HospitalInspections.org

Based on document review and interview, the hospital's Governing Body did not ensure that the quality of patient care provided by medical staff was appropriately monitored. Though aware of concerns identified in the cardiothoracic surgery program, action was not take to address these concerns. In 9 of 9 mortality and morbidity reviews completed for the facility's cardiothoracic surgery program cases were not thorough and complete. The reviews failed to describe actions to address opportunities for improvement identified, failed to address patients preoperative health issues, failed to address technical issues identified within cases and failed to bring back a case that was postponed for review at a future meeting.

These failures placed all patients at risk for serious harm, serious injury or death.

Findings include:

-- The facility failed to address issues identified within the cardiothoracic surgery program.

(Please see Tag A-0049)

Based on document review and interview, the hospital's Governing Body did not ensure that the quality of patient care provided by medical staff was appropriately monitored. Though aware of concerns identified in the cardiothoracic surgery program, action was not take to address these concerns. In 9 of 9 mortality and morbidity reviews completed for the facility's cardiothoracic surgery program, the reviews were not thorough and complete. The reviews failed to describe actions to address opportunities for improvement identified, failed to address patients preoperative health issues, failed to address technical issues identified within cases and failed to bring back a case that was postponed for review at a future meeting. These failures could lead to poor patient outcomes.

Findings include:

-- Per review of document titled "Cardiothoracic Surgical Case Review," in 5 of 9 reviews completed, the facility failed to take action on opportunities for improvement that were identified.

-- Per review of document titled "Cardiothoracic Surgical Case Review," in 1 of 9 reviews completed, the facility indicated there were opportunities for improvement, the facility failed to identify what they were.

-- Per review of document titled "Cardiothoracic Surgical Case Review," in 2 of 9 reviews completed, the facility failed to address patients' preoperative comorbidities.

-- Per review of document titled "Cardiothoracic Surgical Case Review," in 1 of 9 reviews completed, a case was requested to be brought back to next review meeting. The facility failed to bring back this case for discussion.

-- Per review of document titled "Cardiothoracic Surgical Case Review," in 1 of 9 reviews completed the facility failed to address complications that occurred during a case and failed to address technical issues that were identified within the case review.

-- Per interview of Staff I, Chief Quality Officer, and Staff J, Quality Management Supervisor and Staff F, Quality Professional, on 3/21/2024 at 9:20 am and other dates and times throughout the survey, mortality reviews are sent to the office of the surgeons. Cases are sent the week prior to the meeting for the surgeons to review. The cardiothoracic surgery case reviews are interdisciplinary, which include nursing and anesthesia concerns. The surgeons round on each other's patients together and are aware of all the cardiac surgery patients. The reviews are completed by the surgeon that was not involved in the surgery. Staff I indicated they are aware that the cardiothoracic surgery program has elevated mortality rate and that there are concerns within the cardiothoracic surgery program.

-- Per interview of Staff I and Staff BC, Director Quality Management and Regulatory Affairs on 5/2/2024 at 8:53 am and 10:34 am, cardiothoracic surgery case reviews have identified concerns in the cardiothoracic surgery program. Reviews are not addressing the appropriateness of cases being taken. Nursing concerns have been identified. They are aware there needs to be changes within the cardiothoracic surgery program.

-- Per interview of Staff BD, Assistant Vice President of Cardiac Services, on 5/2/2024 at 8:55 am, during a recent meeting regarding cardiothoracic surgery it was identified that there are risks being taken that shouldn't be. There have been conversations started surrounding referring out cardiac surgery patients.

-- Per interview of Staff BE, Chief Medical Officer on 5/6/2024 at 9:00 am, they are aware of problems within the cardiothoracic surgery program.

-- Per interview of Staff BF, Sr. Director of Critical Care on 5/2/2024 at 11:40 am, they are aware of issues with mortalities in the cardiothoracic surgery program. Staff BF is also aware of issue with nursing staff and medical staff.

-- Per interview of Staff AE, Physician on 5/2/2024 at 2:22 pm, various factors can come in to play with patient mortalities. Staff AE indicated there are issue in the ICU. "There is no cardio thoracic intensivist overnight, just a bedside nurse."

-- Per interview of Staff J on 5/3/2024 at 8:52 am, cardiothoracic surgery mortalities are a known area of concern. High level meetings to talk about increased mortality rate have occurred.

-- Per interview of Staff I on 5/3/2024 at 4:46 pm, the chair of surgery, human resources and quality are aware of the issues in the cardiothoracic surgery program. There are a variety of problems in the program. The Hospital Chief Executive Officer has discussed having someone come it to help to ensure the program can go forward. The whole program needs to be revamped.

-- Per interview of Staff AI, Acting Director of Nursing Administration on 5/6/2024 at 1:00 pm, there have been some issues with the cardiothoracic surgery program pertaining to mortality, quality, and physician issues.

-- Per review of Medical Executive Meeting Minutes, dated 3/12/2024, two governing body members were in attendance as well as the Hospital Chief Executive Officer, Chief Medical Officer, and Chief Quality Officer. The minutes revealed "There will be new upcoming initiatives on mortality reviews."

-- Per review of Medical Executive Meeting Minutes, dated 4/11/2024, two governing body members were in attendance as well as the Hospital Chief Executive Officer, Chief Medical Officer, and Chief Quality Officer. The minutes revealed " ... report on issues with peer reviews outstanding since years. ... The Department of Health (DOH) was looking at one cardiothoracic surgery case. They asked for mortality rate."

