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Based on facility policy, medical record review, and interview, the facility failed to ensure patients are given the right to give informed consent to treat with psychoactive medications.

Findings included:

Texas Administrative Code Chapter 414, Subchapter 1 states in part,
"(a) The treating physician, registered nurse (RN) ... will explain to the patient ... the information in paragraphs (1)-(10) of this subsection in simple, nontechnical language in the person's primary language, if possible ...
(1) the nature of the patient's mental illness and condition; ...
(10) the patient's rights under this section."

Facility based policy entitled, "Informed Consent for Medication Administration" revised on 10/2012 stated in part, "Policy: In accordance with State Licensing Standards of the Texas Department of State Health Services, University Behavioral Health of El Paso shall comply with the established guidelines for Prescribing Medications.
Informed Consent: Informed Consent for the administration of psychoactive medication shall be required for all patients, voluntary or involuntary. Such consent must be written and made a part of the medical record. Anytime the medication regiment is altered in a way which would result in significant change in the risks or benefits for the patient, an explanation of the change must be provided to the patient ...
Information required to be given: Before administering psychoactive medications to any patient the treating physician shall explain to the patient and/or the patient's legally authorized representative, the following in a simple, non-technical language (this information may be given by the nurse if the treating physician cannot be present, but the treating physician must confirm the explanation with the patient and/or his legally authorized representative within two (2) working days:

1. The nature of the patient's mental illness and condition.
2. The beneficial effects of the patient's mental illness and/or condition expected as a result of treatment with the medication.
3. The probable consequences to the patient of not taking the medication including, as appropriate, unnecessarily prolonged hospital stays, repeated hospital admission ...
4. A description of the proposed course of treatment with the medication.
5. The fact that side effects of varying degrees of severity are a risk of all medications.
6. The side effects of the medication ...
7. The need to advise staff immediately if any of these side effects occurs.
8. The patient's right to refuse medication or withdraw consent any time.
9. A review of Patient's Rights under the Consent to Treatment with Psychoactive Medication Rule.
10. An offer to ask any questions concerning treatment.
Documentation of informed consent: Informed consent for the administration of psychoactive medications will be evidenced by a copy of the Consent for Treatment with Psychoactive Medications form executed by the patient ... This executed form will establish a rebuttal [sic] presumption of valid consent and will be retrained [sic] in the medication record ...
Patient admitted under Texas statues: Psychoactive medications may not be administered to a patient admitted under the voluntary, emergency, or Order of Protective Custody provisions of Texas Statues without informed consent, except in an emergency ..."

Review of ten medical records on 03/09/16 revealed three medical records missing:

Review of patient #2's medical record revealed consents signed for clozapine, Risperdal and Benadryl without any indication of patient education completed for these medications.

Review of patient #6's medical record revealed consents signed for depakene and Haldol without any indication of patient education completed for these medications.

Review of patient #10's medical record revealed a consent signed for buspar without any indication of patient education completed.

The above was confirmed with the chief operating officer and chief nursing officer on the afternoon of 3/9/16.

Based on facility document review, medical record review, facility video review, and staff interview, the facility failed to ensure patients' rights were protected.

Findings included:

Texas Administrative Code Chapter 404, Subchapter E states in part, "(3) The right to a humane treatment environment that ensures protection from harm, provides privacy to as great a degree as possible with regard to personal needs, and promotes respect and dignity for each individual ...

(8) The right to explanations of the care, procedures, and treatment to be provided; the risks, side effects, and benefits of all medications and treatment procedures to be used, including those that are unusual or experimental; the alternative treatment procedures that are available; and the possible consequences of refusing the treatment or procedure. This right extends to the parent or conservator of a minor, the legal guardian of the person, when applicable, and to any other person authorized by the individual served.

(9) The right to refuse particular treatments without prejudice to participation in other programs, or without compromising access to other treatments or services solely because of the refusal ...

