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901 NORTH HARRY S TRUMAN DRIVE

LARGO, MD 20774

PATIENT RIGHTS

Tag No.: A0115

an onsite investigation consisting of policy and procedure, interviews, 12 patient records and other pertinent documentation, it is revealed that the hospital failed to meet the Conditions for Patients Rights regarding restraint and seclusion as follows:

1) A-0131 - 1) Where patients # 2, 4, 5 and 10 had orders for PRN IM medication (chemical restraint); 2) that hospital staff administered orders for PRN IM medications to patients #2, 4, 5, and also to patient #10 against his expressed refusal of po (by mouth) medication, in the absence of a behavioral emergency, or court ordered medication treatment; and 3) That orders for PRN IM medication resulted in potential and actual violations of patients 2, 5 4, and 10 right to refuse treatment.

2) A-0154 - That patient #10's restraint was not discontinued at the earliest possible time, that staff failed to identify readiness for restraint discontinuation, and, that restraint flow documentation fails to reflect every 15-minute behavioral data by which to detemine discontinuation readiness.

3) A-0162 - The hospital denies the use of seclusion processes, yet patient #10 was clearly kept in his room under a seclusion process without orders or other regulatory processes related to seclusion.

4) A-0168 - That administration of PRN IM medications requiring the use of holds are infrequently documented, yet when documented, fail to have corresponding orders for restraint, and staff omit patient behaviors of resistence to other PRN IM administrations and the subsequent holds by which staff do so, thus circumventing regulatory requirements of physician orders for those holds.

5) A-0169 That the hospital writes orders for PRN IM medication which represents PRN chemical restraints.

6) A-0175 That face to face documentation fails to meet requirements.

PATIENT RIGHTS: INFORMED CONSENT

Tag No.: A0131

Based on an onsite survey inclusive of the hospital restraint policy and procedure and 12 patient records, it is revealed 1) That patients # 2, 4, 5 and 10 had orders for PRN IM medication (chemical restraint); 2) that hospital staff administered orders for PRN IM medications to patients #2, 4, 5, and also to patient #10 against his expressed refusal of po (by mouth) medication, in the absence of a behavioral emergency, or court ordered medication treatment; and 3) That orders for PRN IM medication resulted in potential and actual violations of patients 2, 5 4, and 10 right to refuse treatment.

The hospital policy, "Use of Restraints" (June 13, 2013) states in part, "The patient has the right to be free of restraint and, in accordance with CMS regulations, also has a right to refuse medication, unless a court has ordered medication treatment." (A court ordered medication is from a formal and legal decision process by which a group of clinicians presents evidence to a judge that a patient's behaviors warrant forced medication against the will of the patient. Built in to this process is the right for a patient to appeal).
Review of 12 patient records revealed that patients # 2, 4, 5 and 10 had standing orders for PRN ( as needed) IM (intramuscular) medication. (Also referenced in tag A-169). Review of these records reveals that PRN IM medications were given to patient #2 ([for a behavioral emergency), #4 ( for various levels of agitation and behavioral emergency), #5 (mostly for agitation), and to patient #10 (for refusal of po medication and ranging to behavioral emergencies). Based on review of the documentation, patient #10's record is most representative of providing medications against the patient right to refuse as outlined below:.

