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Based upon observation, record review, and interview, the facility failed to:

1. provide Important Message from Medicare (IMM) Form with in 2 days of admission and before discharge in 5(#2, 1, 14, 3 and 5) of 5 patients reviewed.

Refer to A0117


2. A. ensure informed consent to treat, for a voluntary admission, was signed, and understood by a competent adult that had the capacity to consent in 2 (Patient #1, and 12) of 3 (Patient #1, 11, and 12) charts reviewed.

B. ensure the patients consented and received an explanation by the nurse or physician the name of administered psychotropic medications, the beneficial effects on the patient's mental illness, or condition expected as a result of treatment with psychotropic medication in 2(#2 and #5) of 2 chart reviewed.

Refer to A0131

3. ensure a medical exam table/chair was available for emergency medical conditions and/or treatment that provided respect, dignity, and comfort to all patients.

Refer to A0144

4. nursing failed to administer a chemical restraint as ordered and failed to obtain an order to discontinue the chemical restraint in 1(12) of 2(#5 and #12) patient charts reviewed. The facility failed to document the assessment, monitoring, and evaluation of an individual that recieved a chemical restraint in 1 (#5) of 2 ( #5 and #12) charts reviewed.

Refer to A0160

5. failed to provide a face-to-face on 2/26/21 or completed face to face evaluations on 2/25/21 and 2/27/21 during restraint and seclusions in 1(#5) out of 2(#5 and #12) charts reviewed.

Refer to A0184

Based on record review and interview, the facility failed to provide Important Message from Medicare (IMM) Form within 2 days of admission and before discharge in 5(#2, 1, 14, 3 and 5) of 5 patients reviewed.

Review of Patient #2's chart revealed she was given her 1st IMM letter on 3/5/20 at 0200. The nurse documented on her Admit Nursing Assessment Sheet dated 3/4/2020 (no time was documented) that Patient #2 was oriented only to person and had impaired judgement when the patient was signing consents. The facility failed to give Patient #2 her 2nd IMM letter before discharge on 3/21/20 at 0900.

Review of Patient #1's chart revealed she was not given a IMM letter on admission but was given one at discharge on 3/18/20.

Review of Patient #14's chart revealed he was admitted to the facility on 5/24/22. review of the chart revealed there was an unsigned IMM letter in the admission packet. There was no evidence that he was given the information on admission.

Review of Patient # 3's chart revealed he was not given an IMM letter at admission or discharge.

Review of Patient # 5's chart revealed he was not given an IMM letter at admission or discharge.

Based on record review and interview the facility failed to:

A. ensure informed consent to treat, for a voluntary admission, was signed, and understood by a competent adult that had the capacity to consent in 2 (Patient #1, and 12) of 3 (Patient #1, 11, and 12) charts reviewed.

B. ensure the patients consented and received an explanation by the nurse or physician the name of administered psychotropic medications, the beneficial effects on the patient's mental illness, or condition expected as a result of treatment with psychotropic medication in 2(#2 and #5) of 2 chart reviewed.

A. Patient #1

Patient #1 was admitted to the facility on 3/5/20 at 1415 with a diagnosis of Dementia and delusions. A verbal admission physician order was found on the chart dated 3/5/20 at 1415. The order stated that Patient #1 was to be admitted as a voluntary patient. Review of the Admit Nursing Assessment dated 3/5/20 at 1615 revealed Patient #1 was oriented to person and time, had impaired judgement, and was hyper religious with delusions.

Review of Patient #1's chart revealed she was allowed to sign all of her consents including;

Admission Consent Form (giving consent to treat, transport, photograph, and emergency treatment.)

Advanced Directive

Statement of Patient Acknowledgement (that he received a handbook, the doctors do not work for the hospital, that a physician is not there 24/7, rights and responsibilities as a patient, notice of privacy practices, confidentiality, personal property, and consent to do test on blood without the patients consent.)

Informed Consent for Telehealth Services

Consent For Involvement In Treatment (allows patient to list whom they want to share their personal health information with.)

Financial Responsibility: Authorization and Assignments.

Review of Patient #1's chart revealed she was seen by the psychiatrist on 3/6/20 at 4:00PM. The physician wrote an order to obtain an Order of Protective Custody (OPC). Review of the Application for the OPC dated 3/9/20 revealed the application asked, "Applicant believes Patient lacks the capacity to make a decision regarding the administration of psychoactive medication for the following reason." the psychiatrist stated, "Due to severity of the patent's demented state, the patient does not appear to possess the capacity for such rational decisions at this time." Due to the nurse and psychiatrist comments Patient #1 was admitted as voluntary and allowed to sign consents without the capacity to sign in voluntarily.

Patient #12

Review of patient #12's chart revealed she was admitted to the facility from an ER in Marshall, Texas. The patient was admitted on 5/27/22 at 2210 as a voluntary patient. A verbal admission physician order was found dated 5/27/22 at 2230. The Nurse had checked that the patient was voluntary but documented under "initial treatment plan problem: Alteration in perception ..."

Review of the chart revealed Patient #12 had not signed any of her admission forms except for the "Voluntary Request for Admission Form" on 5/27/22 at 2210. The form stated that the patient agrees to voluntarily remain in the facility until the time of discharge. The form stated, "I consent to the diagnosis, observation, care and treatment provided until the earlier of my discharge or the period prescribed in section 572.004 of the Texas Mental Health Code."

