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Based on observation, record review and interview, the facility's Governing Body failed to carry out responsibilities and ensure facility policies and procedures were followed. Specifically,

1.) The facility's Governing Body failed to follow their policies and procedures in response to a reported allegation of sexual assault by Patient #1. As a result, the facility's administrative staff failed to report the sexual assault allegation to the appropriate agencies, failed to conduct an investigation and failed to provide services and support to Patient #1. Patient #1 reported the allegation of sexual assault on 11/12/20 and then patient was discharged on 11/12/20.

Refer to A 0145 for evidence of specific findings.

2.) The facility's Governing Body failed to provide oversight and monitoring to ensure the operation of the contracted dialysis service provided to patients in the hospital were provided in a safe manner and by ensuring hospital policy and procedures were followed by the dialysis staff and facility nursing staff. As a result,

A.) Hemodialysis treatments have been conducted without Registered Nurse (RN) Supervision and/or oversight during hemodialysis treatments for 3 of 3 months reviewed (August, September, and October 2020) and,

B.) Blood Transfusion records reviewed for June, July and August 2020 revealed Blood products have been initiated and administered by Licensed Vocational Nurse (LVN's) during hemodialysis treatments for 6 of 6 Patients reviewed (#2, #3, #4, #5, #6 and #7) that had blood products transfused.

Refer to A0398 for evidence of specific findings.

The cumulative effect of these deficient practices resulted in the facility's inability to meet the Condition of Participation for Governing Body.

Based on observation, record review, and interview, it was determined that the facility failed to protect and promote patient's rights to be free from all forms of abuse or harassment for 1 of 1 patients reviewed (Patient #1) with a patient rights complaint allegation of sexual assault against an unknown facility staff.

Specifically, the facility's administrative staff failed to follow their policies and procedures in response to a reported allegation of sexual assault by Patient #1. As a result, the facility's administrative staff failed to report the sexual assault allegation to the appropriate agencies, failed to conduct an investigation, and failed to provide services and support to Patient #1. Patient #1 reported the allegation of sexual assault on 11/12/20 and then patient was discharged on 11/12/20.

Refer to A 0145.

The effect of these deficient practices resulted in the facility's inability to meet the Condition of Participation for Patient Rights.

Based on observation, record review, and interview, it was determined the facility failed to ensure patients were free from all forms of abuse or harassment for 1 of 1 patients reviewed (Patient #1) with a complaint allegation of sexual assault against an unknown facility staff.

Specifically, the facility's administrative staff failed to follow their policies and procedures in response to a reported allegation of sexual assault by Patient #1. As a result, the facility's administrative staff failed to report the sexual assault allegation to the appropriate agencies, failed to conduct an investigation, and failed to provide services and support to Patient #1. Patient #1 reported the allegation of sexual assault on 11/12/20 and then patient was discharged on 11/12/20.

This deficient practice could compromise patient safety for all patients in the facility by failing to implement protections and further prevention of abuse and/or neglect.

Findings:

Review of Complaint Intake TX00365494 referred on 11/16/20 to Health Facility Compliance from Department of Family and Protective Services (Intake # 74124200) dated 11/13/20 revealed that the local Police Department reported a sexual assault on Patient #1's behalf. This report indicated Patient #1 stated that sometime between 11/9/20 and 11/11/20, she was "inappropriately touched in her vaginal area by MF [Medically Facility Staff]." According to Patient #1, MF was adjusting her catheter and inserted his fingers into her vagina. Patient #1 stated, she hadn't felt that type of sensation with any other staff members.

Record review of Patient #1's Discharge Summary dated 11/12/20 completed by her attending Physician who is also the Chief Medical Officer (CMO) of the facility dictated the following, in part on 12/8/20, Patient #1, who is a quadriplegic [confirmed later in CMO interview patient is paraplegic, not quadriplegic] was visited on a daily basis. "She was hallucinating on the number of occasions on several occasions." Patient #1 "described that a man with a white coat and beard introduced his fingers into her vagina and then proceeded that a man with a tattoo put the IV on her. Both statements are totally absurd." She was discharged home in stable condition.

