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Based on interview and record review, the hospital failed to follow the State of California reporting requirements for one of one patient, Patient 13, when Patient (Pt) 13 died while in restraints within minutes after medications to sedate him were given and the occurrence was not reported to the California Department of Public Health (CDPH). This failure delayed the investigations of the incident by CDPH and had the potential to place other patients at risk of unreported adverse events that could lead to harm or death.

Findings:

During a review of Pt 13's "Electronic Health Record (EHR)" dated 5/19/22 to 5/23/22, the EHR indicated, Pt 13 was a 38-year-old man who arrived at the Emergency Department (ED) on 5/19/22 at 4:05 p.m. from the County Jail and was admitted to the Neurocritical Care Unit on 5/20/22 at 3:41 a.m., for Altered Mental Status (AMS- a change in the mental function that stems from illness, disorders and injuries that have affected the brain) left thalamic mass (brain tumor) and developing hydrocephalus (buildup of fluid in the brain). The EHR indicated that Pt 13 had a past medical history of Diabetes Mellitus (bodies inability to produce or respond to insulin is impaired, resulting in elevated sugar in the blood and urine), Schizoaffective Disorder (mental illness that can affect your thoughts, mood and behavior) and sleep apnea (a disorder that causes a person's breathing to stop or get very shallow) requiring a CPAP (a machine that uses mild air pressure to keep breathing airways open while you sleep) machine while asleep on the unit. The EHR indicated Pt 13 had a bedside procedure of an External Ventricular Drain (EVD- temporary method of draining fluid from the brain) placed in his skull on 5/20/22. The EHR indicated no issues with the EVD during Pt 13's stay. The EHR indicated the patient required non-violent soft restraints for his upper extremities (hands and arms) during his entire hospital admit stay for interference with medical treatment, as well as a prisoner shackle around his left ankle. An additional restraint was added to the right ankle on 5/23/22 at 2:40 p.m. for interference with medical treatment as well. The EHR indicated a biopsy (a procedure to remove cells, tissue, or fluid for examination by a medical pathologist [a Medical Doctor who determines if there is presence of disease in tissue sampled]) of the thalamic mass was ordered, but never fulfilled due to Pt 13 expiring (died) before transfer to the Operating Room (OR).

During an interview on 7/31/24 at 1:35 pm. with the Director of Risk Management, Regulatory, and Patient Safety (RMD), Pt 1's death in May 2022 was discussed. RMD stated and confirmed Pt 1 was in restraints at the time of death, and death occurred within minutes after being given sedative medication. The RMD stated, "We [meaning the hospital] did not report this incident." RMD stated the case was reviewed and it was decided that the hospital would not report.

During a review of hospital policy titled, "Adverse Event Reporting to the California Department of Health Services" dated 01/03/2022, the policy indicated, " PURPOSE: A. to comply with the mandated reporting requirements of health and safety code 1279. B. to support the improvement of patient safety and quality improvement initiatives. II. Definitions - A. Adverse Event includes any of the following... 23. A patient death or serious disability associated with the use of restraints or bedrails ..."

The Health and Safety Code, Division 2, Licensing Provisions [1200 - 1796.70], Chapter 2 Health Facilities [1250 - 1339.59], Article 3. Regulations [1275 - 1289.5] section 1279.1. indicates: " (a) A health facility licensed pursuant to subdivision (a), (b), or (f) of Section 1250 shall report an adverse event to the department no later than five days after the adverse event has been detected, or, if that event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, not later than 24 hours after the adverse event has been detected. Disclosure of individually identifiable patient information shall be consistent with applicable law. (b) For purposes of this section, "adverse event" includes any of the following: ... 5 ...(E) A patient death or serious disability associated with the use of restraints or bedrails while being cared for in a health facility.

The California Code of Regulations, Title 22 section 76551 - Unusual Occurrences indicates: "(a) Occurrences such as epidemic outbreaks, poisonings, fires, major accidents, deaths from unnatural causes or other catastrophes and unusual occurrences which threaten the welfare, safety or health of clients, personnel or visitors shall be reported by the facility within 24 hours either by telephone with written confirmation, or telegraph to the local health officer and the Department. (b) In the event of any unusual occurrence, including serious illness or accident, impending death or death, the client's parent, guardian or authorized representative shall be notified promptly. (c) An unusual occurrence report shall be retained on file by the facility for five years. The facility shall furnish such other pertinent information related to such occurrences as the local health officer or the Department may require ..."

Based on observation, interview and record review, the facility failed to protect and promote patient's rights for seven of seven sampled patients when:

1. Resident physician broke the sterile field by leaving behind the right index finger of his latex glove inside the pleural cavity of a Pt 3 when doing a chest tube bedside procedure. (Refer to A144 finding 1)

2. Patient 2 had a Penrose drain placed after a procedure that was charted removed by a Resident when it was not. That Penrose drain was found incidentally in a CT scan 4 days after it was charted removed. The drain was then removed bedside, without informed consent. (Refer to A144 finding 2)

3. Pt 1 had physician ordered Intravenous (IV- into or within a vein. IV usually refers to a way of giving a drug or other substance through a needle or tube inserted into a vein) access and continuous cardiac telemetry monitoring (technique or device that enables continuous tracking of your heartbeat. It measures the electrical activity of your heart), was removed, without first notifying the ordering physician in accordance with hospital policies and procedures (P&P). ED LNs then moved Pt 1 from the green zone to the ED Special Care unit (SCU) where Pt 1's complex medical needs could not be met. ED LNs did not adhere to criteria for admission to SCU for Pt 1. (Refer to A144 finding 3)

4. Pt 9 and Pt 10 were admitted to inpatient beds and remained in the ED. The hospital did not provide privacy curtains and showers for Pt 9 and Pt 10. (Refer to A144 finding 4)

5. Patient (Pt) 32, was provided appropriate information about advance directives in accordance with the Policy and Procedure, Advance Care Planning. (Refer to A132)

6. The hospital failed to ensure non-violent restraints were discontinued at the earliest possible time and in accordance with hospital Policy and Procedure (P & P) "Restraints and Seclusion" for one of 68 patients, Patient (Pt) 30, when there was no documentation of behaviors that supported use of the restraints. (Refer to A174)

7. The hospital failed to follow reporting requirements when a Patient (Pt) 13 died while in restraints and the occurrence was not reported to the California Department of Public Health (CDPH) within five days after the event was detected. (Refer to A213)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure patients were cared for in a safe manner, and their rights were protected and promoted at all times.

Based on observation, interview and record review, the hospital failed to ensure an organized nursing service that provides 24-hour nursing when:

1. Emergency Department (ED) nurses assigned to care for Pt (Patient) 1 did not provide the level of care for which Pt 1 was admitted and did not follow physician orders and did not follow criteria for admission to the Special Care Unit (SCU - a secure, restricted area in the ED for behavioral patients) in accordance with hospital policy and procedure. (Refer to A398, Finding 1)

Because of the possible avoidable death of Pt 1 and the serious potential harm related to not following policies and procedures meant to provide Pt 1 CPCU (Cardiac Progressive Care Unit) telemetry (patients with chronic cardiac conditions are monitored remotely using medical equipment) level of care and nurses not following policies related to criteria for admission to the SCU, an Immediate Jeopardy (IJ- a situation where a provider's noncompliance with requirement has, or could, cause serious harm to resident) situation was called on 7/26/24 at 1 p.m. with the Chief Nursing Officer (CNO), Chief Operating Officer (COO) and Director of Nursing Operations (DNO) under A398, CFR 482.23(b)(6). The CMS (Centers for Medicare and Medicaid Services) IJ Template form was provided to the hospital and instructions were given to submit a Plan of Removal (PoR) to address the IJ situation. Version 1.1 of the PoR (Version 1 was rescinded by the hospital) was submitted and determined to be unacceptable on 7/29/24 at 10:35 p.m. PoR Version 2 was submitted and acceptable as of 7/29/24 at 2:25 p.m. The survey team validated all actions on the PoR were implemented and the IJ was removed on 7/30/24 at 9 a.m., while onsite, with CNO, COO and DNO. After removal of the IJ, the hospital remained in substantial non-compliance.

2. Nurses in the Cardiovascular (relating to heart and blood vessels) Intensive Care Unit of Hospital B did not date control solutions for two of four sampled glucometers in accordance with hospital policy and procedure and manufacturer instructions (glucometer -- a device for measuring the concentration of sugar in the blood; control solutions - a liquid used to test the functionality of meter and strips). (Refer to A398, finding 2)

3. Nurses in the ED did not develop, implement and update a current nursing care plan (a patient-centered health document designed to facilitate communication among members of the care team and with the patient) for six of six patients (Pt 9, Pt 10, Pt 37, Pt 38, Pt 39 and Pt 40) in accordance with their policy and procedures (P&P) titled "Admission & Ongoing Assessment - Nursing (Acute Care)" and "Interdisciplinary Plan of Care". (Refer to A398, finding 3)


4. Nurses assigned to one of four sampled patients in the ED (Pt 66) for Hospital A did not perform vital signs (measurements of the body's most basic functions) and pain assessments and monitoring in accordance with hospital P&P. (Refer to A398, finding 4)

5. Nurses in the ED assigned to care for Pt 67 did not follow monitoring protocol in accordance with physician order, hospital P&P and Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar-an instrument used by medical professionals to assess and diagnosis the severity of alcohol withdrawal (symptoms that may occur when a person who has been drinking too much alcohol on a regular basis suddenly stops drinking alcohol). (Refer to A398, finding 5)


6. Nurses in the ED stored empty oxygen tanks in the cage reserved for full oxygen tanks and not accordance with hospital policy and procedure and professional standard. (Refer to A398, finding 6)

7. Nurses in the ED assigned to Pt 70 did not label Pt 70's inhaler in accordance with facility policy and procedure. (Refer to A398, finding 7)

8. Nurses assigned to Pt 28 did not assess Pt 28's chest tubes (plastic tube that is used to drain fluid or air from the chest) within two hours of admission as per the hospital's P&P titled "Standards of Practice - Acute Medical/Surgical, Telemetry, Step-Down (area that provides intermediate-level care between the Intensive care unit and the general medical-surgical wards) and Critical Care Units" dated 2/22/23. (Refer to A398, finding 8)


9. Nurses assigned to Pt 29 and Pt 46 performed electroencephalogram (EEG, test that measures electrical activity in the brain) monitoring while the patients were in a medical-surgical nursing unit and not in accordance with hospital policy and procedure. (Refer to A398, finding 9)

10. Nurses caring for Pt 31, Pt 32 and Pt 33 did not ensure the assigned patient monitor (or a sitter) did not exceed two patients in accordance with hospital policy and procedure. (Refer to A398, finding 10)

11. Nurses did not develop an individualized care plan for Pt 28's chest tube (a plastic tube that is used to drain fluid or air from the chest) care and management. (Refer to A396, finding 1)

12. Nurses did not update and include Pt 45's right buttock and sacral (near the lower back and spine) wounds in the care plan. (Refer to A396, finding 2)

13. Nurses did not develop and are plan interventions to address use of patient monitor for Pts 31, 32 and 33. (Refer to A396, finding 3)

14. Registered Nurse (RN) 2 did not follow the Policy and Procedure (P&P) titled "Blood Products Transfusion" for one of one patient, Patient 44. RN 2 failed to fill the filter drip chamber (a chamber with a filter used to remove contaminants from the infusion of fluids before it enters the bloodstream) with normal saline (a mixture of water and salt concentration of 0.9) above the filter. (Refer to A410)

The cumulative effect of these system problems resulted in the hospital's inability to provide care in a safe and quality setting.

Based on observation, interview, and record review, the hospital failed to have an active Infection Prevention and Control program which adhered to nationally recognized infection prevention and control guidelines for the surveillance, prevention, and control of HAIs (hospital acquired infections) and other infectious diseases, when:

1. Sterile Processing Technician (SPT) was observed in the decontamination (area where reusable medical equipment is cleaned, disinfected, and sterilized [process of complete elimination and destruction of all forms of microbial life]) area of the Sterile Processing Department (SPD) scrubbing instruments above the enzymatic (cleaner that uses a natural process of breaking down bacteria and organic waste) cleaning solution water line. The SPT failed to follow hospital policy and procedure and AAMI (Association for the Advancement of Medical Instrumentation- a primary source for the development, management, and use of safe and effective health technologies for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals) standards of practice. (Refer to A750 Finding 1)

2. Medical Doctor Resident (MDR 2- 2nd year resident at the time of the incident), MDR 2 broke the sterile field by leaving behind the right index finger of his latex glove inside the pleural cavity of a patient when doing a chest tube bedside procedure. This placed Pt 3's safety at-risk due to the possibility of infection. (Refer to A750 Finding 2)

3. Nursing staff did not clean three of three sampled pill crushers (turn pills into powder) in the Emergency Department (ED) were visibly soiled with white-colored chalk-like residue, and orange-colored stains to metal pieces and throughout the device. (Refer to A750 Finding 3)

4. Staff did not ensure equipment, supplies and floors were clean and organized, in two of three sampled ED Supply and Medication Rooms. Patient care supplies found on the floor, outside their designated clean supply storage cupboards and floor surfaces were visibly soiled, dusty with stains and trash on them. (Refer to A750 Finding 4)

5. Hospital staff did not perform hand hygiene according to hospital policies and procedures. (Refer to A750 Finding 5)

6. Staff did not ensure proper infection control practices were implemented during a wound care treatment for one of one sampled patient (Pt 45). (Refer to A750 Finding 6)

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality patient care in a safe environment.

Based on interview, and record review, the hospital failed to ensure one of 68 patients, Patient (Pt) 32, was provided appropriate information about advance directives in accordance with the Policy and Procedure, Advance Care Planning.

This failure resulted in denying Pt 32 the right to elect to have a person make healthcare decision on their behalf.

Findings:

During a record review of the hospital's policy and procedure titled Advance Care Planning effective 4/13/23, showed each adult patient, upon admission, is to be provided written information including when an adult individual is incapacitated at the time of admission and is unable to receive information (due to the incapacitating condition or mental disorder) or articulated whether or not he or she has executed an Advance Directive, information about Advance Directives maybe provided to the family members or Substitute Decision Maker.

During a record review of Pt 32's medical record showed the patient was admitted to the hospital on 6/13/24.

During a record review of Pt 32's Hospitalist History & Physical dated 6/13/24 at 4:54 pm, showed the patient was gravely disabled who came from a skilled nursing facility, and included a medical history of dementia. The patient's primary emergency contact information was included in the documentation.

During a record review of Pt 32's Advance Directives (a document that would inform healthcare providers who should speak for a patient and what medical decisions they should make for the patient if a patient lost the ability of speaking for herself/himself) documentation dated 6/14/24 at 10:37 pm, showed the following;

-the patient did not have a healthcare directive,
-the patient did not request about information on advance care planning,
-the patient did not have an appointed surrogate decision maker.

Further review on the admission assessment of Pt 32 dated 6/21/24 at 2:08 am, showed the patient was unable to provide reliable information and did not have family members to contact for information.

During a concurrent interview and record review on 7/26/24 at 10:34 am with Medical Surgical Director (MSD), MSD acknowledged the above findings. MSD was asked to explain "Information on Advance Care Planning Requested" meant as shown on the Advance Directives documentation of Patient 32's medical record. MSD stated the patient was offered information including advance directives; however, the patient declined to receive information about advance directives. MSD acknowledged Pt 32 did not have the capacity to receive information about advance directives.

Based on, interview and record review, the hospital failed to ensure care was provided in a safe setting for five of five patients (Patient (Pt) Pt 1, 2, 3, 9 and 10) when:

1. Resident physician broke the sterile field by leaving behind the right index finger of his latex glove inside the pleural cavity of a Pt 3 when doing a chest tube bedside procedure.

This failure had the potential to put Pt 3's safety at-risk due to the possibility of infection.

2. Patient 2 had a Penrose drain placed after a procedure that was charted removed by a Resident when it was not. The Penrose drain was later identified incidentally in a CT scan four days after it was charted removed. The drain was then removed during a bedside procedure, without informed consent.

This failure had the potential for infection for Pt 2.

3. Pt 1 had physician ordered Intravenous (IV- into or within a vein. IV usually refers to a way of giving a drug or other substance through a needle or tube inserted into a vein) access and continuous cardiac telemetry monitoring (technique or device that enables continuous tracking of your heartbeat. It measures the electrical activity of your heart) removed without first notifying the ordering physician in accordance with hospital policies and procedures (P&P). Emergency Department (ED) Licensed Nurses (LN) then moved Pt 1 from the green zone to the ED Special Care unit (SCU) where Pt 1's complex medical needs could not be met. ED LNs did not adhere to criteria for admission to SCU for Pt 1.

These failures resulted in nurses not providing the level of care and monitoring ordered by the physician, led to Pt 1 lying on the floor unnoticed for several minutes and later found pulseless with a large amount of blood on the floor next to him and from his mouth and possibly contributed to a delay in nurses recognizing and responding to Pt 1's change in condition. Pt 1 died after unsuccessful attempts at CPR. These failures denied Pt 1 care in a safe setting.

4. Pt 9 and Pt 10 were admitted to inpatient beds and remained in the ED. The hospital did not provide privacy curtains and showers for Pt 9 and Pt 10.

These failures resulted in a violation of Pts 9 and 10's right to have the same level of individualized nursing care, privacy, courtesy and dignity as other patients occupying inpatient beds.

