Boston Medical Center-Brighton

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 45980 The Hospital was out of compliance for the Condition of Participation for Nursing Services. Findings included: Based on record review and interviews, the Hospital failed to ensure physician orders (monitoring and medication administration) were followed for one Patient (#1) out of a total sample of ten patients. Cross Reference: 482.23(b)(3) - A registered nurse must supervise and evaluate the nursing care for each patient. (395) 482.23(c) - Standard: Preparation and Administration of Drugs (405)”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 45980 Based on record review and interview, the Hospital failed to ensure one Patient (#1) out of a total sample of ten patient ’ s received Telemetry monitoring as ordered by the Physician. Findings include: Review of Patient #1 ’ s medical records indicated that he/she was transferred from an outside hospital (OSH) on 12/24/24 for chest pain in the setting of dialysis with a concern for a NSTEMI (non-ST elevation myocardial infarction) given his/her known cardiac history. Patient #1 had a history of cardiomyopathy (a disease where the heart muscle becomes weakened, stretched, or otherwise structurally abnormal, making it harder for the heart to pump blood effectively), kidney disease stage 5 on hemodialysis (a procedure that cleans the blood outside the body using a machine that acts as an artificial kidney). Patient #1 was started on a Heparin (an anticoagulation medication) drip, telemetry monitoring and admitted to the cardiology service for further management. Review of Patient #1 ’ s medical record indicated that there was a physician order entered on 12/24/24 at 6:19 P.M., for Telemetry/EKG assessment (a method of remotely monitoring vital signs and heart activity). Review of the Telemetry/EKG assessment flowsheet dated 12/26/24 at 12:00 A.M., indicated that Patient #1 had pulled off the leads to his/her telemetry monitor and the Physician was aware. Further review of Patient #1 ’ s medical record failed to indicate the Patient was ever placed back on Telemetry monitoring as ordered, after he/she had removed the leads. Review of the Nurse ’ s Note dated 12/26/24 at 2:04 A.M., indicated Patient #1 wanted to leave against medical advice and asked the Nurse to take the IV out and despite attempts at redirection, Patient #1 continued to have behaviors and the provider was notified. The note indicates a code was called, Patient #1 was agitated, punched the psychiatric nurse and was unable to be redirected. The note further indicates Haldol (antipsychotic used to treat nervous, emotional, and mental conditions) 5mg (milligrams), Ativan (a benzodiazepine used to treat anxiety) 2mg and Benadryl (an antihistamine primarily used to prevent extrapyramidal side effects from antipsychotics) 50mg were administered for good effect. The note indicates vital signs were performed and nursing was to continue to monitor Patient #1. Review of the Progress Note documented by the resident physician dated 12/26/24 at 6:56 A.M., indicated Patient #1 was agitated on 12/26/24 around 1:00 A.M. trying to leave the hospital and being aggressive. The note indicated Patient #1 was confused and a code gray was called; Patient #1 was given 5 mg of Haldol, 2 mg of Ativan and 50 mg of Benadryl. The patient went to sleep and was checked every hour. The last vital sign assessment was around 4:15 A.M, which were stable. The note indicated another checkup was completed around 5:30 A.M., the patient was sleeping comfortably and snoring loudly. The note further indicated that multiple attempts were made to put the patient back on Telemetry leads and IV lines, but the patient refused. The RN went to do the GlucoCheck (measures blood sugar) at 6:05 A.M. and found Patient#1 not responsive and pulseless. During an interview on 4/16/25 at 1:45 P.M., the Cardiology Fellow said he saw Patient #1 on 12/25/24 around 7:00 P.M., and he/she was doing okay. He said he was made aware that the patient was refusing telemetry monitoring. The Cardiology Fellow said he checked in with the nursing staff overnight to see how the patient was doing. He said the nursing staff were also notifying the Resident Physicians of the patient refusing telemetry monitoring. He said he asked the nursing staff to keep trying to put the telemetry leads on. The Cardiology Fellow said the Patient (Patient #1) was stable. During an interview on 4/18/25 at 9:45 A.M., the Nurse Manager of 6 West said if a patient removes or refuses telemetry monitoring the expectation is for the Nurse to document in a Nurses Note or telemetry intervention that the patient removed the leads and is refusing telemetry monitoring and that the MD was notified. The Nurse Manager further said if a patient continues to refuse attempts to reapply telemetry, the nurse should document patient continued to refuse and the MD was notified. The Hospital failed to ensure Telemetry monitoring was completed as ordered by the Physician for Patient #1.”

