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Tag No.: A0263
Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.21 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 document review and interviews, the facility failed to identify opportunities for improvement and changes focused on high-risk, high-volume, or problem-prone areas. Specifically, the facility failed to consider the incidence, prevalence, and severity of problems in those areas. The facility failed to take actions aimed at performance improvement in two of three patient records reviewed of patients with Patient Safety Events. (Patients #1 and #9)
Tag No.: A0286
Based on document review and interviews, the facility failed to identify opportunities for improvement and changes focused on high-risk, high-volume, or problem-prone areas. Specifically, the facility failed to consider the incidence, prevalence, and severity of problems in those areas. The facility failed to take actions aimed at performance improvement in two of three patient records reviewed of patients with Patient Safety Events. (Patients #1 and #9) (Cross-reference A395)
Findings include:
Facility policy:
The Patient Safety Event Reporting/Sentinel Event Management Policy read, the purpose was: to guide in the identification and intensive assessment of Sentinel Events in order to improve patient care, treatment, and services and to reduce their probability of recurrence; to have a positive impact in improving patient care, treatment, and services and in preventing unintended harm, and; to increase the general knowledge about patient safety events, their contributing factors, and strategies for prevention. Adverse events are defined as a Patient Safety Event (PSE) that resulted in harm to a patient. Harm to a patient is defined by any physical or psychological injury or damage to the health of a person, including both temporary and permanent Harm. PSE is defined as an event, incident, or condition that could have resulted or did result in harm to a patient. Reviewable sentinel events are defined as the subset of sentinel events that is subject to review by accrediting bodies including any occurrence that meets any of the following criteria: the event has resulted in an unanticipated death or major permanent loss of function not related to the natural course of the individual's condition.
References:
The facility's Patient Safety Excellence Committee 2023 Charter read, the facility's Patient Safety Excellence Committee (PSEC) is responsible to provide oversight on Risk and Feedback electronic occurrence reporting events, review identified patient safety and 2nd level grievance events, and make informed suggestions for patient safety improvement efforts. The committee consists of the following members: Director of Clinical Risk Management, Manager of Patient/Caregiver Safety, Chief Medical Officer (CMO), Chief Operating/Nursing Officer (COO/CNO), Associate Chief Nursing Officer (ACNO), Chief of Staff (MD), Medical Director of Emergency Services (MD), Director of Quality (RN), Director of Critical Care Nursing (RN), Director of Acute Care Nursing (RN), Director of Emergency Department, Patient/Caregiver Safety Manager, Regulatory Manager, Pharmacist, Nursing Professional Development (RN). The corporation is committed to excellence in improving organizational performance, quality, and patient safety. Performance improvement encompasses all aspects of the organization, the way services are provided; the effectiveness of our care; enhancements in safety and reduction of harm to staff, patients, providers, visitors, and volunteers. The Performance Excellence Plan provides the framework for leaders to further the mission and achieve our vision. Structures and processes are monitored, assessed, and improved in the provision of quality care and services throughout the facility.
The Joint Commission Sentinel Event Policy read, The Joint Commission adopted a formal Sentinel Event Policy in 1996 to help hospitals that experience serious adverse events improve safety and learn from those sentinel events. A sentinel event is a patient safety event (not primarily related to the natural course of the patient's illness or underlying condition) that reaches a patient and results in any of the following: death, permanent harm, or severe temporary harm. An event is also considered a sentinel event if a fall resulting in any of the following: any fracture; surgery, casting, or traction; required consult/management or comfort care for a neurological (e.g., skull fracture, subdural or intracranial hemorrhage) or internal (e.g., rib fracture, small liver laceration) injury; a patient with coagulopathy who receives blood products as a result of the fall; or death or permanent harm as a result of injuries sustained from the fall (not from physiologic events causing the fall). All sentinel events must be reviewed by the hospital and are subject to review by The Joint Commission. Accredited hospitals are expected to identify and respond appropriately to all sentinel events (as defined by The Joint Commission). The product of the comprehensive systematic analysis is a corrective action plan. The identified actions should eliminate or control system hazards or vulnerabilities that have been identified by the comprehensive systematic analysis.
1. The facility's quality program failed to identify and implement preventative and performance improvement measures to prevent the recurrence of patient care concerns regarding nursing services. Specifically, the facility failed to ensure patients who required blood glucose monitoring, vital sign monitoring, fall precautions, and telemetry monitoring were treated per physician orders, facility protocol, policy, and national guidelines.
A. On 4/6/23, an immediate jeopardy was declared under the condition of Nursing Services regarding the care of patients. The facility was unable to provide evidence patient safety concerns for Patient #1 were identified and addressed prior to the survey. Further review revealed the PSEC committee reviewed the care received and care outcomes of Patients #1 and #9 and determined no preventable patient safety concerns were identified and no further action was necessary.
i. Review of Patient #1's medical record and interviews with staff revealed leadership staff reviews of the patient's medical record did not address missed blood glucose assessments. In addition, the facility had identified a concern with not assessing blood glucose levels in accordance with physician's orders; however, the quality program failed to ensure interventions put in place to improve compliance were successful.
