HospitalInspections.org

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

1.
adopt and implement 3 of 4 policies reviewed for Hospital #1 and Hospital #2. Also, the Governing Body failed to ensure the policies were reviewed every 3 years. The hospital was unable to provide additional hospital policies that had been adopted and implemented for Hospital #1 and Hospital #2.

Findings:
A review of the policy titled, "Verbal/Telephone Orders", Policy Number: 3.140, Approved by the Chief Clinical Officer with a reviewed date of 3/2018 was a hospital systems policy and had not been adopted by the quality council committee and/or the governing board for Hospital #1 and/or Hospital #2.
The policy had not been reviewed since 2018. This was 3 years over the required every 3-year review process.

Further review of the policy revealed the system policy referred to different states with different rules. The policy was as follows:

" ...D. Authentication
1. The provider must authenticate all verbal and/or telephone orders within the statutory guidelines (Texas:96 hours, New Mexico: 72 hours, and Louisiana: within 10 days) ..."

A review of the policy titled, "Moderate Sedation," Policy Number: 3.400, created 3/2017 with no review or revision date, and approved by the Chief Clinical Officer was a hospital systems policy and had not been adopted by the quality council committee and/or the governing board for Hospital #1 and/or Hospital #2.

Further review of the policy revealed the system policy referred to different states with different rules. The policy was as follows and had attached addendums from multiple states:

" ...B ...The following are position statements from each State Board of Nursing for a Registered Nurse.
a. Appendix A: Texas Board of Nursing
b. Appendix B: Louisiana State Board of Nursing
c. Appendix C: Arkansas State Board of Nursing
d. New Mexico State Board of Nursing ..."

An interview was conducted with RN Staff #2 on 1/24/2024 after 1:00 PM. RN Staff #2 confirmed the Moderate Sedation Policy referred to several different states and placed the staff and patients at risk for medication errors that could cause irreversible damage to a patient because some states are more restrictive, and some states are less restrictive on what medications a nurse may give for moderate sedation." RN Staff #2 confirmed the policy had not been reviewed since 2017. This was 3 years over the required every 3-year review process.

A review of the hospital policy title, "Informed Consent for Invasive/Surgical Procedure" Number 7.003, Approved by the Chief Clinical Officer with a Reviewed/Revised date of 9/23 was a hospital systems policy and had and had not been adopted by the quality council committee and/or the governing board for Hospital #1 and/or Hospital #2.
Further review of the policy revealed the system policy referred to different states with different rules. The policy was as follows and had attached addendums from multiple states:

" ...VI. REGULATIONS/REQUIREMENTS
The Joint Commission ...
CMS CoP ...
Texas Admin Code ...
Remedies Code ...
Louisiana Admin Code ...
See Appendix ...

Risks and Hazards
1. Texas Admin Code ...
2. Louisiana Administrative Code ...
Adult and Surrogate Decision Maker ...
Tx ...
LA Louisiana State Legislature Revised Statute ...
NM New Mexico NMSA 1978 Relating to Healthcare ..."

During an interview on the morning of 1/25/2024 with Physician #89 and Staff #126 it was confirmed the policies had not been adopted by the governing body for the facility and they were the current policies being followed. No further policies were provided for review. Staff #126 was asked how the governing body adopted policies that referred to other state requirements and laws. CEO stated, "They can't. It has to be for this state."

2.
A. ensure a properly executed informed consent was completed in 5 (Patient #41, #44, #46, #62, and #3) of 11 patient medical records reviewed. Also, the facility failed to follow the hospital's Informed Consent Policy and the Moderate Sedation Policy.

Refer to Tag A0131

B. ensure 3 (# 29, # 30, # 31) of 7 staff members working in high-risk areas (hemodialysis and surgery) were vaccinated and/or had positive immunity against the Hepatitis B virus.

C. identify 1 of 6 IV (intravenous) pumps in the dialysis treatment room with overdue preventative maintenance (PM).

D. verify dialysate conductivity and pH with an independent device before treatment initiation on 1 (#5) of 6 patient treatments observed. Also, the hospital staff failed to follow the facility policy, "Water Treatment and Monitoring" and "Hemodialysis: Plan of Care".

E. implement a schedule to ensure each hemodialysis machine was tested quarterly for bacterial growth and the presence of endotoxins. The hospital staff failed to test 7 (#3300/500, #3305/505, #3306/306, #3307/307, #3308/308, # 3309/309, #3310/310) of 11 dialysis machines one or more quarters of 2023.

F. ensure that 2 (# 76 and # 77) of 2 patients undergoing hemodialysis treatment with an unknown Hepatitis B status were treated in a location that prevented the transmission of Hepatitis B to other patients and staff members. Also, the hospital staff failed to follow the hospital policy, "Hepatitis B".

G. ensure the patient's dialysis access was visible throughout the patient's entire treatment in 4 (# 64, # 65, # 66, # 67) of 6 patient observations.

H. ensure the acid and bicarb pick-up wands fit securely on the acid and bicarb concentrate jugs in the dialysis treatment room.

I. follow its policy and procedure and ensured when staff called a code that all employees responded to a possible infant abduction. Also, the facility failed to ensure the infant alarm system was working properly, and that all infants including NICU (Neonatal Intensive Care Unit) infants were protected in 3 of 3 (Women services, Nursery, NICU) units.

Refer to Tag A0144

3.
A. have an acuity tool for the Intensive care units and 4 North patient care unit. Nursing failed to accurately staff up in numbers or down to the acuity of patients according to the minimal staffing matrix provided in 2 (CIVCU and surgical ICU) of 4 (CVICU, Surgical ICU, 4 North, and Emergency Room) units reviewed.

Refer to Tag A0392

B. ensure physician orders were obtained to change ventilator settings for 1 (patient # 22) out of 1 Neonatal Intensive Care Unit (NICU) patient.

Refer to Tag A0395

C. ensure Nursing Services documented verbal orders from physicians for moderate sedation medications in the Radiology Department in 4 (Patient #6, #41, #42, and #43) of 4 medical records reviewed. Also, the hospital failed to ensure physicians signed verbal orders for sedation medications according to the facility's Verbal Order Policy.

Refer to Tag A0409

4.

A. Maintain the condition of the dietary area to ensure the safety and well-being of patients and staff.

Refer to tag 701

B. Promptly dispose of, or properly store decommissioned office chairs, tables, hospital beds, rails, and miscellaneous metal

Refer to tag 713

C. Ensure the emergency generator started for testing

Refer to tag 724

D. Designate or determine who would monitor the "day-to-day" maintenance of the negative pressure rooms. Also, the facility staff failed to monitor and document the negative pressure room that showed 12 air exchanges each hour and verified an air filtration rate of at least 95% per policy, "Tuberculosis Control Plan". In addition, the facility staff failed to provide negative pressure room settings data to the Infection Control Committee to support that they were monitoring and maintaining negative pressure rooms.

