HospitalInspections.org

Based on medical record reviews, review of hospital policies and procedures, interviews with administrative staff, tours of three patient care units, review of credential files, and review of related documentation, it was determined that the hospital failed to protect and promote the rights of each patient:

Findings include:

1. The facility failed to ensure that patients had the right to receive care in a safe setting. (Refer to Tag A 144)

2. The facility failed to maintain the confidentiality of a patient's clinical record. (Refer to Tag A 147)

3. The facility failed to ensure that the use of restraints was in accordance with the order of a physician or other licensed independent practitioner authorized to order restraint by hospital policy (Refer to Tag A 168).

4. The facility failed to ensure that each order used for the management of violent or self-destructive behavior that jeopardized the immediate physical safety of the patient was time limited to 2 hours for children and adolescents 9 to 17 years of age. (Refer to Tag A 171)

A. Based on document review and staff interviews conducted on March 8, 2022, it was determined that the facility failed to ensure that 1) Ketamine, a Schedule III controlled substance approved by the FDA (Food and Drug Administration) as an anesthetic agent, had been administered by intramuscular (IM) route to restrict and manage a patient's behavior, without monitoring patient's condition after administration in the Behavioral Health Emergency Department and 2) ensure that an approved policy is in place for the administration of Ketamine IM, in the Emergency Department, for behavioral management.

Findings include:

Reference: The package insert for Ketalar (Ketamine) states: "INDICATIONS AND USAGE: KETALAR is indicated as the sole anesthetic agent for diagnostic and surgical procedures... . KETALAR is best suited for short procedures but it can be used, with additional doses, for longer procedures. KETALAR is indicated for the induction of anesthesia prior to the administration of other general anesthetic agents. ... CLINICAL PHARMACOLOGY...Elevation of blood pressure begins shortly after injection, reaches a maximum within a few minutes and usually returns to preanesthetic values within 15 minutes after injection. In the majority of cases, the systolic and diastolic blood pressure peaks from 10% to 50% above preanesthetic levels shortly after induction of anesthesia, but the elevation can be higher or longer in individual cases... . WARNINGS: Cardiac function should be continually monitored during the procedure in patients found to have hypertension or cardiac decompensation. ... Respiratory depression may occur with overdosage or too rapid a rate of administration of KETALAR, in which case supportive ventilation should be employed. ... Pediatric Use: Safety and effectiveness in pediatric patients below the age of 16 have not been established. ... "

1. Review of the facility document titled, "Pyxis reports for Ketamine 3/1/21-2/28/22" revealed that Ketamine 100 mg (milligram) / 1 ml (milliliter) [5 ml] injection solutions, was the concentration designated for IM administration for use in the Behavioral Health Emergency Department. During the date range from 3/1/21 to 2/28/22, thirty-six (36) patients had been ordered IM Ketamine in the Behavioral Health Emergency Department. Review of the following medical records revealed:

a. Medical Record #2, a 13 year old patient, was administered Ketamine IM for behavioral management. There was no evidence of monitoring for patient's safety after administration of Ketamine.

b. Medical Record #3, a 15 year old patient, was administered Ketamine IM for behavioral management. There was no evidence of monitoring for patient's safety after administration of Ketamine.

c. Medical Record #14, a 29 year old patient, was administered Ketamine IM for behavioral management. There was no evidence of monitoring for patient's safety after administration of Ketamine.

2. Upon request, the facility failed to provide policies and procedures including but not limited to:

a. appropriate dosing of Ketamine Intramuscularly (IM) for adult and pediatric patients

b. indication and use of Ketamine for psychiatric population

c. monitoring patient's condition including but not limited to before, during, and after administration of Ketamine IM

d. Ordering of the Ketamine IM

e. Upon interview, Staff #15 stated that the facility did not have policies and procedures for Ketamine usage in the Emergency Department for psychiatric indications.

3. The above findings were confirmed with Staff #1, Staff #4, and Staff #15.

This finding resulted in an Immediate Jeopardy (IJ) on March 8, 2022 at 4:15 PM. The facility Administrator was informed of the IJ and a copy of the IJ template was provided. An immediate removal plan was requested at that time.

On March 9, 2022, an acceptable removal plan was received from the facility.

On March 9, 2022 while onsite, the IJ was removed upon confirmation that the removal plan was implemented which included: removing IV (intravenous) and IM (intramuscular) Ketamine from the pyxis in the main ED (Emergency Department) and the Behavioral Health Emergency Department (BHED); restricting the use of IV and IM Ketamine unless deemed appropriate under the conscious sedation policy for approved procedures and staff education.