a. Patient #1 was admitted on 12/30/22 at 9:12 p.m. for knee pain. She had a history of Type 1 diabetes and was diagnosed with DKA (occurs when the body starts breaking down fat which is converted into a fuel called ketones, which causes the blood to become acidic) while in the ED. During her stay, Patient #1 had multiple missed blood glucose assessments in accordance with physician's orders (Cross-reference A-0395). For example, three missed blood glucose checks with an ordered frequency of every four hours were identified from 12/31/22 at 8:50 p.m. to 1/1/23 at 8:16 a.m. On 1/1/23 at 8:16 a.m., Patient #1's blood glucose level was assessed and found to be 37, a panic value (lab values that fall outside the normal range to a degree that may constitute an immediate health risk to the individual or require immediate action on the part of the ordering physician). A Rapid Response/Code Blue Note written by a registered nurse (RN) at 9:26 a.m. read, at approximately 8:00 a.m. on 1/1/23, a patient care technician (PCT) checked Patient #1's blood sugar (which was low at 37), then notified two of the RNs. At this time, the patient was unresponsive, displayed decorticate posturing (a sign of severe damage to the brain where the person had a specific type of involuntary abnormal posturing), and had agonal breathing (an abnormal breathing pattern characterized by labored breaths and gasping). The patient was transferred to the intensive care unit (ICU) where she further decompensated. Patient #1 was intubated (the placement of a flexible plastic tube into the trachea to maintain an open airway), and ultimately died.
b. Interviews were conducted on 4/6/23 at 9:28 a.m. and at 12:20 p.m. with nurse manager (Manager) #5, who was the manager of the unit where Patient #1 experienced the change of condition on 1/1/23. Manager #5 stated Patient #1's case was initially reviewed by the unit safety huddle, consisting of Manager #5, the charge nurse, and nursing staff involved with the patient's care. Manager #5 stated Patient #1's case was selected for review because it occurred quickly, unexpectedly, and the patient was transferred emergently. Manager #5 stated there were no concerns identified during the safety huddle regarding glucose monitoring. Manager #5 stated Patient #1's medical record was then escalated to the Patient Safety Excellence Committee (PSEC) for review due to her overall rapid change in condition. Manager #5 stated no patient care concerns were identified from the review done by PSEC.
c. Interviews were conducted on 4/10/23 at 12:36 p.m. and at 2:01 p.m. with director of quality (Director) #18. Director #18 stated the PSEC reviewed patient cases any time an event with potential harm to a patient occurred. Director #18 stated patient safety concerns and care concerns related to the review of Patient #1's care which preceded her death were not identified during the PSEC review on 1/10/23. Director #18 then stated Patient #1's case was resubmitted for review by the safety and quality committee as a result of areas of improvement not identified prior to the survey. Director #18 verified the Performance Excellence Plan, Patient Safety Excellence Committee charter, and The Patient Safety Event Reporting and Sentinel Event Management Policy were the guidelines and policy used in the quality and safety review process.
d. An interview was conducted on 4/6/23 at 2:13 p.m. with chief medical officer (CMO) #8. CMO #8 stated he attended the PSEC meetings where patient safety cases were reviewed when he could. CMO #8 stated he did not participate when the PSEC reviewed Patient #1's record.
CMO #8's interview was in contrast to The Patient Safety Excellence Committee 2023 Charter which outlined the PSEC committee consisting of a multidisciplinary group of members which included the CMO.
e. An interview was conducted on 4/6/23 at 9:28 a.m. with chief nursing officer (CNO) #19. CNO #19 stated she had not participated in the PSEC review for Patient #1. CNO #19 stated she understood the patient died of liver failure and missed blood glucose checks were not identified in the safety and quality reviews conducted by the PSEC. CNO #9 stated while she was aware Patient #1's medical record was reviewed by the safety and quality department, she was not aware Patient #1 had missed blood glucose point of care testing (POCT) checks.
CNO #19's interview was in contrast to The Patient Safety Excellence Committee 2023 Charter which outlined the PSEC committee consisting of a multidisciplinary group of members which included the CNO.
CNO #19 then stated a hospital-wide nursing improvement plan regarding blood glucose monitor POCT accuracy auditing was initiated on 10/1/22 by the safety and quality department after a review of a critical finding was identified with a patient's missed POCT blood glucose test. CNO #19 further stated blood glucose hospital-wide audits were continued for six to nine months and were discontinued once a 97% compliance rate was met. CNO #9 stated continued compliance with blood glucose monitoring was assessed by monthly audits performed on three patient charts by nurses on each inpatient unit.
CNO #19's interview was in contrast with the blood glucose audits provided by the facility related to the nursing improvement plan titled Hypoglycemia Action Plan. The plan read daily audits of BG checks were to be conducted on all patients on the Hypoglycemia Protocol for all inpatient units; however, review of the audits revealed the oncology unit and the women's unit were not included in the audits. The plan also read the measurement for success would be 100% compliance with the Hypoglycemic Protocol for three consecutive months for inpatient units; however, the audits showed compliance was 98% in October 2022, 98% in November 2022, and 97% in December 2022. There was no evidence of the audit ever reaching 100% compliance.
f. An interview was conducted with medical doctor (MD) #7 on 4/6/23 at 9:04 a.m. MD #7 stated laboratory draws, blood glucose checks, and blood pressure checks were currently missed often on the inpatient units. MD #7 stated missed patient checks were attributed to lower staffing ratios at night and the high number of new staff.
ii. Review of Patient #9's medical record and interviews with staff revealed leadership staff reviews of the patient's medical record did not address missed and late blood pressure assessments, unanswered telemetry alarms, or identify the patient was at risk for a fall.
a. Patient #9 was admitted on 1/7/23 at 7:07 p.m. for treatment of hematuria (blood in the urine). Physician and nurse assessments identified Patient #9 had an extensive cardiac history. His blood pressure was elevated upon admission and remained high throughout his time at the facility. Patient #9's blood pressure was not assessed or monitored according to physician orders during this time. Patient #9 was on cardiac monitoring (telemetry) and alarms were sent to the telemetry monitoring staff five times on 1/8/23. There was no evidence in the medical record in which nursing staff responded to the multiple alarms or notified the physician that Patient #9 had abnormal telemetry readings.
