Kaiser Foundation Hospital-San Jose

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 44733 Based on interview and record review, the hospital failed to ensure that a Physician’s order was obtained in accordance with the facility’s policy and procedure for one of 31 patients (Patient 15). This failure had the potential not to determine whether the type of restraint (any manual method or device that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely) used for Patient 15 was approved and confirmed by the Physician for appropriateness. Findings: Review of Patient 15’s history and physical (H&P), filed 12/30/25, indicated he presented to Emergency Department (ED or ER, medical facility within a hospital that specializes in providing immediate care to patients with sudden, serious medical conditions that require immediate attention, operating 24 hours a day, 7 days a week, without the need for a prior appointment) with questions regarding necessity of foley catheter (a closed sterile system with a catheter and retention balloon that is inserted either through the urethra or supra pubically to allow for bladder drainage) and current prescriptions, and admitted for suspected metabolic encephalopathy (a problem in the brain caused by a chemical imbalance in the blood) from urinary tract infection (UTI, an infection in person’s urinary system) on 12/22/25. Review of Patient 15’s restraint order from 12/23/25 to 12/28/25 indicated, Comments: Restraint order is valid until the end (midnight) of next calendar day; Order Questions: both wrists limb-soft and torso vest for pull out lines/dressings and interfering with medical treatment. Further review of the restraint order from 12/23/25 to 12/28/25 revealed the order dated 12/26/25 at 9:03 p.m. was valid until the end (midnight) of 12/27/25. The restraint order was renewed on 12/28/25 at 5:17 a.m. Review of Patient 15’s Flowsheet Data from 12/23/25 to 12/28/25 indicated, “Restraints continued” from 12/28/25 at 0 a.m. to 4 a.m. During a concurrent interview and record review with the clinical director (CD) on 1/13/26 at 11:35 a.m., she confirmed the restraint was applied on Patient 15 without a physician’s order on 12/28/25 from 0 a.m. to 4 a.m. The CD acknowledged the hospital staff should have followed the policy and procedures in obtaining physician’s order to continue the restraint on Patient 15. During an interview with nurse manager (NM) A at intensive care unit (ICU, a special part of a hospital that provides care to people who are critically ill) on 1/15/26 at 9:05 a.m., she stated there should be a physician’s renewal order after 24 hours of previous restraint order to continue the restraint. During a review of the hospital’s policy and procedure (P&P) titled “Restraints NCAL Regional Policy” dated 3/28/25, the P&P indicated, “If the restraint for non-violent, non-self-destructive behavior health purposes continues, a new order must be written by the physician/LIP by the end of the next calendar day or earlier ...””

“DISCHARGE PLANNING - MD REQUEST FOR PLAN CFR(s): Upon the request of a patient’s physician, the hospital must arrange for the development and initial implementation of a discharge plan for the patient. This Standard is not met as evidenced by: 49345 Based on interview and record review, the hospital failed to ensure implementation of the discharge plan when referral to home health was not coordinated for one (Patient 3) out of 31 sampled patients. This failure had the potential to put Patient 3 at risk for infection and other complications and resulted in Patient 3’s visit to the Emergency Department to get wound care. Findings: A review of Patient 3’s medical record with the Quality Consultant (QC) on 1/12/26, the QC verified Patient 3 was admitted on of 5/1/24 and discharged on 5/9/24. A review of Patient 3’s “Pre-Op H&P [pre-operative history and physical] Note by Patient 3’s doctor (CRMD) dated 5/124 and timed 3:04 p.m. with the QC on 1/12/26 at 3:46 p.m., it indicated: ....”Procedure Information: [Patient 3] is a 79 Y [year] male here for discussion of the following procedure: 5/1/2024 SHOULDER ARTHROSCOPY [a type of surgery used to view the inside of a joint and repair damaged tissues] Right -Shoulder ... Past Surgical History: ....ARTHROSCOPY SHOULDER W [with] REPAIR ROTATOR CUFF RIGHT CUFF [the group of muscles and tendons on the right shoulder] 2/28/2024 ... Assessment and Plan: Preo-Op Diagnosis Codes: *RIGHT ROTATOR CUFF INJURY ...Right post surgical infection Informed Consent Discussion: ....Patient is a 79 Y male now 9 weeks post-op and with surgical site infection which