HospitalInspections.org

Based on document review and interview the Governing Body failed to ensure:

1. patient rights were guaranteed by preventing involuntary holds without an appropriate warrant or guardianship. The facility failed to ensure the patients had the capacity to consent or had a legally authorized representative before implementing consent for admission, treatment, and medication administration in 3(#20, #2, and #17) of 3 charts reviewed.

Refer to Tag A0131


2.

A. a signed Order of Protective Custody with a forced medication order granted by the county judge was on the medical record before administering Intramuscular (IM) injections of psychotropic medications in 1 (Patient #16) of 2 patient medical records reviewed.

B. patient behaviors such as suicidal ideation was documented to support the Order of Protective Custody (OPC).

Refer to Tag A0144

Based on review and interviews the facility failed to:

1. ensure patient rights were guaranteed by preventing involuntary holds without an appropriate warrant or guardianship. The facility failed to ensure the patients had the capacity to consent or had a legally authorized representative before implementing consent for admission, treatment, and medication administration in 3(#20, #2, and #17) of 3 charts reviewed.

Refer to Tag A0131

2.

A. ensure a signed Order of Protective Custody with a forced medication order granted by the county judge was on the medical record before administering Intramuscular (IM) injections of psychotropic medications in 1 (Patient #16) of 2 patient medical records reviewed.

B. ensure patient behaviors such as suicidal ideation was documented to support the Order of Protective Custody (OPC).

Refer to Tag A0144

Based on review and interviews the facility failed to ensure patient rights were guaranteed by preventing involuntary holds without an appropriate warrant. The facility failed to ensure the patients had the capacity to consent or had a legally authorized representative before implementing consent for admission, treatment, and medication administration in 3(#20, #2, and #17) of 3 charts reviewed.

Findings:


Patient #20

A review of patient #20's chart revealed she was admitted to the facility on 12/2/22 for a Neurocognitive disorder, Alzheimer's type with behavioral disturbances and a history of Dementia. Patient #20 was living at an assisted living facility in Tyler, Texas.

A review of the chart revealed a Guardian's Application for Emergency Detention was written on 12/2/22 at 11:12 AM by the patient's daughter. Under the section "emergency detention is sought for the following reason" The daughter had written, "she has punched a caregiver, slapped and bit as well." The physician admission order dated 12/2/22 at 2055 (8:55 PM) stated the patient was admitted by Legal Guardian Emergency Detention Order.

A review of patient #20's "guardianship" papers revealed it was an advanced directive and not a guardianship. The patient's daughter was nominated by patient #20 in the directive as her guardian and conservator. The directive was signed by the patient and only notarized. There was no judge's signature. The directive papers were signed in 2006 for New Mexico. The document stated, "NOTE: Under New Mexico Law, only the court can make official appointments of a Guardian and Conservator for an incapacitated person ..." There was no Texas guardianship on the chart. Guardianship does not continue across state lines. Texas is not part of the Uniform Adult Guardianship and Protective Proceedings Jurisdiction Act and requires a guardian to apply in the state of Texas. All letters of guardianship expire one year and four months after the date of issuance unless renewed.

According to www.hhs.texas.gov/regulations/legal-information/guardianship, "Guardian and ward are legal terms used to indicate the relationship between someone who protects another (the guardian) and the person being protected (the ward). In Texas, the process to appoint a guardian includes:
A guardian is a court-appointed individual, or sometimes an entity such as a state agency, who makes decisions on the incapacitated person's behalf.
Filing an application with a court
Having a hearing before a judge
Having a judge appoint a guardian, if one is needed."
A minor;
An adult individual, such as an elderly person or developmentally disabled adult, who, because of a physical or mental condition, is substantially unable to provide for themselves, to care for their own physical health, or manage their financial affairs; or
An individual who must have a guardian appointed to receive funds due them from any governmental source.

A review of patient #20's chart revealed the following consents were signed by two nurses after they received consent from the daughter via telephone on 12/3/22 at 2130 (9:30 PM) over 24 hours after being admitted.
Admission Consent Form
Informed Consent for Telehealth Services
Substance Use Disorder and Medical Information Consent and Authorization for Disclosures.
Consent for involvement in Treatment
Important Message from Medicare
Financial Responsibility.

A review of the Admit Nursing Assessment dated 12/2/22 at 2100 (9:00 PM) stated the patient was oriented to person only and "memory not intact." The nurse documented that the "patient does not understand questions."

A review of the admit nurse's note on 12/2/22 at 8:55 PM stated, " ...Patient oriented to self only."

A review of the Initial Psychiatric Evaluation dated 12/4/22 stated, she is alert and oriented to person. She knows her first name, last name, could not recall her age but knew her date of birth. She is not oriented to date, month, year, or place .... judgment impaired. She has been hostile and combative. Attention and Concentration: impaired ..."

A review of the physician orders dated 12/4/22 at 11:10 AM stated, "start the OPC (order of Protective Custody) process (pt has guardian)." An application for an OPC was filed on 12/5/22. The physician wrote in her initial evaluation, "We will admit to Ocean's Behavioral Hospital. She does not have capacity and her daughter is her legal guardian. We will start OPC process."

