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Based on review of the facility's unit scope of service, nursing job descriptions, log of bedside hemodialysis catheter insertions, continuing education skills procedure, observation, medical record review and staff and physician interviews, the hospital's governing body failed to provide oversight and have systems in place to ensure the protection of patient rights, failed to ensure an organized nursing service to supervise and oversee care, and failed to ensure a safe setting for the insertion of a hemodialysis catheter.

The findings include:

1. The facility failed to protect and promote patients' rights by failing to ensure a safe environment for the insertion of a hemodialysis catheter for 1 of 10 sampled patients that had a hemodialysis catheter inserted (Patient #5). The hemodialysis catheter insertion was performed on a nursing unit where the procedure was not routinely done and staff were not experienced with the procedure. Supplies and equipment routinely used and available during the hemodialysis catheter insertion were not used or readily available resulting in an unsafe setting. The procedure caused a decline in the patient's condition and the patient was resuscitated; and subsequently expired.

~cross refer to 482.13 Patient Rights' Condition: Tag 0115

2. The hospital's nursing staff failed to have an effective nursing service providing oversight of day to day operations by failing to ensure a safe setting and experienced nursing staff for insertion of a hemodialysis catheter for 1 of 10 sampled patients that had a hemodialysis catheter inserted at bedside (Patient #5).

~cross refer to 482.23 Nursing Services Condition: Tag 0385.

Based on review of the facility's unit scope of service, nursing job descriptions, log of bedside hemodialysis catheter insertions, continuing education skills procedure, observation, medical record review and staff and physician interviews, the facility failed to protect and promote patients' rights by failing to ensure a safe environment for the insertion of a hemodialysis catheter for 1 of 10 sampled patients that had a hemodialysis catheter inserted (Patient #5).

The findings include:

Facility staff failed to provide a safe setting for a hemodialysis catheter insertion for a patient that had a hemodialysis catheter inserted at bedside. The hemodialysis catheter insertion was performed on a nursing unit where the procedure was not routinely done and staff were not experienced with the procedure. Supplies and equipment routinely used and available during the hemodialysis catheter insertion were not used or readily available resulting in an unsafe setting. The procedure caused a decline in the patient's condition and the patient was resuscitated; and subsequently expired.

~cross refer to 482.13(c)(2) Patient Rights' Standard: Tag A0144

Based on review of the facility's unit scope of service, nursing job descriptions, log of bedside hemodialysis catheter insertions, continuing education skills procedure, observation, medical record review and staff and physician interviews, facility staff failed to provide a safe setting for a hemodialysis catheter insertion for 1 of 10 sampled patients that had a hemodialysis catheter inserted at bedside (Patient #5). The hemodialysis catheter insertion was preformed on a nursing unit where the procedure was not routinely done and staff were not experienced with the procedure. Supplies and equipment routinely used and available during the hemodialysis catheter insertion were not used or readily available resulting in an unsafe setting. The procedure caused a decline in the patient's condition and the patient was resuscitated; and subsequently expired.

The findings include:

Review of the "Scope of Service 5 North Orthopedic/ Med-Surg/ Trauma Department" revealed, "... II. Population/Diagnoses Served: The Orthopedic Department provides care primarily to orthopedic patients. ... We also serve low volume general medical/surgical diagnosis as appropriate. Patient populations served include patients with deep vein thrombosis, gastrointestinal and respiratory problems, cellulitis, and diabetes. Admission Criteria: Orthopedic Med/Surg Diagnoses: Any patient requiring 24 hour nursing care with a stable musculoskeletal diagnosis is considered a priority admission. ... Physiologically and Hemodynamically stable: Vital signs and/or Musculoskeletal Assessments must not exceed a frequency of every 1-hour beyond every 4 hours. Routine vital signs every 8 hours. Any patient requiring more frequent assessments and/or is hemodynamically unstable is not appropriate for the department. Routine assessments occur at least every 12 hours, with focused reassessments as indicated. Telemetry Monitoring is for Orthopedic Management. No primary Cardiovascular Diagnoses are appropriate. If while on telemetry, the patient develops changes or events which require cardiac unit monitoring, the MD will be notified and a transfer requested to a cardiac monitoring unit. ... III. Services Provided: Nursing care includes assessment and monitoring of musculoskeletal conditions and expands to self-care needs, environmental management, resources and support systems. ... IV. Staffing Plan/ Ratios: ...Staff Competencies: RN: All health system requirements including: ...CPR (cardiopulmonary resuscitation) ..."

Review of the "Scope of Services 2 Midwest Medical Surgical Intensive Care Unit" revised 04/2019 revealed, "1. Department Description - 2MW is a 16 bed intensive care unit (ICU) which provides care to a diverse group of patients requiring skilled, intensive nursing care 7 days a week, 24 hours a day. ... Each side has 8 beds with a central nursing station that contains a central cardiac monitoring station and patient call system. ... 2. Population/Clients Served - High volume populations include patients with sepsis, ventilator dependent respiratory failure, renal failure and shock, cardiac arrest, respiratory failure, multi- system failure, self-over dose, and pneumonia. ...3. Services Provided - Nursing care is provided 24 hours a day, 7 days a week by RN staff that is supported by an ancillary staff of Nurse Technicians and Nursing Secretary/Monitor Technicians. ... Services include cardiac and hemodynamic monitoring, mechanical ventilation, ... Staff competencies and skills to provide services RN: Assist in placement of hemodialysis catheters; ... ACLS (Advanced Cardiac Life Support) is required for all RNs working in the following departments across the (name of hospital system): ... adult critical care ..."

Review of a current Registered Nurse (RN) job description for a staff nurse working on 5 North (Orthopedic/ Med-Surg/ Trauma unit) revealed a requirement for BLS (basic life support).

Review of a current Registered Nurse job description for a staff nurse working on 2M (Medical Surgical Intensive Care Unit) revealed a requirement for BLS and ACLS (advanced cardiac life support).

Review of a log of hemodialysis catheter insertions over the past year revealed none were placed at the bedside on a medical surgical unit. Review revealed four hemodialysis catheters were inserted at the bedside on 2 Midwest Medical Surgical ICU from November 1, 2019 through January 31, 2019.

Review of the facility's "Central Venous Catheter Insertion - Continuing Education" skills procedure (not dated) revealed, "... OVERVIEW ... Indications for CVC (central venous catheter) placement may include: ... Hemodialysis access. ... ASSESSMENT AND PREPARATION ... assess the patient's vital signs and oxygen saturation. ... PROCEDURE ... For femoral vein insertion, place the patient in a supine flat position with the intended leg extended. ... Observe the cardiac monitor as the guidewire and catheter are advanced and inform the practitioner immediately if an arrhythmia occurs. Monitor the patient for complications during the procedure. Rationale: Advancing the guidewire or catheter into the heart may induce cardiac arrhythmias. Tall, peaked P waves may appear as the catheter tip enters the right atrium or if the guidewire is advanced too far into the right atrium. Arrhythmias may resolve when the catheter or guidewire is withdrawn. ... UNEXPECTED OUTCOMES Complications (e.g., pneumothorax, hemothorax, infection, arrhythmias, air embolus, pulmonary infarction, pulmonary rupture). Misplacement (e.g., carotid artery, subclavian artery). ..."