-- Per review of Medical Executive Meeting Minutes, dated 5/9/2024, two governing body members were in attendance as well as the Hospital Chief Medical Officer. The minutes revealed "We are in transition right now, we don't have cardiothoracic surgery as we are being evaluated by the DOH ... DOH issuing an Immediate Jeopardy and they want an immediate plan to demonstrate safety and high quality care for the patients and part of that plan was to pause the program. ... There was extensive discussion about this being a structural and cultural issue in the organization and how things like this happen ..."

Based on document review, medical record review and interview, 1) in 1 of 1 medical records, Patient #7, the facility failed to follow a patient's wishes concerning their plan of care. 2) In 5 of 10 medical records of patients receiving anesthesia, the facility failed to ensure a properly executed anesthesia consent form was completed. Specifically, the surgical procedures were abbreviated on the anesthesia consent form. This could lead to the facility providing treatment that does not align with the patient's plan of care and patients to be unaware of the procedure to be performed on them.

Findings regarding 1) include:

-- Per medical record review, Patient #7 presented to the facility on 12/21/2023 for a planned transcatheter aortic valve replacement (minimally invasive valve replacement). During the procedure, the valve migrated into the left ventricle after deployment and was unable to be retrieved. Patient #7 went urgently to the operating room for open heart surgery to retrieve the valve. Open heart surgery was successful and Patient #7 was sent to the intensive care unit. Patient #7 had a long hospital course complicated by renal dysfunction and respiratory failure. Patient #7 was refusing treatments and testing and requesting to die. A palliative care meeting was held with Patient #7, Patient #7's nurse, and social work on 1/11/2024. Patient #7 was "awake, alert, and oriented X 4 and able to provide a good understanding of her medical condition." Patient #7 verbalized wishes regarding plan of care and wanted to become a do not resuscitate (DNR) and do not intubate (DNI) (place an artificial airway for breathing). Patient #7 had a health care proxy who did not agree with Patient #7's wishes. During the palliative care meeting on 1/11/2024, Patient #7 rescinded the previous health care proxy in fear their wishes would not be followed. The discussion was deferred and an ethics consult was placed. Patient #7 remained a full code. On 1/13/2024 Patient #7 was changed to a do not resuscitate (DNR) and do not intubate (DNI), two days after they expressed their wishes.

-- Per interview of Staff FF, Registered Nurse, on 5/24/2024 at 10:35 am, Patient #7 made their wishes known about wanting to be comfort care. Patient #7's family did not want to let go. Following the palliative care meeting, a decision was made to wait for family to come in for further discussion.

-- Per interview of Staff GG, Nurse Practitioner, on 5/24/2024 at 11:25 am, there was a goals of care meeting with the multidisciplinary team (physicians, nurses, and social work) where Patient #7's decision making capacity was determined. Patient #7 was able to make her own decisions regarding her care. Patient #7 was a full code but expressed wanting to be comfort measures. Patient #7 understood the outcomes of her decision and again expressed the desire to be comfort care. Patient #7's health care proxy did not want her to be comfort measures. Patient #7 rescinded her health care proxy. Staff GG ordered an ethics consult due to the disagreement between the patient and the family.

-- Per interview of Staff HH, Physician, on 5/24/2024 at 2:25 pm "when patients have capacity, they can make their own plan of care decisions." Staff HH opined that Patient #7 "probably" should have been made a do not resuscitate (DNR) and do not intubate (DNI) following the palliative care meeting (on 1/11/2024).

-- During interview of Staff E, Manager Quality Management on 5/28/2024 at 12:45 pm, they acknowledged these findings.

Findings regarding (2) include:

-- Review of the facility's policy and procedure titled, " Advance Directives, Consents and Medical Decisions Management Plan," revised 2/2024, indicated an informed consent form should have no abbreviations or acronyms.

-- Review of the facility's policy and procedure titled, "Pre-operative/Pre-procedure Management," revised 4/2024, indicated the anesthesia department should complete the informed consent for anesthesia. The policy did not address the use of abbreviations on the informed consent.

-- Review of Patient #27's medical record revealed, the document titled, "Consent for Anesthesia Services," dated 1/2/2024, noted the surgical procedure being performed was "CABG."
(CABG - coronary artery bypass graft)

-- Review of Patient #28's medical record revealed, the document titled, "Consent for Anesthesia Services," dated 12/3/2023, noted the surgical procedure being performed was "ORIF, Fracture, Vertebra, Lumbar."
(ORIF - open reduction and internal fixation)

-- Review of Patient #29's medical record revealed, the document titled, "Consent for Anesthesia Services," dated 1/2/2024, noted the surgical procedure being performed was C/S.
(C/S - Caesarean Section)

-- Review of Patient #30's medical record revealed, the document titled, "Consent for Anesthesia Services," dated 12/31/2023, noted the surgical procedure being performed was C/S.
(C/S - Caesarean Section)

-- Review of Patient #31's medical record revealed, the document titled, "Consent for Anesthesia Services," dated 11/9/2023, noted the surgical procedure being performed was C-section.
(C/S - Caesarean Section)

-- During interview of Staff XX, Educator on 5/8/2024 at 3:10 pm, /they acknowledged the above findings and indicated there should be no abbreviations on an informed consent form.

