 50 mg tablet of tramadol. A patient safety event was entered on 9/10/24, 11 days later.

iii. On 9/3/24, one 10 mg tablet of oxycodone. A patient safety event was entered on 9/10/14, seven days later.

iv. On 11/12/24, one 10 mg tablet of oxycodone. A patient safety event was entered on 11/19/24, seven days later.

v. On 11/13/24, one 5 mg tablet of oxycodone. A patient safety event was entered on 11/19/24, six days later.

These examples were in contrast to the ASHP Guidelines, which stated incident investigations should be performed for unreconciled medications and unreconciled medications should be reported, reviewed, and investigated with resolution within 24 to 72 hours.

B. Interviews with leadership revealed insufficient quality oversight, lack of medication event reporting, and a failure to implement interventions to prevent recurrence.

i. On 12/12/24 at 4:46 p.m., an interview was conducted with DQR #10. DQR #10 stated a patient safety event should be completed when a medication could not be reconciled. DQR #10 stated the Electronic Event Reporting policy and the Medication Diversion Prevention policy did not specify a timeframe for when a patient safety event needed to be completed. DQR #10 stated a patient safety event had not been completed for all unreconciled medications identified at the facility. DQR #10 further stated a patient safety event should be completed for any medication unable to be reconciled.

DQR # 10 stated unreconciled medications were a quality concern as they could lead to potential medication errors or diversion (theft or misuse). DQR #10 stated when medications were unreconciled, it posed risks to patient safety.

DQR #10 stated the facility's Electronic Event Reporting policy and the Medication Diversion Prevention policy did not define a process for resolving unreconciled medication discrepancies or specify timelines for reporting, investigating, and resolving them.

ii. On 12/9/24 at 3:19 p.m., an interview was conducted with the director of pharmacy (Director) #5. Director #5 stated they could not account for many of the medications identified on the Unreconciled Medication report. Director #5 stated it was important to track medications to prevent diversion and misuse. Director #5 stated patients were at risk of not receiving the appropriate medical treatment when medications were unable to be accounted for.

These interviews contrasted with the ASHP Guidelines, which stated that unreconciled medication discrepancies should be reported and investigated for potential diversion. Furthermore, facility policies, procedures, and processes were expected to outline methods for medication diversion prevention, detection, investigation, and reporting, as well as for monitoring medication trends, assessing outcomes, and implementing action plans. The guidelines also emphasized that instances of unreconciled medications should be monitored, analyzed, trended, and tracked as part of quality improvement efforts to identify opportunities for enhancement.

Based on interviews and document reviews, the facility's governing body (GB) failed to oversee the quality assurance and performance improvement (QAPI) program. Specifically, the GB did not ensure the quality department reviewed, analyzed, and investigated safety events, developed actionable corrective plans, implemented preventive measures, or tracked performance improvements in problem-prone areas such as patient falls and unreconciled medications. (Cross-reference A-0286 and A-0494)

Findings include:

The Governing Body Bylaws read the duties and responsibilities of the GB shall include the implementation and maintenance of a hospital-wide program for the assessment, maintenance, and improvement of the quality of patient care and safety and the reduction of medical errors. The GB shall ensure the hospital complies with all applicable federal, state, and local laws and regulations.

The Performance Improvement & Safety Plan read, the Governing Body is the ultimate authority and is committed to the provision of quality and safe patient care and services. The Governing Body shall facilitate performance improvement as follows: provide direction in setting priorities, oversee the planning, design, implementation, and ongoing monitoring of the performance improvement plan, and implement strategies to measurably and equitably improve safety. The Quality Council (Committee) oversees the implementation and success of the facility's safety and performance improvement plan. Its duties include monitoring and assessing relevant data to ensure informed decision-making. The Committee identifies and prioritizes performance improvement projects that address patient care gaps, providing necessary education and training to support these initiatives. Finally, the Committee evaluates the overall effectiveness of the plan and makes adjustments as needed to achieve continuous improvement. Organizational structure for communication: The Quality Committee reports to the Medical Executive Committee, which reports to the Governing Body.