Refer to tag 726

5.
ensure the infection prevention and control program maintained a clean and sanitary environment to avoid sources and transmission of infection in the following departments Hospital #1, Dietary, Labor and delivery, Post- Partum, Main Warehouse, Medical, surgical, cardiovascular ICU's, Central supply Cath Lab, Out Patient Cancer Treatment Area, Out Patient Oncology, Out patient Imaging. Hospital #2- Dietary, Medical Surgical Floor, Laboratory.

Refer to Tag A0750

6.

A. ensure the immediate use of steam sterilization for autoclaves #8 and #9 in the sub-sterile rooms were being used only for carefully selected clinical situations, such as a dropped instrument or no replacement instrument available. Also, the facility failed to complete and record the "Flash Sterilization Log" record per the facility policy.

It was determined that this deficient practice posed an Immediate Jeopardy to patient health and safety and placed all patients having a Surgical procedure in the facility at risk for the likelihood of harm, serious injury, and possibly subsequently death.

B. address the temperature and humidity in the twelve surgical operating rooms and the two surgical instrument room areas that were out of range for November 2023 through January 25, 2024.

C. ensure sterility of transesophageal echocardiography (TEE) scope, which is a scope that is used for echocardiography to assess the structure and function of the heart, and to ensure the HEPA filter was changed every six months in the GUS System (this system is a manual high-level disinfection for endoscopes).

Refer to Tag A0940

Based on document review and interview the hospital failed to:

A. ensure a properly executed informed consent was completed in 5 (Patient #41, #44, #46, #62, and #3) of 11 patient medical records reviewed. Also, the facility failed to follow the hospital's Informed Consent Policy and the Moderate Sedation Policy.

Refer to Tag A0131

B. ensure 3 (# 29, # 30, # 31) of 7 staff members working in high-risk areas (hemodialysis and surgery) were vaccinated and/or had positive immunity against the Hepatitis B virus.

C. identify 1 of 6 IV (intravenous) pumps in the dialysis treatment room with overdue preventative maintenance (PM).

D. verify dialysate conductivity and pH with an independent device before treatment initiation on 1 (#5) of 6 patient treatments observed. Also, the hospital staff failed to follow the facility policy, "Water Treatment and Monitoring" and "Hemodialysis: Plan of Care".

E. implement a schedule to ensure each hemodialysis machine was tested quarterly for bacterial growth and the presence of endotoxins. The hospital staff failed to test 7 (#3300/500, #3305/505, #3306/306, #3307/307, #3308/308, # 3309/309, #3310/310) of 11 dialysis machines one or more quarters of 2023.

F. ensure that 2 (# 76 and # 77) of 2 patients undergoing hemodialysis treatment with an unknown Hepatitis B status were treated in a location that prevented the transmission of Hepatitis B to other patients and staff members. Also, the hospital staff failed to follow the hospital policy, "Hepatitis B".

G. ensure the patient's dialysis access was visible throughout the patient's entire treatment in 4 (# 64, # 65, # 66, # 67) of 6 patient observations.

H. ensure the acid and bicarb pick-up wands fit securely on the acid and bicarb concentrate jugs in the dialysis treatment room.

I. follow its policy and procedure and ensured when staff called a code that all employees responded to a possible infant abduction. Also, the facility failed to ensure the infant alarm system was working properly, and that all infants including NICU (Neonatal Intensive Care Unit) infants were protected in 3 of 3 (Women services, Nursery, NICU) units.

Refer to Tag A0144

Based on document review and interview the facility failed to ensure a properly executed informed consent was completed in 5 (Patient #41, #44, #46, #62, and #3) of 11 patient medical records reviewed. Also, the facility failed to follow the hospital's Informed Consent Policy and the Moderate Sedation Policy.

A review of medical records was completed on 1/23-1/24/24 with RN Staff #75, RN Staff #80, RN Staff #81, and Staff #76.

Findings:

Patient #41
Patient #41 was a 57-year-old male scheduled for a Tunneled Hemodialysis Catheter (a catheter used for a patient to receive Dialysis) on 1/12/2024 by Physician #78. A review of the document titled, "Disclosure and Consent Medical Care and Surgical Procedures" revealed RN Staff #75 signed as a witness to the patient signature 4 minutes before the patient signed the informed consent.

RN Staff #75 and RN Staff #80 confirmed the witness's signature should be signed at the time of the patient's signature but never before the patient has signed.

Patient #44
Patient #44 was a 54-year-old female admitted to the ED on 1/15/2024 with Right Ankle Pain. A review of the Informed Consent titled, "Description of Medical Care and Surgical Procedure(s)" was as follows:

" ...I voluntarily request my physician/healthcare provider (Physician #83) and such other assistants, as he/she deems appropriate to treat my condition which is: Bone Fracture or Deformity.

Laterality: Right

Site Specific: (blank)

I understand that the following care/procedure(s) are planned for me: Closed Reduction of Fracture ..."

RN Staff #80 confirmed the informed consent did not identify the location of the fractured bone and/or deformity. Also, it did not identify the fracture and/or deformity for the closed reduction procedure.

A review of the Informed Consent titled, "Anesthesia and/or Perioperative Pain Management (Analgesia)" revealed the patient consented to Moderate Sedation on 1/15/2024. A review of the medical record confirmed the patient received 100mg of Ketamine (a dissociative anesthetic) IV (intravenous) and 50 mg of Propofol (a general anesthetic drug) IV for procedural sedation.

During an interview on 1/24/2024 after 11:00 AM with RN Staff #80 and Physician #89, it was confirmed the patient should have consented to Deep Sedation. Physician #80 stated, "Administering Propofol should always be considered as a deep sedation and all of our ED Physicians have documented training and privileges to administer Deep Sedation."

An interview was conducted with RN Staff #102 on 1/25/2024 at 11:00 AM. RN Staff #102 was asked what types of sedation were given in the ED. RN Staff #102 stated, "We only consent for Moderate Sedation in the ED." She was asked what medications were given for moderate sedation. RN Staff #102 confirmed Propofol, Ketamine, Versed (A sedative/hypnotic drug), and Fentanyl (an opioid drug used to treat severe pain) were given for moderate sedation in the ED. RN Staff #102 was asked if the physician remained with the patient until the patient returned to baseline from the deep sedation. RN Staff #102 stated, "No, they do not, the nurses monitor them."

