HospitalInspections.org

Based on medical records reviews, facility policy and procedures reviews, facility documents reviews and staff interviews conducted during the revisit to the facility on 01/28/15 and 01/29/15, it was determined that the facility failed to follow its own policy on "Restraint and Seclusion". Specifically, regarding the necessary observations of vital signs for patients who received simultaneous physical restraints and drugs used over objection in the form of Pro re nata (PRN), Intramuscular (IM), or Statim (STAT) psychotropic medications during episodes of violent behavior or "impulsivity". This was evident in 4 of 4 medical records (MR) of patients on the physical restraints list and 4 of 10 medical records reviewed. MRs #1, #2, #4 and #5.

Findings include:

Upon review of the facility policy on Restraint and Seclusion, last revised on 01/14/14, the following was noted:

· Section I - 4, page 9, Item #12, Sub-Item a) states that "The use of drugs as a restraint, while not prohibited is not considered a standard practice.

· "Section I - 4, page 9, Item #12, Sub-Item b) states that "When medication is used as a restriction to manage behavior or to restrict the patient's freedom of movement and is not a standard of treatment for the patient's medical or psychiatric condition, the use of the medication shall be deemed a restraint (i.e., 'drug used as a restraint' )."

· Section I - 4, page 10, Item #12, Sub-Item e) states that "Monitoring and observation must include post-medication administration assessment by a registered nurse and shall include the same monitoring requirement as any other method of restraint, as set forth in this policy directive, provided, however, that monitoring of vital signs shall be done more frequently than with other forms of restraint, in accordance with good clinical practice and facility policy. Vital signs, when drugs used as a restraint are ordered, must have frequency defined by the ordering physician."


The Office of Mental Health (OMH) Office of Medical Director Guidance Memo dated 04/29/10 states:

· In the 3rd paragraph that "The administration of medication in emergency situations requires the input of a physician. Medication treatment over objection in emergency circumstances can be construed as 'drugs used as a restraint'."

· In the 5th paragraph that "Instances where the PRN order is IM (intramuscular) for agitation we presume that the order to deliver a psychotropic medication IM is involuntary since few individuals would voluntarily agree to take an IM medication of this class of drug on a PRN basis."

· In the 6th paragraph that "OMH stresses that early recognition and intervention are extremely important in treating clinically unstable individuals and are an indication of high quality medical care. The appropriate management of agitation requires the use of primary preventive strategies . . . "


A review of the Nursing Manual Policies and Procedures, pages 1 through 33 on the subject of "Medication Administration", last revised in September 2014, found that it states on page 10, under the subtopic "STAT and PRN anti-Psychotic Administration", that "ALL STAT and PRN antipsychotic medications either over objection or not over objection shall have vital signs attempted/obtained at the time of administration. If unable to obtain vital signs within 15 minutes MD should be notified. Vital signs or attempt to obtain vital signs should be documented in patients UCR and if in Restraint also documented on patient monitoring form. Vital signs should be taken at 15 minutes intervals at least 2 times after administration."

Upon further review of the "Restraint and Seclusion" policy, found that it states on page 23, Item #4 (titled "Monitoring Persons in Seclusion or Restraint"), Sub-Item a) ii, that "A written assessment of the need for seclusion or restraint and of the general comfort and condition of the patient shall be done at the time of the initial application of the seclusion or restraint and every 15 minutes thereafter, or at more frequent intervals as directed by the physician. The assessment shall be recorded on the 'MHFPC Special Observational Levels & Restraint or Seclusion Monitoring Form' (FORM98 MED)."

A review of the Pharmacy and Therapeutics Committee memorandum dated November 15, 2014 titled "Agitation Is Not An Approved Indication for Medication Use", found that the 3rd bullet point states that "Medication treatment over objection in emergency circumstances can be construed as a 'drug used as a restraint'. At this point the policy for chemical restraints would be followed." The facility has not updated its "Restraint and Seclusion" policy (last updated 01/14/14) to include the procedures for staff to follow in the care of patients who are given psychotropic medications IM STAT over objection.