Patient #9 was also on fall risk precautions, which included the need for help ambulating, activation of a bed and chair alarm, ensuring his door stayed open, and increased rounding (checking on patients). On 1/8/23, at approximately 5:45 p.m., RN #14 was performing her rounds and found Patient #9 unresponsive on the toilet, with a faint and rapid pulse, non-responsive to a sternal rub (the application of painful stimulus with the knuckles of a closed fist rubbing the center chest), with blood pressure in the 200s/100s, and having pinpoint pupils (pupils shrinking to a small size). Patient #9 was intubated (the act of inserting a breathing tube to assist with breathing) and then emergently taken to the Neuro Intensive Care Unit (ICU).
MD #16 documented that Patient #9 had injured his neck and had significant bruising and a hematoma (a pool of mostly clotted blood that forms in an organ, tissue, or body space, usually caused by a broken blood vessel that was damaged by surgery or an injury). The computed tomography (CT) Angiography Head and Neck (scan that assesses the head, neck, and arteries) results revealed Patient #9 had suffered an intracerebral hemorrhage with intraventricular hemorrhage (IVH) (bleeding inside or around the ventricles, the spaces in the brain containing the cerebrospinal fluid) and subarachnoid hemorrhage (SAH) (bleeding into the space between the surface of the brain and the arachnoid, one of the three coverings of the brain). Patient #9 was pronounced dead on 1/8/23 at 9:52 p.m.
b. An interview conducted with clinical risk director (Director) #9 on 4/11/23 at 11:28 a.m. Director #9 stated the PSEC reviewed Patient #9's medical record and found blood pressure trends were not concerning and the events which led to Patient #9's death had not identified a patient safety event.
c. An interview was conducted on 4/12/23 at 9:01 a.m. with Director #9 and nursing director (Director) #11. Director #9 stated Patient #9's unanswered telemetry alarm, which indicated ST elevation started 1/8/23 at 5:08 p.m., and ended at 5:49 p.m., with no prior pattern or alarm, was not included Patient #9's PSEC review. Director #9 stated the lack of inclusion of the telemetry alarm results in the safety review of the patient's case indicated a comprehensive review of the case was not completed which resulted in areas of improvement not being identified.
Director #9 stated further safety and quality review of Patient #9's record was not conducted because the initial review found a lack of evidence of trauma and lack of evidence a fall had occurred. Director #11 stated concerns related to falls were not included for review of the events which lead to Patient #9's death. Director #11 stated the facility's review established Patient #9 was identified as a fall risk after the intraventricular hemorrhage and subarachnoid hemorrhage were identified on 1/8/23 at 5:45 p.m., and he was admitted to the Neuro ICU.
This was in contrast to the medical record review, which revealed an order written by MD #15 on 1/8/23 at 12:20 a.m. and discontinued on 1/8/23 at 7:07 p.m., which stated Patient #9 was identified as a fall risk at the time the patient was admitted to the unit.
This was also in contrast to Patient #9's medical record review. MD #21 documented on 1/8/23 at 6:48 p.m., Patient #9 had a massive right basal ganglia hypertensive hemorrhage (hemorrhage of the basal ganglia is mostly unilateral and secondary to uncontrolled hypertension) with intraventricular hemorrhage (IVH).
Tag No.: A0385
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: A registered nurse must supervise and evaluate the nursing care for each patient. Based on document review and interviews, the facility failed to provide nursing services within recognized standards of practice and in accordance with facility policy when a patient experienced a change of condition. Specifically, the facility failed to ensure nursing staff provided nursing care and services related to blood glucose assessments, telemetry alerts, vital signs assessments, and fall precautions according to the patient's condition, physician orders, facility policies, and within recognized standards of practice in six of thirteen patient records reviewed (Patients #1, #6, #7, #8, #9, and #12).
Tag No.: A0395
Based on document review and interviews, the facility failed to provide nursing services within recognized standards of practice and in accordance with facility policy when a patient experienced a change of condition. Specifically, the facility failed to ensure nursing staff provided nursing care and services related to blood glucose assessments, telemetry alerts, vital signs assessments, and fall precautions according to the patient's condition, physician orders, facility policies, and within recognized standards of practice in six of thirteen patient records reviewed (Patients #1, #6, #7, #8, #9, and #12).
Findings include:
Facility policies:
The Adult Hypoglycemia (any blood glucose (BG) level of less than 70 mg/dL) Protocol read, perform blood glucose testing. Performed by registered nurse (RN), licensed professional nurse (LPN), and patient care tech (PCT). Guidance: the nursing staff is responsible for performing routine blood glucose tests as ordered by the physician. The nursing staff may perform a blood glucose test, if the patient exhibits signs and/or symptoms of hypoglycemia (e.g., dizziness, diaphoresis, headache, weakness, hunger, shakiness, rapid heartbeat, numbness around the lips, confusion, coma, visual disturbances) or per nursing judgment.
