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1100 BUTTE ST

REDDING, CA 96001

QUALITY IMPROVEMENT ACTIVITIES

Tag No.: A0283

Based on interview and document review, the facility failed to take appropriate actions for performance improvement as evidenced by:

1.The facility quality program did not take appropriate action in response to a significant insulin (medication used to treat diabetes) medication error rate. Specifically, despite identifying a higher insulin medication error rate in the quality data, the facility failed to implement measures to address and reduce these errors. This lack of action highlights a concerning oversight in performance improvement efforts related to medication safety.

2. The facility quality program did not prioritize medication safety meetings as a means of performance improvement. These findings indicate a lack of proactive measures to address issues and make necessary improvements.

3. The facility's quality program failed to identify effective action plans to correct non-compliance with obtaining patient weights, despite seven months of data tracking (1/2023-7/2023) without improvement. This resulted in the potential for patient care interventions to be based on inaccurate information, jeopardizing patient safety and increasing the risk for avoidable patient harm.

4. The facility's quality program failed to identify effective action plans to ensure Registered Nurses (RNs) that were reassigned/floated to the Telemetry (Tele) unit had hands-on orientation by a Tele nurse with clinical expertise, that the floated RNs had demonstrated competencies as required to provide safe nursing care, and that reassigned/floated Clinical Supervisor/Charge Nurses had clinical expertise in Tele care. This resulted jeopardized patient safety and increased the risk for avoidable patient harm.

Findings:

1. A review of the 06/2023 data of medication error rates of insulin indicated a 12.5 percent error rate. During an interview on 08/08/23 at 1 PM, the Director of Pharmacy (DOP) stated that in the month of June, there was a concerning medication error rate of 12.5% of correctional doses for insulin. Out of the 72 opportunities, a total of nine errors were identified. The DOP expressed that they were not aware of any follow-up actions taken to address the recent increase in insulin medication error rates.

During an interview on 08/08/23 at 1:30 PM, the Performance Improvement Employee (PIE) received the pharmacy data and entered it into the quality program data sets. He mentioned that the data was reviewed on a monthly basis. However, upon reviewing the records, they found no evidence of an action plan specifically targeting the increased rate of insulin medication errors.

During an interview on 08/08/23 at 2 PM, the Previous Director of Pharmacy (PDOP) stated that he was not aware of the hospital's quality program addressing the rise in insulin medication error rate. This suggests a potential gap in communication and oversight.

During an interview on 08/08/23 at 2:50 PM, the Director of Performance Improvement (DPI) acknowledged that they did not take any action regarding the July data due to being occupied with staffing improvements. The DPI expressed concern about the higher medication error rates associated with insulin drip. The DPI admitted that had she known about the 12.5% error rate, they would have recommended convening a focus group to thoroughly review the administration of insulin medication. Furthermore, she acknowledged that it has been over six months since the last medication safety meeting, which should have also addressed this issue. She acknowledged that insulin drip is classified as a high-alert medication. High-alert medications are drugs that have a heightened risk of causing significant harm to patients if used in error. The consequences of an error can be much more severe. It is important to take special precautions when handling high-alert medications to reduce the risk of errors and minimize harm.

During an interview on 08/09/23 at 9:30 AM, the Intensive Care Unit (ICU) Clinical Supervisor expressed difficulties in interpreting the insulin protocol due to the presence of multiple equations that required specific patient data like carbohydrate and blood sugar levels to calculate the insulin dose accurately. She had issues with explaining the equations that were used to calculate the dose of insulin.

During an interview on 08/09/23 at 11 AM , Registered Nurse (RN) 1 confirmed the supervisor's concerns, stating that the insulin protocol could indeed be interpreted in multiple different ways. Additionally, RN 4 mentioned that new nurses faced even greater challenges in understanding and interpreting the protocol.

During an interview on 08/09/23 at 11:15 AM, the DOP, mentioned that there used to be a diabetes team responsible for monitoring and dosing patients on insulin. This team had developed the insulin diabetes protocol. However, the DOP shared that the diabetes team no longer exists. The DOP also said he didn't have the staff to have someone continuously monitor insulin, and he also said that the protocol needed to be simplified and more user friendly.

During an interview held on 08/10/23, at 11:10 am, the DOP reviewed the minutes of a Pharmacy and Therapeutics quality meeting held in June and July. During this meeting, the DOP acknowledged the findings concerning the performance of critical care nurses who were responsible for administering insulin. The investigation brought to light that out of the 22 patients who were assessed, 50% exhibited ongoing errors. In light of these findings, the DOP conveyed a strong dedication to rectifying these issues and improving the overall process.

2. A review conducted on 08/10/23, it was found that the facility had a policy in place titled, "Medication Safety Opportunities: Improved Reporting." This policy aimed to encourage the reporting of medication safety opportunities within the organization. Furthermore, the policy stated that a medication safety committee would be responsible for reviewing significant medication safety opportunities and making recommendations for process improvement. This indicates that the hospital had established a framework to identify and address medication-related issues to enhance patient safety and quality of care.

During an interview on 08/08/23 at 2:50 PM the Director of Performance Improvement (DPI) stated that it has been over six months since the last medication safety meeting, which should have also addressed this issue. She acknowledged that insulin drip is classified as a high-alert medication. High-alert medications are drugs that have a heightened risk of causing significant harm to patients if used in error. The consequences of an error can be much more severe. It is important to take special precautions when handling high-alert medications to reduce the risk of errors and minimize harm.

During an interview conducted on 08/10/23 at 9:24 AM, DOP stated that there were no medication safety meetings scheduled for the near future. This information suggests that no specific meetings had been planned to address medication safety concerns. It is important to note that no medication safety meeting took place after the last CMS (Centers for Medicare and Medicaid Services) survey in 4/2023, which identified a significant 42% insulin administration medication error rate. This lack of action raised concerns about the facility's commitment to addressing and improving medication safety issues.