Based on document review and interview, in 2 of 2 adverse events reviewed, the hospital failed to educate appropriate staff to prevent a recurrence of the events. These failures could lead to poor patient outcomes.

Findings include:

-- Review of the hospital's investigation report of an event, involving a patient, dated 10/23/2023, revealed that all registered nursing staff and patient care technician staff were to be provided education.

-- Per interview with Staff B, Patient Care Technician on 3/19/2024 at 3:15 pm, Staff B indicated that they have not received any education on feeding patients that are on oxygen masks

-- Per interview of Staff A, Clinical Nurse Coordinator for Cardiothoracic, on 3/20/2024 at 12:25 pm, they indicated that after this event all patient care technicians and registered nurses were educated via Net Learning (an electronic online learning system) and during staff huddles on feeding patients who are currently wearing bilevel positive airway pressure and continuous positive airway pressure devices. The facility was unable to provide evidence that registered nursing staff completed this education.

-- Review of hospitals investigation report of an event, involving a patient, dated 2/16/2024, revealed "the event has caused us to look at our .... process. ... We will have them go to pre-op ..." There was no documention that staff was educated about the process change.

-- Per interview of Staff BG, Registered Nurse (RN) on 3/20/2024 at 9:38 am, they were not aware the preoperative endoscopy inpatients would be coming to to pre-op area prior to their procedure.

-- Per interview of Staff BH, RN on 3/202024 at 9:43 am, they were not aware the preoperative endoscopy inpatients would be coming to to pre-op area prior to their procedure.

-- Per interview of Staff BI, RN on 3/20/2024 at 9:57 am, they were not aware the preoperative endoscopy inpatients would be coming to to pre-op area prior to their procedure.

-- Per interview of Staff D, Director of Perioperative Services, on 3/19/2024 at 11:24 am and on 3/20/2024 at 10:35 am, Staff D acknowledged they did not have documentation that staff had received education to prevent a similar type event.

Based on medical record review, document review, and interview, the facility failed to ensure midlevel providers were appropriately privileged to perform procedures. These failures were identified in 3 of 7 credential files. This could lead to untoward patient outcomes.

Findings include:

-- The facility failed to ensure midlevel's were appropriately privileged to perform procedures. In 1 of 15 medical records reviewed a patient suffered a serious adverse outcome.

Please see Tag A-0339.

Based on document review, medical record review and interview, the Medical Staff failed to ensure that mid-level providers were privileged or signed off to perform the procedures they were performing. Specifically, 1) 3 of 7 physician assistants, Staff II, Physician Assistant, Staff JJ, Physician Assistant, Staff KK, Physician Assistant, performing or assisting with invasive procedures were not privileged to do so. 2) In 1 of 15 medical records reviewed, (Patient # 15) of patients who had an invasive procedure performed or assisted by a mid-level provider resulted in a serious adverse outcome. This failure to appropriately privilege mid-level providers could place patients at risk for serious harm.

Findings regarding 1) include:

-- Review of the facility's document titled, "Bylaws of Mohawk Valley Health System, Part III Credentials Procedure," dated 6/25/2020, stated "every practitioner practicing at the hospital by virtue of medical staff membership or otherwise, shall, in connection with such practice, be entitled to exercise only those clinical privileges specifically granted to him by the Governing Body. Applications for additional clinical privileges must be in writing. Such requests should specify the type of clinical privileges desired and the applicant's relevant training and/or experience which would substantiate the granting of such privileges. The applicant must provide additional material documenting this training and/or experience if so requested. Such application shall be reviewed by the chairman of the department or other individual so designated, who will make the appropriate recommendations regarding such clinical privileges to the Credentials Committee."

-- Review of the facility's document titled, "Rules and Regulations of Mohawk Valley Health System," dated 6/25/2020, stated "advanced practice practitioners are clinical practitioners who are not authorized to exercise clinical privileges independently. They may provide patient care only under the supervision of a physician with appropriate clinical privileges. Advanced practice practitioners include advanced practice registered nurses (registered nurse practitioner, certified registered nurse anesthetist, certified nurse midwife) and physician assistants."

-- Review of the document titled "Supervising Member Agreement Advance Practice Provider," dated 6/9/2023, indicated Staff II was supervised by Staff LL, Director of Interventional Radiology who accepted full legal and ethical responsibility for the performance of duties and acts under their supervision. Additionally, the supervising physician accepted responsibility for proper conduct of the advanced practice practitioner in the hospital and to abide by all bylaws, policies, and rules governing the use of advance practice provider. This document was signed by Staff LL.

-- Per interview of Staff LL, Physician, Director Interventional Radiology and Supervising Physician for Staff II on 5/30/2024 at 2:00 pm, Staff LL indicated being contracted by the facility. The Physician Assistant, Staff II had been doing thoracenteses in the department. Staff II was instructed how to perform the procedure, watched a number of times, and performed five to ten procedures. The credentialing is performed by the medical director. Staff LL is not involved with credentialing due to being in a private practice. The Physician Assistant (Staff II) was a hospital employee therefore the credentialing and privileging would be their responsibility. Staff LL indicated there were no competencies or skills checklist for the Physician Assistant, Staff II. Staff LL stated they have no documentation of how many thoracenteses the Physician Assistant (Staff II) had performed and was unsure if they were the collaborating physician for oversight of Staff II.

