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

CHRISTUS MOTHER FRANCES HOSPITAL 800 EAST DAWSON TYLER, TX 75701 Oct. 27, 2020
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on observation, document review, and interview, the facility failed to:


1. appropriately prevent the transmission of COVID-19 by following the Centers for Disease Control and Prevention (CDC) Guidelines and Recommendations and facility policy regarding screening of all staff and Health Care Providers upon entering the facility.

2. ensure there was documented COVID-19 education and training for all staff.

3. ensure education and training was provided to staff for the reprocessing of Isolation gowns to mitigate the spread of COVID-19 during a pandemic.

4. properly clean and disinfect 3 of 3 Dynamaps (a portable vital sign machine) observed.

5. ensure there was a current return-to-work policy for employees that followed the CDC guidelines for employees after exposure/illness to COVID-19.


Cross Refer to Tag A0749
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observation, document review, and interview, the facility failed to:


1. appropriately prevent the transmission of COVID-19 by following the Centers for Disease Control and Prevention (CDC) Guidelines and Recommendations and facility policy regarding screening of all staff and Health Care Providers upon entering the facility.

2. ensure there was documented COVID-19 education and training for all staff.

3. ensure education and training was provided to staff for the reprocessing of Isolation gowns to mitigate the spread of COVID-19 during a pandemic.

4. properly clean and disinfect 3 of 3 Dynamaps (a portable vital sign machine) observed.

5. ensure there was a current return-to-work policy for employees that followed the current CDC guidelines for employees after exposure/illness to COVID-19.


This deficient practice had the likelihood to cause serious harm injury, and possibly subsequently death. Failure to adhere to the CDC's recommendations and guidelines placed all patients and staff at a higher risk for contracting and transmitting COVID-19.



Findings for #1:

An interview was conducted on 10/26/2020 at 8:35 AM, with Staff #13 and Staff #17. Staff #13 was asked if the facility was currently treating any positive COVID-19 patients. Staff #13 said, "Yes, we are. We have 59 positive patients and 18 patients under investigation." Staff #13 was asked if the patients were isolated to a specific area in the facility. Staff #13 stated, "No, they are not isolated to one area. The COVID-19 positive patients are located on 7 different units within the facility."


During an observation tour of the 4th floor Ornelas Tower at 11:00 AM on 10/26/2020, an interview was conducted with Staff #10. Staff #10 was asked to explain the process of employee screening for COVID-19. Staff #10 stated, "Well we do not do that anymore. We used to do it when the COVID started but employees don't get screened now."

An interview was conducted with Staff #11 on 10/26/2020 at 11:25 AM. Staff #11 was asked if she was screened for any COVID-19 symptoms or had a temperature taken before her entering the facility. Staff #11 stated, "They stopped screening employees a couple months ago."

An interview was conducted on 10/27/2020 at 8:35 AM, with Staff #2. Staff #2 was asked to explain the process for staff and Health Care Providers screening upon entering the facility. Staff #2 replied, "We no longer screen our staff or providers. We stopped that back in early August when we implemented the universal masking. We are trying to implement a new iPad and an App for smart phones to restart the screening process, but we are not there yet. Hopefully it will be soon." Staff #2 was asked what national guidelines the facility followed during the pandemic. Staff #2 said, "We follow all CDC Guidelines. All of our directives come from the Infection Prevention System Director at our corporate office in Irving."


A review of the facility policy titled, "Associate/Clinician Screening Guideline-Emerging Pathogen" Policy #3.413, Created: 3/13/2020 with a Review/Revision date of 4/27/2020 was as follows:

" ...II OBJECTIVE/S: To prevent person-to-person transmission of infectious diseases in the inpatient unit and in the outpatient clinic. To ensure the health status of associates and clinicians is reviewed upon entry into the hospital.

III. POLICY STATEMENT: CHRISTUS Health follows the guidelines of the Centers for Disease Control (CDC) and provides process to keep patients, Associates and clinicians safe from possible transmission of an emerging pathogens from the community.

IV. DEFINITIONS:

Associate: Any person employed by Christus directly or via contracted services.

Volunteer: Any unpaid person providing support care.

Students: Any students obtaining clinical or operational training experience in the hospital

Clinician: Any person credentialed to provide care and treatment for patients in the hospital ..."

During an interview with Staff #2 on 10/27/2020 at 8:35 AM, Staff #2 was asked to confirm Triage Level the facility was operating under currently. Staff #2 replied, "We are at a Triage level 2 at this time.


