The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.
| LAUGHLIN MEMORIAL HOSPITAL, INC | 1420 TUSCULUM BLVD GREENEVILLE, TN 37745 | Nov. 16, 2018 |
| VIOLATION: GOVERNING BODY | Tag No: A0043 | |
| **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on review of facility Bylaws, review of facility policy, medical record review, review of facility documentation, and interviews, the facility's Governing Body failed to ensure a safe environment during a surgical procedure for 1 patient (#1) of 4 surgery patients reviewed. The findings included: Review of facility Governing Body Bylaws, not dated, revealed "...the board of Directors of the Sole Member has ultimate responsibility for quality patient care and authority for maintaining Performance Improvement and Risk Management Program..." Review of facility policy Patient Rights, last revised 09/2001, revealed "...the patient has the right to expect reasonable safety insofar as the hospital practices and environment are concerned..." Review of facility policy Positioning of Patients, last revised on 7/2015, revealed "...movement or positioning of the patient should be considered with the Surgical Team...specific patient needs should be communicated among team members...when on the procedure bed, the patient will be attended by a surgical team member at all times...safety restraints are applied after patient positioning. Safety straps will we applied carefully..." Review of facility policy Operating Room Objectives and Goals, last revised 1/2017, revealed "...it is the policy of the Operating Room to provide quality nursing care which effectively meets the physical, psychological, and spiritual needs for each individual patient. This should include...safety..." Review of facility policy Positioning of Patients, last revised 7/2015, revealed "...the position of the Patient on the Operating Room table is determined by the surgery to be performed, taking into consideration the safety of the patient. The physician decides the position to be employed. However, the circulating nurse must be familiar with the positions most commonly used...movement or positioning of the patient should be coordinated with the surgical team...when on the procedure bed, the patient will be attended by the surgical team member at all times...safety restraints are applied after patient positioning..." During investigation of complaint # it was found Patient #1 was admitted to Facility A for a Right Hip Closed Fracture on 11/7/18 after a fall. The patient was admitted to the facility on [DATE] and scheduled for an Intramedullary Nailing of the Right Hip (a metal rod inserted into the bone) on 11/8/18. The patient was taken to the Operating Room (OR) on 11/8/18 where the surgical procedure was performed and successfully completed for the patient with no complications related to the surgical procedure. After the surgical procedure was complete the patient remained on a specialty bed used for hip procedures and was under anesthesia. The OR staff were preparing the patient for transfer to a stretcher and had difficulty in the assembly of the specialty bed. While the OR Registered Nurse (RN), the Surgical Scrub Tech (ST), the orienting ST, and the Certified Registered Nurse Anesthetist (CRNA) were assisting in the assembly of the bed and the patient rolled off the OR table onto the floor. Diagnostic radiological testing revealed the patient suffered a Cervical Spine (C2) fracture and an intraventricular (bleeding into the ventricles of the brain) and subdural hemorrhage (bleeding into the brain), which required Patient #1 be transferred to Facility B (a Level 1 Trauma Center) for further treatment. While at Facility B the patient required a Halo Traction (device used to immobilize and protect the cervical spine). The patient expired on [DATE] at Facility B. The investigation revealed the facility had not completed training regarding the use of a safety strap, the use of the perineal post (post used to relieve pressure on the groin), and positioning of the patient after a surgical procedure and the facility failed to follow facility policy for positioning and monitoring of the surgical patient. During a conference on 11/15/18 at 2:15 PM, with the Administrator, the Chief Nursing Officer (CNO), the Risk Manager (RM), the Director of Surgical Services, and the Cooperative Director of Quality Management, in the conference room, the facility was informed of an Immediate Jeopardy (a situation in which the provider's noncompliance with one or more requirements of participation, has caused, or is likely to cause injury, harm, impairment, or death) at CFR PART 482.12, Conditions of Participation, Governing Body. Interview with the Administrator and the Cooperative Director of Quality Management on 11/16/18 at 3:00 PM, in the conference room, revealed the facility had implemented immediate actions related to the use of the fracture table and ensuring the safety of the patients in the OR. The manufacturer's representative provided training on 11/15/18 for the OR staff, anesthesia, and the orthopedic surgeons. All OR staff will be required to complete the training prior to providing care to any surgical hip fracture. The facility implemented training for the fracture table and all staff completed competencies related to the use of the bed. Education was provided to the OR staff, Anesthesia, and Orthopedic surgeons regarding the use of a safety strap and the use of the "Post' to ensure the patients safety while on the fracture table. The facility has implemented ongoing monitoring for correct positioning of the patients and ensuring a safe environment in the OR; which will reported to the Surgical Care Committee, Leadership, Medical Executive Committee, and the Governing Board. Review of an Immediate Action Plan, which removed the Immediate Jeopardy on 11/16/18 revealed the following actions were implemented: 1. Training for Fracture Table a. The representative for the specialty bed provided training to Operating Room Team members that included RNs, STs, Anesthesia Providers, and Orthopedic Surgical Providers on 11/15/18. The training included the requirements for the use of a safety strap and that the perineal post arm was not to be removed until the patient was ready for transfer from the fracture table to the stretcher. Manufacturers recommendations state the "Post" is the last piece of equipment to be removed. b. Review of the sign in sheets revealed the training was completed 11/15/18 and is on-going. c. Observations on 11/15/18 at 5:00 PM revealed the OR Table Representative was providing training to the OR staff. d. Any Team member or providers who had not completed the in-service training will not be allowed to participate in any case that required the use of the specialty bed until the training has been completed. e. The training is ongoing for team members. Review of documentation revealed 4 nursing employees and 2 Anesthesia providers were unavailable for the training. 2. Competencies a. The representative for the OR Table provided and validated training competency for the Operating Room Director (Super Trainer) for training for any team member or provider that is not able to participate in training by the representative on 11/15/18. b. Review of the sign-in sheets revealed the training was completed 11/15/18. 3. Education for the OR Staff a. The American Association of Peri-Operative Nursing (AORN) republished education in 2017, related to "Positioning the Patient Guidelines and Recommendations Education." The AORN On-line Webinar was provided to the OR team members which reviewed safe practices when positioning patients. The required training was initially completed on 11/12/18 by all OR staff. The facility staff was required to complete the additional training on 11/15/18. b. Training completed 11/12/18 and 11/15/18 and ongoing for team members who have not completed the required training. Those employees who have not completed the training will not be allowed to participate in any case that requires the use of the OR specialty bed until the training is completed. . c. Review of the sign-in sheets dated 11/15/18 revealed the training was completed and ongoing. Review of the documentation revealed 4 nursing employees and 2 Anesthesia providers were unavailable for the training. 4. Patient Safety Education a. Education was provided by the Chief Medical Officer (CMO) to the Operating Room Team members on processes to prevent injury during transport, transfer, and positioning during the perioperative phase on 11/12/18. b. The education was completed on 11/12/18 and ongoing for team members that were not available for the 11/12/18 training. c. Review of the sign-in sheets revealed the training was initiated on 11/12/18 and ongoing. d. Sign-in sheets revealed there were 4 hospital employees and 2 contracted staff had not completed the training. Any team member who has not completed the training will not be allowed to participate in any case that requires the use of the specialty bed until training is completed. 5. Initial and Annual Competencies have been developed for the OR Specialty Bed a. In-service was given to OR staff in regard to the fracture table, the specific components of the bed, and the safety precautions related to the bed. The training was completed 11/15/18. b. Date Action Item Completed: 11/15/18 and ongoing for team members that are not available for the 11/15/18 training. Competencies were reviewed with the Perioperative team members. All competencies will be reviewed and completed with OR Team Members prior to the participation in cases that require the use of the specialty bed. c. Review of the sign-in sheets and competencies revealed the OR staff who participated in the OR cases on 11/16/18 had completed the competency training and competency forms were reviewed. 6. Safety and Preventive Maintenance a. Safety checks were performed for the Specialty bed to validate the fracture table was working as designed. The bed was taken out of service on 11/8/18 and remained out of service until 11/14/18 after the Performance Management was completed by the OR Specialty Bed Manufacturer on 11/14/18. 7. Fracture Table Monitor a. A monitor for the use of the specialty bed has been developed that will review 100% of cases performed through the end of the calendar year of 2018 on the fracture table. If compliance is met at 100% after 12/31/18 the number of cases reviewed will be reduced to 75% of cases performed on the fracture table. If compliance is not met by 12/31/18 at 100% the monitor will be extended for an additional month until compliance is met at 100%. Once compliance is met at 100% for the initial review period, the number of cases reviewed will be reduced to 75% of cases performed on the fracture table for an additional 11 consecutive months. If compliance is met at 100% the monitor will be reevaluated. b. The Director of Perioperative Services or her designee will be responsible for the monitoring. c. Monitor to begin on appropriate cases 11/16/18. d. The results of the monitor will be reviewed at the Surgical Care Services Committee quarterly, Leadership, Medical Executive Committee, and Governing Board. e. Quarterly data will be presented 1/2019, and then quarterly. f. Leadership On-Call schedule for the monitoring of the use of the fracture table. The on-call schedule consists of the Director of Perioperative Services, the Chief Nursing Officer (CNO), the OR Supervisor, and the Risk Manager. Review of the monitoring sheet and on-call schedule was performed during the investigation. 8. Patient Safety Transfer Monitor a. A monitoring tool has been developed that will review 60 cases a quarter for safe patient transfers. Monitor criteria is set at 100% compliance. If the monitor is met at 100% for 4 consecutive quarters the monitor will be reevaluated. The results of the monitor will be reviewed at the Surgical Care Committee quarterly. The results of the monitor will be reviewed at the Surgical Care Services Committee quarterly, Leadership, Medical Executive Committee, and Governing Board. b. The Director of Perioperative Services or her designee will be responsible for the monitoring. c. Quarterly Data will be presented 1/2019, and then quarterly. d. The results of the monitor will be reviewed at the Surgical Care Services Committee quarterly, Leadership, Medical Executive Committee, and Governing Board. During a conference with the Administrator, the CNO, the RM, the Director of Surgical Services, and the Cooperative Director of Quality Management on 11/16/18 at 3:10 PM, in the conference room, the facility presented an Immediate Action Plan for the Immediate Jeopardy. Review of the Immediate Action Plan revealed immediate actions were implemented by the facility and the Immediate Jeopardy was removed on 11/16/18. Please refer to A-0068 |
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| VIOLATION: CARE OF PATIENTS - RESPONSIBILITY FOR CARE | Tag No: A0068 | |
| **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on review of facility Bylaws, review of facility policy, medical record review, and interviews, the facility failed to monitor one patient (#1) for safety after a surgical procedure of 4 surgical patients reviewed. The findings included: Review of facility Governing Body Bylaws, not dated, revealed "...the board of Directors of the Sole Member has ultimate responsibility for quality patient care and authority for maintaining Performance Improvement and Risk Management Program..." Review of facility Medical Staff Bylaws, last revised 7/2017, revealed "...Leadership/Quality Council Committee: the leadership committee will provide for planning, directing and coordinating , providing and improving healthcare services that are responsive to community and patient needs and that improve patient health outcomes...responsibilities...responsible for fostering an environment to support effective responses to occurrences and ongoing proactive reduction in errors...provide guidance and support to patient safety committee...review all sentinel events both internal and external..." Review of facility policy Patient Rights, last revised 09/2001, revealed "...the patient has the right to expect reasonable safety insofar as the hospital practices and environment are concerned..." Review of facility policy Operating Room Objectives and Goals, last revised 1/2017, revealed "...it is the policy of the Operating Room to provide quality nursing care which effectively meets the physical, psychological, and spiritual needs for each individual patient. This should include...safety..." Review of facility policy Positioning of Patients, last revised 7/2015, revealed "...the position of the Patient on the Operating Room table is determined by the surgery to be performed, taking into consideration the safety of the patient. The physician decides the position to be employed. However, the circulating nurse must be familiar with the positions most commonly used...movement or positioning of the patient should be coordinated with the surgical team...when on the procedure bed, the patient will be attended by the surgical team member at all times...safety restraints are applied after patient positioning..." Medical record review revealed Patient #1 was admitted on [DATE] with a diagnosis of an Acute Right Closed Hip Fracture after a fall. Continued review revealed the patient was transferred to Facility B on 11/8/18. Medical record review of an Admission History and Physical (H&P) from Facility A dated 11/7/18 at 2:49 PM revealed the patient's had a displaced intertrochanteric (bony protrusions of the thighbone) fracture to the right hip. Medical record review of an Orthopedic Consult dated 11/7/18 at 4:37 PM revealed the patient had a comminuted (bone fragments) intertrochanteric fracture of the right hip and external rotation of the femoral (rotation of bone) and was scheduled for surgery on 11/8/18. Medical record review of a Preoperative Record dated 11/8/18 revealed the patient was admitted on [DATE] at 2:20 PM and was taken to the surgery suite at 2:40 PM and placed on the fracture table in a supine (flat) position. Continued review revealed the surgical procedure started at 3:18 PM and ended at 4:10 PM. Medical record review of an Operating Room (OR) Nursing Progress Note dated 11/13/18 (noted as a late entry in the medical record) revealed "...