The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

HCA HOUSTON HEALTHCARE SOUTHEAST 4000 SPENCER HWY PASADENA, TX 77504 Dec. 29, 2020
VIOLATION: PATIENT RIGHTS Tag No: A0115
Based on record review and interviews, the facility failed to:

A) ensure 4 of 9 behavioral health patients in the ED and SAHA areas were not administered drug restraints using a PRN order;

Cross- Refer to A-0160


B) ensure effective training to ED and SAHA staff regarding drug /chemical restraints.

Cross- Refer to A-0169


The deficient practices identified above were determined to create an Immediate Jeopardy to the health and safety of patients. Without immediate action to correct the identified practices, an unsafe setting is created for all patients who exhibit combative, aggressive, and other unsafe behaviors. These patients are at risk for IM administration of antipsychotic drugs on an "as needed" basis, and not a time-limited drug restraint order, as required. Drug restraints require a specific time-limited physician order, face-to-face assessment, patient monitoring, and other safety requirements.
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0160
Based on interview and record review, the facility failed to provide effective restraint training to nursing staff. Four (4) of 6 nursing staff interviewed in the ED and SAHA areas failed to verbalize understanding of IM medication related to managing/controlling patient behaviors and chemical/drug restraint [RN/IDs : J, K, I, and G ] .

Findings:

Record review of facility policy titled "Patient Restraint Policy," revised date 01/2018, showed : "Drugs as restraints: a drug or medication when it is used to manage the patient's behavior or to restrict the patient's freedom of movement and is not a standard treatment or dosage for the patient's condition is considered a restraint..".


Nursing staff interviews:

Several nursing staff interviews were conducted in the SAHA unit and the main ED on 12-16-2020 between 10 A.M and 11 A.M. All of the nursing staff was asked this same question ( among others) : " If IM meds are given to control/manage patient's behaviors--is this a drug/ chemical restraint'?

The following are excerpts of the nursing staff comments:

RN/ Staff J : "...I don't consider (IM meds to manage behaviors) a restraint. I consider it 'helping them [patients] feel better." Staff J was asked this follow-up question: "When would you consider a drug a restraint?" RN/Staff J answered: "never."

RN/ Staff K: "....Any drug that is not already listed on the EMAR used for this reason would be considered a restraint. We'd have to call the ER physician."

RN/Staff I: " it depends on the drug and the patient's response...--if it puts the person completely out or not..."

RN/ Staff G: "An IM drug is a restraint/chemical restraint if you want to sedate someone. Most of the time is is a STAT order and not PRN.... "

RN/ Staff H: " If an IM drug is used when a patient is combative and a danger to hurt themselves or staff--this is a restraint..."

RN/Staff L : " We do not do chemical restraints here in SAHA. If a patient needed that--they would have to go to the main ER-they have monitoring capabilities we don't have here. Chemical restraint is the last resort for uncontrolled behaviors. I know they cant be ordered PRN."
VIOLATION: PATIENT RIGHTS: RESTRAINT OR SECLUSION Tag No: A0169
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**



Based on record review and interview, the facility failed to ensure that 4 of 9 sampled patients were not administered a drug restraint using a "PRN" restraint order (Patient ID# 1, 2, 5, and 6).

These four patients were administered Haldol IM using a PRN order to manage their behaviors, which is considered a "drug restraint."

Findings:

Review of facility policy titled "Patient Restraint Policy," revised date 01/2018, showed: An order for restraint or seclusion may not be written as a standing order, protocol or as a PRN or "as needed" order.

Review of a facility document titled "Management of the Agitated Psychiatric Patient Protocol,"revised date 07/2016, showed the following:

* "a single medication or combination of of the following medications should be chosen based in the patient's degree of psychosis, profile and comorbidities. Caution and medical monitoring should occur after these acute injections particularly when an antipsychotic agent is given with a benzodiazipine, as respiratory depression can occur.."

* Listing of antipsychotic medication choices in this protocol included: Haldol IM 5-10 mg dosages, Zyprexa 10-20 mg dose, and Geodon 10-20 mg dose;

* "Restraint and/or seclusion should be employed only when absolutely necessary to prevent the patient from severely harming him/herself or others. If the patient begins to self-harm and cannot be stopped with deescalation and psychiatric medication, then seclusion and/or restraint may be needed."

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Review of the of the computerized "ED SAHA Safe Order Set" showed the following antipsychotic medication choices ( by physicians) :

a. Haldoperidol (Haldol) Lactate 5mg syringe 2 mg IM/Q 4 hours PRN psychosis;

b. Haldoperidol Lactate 5mg syringe 5 mg IM/Q 4 hours PRN psychosis;

c. Haldoperidol Lactate 5mg syringe 10 mg IM/Q 4 hours PRN psychosis;

d. Ziprasidone (Geodon) IM 10 mg in (sterile water injection 10ml) 1.2 ml Q 6 hours PRN psychosis;

e. Ziprasidone IM 20 mg in (sterile water injection 10ml) 1.2 ml Q 12 hours PRN psychosis;

f. OLANZapine (Zyprexa) 10 mg in (sterile water injection 10ml) 2.1 ml Q 8 hours PRN psychosis;


PRN Anxiolytics included : Lorazepam IM and PO (by mouth) dosages for physician choice.