Findings:

1. During a review of Pt 3's "History and Physical (H&P)", dated 11/19/23 at 8:17 p.m., the H&P indicated, " ...54-year-old ... patient who was found down ... GSC 12 ... initial x-ray shows severe left sided chest wall deformity. Left chest tube placed in trauma Bay ... hypotension (low blood pressure) to 60s - 70s ... decision was made ... to intubate the patient ... Assessment/Plan: Pedestrian injured in nontraffic accident involving motor vehicle... Closed fracture of nasal bone (broken nose) ... Fracture of body of left scapula (broken left shoulder blade) ... Fracture of multiple ribs of both sides ... Hemopneumothorax (blood collecting in the pleural cavity) on left ... Plan: Service to admit to ICU (Intensive Care Unit) ...".

During a review of Pt 3's "Surgical Operative Report (SOR)", dated 11/22/23 at 10:52 p.m., the SOR indicated, " ...Preoperative Diagnosis: Trauma ... Procedure Performed: 1. Open Reduction (repositioning of bone pieces so they are back to proper alignment) and internal fixation (method of physically reconnecting bones) of left sided ribs 3-9. 2. Intercostal nerve block (an injection of medication under the rib that helps relieve pain) left side levels 3-9. 3. Tube thoracostomy (tube that drains fluid or air around the lungs) left side ... Findings: ... We removed a foreign object which we suspected is a piece of a surgical glove that was sent for pathology for gross evaluation ...".

During a review of Pt 3's "Retained Foreign Object Picture (RFO)", dated 11/22/23, the RFO indicated, a piece of surgical glove measured approximately 1-inch (unit of measurement) in length.

During an interview on 7/31/24 at 3 p.m., with the Chief Medical Quality Officer (CMQO) and the Chief Medical Officer (CMO), the CMQO stated they were aware of the incident. The CMO stated a "broken barrier" should be addressed, acknowledged and rectified. The CMQO stated the resident physician should have "spoke up" when the glove was torn and notified his Attending Physician. The CMQO stated the retained glove could have caused an infection.

During an interview on 8/2/24 at 5:30 p.m., with Medical Doctor Resident (MDR 2- 2nd year resident at the time of the incident), MDR 2's interview on 6/6/24 at 12:30 p.m., was validated, and MDR 2 stated he was the person that put in the original chest tube for Pt 3. MDR 2 stated the chest tube insertion was a sterile procedure. MDR 2 stated during the chest tube insertion was performed by feeling into the pleural cavity (space that surrounds the lungs), so he had to digitally enter (stick finger in) the cavity. MDR 2 stated while in the pleural cavity he manually exploraed the area and this is when his right sterile glove index finger ripped. MDR 2 stated he "didn't think the glove could be in the patient". MDR 2 stated when his glove ripped, he did not notify any staff (three different physicians were with him) involved that it happened. MDR 2 stated in hindsight he should have notified his Attending Physician that was present. MDR 2 stated the expectation for the procedure was that the glove stay intact and not be left inside the patient. MDR 2 stated the patient had the potential to develop an infection. MDR 2 stated Pt 3 could have been harmed by the piece of glove that was left inside.

During an interview on 8/2/24 at 5:30 p.m., with the Director of General Surgery Residency (DGSR), the DGSR's interview on 6/6/24 at 12:50 p.m., was validated, and the DGSR stated the chest tube insertion was a sterile procedure and the sterile field was compromised when the glove ripped inside of Pt 3. The DGSR stated Pt 3 had the potential to develop an infection due to the glove piece being left inside. The DGSR stated MDR 2 did not follow the hospital policy and procedure (P&P) for patient's safety and infection control. The DRSR stated when MDR 2 broke his glove, he should have notified the staff members what happened, removed the gloves and put on new sterile gloves.

During an interview on 8/2/24 at 6 p.m., with the Quality Outcomes Manager (QOM), the QOM stated Medical Doctor- Fellow (MDF) 2 who found the glove in the procedure, no longer was with the organization and the previous interview from 6/6/24 at 1:20 p.m., could be used. The MDF 2 stated he found the piece of glove during Pt 3's procedure. The MDF 2 stated Pt 3 had a potential for an infection by having the glove piece left inside of her after the chest tube was placed. The MDF 2 stated Pt 3's infection risk would be "great". The MDF 2 stated there was ultimately a potential for death for Pt 3 by leaving a glove behind because of her acuity (severity level of an illness or medical condition) level at that time.

During an interview on 8/3/24 at 9 a.m., with the Director of Infection Prevention, the Infection Prevention Manager (MIP) and Infection Prevention Supervisor (IP Sup), the DIP stated the expectation was "that this doesn't happen" and maintain the sterile field. The MIP stated this incident was "concerning". The MIP stated "our intention" was for this not to happen to reduce the "likelihood" of cross-contamination into the sterile field.

During a review of the facility's policy and procedure (P&P) titled, "Safety Management Plan", dated 3/21/23, the P&P indicated, "I. OBJECTIVES: the objective of the safety management plan is to promote a safe, functional and supportive environment within the hospital ... quality and safety are preserved for our patients ... II. SCOPE: the scope of this plan applies to personnel and licensed independent practitioners who work at [Hospital], with applicability to the safety of our patients ... IV. RESPONSIBILITIES: ... 6. Staff: staff members are responsible for abiding by policies and procedures ... following safe practices while working ...".

2. During a review of Patient (Pt) 2's "History & Physical (H&P)", dated 2/8/24, the H&P indicated, " ... Chief Complaint: Generalized Weakness ... History or Present Illness: ... 72-year-old ... female with Type II Diabetes Mellitus (a disease that occurs when your blood sugar is too high) and hypertension (high blood pressure) who presents with malaise (weakness), right lower extremity pain an abnormal labs. Patient recently had a prolonged hospitalization after a pedestrian vs. automobile (accident) resulting multiple fractures (broken bones) ... [right tibia/fibula (leg) status/post ORIF (Open reduction and internal fixation is a surgical procedure for repairing fractured bone using either plates, screws to stabilize the bone), left tibial plateau fracture (broken shin), multiple sacral (bottom of the spine) and pelvic fractures, right proximal humerus (shoulder)] ... discharged to (Skilled Nursing Facility) on 2/2/24 ... Per nursing staff ... patient was more confused than usual and found to have leukocytosis (high white blood cell count) ... she received 1 dose intramuscular (in the muscle) ceftriaxone (antibiotic) prior to transport to the Emergency Department (ED) ... Hospital problems: Healthcare associated pneumonia ... Anasarca (generalized swelling of the body) ... tibia/fibula fracture ... type II diabetes ... Hypertension ...".

During a review of Pt 2's "Consult Note (CN)", dated 2/13/24, the CN indicated, " ...fluid collection anterior (toward the front of the body) right ... shoulder joint ... status/post right shoulder aspiration (a procedure to remove fluid) ... Orthopedics on board and plan for Incision and Drainage (I&D- surgical procedure to release pus or pressure built up under the skin) of right shoulder today ...".

During a review of Pt 2's "Orthopedic Surgery Operative Report (SOR)", dated 2/14/24, the SOR indicated, " ... Postoperative diagnosis: right humerus (upper arm bone) fracture infected hematoma ... Drains: 1 Penrose drain (a soft, flat, flexible tube made of latex. It lets blood and other fluids move out of the area of your surgery) ... Complications: none ... Condition: Stable ...".

During a review of Pt 2's "Progress Note: Orthopedic Surgery (PNOS)", dated 2/17/24 at 9:12 a.m., the PNOS indicated, " ...Hospital course: ... She reports pain everywhere and it is difficult to get a story out of her. She is very ill appearing ... Patient is now status post right shoulder I&D 2/14 ... Objective: ... Right upper extremity: visual: surgical incision clean, dry and intact without surrounding erythema (redness)/edema (swelling) ... Assessment/Plan: ... She is much improved. Patient in stable condition from orthopedic perspective. No further orthopedic intervention indicated ... Drain: Penrose drain s/p (status/post) removal ... (signed) Medical Doctor/Fellow (MDF) 1 ...".

During a review of Pt 2's "CT (a procedure where a computer linked to an x-ray machine takes detailed pictures of the inside the body) Chest Abdomen and Pelvis with Contrast", dated 2/21/24 at 2:12 a.m., the CT indicated, " ... Reason for exam: sepsis, worsening leukocytosis ... Findings: ... Right humeral surgical neck fracture. An internalized drain fragment measuring 8 cm (centimeter- unit of measurement) in length is positioned along the anterior margin of the fracture and does not extend to the dermis. Consider orthopedic consultation ...".

During a review of Pt 2's "Treatment Plan- Orthopedics Update (OU)", dated 2/21/24 at 1:09 p.m., the OU indicated, " ...Ortho service paged regarding incidental finding of retrained surgical Penrose drain in right shoulder ... previously thought Penrose drain was removed previously given it was loosely wedged in tissue, however, it was found incidentally to have been within the subcutaneous tissue (deepest skin layer that lies closest to the muscle) on CT scan ... the finding was communicated with family (daughter) at bedside ortho service then evaluated wound at bedside no signs of gross purulence (pus). Wound clean, dry, intact. Sutures removed at bedside, 10CC's (cubic centimeters equal to milliliters- unit of measurement) lidocaine (numbing medicine) injected into subcutaneous tissue about wound. Wound then prepped and draped in usual sterile fashion. 15 blade scalpel (small and extremely sharp bladed instrument used for surgery or dissection) used to reopen surgical wound. Kelley (forceps- surgical instrument used for holding and manipulating tissue) used to superficially spread tissue. White Penrose drain immediately visible within field and removed. Wound then irrigated (cleaned) with 1L (liter- unit of measurement) saline. Wound then closed with 4-0 (size) nylon (type of thread) suture. Wound dressed (a dressing is applied to protect the wound from complications resulting from contamination or disturbance) ...".

During an interview on 7/26/24 at 3:35 p.m., with Medical Doctor/Resident (MDR) 1, MDR 1 stated he was a first-year resident at the time of the incident. MDR 1 stated he and MDF 2 "did the procedure". MDR 1 stated if they drain was not found incidentally by CT, the drain "might just stay in there and scar". MDR 1 stated if an infection did arise from the drain left in the shoulder, it wouldn't be "overly surprising". MDR 1 stated from his OU, it did not appear that informed consent was documented. The MDR 1 stated he did not feel informed consent was necessary because it was "a very brief superficial intervention". MDR 1 stated he did not think "anything should have been done differently".

During an interview on 7/26/24 at 4:15 p.m., with MDF 2, MDF 2's interview on 6/7/24 at 3 p.m., was validated, the MDF 2 stated he "supervised" MDR 1 completing the bedside procedure. The MDF 2 stated "the biggest error was I charted status post removal and I didn't communicate or investigate very deeply about what happened to the drain". The MDF 2 stated that if there were not incidental CT finding of the drain, the drain could have been an "itis for infection". The MDF 2 stated he and MDR 1, should have gotten consent from Pt 2's family member before the bedside procedure of the drain removal. MDF 2 stated any procedure there should be risk and benefits explained to the patient or family member, regardless of "how small the risk". The MDF 2 stated this procedure for Pt 2 could have taken place in the operating room (OR), but she was "very ill" and the risk for Anesthesia was "far greater" than the risk of a bedside procedure. The MDF 2 stated this bedside procedure was invasive because they had to "pass skin" in order to "retrieve something". The MDF 2 stated when "someone comes at them with a knife, they need to consent that". The MDF 2 stated this procedure should have required informed consent and charted accordingly.

During an interview on 7/31/24 at 3 p.m., with the Chief Medical Quality Officer (CMQO) and the Chief Medical Officer (CMO), the CMQO stated they were aware of the incident. The CMQO stated MDF 2's documentation should have reflected what he did or did not do. The CMO stated informed consent should have been obtained and documented for Pt 2's bedside procedure. The CMO stated Pt 2's rights "were not honored" by not having a documented informed consent. The CMO stated a foreign body could have potentially caused an infection. The CMO stated there was "inappropriate documentation" in this case and also "inappropriate consent".

During a review of the facility's policy and procedure (P&P) titled, "Safety Management Plan", dated 3/21/23, the P&P indicated, "I. OBJECTIVES: the objective of the safety management plan is to promote a safe, functional and supportive environment within the hospital ... quality and safety are preserved for our patients ... II. SCOPE: the scope of this plan applies to personnel and licensed independent practitioners who work at [Hospital], with applicability to the safety of our patients ... IV. RESPONSIBILITIES: ... 6. Staff: staff members are responsible for abiding by policies and procedures ... following safe practices while working ...".

During a review of the facility's P&P titled, "Consents", dated 4/13/23, the P&P indicated, "I. Purpose: A. To describe the principles of consent, protect the rights of patients ... B. To clarify the responsibilities of the hospital for consent to services and verification of informed consent and the physician's responsibilities for obtaining and documenting informed consent ... III. POLICY: ...D. 1. The physician has the legal and ethical duty to obtain the patient's informed consent, or the informed consent of the patient's legal representative, for medical treatment, or for procedures which have been determined to be invasive ... in nature ... ii. Informed consent responsibilities may be delegated to another ... resident privileged to perform the same procedure ... vii. Physician documentation of informed consent must occur prior to commencement of the procedure. If there's no physician documentation the procedure shall not begin ...".

During a review of the facility's P&P titled, "Patient's Rights and Responsibilities", dated 2/10/22, the P&P indicated, "I. PURPOSE: to define the rights and responsibilities of patients who receive services at (Hospital) ... IV. PATIENT RIGHTS: ... 6. To receive as much information about any proposed treatment or procedure as the patient may need in order to give informed consent or to refuse this course of treatment ... 7. To be informed and, when appropriate, for the for their families to be informed about the outcomes of care including unanticipated outcomes ...".


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3. During a concurrent observation and interview on 7/22/24 at 10:15 a.m., with Director of ED (DED), and ED Managers (MEDs), MED 1 and MED 2 in the ED unit, observation of the ED included a tour of the Special Care Unit (SCU). DED stated the purpose of the SCU is to care for patients that require a safe, stripped-down area (hazards are removed) and nursing care to address mental health needs and manage behavioral problems. DED stated the rooms are completely stripped, meaning in the room there is a gurney/bed and that is it; there are no countertops or sinks. DED stated patients that have suicidal ideation or aggressive behaviors are taken care of in the SCU. The SCU patient may be on "a hold such as 5150 (the temporary, involuntary psychiatric commitment of individuals who present a danger to themselves or others) or have behaviors such as suicidal ideation (thoughts of self-harm) and/or anxiety (a group of mental health conditions that cause fear, dread and other symptoms that are out of proportion to the situation)." DED stated the SCU does not take care of any patients requiring cardiac monitoring or intravenous (IV) fluids or IV medications.

During a review of Pt 1's EHR 62-year-old conserved [a legal status in which a court appoints a person to manage the financial and personal affairs of a minor or incapacitated person] male patient with past medical history of schizophrenia [a mental disorder characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions], substance abuse [The use of illegal drugs or the use of prescription or over-the-counter drugs or alcohol for purposes other than those for which they are meant to be used], smoker ..."

During a concurrent interview and record review on 7/23/24 at 9:35 a.m., with the DED, MED 1 and MED 2, the DED stated patients who are conserved and who do not have a need for complex medical care are the types of patients cared for in the SCU. In the SCU, patients who are on oxygen (O2) therapy or IV therapy are not candidates for this unit because of need to strip the rooms/gurneys in the SCU to ensure patient safety from self-harm or injury to staff . DED stated " "in general we have a process where patients are reviewed by primary RN, charge RN, clinical supervisor." DED stated the ED LNs receive training in the care of the Mental/Behavioral Health patient in the ED. DED stated the ED is "fluid [patients move throughout the unit depending on level of medical care they need]." DED stated there are no protocols to guide this decision making, the nursing staff decide to place patients where there is staff that can provide the level of care ordered. DED stated the self-report was submitted due to the event not being part of their normal process in the ED. DED stated there were gaps in the care which led facility to self-report. DED stated the findings of the facility's review/RCA (RCA - root cause analysis - a process that aims to identify the cause of the problem and correct it) indicated Pt 1 did not meet the criteria for admission to SCU. DED stated facility internal investigation findings were that the cardiac monitoring was discontinued, and IV was discontinued as well to place the patient in the SCU. DED stated the documentation that the discussion was had between provider and nursing staff to discontinue the IV and cardiac monitoring was not present in Pt 1's EHR. DED and MED 1 stated the removal of the IV and cardiac monitoring was done without a physician order.

During an interview and viewing of video recording on 7/24/24 at 2 p.m. with DED and MED 2, the video recording was without audio and began with viewing Pt 1 in the SCU on his gurney/bed. The video recording started on 7/11/24 at 11:08 p.m. Shortly after the viewing started, Pt 1 was on his gurney/bed and appeared to be turning from one side to another, sitting up in bed, and back down again. This back-and-forth behavior occurred many times for the next 30-45 minutes. At one point Pt 1 placed his feet on the floor while sitting on the gurney and then went back to lie down. At around midnight 7/12/24, Pt 1 was viewed face down on the floor next to the gurney. Several minutes passed before the security guard looked in on Pt 1 and then tapped on the security window which enclosed the nurse's station. Soon after LVN 1 appeared on the video, went beside Pt 1, turned him over, and a large pool of blood could be seen on the floor. LVN 1 immediately started CPR and soon after a team of nurses entered with a gurney and continued CPR and transported Pt 1 out of view of the video recording. That was the end of the viewing of the video recording. DED was asked if a cardiac monitor was on Pt 1 would that have helped identify a change of condition in Pt 1? To which DED responded "yes."

