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901 NORTH HARRY S TRUMAN DRIVE

LARGO, MD 20774

COMPLIANCE WITH LAWS

Tag No.: A0020

PATIENT RIGHTS

Tag No.: A0115

Based on a review of 7 open and 5 closed medical records, policies and procedures, and other documentation, it was determined that the Condition for Patient Rights was not met where 1) disparate practices between clinical staff, security and contracted law-enforcement officers failed to demonstrate an effective provision for clinical oversight of manual restraint use; 2) No hospital policy governs the decision-making and use of police weaponry for hospital-employed off-duty law enforcement officers; 3) the hospital failed to safely manage a patient who was subsequently tased; 4) the hospital failed to protect a vulnerable patient from elopement; 5) the hospital failed to educate patient #4 to specific medication risk to benefit information; and failed to address the medication in the Interdisciplinary Plan of Care; 6) the hospital chemically restrained patient #4; 7) three of four reviewed clinical documentation that 3 of 4 restrained patients (#3, #4, and #6) had been released at the earliest possible time; 9) the hospital failed to safely monitor and provide clinical interventions/assessments for patients #3, #4, and #6; and 10) the hospital failed to conduct timely face to face assessments for patients #3 and #4.

Please see the following patient rights deficiencies.

PATIENT RIGHTS:PARTICIPATION IN CARE PLANNING

Tag No.: A0130

Based on a review of patient #4's record during the survey on 2/8/18, it was determined that patient #4 received a long-acting injectable psychoactive medication for which the hospital 1) failed to give specific risk to benefit information; and 2) failed to address in the Interdisciplinary Plan of Care.

Patient #4 was an adult less than 20 years old, involuntarily admitted to the behavioral health unit in late January 2018 after demonstrating psychotic behaviors in the community. Based on history, patient #4's psychotic symptoms were relatively new (months), and patient #4 had no identified history of having been on antipsychotic medication.

1) On admission, patient #4 was ordered an oral antipsychotic for which patient #4 was compliant with 8 of 11 doses offered. On day 3 of admission, and prior to patient #4's hearing as to whether patient #4 would be retained for treatment, a nursing note stated in part, "Pt presents as disorganized and disjointed ...and repetitively stating he wants to be D/Cd (discharged) home. Pt was compliant with Haldol Dec 100 mg rec'd (received) to right gluteal max (buttocks) ...Pt states he does not need the oral rx but agreed to injection/long-acting."

The Haldol Decanoate long-acting injectable (HDLAI) antipsychotic medication which patient #4 received had an action of up to 3 weeks, and could have life-threatening side effects for the duration of action. Patient #4 received two doses of HDLAI during admission.

Review of patient #4's record revealed patient #4 received no specific risk to benefit information by which to make an informed decision to accept the medication. Additionally, and based on the nursing note stating patient #4 was "disorganized and disjointed ...," patient #4 may not have been able at that time to accommodate risk to benefit information which the hospital failed to consider.

2) Further review of patient #4's record revealed a 6 page Interdisciplinary Care Plan (ICP) form which was initiated by nursing on day two of admission. An interdisciplinary review was completed on day 5 of admission, one day following the initial dose of HDLAI. No element of the ICP revealed that patient #4 had received HDLAI, nor the monitoring of potential side effects related to HDLAI administration.

Based on all documentation, the hospital failed to give patient #4 informed consent related to HDLAI, and failed to include this treatment in the ICP.

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on review of 7 open records 5 closed records, requests for policies, training and interviews it was determined that 1. Clinical staff failed to provide clinical supervision of patients brought to the hospital by law enforcement, or of contracted off duty police officers (CODPO) and hospital security staff interactions with patients exhibiting adverse behaviors because security and CODPO staff receive different training regarding restraint use; 2) The hospital could provide no policy or guidance related to the use of, or retention by, standard law enforcement weaponry by CODPO or for police officers escorting patients to, and within the hospital for whom the hospital is responsible; and 3) The hospital failed to safely supervise the management of patient #6 who was tased 3 times in the emergency department (ED), and failed to prevent a an elopement for vulnerable patient #1 while on 1:1 supervision.

1) The hospital revealed in part that on orientation and annually, hospital clinical staff receive a hospital approved Crisis Prevention module for de-escalation and manual restraint practices to manage adverse patient behaviors.

The hospital also employs contracted security staff (CSS). Interview with CSS#1 on 2/8/2018 at approximately 1030 revealed in part that CSS#1 and other CSS receive training for de-escalation and a type of "Martial Arts." Interview with the Security Director on 2/8/2018 at approximately 1:30 pm revealed that CSS received de-escalation training, but did not receive the same hospital approved manual restraint training as clinical staff. Based on this disparity in restraint training, clinical staff were not able to give clinical oversight to determine that CSS use safe restraint practices, even though that was part of their job description.