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Review of the Code of Federal Regulation (CFR 482.13 (e)(1)(i)(H) read :" A restraint is 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."

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Medical Record Review :

Review on 12/11/20 and 12/16/20 of the electronic medical records of 9 sampled patients with Staff C, Vice President of Quality and Staff D, Manager of SAHA, showed the following:

Patient ID # 1:

Psychiatric Evaluation: 12/05/20 (1342) : [AGE] year old female patient brought in by police; found laying in middle of the road. Not slept in 3 days; PMH: bipolar; depression, anxiety, medication noncompliant -pt evaluated via telehealth. pt alert /oriented; manic mood; anxious affect. Thought processes illogical, tangential, flight of ideas and disorganized. Inpatient admission was recommended for safety & stabilization. Pt will be an involuntary admission.

Physician orders: Haldol & Ativan , dated 12/04/20:

"Haldol 5 mg IM every 4 hours as needed/PRN Reason: Psychosis

"Ativan 2mg/ml: 2 mg every 6 hours as needed/PRN: Reason: anxiety/sedation

Medication Administration Record (MAR) showed: 12/06/20 (0234) Haldol 5 mg and Ativan 2 mg given IM left deltoid

Nurses Notes prior to med. administration (not all inclusive ) showed:

12/05/2020 ( 2000) rec'd pt standing upright by nurses station very manic and asked ques. after ques.. Thoughts disorganized and very labile. Appears very anxious of so many issues...redirected...

12/05/20 (2200) refused scheduled meds; very labile, delusional, disorganized thoughts..

12/06/20 (0230); patient at first pacing back and forth, appeared paranoid. Patient always watching the nurses in the station and this time very paranoid and without a warning the patient suddenly step(sic) inside the nurses' station and grabbed the phone from the writer's hand and tried to break the telephone and detach the wire and throw it away. Next thing, the patient turned to the other nurse who tried to call a code gray and attacked her and tried to bite the writer and the other nurse inside the nurses' station. Code was called and still the patient very combative and aggressive and wants to bite the writer and the other nurse. Writer somehow was able to the pt and brought the patient outside the nurses' station and tried to put the patient in seclusion room. This time code gray team came and helped put the patient into the seclusion room. IM Ativan 2 mg given and Haldol 5 mg administered to the gluteal area of the patient...


Patient ID # 2

ED Admit 11/27/20 (0043) "PD says she was found wandering streets and neighborhood since yesterday. pt disoriented and does not know where she was." Stated complaint: disoriented found walking in traffic. behavioral health hold.

Psychiatric eval: 11/28/20 (1232): chief complaint she was found wandering in the street. Pt is a [AGE] year old female...psych consulted for mood/psychosis. As per record: pt presented for evaluation after found in street. An EDO filed by police due to concern for self-harm. history is limited due to patients condition because she will not answer questions appropriately, Upon eval....pt found to be covering under the blanket, She moves her extremities but refused to wake up or answer questions..pt was seen by me a few months and was agitated and combative at the time with mood swings. Pt received PRN IM meds last night...Unable to assess thought processes; thought content: bizarre; limited and poor judgment and insight... Assessment: unspecified psychosis.

Physician orders: Haldol & Ativan:

Haldol 5 mg IM every 4 hours PRN; PRN Reason: Psychosis, dated 11/27/20 ( 2112)

Ativan 2 mg/ml ; 2 mg IM every 4 hours as needed PRN; PRN reason: Anxiety/Sedation

Medication Administration Record ( MAR) : showed: 11/27/20 ( 2128): Haldol 5 mg & Ativan 2 mg given IM left upper arm

Nurses notes pror to med. adminstration :( not all inclusive) prior to PRN Haldol/Ativan given 11/27/20 at 2128:

11/27/20 ( 1934): patient awoke and became upset asking what was going on. Pt updated regarding plan of care. EDO and behavioral health process explained. Patient continued to whine and tell this RN that she is not a child. Attempted to reorient patient but patient returned to laying in bed and covered self with blanket. Patient allowed vital signs to be taken.

11/27/20 (2155) : pt is a [AGE] year old female brought to SAHA 2122 due to psychotic behavior. Pt is alert and oriented x 2. pt appears unkempt with disorganized thought process. Pt was uncooperative during transfer from ER to SAHA. Pt was yelling and cursing...saying 'y'all want to rape me', She was threatening to hit this RN when asked to remove her clothes. Pt states she is here because she has bad breath. Pt was not answering questions appropriately. She was loud with rapid speech and flight of ideas, Pt was not following commands. She was given Ativan 2 mg and Haldol 5 mg, IM for her safety and the safety of others. Pt agreed to the medication...Staff will monitor closely for safety and behavioral changes.