likely tracks deep based on MRI [Magnetic Resonance Imaging, an imaging study]. At this point I recommend operative I&D [Incision and Drainage, a medical procedure used to treat infections or abscesses that have formed in the body] with arthroscopy. I would therefore recommend operative I&D within 24 hours ...We discussed post operatively he will be admitted to hospital for PICC line [Peripherally Inserted Central Catheter, a long, thin, flexible tube placed in a vein in the upper arm, guided to a large vein near the heart, used for long-term intravenous treatments] placement ...” During a concurrent interview and record review of Patient 3’s “After Visit Summary” 1/13/26 at 9:58 a.m. with the Discharge Planning Manager (DPM), and the Senior Operations Manager for Discharge Planning (SOM), the DPM and SOM verified a Patient Care Coordinator Note dated 5/7/24 at 11:46 a.m. indicated, “You have been referred to [Hospital Name] Home Health.” The DPM stated, “The case manager [discharge planner] missed the order for home health.” The DPM and the SOM verified, referral to home health was not entered in the patient’s chart, home health agency did not receive a referral and no confirmation of referral was received from the home health agency after the discharge. The SOM stated, when Home Health was not provided for Patient 3, there was risk for infection and complications related to his PICC line. During a concurrent interview and record review of Patient 3’s “Emergency Provider Notes” dated 5/13/24 with the DPM and the SOM on 1/13/26 at 9:58 a.m., the DPM and the SOM verified it indicated, “ ....discharged from hospital on May 9th, pt [patient] has not had any home health care RN [registered nurse] to home for bandage changes. Small areas of redness noted to wound area. Pt with PICC line receiving ABX [antibiotics] ... HPI [history of present illness]: [Patient 3] ...who presents with needing his wound evaluated, he was day 12 post operative from I&D washout of bacterial arthritis of his right shoulder [infection with swelling of joints on right shoulder]. Reports no wound home health care nurse arrived to change his dressings since discharge from hospital. Notes some discharge on wound site ... Physical Exam: Musculoskeletal: ... Comments: Right shoulder with 3 small linear incisions with suture ...” A review of Patient Care Coordinator Case Manager job description revised 7/20/2018 indicated, “Essential Responsibilities: ...Monitors the progression of the discharge plan and facilitates discussions with the multidisciplinary teams..Discharge Planning: Ensures continuity of care through communication in rounds and written documentation, level of care recommendations, transfer coordination, discharge planning and obtaining authorizations/approvals as needed for outside services for the patient..” A review of hospital’s policy and procedure (P&P) entitled “Discharge Planning- Interdisciplinary” revised 2/2017, the P&P indicated, “1.0 ...The patient Care Coordinator (PCC) has the responsibility for the overall coordination of the discharge plan ...5.4.2 Patient Care Coordinator Assistant (PCCA) is responsible for the provision of support to the PCC: 5.4.2.1 Sends required medical records to appropriate referral sources 5.4.2.2 Confirms that the appropriate referrals were received..””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 10918 Based on interview and record review the hospital failed to ensure a patient care policy was followed for one of eight sampled patients (Patient 5) when registered nurses did not accurately assess Patient 5’s coccyx (small triangular bone at the base of the spine) wound upon admission. This failure resulted in a delay of coccyx wound treatment of Patient 5. Findings: Review of Patient 5’s record indicated the patient was admitted on 10/7/24. Patient 5’s Inpatient Wound Care Notes, consulted at 10/9/24 10:19 a.m., indicated the patient in addition to a lower left leg wound had a hospital acquired Stage III chronic pressure wound (full-thickness skin loss where the fat layer is visible. an injury resulting form prolonged pressure). The same note indicated Patient 5 had stated she felt her wound at that location for over four months. During an interview on 12/2/24 at 1:20 p.m., the wound care nurse (WCN) stated she reviewed the record upon admission and it was the floor nurses responsiblity to perform a head to toe skin assessment. WCN also stated Patient 5’s coccyx wound was missed on admission. Patient 5’s Nurse’s Note dated 10/9/24, indicated Patient’5 coccyx wound treatment was not started until 10/9/24. Review of the Pressure Injury Prevention policy, 5/2/24, indicated all patients was to receive a full body assessment of their skin condition within 24 hours of admission simultaneously by two registered nurses.