The Risk Management Plan read, the CEO is responsible for the overall Risk Management and Performance Improvement & Safety plans. The Quality Council/Committee has delegated the task of oversight over the adverse event reporting system and investigation of adverse events to the Director of Quality/Risk (DQR). The Quality/Risk Department develops, implements, and coordinates a systematic organization-wide program. The quality program will include investigating and analyzing the frequency and causes of adverse incidents (patient safety events), the development of appropriate measures to minimize the risk of adverse incidents to patients and others, and the development, implementation, and ongoing evaluation of procedures, protocols, and systems. The appropriate department or service will be required to review the actual or potential problem, determine the root cause and a resolution plan, or follow any action requested by the Quality Committee. Problem resolution will consist of corrective action(s) and identify the appropriate action(s) and measures to be implemented to address the identified problem(s) associated with adverse incidents. A corrective action plan should be a SMART (Specific, Measurable, Achievable, Relevant, and Time-bound) plan, and the action plan will be readily understood and outline a clear link to the vulnerabilities identified. The Quality Committee and Medical Staff Executive Committee shall establish the policies and procedures to ensure the Risk Management Program is integrated and coordinated.

1. The facility's governing body (GB) failed to ensure the quality department reviewed, analyzed and investigated patient safety events. Additionally, the GB failed to ensure departments in high-risk, problem-prone areas developed corrective action plans with clear actions and measures to address issues related to patient safety events in accordance with professional standards of practice in the areas.

A. Document review revealed the facility had an increase in patient falls and a lack of safety event reporting, investigation, tracking, and trending for unreconciled medications (medication removed from the automated dispensing system without documentation of administration, waste, or return).

i. GB meeting minutes for November 2024 revealed the quality department had identified an increase in patient falls, and corrective action plans were developed to address the issue. (Cross-reference A-0286)

a. A review of the Fall Measures Action Plans addressing the rise in patient falls revealed the action plans failed to define a goal, specific, measurable criteria, outline how the facility would conduct surveillance or audits, and a timeframe for achieving the goal.

Upon request, the facility could not provide evidence of preventive measures, surveillance audits, process improvement evaluations, or tracking and trending resulting from the fall action plans.

Additionally, the fall action plans contrasted with the Risk Management Plan which stated action plans developed from patient safety events should be readily understood and use SMART criteria (Specific, Measurable, Achievable, Relevant, and Time-bound) and include clear, actionable measures to address the identified problem.

ii. An additional review of the GB meeting minutes for November 2024 revealed the quality department failed to identify a concern with unreconciled medications.

a. A review of the Unreconciled Medication report provided by the facility on 12/3/24 revealed medications were withdrawn from the automated medication dispensing machine without documentation of administration, waste, or return. Additionally, patient safety events were either not entered or completed more than 72 hours later. (Cross-reference A-0286 and A-0494)

Upon request, the facility was unable to provide evidence the quality department identified the lack of safety event reporting or the delayed safety event reporting for unreconciled medications.

Additionally this contrasted with the Performance Improvement & Safety Plan, which stated the GB oversaw and monitored the performance improvement plan and implemented strategies to achieve measurable and equitable safety improvements.

B. Interviews

i. On 12/12/24 at 6:00 p.m., an interview was conducted with with chief executive officer (CEO) #1. CEO #1 stated the quality department should communicate identified concerns with patient safety to the GB. CEO #1 stated the director of quality and risk (DRQ) presented patient safety events and trends and quality specific performance improvement activities at GB meetings. CEO #1 stated the GB had overseen the fall action plans, and the unreconciled medication surveyors had identified during the survey.

However, upon request, the facility failed to provide evidence the quality department communicated the unreconciled medication concern and fall action plans to the GB or that the GB reviewed, addressed, and provided oversight.

This was also in contrast to the Governing Body Bylaws, which stated the GB oversaw and ensured the implementation, maintenance, and assessment of the quality and safety of the patient care provided at the facility.

Based on interviews and document review, the facility failed to ensure nursing staff evaluated patients after they fell. Specifically, the nurse failed to complete an assessment for a potential head injury to include a neurological exam in three of three medical records reviewed of patients who fell. (Patients #4, #5, and #6)

Findings include:

Facility policies:

The Fall Prevention Program policy read, A post-fall assessment will be performed by a licensed RN/PT/OT/SLP appropriate to their clinical scope of practice and any obvious injuries or change in status must be thoroughly evaluated. If the assessment is outside the scope of practice of the licensed staff present at the time of the fall, assistance will be requested from the appropriate clinician. First priority is to assess the patient for any obvious injuries and discover what happened, including from the patient's perspective when possible.