An interview was conducted on 12/7/22 with Staff #16 and Staff #18. Staff #16 was asked about the directive that was in patient #20's chart. Staff #16 stated it was a guardianship and her daughter could sign for her consent. Staff #16 was shown the paperwork. The surveyors showed her the directive was not signed by a judge and was from another state. Staff #16 shrugged her shoulders and stated, "I was just told she had a guardian." Staff #18 was also shown patient #20's directive and she stated she never noticed anything different about it. She stated that she was instructed that a medical power of attorney could give permission for consent. Staff #16 was unable to differentiate between a Mental Health Power of Attorney or Guardianship. Staff #16 and #18 were not aware that patient #20 would require an OPC for care.
.
A review of patient #20's chart revealed "Education Acknowledgement and Consent to Treatment with Psychotropic Medications" (medication consent) forms were found. The consent stated, "Based upon this explanation, I hereby consent to treatment with a specific psychoactive medication as indicated on the front of this form. I understand that I may withdraw this consent at any time; however, a probate court may decide that I lack the capacity to make the decision whether or not to take the medication(s) and decide that I must continue taking the psychoactive medication prescribed by the physician. If there is an existing court order for psychoactive medications, my signature indicates only that I have received information and education regarding this medication."

A review of patient #20's chart revealed the first medication consent was dated 12/2/22 for Quetiapine (Seroquel- antipsychotic) 25mg. The patient had signed the consent along with the LVN on 12/2/22 at 2213 (10:13 PM).
Review of the Medication Administration Record (MAR) the medication was given on 12/3/22 at 2100 (9:00 PM)

The second medication consent was dated 12/3/22 at 6:21 AM for Zoloft (antidepressant) 50mg. The patient only signed her first name. The LVN signed at 6:29 AM.
A review of the MAR revealed the medication was given on 12/3/22, 12/4/22, and 12/4/22 at 9:00 AM.

The third medication consent was dated 12/3/22 at 6:22 AM by the patient for Ativan (benzodiazepine) 0.5mg. The patient only signed her first name. The LVN signed at 6:23 AM. There was no documentation that the medication was administered.

A review of patient #20's MAR next to the order for Depakote Sprinkles 125 mg (mood stabilizer) revealed a note that stated "no guardian no POA paperwork. Do not give until OPC paperwork is signed." However, the nurse administered Seroquel (antipsychotic) 100mg on 11/18/22 at 9:00 AM.

An interview was conducted on 12/7/22 with Staff #1 and #2. Staff #1 stated that the staff had been instructed on psychotropic consent. Staff #1 stated that it was a problem getting OPC's done in a timely manner through the county courts and patients would have to go days without their medications. Staff #1 stated that the patients were going into withdrawal or having medical issues without their medications on board in a timely manner. Staff #1 stated they do not get paid by the insurance companies if they are unable to provide therapeutic medications to the patients and would have to discharge them. Staff #1 stated she had talked to the staff at the courthouse about the issues but had not talked to the county judge concerning the need for timely processes.

Patient #2

A review of patient #2's chart revealed he was admitted to the facility voluntarily for neurocognitive disorder with a history of Alzheimer's type with behavioral disturbances and Dementia on 11/16/22.

A review of the Admit Nursing Note stated patient #2 was oriented to person and situation but was agitated, restless, irritable, and disorganized. The nurse had documented on the elopement screening that the patient thought he was just coming to see the doctor and just leave but he had agreed to stay.

A review of patient #2's admission consents revealed he was allowed to sign all of his admission consents. There were two forms in the chart at discharge for Important Messages from Medicare and Covid 19 information. The nurse had written on the forms "verbal consent from POA____ (patient #2's daughter) via phone." Patient #2 did not have any paperwork on his chart for a Power of Attorney ( POA).

A review of the "Education Acknowledgement and Consent to Treatment with Psychotropic Medications" forms were found to be signed by patient #2 on 11/16/22 at 1905(7:05 PM) for Seroquel 50mg and Seroquel (antipsychotic) 100mg. Another set of mediation consent forms was found signed by patient #2 on 11/17/22 at 6:15 AM for Seroquel 50mg, and Seroquel 100mg.

Review of the psychiatric exam dated 11/17/22 revealed the psychiatrist documented patient #2 did not have the capacity to consent and that they would start the OPC process. A review of the medication consent revealed the psychiatrist had signed the consent even though the psychiatrist had documented he did not have the capacity to consent. The form stated at the bottom of the patient acknowledgment "If there is an existing court order for psychoactive medications, my signature indicates only that I have received information and education regarding this medication." A review of the OPC paperwork revealed the facility submitted the paperwork on 11/18/22 (Thursday) and the county judge signed the OPC on 11/22/22 at 1:30 PM on the following Tuesday. Patient #2 did not have an existing court order when these consent forms were signed.

A review of patient #2's MAR revealed he was given a dose of Seroquel 100mg on 11/18/22 at 9:00 AM but held an order of Depakote Sprinkles 125 mg (mood stabilizer). Next to the medication, a note stated "no guardian no POA paperwork. Do not give until OPC paperwork is signed."


Patient #17

A review of patient #17's chart revealed she was admitted to the facility on 11/21/22 with a diagnosis of Dementia with behavioral disturbances. The patient was at a living facility and began to have suicidal thoughts and hallucinations. The patient was taken to a local emergency room and transferred to the facility.

A review of patient #2 admission orders stated she was admitted with an OPC on 11/21/22 at 2300 (11:00 PM). A review of the chart revealed there was no OPC or an EDW (Emergency Detention Warrant). There was no legal paperwork in place to hold the patient involuntarily.