Record review of Patient #1's Case Management Progress Notes completed by the Director of Case Management (CM) who is a Licensed Social Worker (LSW) documented the following in part, on 11/12/20 at 13:00 PM: Licensed Vocational Nurse (LVN)/CM (Staff #12) spoke with Patient #1 and expressed a concern that a man with a beard and white coat had put his fingers in her vagina. This was reported and discussed with the facility's Chief Executive Officer (CEO), Chief Nursing Officer (CNO), and the CMO. The CMO who is Patient #1's Primary Care Physician states, she needs to be discharged so she can see her psychiatrist given that she refused to see psychiatrist that has privileges here, given her paranoia. The CMO/Patient #1's physician believed patient is having hallucinations given her mental health history. The CMO/Patient #1's physician gave discharge orders.

Record review of the facility's occurrence/incident report completed on behalf of Patient #1 by LVN/CM (Staff #12) and signed on 11/20/20 by the facility's Interim Quality Director revealed the following, in part:

Date of Occurrence 11/12/20. Time: 11:15 AM.

CM [Staff #12] was called to Patient #1's room wanting to speak about an incident that happened the day before [11/11/20]. During the conversation, Patient #1 started talking about "that man who had put that IV [Intravenous] the day before". Patient #1 "did not want him in her room anymore because she had told him that she was not able to go to the restroom and he told her to turn around and he put his fingers in her vagina". The CM asked her which man was she talking about. Patient #1 said it was the "man with the beard and the white coat the same man who put the IV up". At this point I immediately notified my Director [Director of CM/LSW].

Further review of this occurrence/incident report revealed the "Follow-up Actions" were blank.

Interview on 12/8/20 at 4:14 PM with the facility's CEO was asked the facility's process when a patient makes an allegation of sexual assault and she responded, to "call the physician and he makes the authorization to send the patient to the hospital." The CEO confirmed there was not any contact made to the local Police Department when the facility received the sexual assault allegation by Patient #1.

In a follow up interview on 12/9/20 at 5:00 PM, the CEO stated, she directed the Director of CM/LSW to call Patient #1's Physician/CMO regarding the sexual assault allegation when she was made aware of it. The CEO stated the sexual abuse allegation was "left in the hands" of the CNO and Director of CM/LSW. The CEO confirmed, she was aware the facility had a policy and procedure regarding abuse allegations and reporting, but that she did not review the abuse policy for the procedures. The surveyor notified the CEO that sexual assault allegations need to be reported in accordance with Texas Licensure Requirements and the CEO asked the surveyor how the facility is supposed to do that. The CEO was asked if facility employees receive training regarding abuse, neglect and reporting procedures and she responded the employees receive .25 hours of abuse training where they "go over types of abuse."

Interview on 12/8/20 at 4:16 PM with the facility's CNO confirmed that the local Police Department was not called when Patient #1 made the allegation of sexual assault. After review of the facility's policy and procedures for abuse reporting and sexual assault, the CNO confirmed the facility's policies and procedures were not followed. The CNO stated she had conversations with staff and there was no one who wears white coats and have beards.

Interview on 12/9/20 at 9:18 AM with the Director of CM/LSW stated the following, in part, LVN/CM reported to her on 11/12/20 "around noon" an allegation of sexual assault reported by Patient #1. The Director of CM stated, she had never experienced an allegation like this, so she reported it to the facility's CNO. The Director of CM and the CNO then went to report Patient #1's allegation to the facility's CEO and get direction. The Director of CM stated the CEO directed her to notify Patient #1's physician; who is also the facility's CMO of the sexual assault allegation. The Director of CM then notified Patient #1's Physician/CMO. The CMO responded that Patient #1 had a history of mental health issues, requested that Patient #1 be discharged from the facility and to schedule her with a psychiatric follow-up appointment. Further interview with the Director of CM confirmed this allegation of sexual assault was not reported to an outside agency including the Texas Department of State Health Services or to the local Police Department. The Director of CM stated, she had not been trained on reporting abuse, neglect and sexual assault before this allegation and she was not aware of a facility policy regarding reporting or responding to allegations of abuse, neglect and sexual assault.