Patient #10 is a young adult male who agreed to a voluntary admission and was admitted to the behavioral health unit in mid-June 2014 following homicidal ideation with a plan to harm family members and others. Patient #10 has a history of multiple psychiatric admissions and had not been taking his medication. He was experiencing auditory hallucinations and increased aggression.
On admission, the physician wrote standing orders for po medications, and orders for PRN IM lorazepam (ativan) 2 mg (for severe anxiety), haloperidol (Haldol) 5 mg (for severe disruptive behavior), and Olanzapine (Zyprexa) 10 mg (Agitation). Based on these orders,
1) Nursing did not have to consult a physician to determine the existence of a behavioral emergency requiring STAT (now) orders for IM medication.
2) The regulatory physician oversight and evaluation that accompanies behavioral emergencies was circumvented ;
3) The patient right to refuse treatment under non-emergent , non-court-ordered conditions was also circumvented, and .
4) The medications would be considered PRN chemical restraints. ( as cited at tags A-0169)
During the first few days of admission, patient #10 was on 1:1 staffing due to hostility, aggression, and intermittent violence towards others. In separate incidents, patient #10 reportedly struck a peer and his 1:1 staff. Documentation reveals PRN IM medication was given for these emergencies, which were listed on restraint forms as "Chemical restraints."
On the second day of admission at 0528, a RN #1 documented "Patient remains on one to one close observation. Did not have any outburst during the night. Continue to medicate as ordered, and monitor behavior for any change in status." Though patient #10 had no "outburst during the night, he was medicated with PRN IM Ativan 2 mg at 0722. There is no documentation that patient #10 was asked to take po (by mouth) medication.


At 1115, RN #2 documented "Due to patient being sedated, unable to meet face to face with patient at this time, (name of doctor) was updated on patients behavior and requiring restraints (the night before)" and "Also due to pt ( patient) sedation unable to complete psychosocial assessment."

At 1145, patient #10 again received Ativan 2 mg PRN IM mg, though no documentation indicates any emergent behaviors, and the documentation of 1115 indicated that patient #10 was already "sedated." Additionally, patient #10 is documented as refusing Olanzapine 10 mg po at 1225 that day, but subsequently received Olanzapine 10 mg PRN IM at 1235, again with no emergent behaviors documented. Therefore, patient #10 was receiving PRN IM medications in the absence of an emergency, and despite his expressed refusal of the medication which was his right.

Patient #10 received IM Haldol and Ativan again at 1542 following actual threatening behaviors.

RN #3 wrote a note at 1943 stating "Though this is no longer my assigned Pt, Pt became uncontrollable. Medicated with PRN meds. Before meds, tried to verbally de-escalate, offer diversional activity such as going outside." It is unclear what the RN meant by "Uncontrollable" due to the fact that neither behavioral descriptors nor other restraint documentation could be located and 1:1 notes reveal only that patient #10 had been pacing in his room.

On day three of admission at 0811, RN #4 wrote an addendum note stating, "Pt rested all night. This morning refused his po medication and became restless/agiatated (sic). Ativan 2mg im and hadlol (sic)5mg im prn given. Pt stable will continue with plan of care." Again, patient was given IM medication after refusing po medications, and without adequate documentation to indicate a behavioral emergency Additionally, 1:1 notes indicate that patient #10 had not even awakened from sleep by the time this note was written.


At 1144, RN #3 documented, " Pt is still very aggressive, profane, undirectable, and violent. Pt does not respond to verbal de-escalation, diversional activities, therapeutic communication. Writer forced to use PRN meds IM for safety of other Pts, OPt, and staff. Pt continues to be on 1:1. Pt is being brought all meals. Pt is secluded to his room at this time. The RN failed to write any objective data regarding patient #10 ' s behaviors, and apparently wrote this note prior to giving PRN IM ' s of Ativan 2 mg and Haldol 5 mg at 1219. At the time of this note, 1:1 15-minute documentation indicates that the patient had alternately been sleeping and lying in bed when he received these PRN IM s.


At 1607, RN #3 documented "Pt continues to be highly confrontational. As medication wears off, Pt becomes increasingly hostile. Therefore, it has been necessary to medicate this Pt often. Writer attempted non-pharma alternatives such as diversional activities, re-framing therapeutic communication. None of these were successful. Pt is profane, aggressive, and dangerous aeb (sic) Pt striking two Pts yesterday, day before and Pt's attempt to strike writer yesterday. At 1609, the same RN writes, " Pt refused all PO meds today. Pt given IM PRN." Documentation reveals patient #10 received Haldol 5 mg IM at 1400 and Olanzapine 10 mg IM at 1549. Again, patient #10 exercised his right to refuse which was ignored by staff who administered IM PRN medication.