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 45980 Based on record review and interview, the Hospital failed to ensure IV (Intravenous) Heparin (a medication used to decrease clotting ability of the blood and prevent clots from forming) was administered in accordance with a physician order for one Patient (#1) out of a total sample of 10 patients. Findings included: Review of the Hospital policy titled “Medication Administration Chapter: Medication Management Policy Number: MM 21 Last Revised 7/16/24, indicated the following: A. Orders for Medication Administration: 2. Medications are prepared and administered in accordance with the orders of an Licensed Practitioner (LP) responsible for the patient ’ s care, and in accordance with law and regulation. D. Missed or Untimely Administration: 1. Missed administration of medications: The circumstances for missed administrations may include but are not limited to; the patient is in NPO status, the patient is off the unit, the medication dose is unavailable, the patient refuses the medication, or the patient is not able to take medication. In these circumstances the missed medication administration is reviewed with the provider and/or pharmacy to determine the next time of administration. Documentation is entered in the e-MAR including the reason for the missed administration. Review of Patient #1 ’ s medical records indicated that he/she was transferred from an outside hospital (OSH) on 12/24/24 for chest pain in the setting of dialysis with a concern for a NSTEMI (non-ST elevation myocardial infarction) given his/her known cardiac history. Patient #1 has a history of cardiomyopathy (a disease where the heart muscle becomes weakened, stretched, or otherwise structurally abnormal, making it harder for the heart to pump blood effectively), kidney disease stage 5 on hemodialysis (a procedure that cleans the blood outside the body using a machine that acts as an artificial kidney). Patient #1 was started on a Heparin drip, telemetry monitoring and admitted to the cardiology service for further management. Review of the medical record indicated that an order was placed for intravenous (IV) Heparin on 12/24/24 at 6:03 P.M., to titrate per protocol. Review of the Heparin Medication Detail Flowsheet indicated that on 12/25/24 at 10:54 P.M., the Heparin infusion was decreased by 1 unit/kg/hour per protocol. Review of the IV/Invasive Line Assessment dated 12/25/24 at 7:35 P.M., indicated the IV to the right upper arm was asymptomatic, intact and patent. Review of the Nurses Note dated 12/26/24 at 2:04 A.M., indicated that Patient #1 wanted to leave against medical advice. Patient #1 asked the Nurse to take the IV out, and the nurse attempted to educate and redirect without success. Patient #1 continued to act out and the provider was notified. The note indicates a code was called, the Patient was agitated, punched the psychiatric nurse and was unable to be redirected. The note further indicated medication (Haldol 5mg, Ativan 2mg and Benadryl 50mg) was administered for good effect. The note indicated that vital signs were performed, and nursing was to continue to monitor. Review of the Progress Note documented by the resident physician dated 12/26/24 at 6:56 A.M., indicated that Patient #1 was agitated on 12/26/24 around 1:00 A.M. trying to leave the hospital and being aggressive. The note indicated Patient #1 was confused and a code gray was called; Patient #1 was given 5 mg of Haldol, 2 mg of Ativan and 50 mg of Benadryl. The patient went to sleep and was checked every hour. The last vital checks were around 4:15 A.M, which were stable. Another checkup was around 5:30 A.M., the patient was sleeping comfortably and snoring loudly. The note further indicates that multiple attempts were made to put the patient back on Telemetry leads and IV lines, but the patient refused. The RN went to do the GlucoCheck (blood glucose check) at 6:05 A.M. and found Patient #1 not responsive and pulseless. During an interview on 4/17/25 at 10:42 A.M., the Cardiology Fellow said he was made aware the IV Heparin wasn ’ t running after Patient #1 pulled his/her IV line. He said the resident physician also had a discussion with the Charge Nurse regarding the IV. He said the Charge Nurse was making attempts to place another IV. The Cardiology Fellow said the patient was stable. During an interview on 4/18/25 at 9:45 A.M., the Nurse Manager of 6 West said the expectation when a medication is refused by a patient is to document in the Medication Administration Record (MAR) as well as a nurse ’ s note and that the provider was notified. She said IV Heparin gets documented at change of shift and with any titrations. The Nurse Manager of 6 West said it is the expectation that the nurse documents when a patient removes their IV. She said if a patient refuses a new IV, the provider should be notified, and the IV Heparin order should be discontinued. The Hospital failed to ensure IV Heparin was administered as ordered for Patient #1.