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The Condition of Participation: Quality Assessment and Performance Improvement (QAPI) Program was not met; based on document review and interviews the Hospital failed to demonstrate effective QAPI activities following Patient #1's adverse patient event; Patient #1 experienced a hypoglycemic (low blood sugar) event requiring cardio-pulmonary resuscitation (CPR) approximately one- and one-half hours after receiving Insulin.

Findings included:

1.) The Hospital Quality Assessment & Performance Improvement (QAPI) Program failed for one patient (Patients #1) in a sample of ten (10) patients to ensure that QAPI activities thoroughly analyzed Patients #1's adverse patient event and the Hospital failed to ensure QAPI activities monitored the effectiveness QAPI activities including the safety of Nursing Services in the administration of Insulin.

Refer to TAG: A-0273.

2.) The Hospital Quality Assessment & Performance Improvement (QAPI) Program failed for five patients (Patients #2, #3, #6, #7 & #9) in a sample of ten (10) patients to ensure the Hospital used data collected to identify opportunities for improvement and changes that would lead to improvement regarding the administration of Insulin, a high-risk, high-volume, problem-prone medication, following Patient #1's adverse patient event and their Electronic Medical Record computer system changes following 4/1/2022 (as the corrective action regarding Patient #1's adverse patient event) and take action(s) aimed at performance improvement.

Refer to TAG: A-0283.

3.) The Hospital Governing Body failed for six (6) patients (Patients #1, #2, #3, #6, #7, #9) to ensure the Medical Staff, and Administrative Executives were responsible and accountable for a Quality Assessment and Performance Improvement (QAPI) Program that was maintained (as effective) and all improvement activities were evaluated.

Refer to TAG: A-0309.

Based on records reviewed and interviews, the Hospital Quality Assessment & Performance Improvement (QAPI) Program failed for one patient (Patient #1) in a sample of ten (10) patients to ensure QAPI activities demonstrated a thorough investigation that included a thorough analysis of Patients #1's adverse patient event (Serious Safety Event); the Hospital failed to ensure QAPI activities monitored the effectiveness QAPI activities including the safety of Nursing Services in the administration of Insulin.

Findings included:

The History and Physical, dated 1/26/2022, indicated Patient #1 had a history of Diabetes treated with Insulin and admitted to the Hospital at 7:43 P.M. on 1/26/2022.

A Doctor's Order, dated at 10:29 P.M. on 1/26/2022, indicated an order for Fingerstick Blood Sugar (Point of Care Test, POCT) to be obtained at 7:00 A.M.

A Doctor's Order, indicated Registered Nurse (RN) #1 acknowledged, at 11:07 on 1/26/2022, fingerstick Blood Sugar before each meal prior to insulin dose and at bedtime, Before Meals (AC) and Hours of Sleep (HS).

The Medication Administration Record, dated 1/27/2022, indicated Patient #1 received Insulin at 7:04 A.M. on 1/27/2022.

The Nursing Note, dated at 9:38 A.M. on 1/27/2022, indicated an RN observed Patient #1 sleeping at 7:30 A.M., and at 8:45 a Clinical Care Technician (CCT) notified the RN that Patient #1 looked to be having a seizure, RN #1 evaluated Patient #1 to be unresponsive with no pulse; resuscitation efforts were started, and Patient #1 was transferred to the Intensive Care Unit.

A.) Regarding Analysis:

The document titled Quality and Patient Safety Plan, dated 2022, indicated the following:

-the event investigation included Risk Management, Team Leader, Administrative were responsible for an effective in-depth review and analysis that included conducting interviews and understanding the context in which the event took place, and reviewing all pertinent records.

-a Root Cause Analysis was held when there was a Serious Safety Event to identify underlying problems that increased the likelihood of errors while avoiding the trap of focusing on mistakes by individuals, it used the systems approach to identify both active and latent errors.

During the interview, at 10:30 A.M. on 8/18/2020, Risk Manager #1 said:

-she conducted the interviews,

-the CCTs did the POCT and it was unknown if the glucometer (POCT machine) was not docked or if there was a problem with the flow of the POCT result to the Electronic Medical Record (EMR),

-the 7:00 A.M. RN of 1/27/2022 (RN #1) saw the last blood sugar result in the EMR as 190 and gave the Insulin; at 8:40 A.M. a code (emergency) was called and Patient #1 was obviously hypoglycemic.