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 10918 Based on interview and record review the hospital failed to document the application of physicial restraint (means of purposely limiting or obstructing the freedom of a person’s bodily movement) accordance with hospital policy for one of thirty sampled patients (Patient 1), when the licensed nurse failed to document Patient 1’s physical restraint application on 8/15/24. The lapse in documentation resulted in inaccurate record of what took place and increased the risk of restricting circulation to limbs. Findings: Review of Patient 1’s physician progress notes, dated 8/15/24 at 4:55 p.m., indicated the patient had multiple code grays (summoning security personnel to assist with combative or aggressive persons) this afternoon for agitation. The note indicated Patient 1 required 4 point (both wrists and ankle) restraints and three medications by injection. Patient 1 had a physician’s order, dated 8/15/24 at 6:21 p.m., to apply four limb restraints for violent behavior. There was no nurses note indicating the patient had problem behaviors, was placed on 4-point restraints and duration of use, received medications, had security staff involvement and the outcome of the incident. During an interview on 9/26/24 at 10:40 a.m., the clinical director of quality services who reviewed the record stated she spoke with the nurse manager yesterday to confirm the patient was restrained and could not find nursing assessment documentation for the restraint use. Review of the Restraint policy, dated 11/2023, indicated for violent, self-destructive behavior to conduct an assessment to include level of distress, agitation, mental status and cognitive functioning and continuosly observe the patient. The registered nurse was to document in the patient’s medical record of initial asssessment, the type of restraint used, care provided, results of assessment and monitoring and note the decsion to discontinue.”

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 10918 Based on interview and record review the hospital failed to ensure hospital policy was followed when a patient had the wrong lesion removed from her arm for one of seven sampled surgical patients (Patient 4). The hospital also failed to follow physician’s order when a contrast (dye) was mistakenly administered to one of five sampled patients (Patient 5). These failures had the potiential to cause patient health complications. Findings: 1. Review of Patient 4’s brief operative note, dated 11/6/23 at 5:51 p.m., indicated the patient underwent a surgical procedure to remove a melanoma (type of skin cancer) to the left arm. The long operative note, dated 12/7/23 at 12:52 p.m., indicated Patient 1 had a second surgery to remove the melanoma in her left arm. During an interview on 9/26/24 at 11:33 a.m., the quality nurse stated the patient unfortunately had two moles on her left upper arm. The surgeon marked her intials on the patient’s left arm, did not circle the intended mole and took out the wrong one. The next day the patient noticed the wrong mole was removed and she informed the doctor Review of the Universal Protocol - Patient, Procedure and Site Verification policy, dated 09/2022, indicated the policy was a risk-reduction strategy that was designed to ensure correct site for all operative or invasive procedures and indicated the mark was to be “unambiguous.” 2. Review of Patient 5’s progress note, dated 12/19/24 at 6:16 p.m., indicated the patient was scheduled to undergo a computed tomography (CT, a medical imaging procedure that uses X-rays to create detailed images of the body) scan of the urinary tract with non-contrast due to elevated creatinine (test of a chemical to see how well a person’s kidney work). The note indicated a CT technician had notified the physician about half of the intravenous (IV) contrast had been administered during the procedure before it was noticed. During an interview on 9/26/24 at 1:33 p.m., the assistant director of imaging services stated the CT technician who administered the IV contrast should have check the physician’s order and creatinine lab results before the procedure. Review of the undated STOP! CT Technologist Exam Checkist indicated prior to bringing the patient into the exam room to check labs, allergies and prior studies. It also indicated prior to making the first exposure to double-check the exam (physician order) to be performed.