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715 DELMORE DRIVE

ROSEAU, MN 56751

PATIENTS RIGHTS

Tag No.: C2500

Based on interview and document review, the hospital failed to ensure restraint orders, assessments, and reassessment processes, along with documentation, were performed consistent with hospital policy and accepted standards of practice for 3 of 3 patients (P24, P25, P12), who were restrained for the management of violent or non-violent behaviors. In addition, the facility failed to ensure the hospital restraint policy outlined accepted standards of practice for restraint use and had all contracted emergency department medical providers complete facility restraint training. These deficient practices had the potential to affect all emergency department and hospital patients.


As a result of these failures, these deficient practices resulted in a condition level deficiency and the hospital was found NOT in compliance with the Condition of Participation for Patient Rights at 42 CFR 485.614.

A condition-level deficiency was issued.

Findings include:

See C-2553 Based on interview and document review, the hospital failed to ensure restraint orders, assessments, and reassessment processes, along with documentation, were performed consistent with hospital policy and accepted standards of practice for 3 of 3 patients (P24, P25, P12), who were restrained for the management of violent or non-violent behaviors. In addition, the facility failed to ensure the hospital restraint policy outlined accepted standards of practice for restraint use. These deficient practices had the potential to affect all emergency department and hospital patients.

See C-2560 Based on interview and document review, the facility failed to ensure all contracted emergency department medical providers completed restraint training and had a working knowledge of the facility policy in relation to expectations related to restraints. This deficient practice had the potential to affect all emergency department and hospital patients.

RESTRAINT AND SECLUSION

Tag No.: C2553

Based on interview and document review, the hospital failed to ensure restraint orders, assessments, and reassessment processes, along with documentation, were performed consistent with hospital policy and accepted standards of practice for 3 of 3 patients (P24, P25, P12), who were restrained for the management of violent or non-violent behaviors. In addition, the facility failed to ensure the hospital restraint policy outlined accepted standards of practice for restraint use. These deficient practices had the potential to affect all emergency department and hospital patients.

Findings include:

A facility provided undated restraint use list identified three patients utilized restraints over the past 12 months: P24, P25, and P12.

P24:

P24's medical record identified P24 presented to the emergency department (ED) on 2/26/24 at 10:08 a.m. with a chief complaint of her being suicidal.

P24's ED Care Timeline, dated 2/26/24, identified the following:
-Between 10:40 a.m. and 12:50 p.m., P24 yelled/screamed at, threw things at, spit at, and threatened staff, along with attempts to hit staff. At one point, after an order for "B52" (Benadryl, Haldol (antipsychotic), Ativan (antianxiety) was placed by doctor of osteopathy (DO)-A, P24 kicked staff and broke the needle from the syringe when staff attempted to administer the B52 and punctured the nurse with it.
-At 12:52 p.m., an order for restraints was placed by DO-A.
-At 1:00 p.m., P24 was placed in Velcro restraints due to her being a threat to herself and others. P24 continued to scream and was aggressive. The documentation lacked where the restraints were placed.
-At 1:05 p.m., P24 was administered the B52 injection.
-At 1:40 p.m., P24 slept in bed. Restraints remained on as when she awoke, she was combative and belligerent.
-At 3:01 p.m., the restraints were removed from P24 as she was calm and cooperative.

An Other Order section of P24's medical record identified a Restraint subsection with an identified Restraint for Violent Behavior/Seclusion/Chemical Restraint/Physical Hold order. The following information was identified:
-The order was electronically signed on 2/26/24 at 12:52 p.m. by DO-A.
-The Restraint type was "Soft." No further directions were provided.
-The Indication/Justification was danger to self/others, refusal to obey commands, and aggressive behavior (striking out, destruction of property, threatening others).
-An Order comments section directed an "Initial 1 [one]-hour face to face assessment must be completed by MD [medical doctor] or specially trained RN [registered nurse]. The face to face must be documented in the medical record, dictated, or a timed written progress note completed.
-The order lacked detailed identification related to the "soft" restraint application(s) i.e. which designated soft restraint and/or which applicable limb(s).