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3. During a review of the Quality Performance Improvement Report (QPI), dated 1/2023-7/2023, titled, the "Percentage of Patient's Being Weighed," indicated the compliance goal was 95% (patients weighed 95% of the time, when required). The report indicated actual compliance (the percentage of patient's being weighed, as required during the seven-month period) included 1/2023 at 39%, 2/2023 at 46%, 3/2023 at 48%, 4/2023 at 39%, 5/2023 at 30%, 6/2023 at 36%, and 7/2023 at 34%. The report indicated weights were used by dietary for assessments of nutritional status and needs, pharmacy for drug dosing, and physicians/providers for monitoring weight and conditions such as heart failure, edema, or hydration status. The QPI data indicated data tracking for compliance included patient's being weighed upon admission (within 48 hours of admit) as well as upon initial and follow-up assessments. The corrective action plans included sending an emailed copy of the "malnutrition screening audit form" (identifies missing weights) to each patient's charge nurse and nursing unit/department director. The "proposed new action" included notifying individual nursing directors when the benchmark was not met, which would be presented at the quarterly quality meetings.

During an interview and concurrent review of the QPI report as described above, on 8/10/23 at 9:45 am, the Clinical Nutrition Manager (CNM) acknowledged the previous survey (4/2023) had identified non-compliance with obtaining patient weights as required. CNM acknowledged subsequent action plans had been ineffective to correct the non-compliance. CNM explained that during the 7/2023 quality meeting new action plans included transferring responsibility for compliance (with obtaining patient weights) to the nursing department. Dietary would continue with auditing for compliance, but the responsibility for meeting the benchmark would be nursing services.

During an interview on 8/10/23 at 11:30 am, the DPI explained that one of the reasons nursing had not identified or corrected the problem with patients not being weighed, was having too much on their plates, and thinking it was a dietitian responsibility. DPI explained that after the 7/2023 quality meeting, nursing had identified underlying problems with patient weight compliance. These problems included a scale (used to obtain patient weight), located in the ambulance bay of the emergency department, was not working, and the scale in the triage area had a dead battery, that had not been replaced. These problems were not identified through the facility quality process which resulted in the source of the problem going unidentified, and action plans that were ineffective in resolving the underlying cause. DPI acknowledged this resulted in ongoing non-compliance with obtaining patient weights as required.

4. The Quality Meeting Minutes, dated 7/13/23, indicated action items to address concern that staff from Med/Surg and Ortho/Neuro were not confident with floating to Tele. The action items included 1) additional education that included Repiratory Therapy speeding time educating the nurses on the floors to better equip them to take care of higher acuity patients and 2) the Performaince Improvement department would keep an excel sheet to track competencies up to date.

The facility's "Plan for Provision of Patient Care," dated 12/2020, indicated RN competency validation would be upon orientation, and current competency would be in place to ensure patient care assignments were allocated to RNs competent to meet their care needs.

According to the facility's RN union contract, floating (the temporary reassignment of a Nurse to a clinical area outside of his/her assigned patient care unit) was subject to patient care considerations and staffing needs including skill level, qualifications, and competencies. RNs may be required to float to units for which they are competent.

According to the Board of Registered Nurses article, titled, "RN Responsibility when Floating to New Patient Care Unit or Assigned to a New Population," published at https://www.rn.ca.gov/pdfs/regulations/npr-b-21.pdf, "The RN is always responsible for providing safe, competent nursing care. Therefore, before accepting a patient assignment, the RN must have the necessary knowledge, judgment, skills, and ability to provide the required care. It is the RNs responsibility to determine whether she/he is clinically competent to perform the nursing care required on the new unit or with the new patient population. If the RN is not clinically competent to perform the care, she/he should not accept the patient care assignment. ...If the RN accepts an assignment for patient care and is not clinically competent, the RN license can be disciplined. ...Nursing administrators, supervisors, and managers have a crucial responsibility to assure appropriate and competent nursing care to patients/clients. The BRN requires nursing administrators, supervisors, and managers to only assign patient care to RNs who are clinically competent. Nursing administrators, supervisors and managers may have their licenses subject to discipline if they do not ensure assignment of clinically competent RN staff.

During an interview on 8/8/23 at 4 pm, and concurrent review of staffing documentation on the Ortho/Neuro/Med/Surg Director (OND/MSD), the expectations and process for orientation/training and validation of clinical competence (related to care on the Tele unit) was discussed. OND/MSD confirmed Tele RN patient care required specialized knowledge, judgement, skill, with higher acuity patients than found on the Ortho/Neuro/Med/Surg units. OND/MSD provided documentation related to Orientation Checklists on file for nurses who had been deemed competent to float to the Tele unit. OND/MSD confirmed the hospital's Med/Surg unit was temporarily closed at this time. In addition to filling gaps in staffing for the Ortho/Neuro unit (required Med/Surg level RN care), Med/Surg RNs (and/or Ortho/Neuro RNs when required) were regularly floated to the Tele unit to meet baseline staffing needs. During a concurrent review of Ortho/Neuro staffing assignment documentation, dated 7/6/23-8/6/23, multiple shifts included reassignment of RNs to the Tele unit. OND/MSD was asked how training and competency was validated for staff expected to float to Tele and what considerations were in place to determine who would be reassigned to Tele when required. OND/MSD stated there were some staff who were more comfortable and willing to float more often, but the expectation was that all staff were available to float. All Med/Surg/Ortho/Neuro RNs had completed online training for Advanced Life Support, cardiac drip medications, and on oxygen related equipment. The Orientation Checklist included a Telemetry Addendum (two-page document, adapted from the 10-page core Tele staff checklist), to identify nurse competency for the important skills required for Tele, dated 1/2023 and/or 2/2023. The addendum was also completed for subsequent new hires during orientation. No updates to demonstrate additional knowledge and skill and/or "current competency" were in place. OND/MSD was not involved in the development of the Telemetry Addendum or decision making about who would be floated. OND/MSD confirmed RNs reassigned to the Tele floor did not have clinical expertise and would not be expected to manage cardiac drip medications, or care for patients requiring specialized knowledge and expertise outside their skill level. There should always be a nurse to provide direction and clinical expertise to ensure safe patient care when nurses were floated to Tele.

During a review of the Med/Surg/Ortho/Neuro competency checklist files,the Tele Addendum checklist was in place for 22 of 26 Med/Surg RNs and 22 of 26 Ortho/Neuro RNs. The document showed four options for "Validation of Competency by Preceptor" identified as; 1) Independent Demo, 2) Policy reviewed and Discussed, 3) Skills Checklist Given, 4) Health-Stream Module (online education provided by facility). If any one of these four options were checked, the RN was deemed competent according to the form.

