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Based on a review of the hospital documents, quality policy, and interview, it was determined the hospital failed to implement and maintain an effective, ongoing quality assessment and performance improvement program as evidenced by the failure to be in compliance with the standards found in this Condition of Participation.

Based on the review of policy and procedure, facility documents, medical records, observation, and interviews, it was determined that the hospital failed to:

(A0286) consistently measure, analyze and track adverse patient events.

(A0308) ensure a hospital-wide, data-driven quality assessment and performance improvement program.

(A0322) establish and implement policies and procedures to ensure that the needs and concerns of this facility are given due consideration and that their program has mechanisms in place to ensure that issues localized to this facility are duly considered and addressed separately from other facilities.

The cumulative effect of these systemic deficient practices resulted in the facility's failure to meet the requirement for Condition of Participation for Quality Assessment and Performance Improvement.

Based on the review of policy and procedure, documents, medical records, and interviews, it was determined that the hospital failed to:

1. Consistently track and analyze adverse patient events.
2. Consistently track and analyze medication errors.

These deficient practices pose the potential risk of not recognizing the frequency of events and the errors leading to negative patient outcomes and increased morbidity and mortality, leading to a lack of preventive actions or mechanisms being implemented to correct the deficiencies.

Findings include:

1. Policy titled "Event Reporting" revealed: "...F. GAPS: HPI...." (Healthcare Performance Improvement) "...assessment for classifying defects in care or deviations of Generally Accepted Performance Standards (GAPS)...L. Safety Event (SE): An event, incident or condition that could have resulted or did result in harm to a patient. M. Safety Event Classification (SEC): As defined by HPI Safety Event Taxonomy, is an outcome-based classification system based on the degree of harm that results from a deviation from GAPS. A safety event (SE) may be classified as a Near Miss Safety Event (NME), Non-Safety Event (NSE), Precursor Safety Event (PSE), or Serious Safety Event (SSE). a. NMSE: A deviation from GAPS that does not reach the patient (the error is caught by a detection barrier or by chance). b. NSE: An unexpected patient outcome that was not the result of deviations in GAPS. c. PSE: A deviation from GAPS that reaches the patient and results in minimal harm, no detectable harm or no harm. d. SSE: A deviation from GAPS that reaches the patient and results in moderate to severe harm or death. N. Unanticipated Outcome: an outcome of any treatment or procedure that differs significantly from the anticipated outcome, whether or not resulting from error or fault. This term refers to an outcome that caregiving personnel did not expect to occur (although they may have been aware that the occurrence was possible), and that currently has, or may have in the future, a significant impact on patient care, treatment, or well-being ...."

Policy titled "Critical Results Reporting," revealed: "...Banner Health identifies lab and diagnostic Critical Results that pose a life-threatening situation for the patient...The Responsible Licensed Caregiver receives the Critical Results within 60 minutes of the initial determination that the results are critical...Critical Results by Department...Per the Medical Imaging Clinical Consensus Group...new hemoperitoneum...."

Patient #15's medical record dated 12/30/2021, identified the patient had a CT of the abdomen/pelvis without contrast, which was read at 0933 with the finding: "...Large left rectus sheath hematoma measures approximately 7.2 x10.2x23.2 cm. There is hemoperitoneum in the adjacent anterior low abdomen/pelvis...." Patient #15's doctor was not notified of this finding and the patient coded at 1045 and expired at 1119.

There was no record of the event involving Patient #15 on the SSE list that was provided.


Patient #27 was admitted on 06/18/2021, with gallstone pancreatitis with cholecystitis and scheduled for surgery on 06/22/2022. On 06/21/2022, at 1130, the patient fell, a pelvic X-ray was performed on the patient post fall at 1156 which showed "...acute fracture of left superior and inferior pubic...." At 1639, the patient required restraints due to confusion and trying to remove medical devices. The patient had a code blue event at 2219, and the time of death was 2231, on 06/21/2022.

A hospital document regarding Patient #27 revealed: "...Fall...event reached the patient without harm...Safety Event Classification PSE3 no detectable harm...."

Employee #4 confirmed in an interview on 06/21/2022, that the person who discovers the event is supposed to enter that event into their tracking system but that does not always happen.

