Parkland Medical Center

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 47129 Based on record review and interview, the hospital failed to implement policies for identifying chemical restraints (A drug or medication when it is used as a restriction to manage the patient’s behavior or restrict the patient’s freedom of movement and is not a standard treatment or dosage for the patient’s condition) and monitoring data to ensure proper use of chemical restraints (refer to A167 Patient Rights: Restraint or Seclusion); failed to have a physician’s order for the use of restraints (refer to A168 Patient Rights: Restraint or Seclusion); failed to have a trained staff to monitor the condition of a patient in restraints (refer to A175 Patient Rights: Restraint or Seclusion); failed to specify in the hospital policy the training requirements for physicians and other licensed practitioners (refer to A176 Patient Rights: Restraint or Seclusion); and failed to have training and competencies in the safe application of a restraints for staff, contracted staff, and physicians (refer to A196 Patient Rights: Restrains or Seclusion).”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(4)(ii) [The use of restraint or seclusion must be--] (ii) implemented in accordance with safe and appropriate restraint and seclusion techniques as determined by hospital policy in accordance with State law. This Standard is not met as evidenced by: 47129 Based on interview and record review, it was determined that the hospital failed to implement policies for identifying chemical restraints and monitoring data to ensure proper use of chemical restraints for 3 of 10 patients reviewed for restraints. (Patient identifier’s are #1, #5 and #6.) Findings include: Review on 5/15/25 of the facility’s policy titled “Patient Restraining/Seclusion” effective 12/1/20, revealed, “... 13. Performance Improvement: a. Data on the use of restraint and seclusion is collected to monitor appropriate use and to identify process improvement opportunities. b. Data elements include: 1) Number of patients restrained or secluded 2) Number of restraints or seclusion hours 3) Type of restraints 4) Number of restraint or seclusion episodes 5) Number of patient injuries/deaths while restrained or secluded c. Data is trended, patterns of use, safety, and effectiveness are evaluated. Progress toward preventing, reducing and eliminating the use of restraints or seclusion is assessed. d. Results of analysis are shared with facility leadership and appropriate committees, the Medical Executive Committee and the Board of Trustees/Governing Body. e. If any inappropriate use of restraints or seclusion is identified, a root cause analysis will be performed, measures identified and implemented to remedy the issue(s)...”. Patient #5 Review on 5/15/25 of Patient #5’s Medication Administration Record revealed that on 4/15/25 at 11:43 a.m., Resident #5 was given the following medications by intramuscular injection: Benadryl (diphenhydramine) 50 mg (milligrams) in the outer right thigh; Zyprexa (olanzapine) 10 mg in the upper left arm; and Ativan (Lorazepam) 2 mg in the outer right thigh. Review on 5/15/25 of Patient #5’s Physician Note, dated 4/15/25, at 1:00 p.m. revealed, “...Patient became violent and was chemically restrained for the safety of the staff and his own safety. Patient is now resting comfortably...”. Patient #1 Review on 5/14/25 of Patient #1’s medical record revealed the following physician order, dated 4/20/25 at 4:52 p.m.: Ketalar [ketamine] 500 mg/10 mL (milliliters) Injectable, dose 400 mg/8 mL one time. Review on 5/14/25 of Patient #1’s “Detailed Assessment” dated 4/20/24 at 7:30 p.m. revealed, “... [pronoun omitted] was combative and disoriented... Patient was shoving against staff, yelling, and swearing. The patient could not follow directions. We were able to get the patient back to [pronoun omitted] room with the help of security. A few moments later, the patient came running out of [pronoun omitted] room... trying to go into patient exam rooms... became combative and aggressive towards staff and could not be redirected... Police were called to help control the patient for [pronoun omitted] safety and the safety of other patients and staff. A physical hold was needed for safe administration of ketamine...”