Review of the psychiatric evaluation dated 11/22/21 revealed the patient was unable to consent due to confusion and poor judgment. The psychiatrist wrote, "we will admit to _____ (facility name). She will be involuntary admit. She does not have capacity and we will start the OPC process ..."

A review of the physician orders revealed there was an order written by the psychiatrist on 11/22/22 (Tuesday) at 11:12 AM. The order stated, "Start OPC process." The facility had the 22nd and 23rd to file the paperwork. The courthouse was closed from the 24th-27th for the Thanksgiving holidays. A review of the chart revealed the OPC was not completed by the facility until 11/28/22, (6 days) after the physician ordered it. The OPC paperwork was not filed at the courthouse until 11/29/22. The facility had to take the OPC paperwork to the courthouse for the clerk to file it. There was no documentation found on why the OPC was delayed before or after the holiday. A review of the OPC order revealed it was signed by the judge on 12/1/22, two days after it was filed at the courthouse.

A review of the admission consent revealed the admission nurse documented that the patient was "unable to sign due to cognition". At the bottom of the form, the nurse filled out the daughter was notified and in agreement for the admission on 11/22/22 at 9:06 AM. The following consents revealed the same statement, Advanced Directive, Substance Use Disorder Medical Information Consent and Authorization Disclosures, Informed Consent for Telehealth Services, Consent for Involvement in Treatment, Statement of Patient Acknowledgment, Important Message from Medicare, and Financial Responsibility. There was no found paperwork that stated the patient's daughter was a guardian or an MPOA.

A review of patient #17's chart revealed patient #17 had signed medication consents on 11/22/22 at 6:25 AM for the following medications. The medication administrations were confirmed per the MAR.
Clonazepam (tranquilizer)1 mg
Administered on 11/22 thru 11/28/22 and on 11/29/22.
Seroquel (antipsychotic) 50mg
Administered on 11/22 thru 11/28/22 and on 11/29/22.
Seroquel (antipsychotic) 100mg
Administered on 11/22 thru 11/28/22 and on 11/29/22.
Trazadone (antidepressant) 50mg
Administered on 11/22 thru 11/28/22 and on 11/29/22.
Sertraline (antidepressant) 50mg
Administered on 11/22 thru 11/28/22 when it was increased to 100mg.

On 11/23/22 at 1410 (2:10 PM) a medication consent for Zyprexa was found signed by the patient. The MAR revealed the first dose was started on 11/23/22. Patient #17 signed consent for psychotropic medications and was administered medication without the ability to consent.

Review of the education documentation dated 9/12,15,20,and 22 of 2022 revealed the staff were educated according to the facility policy and procedure for consent. The education stated if the patient did not have the capacity to consent then the "Legal Authorized Representative" (Guardian with valid guardian paperwork, or Medical Power of Attorney with appropriate documentation ) can sign consents. In the absence of an LAR, patients must have Court Order for Psychotropic Medications (except Emergency Administration of Psychotropic Medications.)

Based on document review and interview the facility failed to;

A. ensure a signed Order of Protective Custody with a forced medication order granted by the county judge was on the medical record before administering Intramuscular (IM) injections of psychotropic medications in 1 (Patient #16) of 2 patient medical records reviewed.

B. ensure patient behaviors such as suicidal ideation was documented to support the Order of Protective Custody (OPC).

Findings:

Patient #16

A review of patient #16's medical record was completed with Staff #3 and Staff #11 on 12/05/2022.

Patient #16 was admitted to the facility voluntarily on 10/17/2022 at 2:20 PM with a diagnosis of Bipolar 1 recurrent, severe with psychotic features.

A review of the Psychiatric Evaluation dated 10/18/2022 by Physician #9 was as follows:

" ...Psychiatric Problems: Aggression, sleep disturbances, anxiety, manic symptoms, psychosis, suicidal ideation.
Assessment: This is a 58-year-old, Caucasian male with a history of bipolar disorder and obsessive-compulsive disorder who was transferred from emergency department due to profound depression, suicidal ideations and manic symptoms. He is willing to consent for treatment and has capacity ..."

A review of the progress note dated 10/26/2022 by Physician #9 stated Patient #16 was partially compliant with medications and that he had signed a 4-hour discharge letter to request discharge from the facility. The 4-hour discharge letter was signed by patient #16 on 10/26/2022 at 10:05 AM.
The Psychiatrist had 24 hours to decide if the patient could discharge or to write an order to obtain an Order of Protective Custody (OPC) to hold the patient involuntarily.

Physician #9 wrote an order on 10/26/2022 at 11:00 AM that read, "Start OPC (order of protective custody)".


Review of the medical record revealed an application for an OPC was dated on 10/27/2022 and signed by Staff #11 and Physician #9 that read,

" ...6. An accurate description of the mental health treatment, if any, given by me or administered under my direction is as follows: Admit to Oceans voluntarily; patient signed a four-hour letter to leave; ordered OPC based upon evidence patient is a danger to self a.e.b. (as exhibited by) suicidal ideation ..."

Also, an application to administer psychoactive medications was included in the OPC application that read, " ...the consequences of not having a forced medication order will be; progressive and rapid decline of the patients mental status and overall function. Applicant has considered the following alternatives to psychoactive medications for treatment of Patient: Voluntary inpatient Psychiatric Treatment ..."