It was confirmed that Patient #15 and Patient #27 both had an event that would be considered an SSE but there was no explanation as to why the events were not included on the SSE report provided to the surveyors.

Based on a review of the hospital documents, quality policy, and interviews, it was determined the hospital failed to ensure there is a hospital-wide, data-driven quality assessment and performance improvement program. This deficient practice poses a potential risk to the health, and safety of the patients, due to the insufficient assessment of all hospital departments and services, and the inability to implement and assess performance improvement programs to improve patient safety and positive outcomes.

Findings include:

Document titled "Pathway to Recovery Acute Care Phase 1 - March, April, May. 2022" identified 5 quality improvement initiatives as follows: "...Peri-op: Prevent Surgical Site Infections...Med/Surg: Prevent Hospital Acquired Pneumonia...Facility Increase Near Miss Event Reports...Critical Care: Prevent CLABSI/MRSA...Emergency Department: Identify & Treat Sepsis...."

Document titled "Pathway to Recovery Acute Care Phase 2 - June, July, August 2022" identified 5 quality improvement initiatives as follows: "Increase Early Mobility (new)...Prevent Hospital Acquired Pneumonia (HAP) (continued)...Sepsis & Surgical Site Infection (sustain)...Prevent CLABSI/MRSA (continued)...Increase Near Miss Event Reports (continued)...."

Employee #4 confirmed in an interview on 06/21/2022, that only the nursing departments are monitored for performance improvement and that no quality assessment is monitored for environmental services, dietary services, or Biomed services. It was also confirmed that they were not aware of any department-specific performance improvement projects other than those listed on the "Pathway to Recovery" documents provided.

On 06/30/2022, a list was provided titled "Department Reports (Consent Agenda)," identifying 34 units. Of these units, one was a closed rehab facility on the 3rd floor, and six were units of the adjacent Heart Hospital which is not a part of this facility. There is no clear definition of the units being monitored by this facility for Quality Assessment and Improvement.

Based on the review of hospital policies and procedures, documents, and staff interviews, it was determined that the facility failed to establish and implement policies and procedures to ensure that the needs and concerns of this facility are given due consideration and that their program has mechanisms in place to ensure that issues localized to this facility are duly considered and addressed.

Findings include:

The policy titled "Banner Health System Quality and Safety Plan" applies to 30 Banner hospitals, at least 20 of which are located in Arizona, including the adjacent Banner Heart Hospital. This policy revealed: "...Data for monitoring the effectiveness and safety of services and the quality of care at each Facility, including clinical outcomes, patient safety evidence-based practice, utilization management, and patient satisfaction are collected and evaluated on an ongoing basis and reported up to governance for recommendations and actions on at least a quarterly basis...."

The facility's organizational chart is titled "Banner Baywood Medical Center - Banner Heart Hospital Campus Organizational Chart." Each facility has its own CMO. They share a CEO, CNO, COO, CFO, and HR.

Quality Council reports dated June 2021, to May 2022, are titled "Banner Baywood Medical Center and Banner Heart Hospital Quality Council." The performance improvement entries are not consistently clear as to which facility is being reported.

Patient Event Review Meeting (PERM) minutes are titled "BBMC & BHH Event Review." The metrics in these reports cover both facilities, some of the metrics combine the two facilities, and at times it is not clear to which facility a graph relates. An entry in the PERM report for February 2022, identifies "...Good Catch - February 2022 Winner ...Working on the Baywood side of the house ...."

On 06/27/2022, policies and procedures were requested that direct how the needs and concerns of this facility are considered, monitored, and addressed, separate from the Heart Hospital or other facilities. None were provided.

Employee #6 confirmed in an interview on 06/27/2022, that there are no policies and procedures that ensure the needs and concerns of this facility are considered and addressed, separate from the Heart Hospital or other facilities.

