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The Condition of Participation: Patient Rights was out of compliance.

Based on records reviewed, documents reviewed and interviews, the Hospital failed to provide care in a safe setting for one Patient (#3) out of a total sample of 14 patients. The Hospital failed to ensure Patient #3 remained connected to required supplemental oxygen (O2) during transport from the Emergency Department (ED) to the Heart Station. Upon arrival to the Heart Station, Patient #3 was noted to be sleepy and lethargic, his/her O2 nasal cannula was not attached to any O2 and his/her O2 saturation was documented at 68%. Subsequently, a Rapid Response was called for Patient #3 and he/she was transferred to the Medical Intensive Care Unit (MICU).

Cross Reference:

482.13 (c)(2) Patient ' s Rights: Privacy and Safety (0144)

Based on records reviewed, documents reviewed, and interviews, the Hospital failed to provide care in a safe setting for 1 Patient (#3) out of a total sample of 14 patients. The Hospital failed to ensure Patient #3 remained connected to required supplemental oxygen (O2) during transport from the Emergency Department (ED) to the Heart Station. Upon arrival to the Heart Station, Patient #3 was noted to be sleepy and lethargic, his/her O2 nasal cannula was not attached to any O2 and his/her O2 saturation was documented at 68%. Subsequently, a Rapid Response was called for Patient #3 and he/she was transferred to the Medical Intensive Care Unit (MICU).

Findings included:

Review of the Hospital policy 'Patient Transport with Portable Oxygen Tank', reviewed 9/2023, indicated:
-Patients requiring supplemental oxygen will be transported between areas of the hospital with adequate oxygenation support.
-Prior to sending a patient receiving O2 therapy from a patient care area, appropriate clinical personnel must check the oxygen tank prior to transport (the tank must have greater than or equal to 200) liters; clinical personnel are responsible for connecting the patient to the wall O2 outlet.

Review of the Hospital policy 'Patient Handoff Standardization, reviewed 8/2024, indicated:
-Healthcare professionals at the Hospital will incorporate the I-PASS (Illness Severity, Patient Summary, Action List, Situational Awareness/ Contingency Planning, Synthesis) format to all handoff communications involving a transfer of patient care among caregivers.
-This standardized I-PASS format will be used when transferring the care of a patient during, but not limited to, the following instances: all nurse (RN to RN) interactions; Unit/ Floor RN to Transporter with Ticket to Ride.
-All patients who require continuous O2 sat monitoring will be accompanied by an RN when leaving the Observation unit.

Patient #3 presented to the Emergency Department (ED) on 11/29/23 for lower extremity swelling and shortness of breath. Review of Physician Assistant Progress Note dated 11/30/23 at 1:08 A.M. indicated Patient #3 was noted to have pulmonary edema (a buildup of fluid in the lungs) on chest x-ray with concerns for volume overload and was noted to be hypoxic (low levels of oxygen in the body tissues) with an oxygen saturation of 85% on room air (RA). Patient #3 was placed on supplemental oxygen via nasal cannula (a device that delivers extra oxygen through a tube into the nose) for hypoxia with a plan to admit the Patient. On 11/30/23 at 2:39 A.M. an order was placed for continuous pulse oximetry monitoring. On 11/30/23 at 4:15 A.M., Patient #3 was found sleeping with the nasal cannula (NC) off, his/her oxygen saturation was 70% and subsequently the O2 was increased to 4 liters/min (L/min). On 11/30/23 at 8:56 A.M., Patient #3 was transferred from the ED to the Hospital's Heart Station for testing and was sleepy and lethargic upon arrival. Patient #3 was noted to have the nasal cannula in place; however, the nasal cannula was not attached to any supplemental oxygen and Patient #3's oxygen saturation level at time of arrival was 68%. Patient #3 was placed on 3L of oxygen and initially improved to 92% but remained sleepy. Patient #3 was unable to maintain adequate oxygen saturations which dropped to 55% and a Rapid Response was called. Patient #3 was placed on 100% non-rebreather (a medical device that delivers a high concentration of oxygen) and transferred to the Medical Intensive Care Unit (MICU). On 11/30/23 at 9:05 A.M., Patient #3 was transferred to the MICU for management of hypoxic hypercarbic respiratory failure (a condition where the body doesn't have enough oxygen in the tissues and/or has too much carbon dioxide in the blood) with bilevel positive airway pressure (BiPAP- a non-invasive breathing machine that helps breathing by delivering pressurized air through a mask) initiation. On 11/30/23 at 10:56 A.M., Patient #3 was intubated (a tube is placed through a person's mouth or nose, then down into their trachea. The tube keeps the trachea open so that air can get through) due to the Patient's difficult airway and his/her failing on the BiPAP.