At 1620, patient #10 was placed into 4-point violent restraints. Documentation indicates that patient #10 attempted to attack another patient. Restraint documentation by RN #3 states in part, at 1657 Writer attempted multiple interventions throughout the day not limited to but including chemical restraints. While in this case, a behavioral emergency is clear, the writer documents his understanding that he has been chemically restraining patient #10 on a PRN basis throughout the day.

Patient #10 remained in restraints throughout the night and into the following morning, a total of 16.5 hours. An addendum note at 0833 on the fourth day of admission by RN #5 states, " Pt assessed in room, in and out of sleep, declined po meds so IV (sic) haldol and ativan given. Clearly, no behavioral emergency existed justified giving IM medication to patient #10 who had a right to refuse. Documentation of the 1:1 reveals that patient #10 had been sleeping since just after midnight and continued to do so through 9 am of that fourth day.

By 1539, patient #10 was documented in part by RN #3 as, " Pt is now taking oral medications. Pt is med compliant. "

While patient #10 had intermittent periods of actual violence, both the physician and staff clearly and grossly ignored patient #10 ' s right to refuse medication when IM PRN medication (chemical restraints) were ordered and 12 doses were administered in the absence of a behavioral emergency or court order for forced medication.

USE OF RESTRAINT OR SECLUSION

Tag No.: A0154

Based on a review of restraint policy and procedure and 12 patient records, it is revealed that a restraint event for patient #10 was not discontinued at the earliest possible time due to 1) staff failure to identify readiness for discontinuation, and 2) restraint documentation does not reflect every 15-minute behavioral data.
Patient #10 is a young adult male who signed a voluntary and was admitted to the behavioral health unit in mid-June 2014 following homicidal ideation with a plan to harm family members and others. Patient #10 has a history of multiple psychiatric admissions, and had not been taking his medication. He was experiencing auditory hallucinations and increased aggression.
At 1620 on the third day of admission, patient #10 was placed into 4-point violent restraints. Documentation indicates that patient #10 attempted to attack another patient. Patient #10 remained in restraints throughout that afternoon, night and into the following morning until his release at 9 am. Patient #10 was restrained a total of 16.5 hours.

Based on a review of the restraint 15-minute documentation it was determined that there was no descriptors of the patient's ongoing behaviors other than to state that the patient remains a danger to self or other, or remains disruptive to the environment. No actual documented behaviors that support the use of restraint were noted.

However, documentation by the 1:1 staff reveals that since being restrained, patient #10 was initially lying/sitting in bed, then sleeping at 1645, and then quiet/resting by 1730. Documentation indicates that Patient #10 continued with no dangerous behaviors, and was sleeping after midnight. He continued to sleep through 9 am of that fourth day. There were no documented attempts to remove patient #10 from restraint during those 16.5 hours, and in fact, patient #10 received more PRN IM medication that morning despite the fact that he had not exhibited behaviors to indicate an ongoing behavioral emergency.

Based on all documentation, the hospital failed to identify patient #10's readiness for restraint discontinuation, and failed to document every 15-minute objective behavioral data. Consequently, patient #10 was not removed from restraint at the earliest possible time.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0162

Based on an onsite survey inclusive of 12 patient records, it is revealed that while the hospital staff indicate that seclusion is not used, patient #10 was clearly kept in his room under what is considered seclusion, by this regulation, without physician orders for seclusion.

On interview of August 11, 2014 at approximately 10 am, a hospital administrative staff stated that the hospital does not use seclusion, does not have a seclusion room, nor does the Behavioral Health Unit (BHU) perform seclusion processes. Additionally, no seclusion processes appear in the hospital restraint policy other than the statement that seclusion is not used at the hospital.