Based on the review of policy and procedure, facility documents, medical records, observation, and interviews, it was determined that the hospital failed to ensure:


(A0392) there was an adequate number of staff to provide patient care, meet patient needs, and ensure the safety of the patients, as well as having nurses available for the care of a patient;

(A0395) that a registered nurse was able to supervise nursing care provided to a patient;

(A405) that medications were administered correctly according to policies, procedures, and orders;

The cumulative effect of these systemic deficient practices resulted in the facility's failure to meet the requirement for Condition of Participation for Nursing Services, which poses a potential risk to the health and safety of patients by not ensuring there is a sufficient number of qualified personnel to meet the needs of the patients and ensuring a safe environment for patients.

Based on a review of hospital policies and procedures, documents, medical records, and interviews, it was determined that the Director of Nursing services failed to ensure the following:

1. Providing adequate staffing on all units with the right skill mix of registered nurses and patient care assistants,
2. Monitoring of patients in the Emergency Department (ED) while on vasoactive medications,
3. Writing verbal orders accurately in patient's medical record,
4. Administering of medications as ordered based on policies and procedures, and,
5. Assessing ED patients accordingly.

These deficient practices that were determined above pose the potential risk of unsafe patient care and environment that could lead to increased patient injury, harm, or mortality.

Findings include:

Policy titled "Patient Acuity System" approved by the NEC (Nursing Executive Council) Clinical Practice & Patient Safety Committee, revealed: "...Purpose ...To provide an evidence-based system that will obtain an acuity rating for patient care assignments ...To provide the process for predicting nursing care requirements to provide care to specific patient populations ...Acuity: The measurement of variable nursing care required by the patient ...Care Hours: The amount of time required of direct bedside caregivers to meet the demand of the workload for each patient ...Skill Mix: The various skill levels (for example RN, LPN, CNA ...) of bedside nursing staff required to provide effective care ...The RN Manager or designee will consider the following factors when determining the patient care assignments ...Staff competence and skill mix ...Reports will be used by nursing leadership to review staffing and or skill mix variances ...."

Document titled "Banner Baywood Medical Center- Banner Heart Hospital Campus Organizational Chart "revealed the Chief Nursing Officer has supervisory responsibility for the following Departments: ICU/CCU, PCU, Med Surge/Ortho/Dialysis/Med. Oncology, Neuro/Stroke/7th, and Clinical Care Ops ...", in addition to other departments.

Document titled "Job Description: Senior Director, CNO" revealed "...Serves as a member of the executive leadership team ...and models an emphasis on patient quality and safety ...drives process improvements ...designed to improve clinical services, outcomes, patient throughput and patient safety. Promotes a patient-centered, healing environment ...."

1. Hospital policy titled "Adult Patient Care," received on 06/06/2022, reveals: "...Vital signs Vasoactive Drugs: continuous intravenous medications affecting heart rate and blood pressure 1. Obtain heart rate and BP at least every fifteen (15) minutes when initiated and while titrated until hemodynamically stable. 2. When vasoactive drugs are maintained at a consistent rate and the patient is hemodynamically stable-obtain vital signs per Standard of Care...."

Patient #9 was admitted to the ED on 06/11/2022, at 2234 and had an order placed to admit to the ICU on 06/12/2022, at 0610. The patient was held in the ED until transferred to the ICU on 06/12/2022 at 2203.

Medical record reveals: "...Norepinephrine additive 8mg + Sodium Chloride 0.9% intravenous solution 250ml ...Start Date/Time 06/12/2022 0020...For MAP greater than or equal to 50 -start infusion at 5mcg/min -Increase infusion rate every 2 minutes by 1-5mcg/min until greater than or equal to ordered maintain MAP goal of 65. For MAP less than 50 -Start infusion at 10mcg/min ...If MAP greater than the ordered goal -Decrease infusion rate every 10 minutes by 0.5-5mcg/min as long as MAP remains greater than or equal to ordered MAP goal of 65...."

Patient #9's medical record reveals no mean arterial pressures (MAPs) documented until 06/12/2022 at 1335. The patient was documented as in a procedural area from 1325 to 1355 and was back in ED at 1355 but blood pressure monitoring resumed at 1512. In between 1355 and 2203, when the patient was discharged from the ED and care was assumed in the ICU, the patients' BP was documented 11 out of an expected 32 times, and the norepinephrine was titrated five times, with intervals of up to 95 minutes between BPs.