The Director of Security offered the hospital "Code Green" policy (December 2017) which, when initiated, guides staff in the management of a patient demonstrating aggressive behaviors. Based on review of this policy, calling a Code Green initiates a response from multiple staff including security for the clinical management of an aggressive patient. The policy instructs under "Control Team" in part, "Non-Clinical Trained staff; Security etc. should assist in holding the patient, but should not apply or remove the restraints." It is noted that in addition to the (mechanical) "restraints" to which this policy refers, "Holding" is a form of restraint which when done improperly, can result in serious injury to a patient. While a Code Green initiates clinical oversight, clinicians would continue to be unable to give oversight to manual (holding) by security due to disparate types of restraint training.

Additionally, the hospital employs contracted off-duty police officers (CODPO). A contract dated 2013 revealed under "Principal Duties" in part, "6. Assists with restraining as needed." Further interview with the Director of Security revealed that CODPO have their own police restraint training and the hospital had no expectation that other restraint training was needed. Therefore, CODPO's received no training in the safe and therapeutic use of restraints or in any limitations to those restraints. Based on this information, the hospital had no expectation of giving oversight for CODPO related to safe restraint practices, nor could a clinician provide oversight to CODPO to determine if safe restraint practices are in fact, conducted.

2) Further, the CODPO carry police weaponry inclusive of guns, Tasers, batons, and cuffs. Review of the CODPO contract stated in part under Position Requirements, "Able and willing to serve as the first line of defense." This meant that the CODPO could be out front and making initial decisions related to the management of adverse patient behaviors without clinical supervision. Another area of the contract "Level of Supervision Required" was blank, indicating that no clinical supervision was required. A request to the Director of Security for a "Use of Force" or similar policy revealed no policy exists which governs CODPO indications/contraindications in the use of force and police weaponry in and around the hospital.

3. Patient #6, was a 65+ year old brought to the hospital via police on an emergency petition for a mental health evaluation in November 2017 at 2109. An emergency petition is a court order compelling a patient to undergo a mental health evaluation to determine if the patient requires inpatient treatment or if the patient may be discharged to the community. Patient #6 was not under arrest. Patient #6 had taken multiple drugs prior to presentation, which may cause aggression. Vitals were taken by the nurse at 2112.

Review of other documentation revealed in part, "At 2238 hrs a code green was called in the ER when a patient brought in, apparently on ___ drugs, was very hostile and aggressive towards medical staff in the ___ area of the ER. Security responded to the scene and met him already tased by ER1 (another term for a CODPO)." He was still very aggressive and was tased a couple more times before he was subdued and put on 4 point restraints ..." As per #1 of this citation, a "Code Green" initiates a clinical process. However, in this instance, and regardless of the initiation of a Code Green, a police tasing occurred, indicating the police made that determination without clinical consultation, and continued to tase patient #6 twice again without clinical intervention.

Interview with hospital staff on 2/9 at approximately 1000 revealed the hospital denial that the noted ER1 was one of their CODPO's as noted in documentation. Hospital staff stated it was the community police officer who brought patient #6 into the hospital, and who 1 ½ hours later was still with patient #6. Hospital staff stated that an unwritten agreement existed between community police and the hospital where, if there are multiple psychiatric patients in the emergency department, a police officer will stay with a patient for a period of time to continue oversight. While the identity of the noted ER1 was inconclusive, the event revealed an environmental safety management concern where the potential for patients to be tased at police discretion while in the process of a clinical evaluation, is an ongoing possibility, and where the hospital failed to take responsibility for the safe management of the 65+ year old who had been brought to the ED.

Patient #1 was a 75+ year old patient who presented via Emergency Medical Services in September at 1317 to the hospital's emergency department. Patient #1 was sent from a nursing home for "treatment of dementia." The nursing home physician felt patient #1 might be a danger to self, though no emergency petition for a mental health evaluation was completed by the sending physician.

Patient #1 was triaged at 13:23 and was determined to be an Emergency Severity Index (ESI) level of 3. An ESI 3 indicated that patient #1 could wait, but would require multiple resources. Hospital documentation revealed patient #1 to be alert and oriented x 3 and that patient #1 gave an accurate medical history. A physician assistant (PA-C) saw patient #1 in triage at 13:29 and determined patient needed a psychiatric evaluation. The PA-C ordered 1:1 observation (1:1 means that the patient is kept at arm's length observation at all times) for patient #1 at 13:31 due to the initial findings that patient #1 required close supervision while waiting further evaluation.