Further review of the policy revealed:

" ...V. PROCESS OR PROCEDURES:

Triage Level 2
High volume community spread

Screening Questionnaire and Temperature Screen

Screening of Associates and Clinicians to be performed upon entry

Students and Volunteers should be evaluated regionally to determine inclusion or exclusion

a. Associates and Clinicians will be directed to one point of entry into the hospital to be screened. They are not to use the Visitor access point ..."



A review of the current CDC Guidelines was as follows:

" ...Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic
Infection Control Guidance
Updated July 15, 2020

Background

This interim guidance has been updated based on currently available information about COVID-19 and the current situation in the United States. As healthcare facilities begin to relax restrictions on healthcare services provided to patients (e.g., restarting elective procedures), in accordance with guidance from local and state officials, there are precautions that should remain in place as a part of the ongoing response to the COVID-19 pandemic. Most recommendations in this updated guidance are not new (except as noted in the summary of changes above); they have been reorganized into the following sections:

Recommended infection prevention and control (IPC) practices for routine healthcare delivery during the pandemic

Recommended IPC practices when caring for a patient with suspected or confirmed SARS-CoV-2 infection

This guidance is applicable to all U.S. healthcare settings

Screen and Triage Everyone Entering a Healthcare Facility for Signs and Symptoms of COVID-19

Although screening for symptoms will not identify asymptomatic or pre-symptomatic individuals with SARS-CoV-2 infection, symptom screening remains an important strategy to identify those who could have COVID-19 so appropriate precautions can be implemented.

Take steps to ensure that everyone adheres to source control measures and hand hygiene practices while in a healthcare facility

Post visual alerts (e.g., signs, posters) at the entrance and in strategic places (e.g., waiting areas, elevators, cafeterias) to provide instructions (in appropriate languages) about wearing a cloth face covering or facemask for source control and how and when to perform hand hygiene.

Provide supplies for respiratory hygiene and cough etiquette, including alcohol-based hand sanitizer (ABHS) with 60-95% alcohol, tissues, and no-touch receptacles for disposal, at healthcare facility entrances, waiting rooms, and patient check-ins.

Limit and monitor points of entry to the facility.

Consider establishing screening stations outside the facility to screen individuals before they enter.

Screen everyone (patients, HCP, visitors) entering the healthcare facility for symptoms consistent with COVID-19 or exposure to others with SARS-CoV-2 infection and ensure they are practicing source control.

Actively take their temperature and document absence of symptoms consistent with COVID-19. Fever is either measured temperature ?100.0F or subjective fever.

Ask them if they have been advised to self-quarantine because of exposure to someone with SARS-CoV-2 infection.


People with COVID-19 have had a wide range of symptoms reported - ranging from mild symptoms to severe illness. Symptoms may appear 2-14 days after exposure to the virus. People with these symptoms may have
COVID-19:

Fever or chills
Cough
Shortness of breath or difficulty breathing
Fatigue
Muscle or body aches
Headache
New loss of taste or smell
Sore throat
Congestion or runny nose
Nausea or vomiting
Diarrhea

This list does not include all possible symptoms. CDC will continue to update this list as we learn more about COVID-19 ..."

Staff #2 was asked to confirm that no staff or Healthcare Provider was screened upon entry into the facility. Staff #2 stated, "We are not screening any staff or Healthcare Providers at this time."

Staff #2 and Staff #16 confirmed the facility was not following the facility policy nor the CDC guidelines and recommendations on screening everyone for COVID-19 upon entering the facility.


Findings for #2

An interview was conducted on 10/27/2020 at 8:35 AM, with Staff #2. Staff #2 was asked what education and training the staff had received regarding COVID-19. Staff #2 replied, "Training is completed online. We were having some Town Hall meetings (an open meeting for all staff) monthly and sometimes twice a month during the onset of COVID-19. Our Registered Nurses get information through what we call electronic "Blasts". The last one was sent a couple of weeks ago." Staff #2 confirmed that part-time, contract/agency clinical staff do not have email through the facility and could not provide any evidence they had received any COVID-19 Training or updates. Staff #2 was asked how she ensured that all staff received the education and training on COVID-19. Staff #2 stated, "There is no way for me to know that all staff received the information." There was no "read receipt" attached to the email's and no sign in sheets/registration for the employees that attended the Town Hall meetings." Staff #2 was asked to provide the education and training on COVID-19 and a list of employee names that received the education and training.

After multiple requests no documentation was received or provided.