2. Policy titled "Processing Provider Orders: Inpatient and Outpatient," received 07/07/2022, revealed "...Telephone and verbal orders may be dictated to one of the following practitioners within their scope of practice, who must document and then read back the order to the Provider for verification prior placing {sic} the order...Nursing...."

Patient #14's medical record dated 11/20/2021, identified: "...Notification Record ...2000 patient BP=175/91, no correctional prn medication ...2010 MD ordered Xanax 0.5mg PO tid prn and hydralazine 20mg IV push, q6h prn, for SBP greater than 160. MD ordered to try Xanax first, if BP is still elevated in1 {sic} hr, try hydrolozine {sic}..." by Employee #13.

Patient #14's medical record dated 11/20/2021, at 2012, reveals: "...Original order entered and electronically signed by (Employee #13) on 11/20/2021 at 2012. Verbal w/Readback order...alprazolam (Xanax) 0.5mg, 2 tab ...oral ...tid ...prn yes; prn reason: anxiety .... "

Patient #14 received Xanax three, out of four times given, for systolic blood pressure (SBP) less than 160, on 11/21/2021 and 11/22/2021. Patient #14 received hydralazine three out of three times for an SBP over 160, without receiving Xanax first.

Employee #5 confirmed in an interview conducted on 06/07/2022, that prn medication/s can be verbally ordered by a physician with a note stating the reason for the prn order. The note will then display on the MAR if a nurse/s access the system to ensure that medication/s will be given as prescribed by the physician.

Employee #6 confirmed in an interview on 06/07/2022, that the indications for Xanax ordered verbally for Patient #14 on 11/20/2021 at 2012, were different from the notification record of the said medication on 11/20/2021 at 2010.

3. Hospital policy titled "Medication Administration," received on 06/07/2022, reveals: "...Routine medications are to be started after the order is initiated...."

Patient #20's medical record identifies an order on 02/19/2022, at 1226 "...sodium zirconium cyclosilicate (Lokelma) 10gm powder oral once...."

The medical record dated 02/19/2022, at 1925, reveals: "...Informed NOC nurse that Lokelma needed to be given. The pharmacy had not sent up during day shift after request. Not on counter, tube or in the bucket...."

Patient #20's medical record dated 02/20/2022, at 1059, reveals: "...Medication list reviewed significant for Lokelma ...Started Lokelma for hyperkalemia...."

The medical record dated 02/20/2022, at 2105, identifies: "...Started Lokelma for hyperkalemia, which was never given by the nurse on 02/19/2022 ...Pt had acute cardiorespiratory arrest due to PEA arrest from Hyperkalemia. His stat K is reported at 7.2 at which time the patient coded and attempted resuscitation had been unsuccessful {sic}. He is pronounced deceased...."

Employee #32 confirmed in an interview conducted on 06/07/2022 that sodium zirconium cyclosilicate (Lokelma) was ordered for Patient #20 on 02/19/2022 at 1226pm for hyperkalemia and was not started until 02/20/2022 at 1059am.

4. Hospital policy titled "Emergency Department Patient Care," received on 06/06/2022, identified: "...An Emergency Severity Index (ESI) score is assigned when the triage assessment is completed...ESI 2= High-risk situation or confused/lethargic/disoriented or severe pain distress ...Documented reassessments every 1 hour until hemodynamically stable, then minimally every 4 hours ...Vital Signs: to be completed at a minimum with every ED assessment/reassessment ...."


Patient #25's medical record reveals s/he arrived at the ED on 08/22/2021, was given an ESI of 2, and care was initiated at 2212. A Complete Blood Count (CBC), was ordered and drawn on 08/22/2021, at 2318. The ED was notified by the laboratory that the specimen was clotted and a redraw was required. The CBC was redrawn on 08/23/2021, at 0318. Critical values of hemoglobin of 3.9 and hematocrit of 15.3 were called to the RN. A type and screen were sent at 0417 and an order to transfuse blood was given at 0502. The patient was found pulseless at 0553 before the blood transfusion could be administered.