A Flowsheets section of P24's medical record identified a Restraint for Violent Behavior/Seclusion subsection, and the following information related to nursing staff monitoring on 2/26/24:
-At 1:03 p.m., "Soft Restraint" to right and left wrists and ankles (4-point restraints) were initiated.
-At 1:15 p.m., "Velcro" right and left wrist and ankle restraints continued.
-At 2:00 p.m., a "Physical Hold" continued, along with the Velcro restraints. The flow sheets did not identify an initiated or discontinued date/time.
-At 2:55 p.m., the Velcro restraints were discontinued.

An ED Provider Note dated 2/26/24 at 5:34 p.m., indicated P24 was physically and verbally aggressive with staff and law enforcement. As a result, "soft restraints" were applied. But these proved ineffective which resulted in a staff member being kicked in the arm. Ultimately, "chemical restraints" were applied which seemed more effective at calming P24 down. Under the Medical Decision Making, it was identified P24 was stable with "chemical restraints," and she rested comfortably.

A Medication Administrations section of P24's medical record identified the only medications administered were Benadryl, Haldol, and Ativan which were ordered at 11:32 a.m. by DO-A. The Route identified intramuscular injection (IM); however, the order lacked any additional administration details i.e. per physical hold.

In addition, P24's medical record lacked the following information:
-A chemical restraint order was placed based on the providers documentation of its use.
-A physical hold order was placed in relation to the 2:00 p.m. physical hold restraint flowsheet documentation.
-An order to discontinue the soft restraints before or after the restraints were removed at 3:01 p.m.
-Restraint flowsheet monitoring for the provider identified "chemical restraints."
-Documentation from DO-A related to the nursing documented physical hold and the restraint devices used.
-Documentation to support the 1-hour face-to-face evaluation was completed.

P25:

P25's medical record identified P25 presented to the ED on 4/29/24 at 6:23 p.m. with a chief complaint of weakness and abdominal pain. Additionally, P25 presented with diagnoses of dementia and mental status changes.

P25's ED Care Timeline, dated 4/29/24 at 9:40 p.m., P25 rolled around in bed in which the intravenous (IV) line was pulled out and bled. "Soft wrist restraints applied to protect medical devices" per provider.

An Other Order section of P25's medical record identified a Restraint subsection with an identified Restraint for Nonviolent Behavior order. The following information was identified:
-At 11:41 p.m., the order was entered into the medical record by RN-A based on a provider's verbal order.
-The restraint type was "Velcro." The order lacked additional direction i.e. which designated Velcro restraint and/or which applicable limb(s).
-The Indication/Justification was for "Overt Action (Pulling at tubes, lines, equipment."
-At 11:54, the provider acknowledged the order.

A Flowsheets section of P25's medical record identified a Restraint for Violent Behavior/Seclusion subsection, and the following information related to nursing staff monitoring on 4/29/24:
-At 9:40 p.m., Velcro restraints were applied to P25's right and left wrists
-At 11:46 p.m., the Velcro restraints continued.
-The flowsheets lacked identification when the restraints were discontinued.

P25's ED Care Timeline dated 4/30/24 at 12:18 a.m., identified P25 was admitted to the hospital.

An inpatient nurse Clinical Note dated 4/30/24 at 1:00 a.m., and electronically signed at 7:50 a.m., identified the nurse "reviewed previous restraint order (from ED) with Nocturnist; New orders received to discontinue physical restraints."

P25's medical record lacked the following information:
-A processed order to discontinue the restraints.
-An identified time when the restraints were removed and P25's status at the time of removal.

P12:

P12's medical record identified P12, aged 17, presented to the ED on 11/3/24 at 5:21 p.m. with chief complaints of drug overdose and suicide attempt.

A nurse Clinical Note dated 11/3/24 at 8:03 p.m., identified P12 became increasingly agitated and began hitting her head against the wall and slammed all her extremities into the wall and bed railing. Despite redirection attempts, P12 continued with the behaviors and thus "physical restraints" were initiated by the MD.

A Flowsheets section of P12's medical record identified a Restraint for Violent Behavior/Seclusion subsection, and the following information related to nursing staff monitoring on 11/3/24:
-At 8:03 p.m., a "Physical Hold" and "Soft Restraint" to right and left wrists and ankles (4-point restraints) was initiated.
-The flow sheet lacked an identified discontinuation time for the physical hold; however, the soft restraints continued to be utilized.
-At 11:08 p.m. (three hours later) the soft restraints were removed.
-The flowsheets identified the Length of Order was "4 hours (age 18 and older)."
-During the 15-minute monitoring, the RN completed questions under the heading "Initial 1 Hr. [hour] Face to Face Assessment," which directed this section was to be completed by "Specially Trained RN: Hospital Supervisor and Psych Nurses."

