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.

UNIVERSITY OF VIRGINIA MEDICAL CENTER 1215 LEE STREET CHARLOTTESVILLE, VA 22908 Sept. 17, 2019
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0165
Based on staff interview, medical record review, and review of facility documents, it was determined facility staff failed to ensure that there was an ongoing assessment which demonstrated that continued restraint was needed for one (1) patient (Patient #14).

Findings included:

A review of the medical record for Patient #14, revealed that he/she was admitted to the ED (emergency department) on 8/7/19 at 11:12 a.m., after presenting to the Child and Family Psychiatric Clinic with suicidal ideation (SI), physical aggression, depression, visual and auditory hallucinations. Patient #14 was transferred from the UVA emergency department to another facility on 8/7/19 at 6:46 p.m.

An ED provider note dated 8/7/19 at 12:17 p.m. documented in part that "...Patient is aggressive towards examiner and staff throughout ED stay. Required multiple redirections and intervention by security to deescalate. Due to concerns for patient's safety and safety of staff, IM Benadryl was given and physical restraints were required. Patient was placed into inpatient psychiatric facility. Patient was calm after benadryl and transferred in soft restraints, as these did not appear to be causing any medical harm but patient remained a danger to [him/her]self and others if [he/she] were to become combative upon awakening...".

A note by the ED Social Worker dated 8/7/19 at 2:09 p.m. evidenced that "Pt requires restraints in bed for aggressive outbursts. 2EASY locates stretcher provider to transport child while restrained to [name of accepting facility]. MD signs note to recommend restrained travel. Note scanned to chart".

A review of Patient #14's medical record evidenced a physician order dated 8/7/19 at 2:26 p.m. for "Restraints Violent Adolescent (9-17 years) New; Reason for Restraint: Violent or self destructive behavior jeopardizing the immediate physical safety: to self, to staff, to others; Limb Restraints; RUE, LUE, RLE, LLE (right upper extremity, left upper extremity, right lower extremity, left lower extremity); end date/time 8/7/19 at 4:26 p.m.

A second violent restraint order with the same parameters as the above order was written on 8/7/19 at 4:18 p.m., with an end date of 8/7/19 at 6:17 p.m.

The ED notes and the MAR (medication administration record) evidenced that Patient #14 was administered Benadryl 50 mg (milligrams) IM (intramuscular) on 8/7/19 at 2:10 p.m. and 6:08 p.m.

The restraint monitoring flowsheet was initiated on 8/7/19 at 2:30 p.m., and evidenced documentation every 15 minute checks between 2:30 p.m. and 6:30 p.m. for Patient #14, and documented that [he/she] was in "Cuffs wrist non-locking (Twice as Tough "TAT"); Cuffs ankle non-locking (Twice as Tough, "TAT"); RUE, LUE, RLE, LLE, and "YES" for the need for continued restraint.

Between 3:15 p.m. and 4:00 p.m., the restraint monitoring flowsheet documentation for Level of Distress/Cognitive Functioning evidenced that Patient #14 was "sleeping", and at 3:39 p.m. "resting calmly eyes closed"; however, Patient #14 remained in restraints.

The record lacked documentation of behaviors which would have required restraint between 4:15 p.m. and 5:00 p.m.

At 5:00 p.m. there was documentation that Patient #14 was "yelling out". At 5:50 p.m. on 8/7/19 nursing note documented that Patient #14 "grabbed at computer mouth {sic} in room and attempted to throw it at nurse. Pt says "NO! [Expletive] you! You won't let me go home!".

At 6:46 p.m. on 8/7/19 a nursing note documented that the "Pt cont to take [him/her] self out of upper extremity restraints with security at bedside. Pt yelling out "I WANT TO GO HOME! [Expletive]YOU!" repeatedly. Pt medicated with IM Benadryl for behavior. Pt remains in restraints. Transport team at bedside. Pt moved to transport stretcher with help of security".

Documentation by the contracted transport company was that they were at the facility on 8/7/19 at 6:55 p.m., and upon arrival , the "PT was found restrained and spit mask, highly combative, spitting and trying to bite, scratch, kick and or punch the staff and officers. PT was A&O (alert and oriented) by 4. PMS=by4, Vitals at contact with the pt in the room was 105 HR, 131/78 HP {sic}, SPo2 of 99%, and RR of 18...PT was highly combative. Had to transport in full body soft restraints and a full spit/bite mask. PT was walked to and from the stretcher in full restraints and mask with AIC and multiple Officers to secure [him/her] to the stretcher. PT had all limbs restrained with soft one. and also had the 4point stretcher harness, chest strap, and leg strap. Vitals were monitored, PT was slight {sic} calmer but sit {sic} very aggressive and combative...". Transport company documented arrival to accepting facility as 9:31 p.m. on 8/7/19.