During an interview on 8/9/23 at 10 am, DPI explained Med/Surg/Ortho/Neuro RNs were all competent to float to the Tele unit. After the last survey, the facility had provided additional education regarding high flow oxygen and Bipap (assisted breathing machine) equipment. Education was provided by the Director of Respiratory Therapy. These nurses were then deemed competent with high flow oxygen and bipap equipment as needed for patient care.

During an interview on 8/9/23 at 12:15 pm with the Director of Respiratory Therapy (DRT), a concurrent review of Bipap/ventilator training materials with sign in sheets, dated 1/17, 1/18, 1/26, 1/27, 1/30/23, and 2/16/23 and 2/17/23, took place. DRT curriculum and explained this was a classroom setting where he had equipment in the room and demonstrated how to use it and the most important responsibilities of the nurse when caring for the patient. DRT stated return demonstration was not required. A few staff did stay after and test skills. This was not meant to demonstrate competency for RN assignment to patients with Bipap and/or ventilator. DRT stated this was education to familiarize staff with equipment. Hands on unit specific orientation in the patient care environment, to validate competency. The class was done upon hire and for Ortho/Neuro/Med/Surg nurses who were expected to regularly float to the Tele unit.

During an interview on 8/9/23 at 11:30 am, RN 52 explained that she was a Med/Surg RN and was regularly re-assigned to work on the Tele unit night shift. RN 52 explained that during new hire orientation and training, approximately two years ago, she spent one day on the Tele unit. No subsequent preceptor orientation or training was provided on the unit prior to being expected to float to the unit and take independent assignments. Being a newer nurse, she was used to asking more skilled nurses for direction when she wasn't sure what to do. While floating to the Tele unit there had been many circumstances when this was essential to safe patient care. RN 52 explained that it is getting much harder to find the charge nurse when needed, after the addition of LVNs to the staffing mix. Additionally, LVNs were assigned patients with less intense RN care needs, resulted RNs floated in were taking higher acuity patients. Most of the patients on the Tele unit had intense registered nursing care needs. She certainly did not have clinical expertise to be an independent decision maker while evaluating and responding to changes in in condition for high acuity patients which was outside her experience, skill level, and expertise. She always needed to work with another nurse with clinical expertise available for guidance when necessary.

During an interview on 8/10/23 at 9 am, Telemetry Director (TD) confirmed Med/Surg RNs were regularly floated to the Tele Unit to meet baseline staffing needs. During concurrent review of the employee checklist titled, "Telemetry Addendum," TD stated she was not involved in developing the checklist which was a two-page addendum from the 10-page Tele checklist. TD had not previously reviewed the checklist after recently assuming the TD position. TD confirmed requirements for HealthStream education (text and video training) included advanced life support, and cardiac drip education. TD acknowledged that watching educational videos, reviewing policies and procedures, and attending classroom education, was not sufficient to validate competency for actual patients needing this care. On unit, hands-on orientation with a preceptor and return demonstration to validate knowledge and competency would be required. TD was not involved in decision making for who would be floated to the Tele floor and/or whether they were competent to provide safe patient care. TD was asked about parameters for integrating LVNs into the staffing mix and the effect on assignment for RNs reassigned to Tele. TD acknowledged the difficulty of making appropriate staff assignments for float nurses, when the LVNs staffed on Tele were already assigned the patients with the least intense RN specific care needs (included a lower risk for changes in condition that would require specialized knowledge, managing interventions, updating the patients plan of care, decision making, IV medications with ongoing comprehensive assessments, interpreting the significance of cardiac rhythms as related to patient care needs). TD indicated additional training for float nurses, was important for safe patient care. Float nurses should know how to participate in processes that might be immediately important for patient well-being, such as training on the unit specific protocol for starting cardiac drips that could be needed urgently. TD explained the float nurse should then hand over care of the patient to a nurse who was core staff on the Tele unit. Float nurses should not be left with responsibility for high acuity patients with potential for changes in condition requiring judgement that comes with experience and clinical expertise. When a patient does have a change in condition that requires knowledge and management outside the float nurse's skill level, the care of that patient should be handed off to a core Tele RN with clinical expertise. The unit should never be fully staffed without an RN who has clinical expertise in Tele care. Med/Surg/Ortho/Neuro nurses floated to the Tele unit do not meet these criteria.

During an interview on 8/10/23 at 10:45 am, the Nursing Supervisor (NS, RN 41) was queried about the frequency of med/surg/ortho/neuro nurses floating to Tele to meet baseline staffing needs and stated the averaged was about four nurses per day. How was decision made about who to float? Was it based on level of skill required to meet patient care needs. Her understanding was that all med/surg/ortho/neuro RNs had completed competencies and could be reassigned (floated) as needed to meet staffing needs. Regarding a list of nurses with specialized skills for high acuity patients, NS acknowledged no mechanism was in place to ensure reassignment of RNs was based on skill level. NS confirmed she had gotten push back from nurses who did not feel comfortable, but they were required to float when necessary to meet staffing needs. NS was asked if the facility had a "float pool" (includes nurses with specialized orientation, training and demonstrated competency validation for multiple units in the hospital), NS explained there were only two such nurses and the hospital was not actively recruiting for or replacing the float pool. NS thought it might be because they did not want staff nurses to quit their regular floor and apply for the float pool where the position accounts for a pay differential of six dollars an hour. NS confirmed orientation/training of float pool nurses included a full preceptor lead hands-on-training, and competency validation to each unit prior to independent assignment. NS acknowledged that the hospitals chronic staffing shortage had worsened over the past several months due to termination of contracted traveler RNs (62 since 1/1/23, 24 of which were assigned to the Tele Unit). The hospital consolidated staffing needs by temporarily closing the Med/surg unit. NS confirmed the med/surg staff were essentially being used as a float pool for the Tele Unit without the orientation/training or demonstrated competency required to be a Tele float nurse. The NS confirmed that due to short staffing of night shift charge nurses (Clinical Supervisor, job description requires responsibility for clinical expertise and direction/resource to ensure safe patient care) for the Tele Unit, Med/Surg Charge (and Ortho/Neuro Charge nurses if required) were frequently reassigned to meet base-line staffing needs. The Med/Surg or Ortho/Neuro Charge nurse would be assigned as charge on Tele even when a core Tele Relief Charge Nurse was on the floor. NS stated this was due to the RN-union contract which stipulated the relief charge (union nurse) cannot supersede the full time Charge Nurse (non-union) when both are scheduled on the unit. NS acknowledged the Med/Surg/Ortho/Neuro Charge nurses did not have the clinical expertise required to function in this role (as outlined on the job description for the Tele Clinical Supervisor position). NS was asked about circumstances when no core Tele staff were available. NS confirmed the unit could be staffed entirely with reassigned RNs from other floors. NS was asked what the nurses were then to do if the patient care was outside their level of competence/expertise. NS stated they all had completed competencies (including cardiac drips, and advanced life support) so they could be assigned patients as required on Tele. NS stated the nurses had the nursing supervisor as back up (NS is resource for entire hospital), or the Charge Nurse on Intensive Care Unit could be consulted. NS acknowledged the NS was not a clinical expert for the Tele unit, the ICU Charge nurse had competing responsibilities and may not be available to leave the ICU and would not be available throughout the shift to provide ongoing clinical expertise to meet patient care needs. NS acknowledged that due to short staffing on the Tele, reassigned RNs only shifts had occurred on multiple occasions and no measures were in place to prevent this situation from recurring. Regarding how the staff mix would change if there were patients on Tele requiring PCU level care (Progressive Care Unit - less acute than ICU but more acute than Tele, requires 1:3 nurse to patient ratio instead of 1:4), NS stated the hospital did not have a PCU and patients on Tele were all 1:4 staffing and if not they would stay in the ICU. NS acknowledged PCU care requirements followed the patient and not the specified unit. If a patient required PCU level care, a minimum of 1:3 nurse to patient ratio (per state regulation) was required no matter which unit the patient was located.