. Patient #6 Review on 5/14/25 of Patient #6’s medical record revealed the following physician orders: Ketamine 500 mg/10 mL injectable (250mg) dated 4/23/25 at 2:43 a.m.; diphenhyramine [Benadryl] 50 mg/10 mL injectable; Ziprasidone [Geodon] 20 mg vial, dated 4/23/25 at 3:55 a.m.; and Lorazepam [Ativan] 2 mg/1mL injectable, dated 4/23/25 at 4:22 a.m. Review on 5/14/25 of Patient #6’s Emergency Department Note, dated 4/23/25, revealed the following: “[Pronoun omitted] became combative with staff and started spitting. I talked with the mother and she consented to restraints and medications as needed for the patient’s behavior. Due to the patient’s escalating behavior she was placed in restraints and given IM [intramuscular] ketamine... Once the IM took effect and that patient was sufficiently calmed the restraints were able to be removed. The patient woke up and started to scream at staff. She is not able to be calmed and is demanding to leave. She became combative with staff again and required Geodon and Benadryl IM. this had a brief effect and the patient became agitated again and received IM which provided finally provided good anxiolysis.” Interview on 5/14/25 at 10:10 a.m. with Staff I (Vice President of Quality and Patient Safety) revealed that the facility does not have a process or procedure to capture if medications are being used as a chemical restraint.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 43002 Based on interview and record review, it was determined that the hospital failed to obtain a physician’s order for the use of a physical hold restraint for 1 of 8 patients reviewed for restraints. (Patient identifier is #1.) Findings include: Review on 5/14/25 of Patient #1’s “Detailed Assessment” dated 4/20/24 at 7:30 p.m. revealed, “... [pronoun omitted] was combative and disoriented... Patient was shoving against staff, yelling, and swearing. The patient could not follow directions. We were able to get the patient back to [pronoun omitted] room with the help of security. A few moments later, the patient came running out of [pronoun omitted] room... trying to go into patient exam rooms... became combative and aggressive towards staff and could not be redirected... Police were called to help control the patient for [pronoun omitted] safety and the safety of other patients and staff. A physical hold was needed for safe administration of ketamine...” Review on 5/14/24 of Patient #1’s physician’s orders revealed that there was no physician’s order for the physical hold. Interview on 5/14/25 at 12:45 p.m. with Staff I (Vice President of Quality and Patient Safety) confirmed that there was no physical hold order in Patient #1’s medical record. Review on 5/15/25 of the facility’s policy titled “Patient Restraining/Seclusion” effective 12/1/20, revealed, “... 5. Order for Restraint or Seclusion a. An order for restraint or seclusion must be obtained from a physician or other licensed practitioner... and is responsible for the care of the patient prior to the application of restraint or seclusion... 5B. Order for Restraint with Violent or Self - Destructive Behavior a. Orders for restraints or seclusion must be time limited and must specify clinical justification for the restraint or seclusion, the date and time ordered, duration of restrain or seclusion use, the type of restraint, and behavior-based criteria for release... Appendix D: Definitions... C. Drugs as restraints: A drug or medication, when it is used as a restriction to manage the patient’s behavior or restrict the patient’s freedom of movement and is not a standard treatment or dosage for the patient’s condition, is considered a restraint... ...An additional component of “standard treatment” for a medication is the expectation that the standard use of a psychotherapeutic medication to treat the patient’s condition enables the patient to more effectively or appropriately function in the world around him/her that would be possible without the use of the medication. Psychotherapeutic medications are to enable, not disable... ...E. Physical Holds... Holding a patient in a manner that restricts the patient’s movement against the patient’s will is considered restraint. This includes holds that some members of the medical community may term “therapeutic holds.” Many deaths have occurred while employing these practices. Physically holding a patient during a forced psychotropic medication procedure is considered a restraint... F. Physical Holding for Forced Medications... The use of force in order to medicate a patient, as with other restraint, must have a physician’s order prior to the application of the restraint (use of force)...””

