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Based on review of hospital policies and procedures, hospital documents, medical records, observations, and staff interviews, it was determined that the hospital failed to comply with protecting and promoting each patient's rights as evidenced by the hospital's failure to:

Findings include:

The Condition level deficiency is the result of the standard deficiencies found under the Conditions of Patient Right in the following tags:

A-0117: The facility failed to provide 18 of 18 patients notification of patient rights.

A-0118: The facility failed to process one (1) patient's grievance properly.

A-0144: The facility failed to provide 1:1 observation for nine (9) patients as ordered.

A-0168: The facility failed to ensure orders were in place for one (1) patient placed in restraints.

A-0174: The facility failed to ensure one (1) patient was released from restraints when indicated.

A-0175: The facility failed to ensure one (1) patient in restraints received 1:1 observations as ordered while in restraints.

A-0215: The facility failed to ensure one (1) patient was allowed visitors.

The cumulative effect of these systemic problems resulted in the hospital being ineffective with promoting and protecting the rights of each patient and failure to meet the requirements of the Condition of Participation for Patient Rights.

Based on a review of facility documents and staff interviews, it was determined that the administrator failed to ensure that 18 of 18 patients, or their representative, (#4, #5, #6, #7, #8, #9, #10, #11, #12, #22, #29, #33, #34, #35, #36, #37 (minor), #38 (minor), and #50) received a written copy of their patient rights as delineated in the State hospital rules (A.A.C. Title 9, Ch 10, Article 2).
This failure has the potential risk that patients or their representatives will not know what they are entitled to as a patient or patient representative, how staff should be treating them, and how they may file a complaint/grievance about their care while an inpatient at this hospital.

Cross reference: A0115

Findings include:

A request was made for documentation from the electronic or tactile medical record for 18 of 18 patients (#4, #5, #6, #7, #8, #9, #10, #11, #12, #22, #29, #33, #34, #35, #36, #37 (minor), #38 (minor), and #50) demonstrating they have received a copy of the "Patient Rights" when they were an inpatient at this hospital, none was provided for review at the time of the survey.

Policies and Procedures:
A review of "Patient's Rights and Responsibilities" Policy-7/31/2012, Last Revised: 2/21/2023, revealed: "...The complete and up to date Patient Rights and Responsibility is provided to patients on admission, or upon request...All patients/representative will follow the patient responsibilities as noted...."

Patient #[6] verified, during a one to one interview conducted on 08/02/2023, that the paperwork provided when he/she was admitted is in his/her bag. A review of the documents in the bag was a copy of a signed "Notice of Privacy Practice" and no copy of Patient Rights was located.

Patient #[4] and Patient #[6] verified, during a one to one interview conducted on 08/02/2023, that they do not recall receiving a copy of anything called "Patient Rights."

Employee #4 and Employee #18 verified, during an interview conducted on or about 7/27/2023, that there is no documentation found in the electronic or tactile medical records for 18 of 18 patients (#4, #5, #6, #7, #8, #9, #10, #11, #12, #22, #29, #33, #34, #35, #36, #37 (minor), #38 (minor) and #50) delineating they received a copy of their "Patient Rights" while an inpatient at this hospital.

Based on a review of facility documents and staff interviews, it was determined that the administrator failed to ensure that a grievance filed by one of one patient (patient #54) was addressed and investigated regarding a misinterpreted radiology report. This deficient practice poses a risk to the health and safety of patients if grievances are not thoroughly addressed and investigated leading to identifying potential risk factors and preventing future injuries or poor quality care to patients.

Cross Reference: A-0115

Findings include:

A review of "Rights and Responsibilities" Last Updated: 2/3/23, revealed: "...Voice grievances with respect to treatment of care that...fails to be furnished...."

A review of "Severity" revealed: "...Severity Levels are applied to all patients with actual adverse events...Key factors in assignment are extent of injury, length of stay, level of care required for remedy and actual or estimated physical plant costs...Level 1...Minor: no injury, no increased length of stay or level of care, no necessary review and/or change to policy/procedure/operation (includes re-education)...."

A review of "Injury Level" revealed: "...Level:...1 (one) Injuries that involve little or no care, formal intervention of observation such as abrasions, contusions, small skin tears or minor lacerations that do not require suturing...
Level:...3 (three)Injuries that clearly require medical intervention or consultation...These may include fractures...."

A review of "Interpretation Discrepancy" Final approval date: [2/3/21], revealed: "...To establish a process to report discrepancies of interpretations by the interpreting Radiologist group...
Policy:...
1. Physician identifying any discrepancies will log an incident report with discrepancy identified...
2. Incident report logged...
3. Imaging Director notified by way of incident report...
4. Radiologist group is notified via phone for immediate overread...
5. Radiologist will review and add addendum if discrepancy is found...
6. Support ticket is placed to the Radiologist group to refer to their peer review...
7. Findings will then be placed in the incident report...and
8. Recommendation will be made in incident report to either close case or refer to internal PSST (Patient Safety Treatment Team) or peer review for further evaluation...."

1. Documentation that an "Incident report" logged by the ED physician identifying the discrepancy was requested, none was provided for review at the time of the survey.

Employee #16 verified, during an interview conducted on 08/02/2023, that the incident report logged on the "Regulatory Agency Complaint and Grievance Log" were the allegations submitted electronically by patient [#54].

2. A copy of the "Incident Report" logged by the physician discovering the imaging discrepancy was requested, none was provided for review at the time of the survey.

3. Documentation that the "Imaging Director" was notified of the incident report was requested for review, none was provided for review at the time of the survey.

4. Documentation that the "Radiologist Group" was notified via phone for an immediate overread was requested for review, none was provided at the time of the survey.

5. A copy of the Radiologist conducting the "Overread" and the required addendum report as a discrepancy was found for review, none was provided for review at the time of the survey.

6. Documentation that a "Support ticket" was provided to the Radiologist group to refer to their peer review was requested, none was provided for review at the time of the survey.

7. Documentation that the "Findings" were placed in the incident report was requested for review, none was provided for review at the time of the survey.

8. Documentation that the diagnostic imaging study was being referred to Peer Review was requested, none was provided for review at the time of the survey.

Medical record for Patient #54:
A review of "XR ankle LT min 3V" (X-ray ankle left minimum three view) revealed: "...Clinical History: Pain...IMPRESSION: Acute avulsion fracture of the medial malleolus...."

A review of "Preoperative Diagnosis:...Left ankle...rupture...Left posterior malleolus fracture...Left Maisonneuve (spiral) fracture...."

A review of "Regulatory Agency Complaint and Grievance Log" revealed: "...Detailed Description of Issue: Patient seen in ED after a fall w/ (with) c/o (complaint of) ankle pain...X-ray taken and radiologist misread the film and missed another fracture...Received...[06/26/2023]...Care/Treatment...Resolved: No (unfounded)...Relation to Patient: [Self]...Severity...Severity Level 1-Minor...."

Employee #16 verified, during an interview conducted on 08/02/2023, that an overread was not performed after patient [#54's] ED visit on [06/17/2023]. Employee #16 confirmed that Patient #54 had suffered an ankle fracture and the radiologist did not interpret the ankle x-rays accurately. Employee #16 verifed that the facility did not follow policy when handling the patient's grievance regarding the misread radiology report.

Based on a review of hospital records and interview, it was determined the hospital failed to ensure nine patients (Patients #40, 42, 43, 44, 45, 46, 47, 48, 53, and 54), received one to one observations as ordered. This failure poses the risk of unobserved patients having the opportunity to engage in activities that could potentially endanger themselves or others.

Cross reference: A0115, A0386

Findings Include:

Policy titled "Patient Observation for Prevention of Harm (Non-Behavioral Health Units)," revealed: " ...Patient observation is utilized for patients who are assessed and determined to be at risk for safety and/or harm to self and others. When patient observation is necessary, standardized processes and documentation are implemented...This policy applies to all patients assessed to be a safety risk on inpatient units and in the Emergency Department...One to One (1:1) Observation: Assignment of a qualified staff member to remain with the patient and maintain an unobstructed view of the patient at all times to prevent harm to the patient or others...One to One (1:1) Observation a. Clinical Indications: High risk for Suicide, Patient in restraints for violent or self destructive behavior b. Patient Observer Role (1:1): Will have no other duties assigned, Will never leave a patient on 1:1 unattended...Documents patient safety observations every 15 minutes on the Patient 1:1 Observation Monitoring Tool...."