During an interview on 8/10/23 at 11:15 am, DPI and the Interim CNO stated they were not aware, and had just learned, that the Med/Surg Charge Nurse would supersede the core Tele Relief Charge Nurse when the NS fills the charge nurse staffing assignment on Tele. They confirmed the Med/Surg charge RN did not have clinical expertise on Tele and thus did not meet the criteria for the position as outlined on the Tele Clinical Supervisor job description. DPI and CNO acknowledged the provision of safe patient care on the Tele unit required on unit, immediate availability of an RN who had clinical expertise and competence to provide guidance to less experienced nurses. DPI acknowledged Med/Surg/Ortho/Neuro RNs were being floated to meet daily baseline staffing needs and essentially functioned as a float pool for the Tele unit. DPI acknowledged the facility training official float pool nurses required full orientation, training and competency validation for each unit where floating would be expected. DPI acknowledged this training and/or level of competency validation, had not been provided for the Med/Surg/Ortho/Neuro RNs regularly floating to the Tele unit. DPI acknowledged the quality process action plan that included an excel document to track nurse competency to float to Tele, was based on the methods described above for competency validation. DPI acknowledged the current system for "competency validation" was not sufficient to ensure competency and/or clinical expertise of the clinical supervisor as required.

ORGANIZATION OF NURSING SERVICES

Tag No.: A0386

Based on interview and record review, the facility failed to develop written nursing policies and procedures that outlined well-organized nursing services and delineated the licensed vocational nurse's (LVN) responsibilities for patient care when:

1a. Policies and procedures were not developed to include the facility LVNs as patient care providers on the Telemetry Unit (Tele, a unit where patients are under constant electronic monitoring), the LVN's position in the Tele unit's department staffing and reporting structure, the patient assignment process that is appropriate for LVN licensure, or identify a process for LVN supervision and oversight on the Tele unit.

1b. Policies and procedures were not developed to include facility LVNs as patient care providers on the Orthopedic-Neuroscience Unit (O/N, patient services for major joint, neck, and back surgeries and neurological disorders), the LVN's position in the O/N unit's department staffing and reporting structure, the patient assignment process that is appropriate for LVN licensure, or identify a process for LVN supervision and oversight on the O/N unit.

1c. Policies and procedures were not developed to include facility LVNs as patient care providers in the Emergency Department (ED), the LVN's position in the ED's staffing and reporting structure, the patient assignment process that was appropriate for LVN licensure, or identify a process for LVN supervision and oversight in the ED.

These failures had the potential to result in unsafe and ineffective care given to all patients on the Tele, O/N, and ED units, which could lead to negative clinical outcomes.

Findings:

1a. A review of the facility's policy and procedure titled, "Provision of Patient Care, Plan for Telemetry," revised 12/20, indicated that the Tele unit is staffed with 47 full time, and 2 -part time registered nurses (RNs). The reporting structure is as follows: Nurses' Aides, Patient Care Technicians, Unit Secretaries, Monitor Technicians, and Charge Nurses (CN). The CN, also known as the unit clinical supervisor, in collaboration with the Tele Unit Director (TD) was accountable for the supervision of patient care activities on a daily basis. Registered Nurses are lead by the Charge RN and the Department Director. Nursing assistants are under RN leadership. There is no reference to LVNs in the Provision of Patient Care, Plan for Telemetry.

A review of the facility's policy titled, "Staffing Plan for Telemetry," reviewed on 4/23, indicated that the unit will follow Title 22, California Code of Regulations, Section 70217 and that staffing for licensed nurses shall be determined by the department classification system.

A review of the facility's policy titled, "Patient Classification - Telemetry," reviewed 4/21, indicated the patient classification system shall be used from shift to shift to determine the nurse of staff required to meet the needs of critical care patients. The Tele unit's staffing ratio shall be 1:4 ratio at all times. The Tele RN shall perform individual patient assessments to determine the level of acuity of patients every shift. Level 1 patients who require minimal assistance and are stable require 1 RN: 4 patient nursing care. Level II patients in stable condition, with 2-3 nursing interventions, such as multiple intravenous medications (IV, administering medication through a needle or tube inserted into a vein), tube feeding, cardiac monitoring require 1 RN: 4 patient nursing care. Level III: patients are new admissions, who are stable, but have complex nursing needs, such as multiple IV medications, multiple blood products, frequent observations and vital signs, require 1 RN: 4 patient nursing care. Level IV: patients are stable and may have complex wounds or drains, complex paint management, received out of unit procedures for more than two hours and require RN support, requires high flow oxygen, may have had post-operative heart surgery patients "May require 1 RN: 3 patients nursing care". Level V: patient with multiple cardiac drips, insulin drip, bipap patient, unstable arrhythmia, complex wound therapy, out of unit procedures for more than two hours requiring RN support, patient that require every hour or more frequent monitoring may require 1 RN : 3 patient nursing care. There is no reference to LVNs in the Patient Classification-Telemetry policy.