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 40928 The Condition of Participation: Governing Body was out of compliance. Based on records reviewed and interviews, the Hospital failed to ensure an effective Governing Body was responsible for the conduct of the Hospital, when the Hospital failed to have an adequate institutional budget for supplies and equipment, failed to maintain an adequate stock of supplies and equipment, resulting in supply issues related to vendor holds due to non-payment and failed to implement actions to address these non-payment issues to vendors. Cross Reference: 482.12(d)(7): Governing Body: Institutional Plan and Budget (0077) 482.21(a), (c)(2), (e)(3): Quality Assessment and Performance Improvement: Patient Safety (0286)”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 40928 The Condition of Participation: Quality Assessment and Performance Improvement Program (QAPI) was out of compliance. Based on records reviewed and interviews, for one of 10 sampled patients (Patient #1), the Hospital failed to ensure the Quality Assessment and Improvement Program (QAPI) implemented and maintained an effective, ongoing, hospital-wide, data-driven quality assessment, and performance improvement program to implement preventative actions in response to preventable adverse patient events. Cross Reference: 482.21(a), (c)(2), (e)(3): Quality Assessment and Performance Improvement: Patient Safety (0286)”

“SURGICAL SERVICES CFR(s): 482.51 If the hospital provides surgical services, the services must be well organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. This Condition is not met as evidenced by: 40928 The Hospital was out of compliance with the Condition of Participation for Surgical Services. Based on records and documents reviewed, and interviews: 1) The Hospital failed to provide the appropriate equipment necessary to furnish the surgical services offered by the Hospital in accordance with the acceptable standards of practice which resulted in one of 10 sampled patients (Patient #1) not receiving emergency treatment with an embolization coil, which was unavailable due to repossession by the coil vendor for Hospital non-payment. 2) The Hospital failed to ensure payments were made to vendors and suppliers as evidenced by failing to maintain an inventory of mechanical heart valves used for Type A Aortic Dissections (a medical emergency that occurs when a tear develops in the ascending part of the aorta as it branches off from the heart) due to failure to pay the vendor and the Hospital was on diversion for Aortic Dissections due to the missing mechanical heart valves. Immediate Jeopardy (IJ) was identified on 2/2/24 under 482.51 Surgical Services due to failure of the Hospital to ensure appropriate medical equipment necessary for furnishing surgical services was available. Patient #1 was transferred to an outside tertiary hospital for an emergency embolization procedure secondary to the Hospital not having the necessary coils for the procedure due to failure to pay the vendor. The Hospital replaced the inventory by changing vendors but continued to have supply issues due to nonpayment of vendors as evidenced by not having inventory of mechanical heart valves used for emergent Type A Aortic Dissections due to nonpayment and being on diversion for Aortic Dissections. The Hospital was notified of the IJ on 2/2/24. The Hospital provided an immediate corrective action plan on 2/8/24. In summary, the IJ event Removal Plan was implemented on 2/8/24. The IJ event regarding the CoP of Surgical Services was removed on 2/8/24, when the State Agency/CMS verified by interview with staff, review of all documentation, education attestations, and Patient records that the Removal Plan was fully implemented. Condition of Participation non-compliance for Surgical Services remain. Cross Reference: 482.51(a): Organization and Staffing (941)”

“INSTITUTIONAL PLAN AND BUDGET CFR(s): 482.12(d)(7) The plan must be prepared- o Under the direction of the governing body; and o By a committee consisting of representatives of the governing body, the administrative staff, and the medical staff of the institution. This Standard is not met as evidenced by: 40928 Based on documents reviewed and interviews, the Hospital failed to have an adequate institutional budget for supplies and equipment, failed to maintain an adequate stock of supplies and equipment, resulting in supply issues related to vendor holds due to non-payment and failed to implement actions to address these non-payment issues to vendors. The Hospital’s Quality and Safety Plan, dated December 2022, indicated the Hospital Board of Directors holds overall responsibility and accountability for the quality of patient care, including the safety of patients, staff and visitors and the appropriate utilization of resources. The Hospital Board holds the Hospital Medical Staff accountable for the quality of patient care. Medical staff leadership together with hospital administrative leadership oversees hospital provision of care, treatment, and services, as well as day to day operations of the hospital. Review of Board of Directors meeting minutes and notes indicated the following: -March 30, 2023: System update- Utah hospitals divesture expected to go through around May 1st bringing more financial stability. -December 20, 2023-Challenges: equipment and supplies. Fairly constant issues (due to credit holds) with Respiratory and Anesthesia supplies; Interventional supplies for Interventional Radiology (IR) and some surgical areas; medications; broken beds with no backups so several rooms down. During an interview on 12/20/23 at 11:21 A.M., the Senior Director of Supply Chain said she oversees the central storeroom which supplies items for the floors and that units that perform specialty procedures order the specialty items