A review of the progress notes dated 10/19/2022-10/21/2022, 10/26/2022-10-28-2022 and 10/31/2022- 11/04/2022, and 11/07/2022 revealed Physician #9 documented, "Denies current suicidal thoughts". Patient #19 was not seen by the Psychiatrist on 10/22/2023, 10/23/2022, 10/29/2022, 10/30/2022, 11/05/2022, or 11/06/2022.

A review of the Nursing Shift Assessments for Patient #16 dated 10/17/2022-11/07/2022 did not reveal the patient was having any suicidal thoughts. Nursing shift assessments were documented twice a day. There was no found evidence documented in the chart to support the OPC claim to hold the patient due to suicidal thoughts.

Staff #11 informed this surveyor that all OPC applications from the facility were a 12-page application that included the administration of forced psychoactive medications.

As of 11:30 AM on December 7, 2022, there was no signed court order for inpatient treatment or forced psychotropic medication administration on the medical record. The county judge must grant the OPC and the forced administration of Psychotropic medications.


Review of an order written by Physician #9 on 11/1/2022 10:40 AM was as follows: " ...Pt court ordered for Treatment Give Zyprexa (antipsychotic medication) 10 mg IM (intramuscular) if pt refuses Zyprexa (zydis) 2.5 mg PO BID (by mouth twice a day) ..."

A review of Medication Administration Record dated 11/01/2022 revealed Patient #16 was administered Zyprexa 10 mg IM at 11:30 AM by Staff #24. There was no documentation that Patient #16 refused the PO (by mouth) Zyprexa.

Review of the nursing note documented on 11/01/2022 at 9:00 AM was as follows, "Patient refuses Seroquel and Depakote. Reported to Physician #9. MD order noted. Zyprexa 10mg given IM L (left) gluteus. Pt tolerated well" and on 11/01/2022 at 10:00 AM Staff #24 documented, "Patient less agitated now".

A review of the document titled, "MEDICATION FIRST DOSE RESPONSE & PRN MEDICATION RECORD" revealed Zyprexa 10mg was administered IM on 11/01/2022 at 9:15 AM by the nurse. The nurse signature was illegible. This was 1 hour 25 minutes before the order was written by Physician #9 to give Zyprexa IM if Patient #16 refused the oral Zyprexa.

A review of the Medication Administration Record on 11/01/2022 revealed the IM Zyprexa was administered by the nurse at 11:30 AM.

There was no documentation found on why the patient was given an IM injection instead of by mouth.
A consent was obtained from Patient #16 on 11/01/2022 for Zyprexa 10mg IM. There was no date and time on the consent from the patient. The patient signature was illegible with only an initial. The consent was witnessed by 2 staff nurses on 11/01/2022 at 11:30 AM and signed by Physician #9 on 11/2/2022. Staff #3 confirmed the consent was completed after Physician #9 documented, "Pt court ordered for treatment" on 11/1/2022 at 10:40 AM.


A review of Medication Administration Record dated 11/04/2022 revealed Patient #16 was administered Zyprexa 10 mg IM at 10:15 AM by Staff #25. There was no documentation that Patient #16 was offered or refused the PO (by mouth) Zyprexa.

Review of the nursing note documented on 11/04/2022 at 10:15 AM was as follows, " ...Pt received Zyprexa IM Right Gluteus with no adverse reactions noted. Pt tolerated well. Pt refused his Duloxetine (Cymbalta-a medication used to treat depression and anxiety) this am and requested the IM Zyprexa ..." The nursing signature was illegible.


An interview was conducted with Staff #11 on 12/05/2022 after 1:00 PM. Staff #11 was asked how the facility ensured that the OPC was placed on the chart once it had been granted and signed by the county judge. Staff #11 replied, "Someone from the court brings the documents over here and one copy goes to the patient and the other gets placed on the chart." Staff #11 confirmed the only OPC on the chart was the original application. Staff #11 said, "It was probably brought over late in the day, and it must have been misplaced, I will call the court to get a copy." Staff #11 confirmed there was no monitoring/chart reviews completed to ensure that all court ordered treatments had been placed in the medical record.

On 12/07/2022 at 4:18 PM Staff #11 presented to this surveyor a copy of documents from the county court. Pages 1, 8, and 9 were the only pages of the OPC returned. There was no judge's signature on the pages. A copy of the document titled, "Order Appointing Attorney Ad Litem" with a cause number and county clerk filing date of 10/28/2022 at 2:28 PM with the Judges signature was presented to this surveyor on 12/07/2022 at 4:18 PM. Therefore, the only document signed by the county judge was the appointment of an attorney for the OPC hearing. As of the survey exit date on 12/08/2022, there was no documentation of when the OPC was granted and signed by the County Judge available on the medical record of Patient #16. This was 30 days after patient #16 was discharged.

An interview conducted with Gregg County Clerk Staff #27 confirmed the OPC was filed on 10/28/2022 at 2:28 PM and the order was granted on 11/01/2022. Gregg County Clerk Staff #27 confirmed the facility contacted her for a copy. She also stated the OPC gets filed within 24 hours and the Judge will sign them within 3 days (not including holidays or weekends) and the facility is notified as soon as it has been completed and the patient has been to court with the appointed attorney.

During an interview with Staff #23 on 12/06/2022 after 12:00 PM it was confirmed the IM injections on 11/01/2022 and 11/04/2022 were given to patient #16 without a signed court order for forced psychotropic medications.