4. During a concurrent observation and interview on 7/22/24 at 10:19 a.m., with Director of ED (DED), and ED Managers (MEDs), MED 1 and MED 2 in the ED unit, observation of the ED included a tour of the unit. The ED was observed to be very busy, with many patients of all ages on gurneys or hallway beds as well as in rooms. DED stated the unit was experiencing high volumes of ED patients coming to the ED, and over 100 patients waiting in the ED for an inpatient bed assignment. DED stated the 1 East (1E) overflow hall area, used to place ED patients when the main ED is full, was just being demobilized. During the tour, patients were observed to be waiting, eating, sitting on gurneys interacting with the 1 visitor allowed at bedside or receiving infusions of IV medications. DED stated that patients are provided with privacy screens upon request. Privacy screens observed while providing patient privacy, contributed to the already cluttered state of the hallways, and made visualization of patients without a means to alert staff for help (there are no call bells available to hallway bed patients) difficult. DED provides a department map to facilitate understanding of the ED orientation.

During a review of the facility "ED Map" dated 11/22, with DED, the map indicated the ED can accommodate up to 246 patients within each of the designated zones in the ED: Green Zone: 60 patients, Yellow Zone: 24 patients, Red Zone: 19 patients, Trauma Zone 11 patients, SCU (Special Care Unit) 12 patients, East Hallway: 45 patients and the PAT (Provider At Triage)/LOBBY area: 75 patients. DED stated patients may be moved to a "procedure room" as needed, but otherwise they are out in the open. The ED map indicated the number of shared restrooms available in that zone/area are as follows (compared to capacity provided by DED): Trauma Zone: 3 for capacity of 11 beds; Red Zone: 3 for capacity of 19; Green Zone: 4 for capacity of 60; Yellow Zone: for capacity of 12; SCU: 1 for capacity of 12; Waiting room: 2 for capacity of 75. TOTAL: 13 restrooms for capacity of 246 patients. DED stated patients in the ED are not allowed to go out to smoke, the patient who wants to smoke would have to sign out AMA (AMA-against medical advice).

During a concurrent interview and record review on 7/24/24, at 9:37 a.m., with the DED, MED 1, and MED 2, Pt 9's EHR was reviewed. Pt 9's "ED Pt Care Timeline" dated 7/24/23 indicated " ...Arrival ...7/4/24 at 11:36 p.m. ...TT [time spent in the ED before being moved to the inpatient bed] 74:35 (hours:minutes) ...11:42 Start Triage Initiated ...Ground level fall - loss of consciousness Pain mid-cervical (neck) ...94/M ...witnessed fall by caregiver from standing in the shower this AM Patient was reported to fall back striking head on the ceramic bath tub Denies loss of consciousness ..." " ...Past Medical History: Dizziness, follicular lymphoma (very slow-growing cancer that may appear in your lymph nodes, your bone marrow and other organs), Glaucoma (a group of eye diseases that can cause vision loss and blindness by damaging a nerve in the back of your eye called the optic nerve), Hearing loss, Hypertension (high blood pressure), Peripheral vascular disease (an accumulation of plaque (fats and cholesterol) in the arteries in your legs or arms), Senile macular degeneration (n eye disorder that slowly destroys sharp, central vision), wears eyeglasses ..." Care was provided in the ED with plan to admit Pt 9. On " ...7/4/24 at 18:04 (6:04 p.m.) Place in Observation Status [admission] ...Neuro Med Surg (Medical-Surgical floor) ...7/6/24 at 16:23 (4:23 p.m.) Order updated ...Admit to Inpatient ...7/7/24 at 13:30 [bed] Assigned: 2C MS ...226-A ...14:11 (2:11 p.m.) to department 2C Med Surg ..."

During a concurrent interview and record review on 7/23/24, at 2:05 p.m., with the DED, MED 1, and MED 2, Pt 10's EHR was reviewed. Pt 10's "ED Pt Care Timeline" dated 7/24/23 indicated " ...Arrival 4/16/24 at 15:39 (3:39 p.m.) ... TT [time spent in the ED before being moved to the inpatient bed] 113:21 (hours:minutes) ... 15:40 (3:40 p.m.) Start Triage Initiated ...73 y.o. female with past medical history including GERD (a condition in which stomach acid repeatedly flows back up into the tube connecting the mouth and stomach, called the esophagus), CAD (a disease in which there is a narrowing or blockage of the coronary arteries (blood vessels that carry blood and oxygen to the heart), ETOH (alcohol) abuse, depression, diabetes mellitus (A disease in which the body does not control the amount of glucose (a type of sugar) in the blood and the kidneys make a large amount of urine), hypertension (high-blood pressure), skin cancer, ESRD (End Stage Renal Disease- a medical condition in which a person's kidneys cease functioning on a permanent basis leading to the need for a regular course of long-term dialysis or a kidney transplant to maintain life) on hemodialysis M/W/F, anemia (a problem of not having enough healthy red blood cells or hemoglobin to carry oxygen to the body's tissues) and DVT (Deep vein thrombosis- occurs when a blood clot (thrombus) forms in one or more of the deep veins in the body, usually in the legs) who presents with altered mental status ...Patient is admitted with dx (diagnosis) of sepsis (An extreme immune response to infection that can lead to tissue damage, organ failure, or death if not treated right away) ... 4/16/24 20:29 (8:29 p.m.), Orders Placed ...Admit to Inpatient ...20:33 (8:33 p.m.) ...Patient Admit Service: Medicine Requested Bed Type CPCU Tele ...4/21/24 09:00 (9:00 a.m.) Patient admitted to department 4C CPCU ..."

During a concurrent interview and record review on 7/23/24 at 3:31 p.m., with DED, MED 1 and MED 2, DED stated ED nurses are trained to provide and do provide appropriate level of care to patients holding in the ED for an inpatient bed assignment.

During an interview on 7/24/24 at 3:15 p.m., with RN 9, RN 9 stated admitted patients waiting for an inpatient bed have different orders [they are] waiting in the ED "so we take care of them." RN 9 stated the physician decides the level of care the patient is to be admitted to. The RN role is to reach out to the doctor [for any concerns], "every level of care is different, you do different things based on the level of care they are admitted to." RN 9 stated nurses follow the physician's plan of care and are trained to provide care per zone you are trained to work in. RN 9 stated for any admitted patient you would follow the [physician] plan of care, cardiac monitor and vital signs every 4-hours. RN 9 stated there is a nurses reference guide located in the yellow zone training didactic and she would follow that. RN 9 stated this training is also offered in the training and on the computer (computer-based learning modules). RN 9 stated she is not sure what the CPCU level of care on the CPCU floor "looks like, hasn't gone up there, but states the level of care RN provides in the ED is same as on the [inpatient] unit.

During an interview on 7/25/24 at 8:49 a.m., with DCVS, DVCS stated as director of the CPCU it is her expectation that the LNs in the ED are following the standard of care for the care level ordered for the patient, including the development of a care plan. DVCS stated it is her expectation that telemetry monitoring box is maintained as ordered and this is done throughout the hospital, nurses are to follow MD orders.

During an interview on 7/25/24 at 5:00 p.m., with CNO, DNO, DED, COO, and RMD, the assembled acknowledged holding inpatients in the ED is not ideal and are actively working on the "gaps" observed as well as tracking and trending the volume of patients seen and held in the ED to ensure compliance with regulatory standards.

During a concurrent interview and record review on 7/29/24 at 3:00 p.m., with LVN 3, LVN 3 stated her role in the ED is to support the RN "work as a team." LVN 3 stated she part of her responsibility is to ensure she is monitoring orders regarding [patient care] and ensuring they are done. LVN 3 stated for inpatients "IP (IP-inpatient)" charting is up to date.

During a review of the facility P&P titled "Non-Smoking - Patients" dated 6/8/23 the P&P indicated " ...III. POLICY A. Smoking (including the use of electronic cigarettes/cigars) is prohibited in all areas within ....50 feet of any entrance ...B. A Provider must write an order allowing the patient to leave the patient care unit to smoke in designated areas ...F. The patient needs to be able to independently light their own cigarette and manage their own device or depend on family ...G.. The patient should notify staff prior to leaving the patient care unit to smoke, make every attempt to return within an hour of leaving the unit for a smoke break, and notify staff when they have returned ...V. PROCEDURE ...B. Provider orders 1. Providers may consider several options for the patient who smokes: a. Write an order for a nicotine replacement therapy (NRT) , (e.g., nicotine patch) ... b. Write an order and document justification for the patient to smoke in designated areas only ..."


45977

Based on observation, interview, and record review, the hospital failed to ensure non-violent restraints were discontinued at the earliest possible time and in accordance with hospital Policy and Procedure (P & P) "Restraints and Seclusion" for one of 68 patients, Patient (Pt) 30,when there was no documentation of behaviors that supported use of the restraints.

This failure resulted in not ensuring the patient's rights to be free from restraints and could possibly lead to adverse health outcomes.

Findings:

During a review of the hospital's P&P titled "Restraint and Seclusion" dated 6/8/23, the P&P indicated " ...Restraints must be discontinued at the earliest possible time once the unsafe situation ends, regardless of the length of time identified in the order. Restraint may only be employed while the unsafe situation (clinical justification) continues ...Physicians, residents, APPs (Advanced Practice Provider) and RNs involved in the patient's care are authorized to determine whether or not restraint should be discontinued based on determination that the patient's behavior is no longer a threat." The P&P also indicated to "...Document the following information in the EHR (electronic health record - an electronic record of health related information on an individual) for each restraint or seclusion episode: ...Patient behavior, condition or symptom(s) that warranted restraint or seclusion use and intervention(s) used ..."

During a review of Pt 30's "Hospitalist (a physician who works exclusively in the hospital) History & Physical" dated 12/23/23 at 09:05 p.m., the document indicated Pt 30 was admitted on 12/23/23. The H&P indicated " ...Per reports, patient has been acting out of the normal for the past week. Has outbursts of yelling and hits other residents. Patient is oriented x4 (an individual who is oriented to person, place, time, and event), calm, and cooperative now. Admits to having outburst of yelling. Reports she hit 3 other residents because they have been mean and bullying her ..."

During a review of Pt 30's "Restraints Non-Violent or Non-Self Destructive (Order 414937581)" dated 7/17/24 at 04:48 p.m., the order indicated to place Pt 30 on continuous soft restraints to bilateral (both) wrists and bilateral ankles due to interference with medical treatment.

During a concurrent observation and interview on 7/23/24 at 10:37 a.m. at Pt 30's room, Pt 30 was observed awake, lying flat in bed, with the call light within reach. Pt 30 was calm and stated she did not know why she was in restraints and wanted to have them removed. Pt 30 had bilateral wrists and bilateral ankles soft restraints tied to the bed frame.

During a concurrent follow-up observation and interview on 7/24/24 at 02:55 p.m. with 1 East Manager (1EM), Pt 30 was asleep in bed. Pt 30 still had soft restraints on her bilateral wrists and bilateral ankles. 1EM stated Pt 30 had been sleeping on and off throughout the day. 1EM stated she had not been informed by the staff of any instances of aggressive behavior from Pt 30 recently.

During a review of Pt 30's "Restraint Documentation" dated 7/22/24 at 04:00 p.m. to 7/26/24 at 02:00 p.m., under "Visual Check," the staff documented the patient was "CF" and/or "A." Review of the "Restraint Type" legend showed "CF" meant confused, and "A" meant the patient was asleep. There was no documented evidence showing the specific type of behavior Pt 30 was exhibiting to justify the continued use of restraints.

During a review of Pt 30's eMAR (electronic Medication Administration Record - an electronic record facilities used to document medications), the documentation indicated the nursing staff administered the following medications:
-Ativan (antianxiety) 0.5 mg (milligrams) PO (by mouth) every 6 hours PRN (as needed) for anxiety was administered on 7/22/24 at 12:03 a.m., 7/22/24 at 07:53 p.m., 7/23/24 at 01:52 a.m., 7/23/24 at 06:03 p.m., and 7/24/24 at 06:36 a.m.
-Zyprexa (antipsychotic) 5 mg PO every 8 hours PRN for agitation was administered on 7/22/24 at 04:30 a.m., 7/22/24 at 07:53 p.m., 7/23/24 at 04:10 a.m., 7/24/24 at 06:36 a.m., and 7/26/24 at 01:00 a.m.

There was no documented evidence showing the specific behavior Pt 30 was exhibiting and the reasons for administration.

During a concurrent interview and record review on 7/26/24 at 09:50 a.m. with Medical-Surgical Director (MSD) and Manager 1EM, Pt 30's "Restraint Documentation" dated 7/22/24 at 04:00 p.m. to 7/26/24 at 02:00 a.m., eMAR from 7/22/24 to 7/24/24, and all nursing progress notes dated 7/22/24 to 7/24/24 were reviewed. MSD verified the above findings. MSD stated Pt 30 was placed on restraints due to interference with medical treatment. MSD verified the nursing staff did not document Pt 30's specific behaviors and rationale for the continued use of restraints. MSD acknowledged that based on the medical records reviewed, Pt 30's restraints could have been discontinued earlier. MSD stated Pt 30's restraints were not discontinued until 7/26/24 at 02:05 a.m.

Based on interview and record review, the hospital failed to follow reporting requirements when a Patient (Pt) 13 died while in restraints and the occurrence was not reported to the California Department of Public Health (CDPH) within five days after the event was detected. This failure delayed the investigations of the incident by CDPH and had the potential to place other patients at risk of unreported adverse events that could lead to harm or death.

Findings:

During a review of Pt 13's "Electronic Health Record (EHR)" dated 5/19/22 to 5/23/22, the EHR indicated, Pt 13 was a 38-year-old man who arrived at the Emergency Department (ED) on 5/19/22 at 4:05 p.m. from the County Jail and was admitted to the Neurocritical Care Unit (critical care for patients with illness or injuries to the brain or nervous system on 5/20/22 at 3:41 a.m., for Altered Mental Status (AMS- a change in the mental function that stems from illness, disorders and injuries that have affected the brain) left thalamic mass (brain tumor) and developing hydrocephalus (buildup of fluid in the brain). The EHR indicated that Pt 13 had a past medical history of Diabetes Mellitus (body's inability to produce or respond to insulin is impaired, resulting in elevated sugar in the blood and urine), Schizoaffective Disorder (mental illness that can affect your thoughts, mood and behavior) and sleep apnea (a disorder that causes a person's breathing to stop or get very shallow) requiring a CPAP (a machine that uses mild air pressure to keep breathing airways open while you sleep) machine while asleep on the unit. The EHR indicated Pt 13 had a bedside procedure of an External Ventricular Drain (EVD- temporary method of draining fluid from the brain) placed in his skull on 5/20/22. The EHR indicated no issues with the EVD during Pt 13's stay. The EHR indicated the patient required non-violent soft restraints for his upper extremities during his entire hospital admit stay for interference with medical treatment, as well as a prisoner shackle around his left ankle. An additional restraint was added to the right ankle on 5/23/22 at 2:40 p.m. for interference with medical treatment as well. The EHR indicated a biopsy (a procedure to remove cells, tissue, or fluid for examination by a medical pathologist [a Medical Doctor who determines if there is presence of disease in tissue sampled]) of the thalamic mass was ordered, but never fulfilled due to Pt 13 expiring (died) before transfer to the Operating Room (OR).


During a review of Pt 13's "Certified Registered Nurse Anesthetist (Progress Note (CRNA- a Registered Nurse who has specialized training in anesthesia, PN)", dated 5/23/22 at 3:25 p.m., the CRNA PN indicated, " ...Summary: Pre-code blue (adult in a medical emergency usually cardiac or respiratory arrest [cessation of breathing]) events ... 2:15 p.m., Patient in four-point restraints. Glasgow coma scale 14 (GCS- range from 3 completely unresponsive to 15- responsive, an objective tool to describe the extent of impaired consciousness in all types of acute medical and trauma patients), hypervigilant (a state of heightened awareness and watchfulness), able to converse (talk) in short phrases, pulling against restraints, restless. Pending (MDNS) note prior to transport to operating room. Pulled own condom catheter (urine collection device) off, kicking legs against bottom of bed. Patient given 25 mcg (micrograms- unit of measurement) fentanyl (a potent synthetic opioid [drug used to treat moderate to severe pain] drug approved by the Food and Drug Administration for use as an analgesic (pain relief) and anesthetic [a drug that causes a loss of feeling or awareness) with no noticeable effect after few minutes, then given 50 mcg fentanyl more. I remained immediately available to monitor patient ... 2:55 p.m., MDNS note noted as documented. Preparing to take patient downstairs for surgery. Ambubag (a handheld tool to provide respiratory support) available. Attached to transport monitor. HR (heart rate) 60's, NSR (normal sinus rhythm- cardiovascular rhythm). SpO2 (Oxygen monitor) inconsistent due to patient moving constantly. Determination made that patient too agitated to transport safely, given 25 mcg fentanyl with minimal effect. An additional 50 mcg fentanyl and 30 mg (milligrams- unit of measurement) propofol (used to induce or maintain anesthesia during certain surgeries, tests, or procedures) IVP (Intravenous [in the vein] Push). Shortly thereafter, patient noted to have eye deviation (abnormal eye movement) to one side, respiratory rate decreased. Jaw thrust (a maneuver for opening the airway of an unconscious patient) initiated, called for airway equipment. 100 mm (millimeter- unit of measurement) oral airway (a device that maintains or opens the airway) in place, jaw thrust (lifting the jaw into a position to open the airway) ongoing patient breathing with respiratory rate 6-8 breaths per minute. Placed on nonrebreather mask (a type of oxygen mask that gives a person a lot of oxygen, typically in an emergency) 100% O2 (oxygen) 25 L (liters- unit of measurement). Within a minute, I noted respiratory effort decreasing and started to mask ventilate via Ambubag (a device place over the nose and mouth to force air into a person's lungs) great seal, mist (patient breath) noted in mask with each exhalation. HR decreased to 50's (50 beats per minute (bpm) - normal is 60-100), lead 2 (cardiac monitor) appeared to have no p wave (an integral part of an EKG) on EKG (measurement of the heart's electrical activity). Difficulty getting noninvasive blood pressure. 1mg atropine (medication that treats a low heart rate) given IV and 0.4 mg Narcan (medication that was designed to rapidly reverse an opioid overdose) given IV with no response. Difficulty reading O2 saturation on finger, switched to nasal probe (device that goes on the nose) then earlobe. At this time, femoral (located in the groin) and carotid (artery on either side of the neck) pulse was checked, and no pulse could be felt. Patient noted to be in pulseless electrical activity (a condition where your heart stops) rhythm with heart rate in the 40's (bpm). Code blue (an adult is having a medical emergency, usually cardiac or respiratory arrest) initiated and crash cart (a cart with emergency life-saving medications on it) brought into room by other RN (registered nurse). Code blue initiated ...".