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. This Standard is not met as evidenced by: 43002 Based on interview and record review, it was determined that the hospital failed to ensure that a patient placed in restraint was monitored per hospital policy for 1 of 8 patients reviewed for restraints. (Patient identifier is #1.) Findings include: Review on 5/14/25 of the facility’s policy titled “Patient Restraint/Seclusion” effective 12/1/20 revealed, “...7. Monitoring the Patient in Restraints or Seclusion... b. An RN [Registered Nurse] will assess the patient at least every two hours. The assessment will include where appropriate: 1) Signs of injury associated with restraint, including circulation of affected extremities 2) Respiratory and cardiac status 3) Psychological status, including level of distress or agitation, mental status and cognitive functioning, 4) Needs for range of motion, exercise of limbs and systemic release of restrained limbs are being met 5) Hydration/nutritional needs are being met 6) Hygiene, toileting/elimination needs are being met 7) The patient’s rights, dignity, and safety are maintained 8) Patient’s understanding of reasons for restraint and criteria for release from restraint 9) Consideration of less restrictive alternatives to restraint...d. A trained staff member monitors each patient in restraint or seclusion at least three times an hour for safety, and to confirm that the patient’s rights and dignity are maintained. This check will be documented in either electronic record or on paper. If a paper checklist is used as a summary, recording time and observation from each of the three times an hour check, may be recorded at the end of the shift and the checklist scanned into the... patient record...” Review on 5/14/15 of Patient #1’s physician’s order revealed an order dated 4/20/25 at 5:04 p.m. for bilateral upper extremity soft restraints for attempts to remove device and out of bed is extreme injury risk. Review on 5/14/25 of Patient #1’s “Detailed Assessment” dated 4/20/24 at 7:30 p.m. revealed, “... [pronoun omitted] was combative and disoriented... Patient was shoving against staff, yelling, and swearing. The patient could not follow directions... Soft, bilateral wrist restraints were applied for patient and staff safety...” Review on 5/14/25 of Patient #1’s Restraints Documentation Care Assessment revealed that RN assessments were documented at 5:08 p.m., 8:08 p.m. (three hours later), 8:14 p.m. and the restraint was discontinued at 8:40 p.m. Interview on 5/16/25 at 1:00 p.m. with Staff I (Vice President of Quality and Patient Safety) confirmed that there was no Restraints Documentation Care Assessment for three hours between 5:08 p.m. and 8:08 p.m.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(11) Physician and other licensed independent practitioner training requirements must be specified in hospital policy. At a minimum, physicians and other licensed practitioners authorized to order restraint or seclusion by hospital policy in accordance with State law must have a working knowledge of hospital policy regarding the use of restraint or seclusion. This Standard is not met as evidenced by: 47129 Based on record review and interview, it was determined that the hospital failed to follow the training requirements for 2 of 5 physicians and other licensed practitioners reviewed (Staff identifiers are Staff A and B). Findings include: Review on 5/15/25 of the hospital’s policy titled “Patient Restraint and Seclusion - Appendix A: Training Requirements”, effective date 12/1/2-2 revealed “...D. Physicians and other licensed practitioners authorized to order restraints will have a working knowledge of this policy on the use of restraints and seclusion...” Review on 5/15/25 of Patient #7’s physician orders revealed that Staff A (Medical Doctor) ordered a physical hold for physical aggression on 4/18/25 at !2:30 a.m. Interview on 5/15/25 at 2:00 p.m. with Staff C (Medical Staff Credentialing) revealed that Staff A (Medical Doctor) and Staff B (Advance Practice Registered Nurse) were credentialed to practice in the Emergency Department (ED). Staff C also revealed that anyone credentialed in the ED would be provided restraint training. Staff C was unable to provide documentation that Staff A and Staff B had working knowledge of the Patient Restraint and Seclusion Policy.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(f)(1) Training intervals. Staff must be trained and able to demonstrate competency in the application of restraints, implementation of seclusion, monitoring, assessment, and providing care for a patient in restraint or seclusion- (i) Before performing any of the actions specified in this paragraph; (ii) As part of orientation; and (iii) Subsequently on a periodic basis consistent with hospital policy. This Standard is not met as evidenced by: 47129 Based on interview and record review, it was determined that the hospital failed to demonstrate competency in the application of restraints, implementation of seclusion, monitoring, assessment, and providing care for a patient in restraint or seclusion for 2 of 9 staff records reviewed (Staff identifiers are Staff G and H). Findings include: Interview on 5/15/25 at approximately 10:10 a.m. with Staff G (Security) revealed that he/she would assist holding down combative or violent patients when they require medications or to be restrained. Interview on 5/15/25 with Staff L (Vice President of Human Resources) revealed that the hospital was unable to provide documentation that Staff G and Staff H (Security) had restraint training. Review on 5/15/25 of the facility’s policy titled “Patient Restraint and Seclusion”, effective date 12/1/2-2 revealed “...Section A: Training A. Director Care Staff will demonstrate competency in the application of restraints, implementation of seclusion, monitoring, assessment and providing care for a patient in restraint or seclusion. Training will be provided for all staff designated as having direct patient care responsibilities (the facility to list), including contract or agency personnel. In addition, if hospital security guards or other non-healthcare staff (facility to list) assist direct care staff, when requested, in the application of restraint or seclusion ,the security guard, or other non-healthcare staff (as defined by the facility) are also expected to be trained and able to demonstrate competency in the safe application of restrain and seclusion... ...Training Content: ...B. Nonphysical Interventional Skills: Staff will be trained and able to demonstrate competency in the use of nonphysical interventional skills...”.”