Observation on 02/13/2020 at 1415 during a tour of 2M (medical surgical ICU) revealed 10 patients currently on the unit. Observation revealed all patients were on continuous vital sign monitoring and bedside cardiac monitoring that was visible in each patient's room and at the nursing station. Interview with RN #8 (Charge Nurse) during the tour revealed all patients in the ICU were placed on a cardiac monitor and had continuous vital sign monitoring. Interview revealed hemodialysis (HD) catheter insertions were done at bedside in the ICU by a physician or an Advanced Practice Provider (Nurse Practitioner or Physician's Assistant). RN #8 stated the patient's primary nurse assisted with the HD catheter insertion. Interview revealed during the procedure the patient was on a cardiac monitor that was visible at the bedside with continuous pulse oximetry and vital sign monitoring. Interview revealed oxygen and suction were available in the room. Interview revealed the crash cart was only brought into the patient's room if the patient had a change in condition or vital signs. Interview with the nurse revealed annual competencies for ICU nurses included basic life support (BLS) and advanced cardiac life support (ACLS). Interview revealed competencies were required on hire that include central venous line care and maintenance.

Closed medical record review on of Patient #5 revealed a 68 year-old female admitted to 5 North on 12/20/2019 for low back pain with impingement of the nerves in the lumbar spine. Review of the physician's History and Physical (H&P) recorded on 12/20/2019 at 2308 revealed a plan to administer steroids and pain relief and get physical therapy and orthopedic consults. Review revealed the patient had chronic kidney disease stage IV-V that appeared to be at baseline. Review of the H&P revealed a potassium result of 3.5 (normal level 3.5 - 5.0) on admission. Review of a physician's progress note dated 12/24/2019 at 0824 recorded the patient's potassium had increased to 6.1 on 12/24/2019 at 0403, higher than her usual baseline with a plan to consult nephrology. Review of the physician's progress note revealed the patient was lethargic and easily arousable. The progress note recorded a plan to give Kayexalate and Lokelma (medications to reduce the patient's potassium level), increase hydration and place the patient on telemetry. Review revealed a physician's order dated 12/24/2019 at 1735 for cardiac monitoring. Review revealed the patient was placed on telemetry (portable cardiac monitor that transmits electrocardiographic waveforms wirelessly to a central monitoring station) on 12/24/2019 at 2130. Review of vital signs recorded on 12/25/2019 at 0547 revealed the patient's blood pressure was 149/95; pulse 91; respirations 19; temperature 97.8 degrees Fahrenheit; and oxygen saturation 100%. Review of a physician's progress note dated 12/25/2019 at 0946 recorded the patient was somewhat somnolent and easily arousable and the patient's potassium level was 6.7 (elevated) on 12/25/2019 at 0751. Review of a nephrology consult note dated 12/25/2019 at 1043 recorded the patient had Stage IV chronic kidney disease. Review of the note revealed the patient was lethargic, but non-distressed and "roused and answered questions appropriately." Physician notes recorded the patient had been receiving hydromorphone (narcotic pain medication) every four hours and the most recent doses were on 12/25/2019 at 0525 and 0957. She also received oxycodone (narcotic pain medication) on 12/24/2019 at 2120. Review of the nephrology note revealed a recommendation to "avoid the use of Dilaudid (hydromorphone) for chronic pain in the setting of renal failure due to potential buildup of metabolites leading to altered mental status." Review of the nephrology assessment notes revealed the patient's hypertension (blood pressure) was under adequate control. Review revealed the patient was having diminishing urine output and was not responsive to the medications administered to lower the patient's potassium level. Review revealed an assessment and plan for urgent dialysis. Review of a nursing assessment recorded on 12/25/2019 at 1210 revealed the patient was oriented times four; alert and drowsy, but easily arousable, cognition at baseline with clear speech. Review of a nursing note recorded by RN #3 on 12/25/2019 at 1331 revealed an incident at 1210, "Nurse at the bedside with (Nurse Practitioner NP #1) for insertion of hemodialysis catheter under sterile procedure. During the attempt of the catheter, while the catheter was pulled, the patient became pale and altered mental status. A rapid response was called. The patient had a palpable heart rate, but was assisted with mask/bag. See the code sheet for further details. The patient was transferred to 2 heart." Review of the "Cardiopulmonary Resuscitation Record" (Code Sheet) dated 12/25/2019 recorded the time of the event was 1225 and recorded the patient was in sinus rhythm (via AED - automatic external defibrillator) at 1225 with a blood pressure of 92/59, heart rate of 75 and 91% oxygen saturation. Review of the code sheet revealed the first assisted ventilation via bag valve mask at 1230 and intubation completed at 1300. Review of the code sheet recorded a central left subclavian line was inserted at 1255 and the resuscitation event ended at 1302. Review revealed a second code sheet that recorded an event that started at 1320. The patient was receiving respiratory support via a ventilator and had a blood pressure of 36/25 at 1324. The code sheet revealed the patient was defibrillated at 1330 for ventricular tachycardia (lethal cardiac rhythm). Review revealed the event ended at 1337. Review of a Hospitalists physician progress note dated 12/25/2019 at 0946 revealed an addendum (not timed) that recorded, "Notified by nursing staff that around 1245 that the patient had decompensated. After arrival at bedside it was determined that while patient was undergoing dialysis catheter placement she had respiratory compromise. She became unresponsive. ... Patient was intubated. She was noted to be hypotensive. She was transferred to the intensive care unit. ..." Review of a critical care physician progress note dated 12/25/2019 at 1319 recorded, "... 68 year old female with extensive PMH (past medical history) who presents to PCCM (pulmonary critical care management) originally for placement of an HD (hemodialysis) catheter. In the process of insertion the patient decompensates from a respiratory standpoint and becomes severely hypotension (sic) (low blood pressure). Significant struggle with placement of IV (intravenous) access occurred and once IV access was obtained patient was sedated and intubated. Subsequently the patient developed refractory hypotension (circulatory collapse of obscure cause which occurs in surgical patients who are thought to have a normal blood volume but in whom adequate circulation cannot be maintained). Patient was stabilized on the floor and brought back to the ICU (intensive care unit). ..." Review of physician progress note dated 12/25/2019 at 1608 recorded the patient had been made a limited code blue with no cardiopulmonary resuscitation or cardioversion planned if the patient decompensated further. Review of the medical record revealed the patient continued to decline and expired on 12/25/2019 at 2025.