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 36623 Based on interview and record review, the hospital failed to obtain an order for the use of restraints (any manual method or device that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely) for one of four patients (Patient 5) when Patient 5 was placed in bilateral (both sides) ankle restraints without a physician order. This failure had the potential to result in an inappropriate and prolonged use of restraints. Findings: Review of Patient 5’s medical record, he was admitted to the facility on 8/9/24 with diagnoses including sepsis (a life-threatening condition caused by the body’s reaction to an infection) and urinary tract infection (UTI, infection in the urinary system). Review of Patient 5’s Emergency Department (ED) nursing notes, dated 8/10/24 indicated, “Patient is highly confused, [MD] notified. He will not follow directions. Soft restraints applied at this time on all 4 limbs to protect patient during care.” Review of Patient 5’s restraints flowsheet, dated 8/10/24 to 8/13/24 indicated the patient had soft restraints on the right wrist, left wrist, right ankle, and left ankle starting on 8/10/24 at 12 a.m. The flowsheet indicated the soft restraints on the right wrist, left wrist, right ankle, and left ankle were discontinued on 8/10/24 at 5:27 a.m. Review of Patient 5’s Order History, dated 8/9/24 to 8/12/24 indicated the patient had an order, dated 8/10/24 for restraints for both wrists. There was no order for restraints for both ankles. During an interview on 8/13/24 at 12 p.m., the Clinical Director Quality Services (CDQS) confirmed there was no order for bilateral ankle restraints. Review of the hospital’s policy, “Restraints,” revised 7/2/17 indicated, “Restraint may only be initiated or continued upon the order of a physician or authorized licensed independent practitioner (LIP) primaryly responsible for the patient’s ongoing care ... In a situation requiring the emergency application of restraint, a registered nurse may initiate restraint use ... An order for restraint must be obtained from the physician/LIP either during the emergency application of the restraint, or immediately (within a few minutes) after the restraint has been applied. If an order is not obtained immediately, it would be considered application of restraint without an order.””

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(16)(ii) [there must be documentation in the patient’s medical record of the following:] A description of the patient’s behavior and the intervention used. This Standard is not met as evidenced by: 36623 Based on interview and record review, the hospital failed to document a clear description of the behavior of one of four patients (Patient 5) that warranted the use of restraints (any manual method or device that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely). This failure had the potential to result in patients being unnecessarily restrained. Findings: Review of Patient 5’s medical record, he was admitted to the facility on 8/9/24 with diagnoses including sepsis (a life-threatening condition caused by the body’s reaction to an infection) and urinary tract infection (UTI, infection in the urinary system). Review of Patient 5’s Emergency Department (ED) nursing notes, dated 8/10/24 indicated, “Patient is highly confused, [MD] notified. He will not follow directions. Soft restraints applied at this time on all 4 limbs to protect patient during care.” Review of Patient 5’s restraints flowsheet, dated 8/10/24 to 8/13/24 indicated the patient had soft restraints on the right wrist, left wrist, right ankle, and left ankle starting on 8/10/24 at 12 a.m. The flowsheet indicated the clinical justification for the restraints was the patient was pulling at lines, tubes, and removing equipment. The flowsheet had no documentation that indicated the clinical justification for ankle restraints. Review of Patient 5’s Order History, dated 8/9/24 to 8/12/24 indicated the patient had an order, dated 8/10/24 for restraints for both wrists for pulling out lines/dressings. There was no order for restraints for both ankles. There was no documentation that indicated the clinical reason for ankle restraints. During an interview on 8/13/24 at 2:50 p.m. the Clinical Director Quality Services (CDQS) confirmed there should be documentation that indicated the reason Patient 5 required ankle restraints. Review of the hospital’s policy, “Restraints,” revised 7/2/17 indicated, “The order for restraint shall be based on the specific behaviors that indicate the need for restraint.””