Patient #46
Patient #46 was a 22-year-old male admitted to the ED on 1/12/2024 with a Left Ankle fracture.

A review of the Informed Consent titled, "Anesthesia and/or Perioperative Pain Management (Analgesia)" revealed the patient consented to Moderate Sedation on 1/12/2024. A review of the medical record confirmed the patient received 50 mg of Ketamine IV and 100 mg of Propofol IV for procedural sedation.

During an interview on 1/24/2024 after 11:00 AM with RN Staff #80 and Physician #89, it was confirmed the patient should have consented to Deep Sedation. Physician #80 stated, "Administering Propofol should always be considered as a deep sedation and all of our ED Physicians have documented training and privileges to administer Deep Sedation."

Patient #62
Patient #62 was a 68-year-old female admitted to the ED on 1/7/2024 with a left wrist dislocation. A review of the informed consent for a Closed Reduction of the Left Wrist (a procedure to reset the dislocated bone) revealed Physician #83 failed to date and time his signature on the procedure consent. Further review revealed Physician #83 failed to date and time his signature on the informed consent for Moderate Sedation.

Without a date and time of the physician's signature, this surveyor was unable to determine if the physician discussed the risks and benefits of the procedure before the patient signed the informed consent.
RN Staff #81 confirmed the physician was to date and time the informed consent.

A review of the hospital policy title, "Informed Consent for Invasive/Surgical Procedure" Number 7.003 with a Reviewed/Revised date of 9/23 was as follows:

" ...IV. PROCESS OR PROCEDURES
A. Informed Consent for Invasive Procedures
Responsibility

The law places the duty to obtain informed consent upon the physician/licensed practitioner and it is nondelegable. The physician or licensed practitioner ordering or performing the medical treatment, procedure, or administration of anesthesia has a duty to the patient to disclose the nature of treatment(s), procedure(s), or surgery(s) to be performed and/or administration of anesthesia including possible alternatives and risks of non-treatment. The informed consent process is not delegated ...

3. Documentation of the informed consent communication with the patient regarding benefits, risks, and hazards, of the procedure(s) including possible alternatives and risks of non-treatment will be documented by the physician/practitioner signing the appropriate section of the consent form.

4. The consent form must include:
a. The name(s) of the practitioner(s) performing the treatment or procedure
b. Patient identity;
c. Date when patient informed and date when patient signed the form, if different; ...

12. No elective surgery or procedure requiring shall be performed without a properly executed informed consent (sic). Non-valid incomplete consent forms shall be grounds for cancellation of the procedure or surgery.

VI. REGULATIONS/REQUIREMENTS
The Joint Commission ...
CMS CoP ...
Texas Admin Code ...
Remedies Code ...
Louisiana Admin Code ...
See Appendix ...

Risks and Hazards
1. Texas Admin Code ...
2. Louisiana Administrative Code ...
Adult and Surrogate Decision Maker ...
Tx ...
LA Louisiana State Legislature Revised Statute ...
NM New Mexico NMSA 1978 Relating to Healthcare ..."

An interview was conducted with RN Staff #81 on 1/25/2024 at 9:30 AM. She was asked if the informed consent policy was current. RN Staff #81 confirmed the policy was the current policy.

During an interview on 1/24/2024 after 10:00 AM Physician #89 confirmed the Informed Consent Policy was a systems policy that had not been adopted for the hospital through the local Quality Council or Governing Board and covered multiple states in the policy.

A review of the policy titled, "Moderate Sedation," Policy Number: 3.400 created 3/2017 with no review or revision date, and approved by the Chief Clinical Officer was as follows:

"..II. OBJECTIVE/S: To provide for safe effective administration of medication for the purpose of moderate sedation during interventional procedures ...

III. POLICY STATEMENT:
A. Sedation practices throughout an institution are to be monitored and approved by the department of Anesthesia ...

VIII. GENERAL RESPONSIBILITIES
A. Physicians: Physicians are granted the privilege to administer moderate sedation through the Medical Staff Office. The medication used to achieve moderate sedation is selected and ordered by the physician in conjunction with the procedure and is used to increase the patient's tolerance to the procedure. Medication used for Moderate Sedation is titrated to effect, not a predetermined dose. Although some rapid-acting anesthetic induction agents are administered by physicians for quick procedures they are not considered appropriate medications for an RN moderate sedation in which the physician will be involved in the procedure for a significant period of time.

B ...The following are position statements from each State Board of Nursing for a Registered Nurse.
a. Appendix A: Texas Board of Nursing
b. Appendix B: Louisiana State Board of Nursing
c. Appendix C: Arkansas State Board of Nursing
d. New Mexico State Board of Nursing ..."

During an interview on 1/24/2024 after 10:00 AM Physician #89 confirmed the Moderate Sedation Policy was a systems policy that had not been adopted by the hospital through the local Quality Council or Governing Board. It was also confirmed the policy referenced multiple states in the policy. Physician #89 was asked what medications the nurses were allowed to administer for moderate sedation. Physician #89 confirmed the current policy in use did not define which medications were to be used for moderate sedation.

An interview was conducted with RN Staff #2 on 1/24/2024 after 1:00 PM. RN Staff #2 confirmed the Moderate Sedation Policy referred to several different states and placed the staff and patients at risk for medication errors that could cause irreversible damage to a patient because some states are more restrictive, and some states are less restrictive on what medications a nurse may give for moderate sedation. RN Staff #2 was asked if the nurses were allowed to administer Propofol IV Push for moderate sedation. RN Staff #2 confirmed the nurses were not allowed to administer Propofol for moderate sedation.




48653



Patient # 3

A review of medical records was completed with Staff # 3 on 1/22/2024 at 11:00 AM. A review of patient # 3's medical records with Staff # 3 (Clinical Director) revealed the patient had a new diagnosis of advanced chronic kidney disease, requiring hemodialysis treatment. The patient's first hemodialysis treatment initiation occurred on January 19th, 2024. Upon further review of the patient's medical record, it was determined there was no informed consent provided to the patient prior to the initiation of hemodialysis treatment on January 19th, 2024. There was no hemodialysis consent present in the patient's medical record.

A review of the hospital's policy titled, "Informed Consent for Invasive/Surgical Procedure" with a revision date of 9/23 revealed the following,

"OBJECTIVE/S: To ensure patients are apprised of their rights and afforded the opportunity to make voluntary and informed decisions about medical care and treatment.

POLICY STATEMENT: A competent adult patient or a surrogate decision-maker acting on the patient's behalf has the right to receive from the patient's physician/practitioner information necessary to make informed choices and decisions regarding the patient's medical care and treatment. The primary purpose of the informed consent process is to ensure that the patient or his/her surrogate decision-maker is provided information in a manner that the patient and/or the patient's surrogate decision-maker to effectively exercise the right to make informed decisions.