During an interview on 10/17/24 at 11:03 A.M., the ED Quality Risk Manager said she was made aware of the event involving Patient #3 not being connected to O2 for transport after a safety report (RL) was filed. The ED Quality Risk Manager said that when a transport request order is placed, it is generally done by a nurse in the ED, and that there are different requirement boxes that can be checked off when making the request to indicate if the patient needs anything specific, such as oxygen, during transport. She said these check boxes must be manually checked off and are not automatically populated. She said there are also certain scenarios in which a nurse must accompany a patient during transport, including when a patient is ordered for continuous pulse oximetry monitoring The ED Quality Risk Manager said the transport team is non-clinical and receives the transport order and when they arrive to transport the patient, they will check in with the nurse and the nurse is fully responsible for disconnecting a patient from wall oxygen and connecting them to an O2 tank for transport. The ED Quality Risk Manager said Patient #3 had a transport request order placed by one nurse and that nurse failed to check off that the Patient needed O2 and that when the transporter arrived to bring Patient #3 from the ED to the Heart Station for testing, the Patient's primary nurse disconnected the O2 tubing attached to the Patient's nasal cannula from the wall and never re-connected it to the portable O2 tank for the transport. She said the nasal cannula remained in place but was not connected to any oxygen. The ED Quality Risk Manager said the Hospital review of this event determined that although Patient #3 would have likely needed BiPAP and intubation eventually, this event hastened the Patient's need for the BiPAP and subsequent intubation. The ED Quality Risk Manager said the Hospital was unable to determine how long Patient #3 went without supplemental oxygen, but it was likely anywhere between 5-10 minutes. The ED Quality Risk Manager said her understanding was that the primary nurse was verbally re-educated by the nurse manager after this event, but she was unable to provide any documentation or specifics of this. She also said that re-education should have been done with the ordering nurse as well, but there was no documentation of this. The ED Quality Risk Manager said after the review, she sent an email to all ED staff regarding special requirements for transport requests and attached the Hospital policy regarding when a nurse should accompany a patient to another department (including if a patient is ordered for continuous pulse oximetry) and she also discussed with nursing leadership sharing this with nursing staff. The ED Quality Risk Manager said that some of the emails she sent after the event involving Patient #3 did have read receipts but not all of them and she was unable to say which staff had received the re-education and read the email and policy. She also said there was no formal documentation or minutes indicating that this event and the transport special requirements process was discussed with nursing staff. The ED Quality Risk Manager said that the Hospital was still working with Information Technology (IT) to determine if there is a way to automatically populate transport request orders with oxygen being checked off if the patient has an order for oxygen or if it is being documented by nurses on flowsheets and that there was a test version of a new automated process, but it was not live yet and had not been implemented. She said the current system and process is still the same as it was at the time of this event. The ED Quality Risk Manager said nursing is ultimately responsible for ensuring the patient is connected to oxygen and ensuring a patient is accompanied by a nurse during transport if needed.

The Hospital failed to ensure the Patient #3 received supplemental oxygen and was accompanied by a nurse, as required, during transport and failed to implement corrective actions to prevent a like occurrence.

The Condition of Participation: Surgical Services was out of compliance.

Findings included:

Based on record review and interviews, the Hospital failed to ensure a properly executed informed consent form for a surgical procedure was available for one Patient (#10) out of a total sample of 14 patients; Patient #10 elected to have a sleeve gastrectomy procedure performed, however, a gastric bypass was performed the day of surgery for the Patient.