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 10918 Based on observation, interview, and record review, the hospital failed have an effective governing body (GB) legally responsible for the conduct of the hospital as an institution as evidenced by: 1. Failure to ensure nursing services were provided to safely meet the needs of patients (Refer to A395, A397, and A398). 2. Failure to carry out an effective, system-wide quality assessment and performance improvement (QAPI) program in identifying and developing performance measure projects focusing on nursing care pertaining to high risk and high volume hospital setting to ensure patient safety (Refer to A283). An interview with the administrator (ADM) was conducted on 5/16/24 at 4:55 p.m. The ADM stated the medical executive committee (MEC, also known as GB) had the oversight of hospital operation. The Professional Staff Bylaws for the Hospital, approved 3/19/24, indicated the board of directors as the governing body had the ultimate responsibility for the proper functioning of the hospital and for all related matters. The cumulative effect of these systemic problems resulted in the governing body’s inability to govern the hospital effectively and therefore was not in compliance with the Condition of Participation for Governing Body in ensuring safe delivery of patient care.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 10918 Based on interview and record review, the hospital failed to develop an effective, ongoing, hospital wide, data driven quality assessment and performance improvement (QAPI) program for nursing services in high risk high volume setting as there were no performance measures addressing: 1. Continuous supervision of patients residing in a high risk setting. Patient 1 was not continuously supervised in the telemetry unit (hospital floor that monitors patient’s heart rhythm and rate, respiratory rate, and oxygen saturation using an electronic device) and registered nurses did not timely attend to the patient when he was off his telemetry monitor (Refer to A395). 2. Tracking and evaluating staff performance in adhering to hospital policies and procedures to provide safe patient care. Registered nurses did not use or timely activate Vocera (devise used between caregivers to timely communicate and attend to patient needs), and a staff member did not correctly follow escalation notification process when a patient concern arose (Refer to A398). 3. Ensure registered nurses were provided orientation and deemed competent (documentation of nurses’ clinical knowledge, skills, abilities, and behaviors to ensure provision of safe and effective care to patients) by the time of patient assignment to their respective nursing units (Refer to A397). These cumulative failures resulted in the hospital’s inability to provide quality health care as required by the QAPI Program Condition of Participation and placed patients at health risk.”

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 10918 Based on observation, interview, and record review, the facility failed to ensure the Condition of Participation for Nursing Services was met as evidenced by: 1. One of 30 sampled patients (Patient 1) was not continuously supervised in the telemetry unit (hospital floor that monitors patient’s heart rhythm and rate, respiratory rate, and oxygen saturation using an electronic device) in accordance with physician’s order. Patient 1 disconnected himself a second time from his telemetry monitor, Patient 1 was not timely attended and was found to be in respiratory distress. Patient 1 had a low heart rate and he subsequently died. (Refer to A395) 2. Hospital policies were not followed for patient care. Registered nurses did not use or timely activate Vocera (devise used between caregivers to timely communicate and attend to patient needs), the used of Vocera was not consistently tracked, and the process of ensuring notification (escalation) of patient concern was not followed (Refer to A398). 3. Two of two sampled travel registered nurses personnel files who provided patient care lacked competencies (documentation of nurses’ clinical knowledge, skills, abilities, and behaviors to ensure provision of safe and effective care to patients) and sufficient orientation (Refer to A397). The cumulative effect of these deficient practices resulted in the facility’s inability to provide quality health care and placed patients at health risk.”