Interview on 12/9/20 at 9:47 AM with LVN/CM (Staff #12) confirmed that she completed the occurrence/incident report dated 11/12/20 on behalf of Patient #1 and then gave the report to the Interim Quality Director. She further stated that after she spoke with Patient #1 in her room on 11/12/20, she immediately reported the allegation to her supervisor, the Director of CM. LVN/CM stated, she had not been trained on reporting abuse, neglect, and sexual assault before this allegation and she was not aware of a facility policy regarding reporting or responding to allegations of abuse, neglect and sexual assault.

Interview on 12/9/20 at 11:18 AM with the facility's CMO who was also the attending Physician for Patient #1 stated the following, in part, CMO confirmed he was notified by the Director of CM on the day of her discharge (11/12/20) that Patient #1 alleged an allegation of sexual assault by stating a tall man dressed in white with a beard introduced his fingers into her vagina. CMO responded to this surveyor by saying the allegation was "absurd." CMO was asked if he gave any direction or orders to the Director of CM when she called to report the allegation of sexual assault and he responded, "None." The CMO was asked what would he typically do if someone called him to report an alleged patient sexual assault and what his orders would be. He responded that if he "knew it was a true allegation" he would send the patient to Harlingen [another facility for a SANE], but "with the pandemic, cannot send the patient to Harlingen". Then he said, "not sure with a sexual allegation. This was so absurd." The CMO was asked how he knew this allegation did not happen or in fact it was "absurd" since the patient had since been discharged without an investigation and he said, "because of her past history of allegations." The CMO was advised that it was not documented in Patient #1's medical record that this patient had a history of allegations. He said, "No, because we are busy." He was asked what was done for the patient after she made the allegation of sexual assault and he responded, "We didn't do anything at that point."

Further interview with the CMO stated that he never talked to the patient about the allegation of sexual assault once he was notified on 11/12/20. The CMO stated, he has been involved with a sexual assault case before and that for this Patient; [#1] "This is so unusual with a paraplegic. This patient was already on her way out" from the facility.


Record review of the hospital policy titled, Care of a Sexual Assault Patient (S.A.N.E.) with a last revised date of 1/2020 stated the following in part:

POLICY- Victims of Sexual Assault will be triaged and stabilized at Solara Specialty Hospitals and will be transferred to the nearest S.A.N.E. crisis center within the community.

PROCEDURES included the following, in part:

P. Discharge instructions should include:

1. The name and number of the nearest Sexual Assault Crisis Center

2. The Victim of Sexual Assault Information Packet (which includes the mandatory information sheet provided by the ________________ (Texas - state specific) Department of State Health Services for the victims of a sexual assault), located in the ER.

3. A safe way of transportation to the Sexual Assault Crisis Center

4. Any other support services as deemed necessary, (i.e. nearest shelter, church, support services etc.)

S. The Victim of Sexual of Sexual Assault Information Packet will include

1. _________________(Texas Association Against Sexual Assault Hotline 800-656-HOPE Insert state specific information).

2. _________________(Texas Department of State Health Services Assault Information Sheet (English and Spanish) Insert state specific information).

3. Personal Safety Plan Checklist provided by ___________(Texas Council on Family violence (English and Spanish) Insert state specific information).

4. Education Fact of Violence: Did you know? (English and Spanish)

5. Sexual Assault Survivors: You Have the Right to Know (English and Spanish)

6. Legal Help and Victim Services Contact Page (English and Spanish)

U. Mandatory Reporting of Abuse (mental, physical or sexual) and/or Neglect.

X. Abuse of the Disabled: If the patient is between the ages of 18-59 and there is cause to believe abuse in any way (see above) you must call 800-________________ (insert state specific number).