The Nursing Diabetic Ketoacidosis (DKA) (occurs when the body starts breaking down fat which is converted into a fuel called ketones, which causes the blood to become acidic) Protocol read, blood glucose management: Nurse to perform point of care testing (POCT) glucose while on insulin drip: Routine, every hour, one hour after insulin drip started, monitor one hour after every insulin drip change. Monitor every two hours if no insulin drip rate change for two consecutive hours. Nurse to perform POCT glucose once insulin infusion discontinued: Routine, every two hours. Once insulin drip discontinued, check glucose POCT every two hours times four hours, and then every four hours. Hypoglycemia Protocol routine until discontinued.
The Medication Management policy read, purpose: To ensure safe and accurate prescribing of medications based on order type; To define the licensed healthcare providers with the authority to administer medications in response to physician order or protocol; To ensure accurate and safe administration of medications, to ensure careful monitoring to determine whether the medications result in the therapeutically intended benefit, and to allow for early identification of adverse effects and timely initiation of appropriate corrective action. Policy: medications will be safely prescribed and administered with appropriate patient monitoring and assessment. Determine the type and frequency of monitoring based on an assessment of, but not necessarily limited to: The route/delivery method of the medication; The frequency of medication administration; The patient's prior history (if any) of receiving the medication and the patient's prior response to the medication; Factors that may place the patient at greater risk for adverse effects of medication; Clinical and laboratory data to evaluate the efficacy of medication therapy, to anticipate or evaluate toxicity and adverse effects; Physical signs and clinical symptoms relevant to the patient's medication therapy; Inherent risks of the medication including known/reported side effects, contraindications, and adverse reactions; The patient's purported response to the medication - including their experience of any side effects; Any monitoring recommendations established by the manufacturer of the medication.
The Assessment Time Frames by Department/Nursing Unit: Critical Care ICU (intensive care unit) policy read, within 10 minutes, start initial assessment and identify immediate needs. Complete initial assessment: highly recommended to be done by end of shift of admitting nurse but no greater than 12 hours. Assess physiological, psychological, social, spiritual and cultural needs. Complete all risk assessments: pain, nutrition, pressure ulcer, fall, functional. Consider discharge planning needs. Reassessment: Every four hours and as needed (PRN) as condition changes. Skin assessment every 12 hours. Pain as per policy. Repeat risk assessments and make appropriate referrals upon change in condition.
Telemetry/Step Down PCU (progressive step down unit) policy read, within 30 minutes, start initial assessment and identify immediate needs. Complete initial assessment: highly recommended to be done by end of shift of admitting nurse but no greater than 12 hours. Assess physiological, psychological, social, spiritual and cultural needs. Complete all risk assessments: pain, nutrition, pressure ulcer, fall, functional. Consider discharge planning needs. Reassessment: Complete the head-to-toe physical assessment once per 12 hour shift and complete a focused assessment as needed for any change in the patient's condition. Skin assessment every 12 hours. Pain as per policy. Repeat risk assessments and make appropriate referrals upon change in condition.
Observation Unit policy read, within one hour, start initial assessment and identify immediate needs. Initial assessment within four hours of patient arrival. Assess physiological, psychological, social, spiritual and cultural needs as determined by admitting diagnosis. Complete all risk assessments: pain, fall, functional. Consider discharge planning needs. Reassessment: Focused assessment once per 12 hour shift and as needed for any change in the patient's condition. Pain as per policy. Repeat risk assessments and make appropriate referrals upon change in condition.
1. The facility failed to ensure blood glucose checks and assessments were performed per policies and physician orders.
A. Document and medical record review revealed staff did not follow their policies or physician orders when assessing blood glucose levels. The Adult Hypoglycemia Protocol read, nursing staff was responsible for performing routine blood glucose tests as ordered by the physician. The Medication Management policy read, medications would be safely prescribed and administered with appropriate patient monitoring and assessment.
i. Patient #1's medical record was reviewed. Patient #1 was admitted on 12/30/22 at 9:12 p.m. for knee pain. She had a history of Type 1 diabetes and was diagnosed with DKA while in the ED. Patient #1 had a blood glucose level (the amount of glucose in the blood) of 609 (reference range according to the medical record was between 70-100).
a. On 12/30/22 at 10:20 p.m., the Provider Order revealed Patient #1 was ordered to be on the DKA Protocol and a continuous intravenous (IV) insulin drip with blood glucose levels assessed every hour. The order read if there was no consecutive change in the insulin drip rate for two hours, then the glucose level could be assessed every two hours, instead of every hour.
b. The review of the Medication Administration log revealed on 12/31/22, Patient #1's IV insulin drip rate was changed at 12:19 a.m., 4:04 a.m., and 6:25 a.m. However, Patient #1's blood glucose was not reassessed hourly as ordered. On 12/31/22 blood glucose point of care testing (POCT) results were recorded at 12:14 a.m., 1:35 a.m., 3:23 a.m., 5:15 a.m., 7:42 a.m., 8:33 a.m., 9:47 a.m.,10:57 a.m., and 11:38 a.m. There were three missed hourly blood glucose assessments. From 1:35 a.m. to 3:23 a.m., there was an hour and 48 minutes between assessments and from 5:15 a.m. to 7:42 a.m., there were two hours and 27 minutes between assessments.
c. On 12/31/22 at 12:35 p.m., Patient #1's blood glucose POCT check frequency was changed to every two hours for four hours then every four hours thereafter per the DKA protocol ordered on 12/30/22 at 10:20 p.m. Blood glucose POCT checks were recorded on 12/31/23 at 1:51 p.m., 4:25 p.m., and 8:50 p.m. and on 1/1/23 at 8:16 a.m. A late blood glucose POCT occurred on 12/31/22 from 1:51 p.m. to 4:25 p.m., as the check was 30 minutes late. Three missed blood glucose checks with an ordered frequency of every four hours were identified from 12/31/22 at 8:50 p.m. to 1/1/23 at 8:16 a.m.