Staff Member #1 was interviewed on 9/17/19 at 9:50 a.m. The surveyor discussed concerns related to whether the transport company staff were trained in proper restraint use, and whether the contract personnel had been trained to provide transportation for restrained patients in a safe manner. The surveyor also inquired about the facility's policy for transferring restrained patients. The surveyor inquired as to the "TAT" type of restraints used for Patient #14, and how the decision is made as to which type of restraint to use. SM #1 responded "We don't usually transfer patients in restraints, so we don't have a policy about it, but to be sure, I will have the ED director come talk to you".
The surveyor was given a document titled "Tips for Restraint Device Selection, which included a list of limb restraints consisting of:
soft cloth restraint limb holder: May be used on a low/moderate energy & strength patient to limit upper and lower body access and movement.
Cuffs (wrist or ankle) Non-locking (aka "TATS" or "Twice as Tough"): may be used on a moderate/high energy & strength patient to limit upper and lower body assess and movement.
Cuffs (wrist or ankle) Locking (aka "Locking TATs" or "Locking Twice as Tough"): may be used on a high/extremely high energy & strength patient to limit upper and lower body access and movement.
Cuffs (wrist or ankle) Connect Lock: may be used on a high/extremely high energy & strength patient to limit upper and lower body access and movement. Using both ankle and wrist devices is a 4 point restraint.

On 9/17/19 at 11:00 a.m., the surveyor interviewed SM #19, Director of the ED, and SM #27, Administrator of Emergency Medicine Services. SM #19 stated "We have unit based leadership meetings on a daily basis. The house supervisor also covers risk management. Had this been a red flag for us, we would have been made aware it happened. If it had been our transport service they would not have transported in restraints. I don't think the patient's grandfather wanted the child to be transported in handcuffs. If transport team would take [him/her], the grandfather didn't want an ECO (emergency custody order)/TDO (temporary detention order). If a Be Safe had been done and we would have seen it, and maybe done an A3 (problem solving); we would have notified Quality and Risk Management. There are some things we can do in the short term to take care of this and keep it from happening again". SM #27 added "In my world that documentation would mean that [he/she] was no longer voluntary".
The surveyor inquired as to how the determination is made as to what type of restraint is used. SM's #19 and 27 told the surveyor that the nurse makes the decision, dependent on the patient's behavior, and based on training.

SM #26, Director of Patient Safety and Risk Management was interviewed on 9/17/19, and a discussion was held related to transport of Patient #14 while in restraints, and the facility's policy. SM #26 confirmed that there was no specific policy related to the transfer/transport of patients in restraint, and stated "I don't think there is a hesitancy to ask questions; when managers hear about something and think there needs to be a policy change. We do bring in the front line to help with policy changes and education. We would pull together a group; there needs to be a larger body to help figure it out, and to make things official. The Quality officer, CNO (chief nursing officer), and CMO(chief medical officer) are very accessible, I see them almost every day in the daily huddle, which includes leaders of every service line. Governing body is way down the road after changes are in place. A Be Safe Event triggers an adverse event, and the expectation is that the unit starts working on an event immediately through unit based leadership. Patient safety meets twice a month, and includes the CMO, CNO, and the head of the pharmacy. During the first part of the meeting, adverse events are reviewed. There is one clinical supervisor specific to the ED on each shift. They round on behavioral health (BH) patients, they are expected to look at all aspects of care for BH patients, but don't specifically look at transfers, and don't normally look at every BH patient during their shift. The clinical supervisor doesn't have an assignment, they troubleshoot and problem solve. If there's something they can take care of in the moment, they don't need to put it in the shift report. They can put something they want to share with the rest of the team in the shift report, or if they can't solve an issue on the spot".

A telephone interview was held with SM #42, an employee of the contracted transport company who transferred Patient #14 to the receiving facility on 9/17/19 at 12:50 p.m. SM #42 advised the surveyor that "The only time we would restrain a child like that is if a police officer was there doing it; they would be in control, and transport staff would be assisting. What should have happened is law enforcement or security should have accompanied the patient, we would only transport under their authority; EMS in general does not restrain patients. Sometimes with patients who have dementia we have to be a little more forceful. We are trained with backboard restraints for immobility. Using a device designed to restrain somebody that's not something we would do. I hope the answer is yes that law enforcement accompanied them. I need to check with the team and get back with you".
Several weeks after exiting the survey, the surveyor received a voice mail message from the transport company that there was further information which they could provide related to Patient #14. The surveyor called the company 10/28/19 at 12:37 p.m.; noone was available to discuss the information, and a voice message was left. The surveyor called again on 10/28/19 at 4:25 p.m. and asked to speak with someone who could provide further information; however, noone was available to take the call.

