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Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §482.13, PATIENT RIGHTS, was out of compliance.

A-0118 The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance. Based on document review and interviews the facility failed to ensure staff identified and followed the grievance process in one of one patient complaints (Patient #2).

A-0144 The patient has the right to receive care in a safe setting. Based on interviews and document review, the facility failed to ensure all staff and providers had sufficient training prior to and following an event in which Patient #2 fell to the floor from the operating table and incurred a laceration to her scalp and elbow.

A-0168 The use of restraint or seclusion must be in accordance with the order of a physician or other licensed independent practitioner who is responsible for the care of the patient as specified under §482.12(c) and authorized to order restraint or seclusion by hospital policy in accordance with State law. Based on interviews and record review, the facility failed to ensure a physician order was obtained for each episode which a patient was placed in restraints in 2 of 2 restraint records reviewed (Patients #2 and #4).

Based on document review and interviews the facility failed to ensure staff identified and followed the grievance process in one of one patient complaints (Patient #2).

Findings include:

Facility Policy:

The Patient Complaints and Grievances policy read, the definition of a complaint was a patient care or service issue that is identified and resolved promptly by staff present while the patient was still in the facility and services were still being provided. The policy defines a grievance as a complaint which cannot be resolved at the time of the complaint by staff present, was postponed for later resolution, was referred to other staff for later resolution, required investigation and/or required further actions for resolution. Any complaint when a patient or patient's representative requests a response from the hospital would be considered a grievance. The policy stated the required action for a grievance was to review and investigate the grievance and report findings in writing to patient or patient's representative within seven working days of receiving the grievance.

1. The facility failed to identify Patient #2's complaint as a grievance and as a result, failed to provide a written report of the investigation findings to the family.

a. On 10/7/18 at 7:32 p.m., Patient #2 had an incident filed by House Supervisor #22. According to the incident description, the patient sustained a fall in the operating room resulting in a cut to the patient's head which required stitches.

According to the follow up actions for the incident, a group meeting was held on 10/8/18 at 1:00 p.m., to discuss the incident and next steps as the patient's family continued to have questions regarding the event. The follow up actions documented included an investigation, policy review and evaluation of staff related to the operating table. Also documented in the follow up actions of the incident was a follow-up with Patient #2's family.

According to the follow-up description, on 10/9/18 at 10:55 a.m., a meeting was held with the patient's family and the Patient Safety Program Manager (Manager) #6 and Patient Liaison Advocate #23. During the meeting, the family asked if any training had been done for staff related to the operating room table. Manager #6 informed the family an executive sponsor would be assigned to do an action plan and the outcome would be shared with the family.

According to the next follow-up description documented on 10/9/18 at 12:08 p.m., there was documentation of communication between Patient Liaison Advocate #23, Manager #6 and Vice President of Integrated Services #24 regarding the details of the planned investigation and who would be in contact with the patient's family.

On 11/13/18 the complaint document noted a voicemail from the patient's daughter. Patient Liaison Advocate #23 returned the call to the patient's daughter on 11/14/18. The documentation noted the phone call was not in regards to the original complaint. Following this note, the complaint resolution and outcome was marked at satisfied, being handled by Risk and Safety and referred to Risk Management.

On final review of the case file, there was no evidence in which Patient #2's incident was considered a grievance. This was in contrast to the facility policy which indicated the extended time frame, investigation, and lack of resolution on at the time of the complaint classified Patient #2's incident as a grievance. Furthermore there was no documentation Patient #2's family received a written report of the investigation.

b. On 5/6/19 at 1:58 p.m., an interview was conducted with Patient Representative (PR) #9. PR #9 stated if a care concern or complaint was resolved while a patient was still in the facility and no further investigation was necessary it would not be considered a grievance. However, Patient #2's complaint was never progressed to the level of a grievance despite the extended time frame for resolution and the additional investigation completed.

c. On 5/8/19 at 11:29 a.m., an interview was conducted with Clinical Risk Manager (Manager) #7. Manager #7 stated Patient #2's incident was not converted into a grievance and could not provide documented evidence how the facility determined the grievance was resolved or the written follow up with the family.