d. On 1/1/23 at 8:16 a.m. (after three missed glucose checks), Patient #1's blood glucose level was assessed and found to be 37 (the normal reference range according to the medical record was between 70 - 100). The result of 37 was flagged as "LL", which indicated it was a panic value (lab values that fall outside the normal range to a degree that may constitute an immediate health risk to the individual or require immediate action on the part of the ordering physician).
e. A Rapid Response/Code Blue Note written by a registered nurse (RN) at 9:26 a.m. read, at approximately 8:00 a.m. on 1/1/23, a patient care technician (PCT) checked Patient #1's blood sugar (which was low at 37), then notified two of the RNs. At this time, the patient was unresponsive, displayed decorticate posturing (a sign of severe damage to the brain where the person had a specific type of involuntary abnormal posturing), and had agonal breathing (an abnormal breathing pattern characterized by labored breaths and gasping). The patient was transferred to the intensive care unit (ICU) where she further decompensated. Patient #1 was intubated (the placement of a flexible plastic tube into the trachea to maintain an open airway), and ultimately died.
ii. Patient #12's medical record was reviewed. Patient #12 was admitted on 3/2/23 at 10:43 a.m. for sepsis (the body's overwhelming and life-threatening response to an infection) and pneumonia (lung inflammation caused by an infection).
a. According to the Medication Administration Record (MAR), Patient #12 was given IV insulin on 3/2/23 at 1:44 p.m., in the ED for treatment of elevated potassium levels. Although this medication could lower blood glucose levels, there were no provider orders to assess Patient #12's blood glucose levels prior to administering the insulin.
b. On 3/2/23 at 5:28 p.m., a stat (without delay) glucose POCT was ordered. According to the Lab Results, the glucose level was not assessed until Patient #12 was admitted to the ICU at 6:46 p.m. (an hour and 18 minutes after it was ordered stat). When Patient #12's glucose level was assessed, it was 11 (the normal reference range according to the medical record was between 70 - 100). A blood glucose level of 11 was a critical or panic level. At 6:48 p.m., Patient #12's glucose level was reassessed and was 12.
c. On 3/2/23 at 8:00 p.m., a Provider Order read, blood glucose levels were to be assessed every hour for Patient #12. On 3/3/23, blood glucose POCT checks were recorded at 12:35 a.m. and 2:06 a.m. Review of Patient #12's blood glucose POCT checks revealed a blood glucose assessment was missed at 1:35 a.m.
d. A Provider Order written on 3/3/23 at 6:00 a.m., changed Patient #12's blood glucose POCT assessments from every hour to every two hours. On 3/3/23 blood glucose POCT checks were recorded at 5:53 a.m., 8:40 a.m., and 12:59 p.m. Review of Patient #12's blood glucose POCT checks during these times revealed two missed blood glucose checks, one between 5:53 a.m. and 8:40 a.m., and one between 8:40 a.m. and 12:59 p.m.
e. A Provider Order written on 3/3/23 at 12:00 p.m., changed Patient #12's blood glucose POCT checks from every two hours to every six hours. After this order was written, blood glucose POCT checks were recorded at 12:59 p.m. and 8:55 p.m. Review of Patient #12's blood glucose POCT checks during these times revealed one missed blood glucose check from 12:59 p.m. to 8:55 p.m.
f. On 3/4/23, Patient #12's blood glucose level was assessed at 6:19 a.m. Patient #12 still had provider orders to assess her blood glucose level every six hours. She was discharged at 2:34 p.m., eight hours and 15 minutes later, without staff assessing her blood glucose level another time.
iii. Additional record reviews revealed Patient #6, Patient #7 and Patient #8 also had provider orders for blood glucose levels to be assessed. The medical record review for these patients also revealed missed blood glucose assessments.
B. Interviews revealed RNs relied on PCTs to check blood glucose levels but would not notice if some were missed, which according to physician interviews, could lead to changes in patient condition and possibly death.
i. On 4/5/23 at 12:06 p.m., an interview was conducted with RN #3. RN #3 stated nurses followed provider orders for care, which included orders for blood glucose assessments. RN #3 stated she had a relationship with the PCTs which was built on trust. RN #3 stated she relied on the PCTs to perform blood glucose levels (checks) as ordered, but would not notice if blood glucose checks were missed on her patients during her shift. RN #3 stated blood glucose checks were important for patients because blood glucose levels could change rapidly and a low blood glucose level could lead to a coma or seizures for a patient.
ii. On 4/5/23 at 12:48 p.m., an interview was conducted with PCT #4. PCT #4 stated she performed blood glucose checks as part of her role. She stated blood glucose checks were sometimes missed because the order frequencies differed by floor or the PCTs were too busy to chart the blood glucose values. PCT #4 stated she communicated with the nurses when glucose checks were missed. PCT #4 stated she had previously communicated the issue of missing blood glucose checks to her manager who told her they would implement standard expectations for assessing blood glucose.
iii. On 4/6/23 at 8:48 a.m., an interview was conducted with nurse manager (Manager) #5. Manager #5 stated nurses and PCTs shared the responsibility of checking blood glucose levels. Manager #5 stated nurses were expected to monitor and ensure blood glucose checks were completed as ordered throughout their shift. She stated the risk of a missed blood glucose check was a change in patient condition, hypoglycemia (low blood glucose levels), diaphoresis (sweating), as well as confusion, which could lead to death.