An interview was conducted with Staff #16 on 12/07/2022 after 10:00 AM. Staff #16 was asked to explain the process of administering court ordered medications. Staff #16 said, "If the medication is court ordered and we need to give them IM because they will not take the oral medications that's how we give them." Staff #16 was asked if she looked to see if the OPC or medication order that was signed by the judge was on the record. Staff #16 stated, "Its usually written on the MAR (medication administration record) if the patient is on an OPC, but no, I do not always look to see if the signed order is on the record."

During an interview on 12/06/2022 after 1:00 PM Staff #3 confirmed there was no signed court order for the OPC or the forced psychotropic medications on the record when Patient #16 was given the IM injections of Zyprexa on 11/01/2022 and 11/04/2022. Staff #3 also confirmed the IM injections administered on 11/01/2022 and 11/04/2022 were not administered to patient #16 for a psychiatric behavioral emergency.

Staff #3, #11, and #23 confirmed there was no signed OPC or forced psychotropic medication order on the medical record of patient #16 before the IM injections of Zyprexa were given on 11/01/2022 and 11/04/2022.

Based on record review and interview facility failed to obtain a written signed physician's order to transfer patient #3 to the local acute hospital on 11/30/2022 and later to discharge him from the facility when he did not return from the acute hospital.

This deficient practice had the likelihood to effect all patients of the facility.


Findings included.


On December 7, 2022 at 1:00 PM the medical record, (MR) for patient #3 was reviewed. The MR indicated this patient had a change in condition, and the physician , #12 , left a verbal order to transfer to the local hospital. This information was identified written in the Physician's Orders as a telephone order on 11/30/22 at 1715 (5:15 PM) "#1) Patient to be taken via ambulance to (local hospital) for changes noted in patients behavior.....#2) Per Dr. (#12), pt to go to ER (emergency room via ambulance for work up on 11/30/22". The order was written by staff nurse #26 as a "Read Back Verbal Order, Dr. #12. As of December 7, 2022 there was no evidence that Dr #12 had signed the verbal telephone order."

Further review of the MR failed to find a transcribed physician's phone order to transfer pt #3 or to discharge him from the facility, when he did not return from his acute hospital stay.

The MR was reviewed with the help of staff #3, the Director of Nurses (DON). The DON confirmed verbally that a written physician's telephone order should have been transcribed by the nurse when it was received. The DON offered to search the facility's MR department to see if any portions of the chart for pt #3 had yet to be filed. Nothing was presented by the DON as late MR filings.

A review of facility "POLICY, 14.01.0, Recording Verbal Orders:
1. The physician identifies self, specifies the patient's name, and communicate the order.
2. The receiver: Documents order immediately on the physician's order form including the date, time, physician's name receiver's name status and signature."

Review of facility "Policy HIM-01.11, Management Information:

1. Verbal orders, when allowed, will be immediately written down or documented in the electronic record by the recipient, read back by the recipient, and confirmed or corrected by the prescriber.
5. Prescriber will authenticate the order within the time frame specific to the state which the order is executed. Texas-96 hours of date order is given; with the exception of admit order which is given verbally must be authenticated within 24 hours."

The facility had conflicting, policy's related to obtaining written orders and authentication of said orders. The facility failed to follow either policy when pt #3 was discharge to acute care hospital services on 11/30/2022. On 12/7/2022 the physician's order for transfer and discharge were not found in the MR for pt #3.

Based on observation, document review and interview, the facility failed to ensure that medications were safely stored in a temperature controlled room to ensure the integrity of the patient medications. The facility also failed to follow their own policy.

This deficient practice could cause harm to all patients receiving medications. Without the monitoring and documentation of the controlled room temperature, the facility could not confirm the medication was stored according to the manufactures guidelines and the U.S. Pharmacopoeia guidelines of a controlled room temperature of 68° to 77° Fahrenheit .

Findings:

During a tour of the facility in the morning on 12/05/2022 with Staff #3 it was noted the facility does not operate a pharmacy but has a drug storage room (Medication Room) where all medications are dispensed and prepared for patient use. In the Medication Room was an automated medication dispensing system and a refrigerator used for medication storage.

An interview was conducted with Staff #23 on 12/05/2022 after 9:00 AM. Staff #23 was asked if the temperature was monitored in the medication room daily. Staff #23 stated, "No, we do not write that down, but we do log the temperature for the medication fridge daily." Staff #23 was asked if she was aware that some oral medications are required to be stored at certain temperatures. Staff #23 stated again, "We log the temperature of the fridge every day and there is a thermometer in here, but we don't document the room temperature."

A review of the surveillance rounds completed twice a week by Staff #15 confirmed the room temperature was documented while he was on site. Staff #15 (Pharmacist in Charge) was scheduled to be at the facility twice a week and as needed to restock and reconcile medications in the automated medication dispensing machine.

Staff #1, #2, #3, and #23 confirmed the room temperature was not documented on days Staff #15 was not there.


During an interview on 12/05/2022, Staff #3 and Staff #23 confirmed oral Seroquel and Zyprexa were both stored in the automated medication dispensing machine.