Approximately two hours later, per PA-C note at 15:42, the PA-C was notified by the triage technician that the patient may have eloped. Per RN note at 16:01, they were notified by PA-C "that patient was not in ED triage area." The County Police was notified.

Orders for 1:1 monitoring were not carried out in the protection of patient #1 who without 1:1 monitoring, was able to elope from the hospital. No further determination was made as to patient #1's status following the elopement.

In summary, there was a blurring of behavioral management of patients with clinical staff often deferring patient management to security and law enforcement. Therefore, the hospital failed to consistently provide a safe environment.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0160

Based on a review of patient #4's record, it was revealed that patient #4 received a long-acting injectable medication which 1) was not a standard treatment and dose for patient #4's condition; 2) failed to follow manufacturer's recommendations; and 3) failed to indicate order rationale.

Patient #4 was an adult less than 20 years old, involuntarily admitted to the behavioral health unit in late January 2018 after demonstrating psychotic behaviors in the community. Based on history, patient #4's psychotic symptoms were relatively new (months), and patient #4 had no identified history of having been on antipsychotic medication.

1) On admission, patient #4 was ordered an oral antipsychotic for which patient #4 was compliant with 8 of 11 doses offered. On day 3 of admission, and prior to patient #4's hearing as to whether patient #4 would be retained for treatment, a nursing note stated in part, "Pt presents as disorganized and disjointed ...and repetitively stating he wants to be D/Cd (discharged) home. Pt was compliant with Haldol Dec 100 mg rec'd (received) to right gluteal max (buttocks) ...Pt states he does not need the oral rx but agreed to injection/long-acting. "

Haldol Decanoate long-acting injectable (HDLAI) antipsychotic medication had an action of up to 3 weeks, and can have life-threatening side effects. Review of the manufacturer's indications for administration revealed that, "HALDOL Decanoate is indicated for the maintenance therapy of psychoses; particularly for patients requiring prolonged parenteral (other than oral) neuroleptic (antipsychotic) therapy." While other forms of haldol included oral doses, HDLAI has been used for patients with chronic noncompliance of oral antipsychotic medication therapies. No manufacturer indications recommended HDLAI as a first-line medication for the treatment of new psychosis as identified for patient #4, and no requirement for prolonged parenteral therapy had been established for patient #4 who had no history of taking antipsychotic medication.

Manufacturer's information also revealed that HDLAI comes in 50 mg or 100 mg. doses. Further review of Manufacturers recommendations revealed in part that, " ...patients being considered for haloperidol decanoate therapy have been treated with, and tolerate well, short-acting HALDOL (haloperidol) in order to reduce the possibility of an unexpected adverse sensitivity to haloperidol." Patient #4 had only one oral and two intramuscular doses of short-acting Haldol prior to being started on HDLAI at the highest 100 mg dose.

2) Additionally, the manufacturer cautioned, that if a patient required more than 100 mg of HDLAI as an initial dose, the balance should be followed in "3-7 days." Patient #4 received two doses of HDLAI 100 mg, only two days apart, which failed to follow manufacturer's recommendations.

3) Review of the two physician orders for HDLAI revealed no documented rationale in the medical record for the use of HDLAI.

Based on all documentation, the hospital chemically restrained patient #4 when it medicated patient #4 with two non-standard treatments and doses using HDLAI. The hospital additionally failed to follow the manufacturer's dosing recommendations, and failed to document a rationale in the medical record for its use in this patient at this time.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0168

Based on a review of restraints for 4 patients, it was determined that no restraint orders were found for 3 of 4 restrained patients #4 x 2, #5, and patient #7.

Patient #4 was an adult less than 20 years old, who was taken to the emergency department (ED) in late January 2018 after demonstrating bizarre and psychotic behaviors in the community.

While in the ED, patient #4 began to shadow-box in the hallway of the ED. The physician wrote orders for intramuscular medications to which patient #4 objected. A nursing note stated in part, " ...Patient was uncooperative, 3 additional staff were required to perform this procedure due to patient being combative ..." Based on this, patient #4 was manually restrained to administer intramuscular medications. Review of the ED record revealed no order for the physical restraint.

On the first day of admission, a nursing note of 1644 described that patient #4 grabbed a nurse's arm and touched females inappropriately. On or about 1210, patient #4 was placed in 4-point restraints, and was subsequently released at 1549. No order for this restraint was found in the record.