Interview on 02/12/2020 at 1135 with MD #4 (Medical Doctor) revealed he remembered Patient #5. MD #4 stated he was the on call nephrologist that saw the patient on 12/25/2019 and concluded that the patient needed dialysis. Interview with the physician revealed that the patient's elevated potassium placed her at risk for life threatening cardiac arrhythmia and this was the concern for getting her dialyzed. MD #4 reported that he had a telephone conversation with NP #1 to get a HD catheter placed. Interview revealed NP #1 called MD #4 after he had evaluated the patient and said, "This will be difficult, but he was going to give it a try." The physician stated he thought it was going to be difficult related to the patient's mental status, and her not being able to follow instructions. MD #4 stated "For temporary HD catheter insertions, they are usually done in the ICU. ... She could have gone down to Interventional Radiology (IR) for the HD catheter insertion. Her vital signs were stable and she was on a medical floor. She was a stable patient. ... No, I wasn't told by NP #1 that they don't insert HD catheters on that unit. (Orthopedic/ Med-Surg/ Trauma unit)"

Interview on 02/12/2020 at 1330 with NP #1 revealed he had worked as a Nurse Practitioner for 22 years and was currently working as a pulmonary critical care Nurse Practitioner providing care for critically ill patients. NP #1 reported that he had received a phone call from MD #4 requesting insertion of a hemodialysis catheter for Patient #5. NP #1 stated he evaluated the patient and she was stable, able to verbalize and voiced an understanding of the procedure. Interview revealed the patient was able to follow commands. NP #1 stated he did not think the patient was on a telemetry monitor at the time of the procedure. NP #1 stated RN #3 was the primary nurse and she was not "enthusiastic" about assisting with the insertion of the HD catheter. Interview revealed RN #3 told NP #1 that she was not accustomed to doing HD catheter insertions on that unit. NP #1 stated, "I told her I had done it before." NP #1 stated he visualized the vein and it was deep and under an artery and he told the attending that it would be a difficult stick, but he would attempt it. NP #1 reported that he attempted the procedure in the right femoral vein and the patient started bleeding profusely after the catheter was inserted. Interview reveled the NP removed the catheter and applied pressure, stating that he could have "hit an artery. Her platelets were low and I wanted to be able to hold good pressure. The nurse noted she was not breathing well. She would arouse and groan. She continued to decline. I would have gone to the head of the bed to assist with breathing. I couldn't leave her pressure. ..." NP #1 reported he had the nurse get his phone out of his pocket and call MD #5 for assistance. NP #1 reported there was no IV sedation available when the patient needed to be intubated. Interview revealed the sedation medication arrived with the code team and the patient was successfully intubated and transferred to the ICU. Interview revealed IR was on call and could have performed the procedure. Interview revealed IR was not contacted. NP #1 stated "The nephrologists call us because we routinely do central and HD lines, usually in the ICU. When we go to the floor, they don't know how to help. I have to bring all the supplies and the ultrasound machine. Unit nurses are not familiar with the procedure. I have to talk them through it." NP #1 stated, "I will never put an HD catheter in a patient on a unit again. We should not be doing that on a patient unit outside of ICU. It is better to be doing that in ICU with a respiratory therapist available."

Interview on 02/12/2020 at 1050 with RN #3 revealed she was the nurse that was present at bedside when NP #1 attempted to insert a hemodialysis catheter on Patient #5 on 12/25/2019 around 1210. Interview revealed Patient #5 was alert and oriented and could verbalize her needs to staff. RN #3 reported the patient had received pain medication for her back pain and she had received report of Patient #5's potassium level being elevated. The nurse reported she received a phone call from NP #1 asking her to get a consent for a HD catheter insertion and she had the patient's daughter sign it due to the patient receiving pain medication earlier. Interview revealed NP #1 arrived on the unit (5N) and said he was going to insert a HD catheter. RN #3 stated she went to RN #6 who was the Charge Nurse to ask if HD catheters were inserted on this unit. Interview revealed the Charge Nurse told her that she didn't think so. Interview revealed RN #3 then went to a Case Manager (RN) on the unit that had worked there for many years and asked her if HD catheters were inserted on the unit and was told "No." RN #3 stated "(NP #1) came and got me. I told him we don't do these at bedside on this unit. He said, We do them all the time. He said, All you have to do is hand me some sterile supplies." Interview revealed NP #1 had brought a cart with supplies and an ultrasound machine. The nurse reported that she and NP #1 were the only staff in the room during the procedure. RN #3 stated NP #1 inserted the catheter and at one point said, "I don't think I am in the vein. It looks like I am in an artery. He checked the catheter to see if there was any pulsing. It wasn't. He said he thought he was in an artery and he pulled the catheter out. There was immediately a pool of blood between her legs and on top of her. He applied pressure. During the procedure, she was moaning. She was staring with agonal respirations (gasping, abnormal), pale. I said to hit the emergency button for help. I started bagging and told the secretary to call for rapid response. While waiting, she was bleeding. She was breathing. While (NP #1) held pressure, I had to leave to get more supplies (abdominal pads and 4x4s gauze) to help stop the bleeding. He told me to get his personal cell and find his back up (MD #5). He put him on speaker phone and reported he had a bleeder and needed him to come. He told him that he pulled the hemodialysis catheter. MD #5 said, 'Man, that was a big mistake.' The Code Team got there. ..." Interview revealed the peripheral intravenous line had infiltrated during the code and MD #5 attempted to insert a central line without success initially. Interview revealed the nurse did not recall that Patient #5 was on a telemetry monitor and had not received a call from central telemetry regarding any cardiac arrhythmia (irregular heart rate or rhythm). Interview revealed there was difficulty intubating the patient due to no medication available on the unit to sedate the patient. Interview revealed a respiratory therapist brought a rapid sequence intubation kit that included sedation meds when they arrived for the code and the patient was successfully intubated. RN #3 stated she was under the impression that Patient #5 would go to interventional radiology (IR) or a monitored unit to have the procedure done and questioned NP #1 who told her, "We do it (HD catheter insertion at bedside) all the time." Interview revealed the nurse did not know if IR was available since it was a holiday. The nurse stated, "I felt like when he came in, he was telling me it was a typical thing. He was my superior. I told him I didn't feel like it was appropriate. I felt like he was arrogant and it made me feel stupid. ... This was the first HD catheter insertion I have ever assisted with." The nurse stated the patient should have gone to IR and stated "It would have been safer to do the procedure in IR." RN #3 stated she was not trained to assist with insertion of an HD catheter. Further interview on 02/13/2020 at 1200 with RN #3 revealed there was no crash cart in the room during the HD catheter insertion procedure. Interview revealed there was no visual of the patient's cardiac rhythm during the procedure. The nurse stated there was a dynamap (equipment used to monitor a patient's vital signs) in the patient's room, but it was not used during the procedure. Interview revealed the patient was not on oxygen during the procedure. The nurse stated the provider attempted intubation without sedation because there was not sedation available when it was needed. The nurse stated, "We weren't prepared for something like that to happen. (NP #1) was not prepared for an emergency. He didn't have a back up plan. He had me call the doctor. We (nurses on unit) are not educated on assisting with HD catheter insertions. I had never witnessed the procedure before and was not aware of the possible complications."

Interview on 02/12/2020 at 1430 with MD #5 revealed he was a Pulmonary Critical Care physician and he remembered Patient #5. Interview revealed NP #1 had gone to the unit to evaluate Patient #5 for insertion of an HD catheter. MD #5 reported that NP #1 had called him and said he was concerned that the line was not in the proper place. Interview revealed NP #1 reported that the patient was decompensating and had respiratory problems. MD #5 stated he was told there was blood gushing out and he pulled the line out. MD #5 stated, "He should not have done that." Interview revealed NP #1 was holding pressure and the patient was having agonal breathing when he arrived to the patient's room. Interview revealed the patient's IV line was not working at the time and there were no medications to sedate her to intubate her. Interview revealed the patient was intubated during the code, stabilized and moved to the ICU. Interview revealed he was told after the incident by RN #7 who was an Administrative Coordinator (House Supervisor) that we were not supposed to insert HD catheters on the unit (Orthopedic/ Med-Surg/ Trauma unit).