PROCESS OR PROCEDURES:

A. Informed Consent for Invasive Procedures ...
The law places the duty to obtain informed consent upon the physician/licensed practitioner and it is nondelegable. The physician or licensed practitioner ordering or performing medical treatment, procedure, surgery, or administration of anesthesia has a duty to the patient to disclose the nature of treatment(s), procedure(s), or surgery(s) to be performed as well as the risks, hazards, and benefits of the treatment(s), procedure(s), surgery(s) and/or administration of anesthesia including possible alternatives and risks of non-treatment. The informed consent process is not delegated.

1. For all medical and surgical invasive procedures informed consent will be obtained."

In an interview with Staff # 3 on 01/22/2023 at 11:00 AM, Staff # 3 stated, "We were unable to locate a signed informed consent for hemodialysis for this patient. The RN who initiated dialysis treatment said she remembered printing it, but we are unable to locate it."

Based on observation, record review, and interview the:

A. "Associate Health Department" failed to ensure that 3 (# 29, # 30, # 31) of 7 staff members working in high-risk areas (hemodialysis and surgery) were vaccinated and/or had positive immunity against the Hepatitis B virus.

B. staff failed to identify 1 of 6 IV (intravenous) pumps in the dialysis treatment room with overdue preventative maintenance (PM).

C. staff failed to verify dialysate conductivity and pH with an independent device prior to treatment initiation on 1 (#5) of 6 patient treatments observed. Also, the hospital staff failed to follow the facility policy, "Water Treatment and Monitoring" and "Hemodialysis: Plan of Care".

D. staff failed to implement a schedule to ensure each hemodialysis machine was tested quarterly for bacterial growth and the presence of endotoxins. The hospital staff failed to test 7 (#3300/500, #3305/505, #3306/306, #3307/307, #3308/308, # 3309/309, #3310/310) of 11 dialysis machines one or more quarters of 2023.

E. staff failed to ensure that 2 (# 76 and # 77) of 2 patients undergoing hemodialysis treatment with an unknown Hepatitis B status were treated in a location that prevented the transmission of Hepatitis B to other patients and staff members. Also, the hospital staff failed to follow facility policy, "Hepatitis B".

F. staff failed to ensure the patient's dialysis access was visible throughout the patient's entire treatment in 4 (# 64, # 65, # 66, # 67) of 6 patient observations.

G. staff failed to ensure the acid and bicarb pick-up wands fit securely on the acid and bicarb concentrate jugs in the dialysis treatment room.




A. This deficient practice had the likelihood to result in harm to staff members working in high-risk areas in the hospital due to failure to monitor hepatitis B immunity and vaccination status. The unknown immunity status of staff members could result in the transmission of the hepatitis B virus between patients and staff members.

Staff # 29

A review of Staff # 29's personnel file revealed Staff # 29 had a nonreactive HBV surface Antibody result on 08/22/22. Staff # 29 received dose # 1 of the vaccine series on 01/05/2023 at Associate Health. Staff # 29 did not receive dose # 2 or # 3 of the series. There was no evidence of a complete vaccine series or positive immunity for Staff # 29. Staff # 29 did not sign a Declination Form verifying refusal of vaccine and understanding of occupational risk and exposure to the hepatitis B virus.

Staff # 30

A review of Staff # 30's personnel file revealed Staff # 30 received a complete Hepatitis B vaccine series in 1999. There was no evidence of positive immunity for Staff # 30.

Staff # 31

A review of Staff # 31's personnel file revealed Staff # 31 declined the Hepatitis B vaccine on 3/15/2016. There was no evidence of a complete vaccine series or positive immunity for Staff # 31. Staff # 31 did not sign a Declination Form verifying refusal of vaccine and understanding of occupational risk and exposure to the hepatitis B virus.



A review of the facility policy titled, "Vaccine Preventable Diseases and Immunization Policy" with a revision date of 05/08/2023 revealed the following,

"PURPOSE: The purpose of this policy is to protect the health and safety of patients, associates, patient and associate family members, and the community as a whole from vaccine-preventable diseases and to comply with state and federal laws and regulations.

POLICY STATEMENT: Christus requires, in accordance with the State Safety Code (where applicable) and Centers for Disease Control (CDC), that Covered Individuals working in a CHRISTUS Entity receive vaccines or provide serologic proof of immunity for the following vaccine-preventable diseases based on the level of risk the individual presents to patients by the individuals routine direct or indirect exposure to patients:
Diphtheria, Pertussis, Hepatitis B, Tetanus, Influenza, Rubella, Measles, Varicella, Mumps, Meningococcal.
Other preventable disease immunizations may be required should circumstances, public health or infection control conditions warrant.

PROCESS OR PROCEDURES:
1. Christus will adhere to CDC document and the Immunization Action Coalition Health-Care Personnel Vaccination Recommendations; see attachment A ...

RESPONSIBILITIES:
A. Associate Health Department
1. Associate Health will maintain a record of immune status for Covered Individuals as received. Physicians and other LIP, vendors, students, and Allied Health Professionals are responsible for providing approved documentation of immunity to their sponsoring CHRISTUS department or their sponsoring agency where it will be maintained. Associate Health will maintain proof of vaccination as received.
2. CHRISTUS will evaluate whether a Covered Individual has complied with this policy.
3 ... Covered Individuals and their supervisors will be notified of immunization compliance, failure to meet the requirements may result in the withdrawal of a contingent offer letter or disciplinary actions."
A review of Attachment A titled "Healthcare Personnel Vaccination Recommendations" referenced in the facility policy, "Vaccine Preventable Disease and Immunization Policy" states the following,
"Hepatitis B:
Unvaccinated healthcare personnel (HCP) and/or those who cannot document previous vaccination should receive either a 2-dose series of Heplisav-B at 0 and 1 month or a 3-dose series of either Energix-B or Recombivax HB at 0, 1, and 6 months. HCP who perform tasks that may involve exposure to blood or body fluids should be tested for hepatitis B surface antibody 1-2 months after dose # 2 of Heplisav-B or dose # 3 of Energix-B or Recombivax HB to document immunity.
If antibody is at least 10 mIU/ml (positive), the vaccinee is immune. No further serologic testing or vaccination is recommended.
If antibody is less than 10 mIU/ml (negative), the vaccinee is not protected from hepatitis B virus infection and should receive another 2-dose or 3-dose series of Hep B vaccine on the routine schedule followed by anti-body testing 1-2 months later ...
For HCP with documentation of a complete 2-dose or 3-dose vaccine series but no documentation of anti-body of at least 10 mIU/ml: HCP who are at risk of occupational blood or body fluid exposure might undergo antibody testing upon hire or matriculation."