A review of medical records for Emergency Department patients revealed:
1. Patient #48's medical record revealed an order for one to one observation on [03/23/2022, at 1710]. There were no one to one observations documented.
2. Patient #40's medical record revealed an order for one to one observation on [09/11/2022, at 2316]. There were no one to one observations documented until [09/12/2022 at 0700].
3. Patient #47's medical record revealed an order for one to one observation on [09/15/2022, at 2152]. There were no one to one observations documented on "Patient Observation Monitoring Tool" dated [09/15/2022, from 0100 through 0330].
4. Patient #42's medical record revealed an order for one to one observation on [09/23/2022, at 2000]. There were no one to one observations documented until 09/24/2022 at 0700.
5. Employee #28 documented one to one observations on Patient #53 and Patient #54 on [09/23/2022, from 1145] through [1445].
6. Patient #43's medical record revealed an order for one to one observation on [07/23/2023, at 2311], and was discontinued when the patient was discharged on [07/26/2023 at 1701]. There were no one to one observations documented on[ 07/25/2023 and 07/26/2023].
7. Employee #24 documented one to one observations on Patient #44 and Patient #45 on [07/24/2023, from 0715] through [0815].
8. Patient #46's medical record revealed an order for one to one observation on [07/14/2023, at 1407]. There were no one to one observations documented until [07/16/2023 at 0700].
9. Patient #46's medical record revealed: " ...Order: Restraint Violent ...Start [07/14/2023 15:31]...." There were no one to one observations documented during this restraint episode.

Employee #2 confirmed in an interview on 07/31/2023, there was no one to one observation documented on Patients #42, #47, and #40 for the above times. It was also confirmed that the same observer documented on Patient #44 and Patient #45 at the same time.

Employee #18 confirmed in an interview on 07/31/2023, there was no one to one observation documented on Patients #48, #43, and #46 for the above times.

Based on a review of hospital records and interview, it was determined the hospital failed to ensure an order was received for the use of a physical restraint on a patient. This failure poses the risk of a patient being inappropriately restrained and not receiving adequate care or monitoring during a restraint episode.

Cross reference: A0115

Findings include:

Policy titled "Restraint and Seclusion for Non-Behavioral Health Units," revealed: " ...Physical Hold: A method of restraint in which a patient's freedom of movement or normal access to his or her body is restricted by means of staff physically holding them for safety reasons ...In emergency situations, a RN may initiate a restraint in advance of the order by the treating physician/ordering provider. The restraint order must be obtained either during the emergency application of the restraint or immediately (in a few minutes) after the restraint has been applied. If an order is not obtained immediately, it will be considered restraint without an order ...."

Document titled "Security/Safety/Conduct Incident Details," revealed: " ...Incident Date: [12/15/2022] ...pt was quickly restrained by [Nikolaus] holding [her] and we guided [her] the {sic} stretcher ...."

Patient #49's medical record, dated [12/15/2022], contained a note titled "Nurse Note," which revealed: " ...pt is physically and verbally aggressive towards staff ...pt opened handed {sic} hit me in the left eye ...pt was immediately restrained ...." The medical record did not contain an order for this restraint.

Employee #18 confirmed in an interview conducted on 08/01/2023, that there was no order for the physical restraint performed on Patient #49.

Based on a review of hospital record and interview, it was determined the hospital failed to ensure a patient was released from behavioral or violent restraints after falling asleep. This failure poses the risk of a patient being unnecessarily restrained, a patient suffering injury from prolonged restraint use, and an inappropriate use of restraint.

Cross reference: A0115

Findings Include:

Policy titled "Restraint and Seclusion for Non-Behavioral Health Units," revealed: "...When applying restraints to Violent or Self-Destructive patients, all four limbs must be restrained. This is the only acceptable type of restraint application unless medical conditions warrant the application of fewer limb restraints...Restraint shall be discontinued at the earliest possible time regardless of the length of time identified in the order...Restraint is discontinued as soon as the patient meets DC criteria which includes but is not limited to: Patient is oriented...Ability to follow treatment plan and maintain safety...Patient is asleep; Patient is in behavioral control; Patient can follow directions and participate in their care...."

Patient #51's medical record revealed: "...Restraint Violent Age 18/Older...Start [12/17/22 0555]...Type of Restraint Extremity Soft 4 point...."
Patient #51's medical record contained a flowsheet titled "Care Assessments," dated [12/17/2022], which revealed:
"...Date Restraint Applied [12/17/2022] Time Restraint Applied 05:50...Type of Restraint Nylon Restraint 4 Point...."
"...[12/17/2022 0620]...Nylon Restraint 4 point...Least Restrictive Intervention Yes...Assessment Comment Pt asleep at this time...."
"...[12/17/2022 0635]...Nylon Restraint 4 point...Least Restrictive Intervention Yes...Assessment Comment pt presently asleep...."
"...[12/17/2022 0650]...Nylon Restraint 4 point...Least Restrictive Intervention Yes...Assessment Comment asleep...."
"...[12/17/2022]...Patient #51 had this assessment documented on the flowsheet on 22 out of 22 fifteen minute observations between [0710 and 1400]: "...Nylon Restraint 4 point...Least Restrictive Intervention Yes...Assessment Comment Pt resting comfortably in bed with eyes closed. Will continue to monitor...."
"...[12/17/2022 1400]... Nylon Restraint 4 point...Least Restrictive Intervention Yes...No Longer a Risk to Self, No Longer a Risk to Others, Patient able to follow Treatment Plan...Pt resting comfortably in bed, [mom Anita] at bedside... Pt resting comfortably in bed with eyes closed. [Mom] at bedside. Does not appear to be in distress. Will cotinue {sic} to monitor. Bilateral ankle restraints removed...."
"...[12/17/2022 1418]...Nylon Restraint 4 point...Least Restrictive Intervention Yes...No Longer a Risk to Self, No Longer a Risk to Others, Patient able to follow Treatment Plan...Pt resting comfortably in bed, [mom Anita] at bedside...Pt resting comfortably in bed with eyes closed. [Mom] at bedside. Does not appear to be in distress. Will cotinue {sic} to monitor. Bilateral ankle restraints removed at [1400]. Right arm restraint removed at [14:15] PT remains in left arm restraint...."
"...[12/17/2022 1433]...Nylon Restraint 4 point...Least Restrictive Intervention Yes...No Longer a Risk to Self, No Longer a Risk to Others, Patient able to follow Treatment Plan...Pt resting comfortably in bed, [mom Anita] at bedside...Pt resting comfortably in bed with eyes closed. [Mom] at bedside. Does not appear to be in distress. Will cotinue {sic} to monitor. Bilateral ankle restraints removed at 1400. Right arm restraint removed at [14:15 Left arm restraint removed 1430]...."

Employee #18 confirmed in an interview conducted on 08/01/2023, that Patient #51 was documented as being asleep or resting comfortably for eight hours and ten minutes of his eight hour and forty minute restraint episode and that is not hospital policy.

Based on a review of hospital record and interview, it was determined the hospital failed to ensure a patient requiring restraints for a violent episode also received one to one observations during the restraint to ensure safety. This failure poses the risk of a patient suffering injury during the restraint episode and restraints not being discontinued at the earliest possible time.

Cross reference: A0115

Findings include:
Policy titled "Restraint and Seclusion for Non-Behavioral Health Units," revealed: "...Monitoring and Care...Monitoring of patients in violent restraints or seclusion is accomplished through 1 -to- 1 in-person observation by a qualified staff in order to ensure the patient's safety...."