A nurse Clinical Note dated 11/3/24 at 11:08 p.m., identified the provider removed the restraints at that time.

An Other Order section of P12's medical record identified a Restraint subsection with an identified Restraint for Violent Behavior/Seclusion/Chemical Restraint/Physical Hold order. The following information was identified:
-The order was electronically signed on 11/3/24 at 8:27 p.m. by DO-A.
-The Restraint type was "Medication" with a Time Interval of "2 [two] hours (Children/Adolescents 9 [nine]-17 years)."
-The Indication/Justification was danger to self/others and aggressive behavior (striking out, destruction of property, threatening others).
-An Order comments section directed an "Initial 1 hour face to face assessment must be completed by MD or specially trained RN. Re-evaluation assessment of the patient must be completed by the physician for the continuing of seclusion or restraint for violent behavior. Every 8 hours ages 18 and older - Every 4 hours ages 17 and under." The face to face and the re-assessment must be documented in the medical record, dictated, or a timed written progress note completed.

Additionally, the restraint order identified the order was discontinued on 11/5/24 at 7:22 a.m. after P12 discharged from the ED on 11/5/24 at 5:13 a.m., not after the restraints were removed on 11/3/24 at 11:08 p.m.

An ED Provider Note dated 11/10/24 at 1:53 p.m., indicated a Medical Decision-Making section that identified P12 became exceedingly uncooperative where she screamed/yelled out and thrashed about. P12 repeatedly stated 'make it stop,' in reference to her thrashing. P12 continued in this way for quite some time and initially required physical restraints to keep her from harming herself. While P12 was physically restrained by DO-A, two other staff members, and both of her parents, P12 was given an IM antipsychotic medication. With this medication on board and no apparent results after 10-15 minutes, physical soft restraints were requested and eventually applied at about 8:00 pm. Despite the medications and being physically restrained by multiple individuals, P21 continued to thrash about in a violent manner.

P12's medical record lacked the following information:
-Orders related to the physical hold and the wrist and ankle restraint applications.
-A re-order for continued wrist and ankle restraints after two hours of application (based on initial order).
-Additional documentation from DO-A related to the physical hold and the restraint devices used.
-Documentation to support the 1-hour face-to-face evaluation was completed.
-Documentation to support the 2-hour re-evaluation for continued restraint use was completed.

When interviewed on 1/9/25 at approximately 3:30 p.m., the chief nursing officer (CNO) stated a provider order was required for restraints, and based on the order directions, she expected the provider to complete the face-to-face assessment within an hour of the restraint application. She indicated nursing staff were not trained in this process; however, they completed it [within the restraint flowsheets]. She was unable to comment on the restraint policy details, and stated the need to review the policy for specifics related to monitoring, the overall face-to-face process requirements, and documentation due to the facility's minimal restraint usage.

During an interview on 1/9/25 at 3:49 p.m., the ED medical director (MD)-B stated he expected providers to order restraints when such an intervention was assessed to be appropriate. Once a behavioral restraint was applied, he expected a 1-hour face-to-face to be completed within 1 hour of application. This required a head-to-toe examination, evaluation of the patient's mental, behavioral, and medical status, and the determination if the restraint needed to continue or if the restraint was able to safety be discontinued. Once completed, he expected this assessment to be documented in the patient's medical record. MD-B explained that if a restraint was discontinued; however, was required again, the whole restraint process was expected to start all over, beginning with a new order. MD-B reviewed P12 and P24's medical records and identified these two records lacked particular restraint orders, the 1-hour face-to-face assessments, and a 2-hour re-evaluation for P12.