Interview on 02/12/2020 at 1515 with RN #6 revealed she was the Charge Nurse on 5N when Patient #5 had the attempted HD catheter insertion on 12/25/2019. RN #6 stated that RN #3 had asked her if HD catheters were inserted at the bedside on 5N and she told RN #3 they were not. Interview revealed RN #6 called the Administrator Coordinator (RN #7) and he confirmed HD catheter insertions were not done at bedside on 5N. The nurse stated she also talked with a nurse who was a long term nurse on the unit and she confirmed HD catheter insertions were not done on the unit. RN #6 stated that RN #3 told NP #1 that HD catheter insertions were not done on 5N. Interview revealed NP #1 arrived on the unit asking for a nurse to do the procedure. RN #6 stated, "I told him we don't do that at bedside. He walked away without a response. The Code alarm went off and the secretary said go to (Patient #5's room) and bring the crash cart. I know he went ahead with the procedure and he said he had done it before. (MD #5) arrived and he was requesting sedation meds and requested the Charge Nurse. I told him we don't have sedation meds on the unit." RN #6 stated she didn't believe Patient #5 was on telemetry. She stated the central monitoring staff review and document cardiac monitor strips. RN #6 stated, "I have never seen a HD catheter insertion on this floor before."

Telephone interview on 02/13/2020 at 1230 with RN #7 revealed he was the Administrator Coordinator (house supervisor) involved with Patient #5 on 12/25/2019. Interview revealed RN #7 heard a Code Blue (emergency) called and arrived to Patient #5's room. He stated upon arrival, the Code Team was already in the room. RN #7 stated he didn't think the patient was on telemetry. Interview revealed he asked what the patient's cardiac rhythm was prior to the code and no one could answer him. He observed "bright red blood from a femoral stick. It was a lot. The nurse practitioner was holding pressure at the site. The crash cart was in the room. When I arrived, the Charge Nurse said 'I told him we were not equipped to do this procedure in the room and he did it anyway.' I asked what procedure and she said insertion of a hemodialysis catheter. I have been here 37 years and we do not do HD catheter insertions on a med surg unit. I cannot even recall an event where we did one on the floor. We should never do this on the floor. We don't have drugs that are needed and staff are not trained, not skilled to assist with these procedures."

Based on review of policy, review of medical records, review of the adverse event log, and interviews with staff, the facility staff failed to complete an occurrence report of mislabeled laboratory specimens in 1 of 1 sampled medical records of patients that had laboratory specimens collected (Patient #19).

The findings include:

Review of the facility's policy titled "Incident Reporting" with revision date of April 15, 2016, revealed, "POLICY: (Name of hospital) Incident Reporting Program provides an effective method for reporting, investigation, follow-up, analysis, and trending of incidents involving patients and visitors. This should result in improved risk identification, risk evaluation, and claims management. This in turn should minimize loss and improve the quality of medical services and safety. Incident reports are for the review of the quality of care provided at (Name of hospital). DEFINITION: An incident is an event that is inconsistent with a (Named Hospital) policy or procedure, or that is not part of the routine care of a patient. Such incidents may or may not result in actual injury...."

Closed medical record review revealed Patient #19, a 68 year old female arrived in Clinic A on 04/11/2019 for a "Colpo" (Colposcopy--procedure to closely examine the cervix, vagina and vulva for signs of disease). Review of MD #6's procedure note dated 04/11/2019 revealed "...The patient tolerated the procedure well....The patient will follow up to review the results and for further management...." Review of CMA #9's note dated 04/15/2019 at 1644 revealed "...Called pt (Patient) to schedule appt (appointment) for Coloposcopy (sic). Explained to pt that he (sic) specimens were not labeled and they could not be processed. Pt stated that she can come in on 05/09/2019 at 2:15 pm. Pt verbalized understanding and had no questions." Review of the Assistant Director's (AS #10) note dated 05/01/2019 at 1631 revealed "...We discussed the unlabeled specimen. I apologized...."

Review of the adverse event log dated April through May 2019 revealed no documentation of Patient #19's adverse event.

Interview on 02/13/2020 at 1137 with CMA #9 revealed the patient's specimens were not labeled and the lab notified the office manager of the receipt of specimens without labels. Interview revealed no incident report was completed.

Interview on 02/12/2020 at 1440 with AS #10 revealed no incident report was completed regarding the lack of labels on the specimens. Interview revealed AS #10 took care of the problem without an incident report.

Interview on 02/11/2020 at 1125 with Quality Accreditation Coordinator revealed our department was not aware of this incident until this surveyor questioned the Quality Department Coordinator. Interview revealed no member of staff or management had reported the incident of mislabeling of specimens. Interview revealed the policy was not followed.

Based on review of medical staff Bylaws, Rules and Regulations, credentialing file reviews and staff interview, the facility medical staff failed to evaluate the credentials of Advanced Practice Providers (APPs) for reappointment according to medical staff bylaws, rules and regulations for 2 of 2 sampled APP files reviewed (NP #1 and NP#2).

The findings include:

Review of the "Medical and Dental Staff Bylaws, Rules and Regulations" adopted 09/23/2018 revealed, "... 1.3 Procedure for Reappointment ... (e) Reappointment Process The Advanced Practice Provider (APP) must submit the application for reappointment (at least ninety (90) days prior to the expiration date of the APPs current appointment) to the Medical Staff Services Office. The application will be forwarded to the Chief of the appropriate Service, the Credentialing Committee, and to the Medical Executive Committee. (In addition, the Chief Nursing Officer (CNO) shall review the application and supporting documentation on all RN (registered nurse) Allied Health Professionals seeking reappointment,) In all cases, final determination of reappointment shall be made by the Board of Trustees. ... (g) Request for Additional Privileges ... (2) The request for additional privileges will be considered following the submission of appropriating supporting documents and verification of training and current competence. (In addition, the Chief Nursing Officer (CNO) shall review the request and supporting documentation on all RN Advanced Practice Providers seeking additional privileges.) ..."

1. Review of NP #1's credentialing file revealed the nurse practitioner was employed by the hospital and had been a member of the medical staff since 08/21/2012 as an Advanced Practice Provider (APP) working in the specialty of Pulmonary Medicine. Review of the most recent reappointment for NP #1 revealed his application was submitted on 03/18/2019 and included APP Core Privileges and a request for Additional Privileges. Review of the file revealed NP #1's supervising physician signed on 05/07/2019 recommending approval for reappointment. Review of the file revealed the Chief of Service approved NP #1 on 06/11/2019. Review of a letter dated 08/08/2019 revealed approval from the Board of Trustees to reappoint and grant privileges to NP #1 from 09/02/2019 through 09/01/2021. Review of the credentialing file revealed no evidence that the CNO had reviewed NP #1's application or request for privileges.

Interview on 02/13/2020 at 1640 with the Executive Director of Medical Staff Credentialing and Privileging stated, "You won't find a CNO review. It is not there." The staff member explained that the CNO had changed that practice in 2010 or 2011 to only review non-employed APPs. Interview revealed the current practice is not consistent with the medical staff bylaws, rules and regulations. The staff member confirmed the medical staff bylaws, rules and regulations were adopted in September 2018 and stated, "This was an oversight."