Based on interviews and document review, the facility failed to ensure all staff and providers had sufficient training prior to and following an event in which Patient #2 fell to the floor from the operating table and incurred a laceration to her scalp and elbow.

Findings include:

Facility policy:

The Duties of the Circulating Nurse policy read, after the procedure the circulating RN should remove safety straps and transfer the patient from the OR table slowly and gently when anesthesia states appropriate to move.

a. According to Patient #2's Operative Note (Op Note), she had surgery on 10/7/18 to repair a fractured hip. On 10/7/19 at 3:04 p.m., Physician Assistant (PA) #1 documented an addendum to the Op Note which stated Patient #2 fell off the operating room (OR) table when anesthesia was attempting to place a central venous catheter (CVC, a catheter placed into a large vein) while nursing staff was taking Patient #2's legs out of the fracture boots which secured her to the table. The Op Note was co-signed by Physician #2.

Review of OR registered nurse (RN) #19's note on 10/7/18 at 4:12 p.m., revealed Patient #2 fell from the OR table and sustained an open right sided head wound. Additionally, it was noted when Patient #2 was on the floor, her peripheral intravenous catheter (IV), the breathing tube to the ventilator and all monitoring devices were disconnected. A overhead page was required for additional staff support to assist Patient #2 from the floor to her bed. Once Patient #2 was in her bed anesthesiologist #3 continued the procedure of placing the CVC. After the CVC was placed, Patient #2 required a computerized axial tomography (CT, a form of imaging) of her head and X-ray of her operative hip and chest to assess for injuries related to her fall from the OR table.

After all the imaging had been completed, a general surgeon was consulted to repair the head laceration. According to Physician #20's procedure note on 10/7/18 at 9:45 p.m., he repaired Patient #2's right sided 3.5 centimeter (cm) scalp laceration with five sutures.

According to wound RN #21's note on 10/8/18 at 12:32 p.m., Patient #2 also obtained a 0.5 cm skin tear to her right elbow from the fall from the OR table which was noted on Patient #2's right elbow.

b. Review of the Patient Safety Committee, Orthopedic Steering Committee, OR Steering Committee and Surgery Department Medical Staff meeting minutes from 10/1/18 to 5/1/19 revealed the incident in which Patient #2 fell from the OR table while under anesthesia was not discussed.

c. On 5/7/19 at 7:33 a.m., an interview with Anesthesiologist #3 was conducted. Anesthesiologist #3 stated she was attempting to place a CVC in Patient #2 in which an ultrasound was used to place a large needle into her internal jugular (neck) vein. Anesthesiologist #3 stated the table needed to be in the Trendelenburg (a position where the person is flat on their back on a 15-30 degree incline with the feet elevated above the head) position to prevent air in the left side of the heart.

Anesthesiologist #3 stated PA #1 had attempted to manipulate Patient #2's legs and was moving Patient #2. When PA #1 was asked to stop moving Patient #2, she left the OR. Anesthesiologist #3 stated she continued to place the CVC when RN #19 manipulated Patient #2's legs. Anesthesiologist #3 stated she asked RN #19 to stop, but RN #19 continued to elevate the patient's legs.

Anesthesiologist #3 stated she had a large needle in Patient #2's neck and was concentrating on the ultrasound machine and Patient #2's neck, when she realized Patient #2 was sliding off the OR table. Anesthesiologist #3 stated she was able to remove the needle from Patient #2's neck and assist Patient #2 to the floor with her buttocks hitting the ground first. Anesthesiologist #3 stated the cause of the fall was the manipulation of Patient #2's legs while she was in the Trendelenburg position.