-- Per interview of Staff BA, Medical Staff Coordinator on 6/5/2024 at 9:40 am, they discussed the physician assistant hiring process. The medical staffing office determines who will be the supervising physician for the physician assistant once on the job, and they must sign all required paperwork. Additional privileges are obtained by sending a link to the virtual committee and supervising physicians. Each physician assistant must provide 10 proctor cases that go back to Staff BA and then onto the virtual committee. Physician assistants are told they must let Staff BA know that they are requesting additional privileges.

-- Per interview of Staff II, Physician Assistant on 6/4/2024 at 4:30 pm, Staff II discussed that this was their first job as a physician assistant and all training had been provided through this facility. Staff II discussed that they were observed performing "a handful" of thoracenteses and then allowed to perform on own without supervision. Staff II discussed that they did not feel supported and did not feel adequately trained. Staff II also discussed that physicians were not always available for consultation. Staff II discussed that they had gone to their supervisor and discussed not feeling supported and receiving inadequate training as a new physician assistant in the organization.

-- Per review of Staff II's credential file, it contained the form titled, "Delineation of Privileges, Appointment Provisional 9/1/2023 - 5/1/2024". This form listed multiple privileges that were granted to Staff II, including inpatient, outpatient, patient evaluation/assessment, history and physical, instrumental control of vessel bleeding, repair of minor lacerations, minor surgery, major joint injection/aspiration, etc.

There was no documentation in Staff II's credential file indicating Staff II was privileged or signed off on by their supervising physician to perform thoracenteses. Additionally, there was no documentation of training or competency of this procedure indicating 10 procedures were performed and the request for the privilege approved.

-- Review of six medical records (Patient's #16 - #21, dated 9/25/2023 - 2/27/2024), revealed Staff II was performing ultrasound guided thoracenteses in the interventional radiology unit and at patient's bedside.

-- Review of Staff MM's, Physician Assistant credential file revealed, the form titled, "Delineation of Privileges, Appointment Provisional 12/4/2023- 8/1/2024," had additional privileges granted for fluoroscopy paracentesis, thoracentesis, spinal puncture diagnostics, etc.

-- Review of two medical records (Patient #22 and Patient #23), dated 5/13/2024 and 6/3/2024, revealed Staff JJ, Physician Assistant assisted with surgeries in the operating room.

-- Per review of Staff JJ's credential file, it contained the form titled, "Delineation of Privileges, Appointment 2/1/2023 - 2/1/2025." This form listed multiple privileges that were granted to Staff JJ, including inpatient, outpatient, patient evaluation/assessment, history and physical, instrumental control of vessel bleeding, repair of minor lacerations, minor surgery, major joint injection/aspiration, cryosurgery, emergency stabilization, etc.

There was no documentation that Staff JJ had been privileged to assist with surgeries.

-- Review of 2 medical records, Patient #24 and Patient #25, dated 4/16/2024 and 4/30/2024, revealed Staff KK, Physician Assistant assisted with surgeries and robotic surgeries in the operating room.

-- Per interview of Staff KK on 6/5/2024 at 12:00 pm, they assist providers with surgery and robotics. Staff KK switches instruments out, puts in ports and sometimes closes skin after procedure. Staff KK assists in surgeries done by the thoracic surgeon and also with obstetrical cases.

-- Per review of Staff KK's credential file, it contained the form titled, "Delineation of Privileges, Appointment 10/1/2023 - 10/1/2025." This form listed multiple privileges that were granted to Staff KK, including inpatient, outpatient, patient evaluation/assessment, history and physical, instrumental control of vessel bleeding, repair of minor lacerations, minor surgery, etc.

There was no documentation that Staff KK was privileged to assist with surgery or robotic surgery.

-- During interview of Staff E, Manager of Quality Management on 6/5/2024 at 3:00 pm, they acknowledged the above findings.

Findings regarding 2) include:

-- Review of Patient #15's medical record revealed, they presented to the hospital's ambulatory surgery unit on 12/20/2023 at 9:22 am for evacuation of a hematoma (an abnormal collection of blood outside of a blood vessel) of the left antecubital fossa brachiocephalic AV (arteriovenous) fistula creation site (an access point for dialysis). (Patient #15 had been doing peritoneal dialysis at home) The surgery was cancelled due to the patient's complaint of abdominal distention, nausea and lower extremity swelling. Patient #15 reported no bowel movement for unknown number of days, tried a laxative, but vomited it all up. The provider requested the patient be admitted to the hospital and worked up for a small bowel obstruction.

On 12/21/2023 at 8:57 am a computed tomography of the abdomen indicated there was trace left pleural effusion (accumulation of fluid around the lung), moderate size right pleural effusion, and a small pericardial effusion (accumulation of fluid around the heart). The right pleural effusion and pericardial effusion were larger than prior examination.

On 12/22/2023 Patient #15 had a colonoscopy and was found to have massive diverticulosis in the left colon which likely accounted for their constipation. No evidence of colitis. Peritoneal cultures were drawn which did have gram positive cocci (likely staphylococci) growing, for which the patient was started on antibiotics by the infectious disease team. Patient #15 was being treated for a urinary tract infection prior to admission, urine cultures remained positive for gram-negative rods, and treatment with ceftriaxone (antibiotic) continued. Peritoneal dialysis was initiated per nephrology recommendations.

