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Based on observations, interview, and document review, it was determined facility staff failed to ensure that restraints were discontinued at the earliest possible time for one (1) patient (Patient #3).

Findings included:

A focused review of Patient #3's medical record for restraint use revealed the following information:

On 7/28/2020 at 8:24 p.m. an order was written by Staff Member (SM) #19, Nurse Practitioner (NP) for non-behavioral bilateral unsecured mitten restraints "to promote healing, prevent injury and protect tubes, dressings and other medical equipment", with indications for removal as "No longer meets justification for restraint".

The initial restraint documentation on 7/28/2020 at 8:38 p.m., evidenced that Patient #3 "appears sleeping", and that left (L) and right (R) unsecured mittens were "started". The record lacked documentation of behavior which necessitated use of restraint.

At 9:06 p.m. on 7/28/2020, a Dobhoff feeding tube was inserted into Patient #3's nare, secured with a bridle (a nasal bridle is a way to secure a patient's nasal tube in order to retain nutrition flow to the patient).

At 10:00 p.m. on 7/28/2020, restraint documentation evidenced that Patient #3 appeared asleep, was "calm", and that leadership was notified of the restraint use. Documentation for justification for continued restraint was to "promote healing, prevent injury and/or protect tubes, dressings and other medical equipment".

Restraint assessments were documented as performed on 7/29/2020 at 4:10 a.m., 6:22 a.m., 6:30 a.m., 7:37 a.m., 8:00 a.m., 10:00 a.m., 11:00 a.m., 12:00 p.m., and 2:00 p.m. For each of the documented restraint assessments at the aforementioned times on 7/29/2020, there was documentation that there was leadership notification every shift, the patient either "appeared asleep, or was subdued", and that there "was a continued need for restraint". The clinical justification for continued restraint use was documented as "Promote healing, prevent injury and/or protect tubes, dressings and other medical equipment".

At 2:25 p.m. on 7/29/2020, the surveyor was accompanied to 5 West (W), room 524, by facility staff. Upon entering Patient #3's room, the surveyor observed that Patient #3 had one (1) mitt on the left hand, but there was no mitt on the right hand. Patient #3's Dobhoff feeding tube was secured in the nare with a nasal bridle, and tube feeding was infusing. Patient #3 did not respond to verbal stimuli when spoken to by the surveyor. While in the room, SM #23, Patient #3's primary nurse for the day shift on 7/29/2020 entered the room. The surveyor inquired as to what Patient #3's mood and level of alertness had been during the shift, whether Patient #3 had been restless or attempted to pull at the Dobhoff tube. SM #23 responded "From what I understand, [patient] was a little restless during the last shift. Today I haven't seen any restlessness, [patient] has been subdued and catatonic all day. They are going to try some meds [medications] to reverse the catonia, [patient] has been taking Ativan. For now maybe we could look at removing mittens because [patient] isn't doing anything to need them. I'll call the doctor to see if we can d/c [discontinue] them. I hate to do that if the Ativan reverses, but if that happens, we will just have to get another order". The surveyor inquired as to whether Patient #3 had a sitter prior to the initiation of restraint, and SM #23 responded "I didn't hear anything about [patient] having a sitter".

A nursing progress note documented 7/29/2020 at 7:41 a.m. by SM #23 evidenced the following: "Manual B/P [blood pressure] 150/90, Apical HR [heart rate] 90 ans {sic} irregular. Patient responsive (moans) to tactile stimuli only".

A nursing progress note documented 7/29/2020 at 2:40 p.m. by SM #23 evidenced "Patient has remained subdued all of this shift, mitten restraints not indicated as patient has not attempted to remove doffhoff {sic}. Order received to d/c mittens".