-this was an actual RN error because the evening before, on 1/26/2022, Patient #1's blood sugar was 190 (high),

-the Hospital conducted an investigation, it remained unknown why a POCT was not resulted in Patient #1's EMR (prior to RN #1 administering Insulin),

-the Hospital did not evaluate (investigate) glucometers (issues regarding POCT's resulting into the EMR) Hospital-wide.

The Solutions Plan, dated 5/3/2022 indicated the Hospital's QAPI corrective actions regarding Patient #1's adverse patient event. The Solutions Plan included the following issues identified:

-a new nurse saw documentation of 190; was the reading from the night before, not the morning (that was the nurse read the blood sugar of 190 as the last blood sugar prior to administration of Insulin at 7:04 A.M. and in actuality the blood sugar of 190 was from the prior night at approximately 10:00 P.M.).

1.) QAPI activities failed to ensure analysis Clinical Care Technician (CCT) staffing and assignment.

During the interview, at 10:30 A.M. on 8/18/2020, the Nurse Director #1 said the CCTs were responsible for obtaining POCT, there was one CCT for the Patient Care Unit that night of 1/26/2022 to 1/27/2022 and it was not known how many POCT CCT #1 was responsible to obtain.

2.) QAPI activities failed to ensure analysis, why it remained unknown, that there was not a Before Meal POCT resulted in Patient #1's EMR at the time RN#1 administered Insulin at 7:04 A.M. on 1/27/2022.

During the interview, at 10:30 A.M. on 8/18/2020, the Nurse Director #1 said it was not known the time the glucometer was docked and that Patient #1's POCT was not there (that is there was no Before Meal POCT in Patient #1's EMR for before Patient #1's 7:04 Insulin injection.

During the interview at 9:00 A.M. on 1/19/2022, Clinical Care Technician #1 said Before Meal POCT's were always done by the day shift CCT.

3.) QAPI activities failed to ensure an interview with the CCT working on the day shift of 1/27/2022.

4.) QAPI activities failed to ensure the investigation inquired about the CCTs documentation of POCT completion using the EMR generated worksheet in order to discover potential monitoring tools for compliance.

During the interview at 12:00 P.M. on 8/19/2022, the Associate Chief Nursing Officer (ACNO) #1 said the CCTs were expected to check POCTs to be done using the new EMR computer system worklist implemented on 4/1/2022.

5.) QAPI activities failed to ensure analyzing the functionality of the POCT transmission (including Wi-Fi, wireless transmission of the POCT) from the glucometer to the EMR.

During the interview, at 8:50 A.M. on 8/19/2022, Risk Manager #2 said the glucometer connected with the Hospital Wi-Fi and transmitted the POCT to a Patient's EMR although the Wi-Fi had sketchy transmission.

During the interview, at 9:30 A.M. on 8/19/2022, Registered Nurse (RN) #1 said she did not know how the POCT Wi-Fi worked.

During the interview, at 9:30 A.M. on 8/23/2020, the Informatics Navigator said and confirmed that glucometer POCTs resulted immediately and directly through Wi-Fi to the EMR.

The Hospital demonstrated no clear or consistent knowledge regarding POCT transmission to the EMR.

6.) QAPI activities failed to ensure analysis of Nursing Services in the delivery of care regarding POCT before Insulin administration.

The document titled Quality and Patient Safety Plan indicated this plan was designed to measure key processes and outcomes in order to understand and ensure the reliability of systems and processes, to prioritize improvement of systems of processes. Refer to the Condition of Participation: Nursing Services, TAG: A-0385.

7.) QAPI activities failed to ensure analysis of Pharmacy assigning Insulin administration times.

Refer to TAG: 0392.

B.) Regarding Monitoring:

The document titled Quality and Patient Safety Plan indicated measurement was conducted to establish reliability of process, identify opportunities for improvement, and to evaluate clinical and organizational performance.

-a Solutions Meeting (an aspect of the event analysis, Root Cause Analysis) responsibility was to develop solutions for the contributing factors to the event and determine appropriate measurement strategies.

-Follow-up meetings were scheduled at thirty-day intervals to ensure compliance and effectiveness of the implemented solutions to critical contributing factors.

The Solutions Plan, dated 5/3/2022 indicated the Hospital's QAPI corrective actions regarding Patient #1's adverse patient event. The Solutions Plan interventions (corrective actions) included

-Education to staff at safety huddles as completed, however the Hospital provided no documentation that the education was completed Hospital-wide.