Policy titled "Patient Observation for Prevention of Harm (Non-Behavioral Health Units)," revealed: "...Patient observation is utilized for patients who are assessed and determined to be at risk for safety and/or harm to self and others. When patient observation is necessary, standardized processes and documentation are implemented...This policy applies to all patients assessed to be a safety risk on inpatient units and in the Emergency Department...One to One (1:1) Observation: Assignment of a qualified staff member to remain with the patient and maintain an unobstructed view of the patient at all times to prevent harm to the patient or others...One to One (1:1) Observation a. Clinical Indications...Patient in restraints for violent or self destructive behavior b. Patient Observer Role (1:1): Will have no other duties assigned, Will never leave a patient on 1:1 unattended...Documents patient safety observations every 15 minutes on the Patient 1:1 Observation Monitoring Tool...."

Patient #46's medical record revealed: "...Order: Restraint Violent...Start[ 07/14/2023 15:31]...." There were no one to one observations documented during this restraint episode.

Employee #18 confirmed in an interview on 08/02/2023, Patient #46 had no one to one observations documented while in restraints.

Based on a review of hospital records and interview, the Department determined the administrator failed to ensure patients were able to have visitors while in a specific unit of the hospital. This failure poses the risk of family members who are making medical decisions for the patient, not being involved in their care, and could negatively impact the progress of the patient.

Cross reference: A0115

Findings Include:
Policy titled "COVID 19 Source Control," revealed: " ...Visitor restrictions are based on population of patient, state or municipal orders and/or Hospital leadership assessment of the COVID-19 impact in the community they serve ...Each hospital in Steward may be in a different phase of the pandemic based on the 14- day positivity rate in that area. These documents are solely used as a template for Hospital leadership to ensure consistency in addressing visitation ...."

Patient #16's medical record dated [08/03/2022, through 09/09/2022], revealed s/he was a patient on the [Generations] unit. Visitation guidelines for that unit during the time period of admission was requested multiple times over the duration of the survey and none was provided.

Employee #18 confirmed during an interview conducted on 07/26/2023, that the hospital was allowing visitors but not on that unit due to the geriatric population. Employee #18 also confirmed that not all of the patients on that unit were geriatric.

Based on a review of the hospital documents, quality program, 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.

A-0273: The facility failed to provide and report data on a medical staff assault and a workplace violence incident.

A-0286: The facility failed to ensure failed to ensure appropriate actions were implemented to resolve medication administration errors.
.
A-0315: The facility failed to provide
1. sufficient number of RNs in the Emergency Department (ED), according to hospital policies, to provide care to patients seeking treatment.
2. one to one sitters as ordered in the ED for patients requiring one to one observation.

The cumulative effect of these systemic problems resulted in the hospital's inability to have an effective quality assurance performance improvement program to assess opportunities for improvement.

Based on review of records and staff interviews, it was determined the Hospital failed to report and provide data regarding one medical staff assault and one workplace violence event. This deficient practices poses a risk to the health and safety of patients if accurate reporting and monitoring of safety events are not documented and reviewed.

Cross reference: A0263

Findings include:

A review of "Quality and Patient Safety Plan" revealed: "...embraces a culture of excellence, safety and continuous improvement...Incident and Occurrence Reporting Criteria and Guidelines for Communicating to regulating agencies...Data is presented regularly to Committees and Teams to assess progress towards goals...."

A review of "Environment of Care Safety" revealed: "...Security/Safety...reported...for the Month of February 2023...Incident reports MVMC...2(sic) Assaults (Medical Staff)...2(sic) Workplace Violence...."

The Incident Reports for the two (2) assaults on the (Medical) Staff and the two (2) Workplace violence events was requested for review, only one of two of the assaults and one of two workplace violence reports was provided for review.

Employee #29 verified, during an interview conducted on 08/01/2023 through 08/02/2023, that only two of the incident reports, one medical staff assault and one workplace violence, were presented at the March 8, 2023 Environment of Care Safety (QAPI) meeting.

Based on review of facility documents, policy and procedure, and staff interviews, it was determined that the facility failed to ensure appropriate actions were implemented to resolve medication administration errors within the facility. Failure to analyze data to develop and implement a plan to decrease and/or correct the number and frequency of medication administration errors increases unintended adverse events and increases the risk of patient harm.

Cross reference: A0263

FINDINGS INCLUDE:

Policy titled, "Medication Error and Adverse Drug Reaction (ADR) Reporting ", revealed: "...Procedure. A. General: 1. Medication Error, adverse drug reactions, and medication incompatibilities as defined by the hospital are immediately reported to the attending physician ...3. The staff member or physician who discovers the medication error, even if the error was corrected before reaching the patient or adverse drug reaction, is responsible for reporting. The report is submitted using the hospital online incident report system ...5. A description of the medication error or adverse drug reaction and outcome shall be documented in the patient's medical record...B Medication Errors 1. The department manager and Pharmacy in collaboration with Quality and Safety staff review, follow up and respond as necessary to each medication error 2. Quality and Safety reviews each medication error and follows the incident reporting policy 3. The Medication Safety Committee or equivalent reviews medication errors for trends and potential system failures. Recommendations and findings are reported to the Pharmacy and Therapeutics Committee and the Quality and Safety Committee ...."

Policy titled, "Incident Reports: General Overview", revealed: " ...IV Reporting within the hospital/Steward ...E. Documentation in the Medical Record 1. The medical record should contain a complete, accurate record of clinical information pertaining to the event. When applicable, the documentation should include: a. Objective detail of the event written in non-judgmental language-facts only. b. The patient's condition immediately before the event. c. Intervention and patient response. d. Notification of the physician. e. Notification/discussion with the family ...."

Document titled, "Incident Detail Report", revealed: "...Incident Date [03/28/2021] Department Where Incident Occurred: Emergency Department General Incident Type: Medication/Fluid Specific Incident Type: wrong drug Final Incident Severity: Severity Level 2-Moderate ...Closed Date: [03/31/202]1 ...Incident Description: Pt {sic} was unstable a-fib with rvr (atrial fibrillation with rapid ventricular response) already given bolus of Cardizem, pt continued to worsen and then coded, able to successfully resuscitate after shock x 2, compressions, and medications. This nurse [Will M, RN] accidently ran to put together a Cardizem drip, got interrupted by another nurse concern while pulling the medicine. This nurse was witnessed visualizing the med to confirm and thought he was confirming but attention clearly lacking and continued to mix the med and hang it at 5ml/hr. Immediately after walking out of the room, another nurse asked about rocuronium vials and this nurse realized [his] mistake, immediately stopping the medication and removed the line. Provider and nurses involved made aware of the mistake. The patient had just been intubated and sedated, the medication is not a dose that could cause any harm over 1-2-minute duration. ...."

Quality Meeting Minutes from January-September 2021 were not provided by the facility.

No documentation of the medication error in Patient #21's medical record.

No documentation of communication with attending physician of the medication error in Patient #21's medical record.

Employee #4 confirmed during a medical record review conducted on 07/31/2023 that the administration of rocuronium should have be documented as a medication error by the emergency department nurse. Employee #4 further confirmed that communication with the physician should have been documented in the medical record in either the critical value reporting and/or notification sections.

Employee #18 confirmed during a medical record review conducted on 07/27/2023 that Quality Meeting Minutes from January-September 2021 were not available.

Based on a review of hospital documents and interview, the Department determined the administrator failed to ensure:
1. There was a sufficient number of RNs in the Emergency Department (ED), according to hospital policies, to provide care to patients seeking treatment.
2. There were one to one sitters available in the ED for patients requiring one to one observation.
3. Only qualified personnel performed peritoneal dialysis.
These failures pose the risk of patients having a serious safety event due to an inapropriate amount of supervision, procedures being performed incorrectly, critical patients not being monitored appropriately, a worsening of condition going unnoticed, and a delay in care to critical patients.