Cross reference:
482.51(b)(2) Standard: Informed Consent (A0955)

Based on record review and interviews, the Hospital failed to ensure a properly executed informed consent form for a surgical procedure was available for one Patient (#10) out of a total sample of 14 patients; Patient #10 elected to have a sleeve gastrectomy procedure performed, however, a gastric bypass was performed the day of surgery for the Patient.

Findings include:

Patient #10 presented to the Hospital on 8/2/24 to be admitted for surgery and an inpatient stay with a history of morbid obesity, Gastro-esophageal reflux disorder (GERD), and obstructive sleep apnea (OSA).

Review of the Hospital policy titled "Patient Consent", dated 6/2024, included the following:
-A written consent form is required at the Hospital as a matter of policy in the following circumstances:
-Major or minor surgery which involves an entry into the body, either through an incision or through one of the natural body openings.
-All Procedures in which general anesthesia is used whether or not entry into the body is involved.
-As a general rule the attending physician responsible for the patient's care will review the consent form with the patient or patient representative, provide appropriate information and obtain the written consent.

Review of the Hospital policy titled "Universal Protocol (Time Out)", dated 9/2022, indicated the following:
-Start of Operation: Operation/Procedure - Confirm operation and duration.

Review of Patient #10's medical record indicated the Patient was evaluated by Physician Assistant (PA) #1 in the Hospital bariatric surgery outpatient clinic on 7/10/24 for a final evaluation prior to surgery. PA #1's progress note indicated Patient #10 was ready for surgery, was scheduled for a sleeve gastrectomy (a surgical procedure in which the size of the stomach is reduced to help with weight loss), and the Patient consented to that procedure. The Bariatric Surgeon signed an attestation on 7/12/24 that the management plan for the patient was approved and planned treatment was noted in his assessment and plan. Patient #10 presented to the Hospital on 8/2/24 to prepare for surgery in surgical day care. On 8/2/24 at 7:26 A.M., a time out was documented by RN #4 preoperatively which indicated the Patient #10 was undergoing a gastric bypass procedure (a procedure in which the stomach is divided into two pouches and the small intestine is rearranged to connect to both pouches). An interval H&P (History and Physical) note was entered by the Bariatric Surgeon on 8/2/24 at 8:30 A.M. indicating Patient #10 was examined and no changes were noted to the Patient's condition. The interval H&P was conducted in conjunction to a preoperative H&P written on 7/10/24, which indicated Patient #10 was undergoing a laparoscopic gastric bypass. Patient #10 was also evaluated by Anesthesiologist #1 prior to surgery on 8/2/24; Anesthesiologist #1's paranesthesia evaluation indicated the Patient was scheduled for a laparoscopic gastric bypass procedure. Two time outs were conducted in the Operating Room on 8/2/24 at 9:18 A.M. and 9:39 A.M.; documentation for both time outs indicated the procedure to be performed for Patient #10 was a gastric bypass. Patient #10's operative progress note dated 8/2/24 indicated a laparoscopic gastric bypass was performed on Patient #10.

Further review of Patient #10's medical record indicated a progress note entered by the Bariatric Surgeon on 8/12/24. The progress note indicated Patient #10 had switched his/her desired procedure to a gastric sleeve from a gastric bypass on his/her last preoperative visit and through a series of multiple system failures the Patient received a gastric bypass instead of a sleeve procedure. Patient #10's medical record failed to indicate any signed surgical consents for 8/2/24 nor any anesthesia consents for 8/2/24 were in the Patient's record.

During an interview with the Chief Quality Officer on 10/15/24 at 11:15 A.M., she said Patient #10 was followed by bariatric surgery prior to this surgery, and the original plan for the Patient was for a gastric bypass procedure. She said the Physician Assistant who evaluated Patient #1 preoperatively did not follow Hospital policy regarding obtaining the Patient's consent prior to his/her procedure. She also said the Bariatric Surgeon did not follow up on the changes in the Patient's surgical election prior to the procedure being performed on 8/2/24; she said the Bariatric Surgeon had the consent in hand during the time out in the operating room on 8/2/24. She said policy changes are in process related to these procedures.