[11/8/18] approximately 4:12 PM patient fell off of the fracture table..." Medical record review of an Anesthesia OR Record dated 11/8/18, not timed, revealed "...patient [pt.] fell off of OR table during reassembly of fracture table...To knit bed [stretcher]...plan to go straight to CT...[computed tomography]..." Medical record review of an imaging report of a CT of the Cervical Spine without Contrast dated 11/8/18 at 5:17 PM revealed the patient had a cervical 2 (C2) Vertebrae fracture with displacement. The fracture appeared to be a "...Roy-Camille Type 2 fracture [fracture associated with neurological injuries]...Anterolisthesis [abnormal alignment of bones in the spine] of C3 with respect to C4, very concerning for ligamentous injury..." Medical record review of an imaging report of a CT of the Head without Contrast dated 11/8/18 at 5:23 PM revealed "...Impression: small amount of intraventricular and subdural hemorrhage [bleeding into the brain]. No significant mass effect or a midline shift..." Medical record review of a MD (Medical Doctor) Connection Note (request for transfer) dated 11/8/18 at 5:54 PM revealed a request to transfer to Facility B was completed for Patient #1. Further review revealed "...patient is 80 y/o [year old] male who was in the OR and had a hip nailing. During transfer from OR table to bed [the patient] was dropped. Has C2 fracture with angulation [curved]. Has small intracranial bleed and small subdural..." Medical record review of a Physician's Surgery Procedure note dated 11/8/18 at 6:45 PM revealed a Right Hip Cephalo-Medullary Nailing [repair of a hip fracture] procedure was performed related to a right intertrochanteric femur fracture. Further review revealed "...complications: the patient fell on the floor during transfer after the surgery was complete...disposition: admit to ICU [Intensive Care Unit] pending transfer to [Facility B]...after I had left the room, during the process of reassembling the bed for transfer, the patient is reported to have slipped off the bed and fell to the floor striking his head. I was notified and on returning to the room, the patient was positioned in the supine position on the floor...I preliminarily examined the patient has [had] not noticed any gross deformities to the extremities...the patient was then taken to the CT scanner for evaluation..." Medical record review of a Physician's Progress Note dated 11/8/18 at 7:04 PM revealed "...while the CT scan was being prepared, I went and spoke with the patient's family notifying them of the incident and our plans for evaluation...he was transferred to the CT scanner using standard cervical precautions. CT scans were obtained of the head, cervical spine, thoracic spine, and lumbar spine. It was immediately noted that the patient had a fracture of C2 with extension and displacement. He had small bleeds in the intraventricular and subdural spaces. Once these were noted, I went to speak with the family again to notify them of the injuries and to give them options for transfer since these injuries would need neurosurgical evaluation. They requested transfer to [Facility B]. I then contacted the transfer service to initiate this...skeletal survey [examination of the upper and lower extremity bones] was also performed..." Further review revealed "...I spoke with [named physician at receiving Facility B] who accepted the patient in transfer to the trauma service with plans for neurosurgical consultation. The patient was then transferred to the ICU to await transfer. Our plan is to transfer him by helicopter...during this time, [named Chief Medical Officer] and myself went to update the family in what was going on and the plans to transfer..." Medical record review of an Admission H&P from Facility B dated 11/8/18 at 8:00 PM revealed "...patient had right hip replacement at [Facility A] today...postop during transfer from OR table to stretcher, patient fell . Was still intubated [tube inserted for breathing] at that time and left intubated. CT head, C. spine, T [thoracic] spine and L. [lumbar] spine done at [Facility A] showed IVH/SDH [intraventricular hemorrhage/subdural hemorrhage] and C2 fx [fracture] with acute angulation. Sent as trauma to our ED [Emergency Department]. Reportedly has baseline Alzheimer's disease...CT Scans: Head: small volume hemorrhage within the occipital horn right lateral ventricles [bleeding into the brain]...C. Spine: acute displaced...C2...fracture. Possible very mild superior...compression fracture deformity of T9 [thoracic]...CT pelvis showed pelvic fractures and hemorrhage. I am not sure if this is from his original hip fracture or if these are new. We will trend his Hemoglobin and transfuse [blood] as needed...neurosurgery consulted...will admit to ICU...orthopedic surgery consulted..." Medical record review of a Neurosurgery consult from Facility B dated 11/8/18 at 8:40 PM revealed "...[AGE] year old who was transferred regarding findings of C2 fracture and intraventricular hemorrhage...after surgery today, medical records indicate when patient was moved from the operative table to be placed on a stretcher, there were difficulties and the patient contacted the floor. CT scans revealed small intraventricular hemorrhage and an odontoid [C2] fracture. This prompted transfer...reportedly had history of Alzheimer's disease at baseline..." Medical record review of a Neurosurgery note dated 11/8/18 at 10:10 PM revealed "...discussed with patient's family by telephone and apprised him that no acute intervention is needed and halo placement [device used to keep bones from moving] for the patient's C2 fracture would be first choice or therapy. Halo placement was briefly explained..." Medical record review of a Surgery Progress Note from Facility B dated 11/9/18 at 6:07 AM revealed the patient required a blood transfusion. Further review revealed "...tentative Halo for reduction of C2 fracture versus surgery..." Medical record review of a Case Management note from Facility B dated 11/9/18 at 11:14 AM revealed "...spoke with patient's son...stated patient was sent from [Facility A] due to patient being dropped on his head while being moved off OR table..." Medical record review of a Neurosurgery Progress Note from Facility B dated 11/9/18 at 1:00 PM revealed "...C2 fracture was illustrated...to the wife and son of the patient. Various treatment options were discussed including surgical intervention, halo fixation, and consideration of no interventions...family agrees with reduction and halo fixation would be most appropriate for this situation...family understands and desires application of halo..." Further review revealed the Halo was placed on the patient on 11/9/18. Medical record review of a Surgery Progress Note from Facility B dated 11/12/18 at 7:30 AM revealed "...patient evaluated and discussed at bedside...after a long discussion with family, it is clear that it is in patient's best interest to proceed with comfort measures..." Medical record review of a Physician's Progress note from Facility B dated 11/16/18 at 5:37 AM revealed the patient expired on [DATE] at 5:20 AM. Interview with the Risk Manager at Facility A on 11/14/18 at 1:30 PM, in the conference room, revealed the patient was admitted to the facility after suffering a fall at a local nursing home, resulting in a right hip fracture. Continued interview revealed the patient was taken to surgery on 11/8/18 and a successful right hip repair was completed without incident. Further interview revealed "...the patient was placed on a fracture bed during surgery and after the procedure was completed the staff were getting ready to transfer the patient back to a regular mattress bed...the surgeon had left the room...the staff had difficulty in getting the bed assembled properly...the patient was still under anesthesia and had an airway device in place. During this time the staff were trying to get the bed assembled and the patient rolled from the OR table and landed face down on the floor...his x-rays revealed a C2 fracture and a subdural bleed. He went to ICU first and then was transferred to [Facility B]..." Interview with Certified Surgery Technician (CST) on 11/14/18 at 2:35 PM, in the surgery conference room, revealed "...I had another CST training with me...the procedure was completed and the physician had left the room to talk with the patient's family. The patient was still on the fracture table and he was still under anesthesia. They were having trouble getting the metal part inserted to the bed. The metal apparatus has to be inserted first then the transfer mattress pad. The nurse and the orienting CST was trying to get the bed to work...I'm not sure if the bed was jarred...there was no strap on the bed...the perineal post was not in place on the bed...I stepped down to the end of the bed and showed them the metal piece that needed to be inserted. At that time, the patient fell off the bed into the floor. The RN yelled when she saw the patient falling and said 'he's falling'...his legs were still in the leg spars...the nurse and CRNA [Certified Registered Nurse Anesthetist] went to the patient...they called for the physician to come back to the OR...he came back and the patient was placed on a long spine board...he went to CT scan..." Interview with Registered Nurse (RN) #1 on 11/14/18 at 2:45 PM, in the surgery conference room, revealed "...the surgery procedure was completed...the orienting CST was trying to get the transfer mattress on the fracture table. The metal bar had not been placed into the bed frame so the transfer mattress pad would not go onto the bed...the bed was shaking. I went down to help her and when I looked up I saw the patient go down off the bed into the floor. I yelled but it was too late to catch him...his legs were still in the leg spars...we called for the surgeon, who had already left the room to come back to the room...when the surgeon got there we placed a C. Collar [used to stabilize the neck] on the patient and then moved the patient to a long spine board with the help of the surgeon and Physician's Assistant [PA]...we took the patient immediately to the CT scan and a scan of the head, spine, and hip was performed..." Further interview confirmed "...there were no straps on the bed. The surgeon had placed tape around the patient's arms and body to secure the patient's upper extremities during the surgery...the perineal post was not in place..." Interview with the orienting CST on 11/14/18 at 3:00 PM, in the surgery conference room, revealed the CST was orienting in the OR with the other CST and she had not worked with the fracture table prior to the incident on 11/8/18. Further interview revealed "...the circulating nurse was trying to assemble the bed and could not get the mattress portion of the bed inserted. I went down to the end of the bed to help her and took the mattress pad from her. The metal frame had not been inserted, which had to be in place first...there was some jarring of the bed when we were trying to insert the pad...the patient fell so quick..." Interview with the Orthopedic Surgeon on 11/15/18 at 9:35 AM, in the conference room, revealed the patient was admitted to the facility after he was diagnosed with a right hip fracture related to a fall. The patient's surgery procedure was successful with no complications during the surgery procedure. Further interview revealed "...I was not in the room when the patient fell . He was still under anesthesia when I left the room. The staff called me and told the patient had fallen off the OR table and he was on the floor. The patient's lower extremities were still up in the leg spars when the patient fell ...there was no safety strap in place..." Further interview revealed "...when I got to the room the patient was supine on the floor...I called CT and we took the patient directly to the CT scan for a head, cervical, thoracic and lumbar scans. Continued interview revealed "...his CT scans revealed a C2 fracture and small ventricular and subdural bleed in his head...he was taken to the PACU [Post Anesthesia Care Unit]...and then admitted to the ICU pending transfer..." Telephone interview with CRNA #1 on 11/15/18 at 9:50 AM revealed the patient was in the OR for a nailing of the right hip. Further interview revealed "...after the procedure was completed the patient remained under anesthesia and the staff were preparing the patient for transfer from the fracture table to a stretcher. The OR staff was having difficulty with getting the transfer mattress pad on the bed. I was at the head of the bed initially during the anesthesia...I stepped to the left side of the bed and then went to the lower part of the bed to see if I could help get the mattress pad connected...I felt the patient falling off the bed...we could not get to him in time to keep the patient from falling...the OR staff called the surgeon and told him the patient had fallen off the stretcher...there was a purple area to the right side of his [Patient #1's] forehead but no other obvious injuries were found. I was still assisting his breathing with an ambu bag [hand held device used to assist breathing]...once the CT confirmed the C2 fracture and the brain bleed we took the patient to the PACU. I orally intubated the patient in the PACU and gave him 12 milligrams of Decadron [Steroid] related to the C2 fracture and the bleed..." Further interview confirmed there was no strap on the patient during surgery and when the patient fell off the table there was no OR staff member at the patient's head or at the side of the patient. Interview with the Director of Perioperative Care on 11/15/18 at 11:30 AM, in the conference room, revealed the Director was made aware of the patient's fall on 11/8/18 by the OR Nurse Manager. Further interview revealed "...the surgery procedure was completed and the staff was preparing the patient for transfer from the fracture table to the stretcher. There is a distinct process that must be followed for insertion and removal of the patient transfer board and mattress pad to the fracture table. The staff was trying to insert the transfer board into the fracture table and the metal Jack Mount [metal device used to secure the transfer board to the bed] has to be inserted first before the transfer board. This had not been completed so they were having trouble getting the board in place. The perineal post pad had already been removed from in between the patient's legs. The RN, the CST, and the orienting CST were trying to get the board in place and may have jarred the bed. There were no straps around the patient...the surgeon had taped the patient's arms around his chest to ensure the arms did not get in the way for the surgery procedure...during the process the patient rolled off the fracture table and landed on the floor...he was under anesthesia at that time...the surgeon had already left the room and talked to the patient's family...he was called back to the room...the patient was taken to the CT for a scan of his spine and head. His CT scan of the cervical spine revealed a C2 fracture...the CT of the head revealed a subdural hematoma and an intraventricular