Review of the Admit Nursing Assessment dated 5/27/22 at 2215 Staff #17 RN documented that Patient #12 was only oriented to person only and had impaired judgement. Patient #12 was allowed to sign in as a voluntary patient but was not documented as a competent adult that could make sound legal decisions.


B. Patient #5

Review of Patient #5's chart revealed an Education Acknowledgement & Consent to Treatment with Psychotropic Medication form for Depakote ER 500mg. The form stated Patient #5 was given an oral explanation of the medication by the nurse. On the patient signature line it stated, "verbal consent given." There was no reason documented on why the patient could not give written consent since she had given recent written consent for other forms on admission.

The form was signed by the nurses on 2/26/21 but not signed by the physician until 3/9/21, 11 days later.



Patient #2

Review of Patient #2's chart revealed she was admitted to the facility on 3/5/2020 and discharged on 3/21/2020. Patient was documented as a voluntary admission with Dementia and Suicidal Ideations. Patient #2 was documented upon admission as oriented to person only; with impaired judgement. There was no documented evidence that Patient #2 could understand the required elements which constitute informed consent.

Review of Patient #2's Medication Administration Record (MAR) she was administered Seroquel (psychotropic) on 3/5/20, Buspar(Anxiolytic) (3/5-3/21/20, Remeron(Antidepressant) daily from 3/7-3/20/20, Trazadone(Antidepressant and Sedative) 3/9-3/10/20, and Kolonopin(sedative) 3/18-3/20/20 with no informed consent provided or obtained.

According to the facility's policy and procedure "Psychoactive Medication Administration/Consent-Texas" stated, " ... If psychoactive medications are prescribed by a Physician or NNP, a written informed consent must be obtained from the patient or legally authorized representative...

2. The initiation or continuation of any psychoactive medications prescribed at admission or during the hospital stay requires a signed informed psychotropic medication consent form regardless if the patient was admitted as voluntary or involuntary. The patient or legal representative must sign or give verbal consent with two staff witnesses...

4. The patient must be informed of:
The name of the medication and the beneficial effects on the patient's mental illness or condition expected as a result of treatment with that medication;

The probable health and mental health consequences to the patient of not taking the medication, including the occurrence, increase, or reoccurrence of symptoms of mental illness;

The existence of generally accepted alternative forms of treatment, if any, that could reasonably be expected to achieve the same benefits as the medication and why the physician rejects the alternative treatment;

The description of the proposed course of treatment with medication including any necessary evaluations and lab work;

The fact that side effects of varying degrees of severity are a risk of all medication;

The relevant side effects of the medication, including:

any side effects which are known to frequently occur in most persons;

any side effects to which the particular patient may be predisposed; and

the nature and possible occurrence of the potentially irreversible symptoms of tardive dyskinesia.

The need to advise mental health facility staff immediately if any of these side effects occur;

Instruction that the patient may withdraw consent at any time without negative actions on the part of staff."


An interview with Staff #1 and #2 on 6/1/22 concerning the Psychotropic Medication Consents. Staff #1 stated that she had only been at the facility for 60 days and was not aware of all the issues. Staff #1 was unable to tell me if the staff had any recent training on medication consents and she stated the new hires currently get that information in orientation. Staff #2 stated that she was also recently hired in January of 22. Staff #2 stated that the nursing staff know they need to get consent for medications but was not currently monitoring this issue. There was no Quality data provided upon request for the monitoring of medication consent.

Based on observation and interview the facility failed to ensure a medical exam table/chair was available for emergency medical conditions and/or treatment that provided respect, dignity, and comfort to all patients.


Findings Include:


An observation tour was conducted on 5/31/2022 after 10:00 AM with Staff #2. It was noted in the Emergency Treatment/Exam Room, no exam table or chair was available for patients that required medical or emergency treatment. Along the wall was a table approximately 4 ft-5 ft in length. The table had a hard surface on top and was approximately 1 inch in thickness. Stacked on top of the table was patients belongings, papers belonging to the staff, markers, pencils, and a 4 legged cane belonging to a patient. Staff #2 confirmed there was no other table available for patient exams.

An interview was conducted with Staff #2 on 5/31/2022 after 10:00 AM. Staff #2 was asked how the patients were treated during an emergency medical condition if there was no exam table in the room. Staff #2 replied, "Well, they can be placed in a wheelchair and brought into this room if needed."


An interview was conducted with Staff #1 on 6/01/2022 after 10:00 AM. Staff #1 was asked if there was an exam table or chair for patient exams in the medical treatment room. Staff #1 replied, "No, there is not one here. I called corporate, and they informed me that one was ordered." Staff #1 was then asked how long the Treatment Room had been without an exam table/chair. Staff #1 could not give a specific length of time.

Staff #1 presented information to this surveyor on an exam chair that was emailed to her from the Corporate Office. After multiple requests no purchase order was presented for review.


Staff #1 and Staff #2 confirmed the findings.

Based on record review and interview, nursing failed to administer a chemical restraint as ordered and failed to obtain an order to discontinue the chemical restraint in 1(12) of 2(#5 and #12) patient charts reviewed. The facility failed to document the assessment, monitoring, and evaluation of an individual that recieved a chemical restraint in 1 (#5) of 2 ( #5 and #12) charts reviewed.