An interview with Staff # 103 (Associate Health RN) on 01/24/2024 at 9:30 AM confirmed the immunity status against the hepatitis B virus was unknown in staff members working in high-risk and high-exposure areas in the hospital. Staff # 103 also verified the non-compliance with Attachment A which is referenced in the facility policy "Vaccine Preventable Diseases and Immunization Policy".




B. During a tour of the dialysis treatment room with Staff # 3 on 1/23/24 at 8:32 AM, the surveyor observed 1 of 6 IV pumps with an overdue PM. The IV pump was labeled with a PM due date of "07/2023".

An interview with Staff # 3 confirmed the IV pump was overdue for preventative maintenance. Staff # 3 removed the IV pump from service until the PM could be completed by the appropriate staff.




C. This deficient practice had the likelihood to result in harm to all patients undergoing dialysis treatment at the facility by introducing improper water and dialysate concentrations to the patients.

During a tour of the dialysis treatment room on the 5th floor with Staff # 3 (Clinical Director) on 1/22/24 at 1:05 PM, the surveyor observed Staff # 31 and # 54 preparing the dialysis machine in Bay 2 for patient # 5's dialysis treatment. Staff # 54 was responsible for running the machine tests and verification checks. Staff # 31 did not verify that conductivity had been completed by Staff # 54 prior to initiating treatment on Patient # 5. Neither Staff # 31 nor # 54 completed an independent conductivity check prior to treatment initiation.
Also, the RO (reverse osmosis) and bleach water located at the tri-station were not labeled with the date they were made.

A review of the facility policy titled, "Water Treatment and Monitoring" with a revision date of 07/17 revealed the following,

"PURPOSE: Water used to prepare dialysis fluid for acute hemodialysis should meet the quality requirements set forth by AAMI. Monitoring to demonstrate ongoing compliance with the chemical quality requirements and microbiological quality requirements will be performed as per AAMI guidelines.

POLICY: Prior to initiation of dialysis, dialysate pH and conductivity will be verified with an independent meter. The dialysate sample will be taken from the machine's sample port after the machine is in dialysis mode and the conductivity is in working range. If the pH is below 6.9 or above 8, dialysis should not be started, Biomed and unit manager will be notified."

A review of the facility policy titled, "Hemodialysis: Plan of Care" with a revision date of 01/2018 revealed the following,

"OBJECTIVE: For any critical event to be recognized immediately and have appropriate measures implemented.

POLICY: The team member will provide an environment conducive to safety and security for patients, families, visitors, and team members ...

OBJECTIVE II:
1. Patency and integrity of dialyzer membrane and tubing. Accuracy of dialysate components and testing of its physiologic compatibility with blood.
a. Dialysate is checked with a phoenix meter for pH and conductivity verification prior to initiation of therapy."

In an interview with Staff # 31 and # 54 on 01/22/2024 at 1:15 PM, Staff # 31 and # 54 confirmed they had not conducted an independent conductivity check prior to the initiation of hemodialysis treatment on Patient # 5 as required by the hospital's policy. Staff # 3 was present for the interview.


D. This deficient practice had the likelihood of harming all patients receiving hemodialysis treatment at the hospital due to the improper testing of the hemodialysis machines. An improper testing schedule could result in failure to identify a positive culture and/or endotoxin result thus placing the patient at risk of bacterial and/or endotoxin transmission.

A review of the "Hemodialysis Infection Report" for 2023 revealed the following:

Machine # 3300/500

Machine # 3300/500 underwent culture and endotoxin testing on April 10, 2023, July 24, 2023, and November 13, 2023.
There was no documentation of culture and/or endotoxin testing for machine # 3300/500 for the first quarter of 2023.

Machine # 3305/505

Machine # 3305/505 underwent culture and endotoxin testing on January 27, 2023, February 7, 2023, May 2, 2023, and September 5, 2023.
There was no documentation of culture and/or endotoxin testing for machine # 3305/505 for the fourth quarter of 2023.


Machine # 3306/506

Machine # 3306/506 underwent culture and endotoxin testing on February 7, 2023, June 6, 2023, and September 5, 2023.
There was no documentation of culture and/or endotoxin testing for machine # 3306/506 for the fourth quarter of 2023.


Machine # 3307/507

Machine # 3307/507 underwent culture and endotoxin testing on February 7, 2023, June 6, 2023, and October 3, 2023.
There was no documentation of culture and/or endotoxin testing for machine # 3307/507 for the third quarter of 2023.

Machine # 3308/508

Machine # 3308/508 underwent culture and endotoxin testing on March 7, 2023, June 6, 2023, and October 3, 2023.
There was no documentation of culture and/or endotoxin testing for machine # 3308/508 for the third quarter of 2023.

Machine # 3309/509

Machine # 3309/509 underwent culture and endotoxin testing on March 7, 2023, July 11, 2023, and October 3, 2023.
There was no documentation of culture and/or endotoxin testing for machine # 3309/509 for the second quarter of 2023.

Machine # 3310/510

Machine # 3310/510 underwent culture and endotoxin testing on March 7, 2023, July 11, 2023, and November 7, 2023.
There was no documentation of culture and/or endotoxin testing for machine # 3310/510 for the second quarter of 2023.


A review of the facility policy titled, "Monthly Cultures, Endotoxin Assay of Dialysis Machines and Dialysis Water" with a revision date of 07/14/2017 revealed the following,

"OBJECTIVE: To assure quality water during each hemodialysis treatment by monitoring cultures of dialysate and endotoxin levels from dialysis machines and dialysis water.
POLICY: Cultures and endotoxin testing on dialysate will be done each month on a rotating schedule so at least 1/3 machines and 3 dialysis stations are cultured monthly. The Aquaboss R/O system in the dialysis unit on the 5th floor and all portable reverse osmosis equipment will be cultured and endotoxin testing done monthly."

An interview with Staff # 3 and # 33 on 01/23/2024 at 12:30 PM confirmed the schedule for endotoxin and bacterial growth testing of the dialysis machines was not adequate for ensuring all dialysis machines were tested quarterly for the presence of endotoxins and bacteria.




E. This deficient practice had the likelihood to result in the transmission of Hepatitis B between patients and staff members due to the treatment location and staffing assignments which were determined before the patient's hepatitis status was known.

A review of medical records for patient # 76 and patient # 77 revealed the facility staff were not treating unknown Hepatitis B status patients as if they were positive when determining treatment location and staffing assignments.