bleed. He was then taken to the PACU and then admitted to the ICU pending transfer..." Further interview confirmed neither the CST, the orienting CST, the RN, or the CRNA were at the patient's head or at the side of the patient when the patient fell off the fracture table and no safety straps were in place to ensure the patient's safety. Interview with the Chief Nursing Officer (CNO) on 11/15/18 at 2:00 PM, in the conference room, revealed "...we have initiated a Root Cause Analysis [facility investigation] and were scheduled to meet with the OR staff on [11/14/18]. It looks there were some technical difficulties with the bed by the OR staff and miscommunication between the providers as to who was monitoring the patient. There were no safety straps used for the patient during the procedure and the post was removed from in between the patient's legs prior to the bed assembly for transfer..." Interview with the Chief Medical Officer (CMO) on 11/15/18 at 4:15 PM, in the conference room, revealed the CMO was made aware of the patient's fall on 11/8/18. Further interview revealed "...the surgeon called me and told me the patient had fallen off the fracture table onto the floor. He informed me the patient had a C2 fracture and an intraventricular bleed. We met with the patient's family after the CT results were confirmed...we informed them that a full investigation would be implemented and of the patient's need for transfer to the Level 1 Trauma Center related to the need of neuro surgery evaluation and treatment...the family was in agreement with the transfer...the family had lots of questions about what happened to which we could not answer at that time...they were very upset...I met with the OR staff on [11/8/18] and it appeared they were struggling with the fracture table in getting the transfer board in place. They got distracted with the fracture table and the patient rolled off the table onto the floor...at the time of the fall there was no clear communication who had control of the patient and ultimately the patient rolled off the table..." Interview with the Manufacturer's Representative, on 11/15/18 at 4:35 PM, in the OR hallway, confirmed "...there should be a strap around the patient's waist to ensure the patient's safety. The perineal post should remain in place at all times and should be the last thing that is removed prior to transferring the patient to another bed...the post is the key to ensuring the patient's safety and the patient does not roll off the bed..." Interview with the Administrator on 11/16/18 at 10:30 AM, in the conference room, revealed the facility had implemented an investigation of the patient's fall and the Governing Body was aware of the investigation. Further interview confirmed prior to the incident, the facility had not completed training regarding the use of a safety strap, the use of the perineal post, and positioning of the patient after a surgical procedure. Continued interview confirmed the facility failed to follow facility policy. |
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| VIOLATION: PATIENT RIGHTS | Tag No: A0115 | |
| **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on review of facility policy, medical record review, review of facility documentation, and interviews, the facility failed to provide care in a safe setting for 1 surgical patient (#1) of 4 surgical patients reviewed. The findings included: Review of facility Governing Body Bylaws, not dated, revealed "...the board of Directors of the Sole Member has ultimate responsibility for quality patient care and authority for maintaining Performance Improvement and Risk Management Program..." Review of facility policy Patient Rights, last revised 09/2001, revealed "...the patient has the right to expect reasonable safety insofar as the hospital practices and environment are concerned..." Review of facility policy Positioning of Patients, last revised on 7/2015, revealed "...movement or positioning of the patient should be considered with the Surgical Team...specific patient needs should be communicated among team members...when on the procedure bed, the patient will be attended by a surgical team member at all times...safety restraints are applied after patient positioning. Safety straps will we applied carefully..." Review of facility policy Operating Room Objectives and Goals, last revised 1/2017, revealed "...it is the policy of the Operating Room to provide quality nursing care which effectively meets the physical, psychological, and spiritual needs for each individual patient. This should include...safety..." Review of facility policy Positioning of Patients, last revised 7/2015, revealed "...the position of the Patient on the Operating Room table is determined by the surgery to be performed, taking into consideration the safety of the patient. The physician decides the position to be employed. However, the circulating nurse must be familiar with the positions most commonly used...movement or positioning of the patient should be coordinated with the surgical team...when on the procedure bed, the patient will be attended by the surgical team member at all times...safety restraints are applied after patient positioning..." During investigation of complaint # it was found Patient #1 was admitted to Facility A for a Right Hip Closed Fracture on 11/7/18 after a fall. The patient was admitted to the facility on [DATE] and scheduled for an Intramedullary Nailing of the Right Hip (a metal rod inserted into the bone) on 11/8/18. The patient was taken to the Operating Room (OR) on 11/8/18 where the surgical procedure was performed and successfully completed for the patient with no complications related to the surgical procedure. After the surgical procedure was complete the patient remained on a specialty bed used for hip procedures and was under anesthesia. The OR staff were preparing the patient for transfer to a stretcher and had difficulty in the assembly of the specialty bed. While the OR Registered Nurse (RN), the Surgical Scrub Tech (ST), the orienting ST, and the Certified Registered Nurse Anesthetist (CRNA) were assisting in the assembly of the bed and the patient rolled off the OR table onto the floor. Diagnostic radiological testing revealed the patient suffered a Cervical Spine (C2) fracture and an intraventricular (bleeding into the ventricles of the brain) and subdural hemorrhage (bleeding into the brain), which required Patient #1 be transferred to Facility B (a Level 1 Trauma Center) for further treatment. While at Facility B the patient required a Halo Traction (device used to immobilize and protect the cervical spine). The patient expired on [DATE] at Facility B. The investigation revealed the facility had not completed training regarding the use of a safety strap, the use of the perineal post (post used to relieve pressure on the groin), and positioning of the patient after a surgical procedure and the facility failed to follow facility policy for positioning and monitoring of the surgical patient. During a conference on 11/15/18 at 2:15 PM, with the Administrator, the Chief Nursing Officer (CNO), the Risk Manager (RM), the Director of Surgical Services, and the Cooperative Director of Quality Management, in the conference room, the facility was informed of an Immediate Jeopardy (a situation in which the provider's noncompliance with one or more requirements of participation, has caused, or is likely to cause injury, harm, impairment, or death) at 42 CFR PART 482.13 Condition of Participation, Patient Rights. Interview with the Administrator and the Cooperative Director of Quality Management on 11/16/18 at 3:00 PM, in the conference room, revealed the facility had implemented immediate actions related to the use of the fracture table and ensuring the safety of the patients in the OR. The manufacturer's representative provided training on 11/15/18 for the OR staff, anesthesia, and the orthopedic surgeons. All OR staff will be required to complete the training prior to providing care to any surgical hip fracture. The facility implemented training for the fracture table and all staff completed competencies related to the use of the bed. Education was provided to the OR staff, Anesthesia, and Orthopedic surgeons regarding the use of a safety strap and the use of the "Post' to ensure the patients safety while on the fracture table. The facility has implemented ongoing monitoring for correct positioning of the patients and ensuring a safe environment in the OR; which will reported to the Surgical Care Committee, Leadership, Medical Executive Committee, and the Governing Board. Review of an Immediate Action Plan, which removed the Immediate Jeopardy on 11/16/18 revealed the following actions were implemented: 1. Training for Fracture Table a. The representative for the specialty bed provided training to Operating Room Team members that included RNs, STs, Anesthesia Providers, and Orthopedic Surgical Providers on 11/15/18. The training included the requirements for the use of a safety strap and that the perineal post arm was not to be removed until the patient was ready for transfer from the fracture table to the stretcher. Manufacturers recommendations state the "Post" is the last piece of equipment to be removed. b. Review of the sign in sheets revealed the training was completed 11/15/18 and is on-going. c. Observations on 11/15/18 at 5:00 PM revealed the OR Table Representative was providing training to the OR staff. d. Any Team member or providers who had not completed the in-service training will not be allowed to participate in any case that required the use of the specialty bed until the training has been completed. e. The training is ongoing for team members. Review of documentation revealed 4 nursing employees and 2 Anesthesia providers were unavailable for the training. 2. Competencies a. The representative for the OR Table provided and validated training competency for the Operating Room Director (Super Trainer) for training for any team member or provider that is not able to participate in training by the representative on 11/15/18. b. Review of the sign-in sheets revealed the training was completed 11/15/18. 3. Education for the OR Staff a. The American Association of Peri-Operative Nursing (AORN) republished education in 2017, related to "Positioning the Patient Guidelines and Recommendations Education." The AORN On-line Webinar was provided to the OR team members which reviewed safe practices when positioning patients. The required training was initially completed on 11/12/18 by all OR staff. The facility staff was required to complete the additional training on 11/15/18. b. Training completed 11/12/18 and 11/15/18 and ongoing for team members who have not completed the required training. Those employees who have not completed the training will not be allowed to participate in any case that requires the use of the OR specialty bed until the training is completed. . c. Review of the sign-in sheets dated 11/15/18 revealed the training was completed and ongoing. Review of the documentation revealed 4 nursing employees and 2 Anesthesia providers were unavailable for the training. 4. Patient Safety Education a. Education was provided by the Chief Medical Officer (CMO) to the Operating Room Team members on processes to prevent injury during transport, transfer, and positioning during the perioperative phase on 11/12/18. b. The education was completed on 11/12/18 and ongoing for team members that were not available for the 11/12/18 training. c. Review of the sign-in sheets revealed the training was initiated on 11/12/18 and ongoing. d. Sign-in sheets revealed there were 4 hospital employees and 2 contracted staff had not completed the training. Any team member who has not completed the training will not be allowed to participate in any case that requires the use of the specialty bed until training is completed. 5. Initial and Annual Competencies have been developed for the OR Specialty Bed a. In-service was given to OR staff in regard to the fracture table, the specific components of the bed, and the safety precautions related to the bed. The training was completed 11/15/18. b. Date Action Item Completed: 11/15/18 and ongoing for team members that are not available for the 11/15/18 training. Competencies were reviewed with the Perioperative team members. All competencies will be reviewed and completed with OR Team Members prior to the participation in cases that require the use of the specialty bed. c. Review of the sign-in sheets and competencies revealed the OR staff who participated in the OR cases on 11/16/18 had completed the competency training and competency forms were reviewed. 6. Safety and Preventive Maintenance a. Safety checks were performed for the Specialty bed to validate the fracture table was working as designed. The bed was taken out of service on 11/8/18 and remained out of service until 11/14/18 after the Performance Management was completed by the OR Specialty Bed Manufacturer on 11/14/18. 7. Fracture Table Monitor a. A monitor for the use of the specialty bed has been developed that will review 100% of cases performed through the end of the calendar year of 2018 on the fracture table. If compliance is met at 100% after 12/31/18 the number of cases reviewed will be reduced to 75% of cases performed on the fracture table. If compliance is not met by 12/31/18 at 100% the monitor will be extended for an additional month until compliance is met at 100%. Once compliance is met at 100% for the initial review period, the number of cases reviewed will be reduced to 75% of cases performed on the fracture table for an additional 11 consecutive months. If compliance is met at 100% the monitor will be reevaluated. b. The Director of Perioperative Services or her designee will be responsible for the monitoring. c. Monitor to begin on appropriate cases 11/16/18. d. The results of the monitor will be reviewed at the Surgical Care Services Committee quarterly, Leadership, Medical Executive Committee, and Governing Board. e. Quarterly data will be presented 1/2019, and then quarterly. f. Leadership On-Call schedule for the monitoring of the use of the fracture table. The on-call schedule consists of the Director of Perioperative Services, the Chief Nursing Officer (CNO), the OR Supervisor, and the Risk Manager. Review of the monitoring sheet and on-call schedule was performed during the investigation. 8. Patient Safety Transfer Monitor a. A monitoring tool has been developed that will review 60 cases a quarter for safe patient transfers. Monitor criteria is set at 100% compliance. If the monitor is met at 100% for 4 consecutive quarters the monitor will be reevaluated. The results of the monitor will be reviewed at the Surgical Care Committee quarterly. The results of the monitor will be reviewed at the Surgical Care Services Committee quarterly, Leadership, Medical Executive Committee, and Governing Board. b. The Director of Perioperative Services or her designee will be responsible for the monitoring. c. Quarterly Data will be presented 1/2019, and then quarterly. d. The results of the monitor will be reviewed at the Surgical Care Services Committee quarterly, Leadership, Medical Executive Committee, and Governing Board. During a conference with the Administrator, the CNO, the RM, the Director of Surgical Services, and the Cooperative Director of Quality Management on 11/16/18 at 3:10 PM, in the conference room, the facility presented an Immediate Action Plan for the Immediate Jeopardy. Review of the Immediate Action Plan revealed immediate actions were implemented by the facility and the Immediate Jeopardy was removed on 11/16/18. Please Refer to A-0144 |