SM #19, NP was interviewed by phone on 8/6/2020 at 1:20 p.m. SM #19 said they had an opportunity to review Patient #3's medical record prior to the interview. The surveyor inquired as to behavior exhibited by Patient #3 which required the use of restraint. SM #19 responded "I had been on for seven (7) days when this occurred. Previously [patient] came into the hospital in a catatonic state, but went from agitation to somnolent. The idea behind the mitt was to keep [patient] from pulling out the Dobhoff and to make sure they got it in because [patient's] behavior had been unpredictable over the days before the Dobhoff was placed". SM #19 said, when asked by the surveyor, that they were not sure if less restrictive methods were utilized prior to using restraint, and could not speak as to whether Patient #3 had a sitter. SM #19 added that Patient #3's sister had been at the bedside and may have "acted as a sitter", he/she was not sure". The surveyor inquired as to whether it is usual practice to apply restraints at the time of a procedure such as placement of a Dobhoff feeding tube, in order to protect tubs, dressings, or other medical equipment, prior to a patient exhibiting behaviors which could lead displacement of a tube, dressing, or other equipment. SM #19 responded "I would not say that it is standard practice to place a patient in a restraint before they exhibit behaviors".

The facility's policy entitled "Restraints/Seclusion, Use of", last updated 2/2019 was reviewed, and evidenced the following, in part:
"...III. Policy Statement(s) In accordance with the mission of Carilion Clinic, restraint or seclusion must only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time. This policy applies to all Carilion clinic staff-providers and nursing staff...iv. Diversion activities: 1:1 sitter, use of restorative programs, management of the patient's personal environment, use of supportive devices and special equipment, de-escalation...c. Inappropriate use of restraint or seclusion, includes but is not limited to: i. Restlessness; ii. Falls risk; iii. Alzheimer's; Dementia; iv. Sundowner's syndrome; v. Patients who wander; vi. Critical care setting when a patient is awake, alert, and cooperative...3. Restraint orders:...ii. Non-Behavioral...b. Restraint types include but not limited to : chemical, seclusion, soft limb, mittens, side rails, elbow immobilizer, enclosed bed, restraint chair, body net, locked restraints...d. Orders will include specific restraint placement to include extremity and laterality (ie. left wrist, left mitten, left ankle, etc)...Required Documentation: A description of the patient's behavior and the intervention used; Any alternatives or other less restrictive interventions attempted; the patient's condition or symptom(s) that warranted the use of the restraint...the patient's behavior and staff concerns regarding safety risks to the patient, staff, and others that necessitated the use of restraint...Discontinuation Criteria: The restraint is discontinued when the patient no longer meets restraint criteria found in the order. Inform the patient the criteria to discontinue. Restraints can be removed after a comprehensive assessment by a RN...Before restraints are re-applied, a new order is required...Non-Behavioral Restraint: Used to directly support the medical healing of the patient and the attainment of medical or psychosocial goals when use of alternatives has not proven effective. The use of restraint in these instances is regarded as a safety measure to prevent certain medical decline or injury...Protective intervention: components of care in the medical surgical setting to promote healing (i.e. prevent removal of an endotracheal tube (ETT), nasogastric tube, intravenous lines (IV), central lines, etc.)...Mittens (Mitts): breathable cool knit fabric, padded either with fiberfill or with foam...".

The surveyor asked SM #1 for documentation which demonstrated evidence that Patient #3 exhibited behaviors which warranted the use of restraint; however, no further documentation or information was given to the surveyor. Concerns related to the lack of documentation for behaviors which warranted restraint use for Patient #3 was discussed with SM #1, Director of Accreditation and Licensure on 7/29/2020 at approximately 2:45 p.m., and again with members of Carilion leadership on August 25, 2020 between 8:30 a.m. and 8:45 a.m.

Based on observations, interview, and document review, it was determined facility staff failed to ensure that restraint monitoring was performed per facility policy for two (2) of three (3) patients (Patients #1 and 3).

Findings included:

A focused record review for restraint use for Patient #1 revealed a restraint order written 5/22/2020 at 7:02 p.m. for bilateral upper extremity non-behavioral restraints for 24 hours due to agitation and restlessness. Restraint assessments were documented at 11:00 p.m. on 5/22/2020, and at 1:00 a.m., 4:00 a.m., and 6:00 a.m. on 5/23/2020. There were no two (2) hour restraint assessments documented at 9:00 p.m. 5/22/2020 or 3:00 a.m. on 5/23/2020.