A review of medical records for Patient # 76 revealed the following,

Patient # 76 was admitted to the hospital on 01/20/2024 with an unknown Hepatitis B status. The patient required hemodialysis treatment on 01/20/2024 at 10:20 AM and was placed in Bay 2 (Bay 2 is located at the beginning of the loop and close to the main doors in and out of the dialysis treatment room). The patient's Hepatitis B surface antigen was sent to the laboratory on 01/20/2024 at 10:22 AM and resulted as non-reactive at 11:58 AM. Patient # 76 was not treated in a location that was located outside of normal traffic patterns in the dialysis treatment room.

A review of medical records for Patient # 77 revealed the following,

Patient # 77 was admitted to the hospital on 01/04/2024 with an unknown Hepatitis B status. The patient required hemodialysis treatment on 01/05/2024 at 5:45 PM and was placed in Bay 3 (Bay 3 is in the middle of the loop and the center of the hemodialysis treatment room, just across from the nurses' station). The patient's Hepatitis B surface antigen was sent to the laboratory on 01/05/2024 at 5:34 PM and resulted as non-reactive at 7:37 PM. Patient # 77 was not treated in a location that was located outside of normal traffic patterns in the dialysis treatment room.

A review of the facility policy titled, "Hepatitis B" with a review date of 04/14/2021 revealed the following,

"OBJECTIVE: To minimize the spread of hepatitis infections in the dialysis setting.
POLICY: Hepatitis B Testing:

1. In order to prevent transmission of Hepatitis B among dialysis patients, all new patients will be tested and their HBV serologic status (Hepatitis B surface antigen, Hepatitis B surface antibody, and total Hepatitis B core antibody) results will be obtained prior to completion of first hemodialysis treatment unless otherwise required by applicable state law.

2. If the Hepatitis B surface antigen status is unknown, the Nephrologist and Medical Director will be notified, and the patient treated as a suspect patient for Hepatitis B infection."
In an interview with Staff # 33 (Lead Dialysis Nurse) on 01/24/2024 at 09:00 AM, Staff # 33 stated, "Each nurse picks their assignments, and we try to be flexible with one another when determining who gets which patients." The surveyor asked Staff # 33 if the nurses had taken into consideration the hepatitis B status of the patient when determining the assignments. Staff # 33 stated, "No, we don't consider the hepatitis status of the patient in staffing assignments unless they are hepatitis B positive. If they are unknown, we do not make assignments as if the unknown status patient is positive."

An interview with Staff # 3 (Clinical Director) on 01/24/2024 at 09:05 AM confirmed the facility staff were not treating hepatitis B unknown status patients as if they were positive when determining the patient's treatment location and staffing assignments.




F. This deficient practice had the likelihood of resulting in harm to all dialysis patients receiving hemodialysis at the hospital due to the increased risk of bleeding dialysis patients have during treatment. Ensuring visibility of the patient's dialysis access is imperative in the early recognition of bleeding in dialysis patients.

During a tour of the facility's dialysis treatment room on the 5th floor with Staff # 3, the surveyor observed 4 out of 6 dialysis patient's accesses covered and not visible from the nurse's station.

A review of facility policy titled, "Hemodialysis Plan of Care" with a revision date of 01/2018 revealed,
"OBJECTIVE: For any critical event to be recognized immediately and have appropriate measures implemented.
POLICY:
The team member will provide an environment conducive to safety and security for patients, families, visitors, and team members ....
PROCESS/PROCEDURE:
II. The patient and the equipment are monitored throughout the dialysis to prevent complications ..."

An interview with Staff # 3 on 01/22/24 at 11:30 AM confirmed Staff # 3 recognized that 4 out of 6 patients had accesses that were covered and not visible from the nurse's station. Staff # 3 uncovered the patient's dialysis access upon recognizing the issue.



G. During a tour of the facility's dialysis treatment room on the 5th floor with Staff # 3, the surveyor observed the acid and bicarb pick-up wands at bay 1, 2, 3, 4, 5, and 6 hanging out of the acid and bicarb concentrate jugs during the patient's treatment. The wands did not fit securely onto the acid and bicarb concentrate jugs. There was a gap between the top of the jug and the wands which could allow other fluid and debris to enter the acid and bicarb concentrate jugs during the patient's treatment.

During an interview with Staff # 3 on 01/22/2024 at 11:45 AM, Staff # 3 stated "I was unaware there were wands that could fit securely into the concentrate jugs. I will reach out to our vendor to get them ordered."



32143


H. the facility failed to follow its policy and procedure and ensure when the staff called a code that all employees responded to a possible infant abduction. Also, the facility failed to ensure the infant alarm system was working properly, and that all infants including NICU (Neonatal Intensive Care Unit) infants were protected in 3 of 3 (Women services, Nursery, NICU) units.

Findings:

A nursery and neonatal intensive care unit tour was conducted on 1-22-24 with staff # 2 RN, 104 RN, and 56 RN in the afternoon. A HUGS electronic alarm system was identified as the nursery's infant alarm system used in the facility.
According to https://safesis.pt/wp/wp-content/uploads/2016/10/hugs.pdf, the HUGS system pamphlet stated, "Our Hugs Infant Protection solution offers the most advanced and secure protection from a single department to the entire hospital. Every infant wears a Hugs tag that is attached to the ankle with a special tamper-detecting band. The tag activates as soon as attached and is automatically enrolled in the system. From that moment on, the infant is safeguarded throughout your campus."

An interview with staff #104 was conducted on 1-22-24. Staff # 104 confirmed the NICU babies were not protected with a HUGS tag due to the NICU being a locked unit. The nurse must open the door to allow visitors in and let them out. However, the unit allows housekeeping, maintenance, respiratory, laboratory, radiology, dietary, and visitors onto the unit. The same nurse does not always let the visitors in and out and would not be aware of what they came in with (such as a bag) or left out with. There was no monitor technician in the NICU and twice the surveyor observed no one watching the baby monitors.

During a tour of the nursery, an interview with staff #106 (RN -Nursery) stated, that an upgrade for the HUGS unit had been purchased and they were waiting for an upgrade. The surveyor had the nursery RN activate a HUGS tag which was given to the surveyor. The surveyor walked with the activated HUG tag to the outside doors of the women's care unit, next to the elevators at 1:30 PM. An alarm sounded within the unit but there was no code called overhead. The surveyor waited for two minutes, and a nurse called from the women's care unit to the operator and asked them to call a code overhead. The doors to the unit never closed. There were no security guards that responded to the unit. An abductor would have had 2 minutes to leave the hospital before anyone knew within the hospital that a baby had been abducted.