Cross reference: A0263, A0385, A0397

Findings Include:

1. Policy titled "Patient Acuity System," revealed: "...Nursing administration will: Provide appropriate levels of staffing for each nursing unit according to needs identified...In times when we are unable to meet the appropriate levels of staffing all avenues to correct any deficiencies will be explored including but not limited to reorganization of patient care responsibilities to protect patient safety...The purpose of the Emergency Department Staffing System is to provide a mechanism for determining the staffing matrix in order to provide appropriate assignment of nursing personnel. This is completed by a periodic review of the emergency department's arrival by hour of the day (peak volume times) and average patient Emergency Severity Index (ESI level) assignments...Using the ESI levels, the ratio of nurse to patient is typically 1:4, however this will change throughout the day based upon the influx of patients entering the Emergency Department, the patient's assigned ESI levels, and resources needed. If at any time, the emergency department charge nurse determine that patient requirements outweigh available nursing resources, the emergency department charge nurse is to utilize the hospital chain-of-command to either redistribute available resources, augment current resources by calling in additional staff, and/or activating the hospital's disaster plan. As a result of the utilization of the Emergency Department Staffing System, nursing personnel will be able to: Provide quality patient care based on individualized patient care needs...."

A review of documents titled "ED End of Shift Report," and "Daily Roster by Unit," dated 09/14/2022, and 09/16/2022, revealed:
09/14/2022 at 1700: 51 patients, 6 RNs (1:8.5 ratio)
09/14/2022 at 2100: 24 patients, 5 RNs (1:4.8 ratio)
09/14/2022 at 0100: 15 patients, 3 RNs (1:5 ratio)
09/16/2022 at 0100: 18 patients, 3 RNs ' s (1:6 ratio)

Employee #18 confirmed during an interview conducted on 08/01/2023, that these were the staffing numbers for 09/14/2022 and 09/16/2022.

2. Policy titled "Patient Acuity System," revealed: "...Nursing administration will: Provide appropriate levels of staffing for each nursing unit according to needs identified...In times when we are unable to meet the appropriate levels of staffing all avenues to correct any deficiencies will be explored including but not limited to reorganization of patient care responsibilities to protect patient safety...The purpose of the Emergency Department Staffing System is to provide a mechanism for determining the staffing matrix in order to provide appropriate assignment of nursing personnel. This is completed by a periodic review of the emergency department's arrival by hour of the day (peak volume times) and average patient Emergency Severity Index (ESI level) assignments...If at any time, the emergency department charge nurse determine that patient requirements outweigh available nursing resources, the emergency department charge nurse is to utilize the hospital chain-of-command to either redistribute available resources, augment current resources by calling in additional staff, and/or activating the hospital's disaster plan. As a result of the utilization of the Emergency Department Staffing System, nursing personnel will be able to: Provide quality patient care based on individualized patient care needs...."

Policy titled "Patient Observation for Prevention of Harm (Non-Behavioral Health Units)," revealed: "...Patient observation is utilized for patients who are assessed and determined to be at risk for safety and/or harm to self and others. When patient observation is necessary, standardized processes and documentation are implemented...This policy applies to all patients assessed to be a safety risk on inpatient units and in the Emergency Department...One to One (1:1) Observation: Assignment of a qualified staff member to remain with the patient and maintain an unobstructed view of the patient at all times to prevent harm to the patient or others...One to One (1:1) Observation a. Clinical Indications: High risk for Suicide, Patient in restraints for violent or self destructive behavior b. Patient Observer Role (1:1): Will have no other duties assigned, Will never leave a patient on 1:1 unattended ...Documents patient safety observations every 15 minutes on the Patient 1:1 Observation Monitoring Tool...."

A review of hospital documents titled "Security/Safety/Conduct Incident Details," and "Patient Care Incident Details," revealed 20 incidents reported in the ED from 07/01/2022, through 07/31/2023, documenting there was no one to one sitter available for a patient.

An incident dated [07/14/2022], revealed: "...SI sitter had to be taken off this patient and put on another SI pt that was a minor per House supervisor [Deborah] no sitters avail to send to ER...."

An incident dated [10/21/2022], revealed: "...ER had four patients with one to one sitter orders, three for safety and one for SI. Due to issues with staffing, the ER tech was told [he] was responsible for sitting with all four patients...."

An incident dated [01/29/2023], revealed: "...sitter requested at 1745 from house supervisor...pt has dementia and is a fall risk with an elopement risk...No sitter avail for this patient as per day house supervisor...."

An incident dated [05/30/2023], revealed: "...Patient currently has safety sitter in place. Was informed by shift Charge nurse that the safety sitter is being pulled to do one to one observation for SI and patient would no longer have sitter. Suggested to have one to one SI sitter watch both patients...."

Employee #28 documented one to one observations on Patient #53 and Patient #54 on[ 09/23/2022, from 1145 through 1445].

Employee #24 documented one to one observations on Patient #44 and Patient #45 on [07/24/2023, from 0715 through 0815].

Employee #18 confirmed in an interview on 08/03/2023, that s/he has reviewed several of these incident reports concerning no available one to one sitters in the ED.

3.
Policy titled, " Competency Assessment " , revealed: " ...The hospitals ensure staff is competent to perform the responsibilities identified within their role and job description ....3. Competencies are assessed during the following intervals: Orientation: Organizational and applicable unit-specific entry-level competencies to be assessed prior to functioning independently, during the probationary time frame. Annual: Assessed within each calendar year .... "

Medical Record-Patient #25:

Patient #25 ' s medical record dated [02/25/2022] identified a flowsheet that noted Patient #25 received continuous cycling peritoneal dialysis performed by Employee #8.

Employee Files:

Documentation of Employee #8 skill verifications and competency assessments on peritoneal dialysis was requested. Employee #18 provided the document titled " PD Training " with only employee names and signatures, no content delineated..

Review of Employee #8's personnel records revealed annual nursing assessment on [10/11/2021] and [08/30/2022] and the assessments did not include competency skills check on peritoneal dialysis.

Employee #4 confirmed during an interview conducted on 07/26/2023 that peritoneal dialysis for Patient #25 was performed by Employee #8.

Employee #3 confirmed during an interview conducted on 08/02/2023 that the only documented competency skills check for Employee #8 was for nursing assessments. Employee #3 confirmed Employee #8 had no documented competency skill for peritoneal dialysis.

Based on the review of hospital policies and procedures, documents, medical records observations, and interviews, it was determined that the Hospital failed to meet the requirement of the Conditions of Participation for Nursing Services as evidenced by the following references to standard-level deficiencies:

A-0144: The Hospital failed to ensure nine patients (Patients #40, 42, 43, 44, 45, 46, 47, 48, 53, and 54), received one to one observations as ordered.

A-0315: The Hospital failed to provide:
1. sufficient number of RNs in the Emergency Department (ED), according to hospital policies, to provide care to patients seeking treatment.
2. one to one sitters as ordered in the ED for patients requiring one to one observation.

A-0386: The Chief Nursing Officer failed to manage the overall operations of the nursing services of the facility.

A-0392: The Hospital failed to provide sufficient nursing personnel to ensure the safety of patients.

A-0397: The Hospital failed to ensure qualified personnel were performing peritoneal dialysis for one (1) patient (Patient #25).

A-0438: The Hospital failed to ensure medication administration was documented on patients' medication administration records in the medical record.

A-0449: The Hospital failed to ensure required documentation was present in medical records.

A-0508: The Hospital failed to ensure a medication error was properly documented according to the facilities policies and procedures.

The cumulative effect of these systemic deficient practices resulted in the facility's failure to meet the requirement for Condition of Participation in Nursing Services.

Based on the review of policies and procedures, hospital documents, medical records, observations, and staff interviews, it was determined the Chief Nursing Officer failed to manage the overall operations of the nursing services of the facility. This deficient practice poses a potential risk to the health and safety of patients if a lack of continuous nursing supervision in the provision of quality patient care to meet the needs of patients is provided in a timely manner, ensuring staffing was adequate to address the needs of the patient population, and establishing of policies and procedures for nursing staff adherence and proper surveillance of its implementation to preserve, maintain, and support the patient's physical and mental well-being.

Cross reference: A0385, A0392, A0397, A0438, A0449, A0508, A1104

Findings Include:

A job description for Chief Nursing Officer was requested and not provided.