When interviewed on 1/9/25 at 4:07 p.m., DO-A identified he was a contracted provider. He explained that often he was required to provide a verbal order first due to the nature of the unsafe behaviors when restraints were utilized. Once "the scene [was] stable," he then went back and entered an order into the medical record. He "generally" did not do restraint reassessments himself as "the nurses do that." When questioned on the 1-hour face-to-face process, he was unsure about that process, was not aware he was required to do this, and identified the nurses did this assessment. He did not know if the order, once entered, directed him to complete such a process. He stated he did not do "full examination[s]" on patients when restraints were utilized. He was unaware this was required. He explained behavioral patients were most often placed in the room right next to where the provider sat and thus, he always listened, paid attention, and kept his eye on these patients but he did not document anything official. When questioned on reassessments, he indicated this was required every four hours, to ensure patients were okay and to assess if the restraints could be removed. he stated restraints utilized were such items that restrained the patient to the bed and thus "as a general rule" he did not place orders for any manual/physical holds when required for administration of an IM medication, [such as the B52]. DO-A stated he was unsure what the facility's restraint policy directed, he would have to review for details.

When interviewed on 1/10/25 at 10:42, RN-B, the ED supervisor, stated soft mitts and soft Velcro "Posey" brand restraints were utilized in the ED. She explained a medical provider was required to enter the restraint orders under most circumstances, and only when a nurse was attacked would a verbal restraint order be appropriate. She expected restraint orders to be inputted by the provider within 30 minutes of application, and any restraint initiation/application required an order. She was unable to express specifics related to the policy; however, if restraints were required, she would print the policy and follow it. She was present for P24's "psychotic break" and restraint applications. She explained that initially law enforcement held P24; however, due to her continued behaviors and safety risks, soft Velcro Posey brand restraints were applied. At one point, due to P24's continued attempts to break free of the restraints, the restraints became loose, and staff were required to again hold P24 for adjustment of the restraints. She was not present for P12's ED visit, but she stated she reviewed her record after the fact, and she did not remember any identified concerns with that review. She explained the nurses and the providers worked very closely with each other during unsafe behavioral events, and if an IM medication was ordered in such situations, a verbal order from the provider was given. She did not think this order however was placed officially in the medical record. P25 was the first patient to utilize the restraint mitts, and she was "almost positive" these were removed in the ED, but she was not 100 percent sure. She expected the ED staff to obtain discontinuation orders when restraints were removed.

During interview on 1/10/25 at 11:46 a.m., RN-C stated she was unable to remember any details related to P25's and/or his restraint use. She indicated she had never utilized the restraint mitts on any patients while she worked in the ED. She would need to review the policy for specifics as the facility seldom utilized such interventions. She was expected to follow the policy.

During an interview on 1/10/25 at 12:12 p.m., RN-A stated she was unable to remember any details related to P25's restraints. She was unsure if P25 presented to the inpatient unit with the restraints on, if she removed them, or when she conversed with the provider related to her restraint discontinuation clinical note entry. As she could not remember ever working with a patient who was restrained, that it was highly unlikely P25 presented to the unit with restraints.

When interviewed on 1/20/25 at 12:33 p.m., the quality and risk director (QD) stated all restraint use was brought to her for review. During this review, "We look to make sure there was an order, and the documentation was there." QD stated the policy was "not good."

A Restraint/Seclusion Policy undated, identified restraints were only to be used when ordered by a licensed provider, physician, or trained RN after the need was established. Its purpose was to ensure restraints were appropriately utilized while patients' rights, dignity, and wellbeing were protected. A restraint was defined as "any method of physically or chemically restricting a person's freedom of movement, physical activity, or normal access to his/her body." A physical restraint was any manual method, physical or mechanical device, material, or equipment attached or adjacent to the patient's body and a chemical restraint was a medication used to control behavior or to restrict the patient's freedom of movement and was not a standard treatment for the patient's medical or psychiatric condition.
-For medical (non-violent) restraints, an order must be obtained from a licensed independent practitioner (LIP), physician or mid-level provider. If one was not available, an RN may initiate the restraint based on an appropriate assessment of the patient. The policy identified protocols that directed staff must document on the restraint flow sheet when the restraint was terminated.
-For behavioral (violent) restraints, an RN could initiate the restraint; however, the RN was to obtain a verbal or written order form the LIP within one hour. The LIP or the RN must conduct an in-person evaluation within two hours for patients 17 years or younger to determine continued restraint need(s) and the LIP must also see the patient and re-evaluate the need for continued restraint(s) every hour for patients 17 years and younger. Verbal or written orders must be re-ordered from the LIP every 2 hours for patients nine to 18 years. Once the restraint is removed, the patient was to be assessed for their physical and mental well-being which was to be documented in the medical record.
-The policy failed to reflect standards of practice for violent restraint ordering timeframes where the order is obtained prior to the application or immediately (within a few minutes) after the restraint is applied.
-The policy failed to identify the standard of practice 1-hour face-to-face assessment/evaluation process and the face-to-face components related to the patient's immediate situation, their reaction to the intervention, their medical and behavioral condition, and their needs related to continued use or termination of the restraint.
-The policy failed to identify the standards of practice for timeframes on how often a patient was to be monitored/assessed when medical restraints were applied.
-The policy failed to reflect standards of practice which limited the use of violent restraints for up to a total of 24 hours in which a renewal order was required every two hours for children and adolescents nine to 17 years of age. Then after 24 hours, before a new order was written, the patient was to be seen and assessed by the physician or licensed practitioner who was responsible for the patient.
-The policy failed to identify physician and other licensed practitioner training requirements.
-The policy failed to identify the standards of practice which directed simultaneous use of restraint and seclusion was only permitted when the patient was monitored continually.