themselves. She said items on consignment are brought in by the vendor and paid for after the case and as products are used the department will reorder the items using a bill and replace system. The Senior Director of Supply Chain said there have been a variety of items that had vendor holds placed due to payment issues or not receiving payment. The Senior Director of Supply Chain said staff will make her aware if they haven’t received an ordered item and she will investigate to see if there is a hold due to payment issue. She said if there are vendor holds in place, she will ask questions about the item to see how critical it is and try to find a work round to get the item. The Senior Director of Supply Chain said her understanding is that all payments are sent via the Hospital’s corporate headquarters and said she tries to manage past due invoices by notifying the senior leadership team at the Hospital of payment issues. During an interview on 12/21/23 at 10:55 A.M., the Hospital President said that vendor payments are centralized by the corporate office and the Hospital does not issue payments directly. The Hospital President said there are different ways of learning about issues with vendors and payments and he said once he is notified about a vendor hold, he will try to get a similar item from a different vendor. The Hospital President said bills aren’t paid due to a liquidity problem and said the Hospital Board of Directors is aware of the financial difficulties of the Hospital but was unable to say any actions implemented to maintain adequate supplies and equipment and to address non-payment to vendors. During an interview on 1/29/24 at 3:54 P.M., the Hospital President said the corporate office approves each year’s budget and said the Hospital’s Board of Directors helps hospital leadership come up with goals of the organization. The Hospital President said financial stability is part of the Hospital’s quality program and Board meeting high level planning is communicated to the regional team. During an interview on 1/29/24 at 4:08 P.M., the Hospital President said that 12 of 22 consignment vendors (vendors that provide products that are paid for after being used) for the Hospital were on credit hold due to payment issues. During a follow up interview on 1/30/24 at 2:27 P.M., the Hospital President said company product and vendor challenges are mainly due to credit hold issues. The Hospital President said he has kept the regional team aware of concerns of the Hospital’s Board of Directors but was unable to provide evidence that the Governing Body implemented actions to address non-payments to vendors. During an interview on 2/6/24 at 9:27 A.M., the Hospital President said there were multiple elevators out of service in the Hospital and that the previous elevator vendor stopped working with the Hospital due to not being paid. The Hospital failed to implement actions to address non-payment issues to vendors, resulting in supply and equipment issues due to vendor holds for non-payment.”

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 40928 Based on records and documents reviewed, and interviews, for one of 10 sampled patients (Patient #1), the Hospital failed to ensure the Quality Assessment and Improvement Program (QAPI) implemented and maintained an effective, ongoing, hospital-wide, data-driven quality assessment, and performance improvement program to implement preventative actions in response to preventable adverse patient events. The Hospital’s Policy titled, Incident Reports: General Overview, revised 7/11/23, indicated that the Hospital responds to all incidents in a timely, consistent, and effective manner and that every incident will activate an appropriate investigation and response. The Hospital’s Quality and Patient Safety Plan, dated December 2022, indicated that review of adverse events and systems and process failures that meet certain criteria will be accomplished in part through the mechanism of Root Cause Analysis, a systematic approach of individual or pattern problem identification, followed by the institution of appropriate measures to improve patient care, safety, and patient satisfaction and reduce the likelihood of recurrence. Review of Patient #1’s General Surgery Operative Note, dated 10/17/23, indicated Patient #1 had a vaginal birth earlier in the day, experienced vaginal bleeding post-delivery and later required Dilation and Curettage (D & C) (a surgical procedure in which the cervix is dilated and examined in order to view and remove abnormal tissues) for the vaginal bleeding. The Note further indicated Patient #1’s bleeding was well controlled for many hours before Patient #1 ultimately had a change in mental status and had hemoperitoneum (blood in the peritoneal cavity). Patient #1 was taken to the Operating Room (OR) for exploratory laparotomy (a general surgical operation where the abdomen is opened and the abdominal organs are examined for injury) by the Obstetrics and Gynecology team (GYN), and went into Pulseless Electrical Activity arrest (PEA) (when the heart stops beating because the electrical activity is too weak to make the heart beat) shortly after arrival. Patient #1 received Cardiopulmonary Resuscitation (CPR) and return of spontaneous circulation was achieved. Intraoperatively, Patient #1 was found to have hemoperitoneum from an unidentified source, requiring packing above and around the liver, which