(16) The right to be free from unnecessary or excessive medication, which includes the right to give or withhold informed consent to treatment with psychoactive medication, unless the right has been limited by court order or in an emergency. This right extends to the parent or conservator of a minor or the legal guardian of the person, if applicable. For individuals receiving inpatient services at department facilities, community centers, or other mental health facilities when those services are operated by the department or funded by the department through a contractual or other agreement, this right may only be limited in accordance with the provisions of Chapter 405, Subchapter FF of this title (relating to Consent to Treatment with Psychoactive Medication) ...

(19) The right to withdraw consent at any time in any matter in which the person receiving services has previously granted consent, without limiting or compromising access to services or other treatment(s)."

Facility based policy entitled, "Patient Identifiers" revised in 10/2013 stated in part,
"Purpose To provide patient safety by improving the accuracy of patient identification.
Policy Whenever administering medications ... or providing any other treatment or procedures the-staff [sic] will use two patient identifiers. University Behavioral Health of El Paso Patient identifiers are patient's picture, patient's name, and/or patient's ID bracelet.
Procedure 5. The patient's identification shall be verified using the photo and/or ID bracelet or patient name prior to the administration of medication, provision of patient-specific treatments, prior to blood draws, and for identification of patients on special diets."

Facility based policy entitled, "12.1 Administration of Drugs: General" revised on 1/2013 stated in part, "Policy: Administration of drugs shall be in accordance with all the laws of this state, federal laws, rules, and regulations that govern such acts, and medical staff rules and regulations ...
Procedure:
· Verify drugs to be administered with the prescriber's order. Refer to the MAR and ensure that the dose is correct and that the drug is not contraindicated by allergy, sensitivity, or diagnosis.
· Do not transfer or administer drugs to patients other than patients for whom they are ordered.
· Keep unit-dose packages intact until just prior to administration. Visually inspect the drug for deterioration ...
· Read the drug label at least three times:
o When picking up the drug
o Just prior to administration
o Just after administration
· Properly prepare the drug for administration.
· Be attentive to cautionary statements on the MAR and drug label ...
· Before administering any drug, mentally review the five rights:
1. Right patient. 4. Right route.
2. Right drug. 5. Right time ...
3. Right dose.
· To the maximum extent possible, drugs shall be administered by the individual who prepared the dose, except for unit dose drugs and sterile products prepared by the pharmacy.
· Positively identify the patient before administering drugs. Check the patient's identification and ask the patient to state his/her name.
· Double-check the order if the patient questions or expresses doubts about a drug, dose, administration route or technique, etc."

Facility based policy entitled, "Informed Consent for Medication Administration" revised on 10/2012 stated in part, "Policy: In accordance with State Licensing Standards of the Texas Department of State Health Services, University Behavioral Health of El Paso shall comply with the established guidelines for Prescribing Medications.
Informed Consent: Informed Consent for the administration of psychoactive medication shall be required for all patients, voluntary or involuntary. Such consent must be written and made a part of the medical record. Anytime the medication regiment is altered in a way which would result in significant change in the risks or benefits for the patient, an explanation of the change must be provided to the patient ..."

Facility based policy entitled, "13.2 Clozapine Therapy Monitoring" date issued on 10/2013 stated in part, "Policy: This hospital shall follow the required guidelines set forth by the hospital chosen clozapine manufacturer and the Federal Food and Drug Administration based on the recommendations provided by the Psychological Drug Advisory Committee for the use of clozapine.
Procedure:
1. This hospital shall consider clozapine a high-risk medication ...
3. The appropriate patient informed consent or court order shall be obtained prior to the initiation of treatment in the hospital ...
3.2 Nursing Staff shall ensure the Informed Consent Form is completed or hard copy of the actual court order is in the medical record prior to the administration of the medication ...
4.5 Monitoring Guidelines will be followed based on the current literature."

Review of patient #1's chart revealed a nurse's note dated 3/1/16 at 8:30 pm stated, "Medications for patient #2 given to patient #1 and pt became very sedated and became very sedated [sic] and very pale - BP [blood pressure] 92/72 P [pulse] 45 with O2 [oxygen] on 2 L NC [liters nasal cannula]. Became very sleepy and then to floor with help from MHT [mental health technician]. Clozaril 600 mg PO [by mouth] given, Dilantin 100 mg PO and Benadryl 50 mg PO given. Dr. called and informed re: response and wrong medications given. Stated to send out to ED [emergency department] - code blue called when nonresponsive. Serial BPs taken, sys [systolic] 100-114-68-75 - HR [Heart Rate] 80s, 90s - EMS [emergency medical services] called - O2 on by NRB [nonrebreather] mask. Will cont [continue] to monitor EMS here and sent to ED."