A review of the policy and procedure, "Response to Nursery Alarm Code Two-Two" Policy#: SEC-PP-41 stated, "General Information:
The LDRP/Nursery Department is equipped with a Sekurmed Alarm System that when activated will secure the entrance/exit doors and set off an audible alarm. The alarm system is an electronic device with sensors on the exit doors that will activate the alarm if an infant wearing the coded Sekurmed bracelet is taken near a sensor. There are two centralized monitoring panels for the system, with one located at the nursing station and the other in the resource center communications center. Keypad Reset/Bypass Panels are located at the entrance and exit to each magnetically locked door and only authorized personnel have the access code to these doors. CCTV cameras are located throughout the facility and are monitored internally. Each camera is connected to the CCTV Monitor/Recorders and automatically locks the nursery when the alarm is activated.

PROCEDURE:
I. When the alarm is activated, it alerts the Nursing Staff and PBX.
2. The Nursing Staff immediately accounts for all infants in the unit.
3. The PBX Operator notifies the on-duty Security Officers via the overhead paging system and radio of the alarm and location, zone #
4. Security Two will immediately respond to the LDRP/Nursery Unit -
5. Contact will be made with the unit Charge Nurse by Security Two, who will
investigate the cause of the alarm.
6. In the event of an actual or attempted infant abduction the Security Supervisor or senior officer at the scene will request the PBX Operators to contact the Texarkana, Texas Police Department for assistance. Security officers will take action to secure and search the area both inside and outside CHRISTUS St. Michael. Special care will be taken by security officers to obtain a full description of any suspect(s) in the areas. If the suspected abductor is located, security officers will attempt to detain the suspect taking special care not to cause harm to the infant or create a hostage or shooting situation. Upon arrival of the Texarkana, Texas police, full charge of the situation and investigation will be turned over to them, with full assistance of all security officers.
7. Security Six will report to the first level north tower stairway (located by the playground) and will take a position that will enable him/her to observe the north parking lot and any person exiting the north stairway.
8. Security Seven and Eight will patrol all CSM parking areas.
9. All alarms reported from this unit whether actual or false will be investigated and the finding recorded in the officer's daily activity report.
I 0. Security Two will be responsible for reviewing CCTV security footage."

An interview was conducted with staff # 2 and #104 on 1-22-24 at 1:40 PM. Staff #2 and #104 confirmed that the PBX operator did not call a code overhead and the unit doors to the women's care unit and nursery did not close and lock when the alarm went off. Staff # 104 stated that the RN from the unit should have called the operator to have the code called overhead. Staff # 104 stated the new version of the alarm system should be upgraded soon.

An interview with staff # 108 (bio-med) on 1-22-24 concerning the upgrade for the HUGS system. Staff #108 stated that there was a purchase for an upgrade on the system. Staff #108 provided a purchase order dated 11-11-22, 2 years ago. Staff #108 stated that they have been meeting about the issue and would have to perform some tasks before the upgrade could happen. Staff #108 was asked if there was a team project, a performance improvement project, or any type of meeting minutes to show why there was such a delay. Staff #108 stated they had not been keeping any minutes. Staff # 108 stated that he had an email from 1-11-24 from staff # 118 Project Manager, Clinical Strategies Information Services. The email stated,

"Below are the scheduled times for the site walk. Cassandra Langley with Techsystems will meet you at the Lobby to conduct the walk for your area of responsibility.

9:00am to 11:00am - walk with Facilities, Electrician and Local IT - Identify IDF Closets where our PSs will be hung and work with Electrician** for hard-wiring PS's. Local IT - are there enough ports on switch, are there dedicated network ports available for Hugs PCs, locate Hugs Equipment so TSI may retrieve MAC Addresses for IP Addresses for Hugs Devices

12:00pm - 1:00pm - Walk doors with AC Vendor/Facilities/Security and Jason to discuss cutting data on 1/E AC Readers, Identify doors w/o AC, determine who is supplying power to these maglocks. -

1:00pm to 2:00pm- Walk elevators with Vendor and Facilities/Security/ Nurse Mgmt to determine need for quote to be able to lock-down elevators during an Infant Exit or Band Tamper Hugs Alerts." Staff # 108 was not able to provide any other information.

An interview was conducted with staff # 113 operator and staff # 114 operator on 1/24/22 at 9:30 A.M. Staff # 114 stated that the facility has an alarm system for the HUGS and pointed to a screen above where they sat. Staff # 113 stated that she could hear and see when the alarms went off, but they were instructed to wait until they received a call from the women's unit to call the code overhead. Staff #113 stated the alarms can go off often but it's never an issue. Staff #113 and 114 stated that they should call the code overhead within one minute or sooner.

Based on document review and interview the Medical Staff failed to ensure 1 (Physician #79) of 2 Interventional radiologists had training and were granted moderate sedation privileges in the Radiology Department before ordering moderate sedation in 2 (Patient #43 and Patient #61) of 4 medical records reviewed.

Findings:

Patient #43

Patient #43 was scheduled for a Percutaneous Transhepatic Biliary drainage/cholangiogram procedure in Radiology under moderate sedation by Physician #79 on 1/18/2024.

A review of the medication orders revealed Physician #79 ordered Versed (a sedative drug) Intra-op PRN (as needed) and Fentanyl (an opioid drug used for severe pain) 12.5 mcg (micrograms) Intra-op PRN.

Further review of the medical record revealed RN Staff #75 administered Versed .5mg IV at 1:13 PM and Fentanyl 12.5mcg IV was administered at 1:40 PM.


Patient # 61

Patient #61 was scheduled for a procedure in the Interventional Radiology Department on 12/15/2023 by Physician #79.

A review of the medication orders revealed Physician #79 ordered Fentanyl Intra-op PRN.

Further review revealed RN Staff #75 administered Fentanyl 25 mcg at 3:57 PM, Fentanyl 25 mcg at 4:07 PM, and Fentanyl 25 mcg at 4:11 PM for procedural sedation.


RN Staff #75 and Staff #76 confirmed Physician #79 ordered moderate sedation for Patient #61 on 12/15/2023.


A review of the credential file for Physician #79 was completed on 1/25/2024 at 9:47 AM.

An interview was conducted with RN Staff #75 on 1/25/2024 after 9:30 AM. RN Staff #75 was asked if all the physicians were granted privileges to perform moderate sedation for their procedures. RN Staff #75 stated, "If they are doing interventional radiology, they should have been granted privileges." She was then asked if she was aware that Physician #79 had not been granted privileges to order or administer moderate sedation. RN Staff #75 confirmed she did not and stated, "She very rarely gives sedation for any of her cases, and when she does it's just a very small amount."