A focused record review for restraint use for Patient #1 revealed verbal order for behavioral restraints, bilateral soft wrist and soft ankle on 6/1/2020 at 5:36 p.m. Restraint assessment for the behavioral restraints was documented at 5:45 p.m., 6:02 p.m., 6:15 p.m., and 6:30 p.m. The behavioral restraint order was documented by SM #29, a Registered Nurse (RN) on 6/1/2020 at 7:05 p.m. There were no restraint assessments documented between 6:30 p.m. and 7:05 p.m. SM #29 (Registered Nurse) documented a nursing note 6/1/2020 at 6:39 p.m. which evidenced "Patient calmer, still becomes agitated when any care performed, however is no longer combative. Continuing to titrate propofol".

A telephone interview was conducted with SM #1 Director of Accreditation Readiness, SM #11 Nursing Quality, SM #2 Director of Nursing Quality, and SM #30, Manager of Policies and Procedures (P&P) on 8/24/2020 at 1:00 p.m. SM #1 told the surveyor that every 15 minute documentation was not necessary because Patient #1's behavioral restraints were discontinued on the flow sheet 6/1/2020 at 6:30 p.m. on 6/1/2020. SM #1 continued, saying that the timing of the order "might not be the same as in the medical record". SM #11 added that "Patient care activities and communication with the physician might cause a lag in the timing of the discharge order".

The surveyor noted that on 6/1/2020 at 6:30 p.m., an order for renewal of non-behavioral restraints bilateral soft wrist, and a new order for soft right ankle restraint were documented on the restraint flowsheet at 6:30 p.m. on 6/1/2020 by SM # 29 (Registered Nurse).

SM #1 told the surveyor "Our P&P says we can remove restraints and we do not need a discontinue order".

A review of Patient #3's medical record revealed an order for non-behavioral restraints for non-secured right and left mittens for 24 hours. The order was to remove restraints when patient no longer met justification for restraints. The order was written at 8:24 p.m. on 7/28/2020, and the documented reason for restraint was to "Promote healing, prevent injury and protect tubes, dressings, and other medical equipment".

Restraint flowsheets in Patient #3's record evidenced documentation of restraint assessment at 8:38 p.m. (time of restraint initiation) and 10:00 p.m. on 7/28/2020. On 7/29/2020 at 12:48 a.m. and 2:10 a.m. there were lines in the area where restraint documentation should have been documented. On 7/29/2020 between 4:10 a.m. and 2:41 p.m. there was evidence of restraint documentation at least every two hours on the flowsheet. Restraints were discontinued at 2:41 p.m. on 7/29/2020.

SM #11, RN Nursing Quality, navigated Patient #3's electronic health record (EHR) with the surveyor, and was unable to provide the surveyor with further restraint documentation for the aforementioned episode of restraint.

A review of the facility's policy titled "Restraints/Seclusion, Use of", last updated 2/2019, revealed the following information, in part, related to monitoring of Behavioral Mechanical Restraints: "...Monitor the physical and psychological well-being of the patient every (15) minutes, including respiratory and circulatory status; skin integrity. Vital signs will be assessed as often as needed taking into consideration the patient's condition, cognitive status & intervention risk. RN assessment of continued need for restraint is completed at a minimum every (2) hours...". 6. The facility's policy entitled "Restraints/Seclusion, Use of" last updated 2/2019, was reviewed, and revealed the following information, in part: "...Monitoring Non-Behavioral-Monitor the physical and psychological well-being of the patient every (2) hours, including respiratory and circulatory status; skin integrity & an RN [registered nurse] assessment of continued need for restraint. Vital signs will be assessed as often as needed taking into consideration the patient's condition, cognitive status & intervention risk. RN assessment of continued need for restraint is completed at a minimum every (2) hours...".

Concerns related to restraint assessment documentation was discussed with Staff Members # 1, Director of Accreditation Readiness, and Staff Member #11, Nursing Quality, on 7/29/2020 at approximately 3:30 p.m.
Restraint concerns were discussed with members of administration and leadership on 8/25/2020 between 8:30 a.m. and 8:45 a.m.