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 10918 Based on interview and record review the hospital failed to identify and develop performance measure projects focusing nursing services pertaining to high risk and high volume setting in the hospital to ensure patient safety. This failure resulted in a missed opportunity to prevent unnecessary harm and improve patient care. Findings: Review of Patient 1’s record indicated he had physician’s order to be continuously supervised in the telemetry unit (hospital floor that monitors a patients’ heart rhythm and rate, respiratory rate, and oxygen saturation with an electronic device). During an interview on 5/15/24 at 11:15 a.m., the assistant nurse manager (ANM) D stated registered nurses on the telemetry unit were required to use Vocera (devise used between caregivers to timely communicate and attend to patient needs), the nurse assigned to Patient 1 did not turn it on. Patient 1 was found in the bathroom, and later died. During an interview on 5/15/24 at 12:10 p.m., the clinical nurse educator (CNE) F stated a competency checklist for Vocera communication system was not developed because it was considered a piece of equipment and not necessary. During an interview on 5/16/24 at 8:30 a.m. the monitor technician (MT) stated when she was unable to contact the primary (assigned) nurse by Vocera on the first incident, she used the chat system (online tool to allow user to communicate in real time via text or video chat), then the second incident of the Patient 1 being off monitor and she could not find anyone to check Patient 1. During an interview on 5/16/24 at 2:30 p.m., the clinical director of quality services (CDQ) stated the hospital do not use the chat system to contact a nurse, it was not part of the escalation process. During an interview on 5/16/24 at 4:05 p.m., the nurse manager (NM) H stated after Patient 1’s incident, the hospital learned about problems in the telemetry unit, such as not all nurses were consistently logged on to Vocera and she acknowledged performance measure projects were not developed. Review of two of two sampled travel registered nurses personnel files who were assigned patient care lacked sufficient orientation and competencies (documentation of nurses’ clinical knowledge, skills, abilities, and behaviors to ensure provision of safe and effective care to patients). Review of the Medical Executive Committee Meeting Minutes from 8/7/23 to 3/4/24 did not address performance measure projects addressing high risk high volume potential problems such as continuous patient monitoring, communication systems (equipment and escalation process) and staff competencies. Review of the Hospital Quality and Patient Safety Program Description policy, dated 1/26/24, Under Patient Safety, indicated the hospital was to implement activities to include ensuring actual and potential hazards associated with high risk processes and patient care populations were identified, assess with the ultimate objective of ensuring patients are free from unnecessary harm, ensure staff possess the knowledge and competence to safely perform required duties and improve system safety performance, operate and maintain a safe environment of care as well as evaluate, and utilize equipment that promoted the efficiency and effectiveness with which safe healthcare was provided.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 10918 Based on interview and record review the hospital failed to supervise a patient’s health status for one of 30 sampled patients (Patient 1). Patient 1 was not continuously supervised in the telemetry unit (hospital floor that monitors patient’s heart rhythm and rate, respiratory rate, and oxygen saturation using an electronic device) in accordance with physician’s order. When Patient 1 disconnected himself a second time from his telemetry monitor he was not promptly attended by a registered nurse. Patient 1 was found to be in respiratory distress, low heart rate and he subsequently died. Findings: Review of Patient 1’s record indicated he had a physician’s order dated 3/15/24 at 3:53 p.m. to initiate cardiac monitoring when admitted to the telemetry unit (hospital floor that monitors a patients’ heart rhythm and rate, respiratory rate, and oxygen saturation with an electronic device). During an interview on 5/14/24 at 11:15 a.m., the assistant nurse manager (ANM) D stated on approximately 3/18/24 at 12:22 a.m., Patient 1 had his telemetry leads (device that connects electrode from the patient to a telemetry unit for continuous monitoring) off and it was replaced in five minutes. At 12:33 a.m. Patient 1’s leads were off again and when he was found at 12:45 a.m. a code blue (hospital emergency code that indicates a patient needs immediate medical attention, usually due to cardiac (heart) or respiratory arrest) was called. The ANM stated the registered nurse (TRN, travel nurse A) assigned to Patient 1 did not log in to Vocera (devise used between hospital staff to timely communicate and attend to patient needs). During an interview on 5/16/24 at 9 a.m., registered nurse (RN) C stated she was assigned to provide care to Patient 1 on 3/17/24 at 7 p.m. At 11 p.m. she gave a hand off (report) to the incoming nurse (TRN A) and continued working as a relief in higher class (charge nurse). RN C recalled she reconnected Patient 1’s telemetry monitor when she was informed it was disconnected (first incident) and later when she walked down the hall with TRN A, she found Patient 1 down in the bathroom appearing pale and with agonal breathing (gasping for air). RN C did not remember if TRN A had a Vocera. During an interview on 5/16/24 at 8:30 a.m. the monitor technician (MT) stated she asked the charge nurse to check on Patient 1 when there was no Vocera response from the assigned nurse when the patient was off monitor. When Patient 1 was off monitor the second time there was again no Vocera response from the assigned nurse and she could not find anybody to check on the patient. Review of Patient 1’s Discharge Summary dated 3/18/24 at 6:50 a.m. indicated the patient was found down on the bathroom floor with bradycardia (slow heart rate), hypotensive (low blood pressure) and in pulseless electrical activity (PEA, type of irregular heart rhythm that occurs when the heart’s electrical activity was too weak to pump blood or maintain a heartbeat) and was declared dead on 3/18/24 at 1 a.m. Review of Standard of Care for Telemetry Units policy, revised 10/2022, under Cardiovascular system indicated to monitor continuous cardiac electrical activity.”