An internet search of the Steward Health Care (Mountain Vista Medical Center parent company) website revealed a job description for Chief Nursing Officer. A review of the Chief Nursing Officer job description revealed: "...The Chief Nursing Officer is responsible for the direction of nursing and other patient care services as assigned...this position carries ultimate nursing authority and responsibility for planning, organizing, implementing, and evaluating nursing/patient care programs...The nurse executive or a designee exercises final authority over those associated with providing nursing care, treatment, and services...functions at the executive level to provide effective and coordinated leadership to deliver nursing care, treatment, and services...Directs nursing services in all areas/departments where nursing care is provided...Responsible for ensuring that nursing policies, procedures, and standards describe and guide how the nursing staff provides the nursing care, treatment, and services required by all patients...Assures that patient care needs in assigned departments are assessed, evaluated and met...Establishes the functions and qualifications for nursing positions...."

During the survey it was determined the Chief Nursing Officer failed to manage the overall function of nursing services by the following:

A-0144: Thehospital failed to ensure nine patients (Patients #40, 42, 43, 44, 45, 46, 47, 48, 53, and 54), received one to one observations as ordered

A-0315: The hospital failed to ensure that:
1. There was a sufficient number of RNs in the Emergency Department (ED), according to hospital policies, to provide care to patients seeking treatment.
2. There were one to one sitters available in the ED for patients requiring one to one observation.
3. Only qualified personnel performed peritoneal dialysis.

A-0392: The nurse executive failed to ensure sufficient nursing personnel was provided:
1. for patients requiring 1:1 observation in the Emergency Department (ED) were provided.
2. to prevent one (1) patient with suicidal ideations in restraints from eloping from the ED.

A-0397: The nurse executive failed to ensure qualified personnel were performing peritoneal dialysis for one (1) patient (Patient #25)

A-0438: The hospital failed to ensure medication administration was documented in the electronic medication administration record (eMAR) for one (1) patient (Patient #21)

A-0449: The hospital failed to ensure Hospital failed to ensure:
1. that required documentation was present in the medical record for two of two (2) patients (Patient #17 and Patient #21 ).
2. that the Nursing Staff documented the physician ordered One to One (1:1) observation in the medical record for one of one patient [#7] who eloped from this ED while awaiting a psychiatric evaluation.

A-0508: The hospital failed to ensure that a medication error was properly documented according to the facilities policies and procedures.

A-1104: The hospital failed to ensure that the ED staff made three (3) attempts at calling for a patient before designating the patient a "Left Without Being Seen".

Employee #16 confirmed on 08/01/2023 that the Chief Nursing Officer is responsible for nursing services.

Based on a review of hospital documents and interview, it was determined the Chief Nursing Officer failed to provide sufficient nursing personnel to ensure:
1. 1:1 sitters for patients requiring 1:1 observation in the Emergency Department (ED) were provided.
2. one (1) patient with suicidal ideations in restraints did not elope from the ED.
This failure poses the risk of patients who are experiencing an emergency medical condition or identified as requiring one to one observation not having the appropriate amount of care or supervision to prevent a serious safety event.

Cross reference A0315, A0385, 0386

Findings include:

Policy titled "Patient Acuity System," revealed: " ...Nursing administration will: Provide appropriate levels of staffing for each nursing unit according to needs identified ...In times when we are unable to meet the appropriate levels of staffing all avenues to correct any deficiencies will be explored including but not limited to reorganization of patient care responsibilities to protect patient safety ...The purpose of the Emergency Department Staffing System is to provide a mechanism for determining the staffing matrix in order to provide appropriate assignment of nursing personnel. This is completed by a periodic review of the emergency department's arrival by hour of the day (peak volume times) and average patient Emergency Severity Index (ESI level) assignments ...If at any time, the emergency department charge nurse determine that patient requirements outweigh available nursing resources, the emergency department charge nurse is to utilize the hospital chain-of-command to either redistribute available resources, augment current resources by calling in additional staff, and/or activating the hospital's disaster plan. As a result of the utilization of the Emergency Department Staffing System, nursing personnel will be able to: Provide quality patient care based on individualized patient care needs ...."

Policy titled "Patient Observation for Prevention of Harm (Non-Behavioral Health Units),"
revealed: " ...Patent observation is utilized for patients who are assessed and determined to be at risk for safety and/or harm to self and others. When patient observation is necessary, standardized processes and documentation are implemented ...This policy applies to all patients assessed to be a safety risk on inpatient units and in the Emergency Department ...One to One (1:1) Observation: Assignment of a qualified staff member to remain with the patient and maintain an unobstructed view of the patient at all times to prevent harm to the patient or others ...One to One (1:1) Observation a. Clinical Indications: High risk for Suicide, Patient in restraints for violent or self destructive behavior b. Patient Observer Role (1:1): Will have no other duties assigned, Will never leave a patient on 1:1 unattended ...Documents patient safety observations every 15 minutes on the Patient 1:1 Observation Monitoring Tool ...."

A review of "Patient Elopement and Leaving Against Medical Advice-7/10/2012, Last Reviewed: 6/14/2022, revealed: "...In order to maintain patient and public safety, the staff at every Steward Health Care System LLC hospital...shall take all appropriate measures to prevent patients from eloping from the hospital...If a patient does elope...staff will make reasonable efforts to ensure the patient's safe and timely return, as deemed necessary...
Definition: Elopement: The act, by a patient, of leaving the Hospital after evaluation by a medical or allied health professional staff member but prior to the completion of treatment without informing a member of the healthcare staff...When it is first noticed that an ED patient has eloped, a search of the ED shall be conducted immediately by the nursing and/or the ED's security staff...."

A review of "Patient Elopement (Code Green) and Post Elopement Follow-up"-Safety Manual-Final Approval Date: 10/01/2020, revealed: "...When an elopement occurs...it is the policy of the Hospital to act in accordance with the welfare of the patient and the public while respecting the patient's rights...Elopement...Strategies to reduce elopement risk...a patient is missing without authorization...PBX operator is notified and instructed to announce a Code Green overhead...The security department shall be notified immediately of the patient's elopement, and security personnel shall assist in the search for the patient...."
1.
A review of hospital documents titled "Security/Safety/Conduct Incident Details," and "Patient Care Incident Details," revealed 20 incidents reported in the ED from [07/01/2022], through [07/31/2023], documenting there was no one to one sitter available for a patient.

An incident dated [07/14/2022], revealed: " ...SI sitter had to be taken off this patient and put on another SI pt that was a minor per House supervisor [Deborah] no sitters avail to send to ER ...."

An incident dated [10/21/2022], revealed: " ...ER had four patients with one to one sitter orders, three for safety and one for SI. Due to issues with staffing, the ER tech was told [he] was responsible for sitting with all four patients ...."

An incident dated [01/29/2023], revealed: " ...sitter requested at [1745] from house supervisor ...pt has dementia and is a fall risk with an elopement risk ...No sitter avail for this patient as per day house supervisor ...."

An incident dated [05/30/2023], revealed: " ...Patient currently has safety sitter in place. Was informed by shift Charge nurse that the safety sitter is being pulled to do one to one observation for SI and patient would no longer have sitter. Suggested to have one to one SI sitter watch both patients ...."

Employee #28 documented one to one observations on Patient #53 and Patient #54 on [09/23/2022, from 1145 through 1445].

Employee #24 documented one to one observations on Patient #44 and Patient #45 on [07/24/2023, from 0715 through 0815].

Employee #18 confirmed in an interview on 08/02/2023, that s/he has reviewed several of these incident reports concerning no available one to one sitters in the ED.

2.

A review of "Steward Arizona Live" [07/08/23 13:40] through [07/09/23 01:34] revealed:
"...[07/08/23 13:40] created [07/09/23 01:27 Room 5]...attempting to climb out of gurney, attempting to remove the hands of ER staff from holding direct pressure on [his] bleeding wound...."