During a review of Pt 13's "Addendum by Registered Nurse (RN) 14", dated 5/23/22 at 7:29 p.m., the Addendum indicated, " ... [at]2:30 p.m., writer walked into patient's room to find him agitated ... attempting to put new pulse ox (oximeter - a medical device that measures how much oxygen in in the blood) on finger. At the same time OR team walked into the room to get him ready to go to biopsy of thalamic mass. Attempted to verbally calm down patient, but with no effect. Patient attempting to kick writer with right foot- right ankle restraint placed and left ankle in cuffs. CRNA 2 attempted to pull dexmedetomidine (a non-opioid drug used to manage pain and sedation) but medication was not inpatient profile and was unable to be overridden. CRNA 2 pulled propofol and fentanyl instead ... [at] 2:45 p.m., patient still agitated and pulled condom catheter off and urinated in bed. Writer attempted to clean up patient but very agitated at this point. CRNA 2 Pushed medications total of 75mcg fentanyl and 30mg propofol. Less than a minute after medications being pushed patient started to snore, eye deviation (unintentional eyes moving to the side) and seizure (a burst of brain activity that often causes involuntary shaking) like activity- unresponsive. CRNA 2 Attempt chin thrust (lifting the into a position to open the airway) to open air ... no change in respiratory status. Pulse ox unable to get accurate read due to patient movement. Oral pharyngeal airway placed, and patient bagged with no improvement. Narcan was given- no improvement. Decision was made to intubate at bedside. Writer grabbed supplies and notified other staff of event. Crash cart was pushed to bedside. Patient started to Brady (bradycardia - slowing heart rate) down in 30's, (bpm) atropine given, pulse was checked, and none found ... [at]3:02 p.m., Code blue called, and CPR (Cardiopulmonary resuscitation - chest compressions to try to restart the heart and air forced into the lungs to help the patient breath) initiated ... [at]3:17 p.m., pronounced dead. Code ended.

During an interview on 7/31/24 at 1:35 pm. with the Director of Risk Management, Regulatory, and Patient Safety (RMD), Pt 1's death was discussed. Pt 1 was in restraints at the time of death, and death occurred within minutes after being given sedative medication. The RMD stated, "We did not report this incident." RMD stated the case was reviewed and it was decided that they would not report.
During a review of hospital policy titled, "Adverse Event Reporting to the California Department of Health Services," dated 01/03/2022, the policy indicated, " PURPOSE: A. to comply with the mandated reporting requirements of health and safety code 1279. B. to support the improvement of patient safety and quality improvement initiatives. II. Definitions a period adverse event includes any of the following... 23. A patient death or serious disability associated with the use of restraints or bedrails ..."
During a review of hospital policy titled, "Restraint and Seclusion," dated 6/08/2023, the policy indicated, " ...V. DOCUMENTATION A. Document the following information in the EHR for each restraint or seclusion episode:... 9. Death associated with the use of restraint or seclusion and time and date reported to Centers for Medicare and Medicaid Services (CMS) or recorded in the hospital log.... B. Reporting of Deaths - 2. [name of organization] facility leadership will report deaths associated with the use of seclusion or restraint to CMS. The following will be reported: ...d. Each death referenced above must be reported directly to CMS regional office by risk management. E. Risk management will report electronically using CMS 10455, by no later than the close of the next business day following knowledge of the patient's death. Staff must document in the patient's EHR the date and time the death was reported to CMS.

The Health and Safety Code, Division 2, Licensing Provisions [1200 - 1796.70], Chapter 2 Health Facilities [1250 - 1339.59], Article 3. Regulations [1275 - 1289.5] section 1279.1. indicates: " (a) A health facility licensed pursuant to subdivision (a), (b), or (f) of Section 1250 shall report an adverse event to the department no later than five days after the adverse event has been detected, or, if that event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, not later than 24 hours after the adverse event has been detected. Disclosure of individually identifiable patient information shall be consistent with applicable law. (b) For purposes of this section, "adverse event" includes any of the following: ... 5 ...(E) A patient death or serious disability associated with the use of restraints or bedrails while being cared for in a health facility.


The Center for Clinical Standards and Quality/Quality, Safety & Oversight Group memorandum QSO-20-04-Hospital-CAH DPU, revised January 17, 2020, indicated, "
In accordance with the requirements at 42 CFR 482.13(g), Death Reporting Requirements, all patient deaths associated with restraint and/or seclusion (except 2-point soft wrist restraints that must be recorded in an internal hospital log or other system) are required to be reported to the Centers for Medicare and Medicaid Services (CMS) Regional Locations using the Form CMS-10455, Report of a Hospital Death Associated with the Use of Restraint or Seclusion by all types of hospitals (including Psychiatric Hospitals, Rehabilitation Hospitals, Long Term Care Hospitals, Short Term Acute Care Hospitals) and Critical Access Hospital (CAH) Rehabilitation and/or Psychiatric Distinct Part Units (DPUs)." The memorandum explains the process of electronically submitting reports.


During a review of Professional Reference from https://www.ncbi.nlm.nih.gov/books/NBK558963/, titled, "Adverse Events", dated 8/2023, indicated, " ... Adverse events (AE) frequently occur in our medical system, and at least one in ten patients are affected. An AE is a harmful and negative outcome that happens when a patient has been provided with medical care ... Treatment / Management ... Databases of reported adverse events can provide valuable information that can be used to make the necessary changes in care that can decrease or eliminate adverse events ... There has been a discussion about the under-reporting of adverse events. To promote a true culture of doing no harm, clinicians must adopt the approach of reporting all adverse events. The analysis of the information reported will determine the appropriate system management ..."

Based on interview and record review, the hospital's governing body, medical staff and administrative officials failed to identify and act on two of two adverse events promptly. The Quality Assurance and Performance Improvement (QAPI) program did not collect data, track data, or develop or implement performance improvement measures meant to ensure the events would not re-occur when Patient (Pt) 2 was identified as having a drain (a tube to remove fluid after surgery) in her shoulder that was thought to be removed on 2/21/24, and the investigation did not begin until 4/11/24, and Pt 3 had part of a surgical glove retained in her chest after a chest tube insertion that wasn't investigated until 3/1/24.

These failures resulted in the delay in the implementation of necessary corrective measures resulting in continued risk of injury and infections to patients who received surgical procedures.

Findings:

During a review of Patient (Pt) 2's "History & Physical (H&P)", dated 2/8/24, the H&P indicated, " ... Chief Complaint: Generalized Weakness ... History or Present Illness: ... 72-year-old ... female with Type II Diabetes Mellitus (a disease that occurs when your blood sugar is too high) and hypertension (high blood pressure) who presents with malaise (weakness), right lower extremity pain, and abnormal labs. Patient recently had a prolonged hospitalization after a pedestrian vs. automobile (accident) resulting multiple fractures (broken bones) ... [right tibia/fibula (leg) status/post ORIF (Open reduction and internal fixation is a surgical procedure for repairing fractured bone using either plates, screws to stabilize the bone), left tibial plateau fracture (broken shin), multiple sacral (bottom of the spine) and pelvic fractures, right proximal humerus (shoulder)] ... discharged to (Skilled Nursing Facility) on 2/2/24 ... Per nursing staff ... patient was more confused than usual and found to have leukocytosis (high white blood cell count) ... she received 1 dose intramuscular (in the muscle) ceftriaxone (antibiotic) prior to transport to the Emergency Department (ED) ... Hospital problems: Healthcare associated pneumonia ... Anasarca (generalized swelling of the body) ... tibia/fibula fracture ... type II diabetes ... Hypertension ...".

During a review of Pt 2's "Consult Note (CN)", dated 2/13/24, the CN indicated, " ...fluid collection anterior (toward the front of the body) right ... shoulder joint ... status/post right shoulder aspiration (a procedure to remove fluid) ... Orthopedics on board and plan for Incision and Drainage (I&D- surgical procedure to release pus or pressure built up under the skin) of right shoulder today ...".
During a review of Pt 2's "Orthopedic Surgery Operative Report (SOR)", dated 2/14/24, the SOR indicated, " ... Postoperative diagnosis: right humerus (upper arm bone) fracture infected hematoma ... Drains: 1 Penrose drain (a soft, flat, flexible tube made of latex. It lets blood and other fluids move out of the area of your surgery) ... Complications: none ... Condition: Stable ...".

During a review of Pt 2's "Progress Note: Orthopedic Surgery (PNOS)", dated 2/17/24 at 9:12 a.m., the PNOS indicated, " ...Hospital course: ... She reports pain everywhere and it is difficult to get a story out of her. She is very ill appearing ... Patient is now status post right shoulder I&D 2/14 ... Objective: ... Right upper extremity: visual: surgical incision clean, dry and intact without surrounding erythema (redness)/edema (swelling) ... Assessment/Plan: ... She is much improved. Patient in stable condition from orthopedic perspective. No further orthopedic intervention indicated ... Drain: Penrose drain s/p (status/post) removal ... (signed) Medical Doctor/Fellow (MDF) 1 ...".

During a review of Pt 2's "CT (a procedure where a computer linked to an x-ray machine takes detailed pictures of the inside the body) Chest Abdomen and Pelvis with Contrast", dated 2/21/24 at 2:12 a.m., the CT indicated, " ... Reason for exam: sepsis, worsening leukocytosis ... Findings: ... Right humeral surgical neck fracture. An internalized drain fragment measuring 8 cm (centimeter- unit of measurement) in length is positioned along the anterior margin of the fracture and does not extend to the dermis. Consider orthopedic consultation ...".

During a review of Pt 2's "Treatment Plan- Orthopedics Update (OU)", dated 2/21/24 at 1:09 p.m., the OU indicated, " ...Ortho service paged regarding incidental finding of retrained surgical Penrose drain in right shoulder ... previously thought Penrose drain was removed previously given it was loosely wedged in tissue, however, it was found incidentally to have been within the subcutaneous tissue (deepest skin layer that lies closest to the muscle) on CT scan ... the finding was communicated with family (daughter) at bedside ortho service then evaluated wound at bedside no signs of gross purulence (pus). Wound clean, dry, intact. Sutures removed at bedside, 10CC's (cubic centimeters equal to milliliters- unit of measurement) lidocaine (numbing medicine) injected into subcutaneous tissue about wound. Wound then prepped and draped in usual sterile fashion. 15 blade scalpel (small and extremely sharp bladed instrument used for surgery or dissection) used to reopen surgical wound. Kelley (forceps- surgical instrument used for holding and manipulating tissue) used to superficially spread tissue. White Penrose drain immediately visible within field and removed. Wound then irrigated (cleaned) with 1L (liter- unit of measurement) saline. Wound then closed with 4-0 (size) nylon (type of thread) suture. Wound dressed (a dressing is applied to protect the wound from complications resulting from contamination or disturbance) ...".

During an interview on 7/26/24 at 3:35 p.m., with Medical Doctor/Resident (MDR) 1, MDR 1 stated he was a first-year resident at the time of the incident. MDR 1 stated he and MDF 2 "did the procedure". MDR 1 stated if they drain was not found incidentally by CT, the drain "might just stay in there and scar". MDR 1 stated if an infection did arise from the drain left in the shoulder, it wouldn't be "overly surprising". MDR 1 stated from his OU, it did not appear that informed consent was documented. The MDR 1 stated he did not feel informed consent was necessary because it was "a very brief superficial intervention". MDR 1 stated he did not think "anything should have been done differently".

During an interview on 7/26/24 at 4:15 p.m., with MDF 2, MDF 2's interview on 6/7/24 at 3 p.m., was validated, the MDF 2 stated he "supervised" MDR 1 completing the bedside procedure. The MDF 2 stated "the biggest error was I charted status post-removal, and I didn't communicate or investigate very deeply about what happened to the drain". The MDF 2 stated that if there were not incidental CT finding of the drain, the drain could have been an "itis for infection". The MDF 2 stated he and MDR 1, should have gotten consent from Pt 2's family member before the bedside procedure of the drain removal. MDF 2 stated any procedure there should be risk and benefits explained to the patient or family member, regardless of "how small the risk". The MDF 2 stated this procedure for Pt 2 could have taken place in the operating room (OR), but she was "very ill" and the risk for Anesthesia was "far greater" than the risk of a bedside procedure. The MDF 2 stated this bedside procedure was invasive because they had to "pass skin" in order to "retrieve something". The MDF 2 stated when "someone comes at them with a knife, they need to consent that". The MDF 2 stated this procedure should have required informed consent and charted accordingly.

During an interview on 7/31/24 at 3 p.m., with the Chief Medical Quality Officer (CMQO) and the Chief Medical Officer (CMO), the CMQO stated they were aware of the incident. The CMQO stated MDF 2's documentation should have reflected what he did or did not do. The CMO stated informed consent should have been obtained and documented for Pt 2's bedside procedure. The CMO stated Pt 2's rights "were not honored" by not having a documented informed consent. The CMO stated a foreign body could have potentially caused an infection. The CMO stated there was "inappropriate documentation" in this case and also "inappropriate consent".


During an interview and record review on 8/2/24 at 11:30 a.m. with the Director of Risk Management Regulatory Patient Safety (RMD), a document titled, "Apparent Cause Analysis (ACA)" was reviewed. The RMD stated an ACA was a shorter, less involved version of an RCA (Root Cause Analysis - a structured facilitated team process to identify root causes of an event that resulted in an undesired outcome and develop corrective actions.) The document indicated the retained drain was discovered and removed on 2/21/24, and the Risk Management Department was made aware of the incident on 2/29/24. On 4/11/24 the decision was made to do an ACA for the incident. The RMD did not have a response as to why the investigation wasn't started until 7 weeks after the error was discovered. When asked if a similar event could have occurred between the time of discovery of this incident and the time that the investigation was completed, the RMD stated there was a risk of recurrence.

The ACA did not include how long (measured length) the drain was initially, outside the body. The analysis did not address whether the drain was cut off or if the entire drain tubing migrated (got sucked in) into the shoulder. There was no plan listed for how to keep the situation from happening again. In response to the thoroughness of the investigation, the RMD stated, "the investigation is sparse."

During a review of Pt 3's "History and Physical (H&P)", dated 11/19/23 at 8:17 p.m., the H&P indicated, " ... 54-year-old ... patient who was found down ... GSC 12 ... initial x-ray shows severe left sided chest wall deformity. Left chest tube placed in trauma Bay ... hypotension (low blood pressure) to 60s - 70s ... decision was made ... to intubate the patient ... Assessment/Plan: Pedestrian injured in nontraffic accident involving motor vehicle... Closed fracture of nasal bone (broken nose) ... Fracture of body of left scapula (broken left shoulder blade) ... Fracture of multiple ribs of both sides ... Hemopneumothorax (blood collecting in the pleural cavity) on left ... Plan: Service to admit to ICU (Intensive Care Unit) ...".

During a review of Pt 3's "Surgical Operative Report (SOR)", dated 11/22/23 at 10:52 p.m., the SOR indicated, " ... Preoperative Diagnosis: Trauma ... Procedure Performed: 1. Open Reduction (repositioning of bone pieces so they are back to proper alignment) and internal fixation (method of physically reconnecting bones) of left sided ribs 3-9. 2. Intercostal nerve block (an injection of medication under the rib that helps relieve pain) left side levels 3-9. 3. Tube thoracostomy (tube that drains fluid or air around the lungs) left side ... Findings: ... We removed a foreign object which we suspected is a piece of a surgical glove that was sent for pathology for gross evaluation ...".

During a review of Pt 3's "Retained Foreign Object Picture (RFO)", dated 11/22/23, the RFO indicated, a piece of surgical glove measured approximately 1-inch (unit of measurement) in length.

During an interview and record review on 8/2/24 at 11:30 a.m. with the Dir of Risk Management Regulatory Patient Safety (RMD), a document titled, "Apparent Cause Analysis (ACA)" was reviewed. The document indicated the retained portion of a surgical glove was discovered inside Pt 3's chest on 11/19/23, and the ACA was completed on 3/1/24, over 3 months after the event. The RMD stated the analysis of the occurrence was sparse. An intervention was put into place on 3/1/24 which included changing the color of surgical gloves used for procedures so that it would be more apparent if a surgical glove tore and part of it was retained inside the patient. The RMD stated there was a risk that the same type of incident could happen again between the time that this event occurred, and corrective measures were put into place.

During a review of hospital document titled, "Performance Excellence Plan Fiscal Year 2024," the Table of Contents included 15 pages including 4 attachments, all of which were reviewed. The document indicated, "Annual Review and Goal Setting ... Each year, [corporate name] licensed care facilities will conduct a formal review of its Quality Assurance and Performance Improvement program ... Attachment C - Root Cause Analysis - An RCA is a structured facilitated team process to identify root causes of an event that resulted in an undesired outcome and develop corrective actions. The RCA process gives you a way to identify system vulnerabilities so that they can be eliminated or mitigated. The purpose is to find out what happened, why it happened, and determined what changes need to be made.... This team will utilize performance improvement tools listed within the Performance Excellence Plan along with root cause analysis tools (CMS, QAPI and NPSF RCA2) such as: RCA checklist, Safety Assessment Code (SAC) Matrix, Risk-based prioritization ranking vulnerabilities/events to drive resources and timelines, Triggering Questions for RCA - Drives areas of inquiry, no answers may drive 5 Whys, Interviewing Tips, Timeline, Event and Causal Flow Diagram, 5 Whys, Final Flow Diagram, Cause and Effect Diagram, Fishbone Diagram, Action Plan, Root Causes and Contributing Factors (CMS QAPI) , Measures of Success (CMS QAPI), Action Hierarchy ... Immediate actions to care for patient, ensure safety for others that could be affected. Sequester equipment, products, materials ...within 72 hours. " The document does not include ACA as an accepted tool for the organization.