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| VIOLATION: PATIENT RIGHTS: CARE IN SAFE SETTING | Tag No: A0144 | |
| **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on review of facility policy, medical record review, review of facility documentation, and interviews, the facility failed to provide care in a safe setting for 1 surgical patient (#1) of 4 surgical patients reviewed. The findings included: Review of facility policy Patient Rights, last revised 09/2001, revealed "...the patient has the right to expect reasonable safety insofar as the hospital practices and environment are concerned..." Review of facility policy Operating Room Objectives and Goals, last revised 1/2017, revealed "...it is the policy of the Operating Room to provide quality nursing care which effectively meets the physical, psychological, and spiritual needs for each individual patient. This should include...safety..." Review of facility policy Positioning of Patients, last revised on 7/2015, revealed "...movement or positioning of the patient should be considered with the Surgical Team...specific patient needs should be communicated among team members...when on the procedure bed, the patient will be attended by a surgical team member at all times...safety restraints are applied after patient positioning. Safety straps will we applied carefully..." Medical record review revealed Patient #1 was admitted on [DATE] with a diagnosis of an Acute Right Closed Hip Fracture after a fall. Continued review revealed the patient was transferred to Facility B on 11/8/18. Medical record review of an Admission History and Physical (H&P) from Facility A dated 11/7/18 at 2:49 PM revealed the patient's had a displaced intertrochanteric (bony protrusions of the thighbone) fracture to the right hip. Medical record review of an Orthopedic Consult dated 11/7/18 at 4:37 PM revealed the patient had a comminuted (bone fragments) intertrochanteric fracture of the right hip and external rotation of the femoral (rotation of bone) and was scheduled for surgery on 11/8/18. Medical record review of a Preoperative Record dated 11/8/18 revealed the patient was admitted on [DATE] at 2:20 PM and was taken to the surgery suite at 2:40 PM and placed on the fracture table in a supine (flat) position. Continued review revealed the surgical procedure started at 3:18 PM and ended at 4:10 PM. Medical record review of an Operating Room (OR) Nursing Progress Note dated 11/13/18 (noted as a late entry in the medical record) revealed "...[11/8/18] approximately 4:12 PM patient fell off of the fracture table..." Medical record review of an Anesthesia OR Record dated 11/8/18, not timed, revealed "...patient [pt.] fell off of OR table during reassembly of fracture table...To knit bed [stretcher]...plan to go straight to CT...[computed tomography]..." Medical record review of an imaging report of a CT of the Cervical Spine without Contrast dated 11/8/18 at 5:17 PM revealed the patient had a cervical 2 (C2) Vertebrae fracture with displacement. The fracture appeared to be a "...Roy-Camille Type 2 fracture [fracture associated with neurological injuries]...Anterolisthesis [abnormal alignment of bones in the spine] of C3 with respect to C4, very concerning for ligamentous injury..." Medical record review of an imaging report of a CT of the Head without Contrast dated 11/8/18 at 5:23 PM revealed "...Impression: small amount of intraventricular and subdural hemorrhage [bleeding into the brain]. No significant mass effect or a midline shift..." Medical record review of a MD (Medical Doctor) Connection Note (request for transfer) dated 11/8/18 at 5:54 PM revealed a request to transfer to Facility B was completed for Patient #1. Further review revealed "...patient is 80 y/o [year old] male who was in the OR and had a hip nailing. During transfer from OR table to bed [the patient] was dropped. Has C2 fracture with angulation [curved]. Has small intracranial bleed and small subdural..." Medical record review of a Physician's Surgery Procedure note dated 11/8/18 at 6:45 PM revealed a Right Hip Cephalo-Medullary Nailing [repair of a hip fracture] procedure was performed related to a right intertrochanteric femur fracture. Further review revealed "...complications: the patient fell on the floor during transfer after the surgery was complete...disposition: admit to ICU [Intensive Care Unit] pending transfer to [Facility B]...after I had left the room, during the process of reassembling the bed for transfer, the patient is reported to have slipped off the bed and fell to the floor striking his head. I was notified and on returning to the room, the patient was positioned in the supine position on the floor...I preliminarily examined the patient has [had] not noticed any gross deformities to the extremities...the patient was then taken to the CT scanner for evaluation..." Medical record review of a Physician's Progress Note dated 11/8/18 at 7:04 PM revealed "...while the CT scan was being prepared, I went and spoke with the patient's family notifying them of the incident and our plans for evaluation...he was transferred to the CT scanner using standard cervical precautions. CT scans were obtained of the head, cervical spine, thoracic spine, and lumbar spine. It was immediately noted that the patient had a fracture of C2 with extension and displacement. He had small bleeds in the intraventricular and subdural spaces. Once these were noted, I went to speak with the family again to notify them of the injuries and to give them options for transfer since these injuries would need neurosurgical evaluation. They requested transfer to [Facility B]. I then contacted the transfer service to initiate this...skeletal survey [examination of the upper and lower extremity bones] was also performed..." Further review revealed "...I spoke with [named physician at receiving Facility B] who accepted the patient in transfer to the trauma service with plans for neurosurgical consultation. The patient was then transferred to the ICU to await transfer. Our plan is to transfer him by helicopter...during this time, [named Chief Medical Officer] and myself went to update the family in what was going on and the plans to transfer..." Medical record review of an Admission H&P from Facility B dated 11/8/18 at 8:00 PM revealed "...patient had right hip replacement at [Facility A] today...postop during transfer from OR table to stretcher, patient fell . Was still intubated [tube inserted for breathing] at that time and left intubated. CT head, C. spine, T [thoracic] spine and L. [lumbar] spine done at [Facility A] showed IVH/SDH [intraventricular hemorrhage/subdural hemorrhage] and C2 fx [fracture] with acute angulation. Sent as trauma to our ED [Emergency Department]. Reportedly has baseline Alzheimer's disease...CT Scans: Head: small volume hemorrhage within the occipital horn right lateral ventricles [bleeding into the brain]...C. Spine: acute displaced...C2...fracture. Possible very mild superior...compression fracture deformity of T9 [thoracic]...CT pelvis showed pelvic fractures and hemorrhage. I am not sure if this is from his original hip fracture or if these are new. We will trend his Hemoglobin and transfuse [blood] as needed...neurosurgery consulted...will admit to ICU...orthopedic surgery consulted..." Medical record review of a Neurosurgery consult from Facility B dated 11/8/18 at 8:40 PM revealed "...[AGE] year old who was transferred regarding findings of C2 fracture and intraventricular hemorrhage...after surgery today, medical records indicate when patient was moved from the operative table to be placed on a stretcher, there were difficulties and the patient contacted the floor. CT scans revealed small intraventricular hemorrhage and an odontoid [C2] fracture. This prompted transfer...reportedly had history of Alzheimer's disease at baseline..." Medical record review of a Neurosurgery note dated 11/8/18 at 10:10 PM revealed "...discussed with patient's family by telephone and apprised him that no acute intervention is needed and halo placement [device used to keep bones from moving] for the patient's C2 fracture would be first choice or therapy. Halo placement was briefly explained..." Medical record review of a Surgery Progress Note from Facility B dated 11/9/18 at 6:07 AM revealed the patient required a blood transfusion. Further review revealed "...tentative Halo for reduction of C2 fracture versus surgery..." Medical record review of a Case Management note from Facility B dated 11/9/18 at 11:14 AM revealed "...spoke with patient's son...stated patient was sent from [Facility A] due to patient being dropped on his head while being moved off OR table..." Medical record review of a Neurosurgery Progress Note from Facility B dated 11/9/18 at 1:00 PM revealed "...C2 fracture was illustrated...to the wife and son of the patient. Various treatment options were discussed including surgical intervention, halo fixation, and consideration of no interventions...family agrees with reduction and halo fixation would be most appropriate for this situation...family understands and desires application of halo..." Further review revealed the Halo was placed on the patient on 11/9/18. Medical record review of a Surgery Progress Note from Facility B dated 11/12/18 at 7:30 AM revealed "...patient evaluated and discussed at bedside...after a long discussion with family, it is clear that it is in patient's best interest to proceed with comfort measures..." Medical record review of a Physician's Progress note from Facility B dated 11/16/18 at 5:37 AM revealed the patient expired on [DATE] at 5:20 AM. Interview with the Risk Manager at Facility A on 11/14/18 at 1:30 PM, in the conference room, revealed the patient was admitted to the facility after suffering a fall at a local nursing home, resulting in a right hip fracture. Continued interview revealed the patient was taken to surgery on 11/8/18 and a successful right hip repair was completed without incident. Further interview revealed "...the patient was placed on a fracture bed during surgery and after the procedure was completed the staff were getting ready to transfer the patient back to a regular mattress bed...the surgeon had left the room...the staff had difficulty in getting the bed assembled properly...the patient was still under anesthesia and had an airway device in place. During this time the staff were trying to get the bed assembled and the patient rolled from the OR table and landed face down on the floor...his x-rays revealed a C2 fracture and a subdural bleed. He went to ICU first and then was transferred to [Facility B]..." Interview with Certified Surgery Technician (CST) on 11/14/18 at 2:35 PM, in the surgery conference room, revealed "...I had another CST training with me...the procedure was completed and the physician had left the room to talk with the patient's family. The patient was still on the fracture table and he was still under anesthesia. They were having trouble getting the metal part inserted to the bed. The metal apparatus has to be inserted first then the transfer mattress pad. The nurse and the orienting CST was trying to get the bed to work...I'm not sure if the bed was jarred...there was no strap on the bed...the perineal post was not in place on the bed...I stepped down to the end of the bed and showed them the metal piece that needed to be inserted. At that time, the patient fell off the bed into the floor. The RN yelled when she saw the patient falling and said 'he's falling'...his legs were still in the leg spars...the nurse and CRNA [Certified Registered Nurse Anesthetist] went to the patient...they called for the physician to come back to the OR...he came back and the patient was placed on a long spine board...he went to CT scan..." Interview with Registered Nurse (RN) #1 on 11/14/18 at 2:45 PM, in the surgery conference room, revealed "...the surgery procedure was completed...the orienting CST was trying to get the transfer mattress on the fracture table. The metal bar had not been placed into the bed frame so the transfer mattress pad would not go onto the bed...the bed was shaking. I went down to help her and when I looked up I saw the patient go down off the bed into the floor. I yelled but it was too late to catch him...his legs were still in the leg spars...we called for the surgeon, who had already left the room to come back to the room...when the surgeon got there we placed a C. Collar [used to stabilize the neck] on the patient and then moved the patient to a long spine board with the help of the surgeon and Physician's Assistant [PA]...we took the patient immediately to the CT scan and a scan of the head, spine, and hip was performed..." Further interview confirmed "...there were no straps on the bed. The surgeon had placed tape around the patient's arms and body to secure the patient's upper extremities during the surgery...the perineal post was not in place..." Interview with the orienting CST on 11/14/18 at 3:00 PM, in the surgery conference room, revealed the CST was orienting in the OR with the other CST and she had not worked with the fracture table prior to the incident on 11/8/18. Further interview revealed "...the circulating nurse was trying to assemble the bed and could not get the mattress portion of the bed inserted. I went down to the end of the bed to help her and took the mattress pad from her. The metal frame had not been inserted, which had to be in place first...there was some jarring of the bed when we were trying to insert the pad...the patient fell so quick..." Interview with the Orthopedic Surgeon on 11/15/18 at 9:35 AM, in the conference room, revealed the patient was admitted to the facility after he was diagnosed with a right hip fracture related to a fall. The patient's surgery procedure was successful with no complications during the surgery procedure. Further interview revealed "...I was not in the room when the patient fell . He was still under anesthesia when I left the room. The staff called me and told the patient had fallen off the OR table and he was on the floor. The patient's lower extremities were still up in the leg spars when the patient fell ...there was no safety strap in place..." Further interview revealed "...when I got to the room the patient was supine on the floor...I called CT and we took the patient directly to the CT scan for a head, cervical, thoracic and lumbar scans. Continued interview revealed "...his CT scans revealed a C2 fracture and small ventricular and subdural bleed in his head...he was taken to the PACU [Post Anesthesia Care Unit]...and then admitted to the ICU pending transfer..." Telephone interview with CRNA #1 on 11/15/18 at 9:50 AM revealed the patient was in the OR for a nailing of the right hip. Further interview revealed "...after the procedure was completed the patient remained under anesthesia and the staff were preparing the patient for transfer from the fracture table to a stretcher. The OR staff was having difficulty with getting the transfer mattress pad on the bed. I was at the head of the bed initially during the anesthesia...I stepped to the left side of the bed and then went to the lower part of the bed to see if I could help get the mattress pad connected...I felt the patient falling off the bed...we could not get to him in time to keep the patient from falling...the OR staff called the surgeon and told him the patient had fallen off the stretcher...there was a purple area to the right side of his [Patient #1's] forehead but no other obvious injuries were found. I was still assisting his breathing with an ambu bag [hand held device used to assist breathing]...once the CT confirmed the C2 fracture and the brain bleed we took the patient to the PACU. I orally intubated the patient in the PACU and gave him 12 milligrams of Decadron [Steroid] related to the C2 fracture and the bleed..." Further interview confirmed there was no strap on the patient during surgery and when the patient fell off the table there was no OR staff member at the patient's head or at the side of the patient. Interview with the Director of Perioperative Care on 11/15/18 at 11:30 AM, in the conference room, revealed the Director was made aware of the patient's fall on 11/8/18 by the OR Nurse Manager. Further interview revealed "...the surgery procedure was completed and the staff was preparing the patient for transfer from the fracture table to the stretcher. There is a distinct process that must be followed for insertion and removal of the patient transfer board and mattress pad to the fracture table. The staff was trying to insert the transfer board into the fracture table and the metal Jack Mount [metal device used to secure the transfer board to the bed] has to be inserted first before the transfer board. This had not been completed so they were having trouble getting the board in place. The perineal post pad had already been removed from in between the patient's legs. The RN, the CST, and the orienting CST were trying to get the board in place and may have jarred the bed. There were no straps around the patient...the surgeon had taped the patient's arms around his chest to ensure the arms did not get in the way for the surgery procedure...during the process the patient rolled off the fracture table and landed on the floor...he was under anesthesia at that time...the surgeon had already left the room and talked to the patient's family...he was called back to the room...the patient was taken to the CT for a scan of his spine and head. His CT scan of the cervical spine revealed a C2 fracture...the CT of the head revealed a subdural hematoma and an intraventricular bleed. He was then taken to the PACU and then admitted to the ICU pending transfer..." Further interview confirmed neither the CST, the orienting CST, the RN, or the CRNA were at the patient's head or at the side of the patient when the patient fell off the fracture table and no safety straps were in place to ensure the patient's safety. Interview with the Chief Nursing Officer (CNO) on 11/15/18 at 2:00 PM, in the conference room, revealed "...we have initiated a Root Cause Analysis [facility investigation] and were scheduled to meet with the OR staff on [11/14/18]. It looks there were some technical difficulties with the bed by the OR staff and miscommunication between the providers as to who was monitoring the patient. There were no safety straps used for the patient during the procedure and the post was removed from in between the patient's legs prior to the bed assembly for transfer..." Interview with the Chief Medical Officer (CMO) on 11/15/18 at 4:15 PM, in the conference room, revealed the CMO was made aware of the patient's fall on 11/8/18. Further interview revealed "...the surgeon called me and told me the patient had fallen off the fracture table onto the floor. He informed me the patient had a C2 fracture and an intraventricular bleed. We met with the patient's family after the CT results were confirmed...we informed them that a full investigation would be implemented and of the patient's need for transfer to the Level 1 Trauma Center related to the need of neuro surgery evaluation and treatment...the family was in agreement with the transfer...the family had lots of questions about what happened to which we could not answer at that time...they were very upset...I met with the OR staff on [11/8/18] and it appeared they were struggling with the fracture table in getting the transfer board in place. They got distracted with the fracture table and the patient rolled off the table onto the floor...at the time of the fall there was no clear communication who had control of the patient and ultimately the patient rolled off the table..." Interview with the Manufacturer's Representative, on 11/15/18 at 4:35 PM, in the OR hallway, confirmed "...there should be a strap around the patient's waist to ensure the patient's safety. The perineal post should remain in place at all times and should be the last thing that is removed prior to transferring the patient to another bed...the post is the key to ensuring the patient's safety and the patient does not roll off the bed..." Interview with the Administrator on 11/16/18 at 10:30 AM, in the conference room, confirmed the perineal post was removed prior to placement of the transfer pad and there were no safety straps used while Patient #1 was on the fracture table. Continued interview confirmed the facility failed to ensure Patient #1 received care in a safe setting and the facility failed to follow facility policy. |
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| VIOLATION: NURSING SERVICES | Tag No: A0385 | |
| **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on review of facility policy, medical record review, review of facility documentation, and interviews, the facility failed to provide nursing services to prevent injury to 1 surgical patient (#1) of 4 surgical patients reviewed. The findings included: Review of facility policy Positioning of Patients, last revised on 7/2015, revealed "...movement or positioning of the patient should be considered with the Surgical Team...specific patient needs should be communicated among team members...when on the procedure bed, the patient will be attended by a surgical team member at all times...safety restraints are applied after patient positioning. Safety straps will we applied carefully..." Review of facility policy Operating Room Objectives and Goals, last revised 1/2017, revealed "...it is the policy of the Operating Room to provide quality nursing care which effectively meets the physical, psychological, and spiritual needs for each individual patient. This should include...safety..." Review of facility policy Positioning of Patients, last revised 7/2015, revealed "...the position of the Patient on the Operating Room table is determined by the surgery to be performed, taking into consideration the safety of the patient. The physician decides the position to be employed. However, the circulating nurse must be familiar with the positions most commonly used...movement or positioning of the patient should be coordinated with the surgical team...when on the procedure bed, the patient will be attended by the surgical team member at all times...safety restraints are applied after patient positioning..." During investigation of complaint # it was found Patient #1 was admitted to Facility A for a Right Hip Closed Fracture on 11/7/18 after a fall. The patient was admitted to the facility on [DATE] and scheduled for an Intramedullary Nailing of the Right Hip (a metal rod inserted into the bone) on 11/8/18. The patient was taken to the Operating Room (OR) on 11/8/18 where the surgical procedure was performed and successfully completed for the patient with no complications related to the surgical procedure. After the surgical procedure was complete the patient remained on a specialty bed used for hip procedures and was under anesthesia. The OR staff were preparing the patient for transfer to a stretcher and had difficulty in the assembly of the specialty bed. While the OR Registered Nurse (RN), the Surgical Scrub Tech (ST), the orienting ST, and the Certified Registered Nurse Anesthetist (CRNA) were assisting in the assembly of the bed and the patient rolled off the OR table onto the floor. Diagnostic radiological testing revealed the patient suffered a Cervical Spine (C2) fracture and an intraventricular (bleeding into the ventricles of the brain) and subdural hemorrhage (bleeding into the brain), which required Patient #1 be transferred to Facility B (a Level 1 Trauma Center) for further treatment. While at Facility B the patient required a Halo Traction (device used to immobilize and protect the cervical spine). The patient expired on [DATE] at Facility B. The investigation revealed the facility had not completed training regarding the use of a safety strap, the use of the perineal post (post used to relieve pressure on the groin), and positioning of the patient after a surgical procedure and the facility failed to follow facility policy for positioning and monitoring of the surgical patient. During a conference on 11/15/18 at 2:15 PM, with the Administrator, the Chief Nursing Officer (CNO), the Risk Manager (RM), the Director of Surgical Services, and the Cooperative Director of Quality Management, in the conference room, the facility was informed of an Immediate Jeopardy (a situation in which the provider's noncompliance with one or more requirements of participation, has caused, or is likely to cause injury, harm, impairment, or death) at 42 CFR PART 482.23 Condition of Participation, Nursing Services. Interview with the Administrator and the Cooperative Director of Quality Management on 11/16/18 at 3:00 PM, in the conference room, revealed the facility had implemented immediate actions related to the use of the fracture table and ensuring the safety of the patients in the OR. The manufacturer's representative provided training on 11/15/18 for the OR staff, anesthesia, and the orthopedic surgeons. All OR staff will be required to complete the training prior to providing care to any surgical hip fracture. The facility implemented training for the fracture table and all staff completed competencies related to the use of the bed. Education was provided to the OR staff, Anesthesia, and Orthopedic surgeons regarding the use of a safety strap and the use of the "Post' to ensure the patients safety while on the fracture table. The facility has implemented ongoing monitoring for correct positioning of the patients and ensuring a safe environment in the OR; which will reported to the Surgical Care Committee, Leadership, Medical Executive Committee, and the Governing Board. Review of an Immediate Action Plan, which removed the Immediate Jeopardy on 11/16/18 revealed the following actions were implemented: 1. Training for Fracture Table a. The representative for the specialty bed provided training to Operating Room Team members that included RNs, STs, Anesthesia Providers, and Orthopedic Surgical Providers on 11/15/18. The training included the requirements for the use of a safety strap and that the perineal post arm was not to be removed until the patient was ready for transfer from the fracture table to the stretcher. Manufacturers recommendations state the "Post" is the last piece of equipment to be removed. b. Review of the sign in sheets revealed the training was completed 11/15/18 and is on-going. c. Observations on 11/15/18 at 5:00 PM revealed the OR Table Representative was providing training to the OR staff. d. Any Team member or providers who had not completed the in-service training will not be allowed to participate in any case that required the use of the specialty bed until the training has been completed. e. The training is ongoing for team members. Review of documentation revealed 4 nursing employees and 2 Anesthesia providers were unavailable for the training. 2. Competencies a. The representative for the OR Table provided and validated training competency for the Operating Room Director (Super Trainer) for training for any team member or provider that is not able to participate in training by the representative on 11/15/18. b. Review of the sign-in sheets revealed the training was completed 11/15/18. 3. Education for the OR Staff a. The American Association of Peri-Operative Nursing (AORN) republished education in 2017, related to "Positioning the Patient Guidelines and Recommendations Education." The AORN On-line Webinar was provided to the OR team members which reviewed safe practices when positioning patients. The required training was initially completed on 11/12/18 by all OR staff. The facility staff was required to complete the additional training on 11/15/18. b. Training completed 11/12/18 and 11/15/18 and ongoing for team members who have not completed the required training. Those employees who have not completed the training will not be allowed to participate in any case that requires the use of the OR specialty bed until the training is completed. . c. Review of the sign-in sheets dated 11/15/18 revealed the training was completed and ongoing. Review of the documentation revealed 4 nursing employees and 2 Anesthesia providers were unavailable for the training. 4. Patient Safety Education a. Education was provided by the Chief Medical Officer (CMO) to the Operating Room Team members on processes to prevent injury during transport, transfer, and positioning during the perioperative phase on 11/12/18. b. The education was completed on 11/12/18 and ongoing for team members that were not available for the 11/12/18 training. c. Review of the sign-in sheets revealed the training was initiated on 11/12/18 and ongoing. d. Sign-in sheets revealed there were 4 hospital employees and 2 contracted staff had not completed the training. Any team member who has not completed the training will not be allowed to participate in any case that requires the use of the specialty bed until training is completed. 5. Initial and Annual Competencies have been developed for the OR Specialty Bed a. In-service was given to OR staff in regard to the fracture table, the specific components of the bed, and the safety precautions related to the bed. The training was completed 11/15/18. b. Date Action Item Completed: 11/15/18 and ongoing for team members that are not available for the 11/15/18 training. Competencies were reviewed with the Perioperative team members. All competencies will be reviewed and completed with OR Team Members prior to the participation in cases that require the use of the specialty bed. c. Review of the sign-in sheets and competencies revealed the OR staff who participated in the OR cases on 11/16/18 had completed the competency training and competency forms were reviewed. 6. Safety and Preventive Maintenance a. Safety checks were performed for the Specialty bed to validate the fracture table was working as designed. The bed was taken out of service on 11/8/18 and remained out of service until 11/14/18 after the Performance Management was completed by the OR Specialty Bed Manufacturer on 11/14/18. 7. Fracture Table Monitor a. A monitor for the use of the specialty bed has been developed that will review 100% of cases performed through the end of the calendar year of 2018 on the fracture table. If compliance is met at 100% after 12/31/18 the number of cases reviewed will be reduced to 75% of cases performed on the fracture table. If compliance is not met by 12/31/18 at 100% the monitor will be extended for an additional month until compliance is met at 100%. Once compliance is met at 100% for the initial review period, the number of cases reviewed will be reduced to 75% of cases performed on the fracture table for an additional 11 consecutive months. If compliance is met at 100% the monitor will be reevaluated. b. The Director of Perioperative Services or her designee will be responsible for the monitoring. c. Monitor to begin on appropriate cases 11/16/18. d. The results of the monitor will be reviewed at the Surgical Care Services Committee quarterly, Leadership, Medical Executive Committee, and Governing Board. e. Quarterly data will be presented 1/2019, and then quarterly. f. Leadership On-Call schedule for the monitoring of the use of the fracture table. The on-call schedule consists of the Director of Perioperative Services, the Chief Nursing Officer (CNO), the OR Supervisor, and the Risk Manager. Review of the monitoring sheet and on-call schedule was performed during the investigation. 8. Patient Safety Transfer Monitor a. A monitoring tool has been developed that will review 60 cases a quarter for safe patient transfers. Monitor criteria is set at 100% compliance. If the monitor is met at 100% for 4 consecutive quarters the monitor will be reevaluated. The results of the monitor will be reviewed at the Surgical Care Committee quarterly. The results of the monitor will be reviewed at the Surgical Care Services Committee quarterly, Leadership, Medical Executive Committee, and Governing Board. b. The Director of Perioperative Services or her designee will be responsible for the monitoring. c. Quarterly Data will be presented 1/2019, and then quarterly. d. The results of the monitor will be reviewed at the Surgical Care Services Committee quarterly, Leadership, Medical Executive Committee, and Governing Board. During a conference with the Administrator, the CNO, the RM, the Director of Surgical Services, and the Cooperative Director of Quality Management on 11/16/18 at 3:10 PM, in the conference room, the facility presented an presented an Immediate Action Plan for the Immediate Jeopardy. Review of the Immediate Action Plan revealed immediate actions were implemented by the facility and the Immediate Jeopardy was removed on 11/16/18. Please refer to A-0395 |