B. Based on document review and staff interviews conducted on March 8, 2022, it was determined that the facility failed to ensure that Ketamine, a Schedule III controlled substance approved by the FDA as an anesthetic agent, is administered appropriately and safely.

Findings include:

Reference: The package insert for the medication Ketalar (Ketamine) states, "Intramuscular Route: The initial dose of KETALAR administered intramuscularly may range from 6.5 to 13 mg/kg [milligrams per kilogram]. A dose of 10 mg/kg will usually produce 12 to 25 minutes of surgical anesthesia."

1. Review of the emergency department medical record of Patient #14, dated 4/6/21, revealed the following:

a. "Physical Exam: ...Wt (weight) 68 Kg (kilograms)." The maximum dose calculated for Patient #14, according to the package insert, is 884 mg.

b. "Data: Medications/Fluids:
... Ketamine 100mg/ ml injection ... (400 mg intraMUSCULAR Given 4/6/21 at 0123 [1:23 AM])
Ketamine 100mg/ ml injection ... (400 mg intraMUSCULAR Given 4/6/21 at 0134 [1:34 AM])
Ketamine 100mg/ ml injection ... (500 mg intraMUSCULAR Given 4/6/21 at 0152 [1:52 AM])"

c. Patient #14 was administered a total of 1300 mg of Ketamine in 29 minutes. When questioned if the medication had been administered appropriately, Staff # 4 confirmed that it was not.

2. The above findings were confirmed with Staff #4.

This finding resulted in an Immediate Jeopardy (IJ) on March 8, 2022 at 4:15 PM. The facility Administrator was informed of the IJ and a copy of the IJ template was provided. An immediate removal plan was requested at that time.

On March 9, 2022, an acceptable removal plan was received from the facility.

On March 9, 2022 while onsite, the IJ was removed upon confirmation that the removal plan was implemented which included: removing IV (intravenous) and IM (intramuscular) Ketamine from the pyxis in the main ED (Emergency Department) and the Behavioral Health Emergency Department (BHED); restricting the use of IV and IM Ketamine unless deemed appropriate under the conscious sedation policy for approved procedures and staff education.

Based on a tour of three patient care units and an interview with administrative staff, it was determined that patient clinical information is not maintained in a confidential manner on 1 of 3 units.

Findings include:

1. During a tour of the Emergency Department on the morning of October 12, 2021, a regular trash can in the "Second Workstation" contained a document titled "TRANSPORT REPORT FORM." The form included the the following information for Patient #11:

(i) Patient's name

(ii) Medical record number

(iii) Date of transport

(iv) Date of birth, age, and gender

(v) Weight

(vi) That the patient was being transferred from the emergency department to "______ ____ (facility name) Dementia."

2. Administrator #6 stated that the document should have been place in the shredder box after it was faxed to the ambulance company.

Based on review of policy and procedure and review of the medical records of three (3) of four (4) patients who were physically restrained for the management of behavior that jeopardized the physical safety of the patient, staff members, or others it was determined that the facility failed to ensure the use of restraints is in accordance with the order of a physician or other licensed independent practitioner.

Findings include:

Reference: Policy and procedure titled "Restraint and Seclusion Utilization Policy" states: ".....
III. Policy
.....
G. Restraint Orders
There shall be a written order for restraint by any individual permitted by both state law and hospital policy for patients independently, within the scope of their licensure, and consistent with granted privileges, to order restraint or seclusion. An order authorizing the use of a restraint or seclusion should specify the reason for restraint or seclusion, the type of restraint, and the duration of restraint or seclusion. .....
.....
K. Duration of Restraint/Orders
.....
2. Orders for restraint or seclusion applied to manage violent or self-destructive behavior that jeopardizes the immediate safety of the patient, a staff member or others shall remain in effect until the patient's behavior or situation no longer requires the use of restraint or seclusion, but no longer than
* 4 hours for adults 18 years of age; or
* 2 hours for children and adolescents 9 to 17 years of age;
....."

1. Review of the medical record of Patient #3, a 14 year-old, revealed:

a. Restraint Orders placed for "Restraints violent or self-destructive adult (age 18 and older) For up to 4 hours" (4-point locking) on:

(i) 10/5/21 at 1646 (4:46 PM) to start at 1700 (5:00 PM). Expiration at 8:59 PM on 10/5/21.