Patient #10 is a young adult male who signed a voluntary and was admitted to the behavioral health unit in mid-June 2014 following homicidal ideation with a plan to harm family members and others. Patient #10 has a history of multiple psychiatric admissions, and had not been taking his medication. He was experiencing auditory hallucinations and increased aggression.

On day 2 of patient #10's admission, an RN wrote "Pt is still very aggressive, profane, unredirectable and violent. Pt does not respond to verbal de-escalation, diversional activities, therapeutic communication. Writer forced to use PRN meds IM for safety of other pts, OPt (sic), and staff. Pt continues to be on 1:1. Pt is being brought all meals. Pt is secluded to his room at this time."


An RN note on the 3rd day of admission states in part, "Pt is now taking oral medications. Pt is med compliant. Pt still on seclusion to his room due to potential for silence (sic) .... "


A social services note on the 3rd day of admission states in part, "This social worker went to the Patient's room to conduct the psychosocial assessment. Patient is retained to his room with a 1:1 sitter for continued aggression towards others. This worker greeted the Patient who responded appropriately ... "


RN and social worker documentation indicate that a seclusion process was put into effect for patient #10, mandating that patient #10 stay in his room. There was no documentation of a physician's order for the seclusion. Based on the 1:1 documentation, patient #10 was in his room for all but 2 hours and 45 minutes of day one, the entire 24 hour period of day two, the entire 24 hour period of day three excepting 15 minutes, and the entire 24 hour period of day four. No orders appear in the record for this "seclusion" process, nor is any other documentation found as required by regulation related to a seclusion process.


Based on all documentation it appears that patient #10 was in fact secluded, yet the hospital failed to comply with the regulatory requirements that must be implemented when a person is placed in seclusion.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0168

Based on a review of the hospital restraint policy and procedure and 12 patient records, it is revealed that 1) staff administered chemical restraints via PRN IM medication to behavioral health unit (BHU) patients #4 and #10 and failed to obtain orders related to documented manual holds used to administer the IM medication, 2) staff omit patient behaviors of resistance for other PRN IM administrations and the subsequent holds by which staff do so, thus circumventing regulatory requirements of physician orders for those holds; and 3) failed to obtain an order for restraint for patient #10 who was restrained for ? hour without a physician order.

Surveyor review of the Hospital policy "Use of Restraints" dated June 13, 2013 revealed that it states, in part, under Physician Orders "Each episode of restraint use requires an order (electronic, written and/or telephone by a physician or other licensed independent practitioner who is responsible for the care of the of the patient ..., " and "The application of force to physically hold a patient in order to administer a medication against the patient's wishes is considered a restraint." The hospital failed to follow this policy and procedure in the care of patients# 4 and #10 as evidenced by:

1. Patient #4 is an adult male admitted to the psychiatric unit with paranoia and thoughts of harm to others. On the second day of admission, patient #4 became agitated and demanded to sign out of the hospital. Security was called for assistance of medication administration. The note states in part, "Security notified, pt extremely agitated and fighting everyone. Medication was given with the help of security holding pt down." No restraint order or other required documentation was found in the medical records. Further there was no documentation of this restraint episode on the patient restraint log which is the quality tool used by the hospital to identify and gather data regarding restraints.

2. Patient #10 is a young adult male who signed a voluntary and was admitted to the behavioral health unit in mid-June 2014 following homicidal ideation with a plan to harm family members and others. Patient #10 has a history of multiple psychiatric admissions, and had not been taking his medication. He was experiencing auditory hallucinations and increased aggression.

During his admission, patient #10 was on 1:1 due to hostility, aggression, and at times, intermittent violence towards others. In separate incidents, patient #10 reportedly struck a peer and the staff assined to be as 1:1 . Documentation reveals IM medication was given for these emergencies, which were listed on restraint forms as "Chemical restraints." Additionally the physician wrote standing orders for lorazepam (ativan) 2 mg IM PRN (for severe anxiety), haloperidol (Haldol) 5 mg IM PRN (for severe disruptive behavior), and Olanzapine (Zyprexa) 10 mg IM PRN (Agitation).