Patient #5 was a developmentally disabled adult who was brought to the emergency department in late December 2017 after demonstrating adverse behaviors in the community. A nursing note of 1530 stated, "many attempts to give pt medication po (orally) refuses pt agitated non compliant with care ...with asst. medicated im (intramuscular) pt sitting up ... tearful talking to self." A physician note of 1813 stated in part, "Pt screaming incoherently ...Attempted PO meds without success and so gave IM Zypreza."

Other documentation revealed, "Code Purple was called at 1544 PM, when the patient in ER suddenly became very violent and refusing medical help. (Patient) was later held by all security officers as ordered by -- doctor. (Patient) was medicated." No order for this physical restraint was found in the record.

Patient #7 was a 70+ adult who was admitted in January 2018 following a fall. Patient #7 was intubated during admission and was placed in non-violent 2-point restraint with mittens on nearly a daily basis. However, while nursing restraint documentation was found for 1/30/18, no accompanying restraint order was found.

Based on all documentation, patients #4, #5, and #7 were restrained without evidence of orders to do so.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0174

Based on a review policy "Use of Restraints, 1-41" (revised 02/2017), and of restraints the hospital failed to demonstrate that for 3 of 4 restraints reviewed, patients #3, 4, and 6, were released from restraints at the earliest possible time.

Hospital policy "Use of Restraints" stated in part under "Staff Training: 6. Clinical identification of specific behavioral changes indicating the patients (sic) is ready for discontinuation of restraints or seclusion," and, "G. 2. Assessment of the patient and the need for continued restraint/s, by the RN every hour ..."

Patient #3 was an adult who was brought to the ED at 0448 in late January 2018 after demonstrating adverse behaviors in the community. Patient #3 was restrained in the ED at 0513. A nursing note of 0544 stated in part, "Patient behavior is aggressive, Patient behavior is aggitated (sic), Patient behavior is combative, Patient behavior is hostile ..." A nursing note of 0734 stated in part, "0530 to 0730 hours: ...Patient was put in 4 point restraint with medication given ..." Following patient #3's restraint, no hourly nursing assessment documentation was found for the two hour period between 0530 and 0730 until patient #3's release. Based on the lack of specific documentation of behavioral assessments, it was not possible to tell if patient #3 was released at the earliest possible time.

Patient #3 was admitted involuntarily to the behavioral health unit. Patient #3 was restrained at 2200, and restraints were discontinued at 2358. No behavioral flow date related to the event was evident int he record, and all dated and undated behavioral assessments on the flow sheets indicated only that patient #3 was "lying/sitting." This documentation did not justify ongoing restraint. Therefore, the hospital failed to demonstrate that patient #3 was released at the earliest possible time.

Patient #4 was an adult less than 20 years old, involuntarily admitted to the behavioral health unit in late January 2018 after demonstrating adverse and psychotic behaviors in the community.

On day one of admission, on or about 1210, patient #4 was placed in 4-point restraints, and was subsequently released at 1549. Review of flow sheet documentation revealed only that patient #4 was in restraint, with behaviors of "lying/sitting." No actual behavioral documentation was noted to indicate whether patient #4 was released at the earliest possible time. Additionally, a nursing note of 1619 revealed that at some point during the restraint, "Patient has been arousable and continued to present a danger to self ...and, "Arousable and did not appear to present a danger to self." In both instances, nursing aroused patient #4 from a sleeping state, which of itself, failed to justify ongoing restraint.

Patient #6 was a 65+ year old brought to the hospital via police on an emergency petition for a mental health evaluation in November 2017.

Review of other documentation revealed in part, "At 2238 hrs a code green was called in the ER when a patient brought in, apparently on ___ drugs, was very hostile and aggressive towards medical staff in the ___ area of the ER. Other documentation revealed in part, "Security responded to the scene ...(Patient) was still very aggressive ...(Patient) was subdued and put on 4 pts restraints ..."

An order for 4-point restraints appears in the record at 2305. No other documentation is noted by nursing which indicated patient #6's ongoing behaviors nor when patient #6 came out of restraints. Based on this, it was not possible to determine if restraints were terminated at the earliest possible time.

Based on scant documentation of restraint processes, the hospital failed to demonstrate compliance with the release of patients from restraints at the earliest possible time.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0175

Based on a review of hospital policy, staff restraint/seclusion training, and 4 restraint events, it was determined that the hospital was lacking 15-minute safety checks as required by policy and was lacking clinical interventions for restrained patients #3, #4, and #6.