During an interview with the Director of Risk Management on 10/16/24 at 11:05 A.M., she said the Bariatric Surgeon reported the wrong procedure performed on Patient #10 following the gastric bypass that was performed on Patient #10 on 8/2/24. She said the Patient/Patient's family did want the gastric sleeve procedure to be performed instead of the gastric bypass. She said the PA involved in the preoperative evaluation did not follow the normal process for procedural changes.

During an interview with the Bariatric Surgeon on 10/16/24 at 11:40 A.M., he said Patient #10 had been followed by the bariatric program for over two years. Patient #10's plan was always to have a gastric bypass procedure as a weight loss surgery. He said PA #1 was told during Patient #10's preoperative evaluation that he/she wanted a gastric sleeve procedure performed instead of a gastric bypass. He said the PA should have taken the consent for the gastric sleeve to the clinic scheduler following the appointment with Patient #10 to have the case rebooked and authorization obtained for a gastric sleeve from the insurance provider. He said the consent form exists only as a paper copy and is not scanned into the Electronic Medical Record (EMR) until after the procedure has been completed. He said on 8/2/24 he brought Patient #10's consent form with him and added it to the Patient's paper chart/folder. He said the preoperative unit does not have the paper chart. He said he held the consent during the first time out in the OR and confirmed Patient #10's information on the patient label but quickly looked at the procedure and confirmed with the OR team the procedure being performed was a gastric bypass. He said during the pre-incision timeout, the circulator nurse held the consent form, and the procedure was confirmed to be a gastric bypass a second time. He said following the gastric bypass the surgical residents obtained the consent form from the inpatient floor Patient #10 was transferring to and it was then realized the Patient had consented for a gastric sleeve procedure. He said following this incident with Patient #10, PA #1 had been counseled on the procedure for new case requests and the consent forms have had enlarged print and different coloration between gastric bypass and gastric sleeve procedures.

During an interview with RN #4 on 10/16/24 at 12:05 P.M., she said she works in the Post Anesthesia Care Unit (PACU). She said on 8/2/24 she was working preoperative assignments and getting patients ready for surgery. She said preoperatively RNs go through a preoperative checklist with a surgical patient. She said the majority of the time the surgeon for the case and the anesthesiologist performing the pre-anesthesiology evaluation will obtain consent the day of surgery in the preoperative area with the patients/families. She said she was not sure how consents obtained during an outpatient visit prior to the day of surgery arrive at the preoperative area. She said the attending surgeon verifies the procedure with the patient prior to going to the operating room. She said the consents are put in a folder and remain with the patient to transfer to the operating room, the PACU, and then to the inpatient unit if applicable. She could not recall the consents for Patient #10 for his/her surgery on 8/2/24.

During an interview with PA #1 on 10/17/24 at 8:15 A.M., she evaluated Patient #10 on 7/10/24 prior to his/her surgery on 8/2/24. She said she was discussing the gastric bypass procedure with Patient #10, and at that time the Patient told her he/she wanted to have the sleeve procedure performed instead. PA #1 said she discussed this with the Bariatric Surgeon, who signed the consent form and took it to the clinic scheduler. She said following this event she discussed documentation with the Bariatric Surgeon and scheduler notifications. She said it is common practice to obtain consent from patients in the office prior to their day of surgery.

During an interview with Anesthesiologist #1 on 10/17/24 at 9:15 A.M., he said he evaluated Patient #10 on 8/2/24 for a gastric bypass case. He said he obtains patient consent during the pre-anesthesia evaluation and will place the consent in the folder with the patient. He said he verifies the correct procedure with the patient by asking what the nature of his/her procedure is. He said when he asked Patient #10 he/she said he/she was having weight loss surgery. He said he reviews the booking/surgical schedule for what procedure a patient is having prior to his evaluation of the patient and obtaining consent for anesthesia for the procedure. He said he participates in the time out in the operating room and the surgeon will state the procedure to be performed before every case.

The Hospital failed to produce a written consent for any procedure performed on Patient #10 on 8/2/24; the location of the paper consent forms for Patient #10 are unknown at this time.

The Condition of Participation: Emergency Services was out of compliance.