A review of "Steward Arizona Live" [07/08/23 23:05] created [07/09/23 00:54], revealed: "...pt grasped the side rail of the gurney with [his] right hand and pulled [himself] towards this RN and lunged forward with [his] mouth and attempted to bit(sic) this RN's right hand and forearm...."

Medical Records for Patient [#7]:

A review of "Emergency Department Document" [07/08/2023], revealed: "...Arrival...ED Triage Note...PT with large lac(sic) to left side of head...Poss(sic) self inflicted...Pt not compliant with EMS...Pt is handcuffed with MSCO(sic) [Maricopa County Sheriff's Office] at bedside...The patient became agitated and combative as we removed the dressing from the patient's head, revealing an arterial bleed...I gave a verbal order for restraints...Sheriff's deputy were assisting in holding the patient down for restraint application...ketamine took affect...patient became less combative...
[07/08/2023 18:01] Patient is still restrained...
[07/08/2023 18:52] Restraints removed from the patient at
[18:45]...Discharge:...Clinical Impression:...Medical clearance for psychiatric admission...
Medical Decision Making (MDM)...
[13:35] per nursing staff, patient was seen trying to steal IV start kit...This was taken from [him] and patient became angry and eloped from the department...
[13:36] I was informed by nursing that patient had woken up, gotten out of bed, was awake, alert and oriented and stated that [he] would be leaving...I was not informed of this until patient had already eloped...Patient never reported to EMS, myself, or any other hospital staff that [he] had any SI, HI and by report was clear medical decision-making capacity at the time of [his] departure...." Provider #7

A review of "ED Summary" [07/08/23-07/09/23] revealed:
"...[07/08/23 15:31]...Place on 1:1 observation...Risk of Restraint: Violent...Restraint Application:...< (less than) 4 hours for adults 18 years of age or older...Patient [#7 is 26] years of age...Risk to Self, Risk to Others...Extremity Soft 4 point...[18:15]...Behavior Continues...Restraint removed...leg restraints removed...Behavior Continues...
[18:30]...Restraint Continued...
[18:45]...No Longer a Risk to Others...Restraint Removed...
[23:15]...Pt medically cleared....
[23:37]...Pt eloped from ER...Pt wearing [his] personal belongings [he] retained throughout this ER visit when [he] eloped from the ER...."

Patient #7 medical record revealed a provider order for 1:1 sitter observation. No 1:1 sitter observation documentation was present in the medical record

Employee #18 and Provider #6 verified, during an interview conducted on 07/27/2023 at 11:15 a.m., that the one to one sitter observation form completed for patient [#7] on [07/08/2023-07/09/2023] cannot be located in the patient's medical record or elsewhere in the hospital.

A request was made for documentation of the "Post Elopement Follow-Up", none was provided for review at the time of the survey.

Employee #11 verified, during an electronic interview conducted on or about 07/27/2023, that patient #[7] was not in restraints at this time and did not bite or injure [him]. [He] called a Code Grey (out of control behavior) when [he] heard the patient's [sitter] yell for help. The patient was in room [13] which is directly across from the nurses station in the ED. When the patient eloped [he] reports the ED staff did place a call to law enforcement.

Employee #13 verified, during an electronic interview conducted on or about 08/01/2023, that [he] did not recall if patient [#7] had any restraints on [his] wrist or ankles when [he] eloped. [He] does report before the patient ran out of room [13] [he] was jumping on [his] bed and making animal sounds, then pushed past [him] running through the various ED area rooms and entering the inpatient hall area. Employee #13 verified, during this interview, that [he] did yell for help when the patient pushed past him to get into the hallway.

Based on review of records and staff interview, it was determined that the Hospital failed to ensure qualified personnel were performing peritoneal dialysis for one (1) patient (Patient #25). This deficient practice poses a risk to the health and safety of patients if unqualified staff are performing procedures that staff are not properly trained in performing.

Cross reference: A0315, A0385, A0386

Findings include:


Policy titled, " Competency Assessment " , revealed: " ...The hospitals ensure staff is competent to perform the responsibilities identified within their role and job description ....3. Competencies are assessed during the following intervals: Orientation: Organizational and applicable unit-specific entry-level competencies to be assessed prior to functioning independently, during the probationary time frame. Annual: Assessed within each calendar year .... "

Medical Record-Patient #25:

Patient #25 ' s medical record dated [02/25/2022] identified a flowsheet that noted Patient #25 received continuous cycling peritoneal dialysis performed by Employee #8.

Employee Files:

Documentation of Employee #8 skill verifications and competency assessments on peritoneal dialysis was requested. Employee #18 provided the document titled " PD Training " with only employee names and signatures, no content delineated..

Review of Employee #8's personnel records revealed annual nursing assessment on [10/11/2021] and [08/30/2022] and the assessments did not include competency skills check on peritoneal dialysis.

Employee #4 confirmed during an interview conducted on 07/26/2023 that peritoneal dialysis for Patient #25 was performed by Employee #8.

Employee #3 confirmed during an interview conducted on 08/02/2023 that the only documented competency skills check for Employee #8 was for nursing assessments. Employee #3 confirmed Employee #8 had no documented competency skill for peritoneal dialysis.

Based on review of records and staff interview, it was determined the Hospital failed to ensure medication administration was documented in the electronic medication administration record (eMAR) for one (1) patient (Patient #21). This deficient practice poses a risk to the health and safety of patients if hospital staff do not document medications given leading to possible overdose or missed medications for patients.

Cross reference: A-0385, A-0386

Findings include:

Policy titled, "Medication Administration", revealed: "...E. Administer Medication Safely ...4. Medication are scanned prior to being administered to the patient. If unable to scan a medication, the individual who will be administering the medication enters the bar code or National Drug Code manually into the eMAR. The portion of the packaging which contains the barcode is saved if possible and non-scanned item is reported to the pharmacy...."
Policy titled, "Automated Dispensing Machines", revealed: " ...Policy ...Access to ADMs is strictly managed to ensure medication security, proper documentation of medication use and confidentiality of the patient ...D. Override Access ...4. Nursing may override a medication from the ADM system under the following conditions: ...b. Emergencies when time does not permit the pharmacist review, such as STAT orders or situations when patient harm could result from delay in administration or a medication ...9. Medications removed using the override function will be routinely audited by the pharmacy ...."

Patient #21's Emergency Department medical record dated [03/28/2021] identified " ...Medical Decision-Making Narrative: [1152] The Patient was first evaluated. Plan for labs, EKG, imaging, Diltiazem and admission ....[1155] Patient has agreed to not be cardioverted and try to convert [his] A-Fib with Diltiazem [1211] After patient received Diltiazem [he] began seizing. [1214] Patient's heart brady'd {sic} down into the 50s. [1215] Code Blue was called, chest compressions were started, and first dose of Epi was given. [1222] Chest compression stopped and patient was intubated at this time (please see intubation note). [1223] Patient was Vtach and was shocked x2 with 150J. 1228 50mg of TPA was pushed...."


Patient #21's eMAR dated 03/28/2021 identified three (3) orders of Diltiazem were placed:
Diltiazem 20mg IV once Start: 03/28/2021 1156 Stop: 03/28/2021 1157 Status: DC Last Admin: 03/28/21 1704 Dose Admin Not Given
Diltiazem 25mg IV .STK-MED Start: 03/28/2021 1155 Stop: 03/28/2021 1156 Status: DC Last Admin: Dose Admin:
Diltiazem/Sodium Chloride 125mg in 125mls @ 0mls/hr IV .Q0M SCH Start: 03/28/2021 Stop: Status: DC Last Admin: Dose Admin:
No nursing documentation that Diltiazem was given.
No documentation in eMAR Diltiazem was given.


Employee #2 confirmed during a medical record review conducted on 07/26/2023 that the second order was an eMAR override. Employee #2 confirmed that the override function for the eMAR is used in emergent situations. Employee #2 further confirmed that the order for Diltiazem 20mg IV was prescribed by the physician to be administered as a push. Employee #2 confirmed that Diltiazem/Sodium Chloride 125mg in 125mls was order by the physician to be administered as an IV.