In an interview with the chief nursing officer and the chief operating officer on the morning of 3/9/16, they stated, "The 29th [of February], the patient came in to the PICU, psychiatric intensive care unit, and received the wrong medication on the evening of the 1st [of March]. He received three medications that were not his. Patient #2 and patient #1. Patient #1 did not take any home medications; the physician ordered Haldol 5 mg [milligrams] BID [two times a day] and Benadryl 50 mg HS [at bedtime]. He didn't get the AM does because the order wasn't written until later. After he received the medications, Dilantin 100 mg, Clozaril 600 mg and Benadryl 50 mg, it didn't take long. He was very sedated. They grabbed the 'crash cart', which isn't really a crash cart, and put oxygen on him. They transferred him [to the emergency department]. He was admitted and transferred to the ICU, was intubated, and within 24 hours stepped him down [to the medical floor]."

At 2:13 pm, they stated, "the LVN has been a no call, no show since our review. She hasn't come in and didn't show up for training. We have been trying to call her and she hasn't answered."

In an interview with staff member #8 on the evening of 3/9/16, she stated, "I wasn't familiar with anyone. Staff member #10 usually brings a tray of meds and staff member #9 says just start passing them out. I know better than that, I've been a nurse for 40 years. Over here they don't use last names for some reason and I called for patient #1. He didn't want to come up. He said he was doing better and didn't want to take his meds. I didn't know this med, I know I should have checked, and I didn't know you had to check the WBCs [white blood cell]. Staff #10 had gotten the nurse manager to sign with her. I didn't know there was a 2 nurse check. I didn't know a side effect is low white blood cells. I said, 'I know you don't want to take them but it's supposed to help you with your voices and stuff' and he said, 'I just don't want to take them.' He refused for me. I told the charge. He [patient #1] said 'maybe I'll take two, I don't need all those' and this was the stupidest thing, I said, 'if anything happens to you, you're here at the hospital and we'll keep you safe.' Staff member #9 said, 'if you don't take your meds, they'll eventually order you to take them.' So he took them, he took all of them. Then staff member #10 told me, 'that's not the right patient.' I didn't even know there were two [patients with the same first name] on the floor."
When asked, "When did staff #10 notice it was the wrong patient?" she stated, "Right away, I guess. I went back to the tray to get another patient's meds and I went to get another one and saw there was another [patient with the same name].
When asked how patient #1 came to take his medications, she stated, "the tech's were in the hallway and they brought him. It's like a big window, the nurse's station and over the counter. I said, 'I need patient #1' and the tech's brought him. There was one [patient with the same first name] in one hallway and another one in another hallway."
When asked where she got the medications, she stated, "all on one cart. All one thing and she [staff #10] just pulls the meds out. She had labeled them [the medication cups] with the first names and an initial for the last names. It's for HIPPA." When asked, "Did you have the MAR [medication administration record]," she stated, "No, I didn't have the MAR or the picture." When asked how they pass medications, she stated, "The med nurse gets all the meds ready and brings them out on the tray. Staff #9 had told me before, and I told you, 'I'm a nurse! I know better!' I've only given meds once here. The RNs don't give the meds. When asked why staff #10 did not pass the medications, she stated, "Staff #10 was doing some too and staff #9 was doing some. On other floors, the LVN is the only one who gives the meds. We don't bring them out of the cart. The med nurse gives all the meds. She'll pull them out for herself. Most of the times, she knows who the patients are, but she has the MAR and the pictures there. When she calls the patient, they come up and they check. They know the right medications and check when they come up to the window."
In an interview with staff member #9 on the afternoon of 3/10/16, he stated, "Staff #10 started pulling meds, which she usually does. She usually pulls the meds, it's usually just me and her for 30 patients. What we generally do, we will go into the med room. Check the MAR. Get the patients their meds. Generally, just me and her, we get behind. We all have licenses, so I can help pass the meds. When I don ' t, meds don ' t get given by 11 [pm], if meds aren ' t out by 9:30-10:00 pm, things get a little crazy. We generally go into the room and set it up. Someone brought the tray out, usually it stays in the med room. Apparently, staff #8 was helping out and she didn ' t check the names or pictures and there were two [patient's with the same first name]. She called for the patient and the wrong patient came up. Unfortunately, he came in there because he was paranoid, so he thinks people are trying to hurt him."
Facility Camera Footage dated 3/1/16 from 8:15 p.m. to 8:35 p.m. revealed no evidence of nurses checking medications to MARs, opening medication packages, or verifying patient identity using two identifiers. Patient #1 stepped up to the counter; Staff #8, placed medication cup on counter. Patient observed bringing his hands to his face and head, pacing back and forth and putting hands in pockets. Patient appeared anxious. Patient refused medications. Staff #8 stepped away from area. Staff #9 appears in nurses' station. Talking with patient. Patient #1 continues to pace. Patient took medications, one pill at a time and turned out his pockets. Patient walked away.