In a professional article retrieved from https://journals.lww.com/pqs/fulltext/2017/05000/Improving_Apparent_Cause_Analysis_Reliability__A.7.aspx on 8/8/24 titled, "Improving Apparent Cause Analysis Reliability: A Quality Improvement Initiative," an ACA is defined as follows: "An ACA is a limited investigation of an event with 2 purposes: to identify actions to address the problem/immediate condition and to collect event information that aids in the identification of organizational trends.2 The ACA format gives structure to learning and understanding about the event and facilitates the construction of an action plan to prevent recurrence.3 ACAs typically focus on events that result in no harm, minimal harm, and near miss events that occur in discrete work settings and conventionally do not cross boundaries."

Based on observation, interview, and record review, the hospital failed to ensure nursing staff updated and developed individualized care plans related to wound care management, chest tube (flexible tube placed into the chest acting as a drain) care, and elopement ( the act of leaving a healthcare facility without authorization and without being noticed, and may be a danger to themselves or others) risk for five of five sampled patients (Pt 28, 31, 32, 33, and 45) as evidenced by the following:

1. Nurses did not develop an individualized care plan for Pt 28's chest tube care and management.

2. Nurses did not update and include Pt 45's right buttock and sacral (near the lower back and spine) wounds in the care plan.

3. Nurses did not develop care plan interventions to address use of patient monitor for Pts 31, 32 and 33.

These failures had the potential to cause inconsistent delivery of care which can result in the decline or lack of improvement of the patients' health condition.

Findings:

During a review of the hospital's policy and procedure (P&P) titled "Interdisciplinary Plan of Care" dated 10/12/23, the P&P showed to "... initiate the Plan of Care based on the patient's comprehensive assessment and medical care of the provider responsible for the patient ... Document the Interdisciplinary/Nursing Interventions when identified ... Activate interventions for the problems identified based on patient assessment ... For outcomes not met, develop and document an action plan such as notification of provider, change in interventions, or new orders."

1. During a review of Pt 28's "Hospitalist (a physician who works exclusively in a hospital to care for inpatients) History & Physical (H&P)" dated 7/17/24 at 12:02 a.m., the H&P indicated Pt 28 was admitted to the hospital on 7/16/24. The H&P indicated Pt 28 was a transfer from an acute care hospital for a " ...higher level of care ...with pulmonology (a branch of medicine that specializes in treating the respiratory system) for intervention of subcutaneous emphysema (a condition that occurs when air or gas gets into the tissues under the skin) with the history of 2 chest tubes (a flexible, hollow plastic tube that is inserted into the chest cavity to drain air, blood, or other fluids) to drain his right-sided pneumothorax (a condition that occurs when air leaks into the space between the lung and chest wall)."

During a review of the "Nursing communication (Order 418124647" at 7/16/24 at 1053 p.m., the "Comments" indicated to "place chest tubes back to suction ..."

During a review of Pt 28's "LDA (Lines/Drains/Airways) Documentation" flowsheet dated 7/23/24 at 8:30 a.m., the documentation showed Pt 28 had right lateral (side) and right anterior (front) chest tubes.

During an observation on 7/23/24 at 09:35 a.m. at Pt 28's bedroom, the chest tube drainage system was observed on the floor. There were two tubes connected from the patient to the drainage system. The collection chamber showed approximately 60 ml (milliliters) of serosanguinous (contains or relates to both blood and the liquid part of blood) fluid.

During a concurrent interview and record review on 7/26/24 at 10:33 a.m. with Director 6, Pt 28's "Care Plan Audit Trail" dated 6/30/24 to 7/29/24 was reviewed. The "Care Plan Audit Trail" showed there was a care plan problem initiated for "Problem: Gas Exchange (the exchange of oxygen and carbon dioxide between bloodstream and the lungs) - Impaired" on 7/17/24. However, there was no documented evidence showing an individualized care plan was developed to address Pt 28's chest tube management and care. When asked to show the care plans for Pt 28's chest tubes, Director 6 verified the care plan was not developed. Director 6 stated the care plan should have been initiated on admission and show the current interventions.

2. During a review of the hospital's P&P titled "Pressure Injury (sores [ulcers] that happen on areas of the skin that are under pressure) Risk Assessment, Prevention, Staging (categorizing into four stages based on the depth of skin damage), and Treatment" dated 8/11/22, the document indicated under "Documentation" to " ...update patient care plan to incorporate pressure injury prevention strategies, interventions and individual patient care treatments/needs."

During a review of Pt 45's "History and Physical" dated 7/4/24 at 6:10 p.m., the H&P indicated Pt 45 was admitted to the hospital on 7/4/24. The H&P indicated "since 3/2024 she has had multiple admissions with sepsis due to UTI [Urinary tract infection- a serious condition in which the body responds improperly to an infection], pyelonephritis [a bacterial infection causing inflammation of the kidneys], pressure ulcer [Damage to an area of the skin caused by constant pressure on the area for a long time] complications and failure to thrive. Her last admission was from 6/20 - 7/2/24. She had wound consult with application of wound vac [vacuum-assisted closure therapy to help wounds heal] for the pressure ulcer."

During a review of Pt 45's "LDA Documentation" flowsheet dated 7/4/24, the document indicated Pt 45 had wounds on the sacrum (large, triangle-shaped bone in the lower spine that forms the part of the pelvis) and right buttock upon admission.

During a review of Pt 45's "Order" dated 7/11/24 at 10:30 a.m., the order indicated Pt 45 had a right buttock wound. The "Comments" showed the following:
"1. Cleanse the wound bed by moistening gauze with Vashe [wound cleaner] and lay in wound bed for at least 3-4 minutes. Then pat dry.
2. Next apply no sting barrier film (a skin protectant or prep used to protect the skin from mechanical injury and moisture) to the periwound [the surrounding area of the wound edge] skin.
3. Cut small piece of Therahoney [type of dressing] Sheet to the size of slough [outer layer] in the wound bed and place over slough avoiding peri wound.
4. Cover with silicone foam bordered border (a type of dressing with a soft silicone layer that borders the dressing and forms a seal around the wound) dressing.
5. Change the dressing every 3 days and as needed for soilage, saturation over 75% and/or dislodgement [the action of something moving or being removed from a fixed position, for example inside the body] by bedside nurse."

During a review of Pt 45's "Negative Pressure Wound Therapy (a treatment that uses subatmospheric [pressure that is lower than atmospheric pressure] pressure to help wounds heal) Non-Instillation 2 Wounds Associated (Order 418261811)" dated 7/21/24 at 3:28 p.m., the order indicated Pt 45 had a sacral wound. The "Comments" indicated the following:

"May apply collagen (natural protein that plays a vital role in wound healing) to wound bed. If bedside nurse is unable to correct via troubleshooting, and/or is unable to change independently, and/or the wound specialist is unavailable to change within 2 hours, bedside nurse to discontinue the wound vac and place a normal saline (a mixture of salt and water with a salt concentration of 0.9%) wet to moist ( type of dressing used to keep the wound moist which uses a primary dressing that touches the wound and a secondary dressing that covers it) dressing. Change the dressing twice a day and as needed for saturation >75% and/or dislodgement until wound vac is replaced."

The "Order Questions" showed to use a low intensity of 125 mmHg (millimeters of mercury - a unit of pressure generated by a column of mercury that is one millimeter high).

During a concurrent interview and record review on 7/25/24 at 1:47 p.m. with Educator 7, Pt 45's "Order" dated 7/11/24 at 10:30 a.m. and "Negative Pressure Wound Therapy Non-Instillation 2 Wounds Associated (Order 418261811)" dated 7/21/24 at 3:28 p.m. were reviewed. Educator 7 verified Pt 45 currently had healing Stage 4 (the most severe type characterized by full-thickness tissue loss that exposes bone, tendon, or muscle, and the surrounding tissue may begin to die) wounds on the right buttock and sacrum. Educator 7 stated both wounds were present on admission and were treated separately as per the physician's orders. Educator 7 stated the right buttock wound was treated with Therahoney, and the sacral wound was treated using a wound VAC.

During a concurrent interview and record review on 7/26/24 at 9:36 a.m. with Manager 4 and Director 9, Pt 45's "Care Plan Audit Trail" dated 6/26/24 to 7/25/24 was reviewed. The "Care Plan Audit Trail" indicated there were care plan problems initiated for "Risk of Impaired Skin Integrity" on 7/4/24, "High Risk for Skin Integrity Impairment" on 7/5/24, and "Pressure Injury Care and Treatment" on 7/9/24. The care plans listed the goals and interventions. However, there was no documented evidence showing the care plan was updated to indicate the care, goals, and interventions for Pt 45's healing Stage 4 wounds on the right buttock and sacrum. When asked to show the care plans for Pt 45's wounds, Director 9 verified the care plan was not updated. Director 9 stated the expectation was for the staff to include all current interventions for each wound in the care plan.

3. During a concurrent observation of Room A and interview on 7/23/24 at 10:38 am with RN 8, RN 8 acknowledged Pts 31, 32 and 33 were in Room A and the patients were at risk for elopement. RN 8 explained there was one patient monitor assigned to Pts 31, 32 and 33 who was closely monitoring the patients due to the risk for elopement.

During an interview on 7/23/24 at 10:33 am was conducted with Patient Care Technician, the Patient Care Technician acknowledged the technician was assigned to observe closely Patients 31, 32, and 33 at all times. The Patient Care Technician was asked the reason of observing Pts 31, 32, and 33. The Patient Care Technician stated the patients were at risk for elopement and could lead to a potential harm.

During a concurrent interview and concurrent record review on 7/25/24 at 2:50 pm with the Director 9, Director 9 acknowledged the above findings. The Director explained patient monitor was the same as a patient sitter. Director 9 stated patient monitor should be included in the care plan interventions for Pts 31, 32 and 33.

Based on observation, interview and record review, the hospital failed to ensure nurses followed policies and procedures for 16 of 16 patients (Patient [Pt] 1, Pt 9, Pt 10, Pt 28, Pt 29, Pt 31, Pt 32, Pt 33, Pt 37, Pt 38, Pt 39, Pt 40, Pt 46, Pt 66, Pt 67 and Pt 70) when:

1. Emergency Department (ED) nurses assigned to care for Pt 1 did not provide the level of care for which Pt 1 was admitted and did not follow physician orders and did not follow criteria for admission to the Special Care Unit (SCU - a secure, restricted area in the ED for behavioral patients) in accordance with hospital policy and procedure. Pt 1 was brought in by ambulance into the Emergency Department on 7/10/24, provided an appropriate medical evaluation and the ED physician determined the need to admit as an inpatient for telemetry (patients with chronic cardiac conditions are monitored remotely using medical equipment) level of care on 7/10/24 at 10:17 p.m. The hospitalist (a physician who works exclusively in a hospital to care for inpatients) who admitted Pt 1 to telemetry level of care ordered intravenous (IV- administered into a vein) fluids, medications, cardiac monitoring (a way of watching the electrical activity oof the heart to ensure it is working normally) and frequent vital signs on 7/10/24 at 11:39 p.m. The hospitalist ordered CPCU (Cardiac Progressive Care Unit) telemetry level of care for Pt 1. Pt 1 remained in the ED for a CPCU telemetry inpatient bed to open up. Nurses in the ED discontinued the IV and cardiac monitor on 7/11/24 around 6 p.m. without first notifying the physician and did not adhere to policies and procedures meant to provide CPCU telemetry level of care. Nurses moved Pt 1 into the Special Care Unit of the ED without first determining if Pt 1 met the criteria for admission to the SCU and without first notifying the physician. While in SCU, Pt 1 was without an IV and cardiac monitor and nurses did not provide assessments, cardiac monitoring and care in accordance with policies and procedures for CPCU telemetry level of care.

These failures resulted in nurses inappropriately moving Pt 1 to the SCU, not providing telemetry level of care, and not noticing Pt 1 was on the floor next to his gurney/bed in the SCU for several minutes around midnight 7/12/24. Licensed Vocation Nurse (LVN) 1 was called to the room, turned Pt 1 face up, noted a large pool of blood on the floor and coming from his mouth and immediately started CPR (cardiopulmonary resuscitation - an emergency lifesaving procedure performed when the heart stops beating). The rapid response team was called, Pt 1 was then moved to the trauma room in the ED where CPR continued until Pt 1 was pronounced dead at 12:44 a.m. on 7/12/24.

Because of the possible avoidable death of Pt 1 and the serious potential harm related to not following policies and procedures meant to provide Pt 1 CPCU telemetry level of care and nurses not following policies related to criteria for admission to the SCU, an Immediate Jeopardy (IJ- a situation where a provider's noncompliance with requirement has, or could, cause serious harm to resident)situation was called on 7/26/24 at 1 p.m. with the Chief Nursing Officer (CNO), Chief Operating Officer (COO) and Director of Nursing Operations (DNO) under A398, CFR 482.23(b)(6). The CMS form IJ Template was provided to the hospital and instructions were given to submit a Plan of Removal (PoR) to address the IJ situation. Version 1.1 of the PoR (Version 1 was rescinded by the hospital) was submitted and determined to be unacceptable on 7/29/24 at 10:35 p.m. PoR Version 2 was submitted and acceptable as of 7/29/24 at 2:25 p.m. The survey team validated all actions on the PoR were implemented and the IJ was removed on 7/30/24 at 9 a.m., while onsite, with CNO, COO and DNO. After removal of the IJ, the hospital remained in substantial non-compliance.

2. Nurses in the Cardiovascular (relating to heart and blood vessels) Intensive Care Unit of Hospital B did not date control solutions for two of four sampled glucometers in accordance with hospital policy and procedure and manufacturer instructions (glucometer -- a device for measuring the concentration of glucose in the blood; control solutions - a liquid used to test the functionality of meter and strips).

This failure had the potential for glucose testing to be inaccurate for patient samples being used with the expired controls.

3. Nurses in the ED did not develop, implement and update a current nursing care plan (a patient-centered health document designed to facilitate communication among members of the care team and with the patient) for six of six patients (Pt 9, Pt 10, Pt 37, Pt 38, Pt 39 and Pt 40) in accordance with their policy and procedures (P&P) titled "Admission & Ongoing Assessment - Nursing (Acute Care)" and "Interdisciplinary Plan of Care".

These failures had the potential for the needs of Pt 9, Pt 10, Pt 37, Pt 38, Pt 39 and Pt 40 to go unmet.

4. Nurses assigned to one of four sampled patients in the ED (Pt 66) for Hospital A did not perform vital signs (measurements of the body's most basic functions) and pain assessments and monitoring in accordance with hospital P&P.

These failures had the potential for Patient 66's health to decline and/or continue to have unrelieved pain and no further interventions implemented to decrease the patient's pain.

5. Nurses in the ED assigned to care for Pt 67 did not follow monitoring protocol in accordance with physician order, hospital P&P and Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar-an instrument used by medical professionals to assess and diagnosis the severity of alcohol withdrawal (symptoms that may occur when a person who has been drinking too much alcohol on a regular basis suddenly stops drinking alcohol)).

This failure had the potential for Patient 67's signs and symptoms of alcohol withdrawal to go undetected and result in worsening health and death.

6. Nurses in the ED stored empty oxygen tanks in the cage reserved for full oxygen tanks and not accordance with hospital policy and procedure and professional standard.

This failure resulted in the potential harm of full oxygen tanks not being readily available for patient use.

7. Nurses in the ED assigned to Pt 70 did not label Pt 70's inhaler in accordance with facility policy and procedure.

This failure resulted in the potential of administering the wrong medication to the wrong patient.

8. Nurses assigned to Pt 28 did not assess Pt 28's chest tubes within two hours of admission as per the hospital's P&P titled "Standards of Practice - Acute Medical/Surgical, Telemetry, Step-Down (area that provides intermediate-level care between the Intensive care unit and the general medical-surgical wards) and Critical Care Units" dated 2/22/23.

This failure had the potential to place Pt 28's safety at risk and possibly not meet Pt 28 healthcare needs.

9. Nurses assigned to Pt 29 and Pt 46 p performed electroencephalogram (EEG) monitoring while the patients were in a medical-surgical nursing unit and not in accordance with hospital policy and procedure.

These failures had the potential to place Pt 29 and 46 at risk of complications for EEG.

10. Nurses caring for Pt 31, Pt 32 and Pt 33 did not ensure the assigned patient monitor (or a sitter) did not exceed two patients in accordance with hospital policy and procedure.

This failure had the potential to place patients' safety at risk of negative health outcomes.