Patient #25's medical record dated 08/22/2021, reveals: " ...Initially hypotensive 80/40 for ems ...He is now weak and unable to walk. If he attempts to ambulate, he immediately falls ...Pt c/o SOB that worsens with exertion ...the patient lost pulses ...CPR was in progress. Despite multiple rounds of ACLS, the patient succumbed to his illness presumably from severe sepsis and severe anemia with myocardial ischemia likely secondary to his profound anemia ...Time of death called at 0610 ...."

Employee #10 confirmed in an interview on 06/07/2022, that Patient #25 came to the ED and had a set of vital signs taken on 08/22/2021 at 2247, was assigned an ESI of 2, and died on 08/23/2021 at 0610am without further vital signs documented after the initial vital signs were taken.

Based on a review of hospital policy and procedures, documents, and interviews, it was determined that the administrator failed to ensure an LPN assignment was under the direction of an RN while working in an RN/LPN team assignment. This deficient practice poses a potential risk of a patient receiving duplicate services or an LPN performing patient care outside the scope of practice.

Hospital policy titled "Medication Administration," received on 06/07/2022, identifies: " ...Positive Patient Identification (PPID): process using barcode technology, electronic patient identification, and appropriate medication administration based on Providers' orders ...Document. If using PPID, document at the time of administration ...."

Hospital document, received on 06/14/2022, reveals: " ...Job Profile Name: LPN ...Job Description ...Core functions ...Contributes to the planning of care under the direction of a registered nurse ...implements care based on delegated interventions ...."

The hospital document revealed that while working in an RN/LPN team assignment on 05/05/2022, the RN and LPN each gave a corrective dose of insulin to two separate patients, resulting in both patients receiving two doses of insulin. The document further revealed that "...Why did it happen, contributing, root causes: LPN states that she is typically the nurse that will cover elevated blood sugars with insulin when she is in the Team Nursing assignment. Today she was working with an RN that she has not done a Team Nursing Assignment and due to a communication breakdown, both the LPN and RN covered the patient's lunch blood sugar with sliding scale insulin...."

Employee #40 confirmed in an interview on 06/28/2022, that his/her floor is using team nursing, which means an RN and an LPN work together to provide patient care for up to eight to ten patients. On 05/05/2022, two patients received two doses of insulin administered differently by an RN and an LPN.

Based on a review of hospital policy and procedure, hospital documents, medical records, and interviews, it was determined the hospital failed to ensure ordered medications were given in a timely manner according to hospital policies. This deficient practice poses the potential risk of patients being inadequately or improperly treated and without consistent therapeutic drug levels.

Findings include:

Hospital policy titled "Medication Administration," received on 06/07/2022, identifies: "...If the medication is scheduled daily, weekly, or monthly...within 2 hours before or after the scheduled time...prescribed more frequently than daily, but less frequently than every four (4) hours...within 1 hour before or after the scheduled time...if the next time due is "less than" ½ the interval of the schedule, then schedule the medication for the next standard time...."

Six patients were randomly selected to assess medication administration times:

Patient #39 was randomly selected from a census, and a time frame of 06/21/2022, through 06/25/2022, was randomly selected from his/her admission. On 06/21/2022, a medication ordered to be given at 0600 and two others to be given twice a day at 0800 and 1700, were administered at 1145. On 06/25/2022, seven medications scheduled to be given daily at 0900 were administered at 1220.

Patient #40 was randomly selected from a census and a time frame of 07/03/2022, through 07/07/2022, was randomly selected from his/her admission. On 07/04/2022, two medications were ordered twice a day scheduled at 0800 and 1700, and one medication ordered daily at 0900 was administered at 1246. On 07/07/2022, two medications scheduled for twice a day at 0800 and 1700, were administered at 1011. One medication was ordered TID with administration times of 0800, 1200, and 1700. The medication was given at 1011, and again at 1134.

Patient #41 was randomly selected from a census and a time frame of 06/22/2022, through 06/25/2022, was randomly selected from his/her admission. On 06/24/2022, five medications were ordered once a day with a scheduled time of 0900, and one medication ordered twice a day with scheduled times of 0800 and 1700, was given at 1117.

Employee #38 confirmed in an interview on 06/28/2022, that the administration of patient medications was consistently late.