“PATIENT CARE ASSIGNMENTS CFR(s): 482.23(b)(5) A registered nurse must assign the nursing care of each patient to other nursing personnel in accordance with the patient’s needs and the specialized qualifications and competence of the nursing staff available. This Standard is not met as evidenced by: 10918 Based on interview and record review the hospital failed to ensure two of two sampled contracted (travel) registered nurses received sufficient orientation and had completed competencies(documentation of a nurse’s clinical knowledge, skills, abilities, and behaviors to ensure provision of safe and effective care to patients) adequate for telemetry unit (hospital floor specializing in monitoring patients’ heart rhythm and rate, respiratory rate, and oxygen saturation using an electronic device) for which they were assigned patients. This failure had the potential for patients not receiving quality care and placed them at health risk. Findings: During an interview on 5/15/24 at 11:15 a.m., the assistant nurse manager (ANM) D stated Patient 1 disconnected his telemetry leads (device that connects electrode from the patient to a telemetry unit for continuous monitoring) twice on the night shift (11 p.m. to 7 a.m.) on 3/17/24, the nurse assigned to Patient 1 was not contacted to check on the patient, and on the second incident the patient was found in the bathroom with agonal breathing (gasping breath) and later died. The ANM stated registered nurses on the telemetry unit were required to use Vocera and the the nurse assigned to Patient 1 at the time did not turn it on. 1. Review of travel registered nurse (TRN) A’s personnel file indicated she had a contractual assignment as a registered nurse to work in the intensive care unit (ICU) from 2/27/24 to 5/25/24. The file did not contain competency as an telemetry or ICU nurse from the contracting company. Review of TRN A’s Initial Registered Nurse (RN) Core Competency form, dated from 3/5/24 to 3/6/24, indicated the preceptor/supervisor/educator did not consistently date and or initial all sections of the approximate 30 page form. Review of the RN Initial Competency Intensive Care Unit form other than indicating TRN A’s name was left blank. None of the competencies addressed the use of Vocera (devise used between caregivers to timely communicate and attend to patient needs). The telemetry competency for TRN A was requested and not provided. Review of TRN A’s record indicated the nurse worked in the medical-surgical unit on 3/7/24, 3/11/24, and was assigned to patients in the telemetry unit on 3/17/24. During an interview on 5/15/24 at 12:10 p.m., the clinical nurse educator (CNE) F stated a competency checklist for Vocera communication system was not developed because it was a piece of equipment and not necessary. During an interview on 5/15/24 at 12:30 p.m., clinical nurse educator (CNE) E who reviewed the personnel file stated the Core Competency form was not complete, ideally the preceptor should have date and initial each sections and note discussion indicating the nurse understood the process. CNE E acknowledged an ICU or telemetry competency was not conducted for TRN A. During a concurrent interview and record review on 5/15/24 at 1:07 CNE E the “Orientation Schedule -ICU Traveler” was reviewed, the document indicated on 3/1/24 Travel Nurse (TRN) A was scheduled to orient on the sixth floor telemetry unit from 9 am-11 am., CNE E was not able to provide evidence of the sixth floor telemetry unit orientation. 2. Review of TRN B’s personnel file indicated she had a contractual assignment as a registered nurse to work in the telemetry unit from 1/2/24 and she was currently employed. During an interview on 5/16/24 at 4:14 p.m. the Human resouce representative stated TRN B had renewed her contract and was currently providing patient care in the telemetry unit. A request for TRN B’s telemetry competency was requested and not provided. Review of the Orientation, Training, Education and Competency policy, revised 11/2022, indicated a registered nurse shall be considered competent.... The manager/designee evaluates individual competency on an ongoing basis. In the event of staff member temporary assignment to another unit or patient population, skills/knowledge competencies required on the assigned unit or patient population were assessed and validated prior to independent assignment. “Documentation of orientation, training, education and/or competency was part of the employee record ...”