d. On 5/6/19 at 11:30 a.m., an interview with OR manager (Manager) #8 was conducted. Manager #8 explained the OR table Patient #2 was on was the Steris electric fracture table. The Steris electric fracture table had the ability to be placed in the Trendelenburg position while the legs were elevated. Manager #8 stated Patient #2 was placed in the Trendelenburg position by anesthesiologist #3 while RN #19 had simultaneously removed her safety boots. Patient #2 then slid off the right side of the OR table to the floor. Manager #8 stated the OR staff had been trained on the bed functions prior to Patient #2's fall in the OR, but probably did not receive specific training regarding the safety points for when the Steris electric fracture table was in the Trendelenburg position. Manager #8 stated she had the vendor representative inspect the Steris electric fracture table after Patient #2's fall and verified the table was not faulty. Manager #8 stated she had the vendor representative train the OR staff after Patient #2 slid off the OR table. Manager #8 stated the staff not available for the vendor representative table training were trained by identified superusers.

e. Review of the list of staff which received the Steris Electric Table Review revealed 13 of 33 OR RNs did not receive the training. Additionally, 7 of 18 surgical technicians (ST) did not receive the training. The review also revealed RN #19 who was the OR RN when Patient #2 fell to the floor from the electric fracture table did not receive the safety review.

f. On 5/7/19 at 10:33 a.m., Manager #8 was interviewed again. Manager #8 stated the additional training provided by the Steris vendor representative consisted of a basic run through of the table functions and the specific safety positioning for the patient when in the Trendelenburg position on that particular table. Manager #8 stated the particular safety instructions for the patient would include an additional safety strap across the patient, placing both arms in the arm boards for security, and maintaining the patient strapped in the safety boots when placed in the Trendelenburg position. Manager #8 stated it was unexpected for staff to move a patient while anesthesia was placing a central line. She stated she also spoke with RN #19 after Patient #2 fell from the table. Manager #8 stated RN #19 was distraught and asked her if not removing the safety boots would have prevented the fall. Manager #8 stated she told her yes.

Manager #8 provided an email from 5/6/19 at 3:50 p.m., which stated the facility was unable to provide proof in which RN #19 had initial competencies to safely use the Steris electric fracture table.

g. On 5/6/19 at 12:21 p.m., an interview with OR RN (RN) #5 was conducted. RN #5 explained she had cared for Patient #2 in the OR, but had been relieved by RN #19 prior to her falling off the table. RN #5 stated she had attended the Steris electric fracture table training after the incident. RN #5 stated she was trained about safety straps remaining on a patient for other types of tables, but could not recall for the Steris electric fracture table. She stated she was unsure if safety straps could prevent a patient from falling off the table. RN #5 stated she was told not to put a patient in the Trendelenburg position on the table. She stated if a CVC needed to be placed she would have the anesthesiologist wait until the patient had been transferred back to their bed from the table. RN #5 did not discuss the need to have two safety straps on the patient, secure the patient in two arm boards or keep the patient in the safety boots if a patient was placed in the Trendelenburg position on the Steris electric fracture table which were the safety features Manager #8 described to prevent a future fall from the Steris electric fracture table.

h. On 5/7/19 at 1:52 p.m., an interview with Surgical Technician (ST) # 12 was conducted. ST #12 was identified as the superuser who trained the staff who were unable to attend the Steris vendor representative electric fracture table training after Patient #2 fell while in the OR. ST #12 stated he and the vendor representative went through the manufacture manual for the electric fracture table page by page and created the key points to educate staff about the table. ST #12 identified when the table was in the Trendelenburg position, the safety points were to keep the patient secured in the boots. ST #12 stated the training had not changed since the incident, but was more detailed.

