HospitalInspections.org

Based on interview and document review, the hospital governing body (GB) failed to ensure contracted services had a quality assurance performance improvement (QAPI) plan for animal research.

Findings include:

A complaint dated 2/22/23, indicated the M Health Fairview University of Minnesota hospital had been transporting sheep through the Fairview hospital service elevator. The animals were transported to patient floors to receive services. This service elevator was also used to transport hospital supplies. The elevator was not being cleaned after animal use. The complaint indicated animals were then transported through patient hallways from the elevator. The complaint further indicated the animals were not always sedated, and staff would have to hold them down manually when aggressive. The animals were being transported on a gurney and covered with a sheet.

On 3/8/23, at 12:15 p.m. a tour of the hospital radiology department was conducted with plant operations director (POD)-A, radiology department manger (RDM)-A, vice president of operations (VP)-A and the system program manager. Interview at this time with RDM-A confirmed animals from the University of Minnesota (U of M) research lab were being transported in the service elevator to the radiology floor. The animals were being provided magnetic resonance imaging (MRI) and computed tomography (CT) services. RDM-A stated he was responsible for coordinating appointments with the U of M research lab for these services. The services for the animals were being done before 7:00 a.m. to avoid hospital patient services. RDM-A stated hospital services for the animals had been offered for the past several years, but was unsure if there was a contract for services. RDM-A stated he did not know anything about the animals conditions when transported to the hospital. He stated he also was unsure if the elevators were being cleaned after use. RDM-A confirmed the MRI and CT machines were also used on patients, but sanitized using the same cleaning protocols used for patients. RDM-A stated there had not been a QAPI program implemented related to the services being offered for animal research.

Interview on 3/8/23, at 2:00 p.m. the facility infection control preventionist (ICP)-A stated she had not been aware of the radiology services provided for the animals. ICP-A stated she had not been monitoring or tracking infection control (IC) procedures related to animal transport in the elevators or the use of the radiology procedure rooms/ equipment. Nor were services being tracked related to any affect this may have on patient service or care.

Interview on 3/8/23, at 12:30 p.m. VP-A and the hospital regulatory and accreditation manager (RCM)-A both stated they were unaware of any animal research being done at the hospital until it was brought to their attention by the surveyor. VP-A and RCM-A were prompted to check if the hospital had a contract for animal research services with the U of M hospital. A 1996 dated contract was found.

A document (cover and signature page) titled Academic Affiliation Agreement with Fairview Hospital and the University of Minnesota Hospital dated 1996 was provided, but lacked the content of the agreement. The content was provided through interview on 3/9/23, at 2:00 p.m. with RCM-A. RCM-A indicated the contract was centered around affiliation of the two hospitals related to the support of research, education, and patient care missions. The contract lacked specifics to what research included. RCM-A confirmed services being done at the hospital for animal research did not have a QAPI program implemented.

Based on interview and document review, the Fairview's Children's Mental Health Day Treatment program failed to obtain a separate physician order for use of restraints and seclusion for 1 of 3 patients (P1) reviewed for restraints.

Findings include:

P1's medical record indicated the use of a seclusion and restraint on 1/13/23. The record indicted a start time of 10:32 a.m.; however, did not include evidence a physician's order had been obtained for the use of the physical hold. P1's medical record revealed in a progress note P1 had been in the lounge where her behaviors had escalated, she was about to rip a picture frame, and was pulling on a window shade. Because her behavior was continuing to escalate, P1 was brought to seclusion by two staff. P1 tried to run out of the seclusion room, and staff was unable to shut the door. Staff re-entered the seclusion room and held P1 on the mattress while P1 was checked for items by female staff. Seclusion was started at 10:15 a.m. P1's provider was notified, and seclusion was ordered.

On 3/9/23, at 2:14 p.m. RN-A stated a physician order must be obtained for the use of restraints and seclusion. RN-A verified there was no documentation a separate order for the physical hold and seclusion room was obtained. RN-A verified holding a patient on the mat would be considered a physical hold and would require a separate restraint order.