Findings:

1. Record review of the hospital's Facility Reported Incident (FRI) submitted to the California Department of Public Health on 7/16/24 indicated the following: "We are self-reporting a significant event for the Community Regional Medical Center (CRMC) Emergency Department (ED): On 7/10/24 at 19:44 PM [7:44 p.m.], 62-year-old conserved male patient with past medical history of schizophrenia [a serious mental illness that affects how a person thinks, feels and behaves], substance abuse, smoker, brought in by ambulance on 7/10/24 at 1944 from skilled nursing facility for weakness x [times] 3 days and unsteady gait resulting in a fall, and low blood pressure. Labs showed hemoglobin [a protein inside the red blood cells that carries oxygen from the lungs to the tissues and organs in the body and carries carbon dioxide back to the lungs] of 6.5 [normal range 13.5-17.5g/dl (grams per deciliter - unit of measure)], stool [the solid matter excreted during a bowel movement] negative [result] for occult blood [blood in the stool that is not visible to the naked eye], and CT [computerized tomography - is a specialized imaging equipment that produces 3-dimensional images] head negative. Patient was treated for low blood pressure, blood products transfused (therapeutic substances derived from human blood that are critical to health care transferred from one person to another), and patient admitted to CPCU (Cardiac Progressive Care Unit) Telemetry level of care with continuous cardiac monitoring. Cardiac monitoring placed on 7/11/24 at 1045 (10:45 a.m.): normal sinus rhythm (the normal rhythm of a healthy human heart characterized by a regular rate), slight tachycardia (a heart rate faster than 100 beats per minute) in low 100s. Hemoglobin increased to 7.2 and then 8.11. Blood pressure also increased to systolic (the blood pressure when the heart is contracting; normal pressure is at or lower than 120) of 100s to 120s/ diastolic (the pressure in the arteries when the heart rests between beats; normal pressure is at or lower than 80) of 60s - 70s. On 7/11/24 at 2012 (8:12 p.m.), decision was made to move patient to Special Care Unit (SCU) as he was conserved and was considered an elopement (the act of leaving a healthcare facility without authorization and without being noticed and may be a danger to themselves or others) risk. On 7/12/24, just after midnight, patient laid down on floor (did not fall, purposely laid down on floor). A few minutes later, a large amount of blood came from patient's mouth onto the floor. Security notified nursing, CPR was immediately started, patient moved to gurney, then to red zone (a zone for patients with more complex issues that may require resuscitation and ongoing medical care, or closer observation) for ACLS (advanced cardiac life support - a set of clinical guidelines established for the urgent and emergent treatment of life-threatening cardiovascular conditions). 3 units (1 unit approximately 350 milliliters) Packed Red Blood Cells (PRBCs - prepared from the whole blood by removing plasma [liquid component of blood that contributes to 55% of blood's total volume) given emergently, return of spontaneous circulation (ROSC - the resumption of a sustained heart rhythm and circulation after cardiac arrest) was not achieved, and patient was pronounced deceased at 0044 (12:44 a.m. 7/12/24). Hospitalist and conservator notified. Upon review, we found that the cardiac monitoring was removed on transfer to SCU without a physician review/order. We have identified opportunities for improvement and we are reporting out of an abundance of caution and transparency. We met with our Leadership and implemented immediate action items to address the identified opportunities and next steps. We will conduct an RCA (Root Cause Analysis) and continue to review potential gaps and continue to develop appropriate action items."

During a concurrent observation and interview on 7/22/24 at 10:15 a.m., with Director of ED (DED), and ED Managers (MEDs), MED 1 and MED 2 in the ED unit, the tour of the ED included a tour of the Special Care Unit (SCU). DED stated the purpose of the SCU is to care for patients that require a safe, stripped-down area (hazards are removed) and nursing care to address mental health needs and manage behavioral problems. DED stated the rooms are completely stripped, meaning in the room there is a gurney/bed and that is it; there are no countertops or sinks. DED stated patients that have suicidal ideation (thoughts of killing oneself), or aggressive behaviors are taken care of in the SCU. The SCU patient may be on "a hold such as 5150 (a temporary, involuntary psychiatric hold - a legal process that allows someone to be detained in a psychiatric facility against their will if they are experiencing a mental health crisis and are considered a danger to themselves or others) of individuals who present a danger to themselves or others)." DED stated the SCU does not take care of any patients requiring cardiac monitoring or intravenous (IV) fluids or IV medications. DED explained the SCU is configured into five rooms (1, 2, 3, 4 and 5) and seven (7) hallway beds (A, B, C, D, E, F, G) for a total capacity of 12 patients. Hall beds can be moved as needed to meet patient needs (into room 5 or between hall beds B and D). Rooms have nothing inside except the bed the patients are on. DED stated SCU patients are admitted to the SCU and are placed in burgundy paper scrubs (paper scrubs- or disposable scrubs, are single-use garments made from lightweight, non-woven materials) then all property, including cell phones, are removed, inventoried and secured by a Security Guard (SG). DED stated Room 4 has built-in cabinets or lockers for this purpose. DED stated nursing personnel are located inside the locked unit, in an enclosed, badge-entry only nurses' station. The nurses' station is encased with clear plastic windows that separate patient areas from staff area. SCU is staffed by two (2) licensed nurses LNs (one Registered Nurse (RN), one LVN, one Patient Observer (PO) and one SG who is stationed out in the hallway at the locked unit entry door. The Yellow zone (where emergent ED patients are treated) Team Lead (TL) is the supervising RN for the SCU. If patient safety concerns are present, the SCU may staff a 1:1 sitter (one staff per patient) to ensure patient safety. POs are seated at the nurses' station where they are assigned to continuously observe patient activity on 2 video monitoring screens. PO can view the activity of up to 12 patients (each patient is sectioned off into sectors by location (room or hallway) on the 2 video screens). PO can only be relieved for breaks, lunches, etc. by another PO or similarly trained employee. The PO is not to leave the monitors for any reason and does not go into patient area. The PO is responsible for completing an "Emergency Department 24 Hour Continuous Observation" log on which PO documents patient activity every 15 minutes, one log for each patient in the SCU. The PO alerts SCU nurses to any change in patient behaviors for licensed nurse intervention and may call for additional help by pressing a red button located on the wall to the right of the PO's workstation.

During a concurrent interview and record review on 7/23/24 at 9:30 a.m. with Director of the Emergency Department (DED), Manager of the ED, (MED 1, day shift) 1 and MED 2 (night shift), DED stated the self-report submitted by the hospital to CDPH on 7/16/24 regarding the unexpected death of Pt 1 was basically accurate except that Pt 1 was moved to SCU at 6 p.m. rather than 8 p.m. DED stated and confirmed the hospitalist admitted Pt 1 to CPCU telemetry level of care with physician orders on 7/10/24 at 21:56 (9:56 p.m.). The DED stated and confirmed the clinical record did not include a physician order to discontinue the cardiac monitor and IV. DED stated there was no physician order to discontinue the CPCU telemetry level of care. DED stated and confirmed that at the time Pt 1 was moved to SCU, nursing staff discontinued the cardiac monitor and IV without first notifying the physician. DED stated criteria to admit to SCU does not include a patient requiring CPCU telemetry level of care, such as Pt 1. DED stated Pt 1 did not meet the criteria to be admitted to the SCU. DED stated the SCU is an extension of the ED and is a restricted unit for patients with safety risks or behaviors that can best be handled in the SCU. DED stated, " ...because of this, we go through extensive review to determine the need to admit to SCU. The norm did not occur with [Pt 1]." DED stated Pt 1 was an outlier and not the norm for SCU and Pt 1 should not have been moved to the SCU. DED stated nurses were aware of the inpatient status of Pt 1 and a RCA was started but not completed, as of yet. DED stated immediate measures to correct identified gaps of care included training, following physician orders, not discontinuing services without a physician order and following the escalation process to supervisors and managers. DED, MED 1 and MED 2 stated they were aware inpatients in the ED required the level of care for which they are admitted; for example, Pt 1 was admitted for CPCU telemetry and required CPCU telemetry level of care in the ED.

During a concurrent interview and record review on 7/23/24 at 3:30 p.m., with Licensed Vocational Nurse (LVN) 1, LVN 1 stated he has worked at the hospital for 6.5 years, only in the ED. LVN 1 stated he worked in the SCU and other areas of the ED. LVN 1 stated he was familiar with Pt 1's case and was the nurse assigned to Pt 1 the night he died. LVN 1 stated Pt 1 was cooperative, alert and talkative and in no distress when he assessed Pt 1 at the beginning of his shift, which was 7 p.m. on 7/11/24. LVN 1 stated he was not aware Pt 1 was in the red zone and moved to the green zone and was not involved in the decision to move Pt 1 to SCU. LVN 1 stated he was unaware Pt 1 was ordered to have CPCU telemetry level of care. LVN 1 stated and confirmed Pt 1 was not on a cardiac monitor and no IV because the SCU did not support that level of medical care. LVN 1 stated there was no other nurse in the SCU the night of 7/11/24 and he had six assigned patients including Pt 1. Prior to being called to Pt 1's room, LVN 1 stated the last interaction was about 9 p.m. to provide oral medications and vital signs. LVN 1 stated the vital signs were normal and Pt 1 was alert and cooperative. LVN 1 stated a few minutes after midnight on 7/12/24, he was alerted by the Security Guard to go to Pt 1's room because Pt 1 was on the floor next to his gurney/bed, facedown with a small amount of blood. LVN 1 stated when he went to Pt 1's room, Pt 1 did not respond to his name, and then turned Pt 1 over face up and noticed a large amount of blood on the floor and coming from Pt 1's mouth. LVN 1 stated Pt 1 did not have a pulse and immediately started CPR. LVN 1 stated the rapid response team came and continued the CPR and transported Pt 1 to the ED Trauma room. LVN 1 stated CPR was unsuccessful and Pt 1 died. When asked what he would do differently if confronted with similar occurrence, LVN 1 stated he would review the past medical history more thoroughly including the reason to admit to the SCU and escalate concerns to his supervisor. LVN 1 stated he was aware Pt 1 was admitted as an inpatient but was not aware the cardiac monitor was discontinued without first notifying the physician. LVN 1 was aware Pt 1 was moved from the green zone to SCU but was not aware Pt 1 was first treated in the red zone.

During an interview and viewing of video recording on 7/24/24 at 2 p.m. with DED and MED 2, the video recording was without audio and began with viewing Pt 1 in the SCU on his gurney/bed. The video recording started on 7/11/24 at 11:08 p.m. Shortly after the viewing started, Pt 1 was on his gurney/bed and appeared to be turning from one side to another, sitting up in bed, and back down again. This back and forth behavior occurred many times for the next 30-45 minutes. At one point Pt 1 placed his feet on the floor while sitting on the gurney and then went back to lie down. At around midnight 7/12/24, Pt 1 was viewed face down on the floor next to the gurney. Several minutes passed before the security guard looked in on Pt 1 and then tapped on the security window which enclosed the nurse's station. Soon after LVN 1 appeared on the video, went beside Pt 1, turned him over, and a large pool of blood could be seen on the floor. LVN 1 immediately started CPR and soon after a team of nurses entered with a gurney and continued CPR and transported Pt 1 out of view of the video recording. That was the end of the viewing of the video recording. DED was asked if a cardiac monitor was on Pt 1 would that have helped identify a change of condition in Pt 1 and DED stated yes.

During an interview on 7/24/24 3:15 p.m. with RN 9 and DED, MED 1 and MED 2, RN 9 stated she has worked at the hospital as an RN for 3 years and works only in the ED. RN 9 stated she was familiar with Pt 1's case and was assigned to Pt 1 at the end of her shift on 7/11/24. RN 9 stated her shift is 7 a.m. to 7 p.m. RN 9 stated she was assigned to the SCU on 7/11/24. RN 9 stated the decision to move Pt 1 to SCU had already been made by the lead RN in the green zone, RN 10, and the clinical supervisor for the ED, CS 1. RN 9 stated she was aware Pt 1 was an inpatient but did not know CPCU telemetry level of care was ordered. RN 9 stated by the time Pt 1 was assigned to her, Pt 1 no longer had a cardiac monitor and she removed his IV in order to comply with the safety rules for SCU. RN 9 stated she did not notify the physician prior to discontinuing the IV. RN 9 stated that her assessment of Pt 1 indicated he was alert, cooperative and had not received any IV medications and Pt 1's vitals signs were stable. RN 9 stated she was aware what happened to Pt 1 and had died. RN 9 stated she should have questioned the move of Pt 1 to the SCU but did not. RN 9 stated she was told because Pt 1 was "conserved" he fit the criteria for SCU. RN 9 stated in the future she would escalate concerns to the supervisor or manager if needed and would always double check information in the patient's electronic health record (HER) and to strictly follow physician orders.

During an interview on 7/24/24 at 4:15 p.m. with Clinical Supervisor (CS) 1, DED, MED 1 and MED 2, CS 1 stated he has been an RN since 2001 and a supervisor in the hospital ED for the past 8 years. CS 1 stated his role was to manage the flow of ED patients, address concerns and to elevate issues, if needed. CS 1 stated he reports to the MED 1 and to DED. CS 1 stated he was familiar with Pt 1's case but was not the supervisor the night he died. CS 1 stated he was aware of the sequence of events that led to Pt 1 moving to SCU. CS 1 stated that on 7/11/24 toward the end of his shift about 6 p.m., there was a large influx of patients into the ED and that he called RN 10 to find a patient who is stable and "on hold" to move to the SCU. CS 1 stated the purpose of moving a patient from the green zone (area where the patients are in a stable condition) to SCU was to free up a yellow or red zone bed in order to evaluate patients coming into the ED. CS 1 stated he was unaware Pt 1 was CPCU telemetry level of care and that the physician was not called prior to moving Pt 1. CS 1 stated he did not review Pt 1's EHR (electronic health record - an electronic version of a patients medical history that is maintained by the provider over time and may include all clinical data relevant to the person) to familiarize himself with physician orders and the reason for admission to the hospital at the time Pt 1 was moved to SCU. CS 1 stated he was aware Pt 1 was waiting for an inpatient bed. CS 1 stated he was aware Pt 1 was conserved and was assessed as clinically stable. CS 1 stated he was aware of what occurred to Pt 1 and that he died. CS 1 stated he expected nurses to report accurate information to him in order to make safe decisions. CS 1 stated in the future he will double check information from RNs and would escalate concerns to managers as needed. CS 1 stated the problems that occurred with Pt 1 included miscommunication from RN to RN, not following physician orders and not escalating concerns to supervisors and managers.

During an interview on 7/25/24 at 9:40 a.m. with interview with Director of Inpatient Cardiovascular Services (DCVS) and Manager CPCU (MCPCU), DCVS and MCPCU stated they were not aware of Pt 1's case. DCVS and MCPCU stated the expectation for patients requiring CPCU telemetry level of care is that nurses should follow physician orders and not to discontinue cardiac monitor without first notifying the physician. DCVS and MCPCU were unaware of the number of inpatients in the ED requiring CPCU telemetry level of care. DCVS and MCPCU stated they were available to the ED as a resource, if needed. DCVS and MCPCU stated nurses on the floor are well acquainted with the need to develop and implement care plans and follow all policies and procedures. DCVS and MCPCU stated nurses provide a level of care on the floor that meets the needs of patients and provides CPCU telemetry level of care. Once patients are admitted to the floor, DCVS and MCPCU stated nurses orient patients to the room, provide instructions on the use of equipment in the room, and explain patient rights, privacy and the expectations for nursing care. DCVS and MCPCU stated they were unaware of what ED nurses provided to inpatients in the ED.


During an interview on 7/25/24 at 11:35 a.m. with RN 10 and DED, RN 10 stated she has been an RN for about 5.5 years and worked at the hospital for the entire time and has been a charge nurse for about 4 years. RN 10 stated she was familiar with Pt 1's case and was the RN lead on the day Pt 1 was moved to the SCU. RN 10 stated her role as an RN lead in the green zone was to be a resource for RNs and to manage the patient flow and be accessible to the supervisor for changes that were needed. RN 10 stated on 7/11/24 she received a call from the CS 1 to move a patient from the green zone to the SCU. RN 10 stated the instructions provided to her was to find a clinically stable patient "on a hold" and to move the patient to the SCU. RN 10 stated Pt 1 was "conserved" and her understanding was that conserved patients were on a hold. RN 10 stated that Pt 1 was clinically stable, alert, cooperative and "talkative", and the cardiac monitor strips were "normal" and vital signs were stable, and these were the reasons she used to move Pt 1 to the SCU. RN 10 stated she was unsure how the cardiac monitor was taken off. RN 10 stated, looking back "communication was mixed up" and Pt 1 should have stayed in the green zone and not moved to SCU. RN 10 stated physician orders should be strictly followed and the cardiac monitor not discontinued. RN 10 stated for Pt 1 the expectation would have been to provide nursing care as ordered by the physician for CPCU level of care and not to move to the SCU.


During an interview on 7/25/24 at 2:21 p.m., with MED 1, MED 2, Patient Observer (PO) 1, PO 1 stated she has been a PO for 5 years, only in the ED, only for this hospital. PO 1 stated she was familiar with Pt 1's stay and that he died. PO 1 stated she received training and an orientation for the role of PO. PO 1 stated escalation of behavior and de-escalation techniques training was completed through the facility computer-based learning training and she does not require certification for the role. PO 1 stated her job is to notify nurses if patients behave in a manner that may harm themselves. Her role is to watch the monitor which has a video feed for each of the rooms and patient areas in the SCU. PO 1 stated that on the night of the event she was stationed at the PO monitor station in the locked nurses station. PO 1 stated at the time Pt 1 was on the floor, she was giving hand-off to a fellow worker for break. PO 1 stated she was not watching the monitor at the time Pt 1 was on the floor. PO 1 stated she did not notice any behavior that night from Pt 1 that needed to be brought to the attention of nurses.