The hospital policy #CL-2.5 entitled, "Abuse, Reporting Suspected Abuse," last revised 1/2020 stated the following in part:

Policy - Hospital staff is trained in the use of identifying criteria to objectively recognize possible victims of abuse, neglect or exploitation. This policy applies to all hospital staff and non-hospital health professionals who are involved in the care of a patient.

Reporting Procedures

xii) Any staff member who reasonable suspects abuse is required by law to report such suspicions.

(a) Report possible signs of mistreatment to the Case Manager/Social Worker.

xiii) A clear notation must be placed in the progress notes of the medical record.

xiv) Nursing/Case Management will support the attending physician or one whom he or she designates to inform the family/significant other(s) unless otherwise determined by the interdisciplinary team.

xv) If sexual abuse is suspected, or abuse that will require a chain of evidence, report to the Hospital Administrator or designee and Case Manager/Social Worker.

xvi) The Case Manager/Social Worker will report as follows:

(b) Call DHH/Bureau of Protective Services, for disabled adults age 18-64.

(c) Contact the Police department or Sheriff for those patients with suspected sexual assault or abuse and arrange transfer to an Emergency Department for collection of evidence.

(d) Complete the form of each incident and each victim of suspected abuse. It is imperative that the reporting party signs this report.

(e) Mail the completed report form to the state agency as requested.

xvii) A copy will be placed in the patient's chart and the Case Manager/Social Worker will maintain a copy for follow-up.

xviii) Nursing and the interdisciplinary team will be informed by the Case Manager/Social Worker about any protective service investigation or action, which occurs, and clear documentation is recorded in the medical record.

xx) If the case is still open at the time of discharge, the protective agency will be notified prior to discharge of patient.


Attached to the policy is the Abuse Report pages 7-11.

On 12/8/20 at 9:30 PM, this surveyor reviewed the Texas Unified Licensure Information Portal (TULIP) State Wide Database Program to determine if the facility had reported this sexual assault incident to Texas Health and Human Services Complaint Intake. Upon review, there was no evidence that the facility had made an oral report, email, facsimile or mailed a report of the sexual assault allegation made by Patient #1 against an unknown facility staff and in accordance with their policies and procedures. The only report made was to DFPS on 11/13/20 by the local Police Department which was after the patient was discharged from the facility on 11/12/20. This report was then referred to the Health Facility Compliance for investigation.


Observations on 12/9/20 beginning at 10:30 AM of the hospital's main lobby, receiving area and patient floor revealed that there was not a posting for display in a public area readily visible to patients, residents, volunteers, employees, and visitors, a statement of the duty to report abuse and neglect, or illegal, unethical or unprofessional conduct in accordance with the Health and Safety Code (HSC) 162.132 (e), and ensure the statement contains the number of the Texas HHS patient information and complaint line at (888) 973-0022; in English Spanish in accordance with the State Licensure Requirements.

Based on record review and interview, the facility's Chief Nursing Officer (CNO) failed to provide oversight and monitoring to ensure the operation of the contracted dialysis service provided to patients in the hospital were provided in a safe manner and by ensuring hospital policy and procedures were followed by the dialysis staff and facility nursing staff.

Specifically,

1.) Hemodialysis treatments have been conducted without a dialysis Registered Nurse (RN) Supervision and/or oversight during hemodialysis treatments for 3 of 3 months reviewed (August, September, and October 2020) and,

2.) Blood Transfusion records reviewed for June, July and August 2020 revealed Blood products have been initiated and administered by Licensed Vocational Nurses (LVN's) during hemodialysis treatments for 6 of 6 Patients reviewed (#2, #3, #4, #5, #6, and #7) that had blood products transfused.