Concerns were discussed as noted above, and again on 9/17/19 at 4:30 p.m., with SM #1.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0196
Based on staff interview, interview of contracted service employees, and review of facility documents, it was determined facility staff failed to ensure that contracted staff were appropriately trained in the safe use of restraints for one (1) patient (Patient #14).

Findings included:

Review of the medical record for Patient #14 revealed that he/she was admitted to the ED (emergency department) on 8/7/19 at 11:12 a.m., after presenting to the Child and Family Psychiatric Clinic with suicidal ideation (IS), physical aggression, depression, visual and auditory hallucinations. Patient #14 was transferred from the UV emergency department to another facility on 8/7/19 at 6:46 p.m.

An ED provider note dated 8/7/19 at 12:17 p.m. documented in part that "...Patient was placed into inpatient psychiatric facility. Patient was calm after beady and transferred in soft restraints, as these did not appear to be causing any medical harm but patient remained a danger to [him/her]self and others if [he/she] were to become combative upon awakening...".

A note by the ED Social Worker dated 8/7/19 at 2:09 p.m. evidenced that "Pt requires restraints in bed for aggressive outbursts. 2 EASY locates stretcher provider to transport child while restrained to [name of accepting facility]. MD signs note to recommend restrained travel. Note scanned to chart".

Documentation by the contracted transport company was that they were at the facility on 8/7/19 at 6:55 p.m., and upon arrival , the "PT was found restrained and spit mask, highly combative, spitting and trying to bite, scratch, kick and or punch the staff and officers. PT was A&O (alert and oriented) by 4. PMS=by 4, Vitals at contact with the pt in the room was 105 HR, 131/78 HP {sic}, Po of 99%, and RR of 18...PT was highly combative. Had to transport in full body soft restraints and a full spit/bite mask. PT was walked to and from the stretcher in full restraints and mask with AI and multiple Officers to secure [him/her] to the stretcher. PT had all limbs restrained with soft one. and also had the 4point stretcher harness, chest strap, and leg strap. Vitals were monitored, PT was slight {sic} calmer but sit {sic} very aggressive and combative...". Transport company documented arrival to accepting facility as 9:31 p.m. on 8/7/19.

Staff Member #1 was interviewed on 9/17/19 at 9:50 a.m. The surveyor discussed concerns related to whether the transport company staff were trained in proper restraint use, and whether the the contract personnel had been trained to provide transportation for restrained patients in a safe manner. The surveyor also inquired about the facility's policy for transferring restrained patients. SM #1 responded "We don't usually transfer patients in restraints, so we don't have a policy about it, but to be sure, I will have the ED director come talk to you".

SM #26, Director of Patient Safety and Risk Management was interviewed on 9/17/19, and a discussion was held related to transport of Patient #14 while in restraints, and the facility's policy. SM #26 confirmed that there was no specific policy related to the transfer/transport of patients in restraint. The facility was unable to provide the surveyor with documentation that employees of the contracted provider who transported Patient #14 to the accepting facility had training in the safe and proper use of restraints.

The facility's policy and procedure titled "Medical Center Policy NO. 159 Restraint and Seclusion of Patients" was reviewed, and included the following related to staff education: "...10. Education: All staff who order, apply, and/or monitor restraint and/or seclusion shall receive education on the use of restraint during orientation and before independently participating in the use of restraint/seclusion, and on an annual basis thereafter...".

A telephone interview was held with SM #42, an employee of the contracted transport company who transferred Patient #14 to the receiving facility on 9/17/19 at 12:50 p.m. SM #42 advised the surveyor that "The only time we would restrain a child like that is if a police officer was there doing it; they would be in control, and transport staff would be assisting. What should have happened is law enforcement or security should have accompanied the patient, we would only transport under their authority; EMS in general does not restrain patients. Sometimes with patients who have dementia we have to be a little more forceful. We are trained with backboard restraints for immobility. Using a device designed to restrain somebody that's not something we would do. I hope the answer is yes that law enforcement accompanied them. I need to check with the team and get back with you".
Several weeks after exiting the survey, the surveyor received a voice mail message from the transport company that there was further information which they could provide related to Patient #14. The surveyor called the company 10/28/19 at 12:37 p.m.; noone was available to discuss the information, and a voice message was left. The surveyor called again on 10/28/19 at 4:25 p.m. and asked to speak with someone who could provide further information; however, noone was available to take the call.