During an interview on 7/31/24 at 2:19 p.m., with Medial Doctor Hospitalist (MDH), MDH stated he works from 7:00 a.m. to 7:00 p.m. (12-hr shift). MDH stated he is familiar with Pt 1's case. MDH Stated P1 needed to be on a cardiac monitor, as indicated by order placed, and he expected that any patient with an order for a cardiac monitor would be placed on the monitor as possible and remain on the monitor. MDH stated he was not notified by staff that the patient was not on a monitor for more than 4 hours; his expectation is that they are "supposed to tell me ... They [nurses] are supposed to reach out to me to ask if patient could be downgraded to the Medical Surgical floor level, where he would not need the cardiac monitor." MDH stated he has seen patients in the SCU area before. They are kept safe in the SCU until they go to a psychiatric facility. MDH stated as a provider, and interested in quality care for patients, it is his expectation that he would be notified before the nursing team made the decision to discontinue the cardiac monitoring and IV. MDH stated he did not discontinue the orders. MDH stated that if he was called to discontinue the monitor that night, he would have denied the request for Pt 1 to be downgraded.

During an interview on 8/2/24 at 12:05 p.m., with the CNO and DNO, CNO stated it is his expectation that staff follow policy on orders and standards of care for each unit. The CNO stated his expectations for care plans include ensuring that education has been done and are ensuring that the care plans are pt specific, expectation is the staff will follow the plan and policy to provide safe care, continuity of care and are meeting the patient needs. The CNO stated harm can occur if DC (discharge) is done on admission, not documented, and planned will delay the DC care and the other IDT (interdisciplinary team - a group of healthcare professionals from different disciplines who work together to provide specialized care to patients) members to ensure patient care is being provided and patient education is provided as needed during the stay; goals, wounds skin assessments, turning/offloading, etc. Needs to be updated/current to provide consistent care.

During a review of the facility's (P&P) titled, "Provider Orders", dated 8/25/23, the P&P indicated " ...III. Policy A. Orders may only be given by members of the [GACH - General Acute Care Hospital] physicians and Advance Practice Providers (APPs - healthcare professionals who have graduate-level education and additional training, and are board certified in the state where they practice) who are privileged to do so within their scope of practice ...B. Physician's orders must be obtained on all patients prior to initiating treatments or therapies ...L. The licensed personnel will clarify with the prescriber any order that would be contraindicated [anything, including a symptom or medical condition, that is the reason for a person to not receive a particular treatment or procedure because it may be harmful] based on patient's current condition, diagnostic test results, or medical history ...Q. The RN is to notify the Clinical Supervisor/Manager when unable to follow an order due to a lack of equipment and/or supplies ...R. Questions and concerns regarding carrying out physician's orders ...3. The RN, LVN, and LPT [licensed physical therapist] are health practitioners and must act prudently to deliver optimal patient care ..."

During a review of the facility's policy and procedure (P&P) titled, "Provider Notification Regarding Patient Status", dated 11/141/23, the P&P indicated "...I. Purpose To provide staff with guidelines for keeping the resident, attending physician, consulting physician and /or Advanced Practice Professional (APP) informed of the patient's status ...III. Policy ...The attending physician/APP is to be notified by the RN: ...2. When there is a deterioration in patient condition, i.e., clinical, physical, psychological, behavioral ...6. To coordinate or clarify patient care orders ...VI. Documentation ...B. Document the patient's condition change, physician notification, actions taken, and the patient's response in the EHR ..."

During a review of the facility's guidelines titled, "Special Care Unit Guidelines", undated, the guidelines indicated ...The Special Care Unit (SCU) is a locked unit within the Emergency Department (ED). This space holds up to 12 total patients. The space consists of 5 treatment rooms, 3 gurneys in the dayroom and 4 gurneys in the hallways (1,435 square feet). SCU is utilized as a care area for patients that are in psychiatric crisis that do not require complex medical treatments or devices/equipment, i.e.: IV therapy, cardiac monitoring, etc. If complex medical treatments are required, contact Team Leader or Clinical Supervisor for placement outside of the SCU. Additional mental health patients are placed in the var

DELETE

Based on observation, interview, and record review, the hospital failed to follow the Policy and Procedure (P&P) titled "Blood Products Transfusion" for one of one patient, Patient 44, when RN 22 failed to fill the filter drip chamber (a chamber with a filter used to remove contaminants from the infusion of fluids before it enters the bloodstream) with normal saline (a mixture of water and salt concentration of 0.9) above the filter.

This failure had the potential to cause inadvertent complications and suboptimal flow rates.

Findings:

During a review of the hospital's P&P titled "Blood Products Transfusion" dated 5/6/24, the P&P indicated the following steps when preparing for blood transfusion (a procedure in which whole blood or parts of blood are put into a patient's bloodstream through a vein): " ...3. Prime (the process of removing air from tubing) the blood transfusion filter and tubing with normal saline ...4. Spike the intravenous tubing into the outlet of the normal saline bag ...5. Open clamp above blood filter, making certain that the clamp on the second Y-tubing (a Y-shaped connector set made of plastic tubes used to deliver medication and fluids into the body) is closed ...6. Fill drip chamber with normal saline to just above the filter by squeezing and releasing the drip chamber ..."

During a review of the tubing instructions titled "BD Alaris Pump Infusion Blood Set," the directions indicated to " ...3. Spike first solution container and hang 4. Open clamp below spiked solution container. 5. Squeeze and release blood filter until filter is completely covered ..."

During a review of Pt 44's face sheet, the face sheet indicated Pt 44 was admitted to the hospital on 7/24/24 at 01:56 p.m. due to pregnancy, lower abdominal pain, preterm labor (labor occurring after 20 and before 37 weeks) in the third trimester (final phase of pregnancy), and labor abnormalities.

During a review of Pt 44's physician orders, the "Transfusion Orders" dated 7/25/24 at 09:54 a.m. indicated to transfuse 1 unit of red blood cells (component of the blood responsible for transporting oxygen and nutrients throughout the body).

During a concurrent observation and interview on 7/25/24 at 10:15 a.m. with RN 22 and RN 44, RN 22 stated Pt 44's consent and vital signs were already obtained prior to the blood transfusion. RN 44 stated an urgent transfusion was ordered due to Pt 44's history of chronic anemia (a condition in which the body does not have enough healthy red blood cells). RN 22 then sanitized her hands and donned a clean pair of gloves. RN 2 used an alcohol pad to wipe Pt 44's IV (intravenous - through the veins) hub connector (a device attached to the end of an IV tube that allows for delivering or withdrawal of fluid) on the left arm then flushed the line with normal saline. RN 22 then hung the bag of normal saline on the IV pole and connected one of the plastic spikes of the Y-tubing to the outlet of the normal saline bag. RN 22 primed the tubing by opening the clamp and squeezing the filter drip chamber until it was halfway filled with normal saline. RN 22 continued to prime the entirety of the tubing with normal saline. RN 22 and RN 44 then cross-checked the patient's information against the transfusion form and blood bag label. After verifying the correct information, RN 4 connected the other plastic spike to the blood bag and transfused the blood. The blood transfusion began at 10:28 a.m. When asked about the filter drip chamber level, RN 44 acknowledged the chamber was filled below the filter level. RN 44 acknowledged the chamber was not filled with normal saline above the filter.

During a concurrent interview and document review of the "Blood Products Transfusion" P&P on 7/25/24 at 10:39 a.m. with RN 22, RN 44, Supervisor 8, and Director 8, RN 22 verified the filter drip chamber was not filled with normal saline above the filter as per the hospital's P&P. When asked about the purpose of having the filter drip chamber filled above the filter, the staff were unable to provide an answer.

During a follow-up telephone interview with Director 8 on 7/31/24 at 2:32 p.m., Director 8 stated according to the hospital's clinical nurse specialist, priming the filter chamber completely with normal saline provided the maximum efficacy of the blood filter.

Based on observation, interview, and record review, the facility failed to maintain a clean and sanitary environment to avoid sources and transmission of infection when:

1. Sterile Processing Technician (SPT) was observed in the decontamination (area where reusable medical equipment is cleaned, disinfected, and sterilized [process of complete elimination and destruction of all forms of microbial life]) area of the Sterile Processing Department (SPD) scrubbing instruments above the enzymatic (cleaner that uses a natural process of breaking down bacteria and organic waste) cleaning solution water line. The SPT failed to follow hospital policy and procedure and AAMI (Association for the Advancement of Medical Instrumentation- a primary source for the development, management, and use of safe and effective health technologies for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals) standards of practice.

2. Medical Doctor Resident (MDR 2- 2nd year resident at the time of the incident), MDR 2 broke the sterile field by leaving behind the right index finger of his latex glove inside the pleural cavity of a patient when doing a chest tube bedside procedure. This placed Pt 3's safety at-risk due to the possibility of infection.

3. Nursing staff did not clean three of three sampled pill crushers (turn pills into powder) in the Emergency Department (ED) were visibly soiled with white-colored chalk-like residue, and orange-colored stains to metal pieces and throughout the device.

4. Staff did not ensure equipment, supplies and floors were clean and organized, in two of three sampled ED Supply and Medication Rooms. Patient care supplies found on the floor, outside their designated clean supply storage cupboards and floor surfaces were visibly soiled, dusty with stains and trash on them.

5. Hospital staff did not perform hand hygiene according to hospital policies and procedures.

6. Staff did not ensure proper infection control practices were implemented during a wound care treatment for one of one sampled patient (Pt 45).

As a result of these failures all patients and staff were at risk for transmission of infections (an infectious agent is transferred from a reservoir to a susceptible host) and cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) and increased the potential for hospital acquired infections and illnesses.

Findings:

1. During an observation on 7/23/24 at 2:30 p.m., in the Sterile Processing Department (SPD) Decontamination area, a Sterile Processing Technician (SPT) was observed manually cleaning five different surgical instruments out of the cleaning/water solution.

During an interview on 7/31/24 at 11 a.m., with SPT, SPT stated she made a mistake and brushed the surgical instruments out of the cleaning/water solution. The SPT stated by brushing the instruments out of the solution, surgical patient's safety is put at risk.

During an interview on 7/31/24 at 11:25 a.m., with the SPD Supervisor (SPDS), the SPDS stated he saw SPT doing the manual clean of surgical instruments out of the water. The SPDS stated the expectation for staff is to follow AAMI guidelines, as well as hospital policies and procedures and she did not.

During an interview on 7/31/23 at 11:40 a.m., with the Surgical Services Director (SSD), the SSD stated manually cleaning the surgical instruments out of the water is "ultimately" an infection risk to patients. The SSD stated cross-contamination (transfer of harmful bacteria from one person, object of place to another) can "absolutely" occur. The SSD stated the SPD department uses AAMI as their professional standard. The SSD stated the Decontamination policy and AAMI guidelines were not followed.

During an interview on 8/3/24 at 9 a.m., with the Director of Infection Prevention, the Infection Prevention Manager (MIP) and Infection Prevention Supervisor (IP Sup), the DIP stated the expectation was for the surgical instrumentation to be fully submerged while doing a manual clean.

During a review of the facility's policy and procedure (P&P) titled, "Decontamination", dated 10/30/23, the P&P indicated, "I. PURPOSE: to provide guidelines for cleaning ... decontaminating ... to maintain infection prevention principles, maintain safety and facilitate optimal patient outcomes ... II. DEFINITIONS: A. Cleaning: a process using friction, detergent, water and enzymatic cleaners to remove organic debris the process by which any type of soil, including organic debris, is removed to the extent necessary for further processing or for the intended use ... B. Decontamination: any physical or chemical process that removes or reduces the number of microorganisms or infectious pathogens and renders reusable medical products safe for handling or disposal; the process by which contaminants are removed, either by manual or mechanical means, using specific solutions capable of rendering blood and debris harmless and removing them from the surface of an object or instrument ...C. Decontamination area: the area in the sterile processing department where all soiled or contaminated surgical instruments and other items are received from the operating room or other user departments for decontamination ... D. Perform manual cleaning: ...10. Perform manual cleaning of submersible instruments underwater to minimize aerosolization of cleaning and contaminated fluids ...".

During a review of the professional reference from AAMI titled, "AAMI 3.3.6 Special area requirements and restrictions", indicated, " ...Rationale: Rationale: Airborne microbial and particulate contamination is likely to be high in the decontamination area/room because of the type of work done there (e.g., staging of grossly soiled items and equipment before cleaning, manual cleaning that produces aerosols, and, in some facilities, trash and linen handling from surgical case carts). Contamination can also be spread by personnel who indiscriminately touch environmental surfaces, other devices, or other personnel with contaminated hands. Regular cleaning is necessary to control environmental contaminants. Physical enclosure of the decontamination area is necessary because contaminated aerosols, droplet nuclei, and dust particles can be carried from "dirty" to "clean" areas by air currents ...".

During a review of the professional reference from AAMI titled, "AAMI 7.6.4.2 Manual Cleaning", indicated, " ... When manually cleaning devices, personnel should ... d. clean immersible devices under water to minimize aerosolization ...".

2. During a review of Pt 3's "History and Physical (H&P)", dated 11/19/23 at 8:17 p.m., the H&P indicated, " ...54-year-old ... patient who was found down ... GSC 12 ... initial x-ray shows severe left sided chest wall deformity. Left chest tube placed in trauma Bay ... hypotension (low blood pressure) to 60s - 70s ... decision was made ... to intubate the patient ... Assessment/Plan: Pedestrian injured in nontraffic accident involving motor vehicle... Closed fracture of nasal bone (broken nose) ... Fracture of body of left scapula (broken left shoulder blade) ... Fracture of multiple ribs of both sides ... Hemopneumothorax (blood collecting in the pleural cavity) on left ... Plan: Service to admit to ICU (Intensive Care Unit) ...".

During a review of Pt 3's "Surgical Operative Report (SOR)", dated 11/22/23 at 10:52 p.m., the SOR indicated, " ...Preoperative Diagnosis: Trauma ... Procedure Performed: 1. Open Reduction (repositioning of bone pieces so they are back to proper alignment) and internal fixation (method of physically reconnecting bones) of left sided ribs 3-9. 2. Intercostal nerve block (an injection of medication under the rib that helps relieve pain) left side levels 3-9. 3. Tube thoracostomy (tube that drains fluid or air around the lungs) left side ... Findings: ... We removed a foreign object which we suspected is a piece of a surgical glove that was sent for pathology for gross evaluation ...".

During a review of Pt 3's "Retained Foreign Object Picture (RFO)", dated 11/22/23, the RFO indicated, a piece of surgical glove measured approximately one inch (unit of measurement) in length.

During an interview on 7/31/24 at 3 p.m., with the Chief Medical Quality Officer (CMQO) and the Chief Medical Officer (CMO), the CMQO stated they were aware of the incident. The CMO stated a "broken barrier" should be addressed, acknowledged and "rectified (corrected)". The CMQO stated the resident should have "spoke up" when the glove was torn and notified his Attending Physician. The CMQO stated the retained glove could have caused an infection.

During an interview on 8/2/24 at 5:30 p.m., with Medical Doctor Resident (MDR 2- 2nd year resident at the time of the incident), MDR 2's interview on 6/6/24 at 12:30 p.m., was validated, MDR 2 stated he was the person that put in the original chest tube for Pt 3. MDR 2 stated the chest tube insertion was a sterile procedure. MDR 2 stated during the chest tube insertion he had to feel that he was in the pleural cavity (space that surrounds the lungs), so he had to digitally enter (stick finger in) the cavity. MDR 2 stated while in the pleural cavity he needed to do some manual exploration and that was when his right sterile glove index finger ripped. MDR 2 stated he "didn't think the glove could be in the patient". MDR 2 stated when his glove ripped, he did not notify any staff (three different physicians were with him) involved that it happened. MDR 2 stated in hindsight he should have notified his Attending Physician that was present. MDR 2 stated the expectation for the procedure was that the glove stays intact and not be left inside the patient. MDR 2 stated the patient had the potential to develop an infection. MDR 2 stated Pt 3 could have been harmed by the piece of glove that was left inside of them.

During an interview on 8/2/24 at 5:30 p.m., with the Director of General Surgery Residency (DGSR), the DGSR's interview on 6/6/24 at 12:50 p.m., was validated, the DGSR stated the chest tube insertion was a sterile procedure and the sterile field was compromised when the glove ripped inside of Pt 3. The DGSR stated Pt 3 had the potential to develop an infection due to the glove piece being left inside. The DGSR stated MDR 2 did not follow the hospital policy and procedure (P&P) for patient's safety and infection control. The DRSR stated when MDR 2 broke his glove, he should have notified the staff members what happened, removed the gloves, and put on new sterile gloves.

During an interview on 8/2/24 at 6 p.m., with the Quality Outcomes Manager (QOM), the QOM stated Medical Doctor- Fellow (MDF) 2 who found the glove in the procedure, no longer was with the organization and the previous interview from 6/6/24 at 1:20 p.m., could be used. The MDF 2 stated he found the piece of glove during Pt 3's procedure. The MDF 2 stated Pt 3 had a potential for an infection by having the glove piece left inside of her after the chest tube was placed. The MDF 2 stated Pt 3's infection risk would be "great". The MDF 2 stated there was ultimately a potential for death for Pt 3 by leaving a glove behind because of her acuity (severity level of an illness or medical condition) level at that time.

During an interview on 8/3/24 at 9 a.m., with the Director of Infection Prevention, the Infection Prevention Manager (MIP) and Infection Prevention Supervisor (IP Sup), the DIP stated the expectation was "that this doesn't happen" and maintain the sterile field. The MIP stated this incident was "concerning". The MIP stated "our intention" was for this not to happen to reduce the "likelihood" of cross-contamination into the sterile field.

During a review of the facility's policy and procedure (P&P) titled, "Safety Management Plan", dated 3/21/23, the P&P indicated, "I. OBJECTIVES: the objective of the safety management plan is to promote a safe, functional, and supportive environment within the hospital ... quality and safety are preserved for our patients ... II. SCOPE: the scope of this plan applies to personnel and licensed independent practitioners who work at [Hospital], with applicability to the safety of our patients ... IV. RESPONSIBILITIES: ... 6. Staff: staff members are responsible for abiding by policies and procedures ... following safe practices while working ...".