Employee #2 and Employee #4 confirmed that nursing staff did not document that the medication was given. Employee #2 and Employee #4 further confirmed that nursing staff did not document the route the medication was given. Employee #2 and Employee #4 confirmed that if a medication is override in the eMAR that nursing staff is to document when the medication is administered.

.

A. Based on review of policies and procedures, hospital documents and staff interviews, it was determined the Hospital failed to ensure:
1. that required documentation was present in the medical record for two of two (2) patients (Patient #17 and Patient #21 ).
2. that the Nursing Staff documented the physician ordered One to One (1:1) observation in the medical record for one of one patient [#7] who eloped from this ED while awaiting a psychiatric evaluation.
This deficient practice poses a risk to the health and safety of patients when there is no documentation on continuity of care and patient progress or condition.

Cross reference A0385, A0386

FINDINGS INCLUDE:
1.
Policy titled, "Nutritional Care Planning: Screening, Assessment and Monitoring", revealed: "...A. Nursing ...2. Nutrition screening, assessment, care planning, documentation and monitoring of nutrition status occur on admission and throughout the patient's hospital stay...."

Policy titled, "Medication Administration", revealed: "...E. Administer Medication Safely ...4. Medication are scanned prior to being administered to the patient. If unable to scan a medication, the individual who will be administering the medication enters the bar code or National Drug Code manually into the eMAR. The portion of the packaging which contains the barcode is saved if possible and non-scanned item is reported to the pharmacy...."

Policy titled, "Medication Administration", revealed: "...E. Administer Medication Safely ...4. Medication are scanned prior to being administered to the patient. If unable to scan a medication, the individual who will be administering the medication enters the bar code or National Drug Code manually into the eMAR. The portion of the packaging which contains the barcode is saved if possible and non-scanned item is reported to the pharmacy...."

Policy titled, "Medication Error and Adverse Drug Reaction (ADR) Reporting ", revealed: "...Procedure. A. General: 1. Medication Error, adverse drug reactions, and medication incompatibilities as defined by the hospital are immediately reported to the attending physician ...3. The staff member or physician who discovers the medication error, even if the error was corrected before reaching the patient or adverse drug reaction, is responsible for reporting. The report is submitted using the hospital online incident report system ...5. A description of the medication error or adverse drug reaction and outcome shall be documented in the patient's medical record...B Medication Errors 1. The department manager and Pharmacy in collaboration with Quality and Safety staff review, follow up and respond as necessary to each medication error 2. Quality and Safety reviews each medication error and follows the incident reporting policy 3. The Medication Safety Committee or equivalent reviews medication errors for trends and potential system failures. Recommendations and findings are reported to the Pharmacy and Therapeutics Committee and the Quality and Safety Committee ...."

Medical Record Patient #17:
No documentation or dietary notes present in Patient #17's medical record.
No documentation that Patient #17 received a liquid lunch that was ordered by the physician.

Medical Record Patient #21:
No nursing documentation that Patient #21 was administered Diltiazem.
No documentation in eMAR Diltiazem was administered to Patent #21.
No documentation of the medication error in Patient #21's medical record.
No documentation of communication with attending physician of the medication error in the Patient #21's medical record.

Employee #2 confirmed during a medical recorded review conducted on 07/27/2023 that it was documented that an order for a full liquid lunch diet was placed for Patient #17. Employee #2 further confirmed that there was no documentation that Patient #17 received that liquid lunch.

Employee #2 and Employee #4 confirmed that nursing staff did not document in Patient #21's medical record that the medication was given. Employee #2 and Employee #4 further confirmed that nursing staff did not document the route the medication was given. Employee #2 and Employee #4 confirmed that if a medication is override in the eMAR that nursing staff is to document when the medication is administered.

Employee #4 confirmed during a medical record review conducted on 07/31/2023 that the administration of rocuronium should have be documented as a medication error by the emergency department nurse in Patient #21's medical record. Employee #4 further confirmed that communication with the physician should have been documented in the medical record in either the critical value reporting and/or notification sections of Patient #21's medical record.

2.
A review of policy/procedure "Patient Observation for Prevention of Harm (Non-Behavioral Health Units) revealed: "...Patient observation is utilized for patients who are assessed and determined to be at risk for safety and/or harm to self and others...When patient observation is necessary, standardized processes and documentation are implemented...This policy applies to all patients assessed to be a safety risk...in the Emergency Department...
One to One (1:1) Observation: Assignment...staff member to remain with the patient and maintain an unobstructed view of the patient at all times to prevent harm to the patient or others...
Clinical Indications...
High risk for Suicide...
Patient in restraints for violent or self-destructive behavior...
Patient Observer Role (1:1)...no other duties assigned...never leave a patient on 1:1 unattended...
Remains in the room or at the door facing into the room in direct line of sight with the sole responsibility to ensure patient safety of the patient...
With Registered Nurse approval, may engage patient in diversional activities...
Uses the nurse call system or shouts for help...
Documents patient safety observations every 15 minutes on the 'Patient 1:1 Observation Monitoring Tool'...
Registered Nurse Role (1:1)...
Initiates 1:1 observation as ordered by the LIP...
Provides report to the observer, including patient's diagnosis, reason for observation, frequency of observation and patient care needs...
Retains full responsibility for the provision and/or delegation of all direct care...
Supervises staff observing the patient...
Receives report from the observer at appropriate intervals...
Documents at least every 2 hours...
Communicates assessment findings and changes in patient condition and/or behavior with LIP as appropriate...."

A review of "Patient 1:1 Monitoring Tool" revealed: "...RN Must:...Document Assessment & Reassessment per policy...Place original in medical records...Monitor every 15 minutes...."

The "Patient 1:1 Observation Monitoring Tool" for one of one patient [#7] was requested, none was provided for review at the time of the survey.

Employee #18 verified, during an interview conducted on or about 07/26/2023, that the "Patient 1:1 Observation Monitoring Tool" is missing from patient [#7's] medical record either in an electronic or tactile format.

Based on a review of hospital policy and procedures, medical records, and interviews, it was determined the hospital failed to ensure that a medication error was properly documented according to the facilities policies and procedures. This deficient practice poses the potential risk to the health and safety of the patient when medication errors are not documented resulting in inappropriate medication use or patient harm.

FINDINGS INCLUDE:

Policy titled, "Medication Error and Adverse Drug Reaction (ADR) Reporting ", revealed: "...Procedure. A. General: 1. Medication Error, adverse drug reactions, and medication incompatibilities as defined by the hospital are immediately reported to the attending physician ...3. The staff member or physician who discovers the medication error, even if the error was corrected before reaching the patient or adverse drug reaction, is responsible for reporting. The report is submitted using the hospital online incident report system ...5. A description of the medication error or adverse drug reaction and outcome shall be documented in the patient's medical record...B Medication Errors 1. The department manager and Pharmacy in collaboration with Quality and Safety staff review, follow up and respond as necessary to each medication error 2. Quality and Safety reviews each medication error and follows the incident reporting policy 3. The Medication Safety Committee or equivalent reviews medication errors for trends and potential system failures. Recommendations and findings are reported to the Pharmacy and Therapeutics Committee and the Quality and Safety Committee ...."

Policy titled, "Incident Reports: General Overview", revealed: " ...IV Reporting within the hospital/Steward ...E. Documentation in the Medical Record 1. The medical record should contain a complete, accurate record of clinical information pertaining to the event. When applicable, the documentation should include: a. Objective detail of the event written in non-judgmental language-facts only. b. The patient's condition immediately before the event. c. Intervention and patient response. d. Notification of the physician. e. Notification/discussion with the family ...."