Findings included:

Based on record review and interviews, the Hospital failed to ensure one Patient (#1) out of a total sample of 14 patients who presented to the Hospital for emergency care was reassessed in the Emergency Department (ED) waiting room; Patient #1 presented to the Emergency Department and was brought into the Emergency Department after waiting over 20 hours in the waiting room and was found lethargic and with altered mental status.

Cross reference:
482.55(a) Standard: Organization and Direction (A1101)

Based on record review and interviews, the Hospital failed to ensure one Patient (#1) out of a total sample of 14 patients who presented to the Hospital for emergency care was reassessed in the Emergency Department (ED) waiting room; Patient #1 presented to the Emergency Department and was brought into the Emergency Department after waiting over 20 hours in the waiting room and was found lethargic and with altered mental status.

Findings include:

Patient #1 presented to the Hospital's ED by ambulance on 11/16/24 at 7:33 A.M. with lethargy and altered mental status.

Review of the Hospital policy titled "Nursing Assessment, Reassessment, and Documentation of Plan of Care in the Emergency Department", dated 4/2024, indicated the following:
-Vital signs will be assessed and documented a minimum of every four hours or as clinically indicated.

Review of Patient #1's medical record indicated the Patient was triaged on 1/16/24 at 7:34 A.M. in the Hospital's ED. Patient #1 appeared substance impaired and was incontinent of urine. Patient #1 was assigned an acuity level of 5 and sent to the ED waiting room. On 1/17/24 at 6:01 A.M., Patient #1 was assessed by Registered Nurse (RN) #1 in the ED waiting room with a pulse of 133 (normal range 60-100) and was brought into a trauma room in the ED. On 1/17/24 at 6:18 A.M. Patient #1 had elevated troponins (cardiac enzymes indicating cardiac damage) of 409 an elevated sodium level of 148, an elevated BUN of 44, elevated creatinine of 1.42(kidney function testing), an elevated magnesium level of 2.8 and an elevated AST (liver enzymes) of 71. On 1/17/24 at 6:19 A.M. RN #2 documented Patient #1 was altered and somnolent. On 1/18/24 at 7:22 A.M., Patient #1 became tachycardic (HR 104) in the ED and remained tachycardic while in the ED. On 1/18/24 at 11:27 A.M. Patient #1 was identified to have cryptococcal antigens present in his/her blood; at 11:40 A.M. a lumbar puncture was attempted to rule out cryptococcal meningitis, however, the Patient's oxygen desaturated and required oxygen administration at 6L (Liters) per minute. On 1/18/24 at 1:17 P.M. Patient #1 was intubated, ventilated, and sedated; Patient #1 had an elevated EtCO2 (End-tidal carbon dioxide) of 47. On 1/18/24 at 4:25 P.M., Patient #1 was ordered to received norepinephrine (a medication used to raise blood pressure) 8 mg (milligrams) intravenously; the Patient's blood pressure at 4:40 P.M. was 88/54 and low. On 1/18/24 at 5:09 P.M., Patient #1 was transferred to the ICU (Intensive Care Unit). Patient #1 was discharged from the Hospital on 3/29/24 after treatment for cryptococcal meningitis, elevated intracranial pressure, new diagnosis of AIDS with immune reconstitution inflammatory syndrome, and a right posterior limb IC punctate infarct (damage to the cerebellar part of the brain) secondary to meningitis. Patient #1's medical record failed to indicate the Patient was ever reassessed by a Registered Nurse from his/her initial triage on 1/16/24 at 7:34 A.M. until discovered by RN #1 on 1/17/24 at 6:01 A.M.

The ED was toured on 10/15/24 at 1:15 P.M. by the surveyor. The Vice Chair of the ED explained that patients coming into the ED by ambulance are triaged within the ED and assigned an acuity (ESI number 1-5). He said Patients assigned an ESI of 4 or 5 typically are sent with the ambulance crew to the ED waiting room and transferred to the Rapid Assessment Section (RAS) of the ED. During the tour the surveyor observed the ED ambulance triage area, the ED waiting room, and the ED RAS. The Vice Chair of the ED said ESI 4 and 5 Patients are called into the RAS, assessed by nursing and examined by a physician and discharged from the ED from the RAS if determined to be stable. He said Patients with altered mental status are usually triaged at an acuity of ESI 2 (higher acuity) and moved directly into the ED for evaluation and treatment. He said patients in the ED waiting room are supposed to be reassessed at certain intervals based on the Hospital's policy.