During a review of the facility's policy and procedure (P&P) titled, "Surgical Site Infection Prevention", dated 11/20/23, the P&P indicated, "I. PURPOSE: A. To define a consistent approach for the prevention of surgical site infections (SSIs) in the (Hospital) surgical patient ... B. Broad areas addressed in this policy include: ... B. Aseptic practices, sterile technique ... III. POLICY: ... B. Preventative measures are to focus both prophylactic interventions and reducing opportunities for microbial contamination of the patients' tissues or of the sterile surgical field ... D. Specific methods for preventing SSI include the following: 2. Intra-operative care ... b. Strict sterile technique adherence ... V. PROCEDURE: ... G. Adhere to strict aseptic and sterile technique ...".

3. During a concurrent observation and interview on 7/22/24 at 10:19 a.m., with the Director of ED (DED), and ED Managers (MEDs), MED 1 and MED 2 in the ED unit, the DED stated ED nurses are responsible in ensuring the equipment used to crush medications for administration to patients are to be cleaned by the ED nurses per facility policy and procedure (P&P). DED stated it is his expectation the pill crushers be cleaned as indicated in the manufacturer's instructions for use and per P&P. DED stated the potential harm to patients is possible contamination of the medication being given, placing the patient at risk for infection.

According to Links Medical Products, undated, retrieved on 8/7/2024 from https://imgcdn.mckesson.com/CumulusWeb/Click_and_learn/IFU_Silent_Knight_Cleaning_Instructions.pdf indicated "(Brand Name) pill crusher cleaning and maintenance instructions ...is made entirely of non-rusting materials and may be cleaned regularly with a damp cloth. A facility approved disinfectant wipe may also be used when indicated. In instances when the Silent Knight Pill Crusher requires a more thorough cleaning, please follow the instructions below: ..."

4. During a concurrent observation and interview on 7/22/24 at 10:27 a.m., with the Director of ED (DED), and ED Managers (MEDs), MED 1 and MED 2 in the ED unit, the DED stated if patient care supplies are found on the floor they should be discarded as they would be considered contaminated (infectious). DED stated the floors should be swept and mopped daily and as needed. DED stated the floors did not look as if they had been cleaned of debris and surface stains.

During an interview on 8/2/24 at 9:06 a.m., with Infection Prevention and Control (IP) Supervisor (IPS), IP Manager (IPM) and Director of Accrediting (DA). IP team acknowledged there were opportunities for improvement in the cleanliness of the ED. DA stated soiled items, like the pill crushers and floors should be cleaned as indicated by P&P and by following manufacturer instructions.

During a review of policy titled, "Cleaning of Equipment" effective date 06/28/24, the policy indicated, " ...I. Purpose A. To provided guidance to staff on who is responsible for the cleaning and disinfection of certain equipment. B. To prevent transmission of disease within the hospital to patients, staff, and visitors. II Policy A. The Equipment Cleaning Responsibility Grid ...will be used as a reference for all staff to determine the appropriate responsible party for the cleaning and disinfection of equipment. B. It is the responsibility of the individual department to use the document as a template for specialized equipment in their department ...III Procedure A. The attached cleaning grid includes but not limited to: 1. List of equipment/items 2. Frequency of cleaning ..."

During a review of policy titled, "8-Step Cleaning Procedure" effective date 01/24/24, the policy indicated, " ...I. Purpose To reduce the risk of acquiring and transmitting healthcare associated infections (HAIs)/infectious disease to patients, employees ...by defining the standard steps for environmental cleaning and disinfection of or all areas and departments ...III. 8-Step Cleaning Procedure ...F. Clean the floor ..."

During a review of policy titled, "Environmental Cleaning and Disinfection Policy" effective date 10/31/23, the policy indicated, " ...I. Purpose A. To reduce the risk of HAIs by defining the general requirements for cleaning and disinfection performed by the environmental services department ...II. Policy ...B. Cleaning Schedules 1. Tasks sheets have been developed that detail the cleaning and disinfection requirements for designated areas. Tasks sheets also include general reminders about cleaning and disinfection, as well as a room checklist ..."

During a review of policy titled, "Cleaning of Clean Utility Room" last reviewed 01/24, the policy indicated, " ... B... While cleaning, use all-purpose cleaner to remove adhesives and tape ... E. Clean sinks with cream cleanser and scrubbing pad ..."

According to the Centers for Disease Control (CDC), undated, retrieved 8/2/24 from https://www.cdc.gov/infection-control/hcp/environmental-control/appendix-c-water.html, " Microorganisms have a tendency to associate with, and stick to surfaces ... These adherent organisms can initiate and develop biofilms (a thin layer of bacteria that adheres to the surface.)"

5. During an observation on 7/24/24 at 1:30 p.m., in Operating Room 10, Certified Registered Nurse Anesthetist (CRNA- a Registered Nurse who has specialized training in anesthesia) 1 did not complete hand hygiene six separate times within a ten-minute span. CRNA 1 failed to do hand hygiene before and after touching the patient (Pt 69), before putting on non-sterile gloves, after taking off non-sterile gloves, before drawing up medications and after administration of medications.

During an interview on 7/25/24 at 9 a.m., with CRNA 1, CRNA 1 stated he did not do proper hand hygiene while interacting with Pt 69. CRNA 1 stated an infection could have occurred with Pt 69 because of not performing hand hygiene at the appropriate times. CRNA 1 stated he did not follow the hospitals policy and procedure for Hand Hygiene.

During an interview on 7/31/24 at 11:40 a.m., with the Surgical Services Director (SSD), the SSD stated appropriate hand hygiene was important for infection control purposes. The SSD stated CRNA 1 did not do proper hand hygiene put and that put Pt 69 safety at risk. The SSD stated Pt 69 had the potential to acquire an infection and cross-contamination could have occurred. The SSD stated the expectation would be for CRNA 1 to follow policy and procedure for Hand Hygiene and he did not.

During an interview on 8/3/24 at 9 a.m., with the Director of Infection Prevention, the Infection Prevention Manager (MIP) and Infection Prevention Supervisor (IP Sup), the DIP stated hand hygiene was the best way to prevent the spread of microorganisms (bacteria). The DIP stated the expectation for CRNA 1 was hand hygiene should have occurred before gloving and after doffing (taking off); which is "contained in the policy".

During a review of Patient 58's "History and Physical (H&P-the physician's examination )," dated 7/25/25, the H&P indicated, "The H&P has been reviewed, the patient examined, and no changes found ...Informed Consent ...Diagnosis:-Squamous cell carcinoma (a type of cancer that starts as a growth of cells on the skin) of tongue ...Procedure:-Wide local excision (remove by cutting out) of tongue, tissue placement, local tissue rearrangement (used to rearrange tissue rather than to close a wound). Possible laser ablation (the process of removing material from a solid substance). Possible mandibular tori (noncancerous bony growths that appear on the floor of your mouth, under the tongue) removal ...[Patient 58] is a 73 [year old] male with biopsy (a procedure to remove a piece of tissue or a sample of cells from your body so that it can be tested) confirmed left lateral (side) tongue superficial (seen on the surface) squamous cell carcinoma ...He presents today for surgery. Denies changes in medical history ..."

During an observation on 7/25/24 at 3 p.m., in the Operating Room (OR), CRNA 6 removed his gloves and disposed of them, then taped the tubing onto Patient 58's nose and then sanitized.

During an observation on 7/25/24 at 3:25 p.m., in the OR, CRNA 6 did not perform hand hygiene prior to putting on gloves.

During an observation on 7/25/24 at 3:42 p.m., in the OR, RN 17 put on gloves without first performing hand hygiene.

During an observation on 7/25/24 at 4:09 p.m., in the OR, RN 17 put on a pair of gloves without performing hand hygiene to assist with moving around a medical device.

During an observation on 7/25/24 at 4:33 p.m., in the OR, RN 17 put on gloves to sanitize a cart and did not perform hand hygiene prior to putting on gloves.

During an observation on 7/25/24 at 4:51 p.m., in the OR, RN 17 did not perform hand hygiene prior to putting on gloves.

During an interview on 8/1/24 at 4 p.m. with RN 17, with Manager of Surgical Services (MSS) 2 and Clinical Nurse Specialist (CNS) 2 present, RN 17 stated hand hygiene should be performed before and after taking off gloves, between touching patients and other objects. RN 17 stated hand hygiene could be carried out by using hand sanitizer or washing hands. RN 17 stated the importance of hand hygiene was preventing infections from spreading. RN 17 stated if hand hygiene was not performed appropriately, an infection could spread. The four instances of the lack of hand hygiene on 7/25/24 was presented to RN 17. RN 17 stated hand hygiene should be performed before and after putting on gloves.

During a concurrent interview and record review on 8/1/24 at 4:08 p.m. with RN 17, with MSS 2 and CNS 2 present, the hospital's P&P titled, "Hand Hygiene," dated 4/14/22 was reviewed. RN 17 stated the P&P indicated, " ...Indications for hand hygiene ...Before donning sterile or non-sterile gloves ...After removing sterile or non-sterile gloves ..." RN 17 stated according to the P&P, the policy was not followed when she did not perform hand hygiene prior to putting on gloves. RN 17 stated the importance of following hospital P&P was to prevent infection and patient safety.

During an interview on 8/1/24 at 4:15 p.m. with MSS 2, with the Director of Surgical Services (DOS) and CNS 2 present, MSS 2 stated her expectations of nurses performing hand hygiene was prior to and after putting on gloves and taking off gloves, anytime hands were visibly soiled, anytime in the patient's room, touching different surfaces, and prior to putting on sterile gloves and after removing sterile gloves. MSS 2 stated the importance of hand hygiene was for patient safety, infection prevention, and decreased spread of germs and bacteria from one person to another. MSS 2 stated she ensured staff followed hand hygiene practices by having secret shoppers, internal audits, and discussed hand hygiene during huddles and staff meetings.

During an interview on 8/2/24 at 9:08 a.m. with the Infection Prevention Supervisor and Epidemiologist (IPSE), Manager of Infection Prevention (MIP), and the Director of Accreditation, Licensing, and Infection Prevention (DA/DIP) present, the DA/DIP stated he recognize hand hygiene is the best way to prevent the spread of microorganisms (living things that are too small to be seen with the naked eye The DA/DIP stated his expectations of hospital staff and hand hygiene were they should perform hand hygiene before and after glove use.

During a review of the facility's policy and procedure (P&P) titled, "Hand Hygiene", dated 4/12/22, the P&P indicated, "I. PURPOSE: the purpose of this policy is to promote effective hand hygiene practices and reduce the transmission of microorganisms amongst patients, personnel ... III. POLICY: A. Hand hygiene is the single most important means of preventing the spread of infection and is to be performed in any interaction where transmission of microorganisms is possible ... IV. PROCEDURE: A. Indications for hand hygiene: 1. Before and after touching the patient ... 3. Before donning (putting on) sterile or non-sterile glove... 6. After contact with inanimate surfaces and objects(including medical equipment) in the immediate vicinity of the patient. 7. After removing sterile or non-sterile gloves ... B. In addition to the items above, health care personnel are to clean their hands whether or not there is anticipated contact with the patient or their environment. Including the following moments: ... 3. Before handling medication ...".

During a professional reference review of an article from Cureus titled, "Examining the Importance of Hand Hygiene Policy and Patient Safety Culture on Improving Healthcare Workers' Adherence to Hand Hygiene Practice in Critical Care Settings in the Sultanate of Oman: A Scoping Review," dated 11/20/21, the article indicated, "Several studies suggest that adherence to hand hygiene (HH) policy would be enhanced by improving the culture of safety in an organization. This could be achieved through continuous awareness programs about the dramatic effect of HH practice according to the HH policy on improving patient safety and quality care. Understanding the importance and purposes of HH policy by healthcare workers would allow them to prioritize HH policy in their planning. Therefore, healthcare leaders should be responsible and accountable for strengthening their healthcare system by improving infrastructure, providing adequate support and resources, providing comprehensive monitoring and evaluation of patient safety initiatives, monitoring adherence to the regional Gulf Cooperation Council (GCC) and local Oman HH policy and using World Health Organization (WHO) guidelines for patient safety and HH as a basis for providing safer care. This should involve HH policy as a basic and mandatory program during an internship or in new staff orientation programs, spending enough resources on conducting more research studies and benchmarking findings with other international countries or any other organization such as WHO or Centres for Disease Control (CDC) ... In this sense, patient safety and quality care are the most important issues when adopting any policy ..."

6. During an observation on 7/25/24 at 1:15 p.m. at Pt 45's room, Educator 7 introduced herself and briefly explained the procedure to the patient. Afterwards, Educator 7 performed hand hygiene and donned a new pair of gloves prior to placing the unopened wound care supplies on a clean bedside table. The wound care supplies included clear adherent drapes, black granufoam (a special foam dressing which aids in pulling fluid from the wound over time), wound cleansing solution, no-sting skin barrier swabs, honey dressing, bordered gauze, gauze pads, suction pad, endoform dressing (a dressing designed to treat acute and chronic wounds), and scissors. Educator 7 then elevated the patient's bed and turned the patient to the right side with the assistance of the primary RN (Registered Nurse). Educator 7 checked the wound VAC settings and proceeded to remove the old dressings on the patient's right buttock and sacrum wounds. The old, bordered gauze dressing removed from the right buttock was visibly soiled with serosanguinous drainage (a type of drainage secreted by an open wound that is light red or pink). Educator 7 discarded the old dressings in the trash can. Afterwards, Educator 7 touched the wound VAC screen to turn it off while wearing the same pair of gloves used to remove the old dressings. Educator 7 did not disinfect the screen after she touched it. Educator 7 doffed the gloves, sanitized her hands, and then donned a new pair of gloves. Educator 7 prepared the wound dressings by soaking the gauze pads with wound cleansing solution, cutting the dressings to the appropriate sizes, and cleaning around Pt 45's wound with the no-sting skin barrier swabs. Educator 7 placed the prepared dressings as well as the extra supplies and soiled swabs on the same bedside table. Educator 7 proceeded to apply the new dressings to the patient's sacral wound as per the physician's order. After applying the dressing, Educator 7 applied the suction pad and connected the tube to the wound VAC device. Educator 7 touched the wound VAC screen to turn it on and set it to 125 mmHg (millimeters of mercury). Educator 7 then touched the sacral wound dressing, checked for leaks, then touched the screen again to verify the settings. Using the same gloves, Educator 7 proceeded to dress the patient's right buttock wound. Educator 7 did not disinfect the contaminated wound VAC screen prior to touching it and/or changed gloves prior to touching the sacral wound dressing and applying the new dressing to the right buttock wound.

During a concurrent interview and record review on 7/25/24 at 1:47 p.m. with Educator 7, Pt 45's "Order" dated 7/11/24 at 10:30 a.m. and "Negative Pressure Wound Therapy Non-Instillation 2 Wounds Associated (Order 418261811)" dated 7/21/24 at 5:32 p.m. were reviewed. Educator 7 verified Pt 45 currently had healing Stage 4 (a full-thickness skin and tissue loss with exposed or directly palpable muscle, tendon, ligament, or bone in the ulcer) wounds on the right buttock and sacrum. Educator 7 stated both wounds were present on admission and were treated separately as per the physician's orders. Educator 7 stated the right buttock wound was treated with a honey dressing, and the sacral wound was treated using a wound VAC. When asked how often the wound VAC device was cleaned, Educator 7 stated it was cleaned every dressing change and during safety checks. Educator 7 stated she did not clean the wound VAC device after performing wound care because the primary RN at the bedside will be responsible for cleaning it. Educator 7 was then informed about the observations regarding not disinfecting the wound VAC screen and/or changing her gloves prior to dressing the right buttock wound and placing discarded items on the same table used for the clean supplies. Educator 7 acknowledged the findings and stated she should have changed her gloves after touching the wound VAC screen.

During a review of Pt 45's "History and Physical" dated 7/4/24 at 6:10 p.m., the H&P (History and Physical) indicated Pt 45 was admitted to the hospital on 7/4/24. The H&P indicated " ...Since 3/2024 she has had multiple admissions with sepsis (a life-threatening complication of an infection) due to UTI (Urinary Tract Infection - an infection in any part of the urinary system), pyelonephritis (inflammation of the kidney), pressure ulcer (a localized damage to the skin and/or underlying soft tissue usually over a bony prominence or related to a medical or other device) complications and failure to thrive (a syndrome that can include a gradual decline in physical and mental functioning, weight loss, and social withdrawal). Her last admission was from 6/20 - 7/2/24. She had wound consult with application of wound vac for the pressure ulcer..."

During a review of Pt 45's "LDA (Line, Drain, Airway) Documentation" flowsheet dated 7/4/24, the document indicated Pt 45 had wounds on the sacrum (the triangular-shaped bone at the bottom of the spine) and right buttock upon admission.

During a review of Pt 45's "Order" dated 7/11/24 at 10:30 a.m., the order showed Pt 45 had a right buttock wound. The "Comments" showed the following:

"1. Cleanse the wound bed by moistening gauze with [brand of wound cleansing solution] and lay in wound bed for at least 3-4 minutes. Then pat dry.
2. Next apply no sting barrier film to the periwound (area around the wound) skin.
3. Cut small piece of Therahoney Sheet (a gauze dressing indicated for use on wounds with any drainage level) to the size of slough (yellow to tan dead tissue) the wound bed and place over slough avoiding peri wound.
4. Cover with silicone foam bordered border dressing (an absorptive dressing consisting of 3 layers).
5. Change the dressing every 3 days and as needed for soilage, saturation over 75% and/or dislodgement by bedside nurse."

During a review of Pt 45's "Negative Pressure Wound Therapy Non-Instillation 2 Wounds Associated (Order 418261811)" dated 7