(ii) 10/9/21 at 0449 (4:49 AM) to start at 0500 (5:00 AM). Expiration at 8:59 AM on 10/5/21.

b. Restraint Orders placed for "Restraints violent or self-destructive adolescent (age 9 to 17) For up to 2 hours" (4-point locking) on:

(i) 10/6/21 at 0800 (8:00 AM) to start at 0800. Expiration at 11:59 AM on 10/6/21.

(ii) 10/6/21 at 2125 (9:25 PM) to start at 2130 (9:30 PM). Expiration at 2:29 AM on 10/7/21.

(iii) 10/7/21 at 1649 (4:49 PM) to start at 1700 (5:00 PM). Expiration at 8:59 PM on 10/7/21.

c. "OBSERVATION SHEET" entries indicating that the patient was in physical restraints:

(i) Between 9:00 PM and 10:30 PM on 10/5/21. Although the order was time limited for up to 4 hours, the 14 year-old adolescent should have been released by 8:59 PM, or a new order written. The patient was in restraints without a valid order for 1 hour and 30 minutes.

(ii) Between 7:45 AM and 7:59 AM on 10/6/21 without an order.

(iii) Between 9:15 PM and 9:24 PM on 10/6/21 without an order.

(iv) Between 2:30 PM and 4:59 PM on 10/7/21 without an order.

(v) Between 4:45 AM and 4:59 AM on 10/9/21 without an order.

2. Review of the medical record of Patient #13 revealed:

a. Orders placed for "Restraints violent or self-destructive adult (age 18 and older) For up to 4 hours" (4-point locking) on:

(i) 9/8/21 at 0929 (9:29 AM) to start at 0930 (9:30 AM). Expiration on 9/8/21 at 1:29 PM.

(ii) 9/8/21 at 1935 (7:35 PM) to start at 1945 (7:45 PM). Expiration on 9/8/21 at 11:44 PM.

(iii) 9/8/21 at 2006 (8:06 PM) to start at 2015 (8:15 PM). Expiration on 9/9/21 at 12:14 AM.

(iv) 9/8/21 at 2332 (11:32 PM) to start at 2345 (11:45 PM). Expiration on 9/9/21 at 3:44 AM.

(v) 9/9/21 at 0723 (7:23 AM) to start at 0730 (7:30 AM). Expiration on 9/9/21 at 11:29 AM.

(vi) 9/9/21 at 1553 (3:53 PM) to start at 1600 (4:00 PM). Expiration on 9/9/21 at 7:59 PM.

(vii) 9/9/21 at 2127 (9:27 PM) to start at 2130 (9:30 PM). Expiration on 9/10/21 at 1:29 AM.

(viii) 9/10/21 at 1636 (4:36 PM) to start at 1645 (4:45 PM). Expiration on 9/10/21 at 8:44 PM.

(x) 9/10/21 at 2123 (9:23 PM) to start at 2130 (9:30 PM). Expiration on 9/11/21 at 1:29 AM.

(xi) 9/11/21 at 0345 (3:45 AM) to start at 0400 (4:00 AM). Expiration on 9/11/21 at 7:59 AM.

(xii) 9/11/21 at 1202 (12:02 PM) to start at 1215 (12:15 PM). Expiration on 9/11/21 at 4:14 PM.

(xiii) 9/11/21 at 1551 (3:51 PM) to start at 1600 (4:00 PM). Expiration on 9/11/21 at 7:59 PM.

(xiv) 9/12/21 at 0914 (9:14 AM) to start at 0915 (9:15 AM). Expiration on 9/12/21 at 1:13 PM.

(xiv) 9/12/21 at 1710 (5:10 PM) to start at 1715 (5:15 PM). Expiration on 9/12/21 at 9:14 PM.

(xv) 9/13/21 at 1415 (2:15 PM) to start at 1415. Expiration on 9/13/21 at 6:14 PM.

(xvi) 9/13/21 at 1728 (5:28 PM) to start at 1730 (5:30 PM). Expiration on 9/13/21 at 9:29 PM.

(xvii) 9/14/21 at 1539 (3:39 PM) to start at 1545 (3:45 PM). Expiration on 9/14/21 at 7:44 PM.

(xviii) 9/14/21 at 1828 (6:28 PM) to start at 1830 (6:30 PM). Expiration on 9/14/21 at 10:29 PM.

(xix) 9/15/21 at 1746 (5:46 PM) to start at 1800 (6:00 PM). Expiration on 9/15/21 at 9:59 PM.

(xx) 9/16/21 at 1054 (10:54 AM) to start at 1100 (11:00 AM). Expiration on 9/16/21 at 2:59 PM.