2. Review of NP #2's credentialing file revealed the nurse practitioner was employed by the hospital and was a current member of the medical staff as an Advanced Practice Provider working as a neonatal nurse practitioner. Review of the most recent reappointment for NP #2 revealed her application was submitted on 03/21/2019 and included APP Core Privileges. Review of the file revealed NP #2's supervising physician signed on 03/22/2019 recommending approval for reappointment. Review of the file revealed the Chief of Service approved NP #2 on 03/27/2019. Review of the file revealed approval from the Board of Trustees to reappoint and grant privileges to NP #2 from 10/02/2019 through 10/01/2021. Review of the credentialing file revealed no evidence that the CNO had reviewed NP #2's application.

Interview on 02/13/2020 at 1640 with the Executive Director of Medical Staff Credentialing and Privileging stated, "You won't find a CNO review. It is not there." The staff member explained that the CNO had changed that practice in 2010 or 2011 to only review non-employed APPs. Interview revealed the current practice is not consistent with the medical staff bylaws, rules and regulations. The staff member confirmed the medical staff bylaws, rules and regulations were adopted in September 2018 and stated, "This was an oversight."

Based on review of the facility's unit scope of service, nursing job descriptions, log of bedside hemodialysis catheter insertions, continuing education skills procedure, observation, medical record review and staff and physician interviews, the hospital's nursing staff failed to have an effective nursing service providing oversight of day to day operations by failing to ensure a safe setting and experienced nursing staff for insertion of a hemodialysis catheter for 1 of 10 sampled patients that had a hemodialysis catheter inserted at bedside (Patient #5).

The findings include:

Nursing staff failed to provide a safe setting for insertion of a hemodialysis catheter by failing to assign nursing staff who were familiar and experienced with the procedure for 1 of 10 sampled patients that had a hemodialysis catheter inserted at bedside (Patient #5). The hemodialysis catheter insertion was preformed on a nursing unit where the procedure was not routinely done and staff were not experienced with the procedure. Supplies and equipment routinely used and available during the hemodialysis catheter insertion were not used or readily available resulting in an unsafe setting. The procedure caused a decline in the patient's condition and the patient was resuscitated; and subsequently expired.

~cross refer to 482.23(b)(5) Nursing Standard: Tag A0397

Based on review of the facility's unit scope of service, nursing job descriptions, log of bedside hemodialysis catheter insertions, continuing education skills procedure, observation, medical record review and staff and physician interviews, nursing staff failed to provide a safe setting for insertion of a hemodialysis catheter by failing to assign nursing staff who were familiar and experienced with the procedure for 1 of 10 sampled patients that had a hemodialysis catheter inserted at bedside (Patient #5). The hemodialysis catheter insertion was preformed on a nursing unit where the procedure was not routinely done and staff were not experienced with the procedure. Supplies and equipment routinely used and available during the hemodialysis catheter insertion were not used or readily available resulting in an unsafe setting. The procedure caused a decline in the patient's condition and the patient was resuscitated; and subsequently expired.

The findings include:

Review of the "Scope of Service 5 North Orthopedic/ Med-Surg/ Trauma Department" revealed, "... II. Population/Diagnoses Served: The Orthopedic Department provides care primarily to orthopedic patients. ... We also serve low volume general medical/surgical diagnosis as appropriate. Patient populations served include patients with deep vein thrombosis, gastrointestinal and respiratory problems, cellulitis, and diabetes. Admission Criteria: Orthopedic Med/Surg Diagnoses: Any patient requiring 24 hour nursing care with a stable musculoskeletal diagnosis is considered a priority admission. ... Physiologically and Hemodynamically stable: Vital signs and/or Musculoskeletal Assessments must not exceed a frequency of every 1-hour beyond every 4 hours. Routine vital signs every 8 hours. Any patient requiring more frequent assessments and/or is hemodynamically unstable is not appropriate for the department. Routine assessments occur at least every 12 hours, with focused reassessments as indicated. Telemetry Monitoring is for Orthopedic Management. No primary Cardiovascular Diagnoses are appropriate. If while on telemetry, the patient develops changes or events which require cardiac unit monitoring, the MD will be notified and a transfer requested to a cardiac monitoring unit. ... III. Services Provided: Nursing care includes assessment and monitoring of musculoskeletal conditions and expands to self-care needs, environmental management, resources and support systems. ... IV. Staffing Plan/ Ratios: ...Staff Competencies: RN: All health system requirements including: ...CPR (cardiopulmonary resuscitation) ..."

Review of the "Scope of Services 2 Midwest Medical Surgical Intensive Care Unit" revised 04/2019 revealed, "1. Department Description - 2MW is a 16 bed intensive care unit (ICU) which provides care to a diverse group of patients requiring skilled, intensive nursing care 7 days a week, 24 hours a day. ... Each side has 8 beds with a central nursing station that contains a central cardiac monitoring station and patient call system. ... 2. Population/Clients Served - High volume populations include patients with sepsis, ventilator dependent respiratory failure, renal failure and shock, cardiac arrest, respiratory failure, multi- system failure, self-over dose, and pneumonia. ...3. Services Provided - Nursing care is provided 24 hours a day, 7 days a week by RN staff that is supported by an ancillary staff of Nurse Technicians and Nursing Secretary/Monitor Technicians. ... Services include cardiac and hemodynamic monitoring, mechanical ventilation, ... Staff competencies and skills to provide services RN: Assist in placement of hemodialysis catheters; ... ACLS (Advanced Cardiac Life Support) is required for all RNs working in the following departments across the (name of hospital system): ... adult critical care ..."

Review of a current Registered Nurse (RN) job description for a staff nurse working on 5 North (Orthopedic/ Med-Surg/ Trauma unit) revealed a requirement for BLS (basic life support).

Review of a current Registered Nurse job description for a staff nurse working on 2M (Medical Surgical Intensive Care Unit) revealed a requirement for BLS and ACLS (advanced cardiac life support).

Review of a log of hemodialysis catheter insertions over the past year revealed none were placed at the bedside on a medical surgical unit. Review revealed four hemodialysis catheters were inserted at the bedside on 2 Midwest Medical Surgical ICU from November 1, 2019 through January 31, 2019.

Review of the facility's "Central Venous Catheter Insertion - Continuing Education" skills procedure (not dated) revealed, "... OVERVIEW ... Indications for CVC (central venous catheter) placement may include: ... Hemodialysis access. ... ASSESSMENT AND PREPARATION ... assess the patient's vital signs and oxygen saturation. ... PROCEDURE ... For femoral vein insertion, place the patient in a supine flat position with the intended leg extended. ... Observe the cardiac monitor as the guidewire and catheter are advanced and inform the practitioner immediately if an arrhythmia occurs. Monitor the patient for complications during the procedure. Rationale: Advancing the guidewire or catheter into the heart may induce cardiac arrhythmias. Tall, peaked P waves may appear as the catheter tip enters the right atrium or if the guidewire is advanced too far into the right atrium. Arrhythmias may resolve when the catheter or guidewire is withdrawn. ... UNEXPECTED OUTCOMES Complications (e.g., pneumothorax, hemothorax, infection, arrhythmias, air embolus, pulmonary infarction, pulmonary rupture). Misplacement (e.g., carotid artery, subclavian artery). ..."