somewhat controlled the bleeding and multiple liver hematomas and lacerations were observed. Patient #1 was ultimately accepted for transfer to an outside hospital by the Interventional Radiology (IR) service for coil embolization (a procedure in which metallic occluding coils are used to stop bleeding) of the dominant bleeding. Patient #1’s estimated blood loss was 6 liters. Review of Patient #1’s GYN Operative Note, dated 10/17/23, indicated Patient #1 went into cardiac arrest after arrival to the operative room, advanced cardiovascular life support (ACLS) was started and after cardiac activity was resumed, Patient #1 was prepped for an exploratory laparotomy. The Note further indicated a large hemoperitoneum was noted and over 2 liters of blood was evacuated from the abdomen, the uterus appeared normal with no evidence of perforation, additionally, a large clot was removed from Patient #1’s right upper quadrant and heavy bleeding was noted from the liver and the trauma surgical team was called. The Note further indicated Patient #1 received packing to the right upper quadrant and abdomen and Patient # 1 was sent out for an interventional radiology procedure at an outside tertiary hospital. Review of the Tertiary Hospital’s (the hospital that Patient #1 was transferred to) Interventional Radiology Consult note dated 10/18/23 indicated that Patient #1 had experienced postpartum bleeding and hemoperitoneum (blood in the peritoneum) and had been transferred from the Hospital via MediFlight due to insufficient materials at the Hospital for embolization. During an interview on 12/19/23 at 1:00 P.M., the Chief Medical Officer said she was aware of Patient #1’s case and had been present the night of the event. The Chief Medical Officer said Patient #1 was bleeding from the right upper quadrant and there were multiple liver lacerations. The Chief Medical Officer said that the bleeding had been controlled using a Pringle maneuver (a procedure to stop the flow of blood through the hepatic artery and controls bleeding from the liver) but this is not a permanent solution. The Chief Medical Officer said a call was made to Interventional Radiology (IR) to notify them that Patient #1 needed embolization, but she was told the IR didn’t have the needed embolization coils. The Chief Medical Officer said the Hospital had the technical skills but not the coils, due to no one monitoring par levels. During a follow up interview on 12/21/23 at 9:18 A.M., the Chief Medical Officer said she had been notified by the Chair of Radiology prior to Patient #1’s event that a vendor had taken the embolization coils, conflicting with a previous interview which indicated the coils were unavailable due to Hospital staff failing to maintain par levels, and said the Hospital was considering not taking GI bleed patients due to not having the coils. The Chief Medical Officer said a vendor rep came and took the coils and that she was unsure who released the payment to vendors, as they all come through the corporate office. During an interview on 12/20/23 at 8:12 A.M., IR Technician (Tech) #1 said the Hospital has a specific IR suite and supply room, which was stocked with equipment and supplies, which typically included embolization coils. IR Tech #1 said he maintains IR supplies and stock (PAR levels) and his system was to take the sticker from each procedure after it was completed, and immediately scan it to re-order and replace the used item. He said this PAR level maintenance system had been in place for a few years and there were never issues with IR items not being available. IR Tech #1 said that at the time of Patient #1’s event, the embolization coils were on consignment from the Vendor. IR Tech #1 said sometime in early October 2023, he received an email from the Vendor’s representative notifying the Hospital that the Vendor planned to take the coils back due to not receiving payment and the coils were removed sometime around 10/12/23. IR Tech #1 said he notified his manager of the Vendor’s email and also notified his manager when the coils were taken by the Vendor representative prior to Patient #1’s event on 10/17/23. IR Tech #1 said his understanding was there were no coils available in the hospital at the time of the event, as they were all on consignment and had been taken by the vendor. Review of vendor email to the Hospital dated 10/3/23 indicated that the vendor had been waiting for payment from the Hospital that had not been received and the vendor was planning to pick up the coils that were in the Hospital. During an interview on 12/20/23 at 11:21 A.M., the Senior Director of Supply Chain said items on consignment are brought in by the vendor and paid for after the case and as products are used the department will reorder the items using a bill and replace system. The Senior Director of Supply Chain said there have been a variety of items that had vendor holds placed due to payment issues or not receiving payment. The Senior Director of Supply Chain said staff will make her aware if they haven’t received an ordered item and she will investigate to see if there is a hold due to a payment issue. She said if there are vendor holds in place, she will ask questions about the item to see how critical it is and try to find a work round to get the item. The Senior Director of Supply Chain said her understanding is that all payments are sent via the Hospital’s corporate headquarters and said