(xxi) 9/16/21 at 1227 (12:27 PM) to start at 1230 (12:30 PM). Expiration on 9/16/21 at 4:29 PM.

b. "OBSERVATION SHEET" entries indicating that the patient was in physical restraints:

(i) Between 7:30 PM and 7:44 PM on 9/8/21 without an order.

(ii) Between 11:30 AM and 3:59 PM on 9/9/21 without a written order for the use of physical restraints. The restraints should have been released at 11:29 AM when the order expired or a new order should have been written if the patient's behavior continued to necessitate the use of restraints.

(iii) Between 4:30 PM and 4:44 PM on 9/10/21 without an order.

(iv) Between 8:45 PM and 9:23 PM on 9/10/21 without a written order for the use of physical restraints. The restraints should have been released at 8:44 PM when the order expired or a new order should have been written if the patient's behavior continued to necessitate the use of restraints.

(v) Between 3:45 AM and 4:00 AM on 9/11/21 without an order.

(vi) Between 5:00 PM and 5:14 PM on 9/12/21 without an order.

(vii) Between 12:45 PM and 2:14 PM on 9/13/21 without an order.

(viii) Between 9:30 PM and 10:45 PM on 9/13/21 without an order.

(ix) Between 5:30 PM and 5:59 PM on 9/15/21 without an order.

3. Review of the medical record of Patient #12 revealed:

a. Orders placed for "Restraints violent or self-destructive adult (age 18 and older) For up to 4 hours" (4-point locking) on:

(i) 2/2/22 at 0410 (4:10 AM) to start at 4:15 AM. Expiration on 2/2/22 at 8:14 AM.

(ii) 2/2/22 at 0629 (6:29 AM) to start at 6:30 AM. Expiration on 2/2/22 at 10:28 AM.

(iii) 2/2/22 at 1234 (12:34 PM) to start at 12:45 PM. Expiration on 2/2/22 at 4:44 PM.

(iv) 2/2/22 at 1645 (4:45 PM) to start at 1700 (5:00 PM). Expiration on 2/2/22 at 8:59 PM.

b. "OBSERVATION SHEET" entries indicating that the patient was in physical restraints:

(i) Between 4:00 PM and 4:14 PM on 2/2/22 without an order.

(ii) Between 12:30 PM and 12:44 PM on 2/2/22 without an order.

4. Administrators #1 and #4 were made aware of the findings.

Based on review of two (2) of two (2) patients under 18 years of age who were physically restrained for the management of behavior that jeopardized the physical safety of the patient, staff members, or others, review of policy and procedure, and interview with administrative staff, it was determined that physical restraint orders are not time limited to 2 hours.

Findings include:

Reference: Policy and procedure titled "Restraint and Seclusion Utilization Policy" states: ".....
III. Policy
.....
K. Duration of Restraint/Orders
.....
2. Orders for restraint or seclusion applied to manage violent or self-destructive behavior that jeopardizes the immediate safety of the patient, a staff member or others shall remain in effect until the patient's behavior or situation no longer requires the use of restraint or seclusion, but no longer than
* 4 hours for adults 18 years of age and older
* 2 hours for children and adolescents 9 to 17 years of age; or
* 1 hour for children 8 years of age or younger.
....."

1. Review of the emergency department medical record of Patient #2 revealed:

a. Demographic section:
"____, _____ (surname and first name of Patient #2) .....
(DOB: --- 13 y.o. [year old] F [Female]
....."

b. "Physical Exam
.....
Constitutional:
General: She is active. She is in acute distress.
Appearance: Normal appearance. She is well-developed and normal weight. She is not toxic-appearing.
Comments: Screaming, yelling, kicking, spitting, cursing, requiring sedation and restraints.
....."

c. "Patient Care Timeline (3:22/2021 20:03 to 3/30/2021 12:19)
3/22/2021
.....
Height, Weight and Dosing
Height: 172.7 cm (5' 8")
Weight: 52.2 kg (115 lb)
....."

d. Restraint Order:
"Start
03/23/21 0515 (5:15 AM)
Ordered
03/23/21 0508 (5:08 AM)"
"RESTRAINTS VIOLENT OR SELF-DESTRUCTIVE ADULT (AGE 18 AND OLDER) .....Restraint type: Velcro mechanical - LOCKING
Select location of restraint(s)
ankle, left
ankle, right
wrist, left
wrist, right
.....
Clinical Justification:
Aggressivity [sic]
.....
Interval
For up to 4 hours
....."