Observation on 02/13/2020 at 1415 during a tour of 2M (medical surgical ICU) revealed 10 patients currently on the unit. Observation revealed all patients were on continuous vital sign monitoring and bedside cardiac monitoring that was visible in each patient's room and at the nursing station. Interview with RN #8 (Charge Nurse) during the tour revealed all patients in the ICU were placed on a cardiac monitor and had continuous vital sign monitoring. Interview revealed hemodialysis (HD) catheter insertions were done at bedside in the ICU by a physician or an Advanced Practice Provider (Nurse Practitioner or Physician's Assistant). RN #8 stated the patient's primary nurse assisted with the HD catheter insertion. Interview revealed during the procedure the patient was on a cardiac monitor that was visible at the bedside with continuous pulse oximetry and vital sign monitoring. Interview revealed oxygen and suction were available in the room. Interview revealed the crash cart was only brought into the patient's room if the patient had a change in condition or vital signs. Interview with the nurse revealed annual competencies for ICU nurses included basic life support (BLS) and advanced cardiac life support (ACLS). Interview revealed competencies were required on hire that include central venous line care and maintenance.

Closed medical record review on of Patient #5 revealed a 68 year-old female admitted to 5 North on 12/20/2019 for low back pain with impingement of the nerves in the lumbar spine. Review of the physician's History and Physical (H&P) recorded on 12/20/2019 at 2308 revealed a plan to administer steroids and pain relief and get physical therapy and orthopedic consults. Review revealed the patient had chronic kidney disease stage IV-V that appeared to be at baseline. Review of the H&P revealed a potassium result of 3.5 (normal level 3.5 - 5.0) on admission. Review of a physician's progress note dated 12/24/2019 at 0824 recorded the patient's potassium had increased to 6.1 on 12/24/2019 at 0403, higher than her usual baseline with a plan to consult nephrology. Review of the physician's progress note revealed the patient was lethargic and easily arousable. The progress note recorded a plan to give Kayexalate and Lokelma (medications to reduce the patient's potassium level), increase hydration and place the patient on telemetry. Review revealed a physician's order dated 12/24/2019 at 1735 for cardiac monitoring. Review revealed the patient was placed on telemetry (portable cardiac monitor that transmits electrocardiographic waveforms wirelessly to a central monitoring station) on 12/24/2019 at 2130. Review of vital signs recorded on 12/25/2019 at 0547 revealed the patient's blood pressure was 149/95; pulse 91; respirations 19; temperature 97.8 degrees Fahrenheit; and oxygen saturation 100%. Review of a physician's progress note dated 12/25/2019 at 0946 recorded the patient was somewhat somnolent and easily arousable and the patient's potassium level was 6.7 (elevated) on 12/25/2019 at 0751. Review of a nephrology consult note dated 12/25/2019 at 1043 recorded the patient had Stage IV chronic kidney disease. Review of the note revealed the patient was lethargic, but non-distressed and "roused and answered questions appropriately." Physician notes recorded the patient had been receiving hydromorphone (narcotic pain medication) every four hours and the most recent doses were on 12/25/2019 at 0525 and 0957. She also received oxycodone (narcotic pain medication) on 12/24/2019 at 2120. Review of the nephrology note revealed a recommendation to "avoid the use of Dilaudid (hydromorphone) for chronic pain in the setting of renal failure due to potential buildup of metabolites leading to altered mental status." Review of the nephrology assessment notes revealed the patient's hypertension (blood pressure) was under adequate control. Review revealed the patient was having diminishing urine output and was not responsive to the medications administered to lower the patient's potassium level. Review revealed an assessment and plan for urgent dialysis. Review of a nursing assessment recorded on 12/25/2019 at 1210 revealed the patient was oriented times four; alert and drowsy, but easily arousable, cognition at baseline with clear speech. Review of a nursing note recorded by RN #3 on 12/25/2019 at 1331 revealed an incident at 1210, "Nurse at the bedside with (Nurse Practitioner NP #1) for insertion of hemodialysis catheter under sterile procedure. During the attempt of the catheter, while the catheter was pulled, the patient became pale and altered mental status. A rapid response was called. The patient had a palpable heart rate, but was assisted with mask/bag. See the code sheet for further details. The patient was transferred to 2 heart." Review of the "Cardiopulmonary Resuscitation Record" (Code Sheet) dated 12/25/2019 recorded the time of the event was 1225 and recorded the patient was in sinus rhythm (via AED - automatic external defibrillator) at 1225 with a blood pressure of 92/59, heart rate of 75 and 91% oxygen saturation. Review of the code sheet revealed the first assisted ventilation via bag valve mask at 1230 and intubation completed at 1300. Review of the code sheet recorded a central left subclavian line was inserted at 1255 and the resuscitation event ended at 1302. Review revealed a second code sheet that recorded an event that started at 1320. The patient was receiving respiratory support via a ventilator and had a blood pressure of 36/25 at 1324. The code sheet revealed the patient was defibrillated at 1330 for ventricular tachycardia (lethal cardiac rhythm). Review revealed the event ended at 1337. Review of a Hospitalists physician progress note dated 12/25/2019 at 0946 revealed an addendum (not timed) that recorded, "Notified by nursing staff that around 1245 that the patient had decompensated. After arrival at bedside it was determined that while patient was undergoing dialysis catheter placement she had respiratory compromise. She became unresponsive. ... Patient was intubated. She was noted to be hypotensive. She was transferred to the intensive care unit. ..." Review of a critical care physician progress note dated 12/25/2019 at 1319 recorded, "... 68 year old female with extensive PMH (past medical history) who presents to PCCM (pulmonary critical care management) originally for placement of an HD (hemodialysis) catheter. In the process of insertion the patient decompensates from a respiratory standpoint and becomes severely hypotension (sic) (low blood pressure). Significant struggle with placement of IV (intravenous) access occurred and once IV access was obtained patient was sedated and intubated. Subsequently the patient developed refractory hypotension (circulatory collapse of obscure cause which occurs in surgical patients who are thought to have a normal blood volume but in whom adequate circulation cannot be maintained). Patient was stabilized on the floor and brought back to the ICU (intensive care unit). ..." Review of physician progress note dated 12/25/2019 at 1608 recorded the patient had been made a limited code blue with no cardiopulmonary resuscitation or cardioversion planned if the patient decompensated further. Review of the medical record revealed the patient continued to decline and expired on 12/25/2019 at 2025.

Interview on 02/12/2020 at 1135 with MD #4 (Medical Doctor) revealed he remembered Patient #5. MD #4 stated he was the on call nephrologist that saw the patient on 12/25/2019 and concluded that the patient needed dialysis. Interview with the physician revealed that the patient's elevated potassium placed her at risk for life threatening cardiac arrhythmia and this was the concern for getting her dialyzed. MD #4 reported that he had a telephone conversation with NP #1 to get a HD catheter placed. Interview revealed NP #1 called MD #4 after he had evaluated the patient and said, "This will be difficult, but he was going to give it a try." The physician stated he thought it was going to be difficult related to the patient's mental status, and her not being able to follow instructions. MD #4 stated "For temporary HD catheter insertions, they are usually done in the ICU. ... She could have gone down to Interventional Radiology (IR) for the HD catheter insertion. Her vital signs were stable and she was on a medical floor. She was a stable patient. ... No, I wasn't told by NP #1 that they don't insert HD catheters on that unit. (Orthopedic/ Med-Surg/ Trauma unit)"