Concerns were discussed as noted above, and again on 9/17/19 at 4:30 p.m., with SM #1.
VIOLATION: BLOOD TRANSFUSIONS AND IV MEDICATIONS Tag No: A0409
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on staff interviews, medical record reviews, and review of facility documents, it was determined that the facility staff failed to ensure that administration of blood products was documented per the facility's policy for four (4) patients.

Findings included:

The medical record for Patient #4, admitted to the facility 8/12/19 with the diagnosis of [DIAGNOSES REDACTED].m., at which time vital signs (VS) were also documented. VS were not documented 15 minutes after the initiation of the platelets; VS were documented at 6:44 a.m., 7:06 a.m., 7:46 a.m., and 11:17 a.m. There was no documentation of the completion of the plantlet administration. At 2:45 p.m. on 9/12/19, Staff Member (SM) #1 stated "It looks like (he/she) didn't stop it".

The medical record for Patient #11, admitted to the facility 8/13/19 and discharged [DATE], with diagnoses including, but not limited to myelodysplasti[DIAGNOSES REDACTED] and [DIAGNOSES REDACTED] was reviewed. An order for irradiated platelets was written on 8/27/19 for a plantlet count of less than 10. Prior to initiating the transfusion, the patient's temperature was 100.3, and there was documentation that evidenced that the physician was aware. The transfusion was started at 10:38 a.m. and ran until 12:00 p.m. Vital signs were documented at 10:33 a.m., 10:34 a.m., 11:25 a.m., and 12:00 p.m. Vital signs were not documented 15 minutes after the initiation of platelets, per the facility's policy.

The medical record for Patient #19, admitted [DATE] and discharged [DATE], with diagnoses including but not limited to pneumonia and newly AML, was reviewed. The surveyor noted an order dated 8/27/19 for the transfusion of 1 unit of platelets. The platelets were documented as initiated at 6:15 a.m. on 8/27/19; however, there was no end date or time documented, and no documentation of VS at the end of the transfusion.

Staff Member #15, Assistant Nurse Manager 8 West/Stem Cell was interviewed 9/12/19 at approximately 3:30 p.m., who stated "With this particular case, one missed opportunity caused several issues. What I would anticipate seeing is documentation of completion of the transfusion. It looks like SM #41 cleaned up the charting. The blood transfusion champion does spot checks of documentation, and blood transfusion is part of the yearly unit based competencies. If we see issues with the spot checks, we will do more spot checks. Recently we have been working on doing more spot checks with travelers. T unit based leadership team gets feedback from the audits, and that information is shared with nursing governance. The hospital wide transfusion safety group reports up and out into patient quality".

The medical record for Patient #20, admitted [DATE] and discharged [DATE], with diagnosis including but not limited to progressive renal failure and severe anemia, was reviewed. The surveyor noted an order for 1 unit of packed red blood cells (PRBC) written 8/28/19. The PRBC was documented as initiated at 9:06 a.m., and completed at 11:27 a.m. VS were documented at 9:06 a.m. and 9:36 a.m. VS were not documented 15 minutes after blood was initiated or at the time of the completion of the transfusion.

On 9/13/19 the surveyor was given a copy of an email sent to 8 West and Stem Cell Transplant Unit charge nurses and clinical inpatient oncology RN's, with the subject line "ATTENTION MANDATORY!!! Documentation of Blood Products", importance: HIGH. The email addressed accuracy of documentation related to completion of blood products, record audits until 100 percent compliance for a period of seven (7) days, and coaching for team members not meeting required documentation parameters.

Concerns were discussed with SM's #1 and 15 as noted above, and again on 9/17/19 at 4:30 p.m., with SM #1.

The surveyor reviewed the facility's policy No. 146 titled "Blood Utilization and Administration", which references the Clinical Practice Guidelines for Transfusion, Transfusion Time-Out,, and Lippincott Procedures for Blood administration. The Clinical Nursing Policy for Blood and Blood Product Administration states in part, under "During the Transfusion, the RN" "10. Takes vital signs again 15 minutes after start of transfusion...Completing the Transfusion, the RN: 14. Completes the blood/blood product transfusion within four hours of blood bank issue time, which can be found on the transfusion record tag (pink slip). 15. Takes and documents vital signs at the completion of the transfusion. 16. Documents the actual completion time of the transfusion in Epic, or on the transfusion record tag if not using Epic...".