-the new Electronic Medical Record (EMR) computer system, implemented on 4/1/2022, included views of laboratory results defaulted to four hours. The Solutions Plan indicated that measurement was completed on 4/2/2022, with the implementation of the new EMR computer system.

-the Solutions Plan indicated identified interventions the Hospital intended to implement in order to reduce the risk of similar events occurring in the future. The plan should address pilot testing as appropriate and strategies for monitoring the effectiveness of the interventions.

During the interview, at 10:30 A.M. on 8/18/2020, the Risk Manager #1 said
the Hospital did not monitor for compliance.

During the interview at 12:00 P.M. on 8/19/2022, the Associate Chief Nursing Officer #1 said she the Pharmacy now changed the Insulin times to 8:00 A.M., 12:00 P.M. and 6:00 P.M.

The Solutions Plan indicated no indication of the Pharmacy intervention to alter Insulin times (indicating QAPI activities and Nursing Services were non thoroughly integrated).

The Hospital provided no documentation of Solutions Meetings or Follow-Up meetings in accordance with their Quality and Patient Safety Plan.

The Hospital provided no documentation to indicate monitoring the effectiveness of the Solutions Plan prior to the Survey.

The document titled POCT Task Compliance, dated 8/22/2022 during the Survey, indicated eight Patient Care Units where POCT was performed. The POCT Task Compliance indicated four Patient Care Units were not in compliance (with POCT comparison of the medical order for Insulin that included POCT requirements to the actual POCT result in the EMR).

Based on records reviewed and interviews, the Hospital Quality Assessment & Performance Improvement (QAPI) Program failed for five patients (Patients #2, #3, #6, #7 & #9) in a sample of ten (10) patients to ensure the Hospital used data collected to identify opportunities for improvement and changes that would lead to improvement regarding the administration of Insulin, a high-risk, high-volume, problem-prone medication, following Patient #1's adverse patient event and their Electronic Medical Record computer system changes following 4/1/2022 (as a corrective action regarding Patient #1's adverse patient event) and take action(s) aimed at performance improvement.

Findings included:

The document titled Quality and Patient Safety Plan, dated 2022, indicated the Hospital established priorities for performance improvement that was based on high-volume, high-risk, problem-prone patient experience.

The Hospital policy titled High-Alert Medications Safe Practices, dated 11/5/2019, indicated the administration of all types of Insulin required blood glucose level monitoring.

The Hospital Report, 5/17/2022 through 8/17/2022, indicated two (2) reports regarding Insulin with aspects similar to Patient #1's adverse patient event, Patient #2, dated 7/12/2022 and Patient #3, dated 7/31/2022; three (3) months the implementation of the new Electronic Medical Record (EMR) computer system.

Regarding Patient's #2 and #9: Point of Care Testing.

Patient #2:

The History and Physical, dated at 3:39 A.M. on 6/17/2020, indicated Patient #2 had a history of Diabetes, treated with Insulin and admitted to the Hospital.

The Hospital report, dated 7/12/2022, indicated a Physician wanted to know why Patient #2 crashed (undefined) the previous shift. The Report indicated Insulin was given with the most recent fingerstick (Point of Care Test for a blood sugar level) one and one-half hours prior instead of 30ish minutes; Patient #2 had a blood sugar of 90 and the sliding scale (the progressive increase in the pre-meal or nighttime insulin dose, based on pre-defined blood glucose results) order for Insulin was held; however, the standing order for Insulin was given; and Patient #2 crashed to a blood sugar of 35 (very low) requiring intravenous glucose (sugar) administration to increase Patient #2's blood sugar. The Hospital Report indicated the following investigation information. The RN did not know why she did not re-check the blood sugar prior to giving Insulin and lack of experience, stress and heavy workload led to the event. The Report indicated the probability of this recurring was occasionally and the Report indicated no recommendations. The Report indicated the case was closed.

A Doctor's Order, dated at 6:00 P.M. on 6/21/2022, indicated an order for Insulin to be administered three times a day with meals (standing order).

The Hospital provided no documentation to indicate QAPI activities tracked for monitoring this event considering the like aspects of Patient #2 & #9's POCT experiences to Patient #1's POCT experience seven months prior.

Patient #9:

Medical Record review, dated 8/18/2022, indicated the morning before meal POCT was not recorded in Patient #9's EMR.

Regarding Patients #3, #6, #7: Potentially confusing Insulin orders.