Interview on 02/12/2020 at 1330 with NP #1 revealed he had worked as a Nurse Practitioner for 22 years and was currently working as a pulmonary critical care Nurse Practitioner providing care for critically ill patients. NP #1 reported that he had received a phone call from MD #4 requesting insertion of a hemodialysis catheter for Patient #5. NP #1 stated he evaluated the patient and she was stable, able to verbalize and voiced an understanding of the procedure. Interview revealed the patient was able to follow commands. NP #1 stated he did not think the patient was on a telemetry monitor at the time of the procedure. NP #1 stated RN #3 was the primary nurse and she was not "enthusiastic" about assisting with the insertion of the HD catheter. Interview revealed RN #3 told NP #1 that she was not accustomed to doing HD catheter insertions on that unit. NP #1 stated, "I told her I had done it before." NP #1 stated he visualized the vein and it was deep and under an artery and he told the attending that it would be a difficult stick, but he would attempt it. NP #1 reported that he attempted the procedure in the right femoral vein and the patient started bleeding profusely after the catheter was inserted. Interview reveled the NP removed the catheter and applied pressure, stating that he could have "hit an artery. Her platelets were low and I wanted to be able to hold good pressure. The nurse noted she was not breathing well. She would arouse and groan. She continued to decline. I would have gone to the head of the bed to assist with breathing. I couldn't leave her pressure. ..." NP #1 reported he had the nurse get his phone out of his pocket and call MD #5 for assistance. NP #1 reported there was no IV sedation available when the patient needed to be intubated. Interview revealed the sedation medication arrived with the code team and the patient was successfully intubated and transferred to the ICU. Interview revealed IR was on call and could have performed the procedure. Interview revealed IR was not contacted. NP #1 stated "The nephrologists call us because we routinely do central and HD lines, usually in the ICU. When we go to the floor, they don't know how to help. I have to bring all the supplies and the ultrasound machine. Unit nurses are not familiar with the procedure. I have to talk them through it." NP #1 stated, "I will never put an HD catheter in a patient on a unit again. We should not be doing that on a patient unit outside of ICU. It is better to be doing that in ICU with a respiratory therapist available."

Interview on 02/12/2020 at 1050 with RN #3 revealed she was the nurse that was present at bedside when NP #1 attempted to insert a hemodialysis catheter on Patient #5 on 12/25/2019 around 1210. Interview revealed Patient #5 was alert and oriented and could verbalize her needs to staff. RN #3 reported the patient had received pain medication for her back pain and she had received report of Patient #5's potassium level being elevated. The nurse reported she received a phone call from NP #1 asking her to get a consent for a HD catheter insertion and she had the patient's daughter sign it due to the patient receiving pain medication earlier. Interview revealed NP #1 arrived on the unit (5N) and said he was going to insert a HD catheter. RN #3 stated she went to RN #6 who was the Charge Nurse to ask if HD catheters were inserted on this unit. Interview revealed the Charge Nurse told her that she didn't think so. Interview revealed RN #3 then went to a Case Manager (RN) on the unit that had worked there for many years and asked her if HD catheters were inserted on the unit and was told "No." RN #3 stated "(NP #1) came and got me. I told him we don't do these at bedside on this unit. He said, We do them all the time. He said, All you have to do is hand me some sterile supplies." Interview revealed NP #1 had brought a cart with supplies and an ultrasound machine. The nurse reported that she and NP #1 were the only staff in the room during the procedure. RN #3 stated NP #1 inserted the catheter and at one point said, "I don't think I am in the vein. It looks like I am in an artery. He checked the catheter to see if there was any pulsing. It wasn't. He said he thought he was in an artery and he pulled the catheter out. There was immediately a pool of blood between her legs and on top of her. He applied pressure. During the procedure, she was moaning. She was staring with agonal respirations (gasping, abnormal), pale. I said to hit the emergency button for help. I started bagging and told the secretary to call for rapid response. While waiting, she was bleeding. She was breathing. While (NP #1) held pressure, I had to leave to get more supplies (abdominal pads and 4x4s gauze) to help stop the bleeding. He told me to get his personal cell and find his back up (MD #5). He put him on speaker phone and reported he had a bleeder and needed him to come. He told him that he pulled the hemodialysis catheter. MD #5 said, 'Man, that was a big mistake.' The Code Team got there. ..." Interview revealed the peripheral intravenous line had infiltrated during the code and MD #5 attempted to insert a central line without success initially. Interview revealed the nurse did not recall that Patient #5 was on a telemetry monitor and had not received a call from central telemetry regarding any cardiac arrhythmia (irregular heart rate or rhythm). Interview revealed there was difficulty intubating the patient due to no medication available on the unit to sedate the patient. Interview revealed a respiratory therapist brought a rapid sequence intubation kit that included sedation meds when they arrived for the code and the patient was successfully intubated. RN #3 stated she was under the impression that Patient #5 would go to interventional radiology (IR) or a monitored unit to have the procedure done and questioned NP #1 who told her, "We do it (HD catheter insertion at bedside) all the time." Interview revealed the nurse did not know if IR was available since it was a holiday. The nurse stated, "I felt like when he came in, he was telling me it was a typical thing. He was my superior. I told him I didn't feel like it was appropriate. I felt like he was arrogant and it made me feel stupid. ... This was the first HD catheter insertion I have ever assisted with." The nurse stated the patient should have gone to IR and stated "It would have been safer to do the procedure in IR." RN #3 stated she was not trained to assist with insertion of an HD catheter. Further interview on 02/13/2020 at 1200 with RN #3 revealed there was no crash cart in the room during the HD catheter insertion procedure. Interview revealed there was no visual of the patient's cardiac rhythm during the procedure. The nurse stated there was a dynamap (equipment used to monitor a patient's vital signs) in the patient's room, but it was not used during the procedure. Interview revealed the patient was not on oxygen during the procedure. The nurse stated the provider attempted intubation without sedation because there was not sedation available when it was needed. The nurse stated, "We weren't prepared for something like that to happen. (NP #1) was not prepared for an emergency. He didn't have a back up plan. He had me call the doctor. We (nurses on unit) are not educated on assisting with HD catheter insertions. I had never witnessed the procedure before and was not aware of the possible complications."

Interview on 02/12/2020 at 1430 with MD #5 revealed he was a Pulmonary Critical Care physician and he remembered Patient #5. Interview revealed NP #1 had gone to the unit to evaluate Patient #5 for insertion of an HD catheter. MD #5 reported that NP #1 had called him and said he was concerned that the line was not in the proper place. Interview revealed NP #1 reported that the patient was decompensating and had respiratory problems. MD #5 stated he was told there was blood gushing out and he pulled the line out. MD #5 stated, "He should not have done that." Interview revealed NP #1 was holding pressure and the patient was having agonal breathing when he arrived to the patient's room. Interview revealed the patient's IV line was not working at the time and there were no medications to sedate her to intubate her. Interview revealed the patient was intubated during the code, stabilized and moved to the ICU. Interview revealed he was told after the incident by RN #7 who was an Administrative Coordinator (House Supervisor) that we were not supposed to insert HD catheters on the unit (Orthopedic/ Med-Surg/ Trauma unit).