Patient ID # 5

11/27/20 : ER notes: [AGE] year old male pt via EMS c/o SA via hallucinations, pt was at a gas station complaining of pain in testicles. He said spirits were pulling them. per chart: pt had extensive history of drug abuse ;chart also lists possible diagnosis of schizophrenia .

Psych eval.: Pt presented with confused mood; incongruent affect. Speech: normal rate, rhythm and tone. During the evaluation , patient appeared internally preoccupied by looking around the room and suddenly speaking to inanimate objects. Evaluation was unable to be completed due to pt not being able to answer the questions form clinician. Client reported in ER chart: reason for visit was due to pain in testicles; his family is after him. Unable to assess for SI or HI. Inpatient admission recommended for safety and stabilization. Hallucinations and odd behaviors may be due to drug usage. For now, pt will be involuntary admission.

Physician orders: Haldol & Ativan, dated 11/27/20 :

Haldol 5 mg IM every 4 hours PRN; PRN Reason: Psychosis

Ativan 2 mg/ml ; 2 mg IM every 4 hours as needed PRN; PRN reason: Anxiety/Sedation

Medication Administration Record ( MAR) :

11/28/20 ( 0929) : Haldol 5 mg given IM left deltoid; Ativan 2 mg given IM left arm

12/01/20 (1010) : Haldol 5 mg given IM left deltoid; Ativan 2 mg given IM left deltoid

Nurses Notes prior to med administration (not all inclusive ) showed:

11/28/20 adminstration:

11/28/20 (0801): pt awake automatically begins pacing in circles repetitively,, Pt is also notes to be conversing with internal factors. Pt served breakfast...will monitor.

11/28/2020 (0907) : pt engaging with internal stimuli and made the following statements below: Are you blowing up the earth that's how you looking at me dude? And stated what if there was a gun to blow up his testicles. Patient is actively hallucinating. Haldol and Ativan will be administered.

11/28/20 ( 0929) : Haldol & Ativan administered d/t drug induced psychosis and hallucinations. Will continue to monitor pt for safety.

12/01/20 administration :

12/01/20 ( 0926) : pt spinning around, reports there are sprints. Pt agreed to take Ativan 2 mg and Haldol 5 mg IM...


Patient ID #6

11//11/202: ER rapid initial assessment (2043) arrived via police "pt was found waking on the street of Holland Avenue walking in front of vehicles being a danger to herself. Pt was found walking in the lane of traffic as vehicles were trying to avoid hitting her." Refusing to answer questions, mumbling to self. Unable to hear words being said.

Psych eval:11/12/20: pt is uncooperative with treatment. Recently discharged from an inpatient psych facility. Patient denies admission and then recants and admits admission but unable to discuss diagnosis: Mood & behavior: depressed, guarded, irritable, anxious; thought process: paranoid : pt presented paranoid; delusional "people are messing with my brain." Recommend " transfer to inpatient psych facility. Diagnosis: unspecified Psychosis, severe stimulant use disorder."

Physician orders: Haldol & Ativan, dated 11/11/2020:

Haldol 5 mg IM every 4 hours PRN; PRN Reason: Psychosis

Ativan 2 mg/ml ; 2 mg IM every 4 hours as needed PRN; PRN reason: Anxiety/Sedation

Medication Administration Record ( MAR) :

11/11/ 2020 (2229) Haldol 5 mg given IM left deltoid

11/11/ 2020 (2229) Ativan 2 mg given IM right deltoid

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Nurses Notes prior to med administration (not all inclusive ) showed:

11/11/20 (2111): pt siting up in bed awake, blinking rapidly and shaking legs. When attempting to obtain blood, pt continues to mumble.

11/11/20 ( 2203); pt got out of bed an standing at side of bed mumbling. Pt able to be redirected back to bed. Continues to be uncooperative with questions.

11/11/20 ( 2224) : attempted to draw labs again, pt became increasingly anxious and aggressive pulling her arms away. Pt continued to mumble, blinking rapidly and shaking her legs then stating : " I need to get out of here." Pt. then quickly got out of the bed and was unable to be redirected. Code Gray called"

11/11/20 ( 2229) :Ativan and Haldol administered, Pt agreed with medication administration.

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During an interview on 12/16/2020 at 2:45 PM an extensive discussion was held among Staff A, CEO; Staff C, Vice President of Quality ; and Staff D, Manager of SAHA. Staff C and Staff D explained the "Management of the Agitated Psychiatric Patient Protocol," was developed following a 2016 survey when all drug protocols were reviewed and revised. The facility did not consider Haldol IM or other anti-psychotics administered IM as a drug restraint but as part of the standard treatment for psychosis.

Surveyor discussed the findings of the medical record review that showed IM Haldol was given in response to documented behaviors. The IM acute injection, given in response to behaviors that were a danger to the patient and/or staff, demonstrated immediacy and was used to manage behaviors. This was considered a restraint.