A review of the facility's job description titled, "Job Description- Clinical Supervisor-Telemetry," revised 2/18, indicated that the Tele CN was responsible and accountable for the quality of nursing functions during their shift, which included directing, supervising, and evaluating Tele staff. The policy further indicated that the Tele CN will assume responsibility for the performance of tasks by employees under his/her supervision.

A review of the facility's job description titled, "Job Description - LVN- Telemetry," revised 1/2014, indicated that the Tele LVN provided direct and indirect patient care services, within their scope of practice, and performed under the direction and supervision of a RN.

During an interview on 8/8/23, at 9:30 am, RN 33 reported he had been employed as a Tele CN at the facility for 13 years. RN 33 stated there was a continued lack of communication and written policy that instructed staff on the LVN's role in delivering nursing services to Tele patients, the procedure to identify what acuity level of patients LVNs will be assigned to care for, and outline what RNs were permitted to provide LVN oversight and supervision. RN 33 stated that the prior TD briefly mentioned to him that LVNs would be working on the unit under the direct supervision of CNs only. Tele CNs were required to co-sign LVN patient assessments, administer IV medications, insert any necessary IV access, and patients labs from central line (a tube that is much larger than a regular IV that is placed in a vein in the neck, chest, or groin) . RN 33 reported the Tele unit has informally transitioned to permitting any available and willing RN to provide LVN supervision, perform physical health assessments, and administer nursing tasks outside of the LVN's scope. RN 33 acknowledged that RNs who perform these duties may be operating outside of their current job description requirements and responsibilities. RN 33 has still not been shown a written policy or framework that outlined how to coordinate the LVN's nursing services with an RN to ensure patients are receiving their full scope of nursing services. RN 33 stated not having policies or procedures was unfair to the Tele RNs, LVNs, and CNs and has resulted in patients not receiving RN assessments and MD ordered IV medications.

During an interview on 8/09/23, at 9:29 am, the facility's Telemetry Director (TD) stated she became acting TD on 5/31/23. TD reported she had been the facility's Intensive Care Unit Director (ICUD) for 1.5 years and was a Tele RN for many years prior to being named the ICUD. TD reported she was familiar with the Tele CNs supervisory duties and their required oversight of Tele LVNs. TD stated she had not seen any updated policies that identify the LVN's role in the facility's Tele staffing plans, reporting structures, department processes, or patient acuity systems.

1b. A review of the facility's policy and procedure titled, "Provision of Patient Care, Plan for Orthopedic-Neuroscience Unit," revised 12/20, indicated that the O/N unit is staffed with 28 full time RNs, 4 part time RNs, and 1 per diem RN. The Director (OND) assumes 24 hours per day, 7 days per week responsibility for oversight of the unit. Direct care is provided by RNs and aides. The chain of command is as follows: aides and RNs report to the charge nurse. The charge nurse reports to the department director. The department director reports to the chief nursing officer (CNO). Upon patient admission to the unit, an initial admission assessment is performed by the RN. The patient care nurse and plan of care are reassessed, and re-prioritized by the RN every shift. Vital signs will be performed twice per shift and as needed, and assessed/reassessed by the Registered Nurse. There was no reference to LVNs in the Provision of Patient Care Plan for the O/N unit.

A review of the facility's policy titled, "Staffing Plan for Surgical/Ortho Neuro," reviewed on 4/23, indicated that the unit will follow Title 22, California Code of Regulations, Section 70217 and staffing for licensed nurses shall be determined by the department classification system.

A review of the facility's policy titled, "Patient Classification - Ortho/Neuro," reviewed 4/21, indicated that the O/N unit's staffing ratio shall be 1:5 ratio at all times. The O/N RN shall perform individual patient assessments to determine the level of acuity of patients every shift. Level 1: patients who require minimal assistance. Level II: patients with simple post-operative conditions. Level III: patients with more nursing needs such as IV medications or special equipment. Level IV: patients who are extremely complex require the "expertise of an RN". Patients who qualify for Level IV may require special staffing ratio considerations (1:4). Level IV: patients that are demanding , confused, are extreme fall risks, technically complex, immediately post-operative, may require a special staffing ratio consideration (1:4). There is no reference to LVNs in the Patient Classification - Ortho/Neuro Policy.

A review of the facility's job description titled, "Job Description- Clinical Supervisor- Orthopedics/Neuroscience ", revised 2/18, indicated that the O/N CN was responsible and accountable for the quality of nursing functions during their shift, which included directing, supervising, and evaluating O/N staff. The policy further indicated that the O/N CN will assume responsibility for the performance of tasks by employees directed under his/her supervision.

A review of the facility's job description titled, "Job Description - LVN- Orthopedics/Neuroscience," revised 1/2014, indicated that the O/N LVN provided direct and indirect patient care services, within their scope of practice, and performed under the direction and supervision of a RN.

During an interview on 8/10/23, at 9:17 am, RN 31 stated that she has worked at the facility's O/N and Tele units for three years as a CN and relief CN (a RN that is trained to temporarily assume the duties of a CN). RN 31's CN job duties included creating the Tele and O/N nurse's patient assignments and providing clinical support and supervision to nursing staff, which included LVNs. RN 31 reported since an LVN's licensure scope is limiting, and prohibits independent patient assessments or the administration of intravenous (IV, administering medication through a needle or tube inserted into a vein) medications. RN 31 stated she still has not seen a written policy that defines acuity level of patients LVNs could be assigned or what registered nursing staff are permitted to assist LVNs with tasks outside of their scope. It was unclear if the facility CNs were the only nursing staff approved to assist LVNs, or if other RNs could assist. RN 31 stated the roll out of LVNs in the workplace was "totally chaotic and a joke". There were no tools or processes created for LVNs to inform the CNs of the number of patients they had that required IV medication administration, and the time the medications were to be administered, to ensure an RN was readily available. RN 31 stated LVNs on the O/N unit continue to provide the CNs with several yellow sticky notes at the start of shift that include a list of patients requiring physical health assessments, IV medication administration, the number of IV medications to be administered, and the timing of medication administration.