Patient #12

Review of Patient #12's chart revealed she was admitted to the facility on 5/27/22. Review of the Multi-disciplinary note dated 5/27/22 at 2215 stated, "Pt arrived on unit at this time. After she signed in voluntary admission, V/s were taken, and I began asking questions. While talking to her, she remained very manic, and hyperactive with constant movement of face and all extremities ...she refused to sign or answer any further questions. She was provided snacks but refused and began walking on unit (pacing) and she walked to the door and began hitting and kicking it. She was out of control and Dr. ___ (Staff #18) was called. New orders given for meds. She then asked if she could go to bed. MHT showed her to her room (SA) and oriented her. Medication nurse is awaiting pharmacy fax/approval to administer the ordered meds. 2350- noted pt resting quietly." There was no further nursing documentation on the patient until 9:35AM the next day.

Review of the chart revealed the medication was never documented as given. Staff #1 confirmed the medication was never taken out of the medication cabinet (pyxis) and administered to the patient. There was no documentation that the physician was notified of the patients change in condition and there was no order to discontinue the medication order.



Patient #5

Review of Patent #5's multidisciplinary note dated 2/25/21 at 11:05AM stated, " Pt standing near exit door, pacing. Staff attempted to redirect, offered a snack, drink and blanket. She continued yelling and slapped a nurse that was trying to comfort her. She was placed in seclusion and continued yelling, cursing, and hitting walls. Dr. ___ (Staff #19) and ___ (nurse practitioner) notified. Med ordered and given. Spouse was called and made aware. Dr.___(Staff#19) was here and saw the patient.

Review of the chart revealed there was no documentation from Staff #19 that she was at the facility on 2/25/21. There was a note from the Nurse practitioner on 12/25/21 at 12:02PM. The NP documented, " ...required seclusion, yelling, screaming, banging on doors." There was no face to face documented.

Review of Patient #5's chart revealed a seclusion/restraint flowsheet dated 2/25/21 at 11:05AM. The flow sheet revealed the patient was placed in seclusion at 11:05AM. The RN documented on Patient #5 every 15 minutes until 1:15PM when the seclusion ended. Nursing documentation revealed the patient was still very agitated while in seclusion.

Review of the physician order dated 2/25/21 at 12:25PM revealed the Patient #5 received a verbal order for Geodon 40mg IM x 1 now for psychosis with aggression, refusing po meds. The medication was never added to the restraint flowsheet as an emergency behavioral medication. There was no documentation on the flowsheet that the medication was administered, the effectiveness of the medication, the patient's reaction to the medication, or how the patient was being monitored after the administration of the medication. There were no vital signs taken after the medication administration. The nurse documented "refused vital signs" but there was no respirations or physical descriptions documented.

There was no documentation on who the Patient #5 "slapped" and if that nurse was the writer and nurse applying the restraint. There was no documentation of a face to face to ensure retaliation was not taken on the patient.

Review of Patent #5's multidisciplinary note dated 2/26/21 at 11:30AM patient #5 was aggressive with staff and peers. The patient was placed in seclusion. The patient continued to be aggressive in seclusion and was given an emergency behavioral medication of Geodon 40mg IM. Review of the seclusion/restraint flowsheet talks about Patient #5 in seclusion but there was no documentation of the chemical restraint. The nursing staff documented on the patient's behaviors every 15 minutes. There was no documentation on the flowsheet that the medication was administered, the effectiveness of the medication, the patient's reaction to the medication, or how the patient was being monitored after the administration of the medication. There were no vital signs taken after the medication administration. The nurse documented "refused vital signs" but there was no respirations or physical descriptions documented.

There was only one page of the face to face. There was no signature time or date of the face to face in the chart.

A restraint log was requested for 2/21 through 6/1/22. Patient #5 was on the restraint log but just for the seclusion. There was no mention of a emergency behavioral medication administration.

Review of the policy and procedure "Seclusion and Restraints" stated, " ...Monitoring: The RN will assign a qualified, and trained staff member to continually ensure adequate respirations and circulation of the patient. The RN must assess the patient upon initiation of seclusion/restraint, after the first 15 minutes of seclusion/restraint, during the one-hour face to face assessment, every hour the patient remains in seclusion/restraint, and upon discontinuation of seclusion/ restraint. At a minimum, respiratory status, circulation, and skin integrity will be documented as indicated on Seclusion/Restraint Flow Sheet every 15 minutes by assigned, qualified and trained staff member ..."

Review of the policy and procedure "Psychotropic Medications: Emergencies" had two sets of different rules and definitions for Texas and Louisiana. The policy jumps back and forth and was not clear under the "psychiatric emergencies" on page three if it was for Texas or Louisiana. Staff #1 and Staff #2 were not able to confirm if the psychiatric emergencies section was for Louisiana or Texas. Staff #1 confirmed it was a corporate policy. The policy and procedure were not adapted to the facility. Review of the policies revealed there was no guidance for the staff on specific documentation or monitoring for the patient that had received an emergency behavioral medication.

Based on record review and interview, the facility failed to provide a face-to-face on 2/26/21 or completed face to face evaluations on 2/25/21 and 2/27/21 during restraint and seclusions in 1(#5) out of 2(#5 and #12) charts reviewed.


Review of Patent #5's multidisciplinary note dated 2/25/21 at 11:05AM stated, " Pt standing near exit door, pacing. Staff attempted to redirect, offered a snack, drink and blanket. She continued yelling and slapped a nurse that was trying to comfort her. She was placed in seclusion and continued yelling, cursing, and hitting walls. Dr. ___ (Staff #19) and ___ (nurse practitioner) notified. Med ordered and given. Spouse was called and made aware. Dr.___(Staff#19) was here and saw the patient.

Review of the chart revealed there was no documentation from Staff #19 that she was at the facility on 2/25/21. There was a note from the Nurse practitioner on 12/25/21 at 12:02PM. The NP documented, " ...required seclusion, yelling, screaming, banging on doors." There was no face to face documented.