The patient was ordered to be physically restrained for up to 4 hours even though she was 13 years-old.

2. Review of the emergency department medical record of Patient #3 revealed:

a. Demographic section:
"____, _____ (surname and first name of Patient #3) .....
(DOB: --- 14 y.o. [year old] F [Female]
....."

b. Physical Exam:
..... Ht (Height) 1.626 m (meters) (5' 4") | Wt (Weight) 49.9 kg (kilograms) (110 lb)
....."

c. "ED Course
_______-_____, _________ _'s (hyphenated surname, possessive first name and middle initial) Documentation
Tue (Tuesday) Oct 05, 2021
1646 (4:46 PM) I was called into Behavioral Health as patient has become aggressive, throwing water bottles at the crisis clinician and refusing to stay in her room, cursing at the staff telling us that we are crazy. I spoke with the mother who has given verbal permission to restrain temporarily and medicate patient temporarily to calm her down [sic]
2047 (8:47 PM) Pt [patient] sedated and more calm at this time, restraints removed [sic]"

d. Restraint Order:
"Start
10/05/21 1700 (5:00 PM)
Ordered
10/05/21 1646 (4:46 PM)"
"RESTRAINTS VIOLENT OR SELF-DESTRUCTIVE ADULT (AGE 18 AND OLDER) .....Restraint type: Velcro mechanical - LOCKING
Select location of restraint(s)
ankle, left
ankle, right
wrist, left
wrist, right
.....
Clinical Justification:
Self Injury
Aggressivity [sic]
.....
Interval
For up to 4 hours
....."

e. Restraint Order:
"Start
10/09/21 0500 (5:00 AM)
Ordered
10/09/21 0449 (4:49 AM)"
"RESTRAINTS VIOLENT OR SELF-DESTRUCTIVE ADULT (AGE 18 AND OLDER) .....Restraint type: Velcro mechanical - LOCKING
Select location of restraint(s)
ankle, left
ankle, right
wrist, left
wrist, right
.....
Clinical Justification:
Self Injury
.....
Interval
For up to 4 hours
....."

The patient was twice ordered to be physically restrained for up to 4 hours even though she was 14 years-old.

3. Administrators #3 and #4 were made aware of the findings.

Based on document review and staff interviews conducted, it was determined that the facility failed to ensure implementation of policies and procedures addressing the intentional wasting of partial doses of controlled drug substances.

Findings include:

Reference: Facility policy titled, "Organizational Distribution and Control of Controlled Drug Substances" states, "...IV. Procedure B. ...6. Partial Doses, Waste, and Disposal of Medication a. When partial doses of a product are ordered, the complete product is removed from inventory, and the waste must be recorded and witnessed. 1) Medication can be wasted either during initial removal (i.e. quantity of waste is known/predictable) or retrospectively after administration (i.e. quantity of waste is not known at the time of removal."

1. Review of Medical Record #14, in the presence with Staff #4, revealed the following:

a. On 4/6/21 at 1:17 AM, Ketamine 400 mg (milligram) injection was ordered. At 1:19 AM, one vial of Ketamine 100 mg/ml (milliliter) (5 ml) was removed from the Pyxis, an automated medication dispensing cabinet. At 1:23 AM, Ketamine 400 mg was administered and the remaining 100 mg of Ketamine was wasted at 4:49 AM, 3 hours and 26 minutes after initial removal.

b. On 4/6/21 at 1:30 AM, Ketamine 400 mg injection was ordered. At 1:30 AM, one vial of Ketamine 100 mg/ml (5 ml) was removed from the Pyxis, an automated medication dispensing cabinet. At 1:34 AM, Ketamine 400 mg was administered and the remaining 100 mg of Ketamine was wasted at 4:50 AM, 3 hours and 20 minutes after initial removal.

c. Upon interview, Staff #4 confirmed that the partial dose of Ketamine should have been wasted at the time of initial removal, prior to administration.

2. Review of Medical Record #3 revealed the following:

a. On 10/9/21 at 11:05 PM, Ketamine 250 mg injection was ordered. At 11:26 PM, one vial of Ketamine 100 mg/ml (5 ml) was removed from the Pyxis, an automated medication dispensing cabinet. At 11:36 PM, Ketamine 250 mg was administered and the remaining 250 mg of Ketamine was wasted at on 10/10/21 at 1:30 AM, 2 hours and 25 minutes after initial removal.

b. Upon interview, Staff #4 confirmed that the partial dose of Ketamine should have been wasted at the time of initial removal, prior to administration.

3. The above findings were confirmed with Staff #4.