A. Document Review

i. A live medical record review for Patient #4 was completed on 12/12/24 with chief nursing officer (CNO) #3. The medical record revealed Patient #4 was admitted to the rehabilitation hospital on 11/14/24 after an acute hospitalization for multiple falls at home. Further review of the medical record revealed, on 11/20/24 at 9:00 a.m., Patient #4 was found in a prone position (a patient lying face down on their stomach) with the wheelchair self-releasing seat belt still attached and the wheelchair on top of the patient. Further review of the medical record revealed that staff did not perform a neurological exam at the time of the fall or before notifying the provider, despite the fall being unwitnessed and the mechanism of injury.

Further review of Patient # 4's medical record revealed a nursing note from registered nurse (RN) #12 on 11/21/24 at 11:00 a.m. RN #13 noted worsening facial bruising and new swelling on the right cheek. Further review of the medical record revealed the provider was not notified of the change in condition.

Further review of Patient # 4's medical record revealed on 11/22/24 at 5:58 a.m., the patient had an additional fall that was unwitnessed while the patient was in the bathroom. Further review of the medical record revealed the patient did not receive a neurological exam at the time of the fall.

Further review of Patient # 4 medical record revealed on 11/23/24 at 6:45 p.m., the patient had a third fall, which was also unwitnessed. Further review of the medical record revealed the patient was on one-on-one observations due to the patient being a high fall risk. CNO #3 stated the nurse assigned to the one-on-one observation stepped out of the room to speak to a family member, leaving the patient unattended, and subsequently, the patient fell. Further review of the medical record revealed the patient's level of consciousness (LOC), and a Glasgow coma scale (tool healthcare providers use to measure decreases in consciousness) (GCS) was completed at the time of the fall. However, the nurse did not perform a full neurological exam, including assessing the patient's pupils.

ii. A live medical record review for Patient #5 was completed on 12/12/24 with CNO #3. The medical record revealed Patient #5 was admitted to the rehabilitation hospital on 9/14/24 after an acute hospitalization for a cerebrovascular accident (when blood flow to the brain was interrupted) (CVA). Further review of the medical record revealed on 9/27/24 at 1:00 p.m., the patient fell during a transfer with an occupational therapist (OT) #14. OT #14 stated during a slide board (flat, rigid board that helps patients move between surfaces without using their legs) transfer setup from the edge of the bed to a chair, the patient fell to the floor, striking her head and left arm.

Further review of the medical record revealed the patient's LOC, and GCS was completed at the time of the fall. However, RN #16 did not perform a full neurological exam, to include assessing the patient's pupils.

iii. A live medical record review for Patient #6 was completed on 12/12/24 with CNO #3. The medical record revealed Patient #6 was admitted to the rehabilitation hospital on 10/3/24 for orthostatic syncope (a type of fainting that occurs when blood pressure drops due to a sudden change in position), which resulted in falls. Further review of the medical record revealed on 10/6/24 at 2:20 a.m., the patient had an unwitnessed fall while ambulating to the bathroom. Further review of the medical record revealed a post-fall assessment performed by RN #17. RN #17 noted the patient had a bump on her right forehead. Further review of the medical record revealed the patient did not receive a neurological exam at the time of the fall or before notifying the provider.

a. A patient safety event was completed for Patient #6 for the fall on 10/6/24. Review of the patient safety event revealed at 1:50 a.m., 30 minutes before the patient fell, staff noted the bed alarm (a patient care device used to monitor when a patient attempted to exit the bed) was not operational.

Interviews

i. On 12/4/24 at 3:53 p.m., an interview was conducted with RN #18. RN #18 stated patients who fell should receive a full neurological assessment. RN #18 stated a full neurological assessment included the patient's LOC, GCS, assessing for PERRLA (to see if the pupils were equal, round, and reactive to light and accommodation, a reflex where pupils constrict to focus on near objects), equal hand grasps, sensation in the arms and legs, and the patient's ability to perform range of motion (ROM) on all extremities. RN #18 stated a full neurological assessment should be performed before notifying the provider. RN #18 stated it was important to fully assess the patient after a fall to include a full neurological assessment to rule out major trauma. RN #18 stated if the nurse failed to perform a complete neurological assessment, they could miss a life-threatening injury such as a stroke or brain bleed.