Review of Patient #5's chart revealed a seclusion/restraint flowsheet dated 2/25/21 at 11:05AM. The flow sheet revealed the patient was placed in seclusion at 11:05AM. The RN documented on Patient #5 every 15 minutes until 1:15PM when the seclusion ended. Nursing documentation revealed the patient was still very agitated while in seclusion.

Review of the physician order dated 2/25/21 at 12:25PM revealed the Patient #5 received a verbal order for Geodon 40mg IM x 1 now for psychosis with aggression, refusing po meds. The medication was never added to the restraint flowsheet as an emergency behavioral medication. There was no documentation on the flowsheet that the medication was administered, the effectiveness of the medication, the patient's reaction to the medication, or how the patient was being monitored after the administration of the medication. There were no vital signs taken after the medication administration. The nurse documented "refused vital signs" but there was no respirations or physical descriptions documented.

There was no documentation on who the Patient #5 "slapped" and if that nurse was the writer and nurse applying the restraint. There was no documentation of a face to face to ensure retaliation was not taken on the patient.

Review of Patent #5's multidisciplinary note dated 2/26/21 at 11:30AM patient #5 was aggressive with staff and peers. The patient was placed in seclusion. The patient continued to be aggressive in seclusion and was given an emergency behavioral medication of Geodon 40mg IM. Review of the seclusion/restraint flowsheet talks about Patient #5 in seclusion but there was no documentation of the chemical restraint. The nursing staff documented on the patient's behaviors every 15 minutes. There was no documentation on the flowsheet that the medication was administered, the effectiveness of the medication, the patient's reaction to the medication, or how the patient was being monitored after the administration of the medication. There were no vital signs taken after the medication administration. The nurse documented "refused vital signs" but there was no respirations or physical descriptions documented.

There was only one page of the face to face. There was no signature time or date of the face to face in the chart.

A restraint log was requested for 2/21 through 6/1/22. Patient #5 was on the restraint log but just for the seclusion. There was no mention of a emergency behavioral medication administration.

Review of the policy and procedure "Seclusion and Restraints" stated, " ...Monitoring: The RN will assign a qualified, and trained staff member to continually ensure adequate respirations and circulation of the patient. The RN must assess the patient upon initiation of seclusion/restraint, after the first 15 minutes of seclusion/restraint, during the one-hour face to face assessment, every hour the patient remains in seclusion/restraint, and upon discontinuation of seclusion/ restraint. At a minimum, respiratory status, circulation, and skin integrity will be documented as indicated on Seclusion/Restraint Flow Sheet every 15 minutes by assigned, qualified and trained staff member ..."

Review of the policy and procedure "Psychotropic Medications: Emergencies" had two sets of different rules and definitions for Texas and Louisiana. The policy jumps back and forth and was not clear under the "psychiatric emergencies" on page three if it was for Texas or Louisiana. Staff #1 and Staff #2 were not able to confirm if the psychiatric emergencies section was for Louisiana or Texas. Staff #1 confirmed it was a cooperate policy. The policy and procedure were not adapted to the facility. Review of the policies revealed there was no guidance for the staff on specific documentation or monitoring for the patient that had received an emergency behavioral medication.

Based on observation, document review, and interview the facility failed to use the data collected to identify opportunities for improvement, take action for performance improvements, measure its success, and track the performance to ensure that improvements are sustained. The facility also failed to include the Pharmacist in Charge (PIC) of the facility in the Pharmacy and Therapeutics (P&T) Committee and the Quality Committee to collect, measure, analyze, and track quality indicators that assess processes of care and the operations of the Pharmacy.



Findings Include:


A tour of the Pharmacy Department with Staff #6 and Staff #2 was conducted on 5/31/2022 at 1:00 PM. Staff #6 has a small office behind a secured door in the patient hallway. Staff #6 stated, "I have a Pharmacy office where a few drugs are kept for return and a computer. This office is considered the Pharmacy. The pharmaceutical services for the patients are in a medication room behind a securely locked door in the nursing area. I do my paperwork in here but most of my time is spent in the medication room."

When entering the medication room, it was observed there was an Automated Medication System (AMS), refrigerator for medications, upper and lower cabinets, a secured lock box attached to the wall, a sink, and a combination safe. The keys for the lock box are stored in the AMS.


A review of the document titled, "PHARMACY SERVICES AGREEMENT' effective September 16, 2021 was as follows:

" ...1. Services. For the benefit of the Hospital, the Pharmacy will provide the following to the Hospital:

ii. Render all services in accordance with any applicable requirements of local, state, and federal laws and regulations, community standards of practice, and the Pharmacy's Policies and Procedures Manual as well as the Hospital's pharmacy policies and procedures;
...

viii. Ensure a representative from the Pharmacy is available on a quarterly basis for attendance at appropriate meetings, with reasonable prior notice and during regularly scheduled visits to the Hospital;
...

xi. Participate, as reasonably requested, in Hospital's QA/PI program ..."





A review of the document titled, "INDEPENDENT CONTRACTOR AGREEMENT" dated 9/20/2021 and signed by Staff #6 on 9/20/2021 was as follows:

" ...1. Professional Services:

(a) Statement of Work: The company hereby retains Contractor to provide certain services (the Services) to Company during the term of this Agreement on an independent contractor basis, and Contractor hereby accepts the engagement. Contractor agrees to provide to Company the Services and work product set forth in Schedule A ..."