Findings:

Review of the intake information for Complaint #TX00363888 revealed the following in part:

The dialysis services provided at the facility was a contracted service. "They rarely have any RN's on site. The treatments are done by LVN's and Techs [Technicians] with almost no RN oversight. Techs give antibiotics, meds, and blood infusions without any oversight at all. The techs hang the blood, infuse it, and take the vital signs."

1.) Review of the Daily dialysis machine checks and Reverse Osmosis (RO) logs dated August through October 2020 revealed the following:

A.) August 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, and 31, revealed there was no evidence of a dialysis RN present for hemodialysis treatments.

B.) September logs revealed no dialysis RN present.

C.) October logs revealed no dialysis RN present during treatments, dated 10/01/2020 through 10/19/2020.

D.) The Daily Dialysis Machine Check Logs for 2 of the 3 dialysis/RO machines that were present for the past three months (August, September, and October 2020) were blank, incomplete, undated, missing the RO #, machine number, month, and year.


Interview on 11/10/20 at 2:35 PM with contracted dialysis Staff #5 accompanied by facility's CNO stated, he was previously a Licensed Vocational Nurse before becoming a Registered Nurse. Staff #5 was asked during the times he was a LVN if he had ever performed hemodialysis treatments to patients without a dialysis RN present for monitoring and oversight and he responded, "yes."

Staff #5 further confirmed the records for the daily dialysis machine logs were incomplete for August, September and October 2020.


Interview on 11/10/20 at 3:00 PM with the facility's CNO stated that dialysis has to be monitored by a RN.

Interview on 11/10/20 at 6:10 PM with the Contracted Dialysis Chief Executive Officer stated the following: There should always be a dialysis RN in the building for oversight during dialysis treatments of patients and it was their "practice to make sure an RN is in the building." The Dialysis CEO confirmed there may have been a few months when it was just a LVN and a dialysis technician doing dialysis treatments unsupervised by a dialysis RN. He further stated that moving forward the electronic documentation will have evidence that a RN is monitoring dialysis treatments.


2.) Review of the Blood Transfusion records and dialysis flowsheets for June, July, and August 2020 revealed 7 blood transfusions occurred during Hemodialysis (HD) by a LVN.

June 4th Patient #2, transfused by LVN #8,

June 16th Patient #4, transfused by LVN #8,

June 23rd Patient #3, transfused by LVN #8,

August 1st Patient # 2, transfused by LVN #8,

August 11th Patient#5, transfused by LVN #8,

August 18th Patient#7, transfused by Staff #5 who was an LVN at this time, and

August 29th Patient #6, transfused by Staff #5 who was an LVN at this time.


Interview on 11/10/20 at 2:35 PM with Staff #5 stated, he was a Registered Nurse. When this surveyor asked about his identification badge with his name and title of Licensed Vocational Nurse, he stated that he graduated "May 5th," 2020 and then was a "licensed RN". Staff #5 was asked if he ever transfused Blood products during dialysis to patients when he was a LVN and he confirmed he had transfused Blood products as a LVN once the Blood product was checked by the RN.

Review on 11/10/20 of Staff #5's employee record with the facility's CNO present revealed his original issue date for a licensed RN was 10/20/20. Prior to 10/20/20, Staff #5 had been licensed as a LVN.

Interview on 11/10/20 at 3:00 PM with the facility's CNO stated, it was the facility's policy that, "it has to be an RN that initiates the blood administration of blood products." The CNO further stated she did not know the contracted dialysis service was having LVN's transfuse the blood products during dialysis and further did not know that dialysis was being provided without a dialysis RN on site to monitor the patients.


On November 10th, 2020, the facility's CNO provided a signed document stating, "In speaking with nursing staff, the blood product handoff process to the dialysis nurse is as follows:

1. Solara licensed staff (at least one RN) review the blood product together and document on the provided lab sheet.

2. The blood product id handed off to the HD nurse who spikes the blood and runs.

3. If the HD nurse is an RN, our RN does not stay.

4. If the HD nurse is an LVN, our RN stays for 15 minutes to look for any reactions."


Interview on 11/10/20 at 6:10 PM with the Contracted Dialysis CEO stated the following: Contracted dialysis staff were to follow the hospital's policy and procedures for the administration of blood products during hemodialysis.