The facility failed protect and promote patient #1's rights to receive care in an environment safe from harm, the right to be free from unnecessary or excessive medication and the right to withdraw consent. These failures resulted in actual harm to the patient and caused him to be transported to the emergency room.

Based on facility policy review, medical record review and interview, the facility failed to ensure medications were administered in accordance with standards of practice.

Findings included:

Facility based policy entitled, "Patient Identifiers" revised in 10/2013 stated in part,
"Purpose To provide patient safety by improving the accuracy of patient identification.
Policy Whenever administering medications ... or providing any other treatment or procedures the-staff [sic] will use two patient identifiers. University Behavioral Health of El Paso Patient identifiers are patient's picture, patient's name, and/or patient's ID bracelet.
Procedure 5. The patient's identification shall be verified using the photo and/or ID bracelet or patient name prior to the administration of medication, provision of patient-specific treatments, prior to blood draws, and for identification of patients on special diets."

Facility based policy entitled, "Master Patient Index/Name Alert Label" date issued 11/2008 stated in part, "Purpose: To establish a procedure for the maintenance of the Master Patient Index and establish a procedure for the use of Name Alert Labels.
Procedure:
Master Patient Index (MPI)
A. Definition: The Master Patient Index is a permanent listing of all patient's names who have ever been treated at the facility ...
Name Alert Label
A. The NAME ALERT Label shall be placed on all charts of patient's with the same name in order to notify staff that two or more patients have the same name.
B. The NAME ALERT Label shall be placed directly under the Name Label on the patient's medical record.
C. When a clinician becomes aware that there are two patients with the same name and a NAME ALERT Label has not been placed on the medical record, the clinician will notify the medical records staff so that a label may be placed appropriately on the record."

Facility based policy entitled, "12.1 Administration of Drugs: General" revised on 1/2013 stated in part, "Policy: Administration of drugs shall be in accordance with all the laws of this state, federal laws, rules, and regulations that govern such acts, and medical staff rules and regulations ...
COMPLIANCE WITH DRUG ORDERS Drugs shall be prepared and administered in accordance with the orders of the prescriber or practitioner responsible for the patient's care and accepted standards of practice ...
PERSONS AUTHORIZED TO ADMINISTER DRUGS ...Drugs shall be administered only by individuals who are qualified, competent, and permitted by law or regulation to administer drugs ...
Procedure:
· Verify drugs to be administered with the prescriber's order. Refer to the MAR and ensure that the dose is correct and that the drug is not contraindicated by allergy, sensitivity, or diagnosis.
· Do not transfer or administer drugs to patients other than patients for whom they are ordered.
· Keep unit-dose packages intact until just prior to administration. Visually inspect the drug for deterioration ...
· Read the drug label at least three times:
o When picking up the drug
o Just prior to administration
o Just after administration
· Properly prepare the drug for administration.
· Be attentive to cautionary statements on the MAR and drug label ...
· Before administering any drug, mentally review the five rights:
1. Right patient. 4. Right route.
2. Right drug. 5. Right time ...
3. Right dose.
· To the maximum extent possible, drugs shall be administered by the individual who prepared the dose, except for unit dose drugs and sterile products prepared by the pharmacy.
· Positively identify the patient before administering drugs. Check the patient's identification and ask the patient to state his/her name.
· Double-check the order if the patient questions or expresses doubts about a drug, dose, administration route or technique, etc."