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| VIOLATION: RN SUPERVISION OF NURSING CARE | Tag No: A0395 | |
| **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on review of facility policy, review of a facility document, medical record review, and interview, the facility failed to provide nursing supervision to prevent injury for 1 surgical patient (#1) of 4 surgical patients reviewed. The findings included: Review of facility policy Patient Rights, last revised 09/2001, revealed "...the patient has the right to expect reasonable safety insofar as the hospital practices and environment are concerned..." Review of facility policy Positioning of Patients, last revised on 7/2015, revealed "...movement or positioning of the patient should be considered with the Surgical Team...specific patient needs should be communicated among team members...when on the procedure bed, the patient will be attended by a surgical team member at all times...safety restraints are applied after patient positioning. Safety straps will we applied carefully..." Review of facility policy Operating Room Objectives and Goals, last revised 1/2017, revealed "...it is the policy of the Operating Room to provide quality nursing care which effectively meets the physical, psychological, and spiritual needs for each individual patient. This should include...safety..." Review of facility policy Positioning of Patients, last revised 7/2015, revealed "...the position of the Patient on the Operating Room table is determined by the surgery to be performed, taking into consideration the safety of the patient. The physician decides the position to be employed. However, the circulating nurse must be familiar with the positions most commonly used...movement or positioning of the patient should be coordinated with the surgical team...when on the procedure bed, the patient will be attended by the surgical team member at all times...safety restraints are applied after patient positioning..." Review of facility document, Circulating Nurse Job Description, last revised 9/2017, revealed "...the circulating nurse will be responsible for the following...provide a safe comfortable atmosphere for the patient. Check appropriate positioning of the patient for the procedure...provide optimal safety and comfort for the patient..." Medical record review revealed Patient #1 was admitted on [DATE] with a diagnosis of an Acute Right Closed Hip Fracture after a fall. Continued review revealed the patient was transferred to Facility B on 11/8/18. Medical record review of a Preoperative Record dated 11/8/18 revealed the patient was admitted on [DATE] at 2:20 PM and was taken to the surgery suite at 2:40 PM and placed on the fracture table in a supine (flat) position. Continued review revealed the surgical procedure started at 3:18 PM and ended at 4:10 PM. Medical record review of an Operating Room (OR) Nursing Progress Note dated 11/13/18 (noted as a late entry in the medical record) revealed "...[11/8/18] approximately 4:12 PM patient fell off of the fracture table..." Medical record review of an Anesthesia OR Record dated 11/8/18, not timed, revealed "...patient [pt.] fell off of OR table during reassembly of fracture table...To knit bed [stretcher]...plan to go straight to CT...[computed tomography]..." Medical record review of an imaging report of a CT of the Cervical Spine without Contrast dated 11/8/18 at 5:17 PM revealed the patient had a cervical 2 (C2) Vertebrae fracture with displacement. The fracture appeared to be a "...Roy-Camille Type 2 fracture [fracture associated with neurological injuries]...Anterolisthesis [abnormal alignment of bones in the spine] of C3 with respect to C4, very concerning for ligamentous injury..." Medical record review of an imaging report of a CT of the Head without Contrast dated 11/8/18 at 5:23 PM revealed "...Impression: small amount of intraventricular and subdural hemorrhage [bleeding into the brain]. No significant mass effect or a midline shift..." Medical record review of a MD (Medical Doctor) Connection Note (request for transfer) dated 11/8/18 at 5:54 PM revealed a request to transfer to Facility B was completed for Patient #1. Further review revealed "...patient is 80 y/o [year old] male who was in the OR and had a hip nailing. During transfer from OR table to bed [the patient] was dropped. Has C2 fracture with angulation [curved]. Has small intracranial bleed and small subdural..." Medical record review of a Physician's Surgery Procedure note dated 11/8/18 at 6:45 PM revealed a Right Hip Cephalo-Medullary Nailing [repair of a hip fracture] procedure was performed related to a right intertrochanteric femur fracture. Further review revealed "...complications: the patient fell on the floor during transfer after the surgery was complete...disposition: admit to ICU [Intensive Care Unit] pending transfer to [Facility B]...after I had left the room, during the process of reassembling the bed for transfer, the patient is reported to have slipped off the bed and fell to the floor striking his head..." Medical record review of a Physician's Progress Note dated 11/8/18 at 7:04 PM revealed "...It was immediately noted that the patient had a fracture of C2 with extension and displacement. He had small bleeds in the intraventricular and subdural spaces. Once these were noted, I went to speak with the family again to notify them of the injuries and to give them options for transfer since these injuries would need neurosurgical evaluation. They requested transfer to [Facility B]. I then contacted the transfer service to initiate this...I spoke with [named physician at receiving Facility B] who accepted the patient in transfer to the trauma service with plans for neurosurgical consultation. The patient was then transferred to the ICU to await transfer. Our plan is to transfer him by helicopter..." Medical record review of a Surgery Progress Note from Facility B dated 11/12/18 at 7:30 AM revealed "...patient evaluated and discussed at bedside...after a long discussion with family, it is clear that it is in patient's best interest to proceed with comfort measures..." Medical record review of a Physician's Progress note from Facility B dated 11/16/18 at 5:37 AM revealed the patient expired on [DATE] at 5:20 AM. Interview with the Risk Manager at Facility A on 11/14/18 at 1:30 PM, in the conference room, revealed the patient was admitted to the facility after suffering a fall at a local nursing home, resulting in a right hip fracture. Continued interview revealed the patient was taken to surgery on 11/8/18 and a successful right hip repair was completed without incident. Further interview revealed "...the patient was placed on a fracture bed during surgery and after the procedure was completed the staff were getting ready to transfer the patient back to a regular mattress bed...the surgeon had left the room...the staff had difficulty in getting the bed assembled properly...the patient was still under anesthesia and had an airway device in place. During this time the staff were trying to get the bed assembled and the patient rolled from the OR table and landed face down on the floor...his x-rays revealed a C2 fracture and a subdural bleed. He went to ICU first and then was transferred to [Facility B]..." Interview with Certified Surgery Technician (CST) on 11/14/18 at 2:35 PM, in the surgery conference room, revealed "...I had another CST training with me...the procedure was completed and the physician had left the room to talk with the patient's family. The patient was still on the fracture table and he was still under anesthesia. They were having trouble getting the metal part inserted to the bed. The metal apparatus has to be inserted first then the transfer mattress pad. The nurse and the orienting CST was trying to get the bed to work...I'm not sure if the bed was jarred...there was no strap on the bed...the perineal post was not in place on the bed...I stepped down to the end of the bed and showed them the metal piece that needed to be inserted. At that time, the patient fell off the bed into the floor. The RN yelled when she saw the patient falling and said 'he's falling'...his legs were still in the leg spars...the nurse and CRNA [Certified Registered Nurse Anesthetist] went to the patient...they called for the physician to come back to the OR...he came back and the patient was placed on a long spine board...he went to CT scan..." Interview with Registered Nurse (RN) #1 on 11/14/18 at 2:45 PM, in the surgery conference room, revealed "...the surgery procedure was completed...the orienting CST was trying to get the transfer mattress on the fracture table. The metal bar had not been placed into the bed frame so the transfer mattress pad would not go onto the bed...the bed was shaking. I went down to help her and when I looked up I saw the patient go down off the bed into the floor. I yelled but it was too late to catch him...his legs were still in the leg spars...we called for the surgeon, who had already left the room to come back to the room...when the surgeon got there we placed a C. Collar [used to stabilize the neck] on the patient and then moved the patient to a long spine board with the help of the surgeon and Physician's Assistant [PA]...we took the patient immediately to the CT scan and a scan of the head, spine, and hip was performed..." Further interview confirmed "...there were no straps on the bed. The surgeon had placed tape around the patient's arms and body to secure the patient's upper extremities during the surgery...the perineal post was not in place..." Interview with the orienting CST on 11/14/18 at 3:00 PM, in the surgery conference room, revealed the CST was orienting in the OR with the other CST and she had not worked with the fracture table prior to the incident on 11/8/18. Further interview revealed "...the circulating nurse was trying to assemble the bed and could not get the mattress portion of the bed inserted. I went down to the end of the bed to help her and took the mattress pad from her. The metal frame had not been inserted, which had to be in place first...there was some jarring of the bed when we were trying to insert the pad...the patient fell so quick..." Interview with the Orthopedic Surgeon on 11/15/18 at 9:35 AM, in the conference room, revealed "...I was not in the room when the patient fell . He was still under anesthesia when I left the room. The staff called me and told the patient had fallen off the OR table and he was on the floor. The patient's lower extremities were still up in the leg spars when the patient fell ...there was no safety strap in place..." Further interview revealed "...when I got to the room the patient was supine on the floor...I called CT and we took the patient directly to the CT scan for a head, cervical, thoracic and lumbar scans. Continued interview revealed "...his CT scans revealed a C2 fracture and small ventricular and subdural bleed in his head...he was taken to the PACU [Post Anesthesia Care Unit]...and then admitted to the ICU pending transfer..." Telephone interview with CRNA #1 on 11/15/18 at 9:50 AM revealed the patient was in the OR for a nailing of the right hip. Further interview revealed "...the staff were preparing the patient for transfer from the fracture table to a stretcher. The OR staff was having difficulty with getting the transfer mattress pad on the bed. I was at the head of the bed initially during the anesthesia...I stepped to the left side of the bed and then went to the lower part of the bed to see if I could help get the mattress pad connected...I felt the patient falling off the bed...we could not get to him in time to keep the patient from falling...the OR staff called the surgeon and told him the patient had fallen off the stretcher...there was a purple area to the right side of his [Patient #1's] forehead but no other obvious injuries were found. I was still assisting his breathing with an ambu bag [hand held device used to assist breathing]...once the CT confirmed the C2 fracture and the brain bleed we took the patient to the PACU. I orally intubated the patient in the PACU and gave him 12 milligrams of Decadron [Steroid] related to the C2 fracture and the bleed..." Further interview confirmed there was no strap on the patient during surgery and when the patient fell off the table there was no OR staff member at the patient's head or at the side of the patient. Interview with the Director of Perioperative Care on 11/15/18 at 11:30 AM, in the conference room, revealed the Director was made aware of the patient's fall on 11/8/18 by the OR Nurse Manager. Further interview revealed "...the surgery procedure was completed and the staff was preparing the patient for transfer from the fracture table to the stretcher. There is a distinct process that must be followed for insertion and removal of the patient transfer board and mattress pad to the fracture table. The staff was trying to insert the transfer board into the fracture table and the metal Jack Mount [metal device used to secure the transfer board to the bed] has to be inserted first before the transfer board. This had not been completed so they were having trouble getting the board in place. The perineal post pad had already been removed from in between the patient's legs. The RN, the CST, and the orienting CST were trying to get the board in place and may have jarred the bed. There were no straps around the patient...the surgeon had taped the patient's arms around his chest to ensure the arms did not get in the way for the surgery procedure...during the process the patient rolled off the fracture table and landed on the floor...he was under anesthesia at that time...the surgeon had already left the room and talked to the patient's family...he was called back to the room...the patient was taken to the CT for a scan of his spine and head. His CT scan of the cervical spine revealed a C2 fracture...the CT of the head revealed a subdural hematoma and an intraventricular bleed. He was then taken to the PACU and then admitted to the ICU pending transfer..." Further interview confirmed neither the CST, the orienting CST, the RN, or the CRNA were at the patient's head or at the side of the patient when the patient fell off the fracture table and no safety straps were in place to ensure the patient's safety. Interview with the Chief Nursing Officer (CNO) on 11/15/18 at 2:00 PM, in the conference room, revealed "...It looks there were some technical difficulties with the bed by the OR staff and miscommunication between the providers as to who was monitoring the patient. There were no safety straps used for the patient during the procedure and the post was removed from in between the patient's legs prior to the bed assembly for transfer..." Interview with the Chief Medical Officer (CMO) on 11/15/18 at 4:15 PM, in the conference room, revealed the CMO was made aware of the patient's fall on 11/8/18. Further interview revealed "...the surgeon called me and told me the patient had fallen off the fracture table onto the floor. He informed me the patient had a C2 fracture and an intraventricular bleed. We met with the patient's family after the CT results were confirmed...we informed them that a full investigation would be implemented and of the patient's need for transfer to the Level 1 Trauma Center related to the need of neuro surgery evaluation and treatment...the family was in agreement with the transfer...the family had lots of questions about what happened to which we could not answer at that time...they were very upset...I met with the OR staff on [11/8/18] and it appeared they were struggling with the fracture table in getting the transfer board in place. They got distracted with the fracture table and the patient rolled off the table onto the floor...at the time of the fall there was no clear communication who had control of the patient and ultimately the patient rolled off the table..." Interview with the Manufacturer's Representative, on 11/15/18 at 4:35 PM, in the OR hallway, confirmed "...there should be a strap around the patient's waist to ensure the patient's safety. The perineal post should remain in place at all times and should be the last thing that is removed prior to transferring the patient to another bed...the post is the key to ensuring the patient's safety and the patient does not roll off the bed..." Interview with the Administrator on 11/16/18 at 10:30 AM, in the conference room, confirmed the facility failed to ensure a RN supervised the care of a patient following a surgical procedure, resulting in a fall with injuries to Patient #1. Continued interview confirmed the facility failed to follow policy. |