The following are the results of patients' medical records reviews:

A. On 1/28/15 a review of the medical record for the patient MR #1 revealed that on 1/9/15 at 1525 the patient was noted to be verbally and physically threatening to staff, attempting to throw a chair at staff and kicking objects in the vicinity. The patient was placed into manual hold at 1525 and 4 point restraints at 1530. At 1530 the patient was medicated over objection with Haloperidol 10 milligrams (mgs) IM and Lorazepam 2 mgs IM. After the administration of these psychotropic medications the nursing staff failed to perform vital sign observations every 15 minutes until the patient was released at 1625. Upon the release of the patient from the 4 points physical restraint, the staff did not perform any other vital sign observations to ensure the safety of the patient from the effects of the Haloperidol 10 milligrams (mgs) IM and Lorazepam 2 mgs IM, which were both given over objection. During the debriefing for the 4 point restraint on 1/12/15 at 1443, which was attended by the Nurse Administrator and attested to by the Therapeutic Team Leader (TTL), it was noted that the patient's treatment plan was not revised and the use of the Haloperidol 10 milligrams (mgs) IM and Lorazepam 2 mgs IM over objection was not mentioned.

B. The patient MR #2 was restrained 4 times between 11/29/14 and 12/6/14. On 11/29/14 at 1045 the patient displayed threatening behavior to staff and attempted to assault staff, spitting and undressing herself. The patient MR #2 had been placed in manual restraint and 4 point restraint as ordered, and was given Olanzapine 10 mgs IM STAT over objection. Vital signs observation of the patient was done at the time of the physical restraint and upon the release of the patient from physical restraint at 1135. The nursing staff failed to observe the vital signs of the patient every 15 minutes and also did not continue to observe the patient at least as frequently after the release from the physical restraint to ensure the safety of the patient from the effect of the psychotropic drugs used over the patient's objection during the episode. The Team Debriefing Outcome Report meeting attended by the Nurse Administrator and TTL on 12/1/14 at 0930 for this event indicated that the treatment plan was not revised and the incidence of drugs used over objection was not discussed. The patient had similar occurrences on 12/3/14 and on 12/6/14.

C. In MR #4, which was reviewed on January 29, 2015, the patient was placed in 5 point physical restraints and received drugs as restraints on December 8 and 19, 2014 for severe manifestation of mental illness, but there was no documentation by an RN of the patient's level of consciousness on the RN Initial Restraint/Seclusion Assessment Note Form (MHFPC91A). The renewal for restraints on December 19, 2014 at 1710 does not indicate what type of physical restraints were renewed. In addition, there was no documentation to indicate that the treatment plan was reviewed and or revised at that time despite the patient's multiple episodes of aggression and agitation. This finding was verified during an interview which was conducted on January 29, 2015 at 1145 with Staff #4, the Program Evaluation Specialist.

D. On 12/2/14 at 1815, the patient MR #5 was given "Ativan 2 mg/Haldol 10 mgs IM STAT for assault of staff over objection - highly dangerous". Nursing staff failed to perform vital signs observation every 15 minutes while the patient was in restraints and did not continue monitoring of the patient's vital signs once the patient was released from the physical restraint at 1915 to ensure the safety of the patient from the effect of the drugs used over the patient's objection. The Team Debriefing Outcome Report performed on 12/3/14 for the use of Wrist to Belt, 4 point, and Manual restraints failed to address the use of drugs used over the patient's objection during the episode. The patient's treatment plan was also not reviewed.


The following are interviews, other reviews and observations:

During interview with Staff #1, the Director of Clinical Services on 1/28/15 at 1145, she stated that prior to the last survey of May 2014 and this survey, the facility has not used any medications to restrain patients. Staff #1 stated that as a result, the facility did not have for review a list of patients who received IM psychotropic medications over objections.

A review of Performance Improvement Documentation of 10/21/14 revealed that on 9/19/14 directives were issued to all nursing staff "to begin vital signs monitoring on patients who had administration of PO or IM STAT or PRN antipsychotic medications." (PO means per oral or by mouth).

In an interview with Staff #3, the Chief Nursing Officer on 1/28/15 and 1/29/15 at 1200 and 1330 respectively, Staff #3 stated that nursing staff has been given directives to monitor patients given IM STAT immediately after the administration of the psychotropic drug and again 30 minutes later. This directive is not in compliance with the facility policy that requires monitoring every 15 minutes or at more frequent intervals.

The facility also failed to abide by its Plan of Correction (POC) which was submitted on 01/09/15 to NYSDOH and which indicates that the Team Debriefing Outcome Report (Form 81B-MED) will be completed no later than 24 HOURS following the end of a seclusion or restraint episode. There were no entries on the Team Debriefing Forms (those that were completed after the submission of the POC) which indicated or recorded the use of "Drugs used over the patients' objections or Drugs used as Restraints ".

This is a repeat Citation, the facility has not established as practice and put in place/force a process for the management of patients who are administered Drugs used over objections or Drugs used as Restraints.