Patient #3:

The Admission History and Physical, dated 7/31/2022, indicated an obstetric patient (Patient #3) with a history of Diabetes treated with Insulin.

The Hospital report dated, 7/31/2022, indicated an Insulin order for Breakfast and Dinner with a sliding scale three times a day. The Registered Nurse (RN) interpreted the Insulin order for three time a day to be given at lunch. The Report indicated, inclusion of the RN's note which indicated Insulin orders for 7/31/2022 were confusing with multiple Insulin orders and that active orders were (mixed) in between the discontinued orders (in the Electronic Medical Record). The Report indicated that the RN may not have made the error if the "Brain" (EMR computer system generated worksheet) was configured to flag only active orders. The Report indicated the case was both open and closed.

The Hospital provided no update on the resolution of Patient #3's event.

Patient #6:

The History and Physical, dated 8/17/2022, indicated Patient #6 with a history of Diabetes treated with Insulin.

Insulin orders, dated 8/17/2020 through 8/20/2022, indicated a sliding scale, four times a day and nightly (Was Patient #6 to receive Insulin four or five times a day?)

Regarding Patient #7:

Insulin orders, dated at 8:30 A.M. on 8/15/2022, indicated Insulin four times daily with meals and nightly (Was Patient 7 to receive Insulin four or five times a day?)

The Hospital provided no documentation to indicate clarity on Insulin orders.

Based on records reviewed and interviews, the Hospital's Governing Body failed for six (6) patients (Patients #1, #2, #3, #6, #7, #9) to ensure the Medical Staff, and Administrative Executives were responsible and accountable for a Quality Assessment and Performance Improvement (QAPI) Program that was maintained (as effective) and all improvement activities were evaluated.

Findings included:

The document titled Quality and Patient Safety Plan, dated 2022, indicated:

-the Patient Care Assessment Committee (a Governing Body level committee) was responsible for review and analysis of incidents (adverse patient events) and patterns that affect quality of patient care and make recommendations for performance improvement activities, and

-the Board of Trustees (Governing Body), Senior Leadership, and Medical Staff Leadership established priorities for performance improvement that was based on high-volume, high-risk, problem-prone patient experience.

Medical Record Reviews regarding Patient's #1, #2, #3, #6, #7, #9, indicated Patient's with a history of Diabetes treated with Insulin.

During the interview, at 10:30 A.M. on 8/18/2020, the Risk Manager #1 said
the Hospital did not monitor for compliance, following Patient #1's adverse patient event on 1/27/2022, for compliance with POCT resulting in the EMR prior to Insulin administration.

Hospital Report, 5/17/2022 through 8/17/2022, indicated two (2) reports regarding Insulin with aspects similar to Patient #1's adverse patient event, Patient #2 dated 7/12/2022 and Patient #3 dated 7/31/2022; three (3) months after implementation of the new Electronic Medical Record (EMR) computer system, clearer laboratory results of POCT and Blood Sugar results were implemented as a corrective action following Patient #1's adverse patient event.

Medical Record Reviews regarding Patients #6, #7, #9 indicated aspects similar to the RN report of Patient #3 regarding confusing Insulin orders.

The Hospital provided incomplete QAPI activities to investigate events related to Insulin events. Refer to TAG: 0385.

The Condition of Participation: Nursing Services was not met. Based on records reviewed and interviews, the Hospital failed to demonstrate an organized nursing service in nursing delivery and administration of Insulin. Nursing Services failed to demonstrate effective nursing integration into the Hospital-wide Quality Assessment & Performance Improvement Program for the analysis of Nursing Services regarding Insulin administration.

Findings included:

1.) Nursing Services failed for two (2) patients (Patient #1 & #9) to ensure Patient #1 & #9's needs were met to include a Point of Care Test (POCT), blood sugar test prior to Patient #1 receiving Insulin.

Refer to TAG: 0392.

2.) Nursing Services failed for one patient (Patient #1) to ensure a clear and House-wide process for Registered Nurses assigning the nursing care regarding Point of Care Testing (POCT) for blood sugar tests to other nursing personnel (Clinical Care Technician, CCT) in accordance with patient's needs and competence.

Refer to TAG: 0397.

Nursing Services failed for two (2) patients (Patient #1 & #9) to ensure Patient #1 & #9's needs were met to include a Point of Care Test (POCT, fingerstick blood sugar test) prior to Patient #1 receiving Insulin.