Based on observations, interview, and document review, it was determined facility staff failed to ensure that the medical record included a description of the behavior which warranted the use of restraint for one (1) patient (Patient #3).

Findings included:

A focused review of Patient #3's medical record for restraint use revealed documentation in the progress note of a general physical exam by the hospitalist on 7/28/2020 at 5:09 p.m. that Patient #3 was "very drowsy, arouses briefly. Couldn't get [patient] to sip water for me". Patient #3's psychiatric assessment was "drowsy, mostly cooperative". The note evidenced that Patient #3's sodium level was rising "despite giving d5W". D5W is a form of glucose in water which is given into a vein through an IV (intravenous therapy which delivers fluids directly into a vein). The hospitalist noted that they would discuss Patient #3 with another physician to determine if a Dobhoff could be placed for administration of medications, tube feedings, and water. The hospitalist documented that Patient #3 "might need a sitter and/or mittens...".

On 7/28/2020 at 8:24 p.m. an order was written by Staff Member (SM) #19, Nurse Practitioner (NP) for non-behavioral bilateral unsecured mitten restraints "to promote healing, prevent injury and protect tubes, dressings and other medical equipment", with indications for removal as "No longer meets justification for restraint".

The initial restraint documentation on 7/28/2020 at 8:38 p.m., evidenced that Patient #3 "appears sleeping", and that left (L) and right (R) unsecured mittens were "started". The record lacked documentation of behavior which necessitated use of restraint.

At 9:06 p.m. on 7/28/2020, a Dobhoff feeding tube was inserted into Patient #3's nare, secured with a bridle (a nasal bridle is a way to secure a patient's nasal tube in order to retain nutrition flow to the patient).

At 10:00 p.m. on 7/28/2020, restraint documentation evidenced that Patient #3 appeared asleep, was "calm", and that leadership was notified of the restraint use. Documentation for justification for continued restraint was to "promote healing, prevent injury and/or protect tubes, dressings and other medical equipment".

Restraint assessments were documented as performed on 7/29/2020 at 4:10 a.m., 6:30 a.m., 8:00 a.m., 10:00 a.m., 11:00 a.m., 12:00 p.m., and 2:00 p.m. For each of the documented restraint assessments at the aforementioned times on 7/29/2020, there was documentation that there was leadership notification every shift, the patient either "appeared asleep, or was subdued", and that there "was a continued need for restraint". The clinical justification for continued restraint use was documented as "Promote healing, prevent injury and/or protect tubes, dressings and other medical equipment". The record lacked description of behaviors exhibited by Patient #3 which warranted restraint use.

At 2:25 p.m. on 7/29/2020, the surveyor was accompanied to 5 West (W), room 524, by facility staff. Upon entering Patient #3's room, the surveyor observed that Patient #3 had one (1) mitt on the left hand, but there was no mitt on the right hand. Patient #3's Dobhoff feeding tube was secured in the nare with a nasal bridle, and tube feeding was infusing. Patient #3 did not respond to verbal stimuli when spoken to by the surveyor. While in the room, SM #23, Patient #3's primary nurse for the day shift on 7/29/2020 entered the room. The surveyor inquired as to what Patient #3's mood and level of alertness had been during the shift, whether Patient #3 had been restless or attempted to pull at the Dobhoff tube. SM #23 responded "From what I understand, [patient] was a little restless during the last shift. Today I haven't seen any restlessness, [patient] has been subdued and catatonic all day. They are going to try some meds [medications] to reverse the catonia, [patient] has been taking Ativan. For now maybe we could look at removing mittens because [patient] isn't doing anything to need them. I'll call the doctor to see if we can d/c [discontinue] them. I hate to do that if the Ativan reverses, but if that happens, we will just have to get another order". The surveyor inquired as to whether Patient #3 had a sitter prior to the initiation of restraint, and SM #23 responded "I didn't hear anything about [patient] having a sitter".