ST #12 was unable to provide any training he had done with staff who were unable to attend the training after the incident with Patient #2, to include PA #1 and Physician #2 on how to use the tables. ST #12 stated even though the anesthesiologists control the OR tables during the procedures, they had not been educated specifically on OR tables.

i. During the interview on 5/7/19 at 10:33 a.m., Manager #8 stated physicians, PAs and anesthesiologists (providers) were not mandated to attend training updates, but were invited. Manager #8 stated providers received their training on bed functions during their residencies. Manager #8 stated the superusers were available to train the providers if they did not feel comfortable using a table or piece of equipment, but it was up to the providers to seek out assistance. Manager #8 stated even though they had not been trained on the table safety functions, anesthesiologist had the continued ability to place the patient in the Trendelenburg position.

j. During the interview on 5/7/19 at 7:33 a.m., Anesthesiologist #3 stated she knew how to place the steris electric fracture table in different positions. When asked about specific details of the tables, Anesthesiologist #3 stated it was outside of her expertise. Anesthesiologist #3 stated she had not received any specific training on the tables. Anesthesiologist #3 stated the way she received training or updates was by email which was sent out by Anesthesiologist #4, the medical director, followed up by a staff meeting. Anesthesiologist #3 stated she had not received any safety updates regarding the Steris electric fracture table. Additionally, Anesthesiologist #3 stated she had placed patients in the Trendelenburg position since Patient #2 slid off the table and stated it was a common and necessary position during surgical procedures. Anesthesiologist #3 stated she had not changed her practice since the incident.

k. During the interview on 5/7/19 at 9:23 a.m., the topic of provider training was also discussed. Manager #8 provided an email from Patient Safety Manager (Manager) #6 dated 10/11/18, four days after Patient #2 fell from the OR table while under anesthesia. In the email, Manager #6 asked Manager #8 if providers had received any training on the Steris electric fracture tables. Manager #8 stated there were no training requirement for providers in the OR. Manager #8 stated providers received an orientation to the unit, but the specifics of each table was not discussed. Manager #8 stated the refresher training after Patient #2 fell off the OR table was to ensure everyone had the training. Manager #8 stated OR nurses and surgical technicians received the refresher training after the event, but no physicians, PAs or anesthesiologists since training was not mandated. Manager #8 stated the anesthesiologists were invited to the training, but in a later interview stated an invite never went to the anesthesiologist group to invite them to the safety training.

Manager #8 stated the event in which Patient #2 fell off the OR table was such a big deal she attempted to have a mental health team speak with the OR staff. She stated the mental health team never spoke with the OR staff due to scheduling issues. Manager #8 stated she did have the chaplain speak to each team member individually though for their mental health.

l. On 5/7/19 at 12:15 p.m., an interview was conducted with the OR clinical practice specialist (CPS) #11. CPS #11 stated she coordinated training for the OR team. CPS #11 stated there had been no process changes since Patient #2 fell off the OR table on 10/7/18. CPS #11 confirmed not all OR RNs and STs had received the Steris electric fracture table safety review since the event. CPS #11 stated she was not able to dictate to providers to attend training, but was able to invite them. CPS #11 reviewed her email and confirmed an invitation was never sent to the anesthesia medical director to invite them to the safety training after Patient #2 fell off the OR table.

m. On 5/7/19 at 10:06 a.m., an interview was conducted with director of medical staff services (Director) #10. Director #10 stated she was the person who sent out email correspondence to physicians and PAs. She stated a newsletter was sent once a month as well as postings in the physician lounge to update them. Director #10 stated she had not sent out an email to the physicians or PAs regarding Patient #2's fall from the OR table.

n. Prior to the survey exit the facility sent the following emails: An email was sent to the anesthesia group from Anesthesiologist #4 on 5/7/19 at 6:33 p.m., which stated there was a safety event in which a patient fell off the table towards the head of the bed during a central line placement; in the rare occasion a patient needed to be placed in the Trendelenburg position, communicate with OR staff the patient should not be removed from the boots, legs elevated or moved in any way without your knowledge. On 5/8/19 at 8:25 a.m., the same email was sent to the orthopedic physicians. On review of the provided email education, it was noted the PAs had not received the safety update email regarding the sterile electric fracture table when a patient was placed in the Trendelenburg position. The facility sent the same email to the PAs on 5/8/19 at 3:47 p.m.