Interview on 02/12/2020 at 1515 with RN #6 revealed she was the Charge Nurse on 5N when Patient #5 had the attempted HD catheter insertion on 12/25/2019. RN #6 stated that RN #3 had asked her if HD catheters were inserted at the bedside on 5N and she told RN #3 they were not. Interview revealed RN #6 called the Administrator Coordinator (RN #7) and he confirmed HD catheter insertions were not done at bedside on 5N. The nurse stated she also talked with a nurse who was a long term nurse on the unit and she confirmed HD catheter insertions were not done on the unit. RN #6 stated that RN #3 told NP #1 that HD catheter insertions were not done on 5N. Interview revealed NP #1 arrived on the unit asking for a nurse to do the procedure. RN #6 stated, "I told him we don't do that at bedside. He walked away without a response. The Code alarm went off and the secretary said go to (Patient #5's room) and bring the crash cart. I know he went ahead with the procedure and he said he had done it before. (MD #5) arrived and he was requesting sedation meds and requested the Charge Nurse. I told him we don't have sedation meds on the unit." RN #6 stated she didn't believe Patient #5 was on telemetry. She stated the central monitoring staff review and document cardiac monitor strips. RN #6 stated, "I have never seen a HD catheter insertion on this floor before."

Telephone interview on 02/13/2020 at 1230 with RN #7 revealed he was the Administrator Coordinator (house supervisor) involved with Patient #5 on 12/25/2019. Interview revealed RN #7 heard a Code Blue (emergency) called and arrived to Patient #5's room. He stated upon arrival, the Code Team was already in the room. RN #7 stated he didn't think the patient was on telemetry. Interview revealed he asked what the patient's cardiac rhythm was prior to the code and no one could answer him. He observed "bright red blood from a femoral stick. It was a lot. The nurse practitioner was holding pressure at the site. The crash cart was in the room. When I arrived, the Charge Nurse said 'I told him we were not equipped to do this procedure in the room and he did it anyway.' I asked what procedure and she said insertion of a hemodialysis catheter. I have been here 37 years and we do not do HD catheter insertions on a med surg unit. I cannot even recall an event where we did one on the floor. We should never do this on the floor. We don't have drugs that are needed and staff are not trained, not skilled to assist with these procedures."

Based on review of medical staff Bylaws, Rules and Regulations, continuing education skills procedure review, medical record review, and staff interviews, the facility medical staff staff failed to document a hemodialysis catheter insertion procedure note for 1 of 10 sampled patients that had a hemodialysis catheter insertion procedure (#5).

The findings include:

Review of the "Medical and Dental Staff Bylaws, Rules and Regulations" adopted 09/23/2018 revealed, "... 2.3 Progress Notes (a) During Hospitalization Progress notes will be completed daily on all patients' to record significant changes in the patient's condition and to describe the effects of the treatment. Progress notes will be created, dated and authenticated at the time of the observation of the patient. In addition, all immediate updates shall be documented in the Progress Notes. ... 2.4 Operative Reports (a) Operative or other high-risk procedure reports, shall record the name of the surgeon and assistants, procedure(s) performed and description of the procedure, findings, estimated blood loss (if applicable), specimens removed (if applicable), disposition of each specimen (if applicable), and postoperative diagnosis. ..."

Review of the "Skills: Central Venous Catheter Insertion - CE (continuing education)" procedure (not dated) revealed, "... Indications for CVC (central venous catheter) placement may include: ... Hemodialysis access. ... DOCUMENTATION ... Procedure details, including insertion site, catheter type, and catheter size ... Patient's response to the procedure ... Unexpected outcomes ..."

Closed medical record review of Patient #5 revealed a 68 year-old female admitted to 5 North on 12/20/2019 for low back pain with impingement of the nerves in the lumbar spine. Review of the physician's History and Physical recorded on 12/20/2019 at 2308 revealed a plan to administer steroids and pain relief and get physical therapy and orthopaedic consults. Review revealed the patient had chronic kidney disease stage IV-V that appeared to be at baseline. Review of a physician's progress note dated 12/24/2019 at 0824 recorded the patient's potassium had increased higher than her usual baseline with a plan to consult nephrology. Review of a nephrology consult note dated 12/25/2019 at 1043 recorded the patient had Stage IV chronic kidney disease. Review revealed an assessment and plan for urgent dialysis. Review of a nursing note recorded by RN #3 on 12/25/2019 at 1331 revealed an incident at 1210, "Nurse at the bedside with (Nurse Practitioner (NP #1) for insertion of hemodialysis catheter under sterile procedure. During the attempt of the catheter, while the catheter was pulled, the patient became pale and altered mental status. A rapid response was called. The patient had a palpable heart rate, but was assisted with mask/bag. See the code sheet for further details. The patient was transferred to 2 heart." Review of a Hospitalists physician progress note dated 12/25/2019 at 0946 revealed an addendum (not timed) that recorded, "Notified by nursing staff that around 1245 that the patient had decompensated. After arrival at bedside it was determined that while patient was undergoing dialysis catheter placement she had respiratory compromise. She became unresponsive. ... Patient was intubated. She was noted to be hypotensive. She was transferred to the intensive care unit. ..." Review of physician progress note dated 12/25/2019 at 1608 recorded the patient had been made a limited code blue with no cardiopulmonary resuscitation or cardioversion planned if the patient decompensated further. Review of the medical record revealed the patient continued to decline and expired on 12/25/2019 at 2025. Review of the medical record revealed no evidence of a procedural note recorded for the hemodialysis catheter insertion attempted on 12/25/2019 at 1210 and no documentation of the complications related to the procedure.

Interview on 02/12/2020 at 1050 with RN #3 revealed she was the nurse that was present at bedside when NP #1 attempted to insert a hemodialysis catheter on Patient #5 on 12/25/2019 around 1210. RN #3 stated NP #1 inserted the catheter and at one point said, "I don't think I am in the vein. It looks like I am in an artery. He checked the catheter to see if there was any pulsing. It wasn't. He said he thought he was in an artery and he pulled the catheter out. There was immediately a pool of blood between her legs and on top of her. He applied pressure. During the procedure, she was moaning. She was staring with agonal respirations (gasping, abnormal), pale. I said to hit the emergency button for help. I started bagging and told the secretary to call for rapid response. While waiting, she was bleeding. She was breathing. While (NP #1) held pressure, I had to leave to get more supplies (abdominal pads and 4x4s gauze) to help stop the bleeding. He told me to get his personal cell and find his back up (MD #5). He put him on speaker phone and reported he had a bleeder and needed him to come. He told him that he pulled the hemodialysis catheter. (MD #5) said, 'Man, that was a big mistake.' The Code Team got there. ..."

Interview on 02/12/2020 at 1330 with NP #1 revealed he had worked as a Nurse Practitioner (NP) for 22 years and was currently working as a pulmonary critical care Nurse Practitioner providing care for critically ill patients. NP #1 reported that he had received a phone call from MD #4 requesting insertion of a hemodialysis catheter for Patient #5. NP #1 reported that he attempted the procedure and the patient started bleeding profusely after the catheter was inserted. Interview reveled the NP removed the catheter and applied pressure, stating that he could have "hit an artery. Her platelets were low and I wanted to be able to hold good pressure. The nurse noted she was not breathing well. She would arouse and groan. She continued to decline. I would have gone to the head of the bed to assist with breathing. I couldn't leave her pressure. ..." NP #1 was asked about the documentation of a procedure note related to the attempted hemodialysis catheter insertion and complication. NP #1 stated, "There is not a procedure note documented. I put it out of my mind. (MD #5) took over the procedure."

NC00157370, NC00157667, NC00157804, NC00157991, NC00158224, NC00160057, NC00160239 and NC00160579