A nursing progress note documented 7/29/2020 at 7:41 a.m. by SM #23 evidenced the following: "Manual B/P [blood pressure] 150/90, Apical HR [heart rate] 90 ans {sic} irregular. Patient responsive (moans) to tactile stimuli only".

A nursing progress note documented 7/29/2020 at 2:40 p.m. by SM #23 evidenced "Patient has remained subdued all of this shift, mitten restraints not indicated as patient has not attempted to remove doffhoff {sic}. Order received to d/c mittens".

SM #19, NP was interviewed by phone on 8/6/2020 at 1:20 p.m. SM #19 said they had an opportunity to review Patient #3's medical record prior to the interview. The surveyor inquired as to behavior exhibited by Patient #3 which required the use of restraint. SM #19 responded "I had been on for seven (7) das when this occurred. Previously [patient] came into the hospital in a catatonic state, but went from agitation to somnolent. The idea behind the mitt was to keep [patient] from pulling out the Dobhoff and to make sure they got it in because [patient's] behavior had been unpredictable over the days before the Dobhoff was placed". SM #19 said, when asked by the surveyor, that they were not sure if less restrictive methods were utilized prior to using restraint, and could not speak as to whether Patient #3 had a sitter. SM #19 added that Patient #3's sister had been at the bedside and may have "acted as a sitter", he/she was not sure". The surveyor inquired as to whether it was usual practice to apply restraints at the time of a procedure such as placement of a Dobhoff feeding tube, in order to protect tubs, dressings, or other medical equipment, prior to a patient exhibiting behaviors which could lead displacement of a tube, dressing, or other equipment. SM #19 responded "I would not say that it is standard practice to place a patient in a restraint before they exhibit behaviors".

The facility's policy entitled "Restraints/Seclusion, Use of", last updated 2/2019 was reviewed, and evidenced the following, in part:
"...III. Policy Statement(s) In accordance with the mission of Carilion Clinic, restraint or seclusion must only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time. This policy applies to all Carilion clinic staff-providers and nursing staff...iv. Diversion activities: 1:1 sitter, use of restorative programs, management of the patient's personal environment, use of supportive devices and special equipment, de-escalation...c. Inappropriate use of restraint or seclusion, includes but is not limited to: i. Restlessness; ii. Falls risk; iii. Alzheimer's; Dementia; iv. Sundowner's syndrome; v. Patients who wander; vi. Critical care setting when a patient is awake, alert, and cooperative...3. Restraint orders:...ii. Non-Behavioral...b. Restraint types include but not limited to : chemical, seclusion, soft limb, mittens, side rails, elbow immobilizer, enclosed bed, restraint chair, body net, locked restraints...d. Orders will include specific restraint placement to include extremity and laterality (ie. left wrist, left mitten, left ankle, etc)...Required Documentation: A description of the patient's behavior and the intervention used; Any alternatives or other less restrictive interventions attempted; the patient's condition or symptom(s) that warranted the use of the restraint...the patient's behavior and staff concerns regarding safety risks to the patient, staff, and others that necessitated the use of restraint...Discontinuation Criteria: The restraint is discontinued when the patient no longer meets restraint criteria found in the order. Inform the patient the criteria to discontinue. Restraints can be removed after a comprehensive assessment by a RN...Before restraints are re-applied, a new order is required...Non-Behavioral Restraint: Used to directly support the medical healing of the patient and the attainment of medical or psychosocial goals when use of alternatives has not proven effective. The use of restraint in these instances is regarded as a safety measure to prevent certain medical decline or injury...Protective intervention: components of care in the medical surgical setting to promote healing (i.e. prevent removal of an endotracheal tube (ETT), nasogastric tube, intravenous lines (IV), central lines, etc.)...Mittens (Mitts): breathable cool knit fabric, padded either with fiberfill or with foam...".

The surveyor asked SM #1 (Director of Accreditation Readiness) and SM #11 (RN Nursing Quality) SM #1 for documentation which demonstrated evidence that Patient #3 exhibited behaviors which warranted the use of restraint; however, no further documentation or information was given to the surveyor. Concerns related to the lack of documentation for behaviors which warranted restraint use for Patient #3 was discussed with SM #1, Director of Accreditation Readiness on 7/29/2020 at approximately 2:45 p.m., and again on August 25, 2020 with members of Carilion leadership between 8:30 a.m. and 8:45 a.m.