she tries to manage past due invoices by notifying the senior leadership team at the Hospital of payment issues. During an interview on 12/20/23 at 2:16 P.M., the Director of Radiology and Radiation Oncology said he notified upper levels of management that the coils had been taken but was unable to say how many days the Hospital did not have the coils. During an interview on 12/21/23 at 10:55 A.M., the Hospital President said Patient #1’s case was an extremely difficult case. The President said his understanding of the coils being unavailable on 10/17/23 was due to the vendor pulling the coil supply due to non-payment. The President said he was aware of the coils being pulled prior to Patient #1’s event and said all bill payments are paid by the Hospital corporate offices and that some bills aren’t being paid due to a liquidity problem. The Hospital President said that after this event he sent an email to department leaders after the event to notify them that if a vendor tries to take consigned items back due to payment issues to not let that happen but was unable to provide evidence of any additional corrective actions implemented to address vendor non-payments. During a follow up interview on 1/30/24 at 2:27 P.M., the Hospital President said company product and vendor challenges are mainly due to credit hold issues. The President said the Quality Assurance and Performance Improvement (QAPI) team does not discuss financial issues because there are senior level managers that are already aware of payment issues and challenges with staffing and further said that access to supplies and equipment can impact quality and safety. The Hospital failed to implement any corrective actions towards managing vender accounts to ensure any necessary medical equipment is not repossessed due to non-payment, failed to provide any evidence of tracking and trending payment issues impacting supplies and services. The Hospital also failed to provide any evidence of corrective actions related to the Hospital maintaining par levels of necessary medical equipment or interventions in the event necessary medical equipment is not available during an emergency.”

“ORGANIZATION OF SURGICAL SERVICES CFR(s): 482.51(a) The organization of the surgical services must be appropriate to the scope of the services offered. This Standard is not met as evidenced by: 40928 Based on records and documents reviewed, and interviews: 1) The Hospital failed to provide the appropriate equipment necessary to furnish the surgical services offered by the Hospital in accordance with the acceptable standards of practice which resulted in one of 10 sampled patients (Patient #1) not receiving emergency treatment with an embolization coil, which was unavailable due to repossession by the coil vendor for Hospital non-payment. 2) The Hospital failed to ensure payments were made to vendors and suppliers as evidenced by failing to maintain an inventory of mechanical heart valves used for Type A Aortic Dissections (a medical emergency that occurs when a tear develops in the ascending part of the aorta as it branches off from the heart) due to failure to pay the vendor and the Hospital was on diversion for Aortic Dissections. 1) Patient #1 presented to the Hospital on 10/15/23 for induction of labor and had a vaginal delivery on 10/17/23. Review of Patient #1’s medical record indicated Patient #1 had received a prolonged high dose of intravenous (IV) Pitocin (a hormone used to help the uterus contract) during the labor process and subsequently received prophylactic Methergine (a medication to prevent and control bleeding from the uterus after childbirth) and Cytotec (a medication used to prevent postpartum hemorrhage) after delivery. Review of Patient #1’s General Surgery Operative Note, dated 10/17/23, indicated Patient #1 had a vaginal birth earlier in the day, experienced vaginal bleeding post-delivery and later required Dilation and Curettage (D & C) (a surgical procedure in which the cervix is dilated and examined to view and remove abnormal tissues) for the vaginal bleeding. The Note further indicated Patient #1’s bleeding was well controlled for many hours before Patient #1 ultimately had a change in mental status and had hemoperitoneum (blood in the peritoneal cavity). Patient #1 was taken to the Operating Room (OR) for exploratory laparotomy (a general surgical operation where the abdomen is opened and the abdominal organs are examined for injury) by the Obstetrics and Gynecology team (GYN), and went into Pulseless Electrical Activity arrest (PEA) (when the heart stops beating because the electrical activity is too weak to make the heart beat) shortly after arrival. Patient #1 received Cardiopulmonary Resuscitation (CPR) and return of spontaneous circulation was achieved. Intraoperatively, Patient #1 was found to have hemoperitoneum from an unidentified source, requiring packing above and around the liver, which somewhat controlled the bleeding and multiple liver hematomas and lacerations were observed. Patient #1 was ultimately accepted for transfer to an outside hospital by the Interventional Radiology (IR) service for coil embolization (a procedure in which metallic occluding coils are used to stop bleeding) of the dominant bleeding. Patient #1’s estimated blood loss was 6 liters. Review of Patient #1’s GYN Operative Note, dated 10/17/23, indicated Patient #1 went into cardiac arrest after arrival to the operative