ii. On 12/4/24 at 4:15 p.m., an interview was conducted with RN #19. RN #19 stated that patients who fell should receive a full head-to-toe assessment, including a complete neurological assessment. RN #18 stated a complete neurological assessment included the patient's vital signs, pupils were PERRLA, extremity strength, and facial movements. RN #19 stated a full assessment, including a complete neurological assessment, should be performed before notifying the provider. RN #18 stated the provider needed to know the patient's current clinical state to provide appropriate care. RN #19 stated if the nurse did not perform a complete neurological assessment, the patient may not receive the approperate care and miss life-threatening injures such as a traumatic brain injury (TBI), bleeding into the brain, or strokes.

iii. On 12/4/24 at 3:25 p.m., an interview conducted with medical director (Director) #4. Director #4 stated they expected a full neurological exam to be completed after every fall. Director #4 stated the nurse should do a head-to-toe assessment and a full neurological exam to include assessing the LOC, pupils, cranial nerves, facial symmetry, and grasp strength before notifying the provider. Director #4 stated that if they did not know the full clinical picture to include a complete patient assessment, they would be unable to make an informed clinical judgment on the patient's care. Director #4 stated if the staff failed to provide a full neurological assessment after the patient fell, they could miss potential life-threatening injuries.

Based on document review and interviews, the facility failed to ensure safe dispensing, administration, and tracking of controlled medications in 13 of 15 medication reconciliations reviewed.

Findings include:

Facility policy:

The Medication Diversion Prevention Policy read, the pharmacy department will monitor the timeliness and justifications provided by nursing when resolving discrepancies. If the Director of Pharmacy (DOP) or pharmacist designee discovers a pattern of discrepancies that remain unresolved in an untimely manner, the DOP or pharmacist designee will notify the CNO along with specific report information.

Reference:

The ASHP Guidelines on Preventing Diversion of Controlled Substances read, it is imperative that there is a detailed and thorough approach to investigating and reporting suspected diversion. Incomplete investigations and follow-up can have serious patient care, legal, personal reputation, and compliance implications.

Investigations are conducted as thoroughly and completely as possible; at a minimum, reporting occurs when it is determined that the discrepancy is unresolved or that there has been a known theft or diversion. As the investigation proceeds, there is an escalation and broadening of notifications specified in the policies and procedures defined by the Controlled Substances Diversion Prevention Program (CSDPP).

1. The facility failed to maintain accurate drug records and reconcile missing scheduled drugs, increasing the risk of loss or diversion.

A. Document Review

i. A live document review of the 90-day medication reconciliation record was completed on 12/9/24 with chief nursing officer (CNO) #3 and director of pharmacy (Director) #5.

a. Review of the medication reconciliation record revealed oxycodone 5 mg tab (a narcotic pain medication) was removed from the Pyxis (an automated medication dispensing system) on 11/25/24 by registered nurse (RN) #17. Further review of the medication reconciliation record revealed the medication was removed from the Pyxis and not documented as administered, wasted, or returned to the pharmacy.

b. Review of the medication reconciliation record revealed acetaminophen-hydrocodone 10/325 mg tab (a narcotic pain medication) was removed from the Pyxis on 11/25/24 by RN #21. Further review of the medication reconciliation record revealed the medication was removed from the Pyxis and not documented as administered, wasted, or returned to the pharmacy.

c. Review of the medication reconciliation record revealed acetaminophen-hydrocodone 10/325 mg tab was removed from the Pyxis on 11/24/24 by RN #22. Further review of the medication reconciliation record revealed the medication was removed from the Pyxis and not documented as administered, wasted, or returned to the pharmacy.

d. Review of the medication reconciliation record revealed acetaminophen-hydrocodone 10/325 mg tab was removed from the Pyxis on 11/24/24 by RN #23. Further review of the medication reconciliation record revealed the medication was removed from the Pyxis and not documented as administered, wasted, or returned to the pharmacy.

e. Review of the medication reconciliation record revealed oxycodone 10 mg tab was removed from the Pyxis on 11/12/24 by RN #24. Further review of the medication reconciliation record revealed the medication was removed from the Pyxis and not documented as administered, wasted, or returned to the pharmacy.

f. Review of the medication reconciliation record revealed acetaminophen-oxycodone 5/325 mg tab (a narcotic pain medication) was removed from the Pyxis on 10/30/24 by RN #16. Further review of the medication reconciliation record revealed the medication was removed from the Pyxis and not documented as administered, wasted, or returned to the pharmacy.