A review of the package insert for Seroquel (antipsychotic medication) and Zyprexa (antipsychotic medication) was as follows:

" ...Seroquel
Package insert / prescribing information
Generic name: quetiapine fumarate
Dosage form: tablet, film coated
Drug class: Atypical antipsychotics

How Supplied/Storage and Handling
Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [See USP]

Zyprexa
Package insert / prescribing information
Generic name: olanzapine
Dosage form: tablets, orally disintegrating tablets, injection
Drug class: Atypical antipsychotics

Storage and Handling
Store Zyprexa tablets, Zyprexa ZYDIS, and Zyprexa IntraMuscular vials (before reconstitution) at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP]. Reconstituted Zyprexa IntraMuscular may be stored at controlled room temperature, 20° to 25°C (68° to 77°F) [see USP] for up to 1 hour if necessary. Discard any unused portion of reconstituted Zyprexa IntraMuscular. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses..."


A review of the facility policy titled, "Temperature Storage, Policy Number: Pharm-08.01.0" with an effective date of 01/01/2004. There was no revision date noted on the policy. The policy was as follows:

" ...PURPOSE:

To define appropriate storage temperature.

POLICY:

All drugs shall be stored at appropriate temperatures that do not exceed manufacturers recommendations or warnings.

DEFINITIONS OF STORAGE TEMPERATURE

Storage temperatures are defined as follows:

...
Room Temperature-Same as controlled room temperature.

Controlled Room Temperature-A temperature held between 15 and 30 degrees Celsius (59- and 86-degrees Fahrenheit) ..."



A review of the U.S. Pharmacopoeia Guidelines revealed:

" ...10.30.60. Controlled Room Temperature

"Controlled room temperature" indicates a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25° (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°; and that allows for excursions 15° and 30° (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Provided the kinetic temperature remains in the allowed range, transient spikes up to 40° are permitted as long as they do not exceed 24 hours ..."


A review of the facility policy titled, "INSPECTIONS; PATIENT CARE AND DRUG STORAGE AREAS", Policy Number PHARM-13.02.0 with an effective date of 01/01/2004 was as follows:

" ...PURPOSE: To define a process for inspecting patient care and drug areas.
...
All drugs are stored in accordance with current standards (e,g,, USP) to maintain their integrity, stability, and effectiveness ..."


An interview was conducted with Staff #21 and #22 on 12/08/2022 at 8:30 AM. Staff #21 and #22 confirmed that temperature in the Medication Room should be monitored and documented daily. Staff #21 was asked if the Pharmacy followed the US Pharmacopoeia guidelines for medication storage. Staff #21 and #22 confirmed the guidelines were followed. Staff #21 also confirmed that the temperature ranges on the policy are the excursion temperatures and should only remain at that temperature range for a brief time.

Based on observation, document review, and interview the facility failed to ensure a clean and sanitary environment in 11 (Patient Day Room, Laundry Room, Exam Room, Noisy Therapy Room, Sterile Supply Room, outside storage, Patient rooms, Patient use toilets, patient use Equipment, Supply Cart and Nurses station) of 11 areas observed to prevent the transmission of infectious diseases and hospital acquired infections. The facility also failed to follow their policy.

Findings Include:

An observation tour was conducted on 12/05/2022 at 9:40 with Staff #3.


Patient Day Room

This was a large room used for patient activities, dining, and a common area for patients to watch television. The windowsills were soiled with heavy dirt and dust. Four windows were noted with cloth curtains. There was no identifying mark to indicate when the curtains had last been cleaned or when they were due for routine cleaning. One window was missing a curtain that had been pulled down by a patient. Eleven (11) brown leather chairs were in the common area. A cleaning wipe was used to wipe between the arm of the chair and the seat cushion. Food crumbs and dirt were noted.

During an interview with Staff #1 on 12/07/2022 it was confirmed there was no routine schedule to wash the curtains nor was there any identifier on the curtains to know when they were cleaned last.

Staff #1 and Staff #2 confirmed the policy for routine and terminal cleaning of the facility does not include a schedule or guidance for the cloth curtains.


Laundry Room

The laundry room was used to wash patients laundry. Inside the room was a black, hard plastic, three shelf table. On the top shelf was a large bucket of dry laundry detergent, a clipboard, and a blue laminated tag that read "dirty" and a yellow laminated tag that read "clean". On the second and third shelves there were three laundry baskets that contained patient clothing labeled as clean. On the top shelf, directly above the clean patient items was dirt, dust, trash, and spilled dry laundry detergent. The second and third shelf was noted to have dried laundry detergent, dirt, and dust.

Exam Room

The IV pole on the emergency cart was rusted. When the pole was raised silver and rust colored debris would fall on the top surface of the cart.

Noisy Therapy Room

Inside the room identified as "Noisy Therapy Room" there was 2 blue cloth curtains hanging. There was no identifying mark to indicate when the curtains had last been cleaned or when they were due for routine cleaning. Directly below one of the blue curtains was a brown table. The paint was chipped around the edge of the table exposing the porous surface. Heavy dust and dirt was noted on the bottom shelf.

Sterile Supply Room

A sign posted on the outside of the door read, "ATTENTION DO NOT LEAVE OPEN ITEMS IN STERILE SUPPLY CLOSET THANK YOU!!!"

Inside the room were clean and sterile patient care items such as foley catheters, sterile 4X4 sponges, Urethral Catheterization Tray, Alginate Wound Care dressings, 12-10 milliliter 0.9% Normal Saline Flushes, and multiple 1000 milliliters IV bags of 0.9% Sodium Chloride.