Findings for #3

An interview was conducted on 10/27/2020 at 8:35 AM with Staff #2. Staff #2 was asked if the facility was reusing any PPE (Personal Protective equipment) due to a shortage of supplies during the pandemic. Staff #2 replied, "We have a great Materials Department and they are able to keep us supplied without any shortages at this time. We are reprocessing our Isolation gowns to ensure we will not run short in the near future." Staff #2 was asked if the isolation gowns were reprocessed in the facility. Staff #2 stated, "Yes, our laundry department does the reprocessing of the gowns and then they are returned to the units." Staff #2 was asked if there was a process in place to ensure the isolation gowns were being reprocessed according to the manufacturing guidelines. Staff #2 replied, "Yes."

A facility policy titled, "Reusable/Washable Isolation Gowns" Reference Number: 8350-0300, with an Effective Date of 7/17/2020 was reviewed with Staff #2. Staff #2 stated, "This is a step by step guide on how to reprocess and distribute the isolation gowns." Staff #2 was asked if the isolation gown was worn by staff treating positive COVID-19 patients. Staff #2 stated, "Yes." Staff #2 was asked if there was training and/or competencies with the laundry department staff to ensure the isolation gowns were reprocessed correctly. Staff #2 stated, "I have not completed any training with the department staff." Staff #2 was asked how she ensured the isolation gowns were reprocessed correctly to protect the staff from transmitting infectious diseases between patients. Staff #2 stated, "This is a step by step guide on how the process is to be completed."

Multiple requests were made for documented training, competencies, and the manufacturing guidelines for reprocessing the isolation gowns. No documentation was received or provided for review.

Staff #16 confirmed the above findings.


Findings for #4

An observation tour was conducted on 10/26/2020 at 11:00 AM with Staff #15 and Staff #17. The following was observed on the 4th floor of the Ornelas Tower.

Staff #10 was observed exiting Room #4417 with a portable Dynamap. Staff #10 proceeded down the hallway with the portable Dynamap and placed it in the hallway next to the nurse's station.

An interview was conducted with Staff #10 on 10/26/2020 after 11:00 AM. Staff #10 was asked if the Dynamap was disinfected after exiting the patients room. "Staff #10 stated, "No it was not cleaned when I left the room. I wipe it down when I get to the nurse's station." Staff #10 was observed disinfecting the Dynamap with a Sani-wipe. Staff #10 was asked if disposable blood pressure cuffs were used for all patients. Staff #10 replied, "Yes." Staff #10 did not disinfect the cables to the blood pressure cuff, pulse oximeter, electrical cord, thermometer, or the portable stand the Dynamap was attached to. Staff #10 was asked if the portable Dynamaps, including the pole, were disinfected between each patient use. Staff #10 stated, "Yes they are." Staff #10 was then asked what was used to indicate the Dynamap had been disinfected before using it in a patient's room. Staff #10 stated, "There is not a clean or dirty tag that we place on them. They are left in the hallway plugged in, so they will stay charged."

3 of 3 Dynamaps observed in the hallway on the 4th floor was noted to be heavily soiled with dirt, dust, and debris. There was no dirty or clean indicator attached to the Dynamaps.

Staff #17 confirmed the findings.


Findings for #5

An interview was conducted on 10/27/2020 after 8:30 AM with Staff #2. Staff #2 was asked if the facility had any employees currently out due to COVID-19. Staff #2 replied, "Yes we do." Staff #2 was asked if a policy or protocol following the current CDC guidelines was implemented for staff to return to work after exposure or illness to COVID-19. Staff #2 replied, "We do have a return to work policy and we are following current CDC guidelines for returning to work."

During an interview with Staff #27 on 10/27/2020 after 10:00 AM. Staff #27 stated the facility had multiple policies on COVID-19 to include a return to work policy after exposure or illness to COVID-19. After multiple requests to Staff #2 and Staff #16 a facility policy was provided. The facility policy titled, "Attendance Management Policy" Effective January 15, 2015, Revised January 19, 2019, and updated May 29, 2020 was provided by Staff #14. A review of the facility policy revealed it did not include current CDC Guidelines or recommendations for healthcare personnel to return to work following a symptom-based strategy, test-based strategy, or exposure to COVID-19.

A review of the current CDC Guidelines and Recommendations was as follows:

" ...Criteria for Return to Work for Healthcare Personnel with SARS-CoV-2 Infection (Interim Guidance)
Return-to-Work Criteria
Updated Aug. 10, 2020


Return to Work Criteria for HCP with SARS-CoV-2 Infection
Symptom-based strategy for determining when HCP can return to work.

HCP with mild to moderate illness who are not severely immunocompromised:

At least 10 days have passed since symptoms first appeared, and

At least 24 hours have passed since last fever without the use of fever-reducing medications, and

Symptoms (e.g., cough, shortness of breath) have improved

Note: HCP who are not severely immunocompromised and were asymptomatic throughout their infection may return to work when at least 10 days have passed since the date of their first positive viral diagnostic test.