Hospital policy "Use of Restraints," stated in part:

"G2. Assessment of the patient and the need for continued restraint/s, by the RN every hour. Assessment of the restraints includes:
a. Mental status
b. Appropriateness of continuing restraint
c. Respiration
d. Hydration and nutritional needs
e. Assessment of restricted includes:
i. Circulation
ii. Safe and proper body alignment
iii. Skin Integrity

Additionally, the policy stated in part, "Restraints for Violent & Destructive Behavior: G. 3. Closely observe the patient (including 1:1 ratio) at least every 15 minutes and document each observation by the observer (PCT/RN) that the patient is safe and free from harm ..."
And, "H. Clinical Interventions:
Observing for safety Q 15 minutes ..., and every 2 hours: Circulation checks ...Elimination needs ...Range of motion ...Hydration (fluids offered) ...Nutritional needs ..."

The hospital used a form for restraint/seclusion on which the RN documented in part, the initiation of restraint/seclusion, hourly assessments and clinical interventions. The form was called "Restraint Flowsheet-Violent/Self Destructive Patient (RFVSDP)." Additionally, behaviors and safety checks were documented on the "Q 15-Minute Safety Check (Q15SC) form.

Patient #3 was an adult who was brought to the ED at 0448 in late January 2018 after demonstrating psychotic behaviors in the community. Patient #3 was restrained in the ED at 0513. A nursing note of 0544 stated in part, "Patient behavior is aggressive, Patient behavior is aggitated (sic), Patient behavior is combative, Patient behavior is hostile ..." A nursing note of 0734 stated in part, "0530 to 0730 hours: ...Patient was put in 4 point restraint with medication given ..." No RFVSDP documentation was found of clinical interventions and nursing hourly assessment. Additionally no Q15 SC was found which documented safety checks for a restraint event of at least two hours.

Once admitted to the behavioral health unit, a nursing note read in part, "Security had to hold the patient to stop his aggressive behavior. Patient placed in four point restraints at 2200." A review of flow documentation revealed documentation to initiate restraint and that patient #3's skin integrity and circulation was within normal range. However, no clinical interventions and no nursing one hour assessments were found. Additionally, no contemporaneous Q15 SC relating to the event was found for patient #3 who remained in restraints until 2358.

Patient #4 was an adult, less than 20 years old, involuntarily admitted to the behavioral health unit in late January 2018 after demonstrating psychotic behaviors in the community.

On day one of admission, on or about 1210, patient #4 was placed in 4-point restraints, and was subsequently released at 1549. No RFVSDP form was found. Review of Q15SC documentation revealed only that patient #4 was in restraint, with behaviors listed as "lying/sitting." While Q15SC was present, no clinical interventions showing care, and no nursing interventions were found for patient #4 who was restrained for more than 3 hours was found.

Patient #6 was a 65+ year old brought to the hospital via police on an emergency petition for a mental health evaluation in November 2017.

Review of other documentation revealed in part, "At 2238 hrs a code green was called in the ER when a patient brought in, apparently on ___ drugs, was very hostile and aggressive towards medical staff in the ___ area of the ER. Other documentation revealed in part, "Security responded to the scene ...(patient) was still very aggressive ...was subdued and put on 4 pts restraints ..."

No RFVSDP and no Q15SC documentation was found to indicate that patient #6 who was placed in 4 point restraint was assessment and monitored per policy.

In summary, review of 3 of 4 restrained patient records revealed every 15-minute safety checks were lacking or absent for vulnerable patients #3, and #6. Additionally, no clinical interventions were noted for #3, #4, and #6, and patient #4 was in 4-point restraint for at least 3 hours, yet no clinical interventions of care were found.

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0179

Based on a review of restraint events for patients #3 and #4, it was determined that face to face assessments failed to meet regulatory requirements for timeliness.

Patient #3 was an adult who was brought to the ED at 0448 in late January 2018 after demonstrating psychotic behavior in the community. Once admitted to the behavioral health unit, a nursing note in part read, "Security had to hold the patient to stop his aggressive behavior. Patient placed in four point restraints at 2200." A face to face was documented as being performed by a physician on the day of restraint at 2332 which was ½ hour late. However, documentation also indicated that the face to face was performed on a date which was 6 days later. Based on this information, it was determined that the face to face had not been done within one hour of restraint.

Patient #4 was an adult less than 20 years old, involuntarily admitted to the behavioral health unit in late January 2018 after demonstrating psychotic behaviors in the community.

On day one of admission, on or about 1210, patient #4 was placed in 4-point restraints, and was subsequently released at 1549. The documented physician face to face was timed at 2113, approximately 9 hours from the time of restraint.

Based on this, the hospital failed to meet requirements for a face to face within 1 hour of restraint/seclusion for two patients.