Patient #10 was refusing medication yet was administered 12 PRN ( as needed ) IM injections that included Ativan 2 mg, Haldol 5 mg and Olanzapine 10 mg when he was documented as refusing to take po ( By mouth) medications and during time periods with no objective data describing a behavioral emergency as cited in tag (A-0131). There is no documentation of circumstances that surrounded the patient's refusal of medications or of his behavior and the interventions involved in the administration of the IM medications.

Only one documentary reference is found describing a manual hold required to administer IM medications to patient #10. This hold occurred on the second day of admission during a violent behavioral outburst at 1558, and was documented by RN #3 as "Writer heard loud yelling coming from Pt's room while writer in nursing station. Went to assess situation. Pt was using profane language and verbally threatening. In a calm but stern voice, Writer asked Pt to return to room now because he was disrupting unit. Pt stated, F+$% you, I'll F#$# you up now. Writer observed pt's fist clenched. In less than 2 seconds, the clenched fist began moving very quickly in writers direction. Using CPI (Crisis Prevention Institute) techniques trapped Pt against the wall so that he could not punch or at least keep his punches from gaining any momentum. Writer was assisted by security and (name of patient care technician) . Got patient to bed, asked if he was calm, and then let go. Had Pt sit on the floor in the corner and (name of RN #6) obtained PRN meds: Haldol 5 mg, Cogentin 1 mg, Ativan 2 mg all IM. Pt is sitting calmly in his room now.


It is noted that a physical restraint occurred during patient #10's outburst, though no physician order appears in the record for the physical restraint, nor any other indication that a physician was notified at that time. Therefore, the hospital failed to obtain physician orders for a restraint event.


On patient #10's third day of admission, he was placed into 4-point violent restraints. Documentation indicates that patient #10 attempted to attack another patient. The orders for continuation of restraint were written throughout that afternoon, night and into the following morning, and ended at 0830. However, patient #10 was not removed from restraint until 9 am, which effectively restrained patient #10 without an order for ? hour.


While 12 administrations of IM medication were documented against patient #10 ' s expressed refusal of po medication and without a court order to force medications, nursing largely omitted documentation of patient #10 ' s resistance to these IM administrations, including the need for physical holds by nursing/security. Based on patient #10 ' s history of po medication refusal and general agitation, it is reasonable to think that he continued to resist attempts to administer IM medication as well. Therefore, it is also reasonable to think that manual holds were used for at least some if not all of the IM medications administered. However, nursing failed to document any patient resistance or immediate response to the administration of these IM medications. Therefore, staff may also have circumvented the regulatory requirement for physician orders and all other regulatory requirements associated with restraint processes. Based on all documentation the hospital failed to obtain orders for restraint of patient #4 and #10.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0169

Based on an onsite survey inclusive of policy and procedure and 12 patient records, it is revealed that behavioral health unit patients #2, 4, 5, and 10 had PRN IM orders for chemical restraints.
Hospital policy "Use of Restraints" dated June 13, 2013 states , in part, under Physician Orders, that "Each episode of restraint use requires an order (electronic, written and/or telephone by a physician or other licensed independent practitioner who is responsible for the care of the of the patient ..., " and "An order for PRN restraint is NOT permitted." Their policy is consistent with regulatory requirements, but staff practice does not meet hospital or regulatory requirements.

A review of 12 patient records reveals that behavioral health (BH) patients #2, 4, 5, and 10 had written orders for PRN IM medications inclusive of Haloperidol (haldol) 5 mg, Lorazepam (Ativan) 2 mg, and in some cases, Olanzapine (Zyprexa) 10 mg.