Based on observations, interview and document review, it was determined facility staff failed to ensure that hand sanitizer was available for visitors and staff to maintain a clean and sanitary environment and to help control the transmission of infection.

Findings included:

The surveyor arrived at the facility at 11:00 a.m. on 7/28/2020 and entered the facility from the parking garage via the tunnel into the lobby. There was no hand sanitizer station available from the elevators in the parking garage to the information desk in the lobby. The surveyor was sent to a COVID-19 screening station at the front entrance of the hospital where no hand sanitizer was offered. Staff Member #2, Director of Nursing Quality, arrived to accompany the surveyor to a conference room, and the surveyor observed two (2) brackets on the wall used to hold cans of hand sanitizer at the elevators. One of the brackets did not contain a sanitizer receptacle.

The surveyor was accompanied across the street to the rehabilitation (rehab) building to make observations on the behavioral health units, on 7/28/2020 at approximately 11:20 a.m. Upon entry to the rehab, the surveyor observed that there were no hand sanitizing stations available for use in the lobby area, or at the elevators. Upon returning to the conference room in the main hospital, the surveyor discussed the observations made related to lack of available hand sanitizer for use by the public entering the facility, both at the rehab and the main hospital.

On 7/29/2020 at 2:25 p.m. the surveyor, accompanied by facility staff, went to the 5th (fifth) floor to make restraint observations in room 524. Upon entry into the room, the surveyor attempted to use the sanitizer mounted on the wall just inside door; however, there was no hand sanitizer available for use. The surveyor discussed the lack of available hand sanitizer upon entry to the patient room with accompanying facility staff.

The facility's policy entitled "Hand Hygiene", last updated 6/2020 was reviewed, and revealed the following information, in part: ".... PURPOSE: Hand hygiene compliance has been identified as the most successful means of preventing the transmission of microorganisms. All patients, staff, visitors, and providers should practice proper hand hygiene. Implementation of the Centers for Disease Control (CDC) Guidelines for Hand Hygiene in Health-care Settings, 2002 and an effective multidisciplinary hand hygiene program will decrease the incidence of healthcare associated infections. In order to maintain a high level of care, Carilion Clinic expects employees to perform hand hygiene and to remind their peers to do the same. II. SCOPE: The scope of this policy applies to all patients, visitors, staff, and physicians receiving or providing care at Carilion Clinic...IV. PROCEDURE:...C. Indications for Hand Hygiene outside of performing patient care: 1. BEFORE: a. Eating; b. Touching your own mucous membranes such as handling contact lenses and applying lip products. 2. AFTER: a. Using the restroom; b. Touching your own mucus {sic} membranes, such as handling contact lenses or blowing your nose...V. OTHER ISSUES/CONCERNS: Compliance: Compliance will be monitored by direct observation, to include when entering and exiting the room, and other methods as available. The compliance data will be reported within the organization and to outside organizations as required. Failure to perform hand hygiene may place the employee at risk of disciplinary action...Patient/Family/Visitors Education-Patients, families, and visitors will receive education on hand hygiene".

On 8/14/2020 at 12:40 p.m., the surveyor interviewed Staff Member #28, Infection Preventionist. SM #28 told the surveyor that the facility "relied heavily" on visual signage at entrances and hand sanitizing stations for education of patients and family member. SM #28 stated that hand hygiene audits were conducted throughout the hospital by department leaders, and that the facility has "hand hygiene champions". SM #28 added that infection preventionists round weekly to monitor the environment, and that nursing leadership expects managers to perform environmental rounds, but was unaware of the frequency with which those rounds were performed.

Concerns related to lack of hand sanitizer available for public use were discussed with Staff Members #2 and 3 on 7/28/2020. Facility staff were made aware of the lack of hand sanitizer available in a patient room on 7/29/2020.