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| VIOLATION: SURGICAL SERVICES | Tag No: A0940 | |
| **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on review of facility policy, medical record review, and interviews, the facility failed to ensure safety devices were in place during a surgical procedure for 1 patient (#1) of 4 surgical patients reviewed. The findings included: Review of facility policy Patient Rights, last revised 09/2001, revealed "...the patient has the right to expect reasonable safety insofar as the hospital practices and environment are concerned..." Review of facility policy Positioning of Patients, last revised on 7/2015, revealed "...movement or positioning of the patient should be considered with the Surgical Team...specific patient needs should be communicated among team members...when on the procedure bed, the patient will be attended by a surgical team member at all times...safety restraints are applied after patient positioning. Safety straps will we applied carefully..." Review of facility policy Operating Room Objectives and Goals, last revised 1/2017, revealed "...it is the policy of the Operating Room to provide quality nursing care which effectively meets the physical, psychological, and spiritual needs for each individual patient. This should include...safety..." Review of facility policy Positioning of Patients, last revised 7/2015, revealed "...the position of the Patient on the Operating Room table is determined by the surgery to be performed, taking into consideration the safety of the patient. The physician decides the position to be employed. However, the circulating nurse must be familiar with the positions most commonly used...movement or positioning of the patient should be coordinated with the surgical team...when on the procedure bed, the patient will be attended by the surgical team member at all times...safety restraints are applied after patient positioning..." During investigation of complaint # it was found Patient #1 was admitted to Facility A for a Right Hip Closed Fracture on 11/7/18 after a fall. The patient was admitted to the facility on [DATE] and scheduled for an Intramedullary Nailing of the Right Hip (a metal rod inserted into the bone) on 11/8/18. The patient was taken to the Operating Room (OR) on 11/8/18 where the surgical procedure was performed and successfully completed for the patient with no complications related to the surgical procedure. After the surgical procedure was complete the patient remained on a specialty bed used for hip procedures and was under anesthesia. The OR staff were preparing the patient for transfer to a stretcher and had difficulty in the assembly of the specialty bed. While the OR Registered Nurse (RN), the Surgical Scrub Tech (ST), the orienting ST, and the Certified Registered Nurse Anesthetist (CRNA) were assisting in the assembly of the bed and the patient rolled off the OR table onto the floor. Diagnostic radiological testing revealed the patient suffered a Cervical Spine (C2) fracture and an intraventricular (bleeding into the ventricles of the brain) and subdural hemorrhage (bleeding into the brain), which required Patient #1 be transferred to Facility B (a Level 1 Trauma Center) for further treatment. While at Facility B the patient required a Halo Traction (device used to immobilize and protect the cervical spine). The patient expired on [DATE] at Facility B. The investigation revealed the facility had not completed training regarding the use of a safety strap, the use of the perineal post (post used to relieve pressure on the groin), and positioning of the patient after a surgical procedure and the facility failed to follow facility policy for positioning and monitoring of the surgical patient. During a conference on 11/15/18 at 2:15 PM, with the Administrator, the Chief Nursing Officer (CNO), the Risk Manager (RM), the Director of Surgical Services, and the Cooperative Director of Quality Management, in the conference room, the facility was informed of an Immediate Jeopardy (a situation in which the provider's noncompliance with one or more requirements of participation, has caused, or is likely to cause injury, harm, impairment, or death) at 42 CFR PART 482.23 Condition of Participation, Surgical Services. Interview with the Administrator and the Cooperative Director of Quality Management on 11/16/18 at 3:00 PM, in the conference room, revealed the facility had implemented immediate actions related to the use of the fracture table and ensuring the safety of the patients in the OR. The manufacturer's representative provided training on 11/15/18 for the OR staff, anesthesia, and the orthopedic surgeons. All OR staff will be required to complete the training prior to providing care to any surgical hip fracture. The facility implemented training for the fracture table and all staff completed competencies related to the use of the bed. Education was provided to the OR staff, Anesthesia, and Orthopedic surgeons regarding the use of a safety strap and the use of the "Post' to ensure the patients safety while on the fracture table. The facility has implemented ongoing monitoring for correct positioning of the patients and ensuring a safe environment in the OR; which will reported to the Surgical Care Committee, Leadership, Medical Executive Committee, and the Governing Board. Review of an Immediate Action Plan, which removed the Immediate Jeopardy on 11/16/18 revealed the following actions were implemented: 1. Training for Fracture Table a. The representative for the specialty bed provided training to Operating Room Team members that included RNs, STs, Anesthesia Providers, and Orthopedic Surgical Providers on 11/15/18. The training included the requirements for the use of a safety strap and that the perineal post arm was not to be removed until the patient was ready for transfer from the fracture table to the stretcher. Manufacturers recommendations state the "Post" is the last piece of equipment to be removed. b. Review of the sign in sheets revealed the training was completed 11/15/18 and is on-going. c. Observations on 11/15/18 at 5:00 PM revealed the OR Table Representative was providing training to the OR staff. d. Any Team member or providers who had not completed the in-service training will not be allowed to participate in any case that required the use of the specialty bed until the training has been completed. e. The training is ongoing for team members. Review of documentation revealed 4 nursing employees and 2 Anesthesia providers were unavailable for the training. 2. Competencies a. The representative for the OR Table provided and validated training competency for the Operating Room Director (Super Trainer) for training for any team member or provider that is not able to participate in training by the representative on 11/15/18. b. Review of the sign-in sheets revealed the training was completed 11/15/18. 3. Education for the OR Staff a. The American Association of Peri-Operative Nursing (AORN) republished education in 2017, related to "Positioning the Patient Guidelines and Recommendations Education." The AORN On-line Webinar was provided to the OR team members which reviewed safe practices when positioning patients. The required training was initially completed on 11/12/18 by all OR staff. The facility staff was required to complete the additional training on 11/15/18. b. Training completed 11/12/18 and 11/15/18 and ongoing for team members who have not completed the required training. Those employees who have not completed the training will not be allowed to participate in any case that requires the use of the OR specialty bed until the training is completed. . c. Review of the sign-in sheets dated 11/15/18 revealed the training was completed and ongoing. Review of the documentation revealed 4 nursing employees and 2 Anesthesia providers were unavailable for the training. 4. Patient Safety Education a. Education was provided by the Chief Medical Officer (CMO) to the Operating Room Team members on processes to prevent injury during transport, transfer, and positioning during the perioperative phase on 11/12/18. b. The education was completed on 11/12/18 and ongoing for team members that were not available for the 11/12/18 training. c. Review of the sign-in sheets revealed the training was initiated on 11/12/18 and ongoing. d. Sign-in sheets revealed there were 4 hospital employees and 2 contracted staff had not completed the training. Any team member who has not completed the training will not be allowed to participate in any case that requires the use of the specialty bed until training is completed. 5. Initial and Annual Competencies have been developed for the OR Specialty Bed a. In-service was given to OR staff in regard to the fracture table, the specific components of the bed, and the safety precautions related to the bed. The training was completed 11/15/18. b. Date Action Item Completed: 11/15/18 and ongoing for team members that are not available for the 11/15/18 training. Competencies were reviewed with the Perioperative team members. All competencies will be reviewed and completed with OR Team Members prior to the participation in cases that require the use of the specialty bed. c. Review of the sign-in sheets and competencies revealed the OR staff who participated in the OR cases on 11/16/18 had completed the competency training and competency forms were reviewed. 6. Safety and Preventive Maintenance a. Safety checks were performed for the Specialty bed to validate the fracture table was working as designed. The bed was taken out of service on 11/8/18 and remained out of service until 11/14/18 after the Performance Management was completed by the OR Specialty Bed Manufacturer on 11/14/18. 7. Fracture Table Monitor a. A monitor for the use of the specialty bed has been developed that will review 100% of cases performed through the end of the calendar year of 2018 on the fracture table. If compliance is met at 100% after 12/31/18 the number of cases reviewed will be reduced to 75% of cases performed on the fracture table. If compliance is not met by 12/31/18 at 100% the monitor will be extended for an additional month until compliance is met at 100%. Once compliance is met at 100% for the initial review period, the number of cases reviewed will be reduced to 75% of cases performed on the fracture table for an additional 11 consecutive months. If compliance is met at 100% the monitor will be reevaluated. b. The Director of Perioperative Services or her designee will be responsible for the monitoring. c. Monitor to begin on appropriate cases 11/16/18. d. The results of the monitor will be reviewed at the Surgical Care Services Committee quarterly, Leadership, Medical Executive Committee, and Governing Board. e. Quarterly data will be presented 1/2019, and then quarterly. f. Leadership On-Call schedule for the monitoring of the use of the fracture table. The on-call schedule consists of the Director of Perioperative Services, the Chief Nursing Officer (CNO), the OR Supervisor, and the Risk Manager. Review of the monitoring sheet and on-call schedule was performed during the investigation. 8. Patient Safety Transfer Monitor a. A monitoring tool has been developed that will review 60 cases a quarter for safe patient transfers. Monitor criteria is set at 100% compliance. If the monitor is met at 100% for 4 consecutive quarters the monitor will be reevaluated. The results of the monitor will be reviewed at the Surgical Care Committee quarterly. The results of the monitor will be reviewed at the Surgical Care Services Committee quarterly, Leadership, Medical Executive Committee, and Governing Board. b. The Director of Perioperative Services or her designee will be responsible for the monitoring. c. Quarterly Data will be presented 1/2019, and then quarterly. d. The results of the monitor will be reviewed at the Surgical Care Services Committee quarterly, Leadership, Medical Executive Committee, and Governing Board. During a conference with the Administrator, the CNO, the RM, the Director of Surgical Services, and the Cooperative Director of Quality Management on 11/16/18 at 3:10 PM, in the conference room, the facility presented an Immediate Action Plan for the Immediate Jeopardy. Review of the Immediate Action Plan revealed immediate actions were implemented by the facility and the Immediate Jeopardy was removed on 11/16/18. Please refer to A-0941 |
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| VIOLATION: ORGANIZATION OF SURGICAL SERVICES | Tag No: A0941 | |