On 12/23/2023 at 12:23 pm internal medicine provider documented, patient was assessed and evaluated at bedside. " ... was sitting up in the chair. Overnight, ... had a rapid response called due to hypotension. ... was given intravenous fluids, started on hydrocortisone injection, and Levophed (medication that increases blood pressure). "Continues to experience LLQ (left lower quadrant) pain especially when coughing or with movement. ... is hypothermic. ... endorses a cough as well. Denied fever chills, sweats, chest pain, shortness of breath, diarrhea, and constipation."

At 5:48 pm a computed tomography scan of the chest revealed, bilateral pleural effusions, right larger than left. These were seen previously as well. There is a small pericardial effusion. Patency of the vessels cannot be determined in the absence of intravenous contrast. There is some areas of atelectasis and patchy infiltrates (parts of lung collapse) at the lung bases, right greater than left. There is no adrenal mass. There are atherosclerotic changes of aorta. There is some fluid in the left upper quadrant suspect for some possible significant ascites (fluid in the abdominal cavity).

On 12/25/2023 at 7:08 am, a repeat chest x-ray revealed impression: cardiomegaly (enlarged heart), pleural effusion on the right with loculated (inflammation of the pleura causes scarring and the tissue creates pockets of fluid that prevent the fluid from draining properly) component as before. Improved aeration at the left base.

At 3:13 pm, internal medicine provider documented, "Persistent loculated right pleural effusion. Discussed with pulmonology. Obtain computed tomography-guided thoracentesis for further analysis of pleural fluid, cytology and culture. Pulmonology on board."

On 12/26/2023 at 11:29 am, documentation of the interventional radiology thoracentesis procedure indicated, consent was obtained and the patient was educated on the "risks and benefits including but not limited to bleeding, infection, pneumothorax, and trapped (lung can't fully expand) were discussed. Alternative therapies were reviewed as well. All questions were answered. Consent was given." He underwent an ultrasound guided thoracentesis performed by Staff II.

At 4:56 pm internal medicine provider documented, patient started to experience bright red hemoptysis (bloody sputum) and had rhonchi (abnormal breath sound) post thoracentesis which was new and were not present during the morning assessment. During thoracentesis, 450 cubic centimeters of serosanguinous (bloody) fluid was removed. Post thoracentesis chest x-ray showed 25 percent pneumothorax as a complication. Patient did not receive morning dose of deep vein thrombosis prophylaxis and international normalized ratio (a blood test that measures how long it takes for blood to clot) in the morning was 1.2. Repeat stat chest x-ray showed right sided hydropneumothorax (air and fluid are around the lung) with progressive collapse of right lung. Concern for hemothorax. Call was placed to interventional radiology. Plan for patient to undergo immediate right-sided chest tube placement.

Patient #15 continued to decline and on 12/28/2023 at 1:00 pm was taken for a video assisted thoracoscopic surgery (VATS - surgery for diagnosing and treating many conditions affecting the chest area), which was converted to open thoracotomy (opening chest), right lung decortication (removal of the surface layer, membrane, or fibrous cover of an organ, usually the lung to restore normal organ function by removing the tissue that restricts expansion), mechanical pleurodesis (a procedure performed to obliterate the pleural space to prevent recurrent pleural effusions, pneumothorax, or to treat a persistent pneumothorax), and evacuation of 2 liters of clotted blood. Post-operatively he remained intubated and sedated, with two chest tubes in place, and was transferred to the intensive care unit. The patient died on 12/30/2023 at 1:34 am.

-- Review of Staff II's credential file revealed, they were not privileged to perform the thoracentesis procedure.

-- Per interview of Staff NN, Physician on 5/29/2023 at 1:40 pm, Staff II had done a number of thoracenteses before the complication with Patient #15. After the thoracentesis was completed a chest x-ray was done a few hours later that indicated there was air in the pleural space. The first chest x-ray looked like a pneumothorax but the follow-up x-ray revealed a larger amount of fluid in the parenchymal (lung) space. There was clearly an air leak and after being made aware Staff NN place a chest tube in the patient. There was blood in the space due to injury to the lung. Staff NN spoke with the patient's primary physician and the surgical team became involved. Thoracic surgery was not available so the trauma team became involved. Hemothorax is a potential complication of a thoracentesis. There is always potential for lung injury. When you enter the lung and apply suction it could cause a tear in the lung. Typically, when you enter the pleural space you back off a little.

Staff II was credentialed to perform the procedure and had been there 4 months. Staff NN was unsure how the staff was credentialed, they had a different provider as a preceptor. Staff II performed the procedure without supervision, but Staff NN was available if needed. After the incident Staff NN indicated sitting down with Staff II and reviewing what to do and what not to do. This was an unusual event, no formal changes were made in the department following this.

-- During interview of Staff E, Manager of Quality Management on 5/31/2024 at 12:15 pm, they acknowledged the above findings.

Based on medical record review, interview and document review, the facility did not ensure a registered nurse adequately supervised and evaluated the treatment of Patient #2's abnormal critical blood glucose levels. This could increase the risk of adverse outcomes.

Findings include:

-- Per medical record review, Patient #2 was an elderly patient admitted on 1/5/2024 with shortness of breath and decreased oxygenation. Past medical history included lung disease, cardiac disease, prostate cancer, kidney disease and diabetes. He continued to have decreased oxygenation and shortness of breath. A computed tomography scan revealed multiple masses in both lungs. Patient #2's orders included point-of-care-testing glucose monitoring before meals and at bedtime.