A review of the document titled, "SCHEDULE A STATEMENT OF WORK" was as follows:

1. Services

Contractor shall provide the following pharmacy services at the hospital located at 615 Clinic Drive, pursuant to a schedule agreed to by the Director of Pharmaceutical Services and Contractor:

Serve as pharmacist-in-charge (PIC) for the assigned facility(ies) and assume associated responsibilities in compliance with industry standards and Company's policies and procedures for such Services; and

Restock the automated medication system (AMS) (Restocking Trip) a minimum of twice weekly, and as needed upon request by Company; and

Ensure integrity of pharmacy medication inventory as it relates to expiration dating, accuracy, and orderliness of the AMS; and

Submit reports and audits as scheduled and as requested by Company ..."




An interview was conducted Staff #6 on 5/31/2022 at 1:20 PM. Staff #6 was asked if he was contracted by the facility. Staff #6 replied, "Yes, well the facility uses a contracted pharmacy out of Louisiana, and I am contracted with them as the Pharmacist in Charge to be on site." Staff #6 was then asked to explain his duties in detail. Staff #6 replied, "I come and fill the AMS twice a week. The Physicians will write prescriptions for the patients and the staff send the medication orders to the Corporate Pharmacy in Louisiana. The pharmacy fills the prescription and mails it here and I come twice a week and place those medications in the AMS. They arrive in a taped box and they are put in the medication room until my next visit. I check for expired medications and remove them. Over stock of medications that will not fit into the AMS, I place them in the pharmacy and then return them to Cardinal. Sometimes there's specific medications that are ordered for patients and when they get discharged, I call the Pharmacy Director in Louisiana and ask to return them to the pharmacy. Most of the time I am told to just leave them in the AMS in case they are needed in the future. The AMS is small and already overfilled so they get locked in the pharmacy.


Staff #6 was asked if he was involved in the Pharmacy and Therapeutics (P&T) Committee or Quality Committee and if he attended the meetings. Staff #6 stated, "No, I am not involved in any of the meetings. I only come here to stock the AMS and run the monthly reports that are required and complete my monthly audits. That is what is in my contract." The staff will call me if they have questions." Staff #6 was then asked if he was involved in any of the facility policy revisions. Staff 6 replied, "I cannot even access the policies because my computer has been down for a while now. I was told no policy manual could be kept in a notebook in the pharmacy and have asked for the computer to be repaired on multiple occasions to the Pharmacy Director."

Staff #6 was unaware of any ongoing process improvements for the Pharmacy. Staff #6 also confirmed that no Pharmacist from the Oceans Corporate Pharmacy based in Louisiana was ever on site at any time he was in the facility.

Staff #1 confirmed the last time a Corporate Pharmacist from Louisiana was on site at the facility was September 15-17, 2021.




A review of the document titled, "Pharmacy and Therapeutics Committee Meeting," dated May 12, 2022 confirmed Staff #6 was not in attendance. However, it does show Staff #14 in attendance. Staff #14 is not a Registered Pharmacist in the State of Texas. The document listed no absences. Further review revealed data Performance Improvement Data was submitted but no Performance Improvement Plan or tracking was in place to address the items that fell below the stated goals of the Pharmacy.

Staff #1 and Staff #5 confirmed the findings.



A review of the Medical Staff Bylaws approved 12/02/2021 was as follows:

" ...SECTION 4: QUALITY ASSESSMENT AND PERFORMANCE IMPROVEMENT COMMITTEE

(6) Develop and monitor corrective action plan to address any identified opportunities for improvement and ensure that improvement is achieved and sustained ...;

(7) Receive, Analyze, and recommend action regarding with respect to special treatment procedures, including restraints, seclusion, and safety indicators specific to the population served. Create and maintain, in coordination with administration and the Staff, a quality of safety culture throughout the organization.


SECTION 5: PHARMACY AND THERAPEUTICS COMMITTEE

A. Composition: The Pharmacy and Therapeutics Committee shall be chaired by a member of the MED to be appointed by the President. At a minimum, The Pharmacy and Therapeutics Committee shall consist of the MEC member, a Pharmacist, Quality Director, Director of Nursing and the Administrator, and any other individuals the Chairman deems appropriate ..."



A telephone interview was conducted with Staff #7 on 6/1/2022 at 2:35 PM. Staff #7 was asked what the responsibilities and duties of the Pharmacist on site were. Staff #7 replied, "He stocks the AMS twice a week when the ordered medications are delivered. He is responsible for a monthly audit checklist. He basically keeps an eye on things."

After multiple requests for a list of the P&T Committee members and Quality Committee members appointed by the Governing Body, none was provided.



Staff #1, #2 #6, #7, and #15 confirmed the findings.

Based on record review and interview, the facility failed to use the facility's system of authentication to ensure information in the patients chart belongs to that patient in 2 (#11and #12) of 4 (#1,2,11,and 12, ) charts reviewed.

Review of patient #11's chart revealed he had signed a consent on his chart titled, "Substance Use Disorder And Medical Information Consent And Authorization For Disclosures." The two page form consisted of information concerning the patients protected health information. The form failed to have any identifying information on it except the patients signed signature dated 5-31-22 1655. There was no patient name, patient sticker, or a signed witness, date or time.

Patient #11 had a form in the chart called, "Important Message from Medicare. "This form instructs the patient on their right to appeal their hospital discharge, rights as a hospital inpatient, and alternate appeal rights. There was no identifying information that this 2-page form was for Patient #11 except for his signature, date, and time on the second page only.