During an interview on 8/9/23, at 11:16 am, Ortho/Neuro Unit Director (OND) stated it was primarily the responsibility of the unit CN to provide supervision and oversight to the facility's LVNs, but any available RNs can assist the unit's LVNs if the CN is unavailable. OND verified that the facility still has not disseminated any communications, or developed written policies, regarding the LVNs role on the nursing team and the delegation of LVN supervision.

During a combined interview on 8/9/23, at 2:30 pm, the Chief Executive Officer (CEO) and Interim Chief nursing Officer (ICNO) confirmed that the written policies and procedures that included LVNs in the provision of patient care on the Tele and O/N units were still in development. CEO verified that LVNs were introduced into the facility's workforce in 11/2022, and that policies have not been revised to include LVNs in the facility's staffing plans, reporting structures, department processes, or patient acuity systems.


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1 c. The facility's "Patient Classification" policy for the Emergency Department (ED), approved 12/2018, the "Staffing Plan for ED," approved 6/2023, and "Plan for Provision of Patient Care" policy for the ED, approved 2/2021,were reviewed. The Plan for Provision of Patient Care policy included "the progressive path of reporting as follows: Patient Care Tech/Unit Secretary/EMT, Registered Nurse, Charge Nurse, Director of Emergency Services, and Chief Nursing Officer." There was no mention of the use of LVNs in the ED. None of the above policies included the use of LVNs or their function and role within the ED.

During an interview on 8/7/23 at 2:38 pm, ED Registered Nurse (RN) 50 said she was often the charge nurse in the ED. She said when she works as charge nurse, she has to answer the radio and help LVNs and give their intravenous (IV) medications. She said the LVNs take care of lower acuity patients such as the triage level 4 and 5 patients (Triage Level 4 The patient presents with a condition that has a low potential for deterioration or complications. One resource was expected to treat this patient. Triage Level 5 The patient presented with a condition that may be acute but is not urgent; the condition may be part of chronic problem with very low potential for deterioration or complications. The presenting condition is anticipated to require no resource utilization), so higher acuity patients wait longer in the ED waiting room to be seen.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on interview and record review, the facility's registered nurses (RN) failed to perform initial and on-going patient assessments of patients assigned to licensed vocational nursing (LVN) staff on the Telemetry unit (Tele, a unit where patients are under constant electronic monitoring for irregular heart rates and rhythms) when the Tele charge nurse (CN, a specially trained RN who supervises and manages a department of nurses) became unavailable to supervise the LVNs. This failure caused, or contributed to a RN not supervising, reviewing, or performing independent physical health assessments on 21 of 35 (60%) patients assigned to LVNs.

Findings:

A review of the Nursing Practice & Patient Advocacy Alert, published by the California Nurses Association, 2022 edition, provided clarification on the roles of RNs and LVNs in patient assessment and responsibility. The nursing practice alert clarified the legal scopes of practice of RNs and LVNs in regards to assessment/responsibilities. An assessment consists of two parts: 1) Data collection (observation, palpation or auscultation); 2) Analysis, synthesis and evaluation of data. The RN carries legal responsibility for analysis, synthesis and evaluation of the patient through direct observation as stated in the Nursing Practice Act, Business and Professions Code Sec 2725(b) (4). The practice of RNs include: Observation of signs and symptoms of illness, reactions to treatment, general behavior, or general physical condition, and (1) determination of whether such signs, symptoms, reactions, behavior, or general appearance exhibit abnormal characteristics; and (2) implementation, based on observed abnormalities, of appropriate reporting, or referral, or standardized procedures, or changes in treatment regimen in accordance with standardized procedures, or the initiation of emergency procedures.

A review of the facility's policy and procedure titled, "Provision of Patient Care, Plan for Telemetry," revised 12/20, indicated that the Tele unit CN, also known as the unit clinical supervisor, was accountable for the supervision of patient care activities on a daily basis. The CN duties included oversight of staffing assignments, oversight of unit patient placement, clinical leadership, and coaching. The policy further indicated that Tele patients are assessed on admission by a Registered Nurse (RN), and reassessed at least every four hours to ensure patient care needs are identified.

A review of the facility's policy titled, "Patient Classification - Telemetry", reviewed 4/21, indicated the Tele RN shall perform individual patient assessments to determine the level of acuity of patients every shift.

A review of the facility's job description titled, "Job Description- Clinical Supervisor-Telemetry," revised 2/18, indicated that the Tele CN was responsible and accountable for the quality of nursing functions during their shift, which included directing, supervising, and evaluating Tele staff. The Tele CN shall continually assess patient care and direct staff to make immediate changes to a patient's plan of care when needed. The policy further indicated that the Tele CN will assume responsibility for the performance of tasks by employees under his/her supervision.

A review of the facility's job description titled, "Job Description - LVN- Telemetry," revised 1/2014, indicated that the Tele LVN provided direct and indirect patient care services, within their scope of practice, and performed under the direction and supervision of a RN. The Tele LVN, under the direct supervision of an RN, will perform basic assessments (data collection) and reassessments on all patients.

A review of LVN physical assessments administered to patients on the Tele unit, from 7/05/23 to 8/06/23, indicated that 21 of 35 (68%) patients (Patient 12, Patient 23, Patient 24, Patient 25, Patient 26, Patient 27, Patient 28, Patient 29, Patient 30, Patient 31, Patient 32, Patient 33, Patient 34, Patient 35, Patient 36, Patient 37, Patient 38, Patient 39, Patient 40, and Patient 41) assigned to LVNs did not have a RN supervising, reviewing, or performing an independent physical health assessment as required by their licensure.