Findings included:

The Hospital policy titled High-Alert Medications Safe Practices, dated 11/5/2019, indicated the administration of all types of Insulin required blood glucose level monitoring.

Regarding Patient #1:

The Hospital Report, dated 2/3/2022, indicated an RN administered Patient #1 Insulin for a blood sugar result, that was read as a before meal result, of 190 mg. dL. The actual before meal blood sugar was not documented in the Electronic Medical Record; Patient #1 experienced a hypoglycemic (low blood sugar) event requiring cardio-pulmonary resuscitation (CPR) approximately one- and one-half hours after receiving the Insulin.

During the interview at 9:00 A.M. on 1/19/2022, Clinical Care Technician #1 said Before Meal (AC) POCTs were always done by the day shift Clinical Care Technician (CCT).

During the interview at 9:30 A.M. on 8/19/2022, Registered Nurse (RN) #1 said it was routine practice for the night nurse to administer the 7:00 A.M. Insulin injection.

During the interview at 12:00 P.M. on 8/19/2022, Associate Chief Nursing Officer (ACNO) #1 said RN #1 administered Patient #1 Insulin at 7:04 A.M. on 1/27/20220, because Patient #1 had breakfast in from of him/her. Associate Chief Nursing Officer #1 said the Pharmacy assigned the times of 7:00 A.M. for the Breakfast Meal, 11:00 A.M. for the Lunch Meal and 5:00 P.M. for the Evening Meal and 10:00 P.M. for Bedtime. The Associate Chief Nursing Officer #1 said it remained unknown why a Before Breakfast POCT was either not done or resulted in Patient #1's Electronic Medical Record (EMR). The ACNO said the CCTs were expected to check POCTs to be done using the new EMR computer system worklist implemented on 4/1/2022. The ACNO she did not know if the CCT's used the EMR generated worksheet (collection of these documents could assist in monitoring compliance following Patient #1's adverse event). The ACNO said the Hospital was not monitoring (for compliance with this expectation).

The document titled POCT Task Compliance, dated 8/22/2022 during the Survey, indicated eight Patient Care Units where POCT was performed. The POCT Task Compliance indicated four Patient Care Units were not in compliance (with POCT comparison of the medical order for Insulin that included POCT requirements to the actual POCT result in the EMR).

Regarding Patient #9:

Medical Record review, dated 8/18/2022, indicated the morning before meal POCT was not recorded in Patient #9's EMR.

Nursing Services failed for one patient (Patient #1) to ensure a clear and House-wide process for Registered Nurses assigning (delegating) the nursing care regarding Point of Care Testing (POCT) for blood sugar tests to other nursing personnel (Clinical Care Technician, CCT) in accordance with patient's needs and competence.

Findings included:

The Professional Registered Nurse Job Description, dated 7/2013, indicated the RN delegated responsibilities to others with an understanding of their roles, knowledge and capabilities.

The Hospital policy titled High-Alert Medications Safe Practices, dated 11/5/2019, indicated the administration of all types of Insulin required blood glucose level monitoring.

During the interview at 9:00 A.M. on 1/19/2022, Clinical Care Technician #1 said she knew what patients required POCT from the report she received from the CCT of the prior shift and documented completion on her own generated worksheet.

During the interview at 4:00 P.M. on 8/23/3033, Registered Nurse #1 said that the CCT's know the need to obtain a POCT on a patient by the Sign on the Door. Registered Nurse #1 said that either the day shift or the night shift CCT obtained patient POCTs.

The Point of Care Testing Door Sign, dated 8/23/2022, indicated a patient required Every Before Meal (QAC) and Every Hours of Sleep (QHS, at Bedtime) finger sticks.

The Point of Care (POCT) Educational Module, dated 1/4/2022, indicated no documentation that a Before Meal (AC) POCT was required thirty (30) minutes prior to the meal.

During the interview at $:15 P.M. on 8/23/2022, Registered Nurse #2 said the night shift CCT obtained the POCT for a 7:00 A.M. patient's meal.

The Hospital provided no documentation nor interview to indicate guidelines for before meal POCT or Hospital-wide use of the Door Sign.

The Hospital provided no policy, procedure, guideline to clearly demonstrate Nursing Services delivery of care regarding Point of Care Testing (POCT) to monitor blood glucose levels in accordance with an Insulin order. The Hospital provided no documentation to ensure, House-wide, Registered Nurses responsibility to assign (delegate) blood sugar Point of Care Testing to Clinical Care Technicians.