Manager #5 stated she was not aware of any projects for improvement related to blood glucose monitoring. Manager #5 stated the quality team audited charts once or twice per week and had not identified any specific trends which required follow-up.
iv. On 4/6/23 at 9:04 a.m., an interview was conducted with medical doctor (MD) #7. MD #7 stated he provided care to Patient #1. MD #7 stated the risk of untreated high glucose levels included DKA or hyperosmolar hyperglycemic state (where very high blood sugar leads to severe dehydration and highly concentrated blood without the production of ketones). He stated failure to monitor blood glucose per provider orders could lead to missed opportunities to identify life threatening changes in condition. MD #7 stated the risk of the failure to monitor blood glucose orders per physician order included hypoglycemia, unresponsiveness, the heart stopping, stroke symptoms, and death.
MD #7 stated he had not been informed Patient #1 had missed blood glucose assessments on 12/31/22 and 1/1/23 before she experienced a change in condition.
2. The facility failed to ensure nursing staff responded to telemetry (heart monitoring) alarms to ensure patient safety.
A. Document and medical record review revealed staff did not follow their policies to assess changes in patient condition. This lack of assessment in response to a change in condition was in contrast with the Telemetry/Step Down PCU (progressive step down unit) policy which instructed nursing staff to complete the head-to-toe physical assessment once per 12 hour shift and complete a focused assessment as needed for any change in the patient's condition. The policy also instructed to repeat risk assessments and make appropriate referrals upon change in condition.
This was also in contrast with the Observation Unit policy which instructed to complete a focused assessment once per 12 hour shift and as needed for any change in the patient's condition. The policy instructed repeated risk assessment and appropriate referrals were required after a patient change in condition.
i. Patient #9's medical record was reviewed. Patient #9 was admitted on 1/7/23 at 7:07 p.m., for treatment of hematuria (blood in the urine).
a. Physician and nurse assessments identified Patient #9 had an extensive cardiac history which included atrial fibrillation (irregular heartbeat), endocarditis (inflammation of the membrane which lined the inside of the chambers of the heart and formed the surface of the valves), hypertension (high blood pressure), left bundle branch block (a condition which occurred when the electrical impulse that caused the heart to beat was blocked or disrupted), and an implanted pacemaker.
b. On 1/8/23 at 12:20 a.m., MD #15 ordered cardiac monitoring (telemetry).
c. A review of Patient #9's telemetry strips revealed alarms with ST elevations (abnormal reading from telemetry monitoring) were sent to the telemetry monitoring staff five times on 1/8/23. These alarms occurred at 5:08 p.m., 5:35 p.m., 5:43 p.m., 5:44 p.m., and 5:49 p.m.
d. There was no evidence in the medical record in which nursing staff responded to the multiple alarms. Additionally, there was no evidence nursing staff notified the physician Patient #9 had an abnormal telemetry reading.
e. The telemetry order was discontinued on 1/8/23 at 7:07 p.m.
f. RN #14 documented in her nursing note, at approximately 5:45 p.m., she was performing her rounds (checking on patients) and found Patient #9 unresponsive on the toilet, with a faint and rapid pulse. RN #14 documented although Patient #9 was breathing, he did not respond to a sternal rub (the application of painful stimulus with the knuckles of closed fist rubbing the center chest). Patient #9's blood pressure was in the 200s/100s and he was observed to have pinpoint pupils (pupils shrinking to a small size). RN #14 documented Patient #9 was intubated (the act of inserting a breathing tube to assist with breathing) and then emergently taken to the Neuro Intensive Care Unit (ICU).
g. On 1/8/23 at 5:51 p.m., MD #16 documented she responded to a code (a medical emergency including cardiac and or respiratory arrest) for Patient #9. She documented Patient #9 was sitting on the toilet, did not respond to verbal or painful stimuli, had pinpoint pupils, and had agonal breathing. MD #16 documented Patient #9 had injured his neck and had significant bruising and a hematoma (a pool of mostly clotted blood that forms in an organ, tissue, or body space, usually caused by a broken blood vessel that was damaged by surgery or an injury).
h. On 1/8/23 at 7:22 p.m., the computed tomography (CT) Angiography Head and Neck (scan that assesses the head, neck and arteries) results revealed Patient #9 had suffered an intracerebral hemorrhage with intraventricular hemorrhage (IVH) (bleeding inside or around the ventricles, the spaces in the brain containing the cerebrospinal fluid) and subarachnoid hemorrhage (SAH) (bleeding into the space between the surface of the brain and the arachnoid, one of the three coverings of the brain).
i. On 1/8/23 at 6:56 p.m., respiratory therapist (RT) #17 documented in a Respiratory Therapy Evaluation and Treatment Note Patient #9 had slumped over and hit his head on the wall in the restroom. RT #17 documented Patient #9 required resuscitation (the attempt to restart a person's breathing and/or heartbeat) and subsequent intubation.
j. On 1/9/23 at 7:20 a.m., MD #22 documented Patient #9 was pronounced dead on 1/8/23 at 9:52 p.m.