room, advanced cardiovascular life support (ACLS) was started and after cardiac activity was resumed, Patient #1 was prepped for an exploratory laparotomy. The Note further indicated a large hemoperitoneum was noted and over 2 liters of blood was evacuated from the abdomen, the uterus appeared normal with no evidence of perforation, additionally, a large clot was removed from Patient #1’s right upper quadrant and heavy bleeding was noted from the liver and the trauma surgical team was called. The Note further indicated Patient #1 received packing to the right upper quadrant and abdomen and Patient # 1 was sent out for an interventional radiology procedure at an outside hospital. Review of the Tertiary Hospital’s (the Hospital where Patient #1 was emergently transferred to) Interventional Radiology Consult Note, dated 10/18/23, indicated that Patient #1 had experienced postpartum bleeding and hemoperitoneum and had been transferred from the Hospital via MedFlight due to insufficient materials at the Hospital for embolization. During an interview on 12/20/23 at 11:51 A.M., the Interventional Radiologist said he was on call the night of Patient #1’s event. He said he was notified of a postpartum patient with intra-abdominal bleeding that appeared to be from Patient #1’s liver. The Interventional Radiologist said that at the time of the event, the Hospital did not have embolization coils and the IR tech confirmed there were no coils, and he notified the team in the OR that the embolization coils were not available. During an interview on 12/19/23 at 10:07 A.M., the Chief Medical Officer said the hospital is equipped for trauma cases, that the Hospital is a tertiary center and receives patients that require trauma services. During an interview on 12/19/23 at 1:00 P.M., the Chief Medical Officer said she was aware of Patient #1’s case and had been present the night of the event. The Chief Medical Officer said she arrived at the OR and Patient #1 was being worked on by Attending OB #1 and General Surgeon #1. The Chief Medical Officer said Patient #1 was bleeding from the right upper quadrant and there were multiple liver lacerations. The Chief Medical Officer said that the bleeding had been controlled using a Pringle maneuver (a procedure to stop the flow of blood through the hepatic artery and controls bleeding from the liver) but this is not a permanent solution. The Chief Medical Officer said a call was made to Interventional Radiology (IR) to notify them that Patient #1 needed embolization, but she was told the IR didn’t have the needed embolization coils. The Chief Medical Officer said the Hospital had the technical skills but not the coils, due to no one monitoring par levels and the decision was made to send Patient #1 to an outside hospital for the embolization. During a follow up interview on 12/21/23 at 9:18 A.M., the Chief Medical Officer said she had been notified by the Chair of Radiology prior to Patient #1’s event that a vendor had taken the embolization coils, conflicting with a previous interview which indicated the coils were unavailable due to Hospital staff failing to maintain par levels, and said the Hospital was considering not taking GI bleed patients due to not having the coils. The Chief Medical Officer said a vendor rep came and took the coils and that she was unsure who released the payment to vendors, as they all come through the corporate office. During interviews on 12/19/23 at 1:23 P.M. and throughout the survey, General Surgeon #1 said he received an urgent request at approximately 8:50 P.M. on 10/17/23 to assist in surgery for Patient #1. General Surgeon #1 said he arrived a little after 9:00 P.M. and identified Patient #1’s liver as the presumed bleeding source. General Surgeon #1 said Patient #1 had a midline incision and most of Patient #1’s abdomen was packed, and Patient #1 had already received 3 units of blood and other products. General Surgeon #1 said he decided to implement a Pringle maneuver. General Surgeon #1 said he counted several liver lesions and lacerations but was unable to determine which was the main bleed. General Surgeon #1 said every time the Pringle was released, the lacerations would bleed profusely with torrential blood coming out. General Surgeon #1 said IR coil embolization of the liver could typically be done at the Hospital and said that the Hospital had the expertise, but they didn’t have the coils to use on Patient #1 in attempts to stop the excessive bleeding. General Surgeon #1 said Patient #1 was transferred to a Tertiary Hospital for the embolization procedure. During an interview on 12/20/23 at 8:12 A.M., IR Technician (Tech) #1 said the Hospital has a specific IR suite and supply room, which was stocked with equipment and supplies, which typically included embolization coils. IR Tech #1 said he maintains IR supplies and stock (PAR levels) and his system was to take the sticker from each procedure after it was completed, and immediately scan it to re-order and replace the used item. He said this PAR level maintenance system had been in place for a few years and there were never issues with IR items not being available. IR Tech #1 said that at the time of Patient #1’s event, the embolization coils were on consignment from the Vendor. IR Tech #1 said sometime in early October 2023, he received an email from the Vendor’s representative notifying the Hospital that the Vendor planned to take the coils