On the front of the IV bags were storage directions that read "Store at 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit). RX Only. (Prescription only)"

Staff #3 was asked if the temperature was monitored in the room. Staff #3 replied, "No."

An interview was conducted with Staff #1 in the afternoon on 12/07/2022. Staff #1 was asked if the temperature was monitored in the supply room. Staff #1 stated, "No it is not." Staff #1 confirmed that the IV bags of Sodium Chloride were stored in the sterile supply room and stated, "They really are not medications." After multiple requests Staff #1 confirmed there was no policy for the storage of supplies or medications in the Sterile Supply Room.



A review of the facility policy titled, "Temperature Storage, Policy Number: Pharm-08.01.0" with an effective date of 01/01/2004. There was no revision date noted on the policy. The policy was as follows:

" ...PURPOSE:

To define appropriate storage temperature.

POLICY:

All drugs shall be stored at appropriate temperatures that do not exceed manufacturers recommendations or warnings.

DEFINITIONS OF STORAGE TEMPERATURE

Storage temperatures are defined as follows:
...
Room Temperature-Same as controlled room temperature.

Controlled Room Temperature-A temperature held between 15 and 30 degrees Celsius (59- and 86-degrees Fahrenheit) ..."


A review of the US Pharmacopeia guidelines was as follows:
" ...In the USP 36 "General Notices and Requirements" Section 10.30.60 Controlled Room Temperature states that warehouse temperature should be maintained between 20°C to 25°C (68-77 degrees Fahrenheit) with excursions allowed between 15°C and 30°C (59-86 degrees Fahrenheit) ..."
Excursion temperature is a brief period when a medication or biologic is stored outside the manufacture's guidelines.


An interview was conducted with Staff #21 and #22 on 12/08/2022 at 8:30 AM. Staff #21 and #22 confirmed that the IV solutions stored in the sterile supply room were a medication and should be monitored for temperature daily. Staff #21 and #22 confirmed the manufactures guidelines say not to exceed 77 degrees Fahrenheit. Staff #21 also confirmed that the temperature ranges on the policy are the excursion temperatures and should only remain at that temperature range for a brief time.


A review of the facility policy titled, "CLEANING AND DISINFECTING EQUIPMENT" Policy Number IC-05.01 with a revision date of 4/01/2022 was as follows:

" ...Purpose: To define a process for the cleaning and disinfecting of equipment and environmental surfaces.

Policy: An environmental Protection Agency (EPA) registered disinfectant will be utilized to disinfect equipment and environmental surfaces. Equipment or supplies listed as single use devices shall not be reprocessed or reused.

Medical equipment usually only requires cleaning followed by low level disinfection, depending on the nature and degree of contamination.
...
Procedure: Disinfection of instruments, equipment, and environmental surfaces for patient care are categorized as critical, semi critical, and non-critical according to the degree of risk for infection involved in use of the items:
...
Noncritical items are those that come into contact with intact skin but not mucous membranes. Intact skin acts as an effective barrier to most microorganisms; therefore, the sterility of items coming in contact with intact skin is "not critical" Noncritical items are divided into noncritical patient care items and noncritical environmental surfaces. Most equipment and environmental surfaces in this facility will fall into the noncritical category.
...
Below is a list of noncritical equipment and surfaces that may be located in the hospital. If other noncritical equipment is identified in the hospital, it will be wiped with a disinfectant laden cloth between patient use and when visible soiled.
1. Intravenous (IV) Pumps, Feeding Pumps, IV Poles, Oxygen concentrators, Oxygen Tanks, Beds/Mattresses ...Pumps, poles, oxygen concentrators and oxygen tanks are wiped with a disinfectant laden cloth between patient use and when visibly soiled.
...
6 ...Medicine Carts/Emergency Carts/Isolation Carts or Totes
The inside and outside of all carts will be cleaned and wiped with a disinfectant laden cloth when visibly soiled.
7. Environmental Surfaces
Patient furniture, bed/handrails, floors and other wipeable hard non-porous surface areas will be cleaned and wiped with a disinfectant laden cloth daily and when visibly soiled ..."

A review of the facility policy titled, "Environmental Services Cleaning Guidelines", Policy Number EOC-78 with a revision date of 11/1/2020 was as follows:

" ...PURPOSE: To provide guidelines for cleaning the facility's physical environment.

POLICY: Facility shall provide the necessary services required to maintain a clean, sanitary, and safe environment in accordance with industry best practices.

PROCEDURE:
...
Cleaning Schedules and Daily Responsibilities

Patient rooms- Daily
...
4. Perform the following tasks:
a. drapes to be cleaned/repaired as needed
b. spot clean walls
c. dust ledges, windowsills, and orizontal surfaces
d. wipe down furniture
e. empty trashcans/replace paperbag
f. sweep/mop floors
...
Bathroom and Showers-Daily
...
5. Clean shower area/stall including valves, shower head and curtain thoroughly
6. Spot clean ceiling and walls as needed
7. Dust lights, ledges, and vents
8. Clean mirror
9. Clean sink and plumbing protection cover
10. Clean toilet ...
11. empty trash containers and wipe with germicidal solution and replace paperbag
12. Damp mop floors ...