During a concurrent interview and record review on 8/07/23, at 3 pm, LVN 5 stated she had worked at the facility's Tele unit for approximately six months. Since LVN 5 was new to the facility, and new toTele nursing, the Tele CN and RNs were always available for consultation and supervision because they were aware that LVN 5 was a new,"green nurse", with a limited scope of practice, on a unit with very sick patients. LVN 5 reported she relied on the Tele CNs, or any available RNs, to perform independent physical health assessments on her patients to ensure she was delivering appropriate nursing care and wasn't overlooking any factors that indicated a patient's condition was worsening. Once the facility's Medical-Surgical Unit (M/S, a unit for acute and/or chronically ill patients requiring surgery or other medical interventions) closed in late April 2023 due to low census (the number of patients in a hospital during a designated time), the Tele CNs became very busy providing support and oversight to M/S nurses who were required to float to the Tele unit with very little Tele nursing experience. LVN 5 stated this caused CNs to become unavailable to perform independent physical assessments and reassessments on patients assigned to LVNs.

During a concurrent interview and record review on 8/08/23, at 10:11 am, the Ortho-Neuro unit Director (OND), who was acting interim Telemetry Director (TD) until the current TD was named on 5/31/23, verified that the 21 of 35 patients assigned to LVNs, on 7/05/23 to 8/06/23, had physical assessments administered by LVNs without a RN supervising, reviewing, or performing an independent physical health assessment as required by their licensure.

During an interview on 8/09/23, at 9:29 am, the facility's TD stated she became acting TD on 5/31/23. TD reported she had been the facility's Critical Care Unit Director (CCUD) for 1.5 years and was a Tele RN for many years prior to being named the CCUD. TD reported she was familiar with the Tele CN managerial duties which included supervising and overseeing LVNs due to their limited licensure scope. TD acknowledged that the Tele CNs were repeatedly deficient in performing or supervising the physical health assessments of patients assigned to LVNs due to on-going insufficient staffing on the unit. TD reported the facility aimed to increase nurse staffing on the Tele unit so CNs were not required to assume their own patient assignment, and could focus on performing managerial duties, leadership, and LVN oversight. However, since the closure of the M/S unit, the M/S nurses have been floated to Tele, creating a staffing pool of inexperienced and unqualified nurses who require a close CN oversight and support. TD reported the lack of qualified Tele nurses have attributed to the CNs increased workload and inability to perform independent physical health assessments/reassessments on patients assigned to LVNs.

During a combined interview on 8/09/23, at 2:30 pm, with the Chief Executive Officer (CEO) and Interim Chief Nursing Officer (ICNO), the ICNO reported she was appointed to her position as ICNO one week prior and was briefly brought up to speed regarding the facility's ongoing past deficiencies relating to a lack of LVN oversight and an absence of RN physical assessments performed on patients assigned to LVNs. CEO reported he had actively put interventions into place to relieve the Tele CNs of patient assignments so they were "freed up" and available to conduct LVN oversight and physical health assessments, along with other supervisory duties. CEO and ICNO were informed there had been improvement with Tele CNs taking on patient assignments, however; the CN workload became displaced again once they had to provide close supervision and oversight to the M/S nursing staff who were required to float to the Tele unit to supplement the Tele nurse shortage. CEO and ICNO stated they were unaware that 21 of 35 patients assigned to LVNs continued to not have an RN supervise, perform, or review physical health assessments and suggested they seek out hiring experienced Tele traveler nurses (nurses who are available for a short assignment to assist facilities with urgent staffing shortages) to help with the gap in nursing care.

During an interview on 8/10/23 at 9:17 am, RN 31 stated that she has worked at the facility's Tele unit for three years as a CN and relief CN (a RN that is trained to temporarily assume the duties of a CN). RN 31's CN job duties included creating the Tele nurse's patient assignments and providing clinical support and supervision to nursing staff, which included LVNs. RN 31 reported since an LVN's licensure scope is limiting, and prohibits independent patient assessments or the administration of intravenous (IV, administering medication through a needle or tube inserted into a vein) medications, the CNs were responsible for performing all physical health assessments on the LVN's patients, administering all IV medications, inserting any needed IVs, and accessing any central lines for lab draws. RN 31 reported since the closure of the facility's M/S unit in May 2023, and the turnover of experienced Tele staff, CNs have been tasked with providing extensive oversight to the M/S nurses who float to Tele, new hire Tele RNs, and Tele LVNs. This increased workload, in addition to the CN's managerial activities, made it difficult for CNs to administer physical assessments to patients assigned to LVNs.

ADMINISTRATION OF DRUGS

Tag No.: A0405

Based on interview and record review:

1. The facility failed to ensure antibiotics were given in a timely manner (according to accepted standards of practice) to a patient (Patient 6) who was admitted with sepsis (the body's extreme response to an infection. According to the Centers for Disease Control and Prevention sepsis is a left-threatening medical emergency. Sepsis happens when an infection you already have triggers a chain reaction throughout your body. Most cases of sepsis start before a patient goes to the hospital. Without timely treatment, sepsis can rapidly lead to tissue damage, organ failure, and death). This had the potential to result in further decline in Patient 6's condition including death; and

2. The facility failed to properly rotate the injection sites when administering insulin lispro and insulin glargine to Patient 21 and Patient 5. The failure to properly rotate injection sites when administering insulin injections can increase the risk of developing lipodystrophy at the site of repeated insulin injections. Lipodystrophy is a disorder that affects how the body accumulates and stores fat. It can cause changes in the appearance of the skin and underlying tissue, such as lumps or indentations, and can also affect the absorption of insulin, making it more difficult to control blood sugar levels.

Findings:

1. The "Initial Treatment of the Patient with Positive Sepsis Screening" policy, dated 7/2019, was reviewed. According to the clinical presentation/indications included in the policy, Patient 6 had sepsis. "Goal: Initiate antibiotics as soon as possible, after all cultures obtained, within 180 minutes of arrival to ED. Recommended antibiotics for unknown source of sepsis: Vancomycin 1 gram IV and Zosyn 4.5 gram."