back due to not receiving payment and the coils were removed sometime around 10/12/23. IR Tech #1 said he notified his manager of the communication that the Vendor was planning on taking the coils back due to non-payment and again when the coils were taken. IR Tech #1 said his understanding was there were no coils available in the hospital at the time of the event, as they were all on consignment and had been taken by the vendor. Review of vendor email to the Hospital dated 10/3/23 indicated that the vendor had been waiting for payment from the Hospital that had not been received and the vendor was planning to pick up the coils that were in the Hospital. During an interview on 12/20/23 at 2:16 P.M., the Director of Radiology and Radiation Oncology said that IR Tech #1 notified him that the Vendor provided notification that the Vendor representative planned to remove the coils from the Hospital. The Director said he told IR Tech #1 not to release the coils back to the Vendor but to request the Vendor representative contact the Director and administration. The Director said he was notified when the coils were removed from the Hospital and said he then notified the Corporate Director of Radiology and upper levels of management. The Director was unable to say when the coils were taken, or any actions taken to address possible safety issues related to the coils being taken. During an interview on 12/20/23 at 11:21 A.M., the Senior Director of Supply Chain said there have been a variety of items that had vendor holds placed due to payment issues or not receiving payment. The Senior Director of Supply Chain said staff will make her aware if they haven’t received an ordered item and she will investigate to see if there was a hold due to a payment issue. She said if there are vendor holds in place, she will ask questions about the item to see how critical it was and try to find a work round to get the item. The Senior Director of Supply Chain said her understanding is that all payments are sent via the Hospital’s corporate headquarters and said she tries to manage past due invoices and notify the senior leadership team at the Hospital of payment issues. During an interview on 12/21/23 at 10:55 A.M., the Hospital President said Patient #1’s case was an extremely difficult case. The President said his understanding of the coils being unavailable on 10/17/23 was due to the vendor pulling the coil supply due to non-payment. The President said he was aware of the coils being pulled on 10/17/23, prior to Patient #1’s event, and said all bill payments are paid by the Hospital corporate offices and that some bills aren’t being paid due to a liquidity problem. The Hospital President said that after this event he sent an email to department leaders after the event to notify them that if a vendor tries to take consigned items back due to payment issues to not let that happen but was unable to provide evidence of any corrective actions implemented to address vendor non-payments or potential safety issues related to vendor non-payment. 2) The Hospital failed to ensure payments were made to vendors and suppliers as evidenced by the Hospital failing to maintain an inventory of mechanical heart valves used for Type A Aortic Dissections (a medical emergency that occurs when a tear develops in the ascending part of the aorta as it branches off from the heart) due to failure to pay the vendor. The Hospital was subsequently on diversion for Aortic Dissections. During an interview on 1/31/24 at 7:20 A.M., the Chief Medical Officer provided the surveyor with a list of procedures that the Hospital was unable to perform due to supply issues and said the Hospital was on diversion for Aortic Dissections (a medical emergency that occurs when a tear develops in the ascending part of the aorta as it branches off from the heart) due to lack of a specific mechanical valve (valved aortic graft). During an interview on 12/21/23 at 10:55 A.M., the Hospital President said all bill payments are paid by the Hospital corporate offices and that some bills aren’t being paid due to a liquidity problem and the Hospital has had issues with vendors putting accounts on hold or not delivering products due to non-payment. During a follow up interview on 1/29/24 at 11:13 A.M., the Senior Director of Supply Chain said she has lots of concerns with supplies and vendors due to non-payment. She said the Hospital was not taking patients that need certain types of procedures and that she and her staff try to find and source alternate supplies to replace supplies that are on vendor payment hold. During an interview on 1/31/24 at 8:47 A.M., the Hospital President said the item needed to treat an Aortic Dissection was unavailable due to payment issues and the vast majority of supply issues were due to credit holds. During an interview on 2/1/24 at 10:36 A.M., the Chief of Cardiac Surgery said most aortic dissections are acute and that the Hospital did not have a specific size mechanical valve that can be used to treat a Type A Aortic Dissection. Review of Hospital email communication with the mechanical valve vendor indicated a request was made for a valved graft 11/7/23 and due to credit review, the vendor would not fulfill the order. The Hospital failed to ensure payments were made to vendors and suppliers in order to maintain necessary emergency supplies and equipment, in accordance with acceptable standards of practice.”