B. Interviews revealed alarms from the telemetry monitoring indicated a change in patient condition.
i. An interview was conducted on 4/12/23 at 9:01 a.m., with nursing director (Director) #11. Upon review of Patient #9's telemetry alarms, Director #11 stated the multiple alarms from the cardiac monitoring (telemetry), when there were no similar patterns in the past for this patient, and for which there was no documentation nursing staff assessed the patient, would have indicated a change in condition which was not assessed.
ii. An interview was conducted on 4/12/23 at 9:01 a.m., with clinical risk director (Director) #9. Director #9 stated Patient #9's telemetry changes, which started 1/8/23 at 5:08 p.m. and ended at 5:49 p.m., had not been part of Patient #9's quality case review. Director #9 stated the nursing staff could have improved the care provided to this patient. She also stated Patient #9's record should have progressed to a more in-depth review during the quality review meeting.
3. The facility failed to ensure vital signs were monitored per facility policies and provider orders.
A. Document and medical record review revealed staff did not follow physician orders when assessing vital signs.
i. Patient #1's medical record was reviewed. Patient #1 was admitted on 12/30/22 at 9:12 p.m., for knee pain. She had a history of Type 1 diabetes and was diagnosed with DKA. Patient #1's blood pressure assessment was ordered every four hours per Provider Order starting on 12/31/22 at 6:08 a.m. A review of her vital signs revealed a late blood pressure check on 1/1/23 at approximately 8:00 a.m., when the patient experienced a change in her condition.
a. On 1/1/23 at 3:28 a.m., the Vital Signs revealed her blood pressure was 102/81, her SpO2 (a measure of oxygen saturation) was 100%, and pulse rate (PR) was 103. At 4:11 a.m., no blood pressure was assessed, and her PR was 99. At 6:05 a.m., no blood pressure was assessed, her SpO2 had decreased to 92%, and her PR was 94. At 8:38 a.m., approximately five hours after the prior blood pressure was taken, Patient #1's blood pressure was documented at 57/42, PR was 93, and SpO2 was 78%.
b. A note titled Rapid Response/Code Blue written by an RN at 9:26 a.m. read, at approximately 8:00 a.m. on 1/1/23, a PCT notified two of the RNs Patient #1's blood sugar was below range. At this time, the patient was unresponsive, displayed decorticate posturing, and had agonal breathing. The patient was transferred to the ICU where she further decompensated (inability of the body to maintain function). Patient #1 was intubated and ultimately died.
ii. Patient #9's medical record was reviewed. Patient #9 was admitted on 1/7/23 at 7:07 p.m., for treatment of hematuria (blood in the urine).
a. On 1/7/23 at 7:01 p.m., a review of Patient #9's admission vital signs revealed an elevated blood pressure of 174/99. His blood pressure was not reassessed until five hours and 42 minutes later, on 1/8/23 at 12:43 a.m., when it was revealed to be 189/115, even higher than the previous reading.
b. On 1/8/23 at 12:30 a.m., Patient #9 was ordered to have vital signs, which included blood pressure, assessed every four hours.
c. Patient #9's blood pressure was assessed on 1/8/23 at 12:43 a.m., 8:40 a.m., 1:22 p.m., and 3:46 p.m. A gap was found in blood pressure checks from 1/8/23 at 12:43 a.m. to 8:40 a.m. when compared to the order requiring an assessment every four hours.
d. On 1/8/23 at 4:09 p.m., RN #14 documented in a nurse's note she notified the provider that Patient #9's blood pressure was outside of parameters (165/98 at 3:46 p.m.) and Coreg (a medication used to decrease blood pressure) was administered. RN #14 documented Patient #9's blood pressure would be rechecked and the patient would continue to be monitored.
e. At approximately 5:45 p.m., RN #14 documented in a note, she was performing her rounds and found Patient #9 unresponsive on the toilet, with a faint and rapid pulse. RN #14 documented although Patient #9 was breathing, he did not respond to a sternal rub. She documented Patient #9's blood pressure was in the 200s/100s and he was observed to have pinpoint pupils. RN #14 documented Patient #9 was intubated and then emergently taken to the Neuro ICU.
e. There was no evidence Patient #9's blood pressure was rechecked or the patient was monitored after RN #14 noted at 4:09 p.m. further assessment would be needed after having administered Coreg for a blood pressure measurement outside of parameters.
f. On 1/8/23 at 7:22 p.m., the CT Angiography Head and Neck results revealed Patient #9 had suffered an intracerebral hemorrhage with intraventricular hemorrhage and subarachnoid hemorrhage.
g. On 1/8/23 at 9:52 p.m., Patient #9 was pronounced dead.
B. Interviews revealed staff did not follow policy or physician orders when assessing vital signs which could have led to changes in patient condition.
i. On 4/6/23 at 8:24 a.m., an interview was conducted with RN #6. RN #6 stated vitals were assessed every four hours unless the doctor ordered a different frequency. She stated RNs assessed the patient while obtaining blood pressure measurements to validate the reading. RN #6 stated the risk of not assessing blood pressure as ordered could lead to unaddressed changes in condition including the heart stopping, an abnormal heart rhythm, or a stroke.
ii. On 4/5/23 at 12:06 p.m., an interview was conducted with RN #3. RN #3 stated when patients were admitted from the emergency department, the doctor documented orders for the patients. RN #3 stated the nurses followed the doctors' orders which included the frequency for blood pressure checks. RN #3 stated the standard practice for monitoring blood pressure was to check every four hours when the patient was assessed. RN #3 stated changes in condition due to uncontrolled blood pressure could include headache, mental status changes, and stroke symptoms.
iii. On 4/5/23 at 12:48 p.m., an interview was conducted with PCT #4. PCT #4 stated obtaining a patient's vital signs which included blood pressure checks, was part of her role. PCT #4 also stated the importance of checking blood pressure was to see how the patient's heart was functioning and to assess the effects of their medications.PCT #4 stated if blood pressure assessments were missed during her shift, she would inform the nurse.