.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 10918 Based on interview and record review the hospital failed to ensure policies and procedures were followed for patient care. Registered nurses did not use or timely activate Vocera (devise used between caregivers to timely communicate and attend to patient needs) when providing patient care, the use of Vocera were not consistently tracked, and the process of ensuring notification (escalation) of patient concern were not followed. These failures placed patients at health risk. Findings: 1. During an interview on 5/15/24 at 11:15 a.m., the assistant nurse manager (ANM) D stated Patient 1 disconnected his telemetry leads (device that connects electrode from the patient to a telemetry unit for continuous monitoring) twice on the night shift (11 p.m. to 7 a.m.) of 3/17/24, the nurse assigned to Patient 1 was unable to be contacted by Vocera to check on the patient. On the second incident the patient was found in the bathroom with agonal breathing (gasping breath) and he later died. The ANM D stated registered nurses on the telemetry unit were required to use Vocera and the the nurse assigned to Patient 1 did not turn it on. Review of the undated Vocera Phone Workflow Roles and Responsibilities form, indicated Vocera phone assignments to the nurses was to be completed by the oncoming/out going unit assistance at shift change. The nurse was to log in to their Vocera upon receipt. 2. During an interview on 5/16/24 at 8:30 a.m., the monitor technician (MT) stated Patient 1 had his telemetry leads off twice on the night shift of 3/17/24, she tried but was unable to contact the nurse (primary) assigned by Vocera to check on the patient. The MT stated on the second incident she used the chat system (online tool to allow user to communicate in real time via text or video chat) twice and there was still no response from the nurse and she could not contact another nurse. During an interview on 5/16/24 at 2:30 p.m., the clinical director of quality services (CDQ) stated we do not use the chat system to contact a nurse, and it was not part of the escalation process. 44577 3. During a concurrent observation, interview, and record review on 5/14/24 at 11:20 a.m. with nurse manager (NM) L and ANM I, the “Staff Assignment Premier and the Phone/Patient Nurse Assignment Form” were reviewed. The Assistant manager stated, the ANM matches the staff assignment, and the phone/patient nurse assignment and signs it off. During the concurrent interview and observation, the staff assignment failed to include registered nurse (RN) G, the ANM I confirmed RN G should have been on the staff assignment. During an interview on 5/16/24 at 4:05 p.m., the nurse manager stated after Patient 1’s incident, the hospital learned not all nurses were consistently logged on. During a concurrent interview and record review on 5/16/24 at 4:30 p.m. with ANM M the “Nursing Assignment - 6th Floor”, dated 3/17/24 and “Vocera user activity details” for 3/17/24 and 3/18/24 was reviewed. Review of the documents with ANM M, there was no evidence that indicated three of 12 Scheduled Registered Nurses (TRN A, RN J, RN K) were signed onto the Vocera device on 3/17/24 7 p.m. to 7 a.m. shift. The ANM M stated, “there was no indication they were signed into Vocera, they should have been signed in”. During a review of the facility’s policy and procedure titled, “Clinical Alarm Notification Systems (CANS) NCAL Regional Policy”, dated 10/25/2023, indicated “RN will ensure that phone is correctly programmed with assigned patients, and all required alarms are audible (red, yellow and inoperative). Review of Monitor Technician Skills Assessment form, dated 03/2019, indicated a skill/responsibility was to follow a chain of command if unable to reach primary registered nurse. Under guidelines/expectations, it indicated any concerns with phone or telemetry monitor performance was to be escalated to the unit assistant nurse manager, nurse manager or designee.”