Facility based policy entitled, "13.2 Clozapine Therapy Monitoring" date issued on 10/2013 stated in part, "Policy: This hospital shall follow the required guidelines set forth by the hospital chosen clozapine manufacturer and the Federal Food and Drug Administration based on the recommendations provided by the Psychological Drug Advisory Committee for the use of clozapine.
Procedure:
1. This hospital shall consider clozapine a high-risk medication ...
3. The appropriate patient informed consent or court order shall be obtained prior to the initiation of treatment in the hospital ...
3.2 Nursing Staff shall ensure the Informed Consent Form is completed or hard copy of the actual court order is in the medical record prior to the administration of the medication ...
4.5 Monitoring Guidelines will be followed based on the current literature."

Facility based policy entitled, "12.2 Administration of Drugs: Recording in Patient's Record" revised 1/2013 stated in part, "Recording Procedure: Properly record every dose of every drug administered in the patient's MAR [Medication Administration Record] after administration."

Review of patient #1's chart revealed a nurse's note dated 3/1/16 at 8:30 pm stated, "Medications for patient #2 given to patient #1 and pt became very sedated and became very sedated [sic] and very pale - BP [blood pressure] 92/72 P [pulse] 45 with O2 [oxygen] on 2 L NC [liters nasal cannula]. Became very sleepy and then to floor with help from MHT [mental health technician]. Clozaril 600 mg PO [by mouth] given, Dilantin 100 mg PO and Benadryl 50 mg PO given. Dr. called and informed re: response and wrong medications given. Stated to send out to ED [emergency department] - code blue called when nonresponsive. Serial BPs taken, sys [systolic] 100-114-68-75 - HR [Heart Rate] 80s, 90s - EMS [emergency medical services] called - O2 on by NRB [nonrebreather] mask. Will cont [continue] to monitor EMS here and sent to ED."

Review of patient #1's MAR revealed ordered medications were given at 9:00 pm and initialed by staff #10.

Review of patient #2's MAR revealed ordered medications were given at 9:00 pm and initialed by staff #10. Clozapine, a high alert medication, was initialed by staff #10 and staff #9.

In an interview with the chief nursing officer and the chief operating officer on the morning of 3/9/16, they stated, "The 29th [of February], the patient came in to the PICU, psychiatric intensive care unit, and received the wrong medication on the evening of the 1st [of March]. He received three medications that were not his. Patient #2 and patient #1. Patient #1 did not take any home medications; the physician ordered Haldol 5 mg [milligrams] BID [two times a day] and Benadryl 50 mg HS [at bedtime]. He didn't get the AM does because the order wasn't written until later. After he received the medications, Dilantin 100 mg, Clozaril 600 mg and Benadryl 50 mg, it didn't take long. He was very sedated. They grabbed the 'crash cart', which isn't really a crash cart, and put oxygen on him. They transferred him [to the emergency department]. He was admitted and transferred to the ICU, was intubated, and within 24 hours stepped him down [to the medical floor]."

At 2:13 pm, they stated, "the LVN has been a no call, no show since our review. She hasn't come in and didn't show up for training. We have been trying to call her and she hasn't answered."