iv. On 4/11/23 at 11:28 a.m., an interview was conducted with clinical risk director (Director) #9. Director #9 stated the Patient Safety Excellence Committee (PSEC) reviewed Patient #9's medical record and found blood pressure trends were not concerning and the events which led to Patient #9's death had not identified a patient safety event.
v. On 4/12/23 at 9:01 a.m., an interview was conducted with nursing director (Director) #11. After review of Patient #9's medical record, Director #11 verified the patient had a missing blood pressure assessment at 4:00 a.m.
vi. On 4/6/23 at 9:04 a.m., an interview was conducted with MD #7. MD #7 stated he provided care to Patient #1. MD #7 stated he was not aware physician orders for Patient #1's vital signs were not followed as ordered, but in general, he noticed blood pressure checks were frequently missed at the facility.
vii. On 4/11/23 at 2:18 p.m., an interview was conducted with MD #10. MD #10 stated elevated blood pressure could lead to headaches, blurred vision, or stroke symptoms which included neurological deficits such as facial droop, slurred speech, or unilateral weakness. MD #10 stated if stroke symptoms were not treated, it could lead to death or significant life-long deficits.
4. The facility failed to ensure fall risk precautions were implemented by the nursing staff to ensure the safety of the patients.
A. Document and medical record review revealed staff did not follow physician orders for patients at risk of falling.
i. Patient #9's medical record was reviewed. Patient #9 was admitted on 1/7/23 at 7:07 p.m., for treatment of hematuria (blood in the urine).
a. On 1/7/23 at 11:07 p.m., a nurse Morse Fall Risk Assessment note showed implemented interventions for Universal Fall Risk included supervised ambulation, verbal reminders for the patient to call for help before he got out of bed, encouraged use of three raised bed rails, and use of a low bed (a bed located close to the floor).
b. On 1/8/23 at 12:20 a.m., MD #15 documented an order which read, Patient #9 was a fall risk.
c. On 1/8/23 at 12:40 a.m., a nurse Morse Fall Risk Assessment revealed additional fall risk interventions were indicated, which included supervised ambulation with the use of a gait belt (a belt used to assist someone with ambulating) when the patient transferred, activation of a bed, chair, and commode alarm, ensuring the door and privacy curtain remained open, and conducting increased rounding (checks on the patient).
d. On 1/8/23 at 7:55 a.m., a Care Plan nurse note revealed Fall Risk and Patient Safety were identified as problems with the goal for Patient #9 to remain in a safe environment and free from injury.
e. On 1/8/23 at 11:23 p.m., a nurse Safety and Activities of Daily Living (ADL) assessment note revealed Fall Risk was documented under Patient #9's Safety Risk Alerts. The assessment note revealed two side rails were elevated and no other precautions were in place.
f. On 1/8/23 at 12:02 a.m., MD #15's Clinical Note revealed Patient #9's skin had no rashes or wounds.
g. On 1/8/23 at approximately 5:45 p.m., a nursing note revealed Patient #9 was found by a nurse unresponsive on the toilet after hitting his head. He was described by his doctor to have pinpoint pupils and agonal breathing. There was no evidence the fall precautions identified on 1/8/23 at 12:40 a.m., including the use of a bed or chair alarm, open doors, and assistance with ambulation, were implemented prior to the nurse finding the patient on the toilet.
h. On 1/8/23 at 7:22 p.m., the CT Angiography Head and Neck results revealed Patient #9 had suffered an intracerebral hemorrhage with intraventricular hemorrhage and subarachnoid hemorrhage (bleeding in the brain).
i. On 1/8/23 at 5:51 p.m., MD #16 documented she responded to a code for Patient #9. She documented Patient #9 was sitting on the toilet, did not respond to verbal or painful stimuli, had pinpoint pupils, and agonal breathing. MD #16 documented Patient #9 had injured his neck and had significant bruising and a hematoma.
j. This was a change from Patient #9's previous assessment at by MD #15 12:02 a.m., which read he had no rashes or wounds on his skin.
k. On 1/8/23 at 9:52 p.m., the patient was pronounced dead.
B. Interviews revealed in contrast to physician orders and nursing interventions documented in Patient #9's medical record, director level staff stated fall risk precautions were implemented only after the patient experienced the event on 1/8/23 at approximately 5:45 p.m.
i. An interview was conducted on 4/12/23 at 9:01 a.m. with nursing director (Director) #11. Director #11 stated Patient #9 was identified as a fall risk after the intracerebral hemorrhage with intraventricular hemorrhage and subarachnoid hemorrhage was identified on 1/8/23 at 5:45 p.m. and the patient was admitted to the Neuro ICU. This statement was in contrast to the physician's order on 1/8/23 at 12:20 a.m. which documented Patient #9 was a fall risk, 17 hours and 25 minutes before his admission to the ICU.
Director #11 also stated the facility's investigation found Patient #9 experienced an event on the toilet and then slumped forward versus having fallen and injured himself. Director #11's statement was in contrast to a Respiratory Therapy Evaluation and Treatment Note written by RT #17 on 1/8/23 at 6:56 a.m. which documented the patient had slumped over and hit his head on the wall in the restroom.
ii. An interview was conducted on 4/12/23 at 9:01 a.m. with clinical risk director (Director) #9. Director #9 stated the investigation found the nurses denied hearing a "thud" from Patient #9's room when doing hourly rounding at the time he was found. As such, Director #9 stated there was a lack of evidence a fall had occurred.