On 1/5/2024 at 3:38 pm Patient #2's point-of-care-testing glucose fingerstick was 36 (normal range 70 - 110). (Medical record does not provide name of staff member performing point-of-care-testing glucose fingerstick.) At 4:01 pm, 23 minutes after initial fingerstick, point-of-care-testing glucose fingerstick was 91. (Medical record does not provide name of staff member performing point-of-care-testing glucose fingerstick.)

-- Per interview of Staff K, Senior Director of Nursing: Medical Surgical and Nursing Quality Staff, on 3/20/2024 at 10:00 am, they stated the staff that performed the point of car glucose testing on 1/5/2024 at 3:38 pm and 4:01 pm on Patient #2 was Staff L, Patient Care Technician.

-- Per medical record review, Staff M's, Registered Nurse end of shift summary documented on 1/5/2024 at 6:24 pm revealed "Assessment per flowsheet. Denies nausea/vomiting. Medicated x 1 for c/o pain with little relief; see eMAR. Napped in long intervals throughout shift. Pills crushed in applesauce per patient request. Turned and repositioned as per flowsheet. All questions answered within scope of practice. Contact precautions maintained. Bed alarm active; call bell in reach; comfort and safety maintained."

-- Review of the facility's policy and procedure titled "Adult Diabetes Management Policy," dated 7/2023, indicated the nurse shall be aware of clinical situations that increase the risk of hypoglycemia and observe for signs and symptoms. Refers to provider orders for the treatment of hypoglycemic (low blood sugar) as outlined in "Appendix A: Hypoglycemic Treatment Protocol," dated 9/2022. Protocol outlines a blood glucose less than 40 requires a STAT (immediately without delay) venous (blood is drawn from a vein) glucose level. Outlines providing immediate treatment to the patient with either specific quantities of glucose gel, juice, soda, or milk. Blood glucose is to be rechecked in 15 minutes. Nursing documentation in the medical record is to include blood glucose results, registered nurse assessment including patient's response to interventions, vital signs and assessments, notification of provider for any change in condition, and education completed with the patient.

The medical record lacked documention by a registered nurse of interventions to address critically low blood sugar, a venous glucose level, an assessment including patient's response to interventions, vital signs and assessments done when the patient experienced critically low blood glucose level.

-- Per interview of Staff N, Senior Nurse Manager, on 3/20/2024 at 2:30 pm, they explained registered nurses and patient care technicians receive blood glucose monitoring education at hire and through eLearning any time there is a policy change. Staff N reviewed the care provided by staff to Patient #2 and felt that staff should have been more closely monitoring Patient #2's glucose level. Staff N engaged in education with staff involved with Patient #2's care and communicated care needs to other staff at their nursing huddles.

-- Per interview of Staff K, Senior Director of Nursing: Medical Surgical Nursing and Nursing Quality on 3/21/2024 at 1:00 pm, diabetic education went out to all nursing staff and patient care technicians through eLearning on 1/9/2024. Reviewed the list of staff that have completed and have not completed the mandatory diabetic education through eLearning. Staff K acknowledged Staff L had not completed the required diabetic education. Staff K verified Staff M was not on either the completed or incomplete diabetic education lists due to a technical error with his/her/their eLearning account. This error prevented Staff M, along with other staff, from accessing required education for completion.

Based on observation, interview and document review, the facility did not provide basic safe practices for medication administration by confirming a patient's, Patient #12, identity with their arm band prior to administration of medication. This could increase the risk of medication errors.

Findings include:

-- Per observation on 3/20/2024 at 9:45 am of Patient #12 on 8 West Medical Surgical Unit, a medication vial and patient bar-coded armband were on the countertop inside the room.

-- Per interview with Staff O, Registered Nurse on 3/20/2024 at 9:45 am, they acknowledged the above findings. Staff O indicated being assigned to care for the above patient and the bar-coded armband was on the counter at the start of the shift instead of being worn by the patient. They indicated the patient bar-coded armband was used to scan for medication administration.

-- During interview with Staff N, Senior Nurse Manager on 3/20/2024 at 10:00 am, they acknowledged the above finding.

-- Review of facility policy and procedure titled "Medication Administration and Documentation Policy," revised 1/2023 indicated all patients are to have a bar-coded armband, if the armband has been removed a new armband must be requested prior to administering medications, even if the patient is known to the clinician. It further stated that "medications may not be administered to a patient without a bar-coded armband in place except during emergency situations and registration downtime."

-- During interview of Staff K, Senior Director of Nursing: Medical Surgical Nursing and Nursing Quality on 3/20/2024 at 1:00 pm, they acknowledged Patient #12 did not have an approved reason to not wear the required bar-coded armband.

Based on observation, interview, and document review, the hospital's contracted food service did not consistently implement recognized food safety standards, for example, Hazard Analysis Critical Control Points as adopted by the Food and Drug Administration (FDA) for documenting food temperatures throughout the cooling process. Specifically: (1) 9 large turkey breasts were cooked and cooled without documentation of the critical time and temperatures required for the cooling process, (2) a 4-gallon container with chicken noodle soup and 4-gallon container with cheese sauce were cooled without documentation of the complete cooling times and temperatures, and (3) documented cooling logs to track proper cooling of hazardous foods were not consistently maintained. Additionally, this lack of compliance was also not resolved after being identified in several monthly safety meeting minutes. Failure to monitor temperatures and cooling of foods can result in untoward outcomes for patients and staff.