The following forms located in the patients chart were signed, dated and timed by Patient #11 with no patient identifiers other than the patients signature at the bottom.

Admission Consent Form (giving consent to treat, transport, photograph, and emergency treatment.)

Advanced Directive

Statement of Patient Acknowledgement (that he received a handbook, the doctors do not work for the hospital, that a physician is not there 24/7, rights and responsibilities as a patient, notice of privacy practices, confidentiality, personal property, and consent to do test on blood without the patients consent.)

Informed Consent for Telehealth Services

Consent For Involvement In Treatment (allows patient to list whom they want to share their personal health information with.)Financial Responsibility: Authorization and Assignments.


Review of Patient # 12's chart revealed the patient's chart had no patient identifiers on the following forms;

Admit Nursing Assessment
Admission Consent
Advanced Directive
Informed Consents
IMM Letter

Based on observation, document review and interview, the facility failed to:

1. ensure a clean and sanitary environment to prevent the transmission of infectious diseases in 10 (Patient Hallway, Patient Nutrition Room, Kitchen, Emergency/Treatment Exam Room, Laundry Room, Clean Supply Room, Soiled Room, Seclusion Room, Medication Room, Sterile Supply Room) of 10 areas observed.

2. follow the facility policy and ensure the refrigerator/freezer temperatures were monitored in 2 (Patient specimen refrigerator and Patient Nutrition Refrigerator) of 3 refrigerators observed to provide safe storage for patient nutrition and patient laboratory specimens.

Cross Refer to Tag A0749

Based on observation, document review and interview, the facility failed to:

1. ensure a clean and sanitary environment to prevent the transmission of infectious diseases in 10 (Patient Hallway, Patient Nutrition Room, Kitchen, Emergency/Treatment Exam Room, Laundry Room, Clean Equipment Room, Soiled Utility Room, Seclusion Room, Medication Room, Clean and Sterile Supply Room) of 10 areas observed.


2. follow the facility policy and ensure the refrigerator/freezer temperatures were monitored in 2 (Patient specimen refrigerator and Patient Nutrition Refrigerator) of 3 refrigerators observed to provide safe storage for patient nutrition and patient laboratory specimens


Findings Include:


Observation tours were conducted with Staff #1, Staff #2, Staff #6, and Staff #9 from 5/31/2022-6/02/2022. The following was observed.



1.

Patient Hallway

At the end of the patient hallway was an exit door leading out to the courtyard. The window frame to the side of the exit door was heavily covered with dirt and dust.


Emergency Exam/Treatment Room

Inside the Exam room was an Emergency cart dedicated for patient emergencies. The bottom of the Emergency cart was noted to be soiled with dirt, dust, and debris. Rolling equipment used to take patients vital signs was heavily soiled with dirt, dust, and debris at the base. The pulse oximeter (equipment used to measure a patients oxygen level) was noted with scotch tape holding the batteries in place. Inside the basket that held the blood pressure cuffs was gloves. Staff # 2 could not confirm nor deny if the gloves were clean or contaminated. Inside the refrigerator used to store patients specimens awaiting pick up by the lab, was noted to be heavily soiled with dirt and dust on the rubber seal inside the door.

The following blood tubes were found in the drawers expired.
1. 4 red tops expired 10-31-21
2. 5 purple tops expired 4-30-22
3. 6 gray tops expired 4-30-22
4. 2 Xpress nasopharyngeal sample collection kits for viruses expired on 3-31-22.

The cabinet under the sink was found to be unsecured exposing the pipes. The cabinet was found soiled with dust and plastic trash items.


Patient Nutrition Room

Inside the Patient Nutrition Room was a refrigerator with a sign that read, "Patient Food And Drinks Only No Staff Food". The freezer is noted to be soiled with a dried liquid and dust. Inside the refrigerator, there was a dried liquid that was red in color. The inside of the door was noted with a red colored dried liquid that had dirt and dust. At the base of the door, there was a dark red/brown color in the grooves of the door. The microwave was dirty on the inside with what appeared to be splattered food particles. Next to the microwave was a Community coffee pot. At the top of the coffee pot where you pour the water was noted to be heavily soiled with a dried white and brown liquid. The inside of the black lid had a dried red colored stain. Behind the coffee pot, on the counter, was a large dried brown liquid spot. On top of the counter were 5 (five) plastic bins that held dried goods, i.e., crackers, snacks, and potato chips. The inside of the bins was soiled with food crumbs, dirt, dust, and trash. In the drawer below the plastic bins was an open container of "Ice Cubes" chewing gum. The chewing gum was not individually wrapped. A drawer containing plastic ware and individually wrapped condiments was heavily soiled with dirt, dust, and dried liquids. In a cabinet above the sink was an empty Prune Juice bottle without a lid. There was tissue shoved into the top of the bottle.

An interview was conducted with Staff #12 on 6/1/2022 at 12:45 PM. Staff #12 was asked who was responsible for cleaning the nutrition room. Staff #12 stated, "I think that housekeeping does it. Most of our housekeeping is new." Staff #12 was asked if the Mental Health Tech's or the Nursing staff come in to clean the room. Staff #12 replied, "If there is a spill or something, we will clean it up but, we don't do it on a schedule," Staff #12 confirmed the findings in this room.


Medication Room

A pill crusher on the countertop was covered with dirt and dust.

Inside the cabinet above the sink were two (2) Nutri Grain bars and a sealed package of graham crackers. Staff #2 or Staff #11 could not confirm nor deny if the items belonged to the staff or to patients. Staff #2 and Staff #11 could not confirm how long the items had been there.