During an interview with RN #3 on 10/15/24 at 3:20 P.M., she said Patient #1 entered the ED on ambulance stretcher and she performed his/her triage. She said Patient #1 did not have any medical complaints but was likely substance impaired based on presentation and the Emergency Medical Service (EMS) report. She said she triaged Patient #1 as an ESI 5 and he/she went to the waiting room with the EMS crew. She said if a Patient is triaged when brought into the ED by ambulance and acuity is ESI 4 or 5, the Patient will stay on the stretcher and be taken to the waiting room. She said patients at an ESI of 4 or 5 do not go directly to RAS and the triage nurses working the waiting room of the ED take responsibility for those patients. She said the triage nurses in the ED waiting room can see which patients have come to the waiting room as the ED board in the Electronic Medical Record (EMR) updates as patients are triaged and moved. She said patients are reassessed in the waiting room by triage nurses but was unsure what the Hospital's policy was. She could not recall if Patient #1's encounter was reviewed after waiting over 20 hours in the waiting room.

During an interview with the ED Quality Risk Manager on 10/15/24 at 3:25 P.M., she said Patient #1's case was reviewed by the Patient Safety Steering Committee. She said the Patient was triaged as an ESI 5 and was appropriate to be moved to the waiting room; Patient #1 was found in the waiting room almost 24 hours after transferring there. She said fulltime flow nurse positions were created to help with Patient movement in the ED; currently a flow tech is staffed full time but is not assigned to the waiting room.

During an interview with RN #2 on 10/16/24 at 8:30 A.M. she said on 1/17/24 the triage nurse (RN #1) was concerned about Patient #1's mental status and brought the Patient back to the ED trauma room. RN #2 was working trauma on 1/17/24. She said it is not typical for near 24 hour wait times in the ED waiting room. She said Patient #1 went from being an ESI 5 acuity (lowest acuity) to intubated in the ED. She said usually a tech and security staff will round the waiting room checking wrist bands. She said the ED RAS opens around 10:00 A.M. and closed around 11:00 P.M. She said while a flow tech is available for helping manage bed designations for patients in the ED, the triage nurse is still responsible for reassessing any patients in the waiting room.

During an interview with RN #1 on 10/17/24 at 7:30 A.M., he said he worked triage in the ED from 7:00 P.M. on 1/16/24 to 7:00 A.M. on 1/17/24. He said he saw Patient #1 on the board and called for the Patient twice but could not remember the times he did. He said around 6:00 A.M. on 1/17/24 he saw Patient #1 sitting in the waiting room and had not seen him/her earlier and was not sure when he/se arrived in that spot. He said Patient #1's mental status was off, and he transferred the Patient into a wheelchair and brought him/her into the trauma section of the ED. He said the population coming into the Hospital ED will register for the ED in the waiting room and come and go from the waiting room knowing they have time before being called into the ED. He said there are many Patients presenting to the ED waiting room and it can be difficult to manage tracking patients in the waiting room and patients who have left without being seen. He said the flow tech position has helped with helping the triage nurses and other ED sections stay informed as to where patients can be moved to for better flow of patients in the ED; the flow techs do not assess patients in the waiting room. He said some ED techs and security staff have started doing role call for the waiting room, in which they move person to person in the waiting room to see if they are registered as patients for the ED and how long they have been waiting for, however, it is not a formal or set process and is not consistent. He said during triage patients with a lower acuity can have notes entered in the ED tracker in the EMR to indicate if they are appropriate for RAS evaluation. He said ED leadership had not followed up with him following Patient #1's encounter in January 2024.

The Hospital failed to ensure Patient #1 was reassessed by a RN in the ED waiting room and Patient #1 was discovered in the waiting room over 20 hours after presenting to the ED with altered mental status, tachycardia, and abnormal labs.