A review of Patient 6's record indicated she presented to the Emergency Department (ED) on 8/2/23 at 3:34 pm with a complaint of weakness and an abscess (collection of pus) to the right hip. She had been on antibiotics at home. She was seen by a mid-level provider (health care provider who assess, diagnoses and treats patients but does not have as extensive of an education as a physician) at 3:56 pm. Numerous lab tests were ordered. Patient 6's white blood cell count (WBC) was elevated at 41,000 (normal range is 4500 to 11,000, indicates infection), Hemoglobin (protein in red blood cells that carries oxygen throughout the body) was very low at 6.9 (normal range is 12.1 to 15.1, indicates anemia), Lactic acid (test that helps diagnose sepsis) elevated at 2.3 (normal range is 0.5 to 1.0), Potassium level was very low at 1.8 (normal 3.5 to 5.2), rapid heart rate of 131 (more than 100 beats per minute), blood pressure (BP) was in the low 90s. Patient 6 also had a draining wound to her right lateral posterior thigh. Rocephin (antibiotic) was ordered at 4 pm and given at 4:30 pm and intravenous (IV) fluids were given to Patient 6 while she was in the ED. Patient 6 was admitted to the hospital to the Telemetry unit (Tele, continuous remote monitoring of the patient's heart rate and rhythm). The Hospitalist (a physician who cares for inpatients and works only inside a hospital) did a reassessment of Patient 1, while she was in the ED, and dictated a note at 9:12 pm. His impression was sepsis, and qualified codes included severe sepsis without septic shock. He ordered Zosyn (antibiotic) 4.5 grams IV at 8:57 pm and Vancomycin (antibiotic) at 9:02 pm. Patient 6 was transferred from the ED to the Tele unit at 10:04 pm on 8/2/23. The Zosyn and Vancomycin had not been started prior to the transfer.

Upon further review of Patient 6's record, her condition declined and she was transferred to the ICU (intensive care unit) around 3 am on 8/3/23. The Zosyn was then started at 4:01 am. The Vancomycin order was discontinued by the pharmacist at 8:06 am who noted the dose had not been given according to the bedside nurse. A new order for Vancomycin was then written by the Infectious disease physician, on 8/3/23 at 9 am and started at 9:36 am.

During an interview on 8/8/23 at 9:40 am, the ICU Director (ICUD) said there had been a significant delay of antibiotics for a patient who was in ICU. She said Patient 6 had presented to the ED on 8/2/23, had sepsis and had an order for Vancomycin IV Now and another order for Zosyn around 9 pm. She confirmed the antibiotics had not been started in the ED before Patient 6 was transferred to the Tele unit or while she remained on the Tele unit. Zosyn was started shortly after Patient 6 was transferred to ICU. She said the physician was notified the next morning that the Vancomycin had not been started and he gave another order to start it that morning, which was done.

During a concurrent interview and record review on 8/9/23 at 8:25 am, ICUD confirmed Patient 6 had been transferred from the ED to Tele at 10 pm then transferred to ICU at 3 am. The pharmacist was not in-house and an automatic medication dispensing cabinet (Omnicell) was placed in room 304. Nurses were to notify the house supervisor (nurse in charge of the hospital on night shift) if a patient needed a medication and the house supervisor would get it from room 304. She said the antibiotic Zosyn, ordered at 8:57 pm on 8/2/23, was in the medicine cabinet in the offsite pharmacy room. She said the ICU charge nurse called the house supervisor to go to room 304 to get Zosyn and that was given 4:01 am on 8/3/23. ICUD said Vancomycin was ordered as 1 gram and that was not available in room 304. The doses available were 750 milligrams (mg) and 1500 mg. She said the ICU nurses knew the Vancomycin, as ordered, wasn't available in room 304 and the house supervisor should have called the on call pharmacist for this, as well as any other medication that was needed, if it was not available. She said she did not know why the house supervisor did not call the on call pharmacist.

ICUD was also the director of the Tele unit. She said she did not know why the antibiotics were not started while Patient 6 was in the Tele unit, but was told the antibiotics were delayed partly because Patient 6 only had two IV lines, and was receiving blood through one of them. Upon Patient 6's arrival to ICU, the first unit of blood was running, according to the nurse's note (the order was to give two units of blood), and then Zosyn started around 4 am, and she said that takes four hours to infuse. She said the policy for antibiotics for patients with sepsis was within 180 minutes of arrival in ED and that was not done, as there was a definite delay in several places including the ED, Tele and ICU to a lesser extent.

During a concurrent interview and record review on 8/9/23 at 9:30 am, the Director of Performance Improvement (DPI) said the ED has Vancomycin 1 gram in their Omnicell. She said the first unit of blood was not started until 1:57 am on 8/3/23 while Patient 6 was on the Tele unit, so she had an available IV line to start antibiotics. DPI said the Tele nurses should have called the house supervisor to get the antibiotics. If lack of IV access was an issue then the mid-level provider in the ED should have escalated this to the supervising ED physician or the Hospitalist should have asked the ED physician to put in a central venous line (catheter placed into a large vein for IV access to give fluids, blood, and medications).


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2. A review of the Lispro and Glargine insulin manufacture's insert indicated that Lispro and Glargine are a type of medicine that helps people with diabetes keep their blood sugar at a healthy level. Lispro and Glargine subcutaneous administration (given as a shot under the skin) should be given in different places on the body like the stomach, thigh, upper arm, or buttocks. It is important to rotate (change where the shot is given each time) the injection site so that the skin stays healthy. This is because long-term use of Lispro and Glargine insulin can cause lipodystrophy at the site of repeated insulin injections. Lipodystrophy is a disorder that affects how the body accumulates and stores fat.

During a concurrent observation amd interview on 8/09/23, at 11 AM, ICU Nurse Supervisor acknowledged that there were instances where nurses did not rotate the injection site for subcutaneous injections. She also acknowledged that repeated injections in one site could contribute to adverse drug reactions.

A review on 8/09/23 of Patient 21's Medication Administration Record (MAR) revealed a failure to rotate the insulin administration sites by different nurses. The following injection sites were not rotated as follows:
*On 8/8/23 at 1:10 PM, 17 units of insulin human Lispro were administered on the left abdomen.
*Subsequently, on the same day at 6:29 PM, 16 units of insulin human Lispro were again administered on the left abdomen.

A review on 8/09/23 of Patient 5's Medication Administration Record (MAR) revealed a failure to rotate the insulin administration sites by different nurses. The following injection sites were not rotated as follows:
*7/23/23: injected in the right abdomen.
*7/24/23: Next dose given in the right abdomen.
*7/31/23: injected in the left abdomen.
*8/1/23: Next dose given in the left abdomen.
*8/4/23: injected in the right abdomen.
*8/5/23: Next dose give in the right abdomen.
*8/5/23: Same day next dose injected in the right abdomen.
*8/8/23: injected in the left arm.
*8/8/23: Same day next dose injected in the left arm.