On 5/7/19 at 1:47 p.m., a training plan for educating OR RNs and STs was provided by Manager #8 and CPS #11. The training plan identified the gap of RNs and STs who did not receive the Steris electric fracture table safety training after Patient #2 fell off the OR table while under anesthesia. On 5/8/19 at 10:57 a.m., an email was sent to the OR staff which attached the safety points when using the Steris electric fracture table with the instructions to ensure they received their refresher safety training during the side table presentation provided by ST #12. The training to all OR staff had not occurred prior to survey exit.

Based on interviews and record review, the facility failed to ensure a physician order was obtained for each episode which a patient was placed in restraints in 2 of 2 restraint records reviewed (Patients #2 and #4).

Findings include:

Facility policy:

The Restraint and Seclusion policy read, a restraint was any manual or mechanical device, material or equipment that immobilized or reduced the ability of a patient to move their arms, legs,body or head freely. Example included was wrist restraints. A physician order was required for the use of restraints within one hour of the initiation.

1. The facility failed to ensure a physician order was obtained each time a restraint was initiated.

a. According to Patient #4's Discharge Summary, she was admitted on 11/6/18 with a femoral neck fracture (broken hip). Review of Patient #4's Restraint Flow Sheet revealed bilateral wrist restraints were documented by RN #26 on 11/7/18 at 8:00 p.m., to protect her from removing or dislodging her airway management device. Further review of Patient #4's medical record revealed an order for Patient #4's restraints was not obtained until 11/8/18 at 8:10 a.m., 12 hours later. This was in contrast to the policy which stated a physician order should be obtained within one hour of initiation of restraints.

b. According to Patient #2's Operative Note (Op Note), she had surgery on 10/7/18 to repair a fractured hip. Review of Patient #2's Restraint Flow Sheet revealed bilateral wrist restraints were initiated on 10/9/18 at 3:00 p.m. by registered nurse (RN) #25. The reasons listed for the restraints was to protect Patient #2 from injury due to inability to comply with safety measures and to prevent her from removing or dislodging her airway management devices. Further review of Patient #2's medical record revealed an order was not obtained until 10/9/18 at 8:11 p.m., five hours later.

c. On 5/7/19 at 4:23 p.m., an interview with RN #13 was conducted. RN #13 stated when restraints were initiated she would call the patient's physician to discuss the reason needed, such as attempting to remove the endotracheal tube (airway management device). RN #13 stated she would get the order for restraints immediately or within one hour of initiation to protect the patient's rights. RN #13 referenced the restraint policy as to the reason she knew to obtain an order within one hour. RN #13 stated she was not allowed to restrain a patient without a physician's order because it was illegal to tie someone down without a reason. RN #13 stated the facility provided yearly updated reviews for restraint use.

d. On 5/8/19 at 10:22 a.m., RN #15 was interviewed while clinical informatics (CI) #16 assisted him to review the medical records of Patient #2 and #4. RN #15 stated a physician's order was required within one hour anytime restraints were initiated. RN #15 stated without a physician's order, the patient's rights were not protected. RN #15 stated the facility provided an annual refresher regarding restraint ordering, application and documentation requirements. RN #15 referred to the restraint policy as the way he had his knowledge about restraints. Additionally, RN #15 stated orders were supposed to be reviewed during shift report in order to verify they had been obtained.

RN #15 verified Patient #2 and Patient #4 were restrained without a physician order as required within one hour.

e. On 5/8/19 at 1:08 p.m., the intensive care unit (ICU director (Director) #17 was interviewed. Director #17 referenced the restraint policy and stated a physician order had to be obtained within one hour of initiation. Director #17 stated the order was obtained at the same time the RN informed the physician of the patient change in behavior. Director #17 stated nurses were required to obtain an order even if a patient was admitted to the ICU in restraints from another unit. During the interview Director #17 and Charge RN #18 verified Patient #2 was restrained and a physician order was not obtained until five hours later, as well as Patient #4 was restrained and a physician order was not obtained until 12 hours later.