Regarding finding (1) include:

-- Per observation and tour of the kitchen on 5/23/24 at 10:00 am, the walk-in meat cooler had 9 approximately 12 pound turkey breasts wrapped in foil on carts, with stickers dated 5/23/2024 indicating they were cooked and cooling.

-- Per interview of Staff SS, Production Manager, on 5/23/2024 at 10:00 am, the 9 turkey breasts were rapidly cooled in the blast chiller.

-- Review of policy and procedure titled "Guidance on Cooling of Time/Temperature Controlled for Food Safety," last revised 1/29/2021, indicated turkey breasts should be cooled from 140 to 40 degrees Fahrenheit under Hazard Analysis Critical Control Points timed protocols and documented in cooling logs to verify compliance.

-- Per interview of Staff TT, Director of Food & Dietary Services, on 5/23/2024 at 4:10 pm, they indicated that the cooling logs documentation for the turkey breasts were not completed. He/she/they was unable to determine if the turkey breasts were properly cooled.

(The 9 turkey breasts were discarded by facility staff.)

Regarding finding (2) above:

-- Per observation on 5/24/2024 at 10:45 am, there were 2 - 4 - gallon plastic containers stored in the walk-in meat cooler. One container was being used to cool chicken noodle soup (approximately 1 gallon of soup at an 8-inch depth) and the other container was being used to cool cheese sauce (approximately 2 gallons of sauce at a 10-inch depth).

-- Review of policy and procedure titled "Guidance on Cooling of Time/Temperature Controlled for Food Safety," last revised 1/29/2021," indicted soup and cheese sauce should be cooled from 140 to 40 degrees Fahrenheit under Hazard Analysis Critical Control Points timed protocols and documented in cooling logs to verify compliance. Also, to expedite rapid cooling, food should be in shallow pans, less than 2 inches deep, and in stainless steel containers to conduct cooling transfer.

-- During interview of Staff TT and Staff UU, on 5/24/2024 at 10:45 am, they did not have completed cooling logs for the soup or cheese sauce. Staff UU indicated the cheese sauce had partial log temperatures started but the cooling process was not finished at the end of the staff shift (log documentation only reached 68 degrees Fahrenheit vs 40 degrees Fahrenheit or below as required), and the missing final temperatures were not monitored by any staff next shift.

(The soup and cheese sauce were discarded by facility staff.)

Regarding finding (3) above:

-- Review of food cooling logs for the period of 11/1/2023 - 5/23/2024 revealed that logs were not consistent or complete, for example:

- On 11/7/2023, a roast turkey breast was documented to have started the Hazard Analysis Critical Control Points chilling process at 3:00 pm, but without any temperatures recorded for the start and completion of cooling.

- On 1/15/2024, 4 containers of chicken and dumplings were documented to have started the Hazard Analysis Critical Control Points chilling process at 1:20 pm, with an initial temperature recorded at 190 degrees Fahrenheit, but no other cooling temperatures recorded for the completion of cooling.

- On 4/10/2024, chicken was documented to have started the Hazard Analysis Critical Control Points chilling process at 8:44 am, with an initial temperature recorded at 182 degrees Fahrenheit, but no other cooling temperatures recorded to show completion of cooling.

-- Review of Safety Committee Meeting Minutes from meetings conducted on 11/28/2023, 12/13/2023, 1/10/2024, and 2/21/2024 revealed that Staff VV, Food Safety Manager, had documented that Hazard Analysis Critical Control Points food temperature logs were incomplete or not being done consistently. Though additional training was listed as the corrective action for each of these months, there was no documentation provided to ensure that the ongoing issues were resolved.

-- Per interview of Staff TT on 5/24/2024 at 11:10 am, they confirmed no other cooling logs or documents were available.

Based on document review, medical record review, interview, and observation (1) in 2 of 10 medical records reviewed, Patient #27 and Patient #28, the facility failed to ensure the pre-procedural documentation was completed before the patient arrived in the operating room. (2) Staff were not following generally accepted standards of practice and facility policies and procedures related to hand hygiene and personal protective equipment. (3) Staff failed to use alcohol based skin preparation/antiseptics properly. This could increase the risk for adverse outcomes in the perioperative services departments.

Findings related to (1) include:

-- Review of the facility's policy and procedure titled "Pre-Operative/Pre-Procedure Management," revised 4/2024 indicated nursing should provide proper preparation of the patient. Ensure the pre-operative checklist is completed in the medical record.

-- Review of Patient #27's medical record indicated they were admitted to the facility on 12/25/2023 with chest pain and was scheduled for coronary artery bypass graft surgery on 1/3/2024. The nursing pre-operative checklist documentation was not completed.

-- Review of Patient #28's medical record indicated they were admitted to the facility on 12/2/2023 after a fall and was scheduled for an open reduction and internal fixation of fractured vertebra, lumbar L3-S1 on 12/3/2024. The nursing pre-operative checklist documentation was not completed.

-- Per interview of Staff WW, Interim Director Operating Room on 5/9/2024 at 10:35 am, the pre-operative checklist should be completed by the inpatient unit nurse prior to the patient going to surgery.