Contracted dialysis LVN staff #8 was interviewed on 12/08/20 at 3:18 p.m. via telephone and according to him: The facility RN started the blood for him and he just monitored the patient. The RN punctured the bag, waited 15 minutes, would leave and he would write the vitals. The nurses were from the hospital. The RN would spike the blood and start the blood. If there was no reaction after 15 minutes they would leave. He would follow-up every 15 minutes taking the blood pressure and temps.


Contracted dialysis Supervisory RN staff #6 was interviewed on 12/08/20 at 3:20 p.m. in a conference room and according to him: The LVN's never spike blood. The contracted dialysis staff, Registered Nurse #5 was spiking the blood. This surveyor informed supervisor RN staff #6 there were 3 patients in June 2020 and 4 in August 2020 who received blood transfused by a LVN. RN staff #6 was also informed RN #5 was not licensed as a RN until 10/20/20. RN staff #6 was asked who gave the direction for the nurses at Solara to spike and connect blood to the dialysis machines and he answered, "Good question." He stated he "had no clue someone else was spiking the blood" and to his knowledge it was staff #5. RN staff #6 said when they give blood it is rare and the RN spikes it.


Further interview, Supervisory RN # 6 acknowledged and confirmed that the LVN's were administering Albumin but said, "not anymore." He acknowledged it was never ok for an LVN to spike the blood and he stated that he did not catch it from the patient's record that the LVN was spiking the blood. Surveyor asked RN staff #6 how long he was aware of dialysis LVN's working at Solara without dialysis RN oversight. He answered since RN staff #13 left [approximately 3 months ago]. He said he knew there was supposed to be an RN there and stated, "We did not make ourselves visible here, maybe 3 months." He was asked what it meant when he said they did not make themselves visible. He responded that sometimes he would be at the facility to look at storage or charges but staff did not know he was there; they would find out later that he was there. RN staff #6 further confirmed dialysis technician staff #9 was completing treatments along with everyone else but stated, "not anymore."


The facility's CEO was interviewed on 12/08/20 at 3:23 p.m. in a conference room and according to her:
CEO was asked if she was aware that facility nursing staff were hooking up blood products to the dialysis machines. She said she was not aware of this in the past; but is aware now.

She acknowledged the RN's spiking blood were the facility's RN's and not the contracted dialysis RN's. She stated the facility RN's are not spiking the blood now. When asked, the CEO did not know who directed the facility RN's to hook up blood to the dialysis machines. The CEO confirmed that dialysis technician staff #9 had been doing treatments; but not anymore.

The facility's CNO was interviewed on 12/08/20 at 3:30 p.m. in a conference room and according to her: She asked the facility RN's if they touched the dialysis machine and spiked blood and said they did not spike or attach blood to the dialysis machines. One of the facility RN's does do the verification of the armband. CNO stated that a nurse, not an RN has to be present at the bedside for the first 15 minutes. The RN checks compatibility and initiates administration. LVN staff may monitor the patient. For a dialysis patient, the facility RN does a two person check of the blood with another nurse and checks off.


Review of Policy # CL3.2 Title Blood and Blood Components-Administration Effective 05/2007 latest revision 02/2020, states in part,

Policy:
Registered Nurses may initiate the administration of and monitor blood and blood components. Licensed Vocational nursing staff may monitor the administration of blood and blood components.

III. At the time of infusion
The registered nurse who administers the blood is the last point at which positive identification occurs before the patient is transfused. The Registered Nurse and a second licensed nurse must check all identifying information before beginning the transfusion, and record on the transfusion flowsheet that this information has been checked and found to be correct.