Document titled, "Incident Detail Report", revealed: "...Incident Date [03/28/2021] Department Where Incident Occurred: Emergency Department General Incident Type: Medication/Fluid Specific Incident Type: wrong drug Final Incident Severity: Severity Level 2-Moderate ...Closed Date: [03/31/2021] ...Incident Description: Pt {sic} was unstable a-fib with rvr (atrial fibrillation with rapid ventricular response) already given bolus of Cardizem, pt continued to worsen and then coded, able to successfully resuscitate after shock x 2, compressions, and medications. This nurse [Will M, RN] accidently ran to put together a Cardizem drip, got interrupted by another nurse concern while pulling the medicine. This nurse was witnessed visualizing the med to confirm and thought he was confirming but attention clearly lacking and continued to mix the med and hang it at 5ml/hr. Immediately after walking out of the room, another nurse asked about rocuronium vials and this nurse realized [his] mistake, immediately stopping the medication and removed the line. Provider and nurses involved made aware of the mistake. The patient had just been intubated and sedated, the medication is not a dose that could cause any harm over 1-2-minute duration. ...."

Quality Meeting Minutes form January-September 2021 were not provided by the facility.

No documentation of the medication error was recorded in Patient #21's medical record.

No documentation of communication with attending physician of the medication error in Patient #21's medical record.


Employee #4 confirmed during a medical record review conducted on 07/31/2023 that the administration of rocuronium should have be documented as a medication error by the emergency department nurse in Patient #21's medical record. Employee #4 further confirmed that communication with the physician should have been documented in the medical record in either the critical value reporting and/or notification sections in Patient #21's medical record.

Based on observation on tour and staff interview, it has been determined the hospital failed to ensure the condition of the physical plant and overall hospital environment is maintained in a manner that the safety and well-being of patients are assured.
This failure has the potential risk that without proper maintenance of the hospital property and proper storage of outside oxygen tanks puts the patients, visitors, and staff at risk of physical injury from their environment.

Findings include:

A review of "Environment of Care Safety/Emergency Management/Threat Assessment Team Committee Meeting" revealed no indicators or discussion of the condition of the hospital property and the two uncovered oxygen tanks stored in the open on the helipad.

1.) OBSERVATION on tour and photographs::
Entering the hospital property occurred on 07/26/2023 through 08/02/2023, and 08/09/2023 and revealed when driving onto the hospital property and throughout the asphalt covered roadways there are multiple overgrown trees obstructing passage on the driveways to the hospital main entrance and ED entrance.

There are dried and dead cacti laying flat on the ground and unidentifiable dry weeds located at the hospital entrance signage and throughout the property flower beds.

Located on either side of the hospital's main entrance are grassy areas which appears overgrown to a height of approximately four to six inches. At the base of some of the grass areas are yellow to brown areas.

The area of the hospital helipad, across from the Emergency Department location, revealed multiple tall trees located around the helipad fence.


2.) OBSERVATION on tour:
Based on a review of the "National Weather Service Report" for Maricopa County, Arizona revealed: Excessive Heat Warnings for July 2023 through August 16, 2023.

The National Weather Services defines a "Warning"as meaning it's time to take precautions to protect yourself from severe weather.

The hospital helipad is located across an asphalt paved roadway from the Emergency Department entrance.

Currently, 07/26/2023 through 08/02/2023 and 08/09/2023 there are two size H oxygen tanks stored in metal carts standing in direct sunlight on the helipad. Using a temperature gun revealed a current oxygen tank temperatures measuring 145 degrees Fahrenheit, exceeding the acceptable temperature of 135, at 1455 hours on 08/09/2023, with an ambient temperature of 103 degrees Fahrenheit. Photos provided.

A review of "NFPA 99 2012 Edition Chapter 11 Section 11.6.5. Special Precautions - Storage of Cylinders and Containers. Section 11.6.5.4 revealed: "...Cylinders stored in the open shall be protected as follows: (1) Against extremes of weather and from the ground beneath to prevent rusting... (3) During summer, screened against continuous exposure to direct rays of the sun in those localities where extreme temperatures prevail...11.3.2.1 Storage locations shall be outdoors in an enclosure...with doors (or gates outdoors) that can be secured against unauthorized entry...."

Employee #18 verified, during an electronic interview conducted on 08/10/2023, that the physical enviroment is creating a risk to the patient, staff, and visitor safety due to overgrowth of trees and grass, dead plants and weeds, and two uncovered oxygen tanks stored on the helipad that are exceeding the acceptable temperature range by 15 degrees Fahrenheit.

Based on a review of facility documents and staff interviews, it was determined the emergency department medical staff failed to ensure that ED staff made at least three attempts to call for a patient in their waiting area over no less than 30 minutes before a one of one patient [#8] is designated as "Left Without Being Seen".

This failure has the potential risk that a patient may not be able to receive ED services if they do not respond to their name when it is called out only once while they are in the ED waiting area.

Findings include:

A review of "Emergency Department Left Without Being Seen" 02/19/2019, revealed: "...Patients given this designation, leave the ED before being placed in the room...before the physician completes the medical record screening exam...They will be called in the waiting room three times covering no less than 30 minutes before closing the chart...Documentation of attempts to find the patient without success and disposition of the patient being left without being seen must be documented in the patient's chart...."

Medical Record for Patient [#8]:

A review of "Care Assessment" [07/29/22] revealed: "...Patient [#8] was triaged at [20:29] and 'ED Disposition Documentation' was completed at [20:47] or 18 minutes later.

There is no documentation in the ED record of staff attempts to call the patient in the waiting room three times covering no less than 30 minutes before closing the chart.

A review of "Care Assessment" [08/15/22] revealed: "...Patient [#8] was triaged at [23:56] and 'ED Disposition Documentation' was completed at [08/16/22 01:28] or one hour: thirty-two minutes for 92 minutes later.

There is no documentation in the ED record of staff attempts to call the patient in the waiting room three times covering no less than 30 minutes before closing the chart.

A review of "Care Assessment" [08/19/22] revealed: "...Patient [#8] was triaged at [02:09] and 'ED Disposition Documentation' was completed at [02:54] or 45 minutes later...."

There is no documentation in the ED record of staff attempts to call the patient in the waiting room three times covering no less than 30 minutes before closing the chart.

A review of "Care Assessment" -[07/29/22 20:29] revealed: "...ED Triage Assessment...Walk-In...ED Triage Note...CP (chest pain) and headache x 7 months...Feels [he] is 'targeted through my electronics and feels [he] is being radiated by my phone...Exposed to ultra high pitched radio frequency'...ED Vital Signs with Sepsis...Clinical criteria Present...None...."

Employee #18 verified, during an interview conducted on 07/31/2023 at 10:22 am, that patient #8 left the ED without being seen by the provided after approximately 19 minutes after being triaged.

A review of "Care Assessment" -[08/11/22 23:56] revealed: "...ED Triage Assessment...Walk-In...ED Triage Note...Chest Pain started 30 min ago non radiating to L chest denies cough or SOB (shortness of breath)...States someone is targeting [him] with high frequency radiation with corrupt cops in the Freemont(sic), Neb precinct...."

A review of "Emergency Department Document" [08/12/22 00:10-05:01] revealed: "...Chest Pain...history of MI (myocardial infarction) and anxiety...chest pain onset about one hour...H/O (history of) angioplasty...[08/12/22 00:40]...Patient initially evaluated...[08/12/22 04:53] Follow up and discharge instructions were discussed, Patient was given strict return precaution to the ED if symptoms worsen...[08/11/22 23:54] EKG ED Electrocardiogram Stat......Discharge Date/Time: [08/12/22 05:01]...."

A review of "Care Assessment" [08/15/22 23:56] revealed: "...Walk-In...Triage Note...'My pancreas is really hurting me'...ED Disposition Documentation [08/16/22 01:28]...Discharge Comment...patient did not want to wait any longer...Patient Disposition...Left Without Being Seen...."

A review of "Care Assessment" [08/19/22 02:09] revealed: "...Walk-In...ED Triage Note...chest pain, pancreas hurts...[08/19/22 02:54]...Patient Disposition...Left Without Being Seen...."

Employee #18 verified, during an interview conducted on 07/31/2023 , that patient [#8] did have an EKG obtained six minutes after arrival and results were a 'normal ECG.'

Employee #18 verified, during an interview conducted on 07/31/2023, that the staff failed to follow the facility policy
when a patient has been designated as "Left Without Being Seen" for one of one patient (#8) over three of four ED visits.