Patient #2 had orders for PRN IM Ativan 2 mg, Haldol 5 mg, and Benzotropine 1 mg. Patient #2 received one dose of each medication on his day of hearing, July 2, 2014 when he became agitated with being retained.


Patient #4 had orders for PRN Haldol 5 mg and Ativan 2 mg IM of which he received 5 doses each over the course of (5) five days.

Patient #5 had orders for PRN IM of Ativan 2 mg, Haldol 5 mg, and Olanzapine 10 mg. She received two (2) doses of Ativan, two (2) doses of Haldol, and one dose of Olanzapine PRN IM over the course of 2 days.

Patient #10 had orders for PRN IM of Ativan 2 mg, Haldol 5 mg, and Olanzapine 10 mg. He received ten (10) doses of Ativan, nine (9) doses of Haldol, and five (5) doses of Olanzapine over the course of five days.

Based on this documentation, the hospital routinely writes orders for PRN IM medication which is not permitted by this regulation.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0175

Based on a review of one restraint record for patient #10, it is revealed that while face-to-face assessments are completed by physicians, the assessment failed to document al the required elements as evidenced by :
Hospital restraint forms on the behavioral health unit include a "Restraint Order - Violent or Self Destructive Patient" on which the details of the restraint are documented and the order is given. This form also includes the "Face-to-Face Assessment Note" featuring check boxes for "Behavior leading to the use of restraint" as "Danger to self, Danger to others, and Disruptive to therapeutic environment." While these check boxes may describe the result of patient behaviors, they do not describe the immediate situation, the patient reaction to the intervention, nor their medical and behavioral condition.
A physician note is found associated with a face-to-face for patient #10 which states "I was called last night for the face to face sheet to be signed. I evaluated the pt and did the brief examination. Pt has 4 pt hard restraints. No medical cause was found for this aggressive behavior. Face to face sheet was signed."

Based on the physician note, the face to face evaluation was completed, though much of the information required by the face to face was not documented. Therefore, while the face to face is being done, it is not well documented by way of a check box which fails to detail the actual parts of the face to face.

DATA COLLECTION & ANALYSIS

Tag No.: A0273

Based on a review of 12 patient records, it is revealed that data gathering for restraint use on the behavioral health unit was incomplete and also failed to account for events that involved the use of seclusion for Patient #10 as evidenced by:

Review of the behavioral health unit restraint log for reveals two restraints of the same person (patient #10) between June 1 and July 1, 2014. However, and as written under tag A-0168, patient #10 was chemically restrained multiple times. Only one hold is documented related to these chemical restraints, and this hold does not appear on the restraint log as a instance of restraint. Further, documentation reveals and staff document in progress notes that patient #1 was secluded as described under tag A-0162, yet interviews with staff and even hospital policy deny seclusion is utilized. Therefore, the hospital cannot gather data related to restraint and seclusion where it ignores actual practices on the unit.

FORM AND RETENTION OF RECORDS

Tag No.: A0438

Based on a review of 12 patient records, it is determined that for patient #10: 1) No History and Physical (H & P) was found in the record, and 2) the Discharge Summary fails to give an accurate account of patient #10's hospital course.

Patient #10 is a young adult male who signed a voluntary and was admitted to the behavioral health unit in mid-June 2014 following homicidal ideation with a plan to harm family members and others. Patient #10 has a history of multiple psychiatric admissions, and had not been taking his medication. He was experiencing auditory hallucinations and increased aggression.
Review of patient #10's closed record revealed no H & P. Additionally, the Discharge Summary under "Hospital Course" states, in part, "Remarkable for disorganized behavior. Patient needed to be medicated. Patient is ambulatory, cooperative, not in distress ... " Nowhere in the Discharge Summary is patient #10's aggression mentioned, his attacks on others during admission, nor that staff use of chemical and physical restraints. Therefore, the Discharge Summary fails to accurately describe patient #10's hospital course as required by regulation.