In the sink, a rust color was noted on the drain. Behind the sink was a plastic bin containing patient medications. No splash guard was present. This had the potential for contaminated water to breach the medication barrier and contaminate the patient's medications.

Directly above the cabinets labeled, "Home Meds" was a drawer with 2 chipped areas exposing the particle board beneath. The porous surface cannot be cleaned to mitigate the spread of infections.

29 Nasopharyngeal swabs used for SARS-CoV-2 Viral testing were expired on 4/30/2022.

The top of the large medication disposal container was heavily soiled with dust next to the medication preparation area.

A cloth and plastic caddy were found in the cabinet holding wound care supplies. The caddy had an open tube of Neosporin (not dated), opened therahoney gel (not dated) 5 rolls of tape, coban, opened 2x2's, measuring strips, and tegaderm. The caddy was soiled on the outside with dried liquid and dust particles inside the caddy.

2 bottles of betadine were found opened and not dated when opened. The surveyor was unable to determine when the contents would expire due to no opening date.

6 large bottles of wound cleanser were found opened with no dates.

1 large 10 oz. canister of food and beverage thickener was opened and ¾ empty with no opened date documented.

A bag of staff belongings brought from home was sitting on the floor in the medication room.





Kitchen

An observation tour of the kitchen was conducted on 6/2/2022 at 9:45 AM with Staff #9.

7 (seven) large flat trays, 3 (three) small flat trays, and one large pot were noted with heavy carbon on the outside. The carbon prevented the trays and pot from properly being sanitized and placed patients at risk of receiving contaminated food.

Shipping boxes were found stacked in the food prep area and with unpacked dry goods.

All door frames within the kitchen had chipped and missing paint exposing the metal surface that could not be properly sanitized. The door frame was rusted where the tile meets the metal door frame.

The floor in the kitchen was noted to be holding water and not draining. No slip proof mats were in the kitchen area.

An electrical outlet in between 2 food prep tables was heavily soiled with food particles and dried liquids. The table legs next to the electrical outlet were rusted and heavily soiled.

The tile floor was coated with a black substance of unknown origin.

The legs of the table where the food trays and lids were stored was noted to be missing paint and exposing the metal surface.

The pre-wash sink was not in working order. The water drainpipe leading into the drain on the tile floor was rusted and soiled with a green color coating the metal surface. The floor around the drain was covered with dirt, dust, and debris. The wall behind the sink was missing paint and exposing the porous surface. The porous surface cannot be sanitized to mitigate the spread of infections.

A 3 (three) sink system was being used by the staff. In the facility environment, there are two ways to wash wares. Staff can manually wash wares using the 3-compartment sink method or automatically wash them with a commercial dishwasher. The FDA (Food and Drug Association) requires all commercial kitchens to provide a stainless-steel sink with three compartments for the 3-sink method if there is not an appropriate automatic dishwasher available or the pots and pans are too large for the dishwasher or if the commercial dishwasher breaks down or fails to operate properly.

The 3-compartment sink method requires three separate sink compartments, one for each step of the ware wash procedure: wash, rinse, and sanitize.

Although the 3-sink method uses three sinks to perform three different procedures, the entire cleaning process has five steps: Prep, Wash, Rinse, Sanitize, Air Dry. According to the FDA the following steps ensure proper dishware sanitizing and to prevent food borne illnesses.

A. Prep- The staff should ensure each sink is clear of food debris and any remaining residue from the last wash session. The sinks can then be prepared for use.

B. Wash- The first sink is for washing the dishes. The pot and pan detergent should have been diluted into the water during the prep step. You should not apply pot and pan detergent directly to the wares. The proper dilution can be found on the detergent's label. The wash sink needs to maintain a temperature of at least 110 degrees Fahrenheit but no more than 120 degrees Fahrenheit throughout the wash procedure. The water should be changed frequently when it becomes dirty during the washing process. After the wares are washed, they are placed into sink two.

C. Rinse- The second sink is used to remove all detergent and residues from the wares. There should be no soap or chemicals placed in this water. The ware should be submerged. The water in this bay will need to be replaced when the water becomes too soapy.

D. Sanitizing- The final sink in the 3-sink method is used for sanitizing the wares. The wares can be sanitized using either chemical sanitizer or hot water sanitization. "Sanitizing kills 99.99% of bacteria and germs on the wares."

If a chemical sanitizer is used the facility must follow the directions of the proper amount of chemical per "parts per million." There is a minimum concentration of the sanitizer that must be present to effectively kill germs. The solution is mixed with the water in the 3rd sink.

Each chemical solution comes with a test strip (always refer to the product label for the proper dilution ratio) The dilution ratio will be affected every time dishes are added. The staff should check to ensure the right amount of solution is in the sink using the test strip. If the sanitizer is insufficiently diluted it can be hazardous to your staff. If the chemical is overly diluted, it will not kill germs and can put your patrons at risk. Do not rinse the wares after the sanitization step.

E. Air Dry- Dishes and utensils should always be air-dried on a drain board, utensil rack or similar piece of equipment. Drainboards control the excess water running off the wares and allows for the items to fully dry without becoming contaminated. The facility should never stack wet wares due to the likelihood of bacteria growth. Staff should not dry items with a towel or cloth; doing so can result in cross-contamination.