On 3/9/23, at 2:26 p.m. certified nurse practitioner (CNP)- A verified she had signed off on the restrain/seclusion order initiated on 1/13/23, stated she expected facility staff to follow the policy and procedure on restraints. CNP-A verified the order for P1 on 1/13/23, did not have a separate order in place for the physical hold, and the order was only the seclusion room. CNP-A stated a provider order was needed for each episode of restraint use.

The Seclusion or Restraint policy dated 6/17/19, directed, "Restraint: any manual method, physical or mechanical device, material or equipment." The policy directed staff (a Licensed Independent Practitioner [LIP]) orders the use of restraint. If the LIP is not immediately available, the RN may initiate the intervention that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely. A Registered Nurse may initiate restraint if necessary to protect the patient, staff members or others from harm provided that an order is obtained from an LIP who is responsible for the patient as soon as the situation that required the application of the restraint is addressed and the patient is determined to be safe and stabilized (at least within 1 hour).

Based on observation, interview, and documentation review, the hospital was found to be out of compliance with Life Safety Code (LSC) requirements. These findings have the potential to affect all patients in the hospital.

Findings include:

Please refer to LSC deficiencies cited at K-933 for additional information.

Based on observation, interview, and document review, the hospital failed to ensure the safe use of an electrocautery device, resulting in a risk for fire in the operating room and/or risk for patient burns for 1 of 4 patients (P15) observed during a surgical procedure where the surgeon and/or surgical staff failed to operate the electrocautery device as directed by hospital policy and manufacturer recommendations.

Findings include:

P15 was observed on 3/8/23, at 2:30 p.m. during a right cranio-orbital surgical procedure approach for resection of a tumor. P15 was observed to utilize oxygen through a ventilation tube during the surgical procedure. During the procedure, it was noted the use of a Valleylab FT 10 electrosurgical generator with use of a cautery pencil device (used for cutting and coagulating tissue). The cautery pencil was utilized by medical doctor (MD)-A and was placed on top of P15's surgical drape. MD-A and surgical technician (ST)-A failed to place the electrocautery device into the holster during the procedure as follows:

At 2:45 p.m. MD-A was observed to utilize the cautery pencil and place it on top of P15's surgical drape, about 1/2 inch below the neck. After 30 seconds, ST-A picked up the cautery pencil from the drape, and placed it in the holster.

Interview on 3/8/23, at 3:00 p.m. registered nurse (RN)-A confirmed the use of the electrocautery pencil during the surgical procedure, but stated she did not observe the cautery pen being placed on the patients drape. RN-A verified all staff have been trained on the safety and use of the electrcautery equipment, and the cautery pen should have been placed in the holster when not in use.

Interview on 3/9/23, at 1 30 p.m. peri-operative director of nursing (DON)-A stated all surgical staff are responsible for holstering the cautery pen when not in use. DON-A confirmed all staff had been trained on the use and safety of the cautery equipment. DON-A further stated MD-A should have holstered the cautery pen or hand it to surgical technician (ST)-A, instead of placing it on the patients drape.

MD-A was unavailable for interview.

A review of the hospital's incident/accident reports for the past year revealed no incidents of fire/injury related to the use of electrocautery devices.

The hospital policy Electrosurgical Safety in the Operating Room dated 8/9/22, directed directed any heat generating device (electrocautery) not in the hand of the provider during a procedure is either in a holster, or appropriately managed by an intra-operative team member.

Review of the Manufacturer's Guidance (undated) for use of the Valleylab FT 10 electrosurgical generator with the subject title "Warning" directed staff: "Fire Hazard: do not place active cautery equipment near or in contact with flammable materials (such as gauze or surgical drapes) flammable gases, or high levels of oxygen. Electrosurgical instruments that are activated or hot from use can cause a fire. When not in use, place electrosurgical instruments in a safety holster or safely away from patients, surgical team and flammable materials."