HCP with severe to critical illness or who are severely immunocompromised1:

At least 10 days and up to 20 days have passed since symptoms first appeared

At least 24 hours have passed since last fever without the use of fever-reducing medications and

Symptoms (e.g., cough, shortness of breath) have improved

Consider consultation with infection control experts


Test-Based Strategy for Determining when HCP Can Return to Work.

In some instances, a test-based strategy could be considered to allow HCP to return to work earlier than if the symptom-based strategy were used. However, as described in the Decision Memo, many individuals will have prolonged viral shedding, limiting the utility of this approach. A test-based strategy could also be considered for some HCP (e.g., those who are severely immunocompromised1) in consultation with local infectious diseases experts if concerns exist for the HCP being infectious for more than 20 days.

The criteria for the test-based strategy are:

HCP who are symptomatic:

Resolution of fever without the use of fever-reducing medications, and

Improvement in symptoms (e.g., cough, shortness of breath), and

Results are negative from at least two consecutive respiratory specimens collected ?24 hours apart (total of two negative specimens) tested using an FDA-authorized molecular viral assay to detect SARS-CoV-2 RNA. See Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for 2019 Novel Coronavirus (2019-nCoV).


HCP who are not symptomatic:

Results are negative from at least two consecutive respiratory specimens collected ?24 hours apart (total of two negative specimens) tested using an FDA-authorized molecular viral assay to detect SARS-CoV-2 RNA. See Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for 2019 Novel Coronavirus (2019-nCoV) ..."

Staff #2 and Staff #16 confirmed the findings.
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**



Based on document review and interview, the facility failed to follow their policy on Informed Consent for treatment in 6 (Patient #1, #3, #9, #18, #19, and #20) of 20 medical records.

This deficient practice had the likelihood to cause harm in all patients admitted to the facility for care and treatment without a properly executed consent to treat.


Findings:

Patient #1

A review of the document titled "PATIENT CONSENT" was as follows:

A review of the document titled, "PATIENT CONSENT" dated 9/22/2020 revealed documentation that a "verbal" consent was given. It was witnessed by one staff member.

No further documentation was provided or reviewed during chart review with Staff #22 on the morning of 10/27/2020.


Patient # 3

A review of the document titled "PATIENT CONSENT" was as follows:

A review of the document titled, "PATIENT CONSENT" dated 10/23/2020 revealed documentation that a "verbal" consent was given. It was witnessed by one staff member.

No further documentation was provided or reviewed during chart review with Staff #22 on the morning of 10/27/2020.



Patient #18

A review of the document titled "PATIENT CONSENT" was as follows:

A review of the document titled, "PATIENT CONSENT" dated 10/21/2020 revealed documentation that a "verbal" consent was given. It was witnessed by one staff member.

There was no documentation that staff attempted to get family member authorized to consent for the patient, sign the consent to treat.

No further documentation was provided or reviewed during chart review with Staff #22 on the morning of 10/27/2020.



Patient #19

A review of the document titled "PATIENT CONSENT" was as follows:

A review of the document titled, "PATIENT CONSENT" dated 10/25/2020 revealed documentation that a "verbal" consent was given. It was witnessed by one staff member.

There was no documentation that staff attempted to get family member authorized to consent for the patient, sign the consent to treat.

No further documentation was provided or reviewed during chart review with Staff #22 on the morning of 10/27/2020.



Patient #20

A review of the document titled "PATIENT CONSENT" was as follows:

A review of the document titled, "PATIENT CONSENT" dated 10/25/2020 revealed documentation that a "verbal" consent was given. It was witnessed by one staff member.

There was no documentation that staff attempted to get family member authorized to consent for the patient, to sign the consent to treat.

No further documentation was provided or reviewed during chart review with Staff #22 on the morning of 10/27/2020.


An interview was conducted with Staff #16 and #22 on 10/27/2020 after 9:00 AM. Staff #16 was asked if all consents were being completed with a "verbal" authorization by the patient. Staff #16 stated, "They are upon admission, but not for procedures." Staff #16 was asked if the facility policy required 2 signatures for verbal consent. Staff #16 replied, "Yes that is correct. It does require two signatures for a verbal consent to ensure the patient or representative of the patient agrees to treatment." Staff #16 was asked if the facility policy was updated to reflect that only one signature was required. Staff #16 replied, "No, it was not. There was concern from the registration desk regarding the spread of COVID-19.


Patient #9


A review of the clinical record of Patient #9 revealed she was a [AGE]-year-old female who (MDS) dated [DATE] for a stroke.