Nursing Stations-Daily
...
Hallways-Daily
...
Dining Rooms and Common Areas-Daily
1. Dining areas are cleaned after each mealtime
2. Garbage removed and tables/chairs wiped down with clean cloth sprayed with germicidal solutions ...
4. Sweep ad damp mop floors according to established procedures
5. Walls and windows are spot cleaned as needed ...
8. Dust lights, horizontal surfaces, and vents ..."


Staff #6 confirmed the facility policy did not address the cloth curtains hanging in the day room or in the therapy room.

An observation tour was conducted on 12/05/2022 at 9:40 with Staff #3.







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Outside linen storage:

On 12/6/202 during a tour of the plant operations the Plant Operations Director (POD)was asked to open an outside door on the North side of the building. He explained the room was an mechanical room and was also used for storage. Looking into the room the mechanical portion was on the left side of the small room, 1 gallon waters bottles were stacked on the right side of the room, in the middle was a loaded soiled linen art. The cart held soiled bagged linen awaiting pick up from the contrasted linen provider.

The cart was within inches of the water bottles. There was no barrier between the dirty linen and the water that likely would be used to provide a water source during emergency protocol. This did not allow a sanitary distance between clean and dirty.

The POD confirmed there was no protected location in or outside of the building to store the soiled linen while awaiting pick-up, but stated, "I understand the problem".


Patient rooms:

Every patient room was observed with exposed particle board. (Doors, and shelving) The wooden particle surface can not be sanitized.

Each room contained two beds with frames secured to the floor. All bed frames had debris accumulated in the base of the frames, where they were secured to the floor.

Patient use toilets:

The toilets in every patient use bathroom was observed with wring of scratched paint below the bowls. This exposed bare metal and did not permit thorough sanitation.

Equipment:

Patient use equipment, (stretcher with pink mattress) had the paint scratched from the metal frame.

A wall mounted plastic cover for the thermostat fell off into the hand of the surveyor when its placement was checked for security. The broken thermostat cover was shown to the Licensed Counselor, staff #8.

A suction pump, being stored in the clean storage, was observed with residual paper label stuck on the side of the pump. The pump was not tagged, bagged, or otherwise stored in a manner that indicated it had been sanitized prior to placement in the clean storage area. The pump also had no preventative maintenance tag affixed to it. The Director of Nursing (DON), staff #3, provided the tour. She stated, "I couldn't tell you when the pump might have been used last or if it has been cleaned. If it is in here it is supposed to be clean".

Supply cart in seclusion hallway:

The DON provided the tour. A supply cart was observed stored against the wall outside if the secure holding room. The cart was opened and the following was observed.
1. A fabric blood pressure cuff with the paint scratched off the gauge.
2. Two (2) bottles of nasal spray. Both bottles were not in the manufacturer's box. One bottle was partially empty implying it had been used for a patient. The second bottle did not appear to have the safety seal broken. both were found at the bottom of the lower drawer.
3. Oxygen tubing with the protective plastic covering open. Once the package has been opened the sanitation of the content can no longer be guaranteed if replaced into a cabinet or drawer.
4. The bottom of all three drawers held small debris, bits of paper and dust.

Nurses station:

Plexiglas was in use to provide privacy for the working portion of the nurses station. The glass was observed with tape residue on the surface. Tape residue collects dirt and bacteria and cannot be sanitized. The patient use side of the window remained smeared with unknown substances from 11/6/2022 through 11/7/2022.

Based on review and interview the facility failed to ensure 2 nurses were always on duty per the staffing grid. A review of the nursing schedules from 11-15-22 thru 12-4-22 revealed the 7:00 PM-7:00 AM LVN took a lunch break 18 out of 20 times without coverage leaving the RN on the unit with no other nursing coverage (11/22, 11/25, and 11/27/22 were covered by the bridge nurse).

A review of the policy and procedure "Rest/Meal Periods" on page 2 under Meal Periods stated, "Employees who work six or more continuous hours are expected to take an uninterrupted meal period of 30 minutes, which is unpaid ...A lunch/dinner break of thirty minutes will automatically be deducted from each 6-hour shift worked unless the employee's supervisor or HR notes otherwise on the employee's timesheet."

A review of the facility Staffing Matrix revealed the minimum staff from 1- 24 patients required 1 Registered Nurse (RN) and 1 Licensed Vocational Nurse) LVN per 12-hour shift. The grid also shows a "bridge nurse which is an RN that works between both shifts for 8 hours total. The grid stated, "BRIDGE role: Assigned to assist with admissions, complete 6 shift RN assessments on days, and 6 shift assessments on nights. Relieve the RN charge for a break. Other RN duties as time allows."

A review of the working schedule revealed the RN and LVN were writing down their lunch times and who covered for them during their lunch break. A review of the nursing schedules from 11-15-22 thru 12-4-22 revealed the 7:00 PM-7:00 AM LVN took a lunch break 18 out of 20 times without coverage leaving the RN on the unit with no other nursing coverage (11/22, 11/25, and 11/27/22 were covered by the bridge nurse).

An interview with Staff #18 Bridge Nurse was conducted on 12/7/22. Staff #18 stated that she works usually from 10:00 AM thru 10:30 PM but could vary an hour or so. Staff #18 stated the LVN usually goes later in the shift after she is gone. Staff #18 stated that she never thought about the RN on the floor alone when the grid stated 2 nurses are to be always on duty. Staff #18 stated that the LVN will just have to go earlier to allow the bridge nurse to help.