An interview was conducted with Staff #9 and #1 on 6/02/2022 at 9:50 AM. Staff #9 was asked how long the pre-wash sink has been out of service. Staff #9 stated, "The pre-wash sink has not worked since we opened the kitchen. We have to fill a pan with soap and water and hand wash the items before we place them in the washer." The prewash sink was in the clean food prep area and not in the soiled dish washing room. The staff would have to presoak the dishes in the clean food prep area then move them through the clean kitchen to the soiled area for the dish washer.

Staff #9 was asked about the three-sink method that she used. Staff #9 was asked if she was using a chemical sanitizer. Staff #9 stated that she was, but it was difficult to use due to the damage of the sinks. Staff #9 stated all three bays(sinks) were unable to hold water for any period and all three leaked. The surveyor observed the buckets under the sinks to catch the water. Staff #9 stated the sterilization sink required a towel to be placed in the bottom to hold the water in long enough to sanitize. Staff #9 stated that she was using the test strips to sanitize but due to the frequent refilling of the sink she was not sure the dilution was correct. Failure to have a correct amount of solution can result in food borne illnesses. Staff #9 stated that the middle wash bay had a pin hole in the bottom of it and all bays leaked around the drain. Staff #9 confirmed that the sinks had been leaking since January and she had reported this to administration many times.

Staff #1 stated that she was aware of the sink issue and thought maintenance had fixed the issue.


A review of the Infection Control Environmental Surveillance rounds dated 4/06/2022 and 5/05/2022 by Staff #5 did not reveal any deficiencies in the Kitchen.



2.

Patient Specimen Refrigerator

The temperature log for the specimen refrigerator located in the Emergency Exam/Treatment Room was incomplete. There was no documentation of the temperature for 16 of 31 days in May 2022.

Patient Nutrition Refrigerator

During an observation of the Patient Nutrition Room Staff #12 confirmed there was no temperature log for the patient nutrition refrigerator.





A review of the facility policy titled, "Care and Monitoring of Refrigerators and Freezers", Policy Number EOC-54 with a Revision date of 8/01/2021 was as follows:

" ...POLICY:
Medications, food and nutrition products, and laboratory specimens will be stored under proper condition of sanitation, temperature, light, moisture, ventilation, and security to maintain stability.

All refrigerator/freezer temperatures shall be maintained within acceptable standards to inhibit microbial growth and reduce the risk of infection.

TEMPERATURE:

There are two options for monitoring temperatures in refrigerators and freezers:

Option 1: The temperature for any refrigerator or freezer that contains drugs, patient food, lab specimens, or blood will be checked and recorded in degrees Fahrenheit (F) on a log.

Option 2: For refrigerators that have an internal thermometer with a temperature display:

The temperature will be displayed continuously.

Maintenance:

Refrigerators/freezers will be cleaned according to the following schedule:
Patient food, Drugs (medication), and Laboratory Specimens will be cleaned monthly and as needed ..."


On 6/1/2022 after 10:00 AM Staff #5 confirmed no refrigerators have an internal thermometer.









32143

Observation tours were conducted with Staff #1, Staff #2, and Staff #6 on 5/31/2022. The following was observed.

Patient Hallways
The door frames to 14 patient rooms were missing paint, soiled with dust, and rusted. 2 rolling stands blood pressure monitoring stands were found in the hallway next to the seclusion room. The stands were soiled with dust and hair. The bottoms of the stands were soiled with dirt and dried liquids. The bases were rusted and missing paint.

Laundry Room
A pile of various clean laundry (gowns, sheets, towels, and gate belts) was found stacked on the counter by the sink. A portion of the laundry had fell into the soiled sink.
A random patient or staff seater was found wadded up and stuck in a cabinet with clean linen. No staff member was able to identify the sweater, where it came from, or if it was clean.
The door frame was missing paint and was rusted.

Soiled Utility Room
The doors to the cabinet under the sink had fallen off the hinges. The doors were just propped up against the cabinet.
A trash bag was found wrapped around a cabinet door with dirty laundry in it. The bag was sitting on the floor.
The door frame was missing paint and rusted.

Clean Equipment Room
2 Bedside commode chairs and 1 shower chair were hanging up on the wall to dry. Wheelchairs were parked underneath. The bedside commode chairs had dripped rusted water all over the wheelchairs.
6 out of 6 wheelchairs in the clean equipment room were heavily soiled and damaged. 6 wheelchairs were found to be soiled with dried rusted water, dirt, grime, and hair. The buttons on the seats had all rusted. 2 of the wheelchairs had ripped backs and seats.
2 shower chairs were found to be soiled with grime and had rusted wheels. There was no identification on the equipment to determine if it was clean or dirty.

Clean and Sterile Patient Supply Room
Three bags of Normal Saline IV bags were found expired 4/22.
15 shipping boxes were found stacked in the middle of the floor and in shelves sitting next to clean and sterile supplies.
1 soiled and rusted rolling IV pole and a rusted step stool was found near clean supplies.
A two-tier rolling cart was found soiled with dust and had both tiers loaded with sanitizing wipes. A sign on the cart stated, "Do Not Use Bleach Wipes! Recall Thanks." Staff could not state how long the recalled wipes had been sitting there. They were available for staff to grab and use if they did not see the sign.
Medical supplies had fallen off the shelves and were laying on the floor dusty (bed pans, wound supplies, and lids to the containers holding supplies.
The floor was soiled with dirt and debris.

Seclusion Room
The bed base in the seclusion room was soiled with dust and debris. The mattress was clean on top but was soiled underneath with dirt and debris. Paint was missing in large pieces next to the floor exposing the sheet rock.