A review of the consent to treatment dated 10/19/2019 revealed documentation that "verbal" consent was given. It was witnessed by one staff member.

A review of a consent dated 10/20/2020 revealed a legal representative signed consent for a peripherally inserted central catheter to be placed.

There was no documentation that staff went back and got the family member to sign the consent to treat.

During an interview on 10/26/2020 after 1:45 p.m., Staff #27 confirmed the consent and was not able to find another one that was signed.




A review of the facility policy title, "Anesthesia, Surgical & Medical Informed Consent" with an effective date of 12/26/2018 revealed the following:

18.5 When a person is unable to make a Signature by Mark:
a. Verbal consent of a person who is unable to write or make a mark should be noted and witnessed by two people and documented on the consent form..

..d. Verbal consent via telephone may be accepted if the legal representative of the patient is only available by phone..
..f. Telephone consent is to be followed by a signature upon the arrival of the legal representative.


Staff #16, #22, and #27 confirmed the findings.
VIOLATION: ADMINISTRATION OF DRUGS Tag No: A0405
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**



Based on observation, interview, and record review, the facility failed to ensure 2 of 20 sampled patients medication was administered as ordered by the physician (Patient#'s 6 and 11). The facility failed to ensure insulin (diabetic medication) was administered as ordered and blood sugar checks were documented.


This deficient practice had the likelihood to cause harm to all patients who received insulin therapy.


Findings:


Review of the clinical record of Patient #11 revealed she was a [AGE] year old female who (MDS) dated [DATE]. Patient #11 had diagnoses which included diabetes mellitus and renal disorder.

Review of physician orders and medication administration records revealed the following:"

Review of October 2020 physician orders revealed Patient #11 was to receive Humalog (sliding scale insulin) three times a day with meals. For a range of 131-180, 8 units of insulin was to be administered.

On 10/24/2020 at 4:27 p.m., Patient #11 had a blood sugar of 172.

On 10/24/2020 at 5:29 p.m., Patient #11 was given 8 units of Humalog insulin.


Review of October 2020 physician's order revealed staff were to administer Lantus 15 units (long acting insulin), 2 times daily breakfast and bedtime. Underneath the instructions revealed the following:

"Hold for blood sugar <140 to prevent [DIAGNOSES REDACTED] High- Alert Medication: May cause [DIAGNOSES REDACTED]; monitor blood sugar"

On 10/24/2020 at 9:14 p.m., Patient #11 received 15 units of Lantus. There was no documentation of what the blood sugar was at that time.

On 10/25/2020 at 8:01 a.m.(over 13 hours later), Patient #11 had a blood sugar that was >500.

The physician changed the Lantus order on 10/25/2020 to the following:

Administer Lantus 20 units (long acting insulin), 2 times daily breakfast and at bedtime. Underneath the instructions the following was documented:

"Hold for blood sugar <140 to prevent [DIAGNOSES REDACTED] High- Alert Medication: May cause [DIAGNOSES REDACTED]; monitor blood sugar"

On 10/26/2020 at 6:22 a.m., Patient #11 had a blood sugar of 118.

On 10/26/2020 at 6:25 a.m., Patient #11 was given 20 units of Lantus.


According to a physician's order the insulin was to be held for blood sugars less than 140.

The insulin was given in error and against physician's orders.

On 10/26/2020 at 8:58 p.m., Patient #11 was given 20 units of Lantus insulin and there was no documentation of what the blood sugar was.

During an interview on 10/26/2020 after 1:45 p.m., Staff #27 confirmed the missing blood sugars and that the medication given in error on 10/26/2020.






On the morning of 10/26/2020 staff Registered nurse (RN) #26 entered the room of patient (Pt/pt)#6 for the purpose of a bed side blood glucose check. Pt #6 had been served his noon meal, but indicated he had not eaten anything. Pt #6's blood glucose results was 131. RN #26 confirmed the portable blood glucose monitor would record the blood glucose results into pt #6's medical record.

On 10/27/2020 in the board room the medical record for pt #6 was reviewed. The blood glucose was recorded in the medical record in red with an exclamation point beside it.

A review of the sliding scale insulin parameters which were printed in the medical record revealed a numeric blood glucose results of 70 to 130 required no insulin. A numeric results of 131 to 180 required 4 units of subcutaneous insulin. The medical record read, "No insulin given, patient did not meet parameters".

However, Pt #6 did meet parameters and should have received 4 units of sliding scale insulin, as his blood glucose was 131.

The above findings were confirmed by Registered Nurse #16 who was assisting with the electronic medical record review.