| **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on review of facility policy, medical record review, and interviews, the facility failed to ensure surgical services was provided in a safe manner and safety devices were used during a surgical procedure for 1 patient (#1) of 4 surgical patients reviewed. The findings included: Review of facility policy Operating Room Objectives and Goals, last revised 1/2017, revealed "...it is the policy of the Operating Room to provide quality nursing care which effectively meets the physical, psychological, and spiritual needs for each individual patient. This should include...safety..." Review of facility policy Positioning of Patients, last revised 7/2015, revealed "...the position of the Patient on the Operating Room table is determined by the surgery to be performed, taking into consideration the safety of the patient. The physician decides the position to be employed. However, the circulating nurse must be familiar with the positions most commonly used...movement or positioning of the patient should be coordinated with the surgical team...when on the procedure bed, the patient will be attended by the surgical team member at all times...safety restraints are applied after patient positioning..." Medical record review revealed Patient #1 was admitted on [DATE] with a diagnosis of an Acute Right Closed Hip Fracture after a fall. Continued review revealed the patient was transferred to Facility B on 11/8/18. Medical record review of an Admission History and Physical (H&P) from Facility A dated 11/7/18 at 2:49 PM revealed the patient's had a displaced intertrochanteric (bony protrusions of the thighbone) fracture to the right hip. Medical record review of a Preoperative Record dated 11/8/18 revealed the patient was admitted on [DATE] at 2:20 PM and was taken to the surgery suite at 2:40 PM and placed on the fracture table in a supine (flat) position. Continued review revealed the surgical procedure started at 3:18 PM and ended at 4:10 PM. Medical record review of an Operating Room (OR) Nursing Progress Note dated 11/13/18 (noted as a late entry in the medical record) revealed "...[11/8/18] approximately 4:12 PM patient fell off of the fracture table..." Medical record review of an Anesthesia OR Record dated 11/8/18, not timed, revealed "...patient [pt.] fell off of OR table during reassembly of fracture table...To knit bed [stretcher]...plan to go straight to CT...[computed tomography]..." Medical record review of an imaging report of a CT of the Cervical Spine without Contrast dated 11/8/18 at 5:17 PM revealed the patient had a cervical 2 (C2) Vertebrae fracture with displacement. The fracture appeared to be a "...Roy-Camille Type 2 fracture [fracture associated with neurological injuries]...Anterolisthesis [abnormal alignment of bones in the spine] of C3 with respect to C4, very concerning for ligamentous injury..." Medical record review of an imaging report of a CT of the Head without Contrast dated 11/8/18 at 5:23 PM revealed "...Impression: small amount of intraventricular and subdural hemorrhage [bleeding into the brain]. No significant mass effect or a midline shift..." Medical record review of a MD (Medical Doctor) Connection Note (request for transfer) dated 11/8/18 at 5:54 PM revealed a request to transfer to Facility B was completed for Patient #1. Further review revealed "...patient is 80 y/o [year old] male who was in the OR and had a hip nailing. During transfer from OR table to bed [the patient] was dropped. Has C2 fracture with angulation [curved]. Has small intracranial bleed and small subdural..." Medical record review of a Physician's Surgery Procedure note dated 11/8/18 at 6:45 PM revealed a Right Hip Cephalo-Medullary Nailing [repair of a hip fracture] procedure was performed related to a right intertrochanteric femur fracture. Further review revealed "...complications: the patient fell on the floor during transfer after the surgery was complete...disposition: admit to ICU [Intensive Care Unit] pending transfer to [Facility B]...after I had left the room, during the process of reassembling the bed for transfer, the patient is reported to have slipped off the bed and fell to the floor striking his head. I was notified and on returning to the room, the patient was positioned in the supine position on the floor...I preliminarily examined the patient has [had] not noticed any gross deformities to the extremities...the patient was then taken to the CT scanner for evaluation..." Medical record review of a Physician's Progress Note dated 11/8/18 at 7:04 PM revealed "...CT scans were obtained of the head, cervical spine, thoracic spine, and lumbar spine. It was immediately noted that the patient had a fracture of C2 with extension and displacement. He had small bleeds in the intraventricular and subdural spaces...I spoke with [named physician at receiving Facility B] who accepted the patient in transfer to the trauma service with plans for neurosurgical consultation. The patient was then transferred to the ICU to await transfer. Our plan is to transfer him by helicopter...during this time, [named Chief Medical Officer] and myself went to update the family in what was going on and the plans to transfer..." Medical record review of an Admission H&P from Facility B dated 11/8/18 at 8:00 PM revealed "...patient had right hip replacement at [Facility A] today...postop during transfer from OR table to stretcher, patient fell . Was still intubated [tube inserted for breathing] at that time and left intubated. CT head, C. spine, T [thoracic] spine and L. [lumbar] spine done at [Facility A] showed IVH/SDH [intraventricular hemorrhage/subdural hemorrhage] and C2 fx [fracture] with acute angulation. Sent as trauma to our ED [Emergency Department...CT Scans: Head: small volume hemorrhage within the occipital horn right lateral ventricles [bleeding into the brain]...C. Spine: acute displaced...C2...fracture. Possible very mild superior...compression fracture deformity of T9 [thoracic]...CT pelvis showed pelvic fractures and hemorrhage. I am not sure if this is from his original hip fracture or if these are new..." Medical record review of a Neurosurgery consult from Facility B dated 11/8/18 at 8:40 PM revealed "...[AGE] year old who was transferred regarding findings of C2 fracture and intraventricular hemorrhage...after surgery today, medical records indicate when patient was moved from the operative table to be placed on a stretcher, there were difficulties and the patient contacted the floor..." Medical record review of a Case Management note from Facility B dated 11/9/18 at 11:14 AM revealed "...spoke with patient's son...stated patient was sent from [Facility A] due to patient being dropped on his head while being moved off OR table..." Medical record review of a Surgery Progress Note from Facility B dated 11/12/18 at 7:30 AM revealed "...patient evaluated and discussed at bedside...after a long discussion with family, it is clear that it is in patient's best interest to proceed with comfort measures..." Medical record review of a Physician's Progress note from Facility B dated 11/16/18 at 5:37 AM revealed the patient expired on [DATE] at 5:20 AM. Interview with the Risk Manager at Facility A on 11/14/18 at 1:30 PM, in the conference room, revealed "...the patient was placed on a fracture bed during surgery and after the procedure was completed the staff were getting ready to transfer the patient back to a regular mattress bed...the surgeon had left the room...the staff had difficulty in getting the bed assembled properly...the patient was still under anesthesia and had an airway device in place. During this time the staff were trying to get the bed assembled and the patient rolled from the OR table and landed face down on the floor...his x-rays revealed a C2 fracture and a subdural bleed. He went to ICU first and then was transferred to [Facility B]..." Interview with Certified Surgery Technician (CST) on 11/14/18 at 2:35 PM, in the surgery conference room, revealed "...The patient was still on the fracture table and he was still under anesthesia. They were having trouble getting the metal part inserted to the bed. The metal apparatus has to be inserted first then the transfer mattress pad. The nurse and the orienting CST was trying to get the bed to work...I'm not sure if the bed was jarred...there was no strap on the bed...the perineal post was not in place on the bed...I stepped down to the end of the bed and showed them the metal piece that needed to be inserted. At that time, the patient fell off the bed into the floor. The RN yelled when she saw the patient falling and said 'he's falling'...his legs were still in the leg spars...the nurse and CRNA [Certified Registered Nurse Anesthetist] went to the patient..." Interview with Registered Nurse (RN) #1 on 11/14/18 at 2:45 PM, in the surgery conference room, revealed "...the surgery procedure was completed...the orienting CST was trying to get the transfer mattress on the fracture table. The metal bar had not been placed into the bed frame so the transfer mattress pad would not go onto the bed...the bed was shaking. I went down to help her and when I looked up I saw the patient go down off the bed into the floor. I yelled but it was too late to catch him...his legs were still in the leg spars...we called for the surgeon, who had already left the room to come back to the room...when the surgeon got there we placed a C. Collar [used to stabilize the neck] on the patient and then moved the patient to a long spine board with the help of the surgeon and Physician's Assistant [PA]...we took the patient immediately to the CT scan and a scan of the head, spine, and hip was performed..." Further interview confirmed "...there were no straps on the bed. The surgeon had placed tape around the patient's arms and body to secure the patient's upper extremities during the surgery...the perineal post was not in place..." Interview with the orienting CST on 11/14/18 at 3:00 PM, in the surgery conference room, revealed "...the circulating nurse was trying to assemble the bed and could not get the mattress portion of the bed inserted. I went down to the end of the bed to help her and took the mattress pad from her. The metal frame had not been inserted, which had to be in place first...there was some jarring of the bed when we were trying to insert the pad...the patient fell so quick..." Interview with the Orthopedic Surgeon on 11/15/18 at 9:35 AM, in the conference room, revealed the patient was admitted to the facility after he was diagnosed with a right hip fracture related to a fall. Further interview revealed "...I was not in the room when the patient fell . He was still under anesthesia when I left the room. The staff called me and told the patient had fallen off the OR table and he was on the floor. The patient's lower extremities were still up in the leg spars when the patient fell ...there was no safety strap in place..." Further interview revealed "...when I got to the room the patient was supine on the floor...I called CT and we took the patient directly to the CT scan for a head, cervical, thoracic and lumbar scans. Continued interview revealed "...his CT scans revealed a C2 fracture and small ventricular and subdural bleed in his head...he was taken to the PACU [Post Anesthesia Care Unit]...and then admitted to the ICU pending transfer..." Telephone interview with CRNA #1 on 11/15/18 at 9:50 AM revealed the patient was in the OR for a nailing of the right hip. Further interview revealed "...after the procedure was completed the patient remained under anesthesia and the staff were preparing the patient for transfer from the fracture table to a stretcher. The OR staff was having difficulty with getting the transfer mattress pad on the bed. I was at the head of the bed initially during the anesthesia...I stepped to the left side of the bed and then went to the lower part of the bed to see if I could help get the mattress pad connected...I felt the patient falling off the bed...we could not get to him in time to keep the patient from falling...the OR staff called the surgeon and told him the patient had fallen off the stretcher...there was a purple area to the right side of his [Patient #1's] forehead but no other obvious injuries were found. I was still assisting his breathing with an ambu bag [hand held device used to assist breathing]...once the CT confirmed the C2 fracture and the brain bleed we took the patient to the PACU. I orally intubated the patient in the PACU and gave him 12 milligrams of Decadron [Steroid] related to the C2 fracture and the bleed..." Further interview confirmed there was no strap on the patient during surgery and when the patient fell off the table there was no OR staff member at the patient's head or at the side of the patient. Interview with the Director of Perioperative Care on 11/15/18 at 11:30 AM, in the conference room, revealed the Director was made aware of the patient's fall on 11/8/18 by the OR Nurse Manager. Further interview revealed "...the surgery procedure was completed and the staff was preparing the patient for transfer from the fracture table to the stretcher. There is a distinct process that must be followed for insertion and removal of the patient transfer board and mattress pad to the fracture table. The staff was trying to insert the transfer board into the fracture table and the metal Jack Mount [metal device used to secure the transfer board to the bed] has to be inserted first before the transfer board. This had not been completed so they were having trouble getting the board in place. The perineal post pad had already been removed from in between the patient's legs. The RN, the CST, and the orienting CST were trying to get the board in place and may have jarred the bed. There were no straps around the patient...the surgeon had taped the patient's arms around his chest to ensure the arms did not get in the way for the surgery procedure...during the process the patient rolled off the fracture table and landed on the floor...he was under anesthesia at that time..." Further interview confirmed neither the CST, the orienting CST, the RN, or the CRNA were at the patient's head or at the side of the patient when the patient fell off the fracture table and no safety straps were in place to ensure the patient's safety. Interview with the Chief Nursing Officer (CNO) on 11/15/18 at 2:00 PM, in the conference room, revealed "...It looks there were some technical difficulties with the bed by the OR staff and miscommunication between the providers as to who was monitoring the patient. There were no safety straps used for the patient during the procedure and the post was removed from in between the patient's legs prior to the bed assembly for transfer..." Interview with the Chief Medical Officer (CMO) on 11/15/18 at 4:15 PM, in the conference room, revealed the CMO was made aware of the patient's fall on 11/8/18. Further interview revealed "...the surgeon called me and told me the patient had fallen off the fracture table onto the floor. He informed me the patient had a C2 fracture and an intraventricular bleed. We met with the patient's family after the CT results were confirmed...we informed them that a full investigation would be implemented and of the patient's need for transfer to the Level 1 Trauma Center related to the need of neuro surgery evaluation and treatment...the family was in agreement with the transfer...the family had lots of questions about what happened to which we could not answer at that time...they were very upset...I met with the OR staff on [11/8/18] and it appeared they were struggling with the fracture table in getting the transfer board in place. They got distracted with the fracture table and the patient rolled off the table onto the floor...at the time of the fall there was no clear communication who had control of the patient and ultimately the patient rolled off the table..." Interview with the Manufacturer's Representative, on 11/15/18 at 4:35 PM, in the OR hallway, confirmed "...there should be a strap around the patient's waist to ensure the patient's safety. The perineal post should remain in place at all times and should be the last thing that is removed prior to transferring the patient to another bed...the post is the key to ensuring the patient's safety and the patient does not roll off the bed..." Interview with the Administrator on 11/16/18 at 10:30 AM, in the conference room, confirmed the perineal post was removed prior to the assembly of the transfer pad and no safety straps were used during Patient #1's surgical procedure, resulting in a fall with injuries. Continued interview confirmed the facility failed to follow facility policy. |
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