In an interview with staff member #8 on the evening of 3/9/16, she stated, "I wasn't familiar with anyone. Staff member #10 usually brings a tray of meds and staff member #9 says just start passing them out. I know better than that, I've been a nurse for 40 years. Over here they don't use last names for some reason and I called for patient #1. He didn't want to come up. He said he was doing better and didn't want to take his meds. I didn't know this med, I know I should have checked, and I didn't know you had to check the WBCs [white blood cell]. Staff #10 had gotten the nurse manager to sign with her. I didn't know there was a 2 nurse check. I didn't know a side effect is low white blood cells. I said, 'I know you don't want to take them but it's supposed to help you with your voices and stuff' and he said, 'I just don't want to take them.' He refused for me. I told the charge. He [patient #1] said 'maybe I'll take two, I don't need all those' and this was the stupidest thing, I said, 'if anything happens to you, you're here at the hospital and we'll keep you safe.' Staff member #9 said, 'if you don't take your meds, they'll eventually order you to take them.' So he took them, he took all of them. Then staff member #10 told me, 'that's not the right patient.' I didn't even know there were two [patients with the same first name] on the floor."
When asked, "When did staff #10 notice it was the wrong patient?" she stated, "Right away, I guess. I went back to the tray to get another patient's meds and I went to get another one and saw there was another [patient with the same name].
When asked how patient #1 came to take his medications, she stated, "the tech's were in the hallway and they brought him. It's like a big window, the nurse's station and over the counter. I said, 'I need patient #1' and the tech's brought him. There was one [patient with the same first name] in one hallway and another one in another hallway."
When asked where she got the medications, she stated, "all on one cart. All one thing and she [staff #10] just pulls the meds out. She had labeled them [the medication cups] with the first names and an initial for the last names. It's for HIPPA." When asked, "Did you have the MAR [medication administration record]," she stated, "No, I didn't have the MAR or the picture." When asked how they pass medications, she stated, "The med nurse gets all the meds ready and brings them out on the tray. Staff #9 had told me before, and I told you, 'I'm a nurse! I know better!' I've only given meds once here. The RNs don't give the meds. When asked why staff #10 did not pass the medications, she stated, "Staff #10 was doing some too and staff #9 was doing some. On other floors, the LVN is the only one who gives the meds. We don't bring them out of the cart. The med nurse gives all the meds. She'll pull them out for herself. Most of the times, she knows who the patients are, but she has the MAR and the pictures there. When she calls the patient, they come up and they check. They know the right medications and check when they come up to the window."
In an interview with staff member #9 on the afternoon of 3/10/16, he stated, "Staff #10 started pulling meds, which she usually does. She usually pulls the meds, it's usually just me and her for 30 patients. What we generally do, we will go into the med room. Check the MAR. Get the patients their meds. Generally, just me and her, we get behind. We all have licenses, so I can help pass the meds. When I don ' t, meds don ' t get given by 11 [pm], if meds aren ' t out by 9:30-10:00 pm, things get a little crazy. We generally go into the room and set it up. Someone brought the tray out, usually it stays in the med room. Apparently, staff #8 was helping out and she didn ' t check the names or pictures and there were two [patient's with the same first name]. She called for the patient and the wrong patient came up. Unfortunately, he came in there because he was paranoid, so he thinks people are trying to hurt him."
Facility Camera Footage dated 3/1/16 from 8:15 p.m. to 8:35 p.m. revealed no evidence of nurses checking medications to MARs, opening medication packages, or verifying patient identity using two identifiers. Patient #1 stepped up to the counter; Staff #8, placed medication cup on counter. Patient observed bringing his hands to his face and head, pacing back and forth and putting hands in pockets. Patient appeared anxious. Patient refused medications. Staff #8 stepped away from area. Staff #9 appears in nurses' station. Talking with patient. Patient #1 continues to pace. Patient took medications, one pill at a time and turned out his pockets. Patient walked away.

In an interview with the chief nursing officer on 3/9/16, at 11:25 a.m., she stated, "Staff #10 signed the MARS [Medication Administration Record] as she pulled out the meds, as she pulled them out and put into cups. She did not sign [the MARS] while giving meds to the patients. Staff #8 helped give meds and gave the wrong patient the wrong meds. I know. She knows she shouldn't have done that. She was trying to help because the nurse was new to that unit."

The nursing staff failed to follow facility policy, acceptable standards of practice and state and federal regulations which resulted in actual patient harm.