-- Per interview of Staff XX, Educator on 5/9/2024 at 11:50 am, completion of pre-operative nursing duties has been an ongoing struggle. Staff XX has met with other educators on the nursing units to reinforce the need for floor staff to perform pre-procedure documentation. Staff have been assigned net learning education as well. Education is also provided during hospital orientation. Tip sheets have been posted on units to ensure patients are getting their chlorhexidine gluconate (a special antiseptic cleanser to clean your skin, especially the area on your body where surgery will be performed) baths prior to surgery.

-- During interview of Staff E, Manager of Quality Management, on 5/8/2024 at 3:00 pm, they acknowledged the above findings.

Findings related to (2) include:

-- Review of the facility's policy and procedure titled "Hand Hygiene," revised 10/2023 indicated handwashing or hand antisepsis is to be done immediately after glove removal.

-- Per observation on 5/10/2024 at 11:40 am, Staff AB, Registered Nurse entered the operating room charge nurse area from the operating room corridor wearing their surgical mask and gloves. Staff AB removed and discarded their surgical mask and gloves. Staff AB did not perform handwashing/hand antisepsis after removing their surgical mask and gloves.

-- During interview of Staff WW on 5/10/2024 at 11:45 am, he/she/they acknowledged the above finding.

-- Review of the facility's policy and procedure titled "Surgical Attire," revised 1/2024 indicated masks will not be worn hanging down from the neck. A fresh, clean surgical mask will be worn for every procedure. The mask will be replaced and discarded whenever it becomes wet or soiled.

-- Per interview on 5/13/2024 at 12:50 pm, Staff AC, Surgical Technician, stated they change their mask after lunch but not between operating room cases.

-- Per interview of Staff WW on 5/9/2024 at 10:35 am and 5/10/2024 at 9:45 am stated they submitted a Midas (occurrence) report regarding Staff P, (Physician) for ripping off their mask in the operating room after a procedure. Masks should not be taken off until the patient is extubated, there are no patient complications, and the patient is ready to go to the post anesthesia care unit. A new mask should be worn with every case. Staff WW has seen staff with masks around their necks and instructs them to remove them. As soon as a mask comes down it is to be discarded and a new mask worn with every case.

-- Per interview of Staff XX, Educator on 5/9/2024 at 11:50 am and 5/10/2024 at 12:30 pm revealed some operating room staff walk around the department with masks hanging around their neck. Masks are to be on or off, not hanging around a person's neck.

Findings related to (3) include:

-- Review of the facility's document titled "Surgical Fire Safety 2024," (with references to Fire Prevention and Management, Operating Room, Lippincott Procedures, revised 5/2023) indicated to prevent flammable skin prep solutions from pooling or soaking into the linens or patient's hair, remove materials saturated with the skin prep solution and wick excess solution with a sterile towel to help dry the prep area. Ensure skin prep solutions, especially those that contain alcohol, are allowed to dry thoroughly and fumes are allowed to dissipate before applying surgical drapes or using a potential ignition source. ChloraPrep (contains 2% Chlorhexidine gluconate and 70% isopropyl alcohol) instructions state "avoid getting solution into hairy areas. Hair may take up to one hour to dry. Wet hair is flammable. Do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of three minutes on hairless skin; up to 1 hour in hair".

-- Per interview of Staff QQ, Registered Nurse on 5/6/2024 at 11:05 am stated regarding skin preps, Staff P, Physician uses 70% alcohol in a sterile basin with four 4X4 sponge sticks and uses it from the patient's neck to ankle bilaterally. The sternum is prepped with the alcohol first away from the incision area. ChloraPrep is then used. Staff QQ has seen Staff P pour the last bit of alcohol left over on the patient. Staff AE, Physician uses ChloraPrep. There is a three minute drying time when ChloraPrep is used, and he/she/they adds another one - two minutes. Per the Association of periOperative Registered Nurses (AORN) you wait one hour with hair and alcohol involved.

-- Per interview of Staff AE, Registered Nurse on 5/6/2024 at 11:35 am stated both cardiothoracic surgeons use different skin preps. Staff P takes 70% alcohol and cleanses a patient's skin from chin to toes and doesn't wait for it to dry. You're supposed to wait one hour for the areas to dry.

-- Per interview of Staff WW on 5/9/2024 at 10:35 am and 5/10/2024 at 9:45 am, staff brought concerns to him/her/them about Staff P use of alcohol skin preps. There is annual net learning on fire safety in the operating room. Patient safety is the #1 priority.

Based on document review, medical record review, and interview, in 1 of 10 medical records reviewed, Patient #28, the facility failed to ensure a properly executed informed consent form was completed. Specifically, the surgical procedures were abbreviated on the surgical consent form. This could cause patients to be unaware of the procedure to be performed on them.

Findings include:

-- Review of the facility's policy and procedure titled, " Advance Directives, Consents and Medical Decisions Management Plan," revised 2/2024, indicated an informed consent form should have no abbreviations or acronyms.

-- Review of Patient #28's medical record revealed, the document titled, "Consent for Operative and/or Diagnostic Procedures and/or Treatment," dated 12/3/2023, noted the surgical procedure being performed was "ORIF, Fracture, Vertebra, Lumbar L3-S1."

-- During interview of Staff XX, Educator on 5/8/2024 at 3:10 pm, they acknowledged the above finding and indicated there should be no abbreviations on an informed consent form.