RESTRAINT AND SECLUSION

Tag No.: C2560

Based on interview and document review, the facility failed to ensure all contracted emergency department medical providers completed restraint training, and had a working knowledge of the facility policy in relation to expectations related to restraints. This deficient practice had the potential to affect all emergency department and hospital patients.

Findings include:

A Medical Staff Credentialing information list identified 31 contracted Wapiti (medical staffing agency) medical practitioners.

During an interview on 1/7/25 at 10:42 a.m., ED medical doctor (MD)-A identified she was a Wapiti contracted provider. MD-B was unaware of the facility's restraint policy and stated she had yet to order restraints there. If this was required, she would review the policy and follow policy direction.

When interviewed on 1/9/25 at 9:33 a.m., ED MD-D identified he was a Wapiti contracted provider and had only worked a couple days in the past six or so months. He was unaware of the facility's restraint policy; however, he identified a 1-hour face-to-face would be required within an hour of application. For specific policy details, he would have to review the policy.

During an interview on 1/9/25 at 3:49 p.m., the ED medical director (MD)-B stated he was unsure what restraint training the contracted ED medical providers received as "they come to us trained already" from their company. MD-B stated each of these providers went through the credentialing processes in which psychiatric services fell under the core of ED privileges. Despite this, he was unsure if restraint training was specifically identified within this process.

When interviewed on 1/9/25 at 4:07 p.m., doctor of osteopathy (DO)-A identified he was a Wapiti contracted provider. He explained that often he was required to provide a verbal order first due to the nature of the unsafe behaviors when restraints were utilized. Once "the scene [was] stable," he then went back and entered an order into the medical record. He "generally" did not do restraint reassessments himself as "the nurses do that." When questioned on the 1-hour face-to-face process, he was unsure about that process, was not aware he was required to do this, and identified the nurses did this assessment. He did not know if the order, once entered, directed him to complete such a process. He stated he did not do "full examination[s]" on patients when restraints were utilized. He was unaware this was required. He explained behavioral patients were most often placed in the room right next to where the provider sat and thus, he always listened, paid attention, and kept his eye on these patients but he did not document anything official. When questioned on reassessments, DO-A indicated this was required every four hours - to ensure patients were okay and to assess if the restraints could be removed. Restraints utilized were such items that restrained the patient to the bed and thus "as a general rule" he did not place orders for any manual/physical holds when required for administration of an IM medication, [such as the B52]. He was unsure what the facility's restraint policy directed, he would have to review for details.

On 1/10/25 at 11:37 a.m., the quality and risk director (QD) relayed information related to contracted provider restraint education. She stated Wapiti did not provide their providers with restraint education as this was a facility responsibility. She expected when the facility contracted with a staffing agency, those providers would be educated by the agency.

An email to QD, from a Wapiti employee, dated 1/10/25 at 12:21 p.m., identified confirmation the staffing agency did not provide restraint education to their providers as they followed "each facility's lead with provider education."

A Restraint/Seclusion Policy undated, identified education on the appropriate use of restraints and alternatives to them was provided at the initial orientation and updated for all nursing staff as indicated. The policy lacked direction when medical providers (in-house and/or contracted practitioners) were educated.