g. Review of the medication reconciliation record revealed oxycodone 5 mg tab was removed from the Pyxis on 10/29/24 by RN #24. Further review of the medication reconciliation record revealed the medication was removed from the Pyxis and not documented as administered, wasted, or returned to the pharmacy.

h. Review of the medication reconciliation record revealed oxycodone 10 mg tab was removed from the Pyxis on 10/18/24 by RN #16. Further review of the medication reconciliation record revealed the medication was removed from the Pyxis and not documented as administered, wasted, or returned to the pharmacy.

i. Review of the medication reconciliation record revealed tramadol 50 mg tab (a narcotic pain medication) was removed from the Pyxis on 10/12/24 by RN #17. Further review of the medication reconciliation record revealed the medication was removed from the Pyxis and not documented as administered, wasted, or returned to the pharmacy.

j. Review of the medication reconciliation record revealed oxycodone 5 mg tab was removed from the Pyxis on 10/2/24 by RN #2. Further review of the medication reconciliation record revealed the medication was removed from the Pyxis and not documented as administered, wasted, or returned to the pharmacy.

k. Review of the medication reconciliation record revealed oxycodone 5 mg tab was removed from the Pyxis on 10/1/24 by RN #19. Further review of the medication reconciliation record revealed the medication was removed from the Pyxis and not documented as administered, wasted, or returned to the pharmacy.

l. Review of the medication reconciliation record revealed oxycodone 10 mg tab was removed from the Pyxis on 9/20/24 by RN #17. Further review of the medication reconciliation record revealed the medication was removed from the Pyxis and not documented as administered, wasted, or returned to the pharmacy.

m. Review of the medication reconciliation record revealed oxycodone 10 mg tab was removed from the Pyxis on 9/3/24 by RN #16. Further review of the medication reconciliation record revealed the medication was removed from the Pyxis and not documented as administered, wasted, or returned to the pharmacy.

ii. A live document review of the medication reconciliation record of the last year was completed on 12/9/24 with CNO #3 and Director #5.

a. Review of the medication reconciliation record revealed RN #16 had ten controlled medications from 1/28/24 to 10/19/24 that were pulled from the Pyxis, not documented as administered, wasted, or returned to the pharmacy.

b. Further review of the medication reconciliation record revealed RN #20 had seven controlled medications from 2/23/24 to 8/1/24 that were pulled from the Pyxis, not documented as administered, wasted, or returned to the pharmacy.

The medication reconciliation record review was in contrast to the Medication Diversion Prevention Policy which read, the pharmacy department monitored the timeliness and justifications provided by nursing when resolving discrepancies. If the Director of Pharmacy (DOP) or pharmacist designee discovered a pattern of unresolved discrepancies, they notified the CNO with specific report information.

The medication reconciliation record review was in contrast to the ASHP Guidelines on Preventing Diversion of Controlled Substances which read, the need for a detailed and thorough approach to investigating and reporting suspected diversion. Incomplete investigations and follow-ups posed serious risks to patient care, legal compliance, personal reputations, and organizational integrity.

Staff conducted investigations as wholly and thoroughly as possible, ensuring that, at a minimum, they reported unresolved discrepancies or known theft or diversion. As investigations progressed, staff escalated and broadened notifications as outlined in the policies and procedures defined by the Controlled Substances Diversion Prevention Program (CSDPP).

B. Interviews

i. On 12/9/24 at 10:59 a.m., an interview was conducted with CNO #3. CNO #3 stated they were unable to account for the 13 narcotics that were pulled from the Pyxis, not administered in the MAR, not wasted, and not returned to the pharmacy. CNO #3 stated they did not thoroughly investigate the missing narcotics. CNO #3 stated the facility was unable to determine if the narcotics were diverted. CNO #3 stated they did not follow the facility's policy and procedures. CNO #3 stated the facility should have reported the incident to their legal team, the State Board of Nursing, and the Colorado Department of Public Health and Environment.

ii. On 12/9/24 at 3:19 p.m., an interview was conducted with Director #5. Director #5 stated they conducted an investigation on the missing narcotics by reviewing the Pyxis log and the MAR. Director #5 stated they were unable to account for the 13 missing narcotics. Director #5 stated it was important to track the narcotics from the moment they entered the facility to the time they were administered to the patients, wasted, or returned to the manufacturer. Director #5 stated it was important to track the narcotics to prevent diversion. Director #5 stated if the narcotics were diverted, the patients may not receive their medications and may not have their pain or anxiety controlled.