During an interview on 1/25/2024 after 9:30 AM with Physician #89 it was confirmed there were no requested or approved privileges or certificate of training for moderate sedation in the credential file for Physician #79.

Based on review and interview nursing failed to:

A. have an acuity tool for the Intensive care units and 4 North patient care unit. Nursing failed to accurately staff up in numbers or down to the acuity of patients according to the minimal staffing matrix provided in 2 (CIVCU and surgical ICU) of 4 (CVICU, Surgical ICU, 4 North, and Emergency Room) units reviewed.

Refer to Tag A0392

B. ensure physician orders were obtained to change ventilator settings for 1 (patient # 22) out of 1 Neonatal Intensive Care Unit (NICU) patient.

Refer to Tag A0395


C. ensure Nursing Services documented verbal orders from physicians for moderate sedation medications in the Radiology Department in 4 (Patient #6, #41, #42, and #43) of 4 medical records reviewed. Also, the hospital failed to ensure physicians signed verbal orders for sedation medications according to the facility's Verbal Order Policy.

Refer to Tag A0409

Based on review and interview nursing failed to have an acuity tool for the Intensive care units and 4 North patient care unit. Nursing failed to accurately staff up in numbers or down to the acuity of patients according to the minimal staffing matrix provided in 2 (CIVCU and surgical ICU) of 4 (CVICU, Surgical ICU, 4 North, and Emergency Room) units reviewed.

On 1-25-24 at 9:45 AM staff #2 RN, # 82 RN, and #94 RN reviewed the staffing schedules for the month of January and provided the minimal staffing grid required to staff the nursing units of the Intensive Care Unit (ICU), 4 North, and the Emergency Room.

A review of the ICU staffing revealed that in the first 2 weeks of January 2024, the ICUs were short 1 nurse on the day shift. Staff # 94 stated that the unit did not have Cardiovascular Intensive Care Unit (CVICU) patients and was being filled with patients on telemetry or patients who did not require that much care. Staff #94 stated that due to the patient acuity level being lower he did not need that many nurses per shift. However, nursing did not have acuity levels approved to lower the minimum grid staffing level. Staff #94 stated he did not understand that until now and would be working with the nurse staffing committee to develop the acuity levels to staff up or down from the grid when needed.

Based on review and interview nursing failed to ensure physician orders were obtained to change ventilator settings for 1 (patient # 22) out of 1 Neonatal Intensive Care Unit (NICU) patient.

A review of Baby B's chart revealed she was born on 12-11-23 at 26 weeks and 2 days gestation. The patient chart revealed a physician order for a respiratory ventilator ordered on 12/11/23 at 8:33 PM.

A review of baby B's physician's order on 12/11/23 at 8:33 PM revealed an order to intubate the baby and settings for the ventilator as follows;
Titrate to keep SPO2 @ greater than 88%
Inspiratory pressure- 18
I time percentage- 0.35
Peep-6
Rate- 40
Pressure support-6

A review of the ventilator flowsheet revealed on 12/12/23 at 6:00 AM the Peep was decreased from 6 to 5. There was no physician order to change the setting and no protocol to follow for setting changes.

9:25 AM the rate was decreased to 25 and the Inspiratory pressure decreased from 18 to 16. There was no physician order to change the setting and no protocol to follow for setting changes.

4:35 PM- the rate had changed from 25 to 20. There was no physician order to change the setting and no protocol to follow for setting changes.

12/13/23 at 7:34 AM the rate changed from 20-15. There was no physician order to change the setting and no protocol to follow for setting changes.

An interview was conducted with staff # 104 RN and staff # 110 Respiratory Therapy (RT) Director on 1-22-24. Staff # 104 confirmed that the NICU physicians were changing the settings on the ventilators and not writing the orders for the changes. Staff #104 stated that the physicians were asked to put the orders in but didn't. The nurses would put in verbal orders, but the physicians asked the nurses not to because they wanted to write their own orders. The nurses of the unit were frustrated because the orders were not written, and the physicians would not write the orders for the changes. Staff #104 stated that this had been going on for several months but was not sure how long. There was no evidence that this issue had been directed up to the CMO to address with the NICU physicians nor was there any variance reporting. Staff #110 stated that there were no protocols to follow and that the physicians were changing the settings without putting in orders.

Based on observation, policy review, and interview, the facility failed to follow its policy Telemetry Monitoring dated 03/23/2022 as observed in the Neonatal Intensive Care Unit (NICU). The facility failed to ensure all patients on telemetry were being monitored at all times.

Findings include:

During an observation tour conducted on 01/22/2024 at 3:45 PM of the NICU, there was not a telemetry technician observed at the nurse's station, monitoring the patients' telemetry readings.

A review of the facility's policy Telemetry Monitoring dated 03/23/2022 stated,

"POLICY:
All patients require a physician order to be placed on telemetry. There will be a trained RN, LVN, or monitor technician (MT) assigned to continually visualize the telemetry monitors. All patients receiving specialty drips will be on telemetry (See IV Drug Administration-Vasoactive and Anti arrhythmia Policy). PCU or 6 South may, in extreme cases, accept patients who require closer monitoring for hemodynamic instability providing that the staff is sufficient in number and has the educational preparation and experience to care for such patients. Such a decision will be made by the Director/Clinical Director/RN Lead/House Supervisor in collaboration with the Team Leader. If the patient requires further interventional treatment beyond the scope of the unit providing basic telemetry monitoring, the patient will be transferred to the ICU. The need to continue telemetry will be evaluated daily. A physician order is required to transfer a patient to a non-telemetry bed.

A review of the facility's Monitor Technician Job Description dated 02/25/2013 stated,

"POSITION SUMMARY
The Monitor Tech maintains efficient operation of the nursing unit by assessing and maintaining supplies, promoting effective communication, both external and internal, accurate transcription, and transmission of physician orders through order management system. Also responsible for the activities of cardiac monitoring.

MAJOR RESPONSIBILITIES
1. Maintains consistency with Administrative and Departmental policies with appropriate
behavior, dress, attitude, attendance, confidentiality, professionalism, and reliability.

2. Respect the patient's right to privacy by protecting confidential information unless
obligated to or allowed by law to disclose the information.
* Follows policies and procedures for "No Information" patients.
* Awareness of conversations held at nursing stations.
* No participation in conversations outside the patient care environment.

3. Contribute to the fulfillment of departmental and organizational goals.
* Participates in voluntary departmental/organizational activities.
* Supports cost containment activities by the efficient use of equipment and supplies.
* Actively participates in department meetings.

4. Supports patient care activities.
* Greets visitors promptly and courteously.
* Answers call lights promptly and notifies the appropriate caregiver.
* Directs phone calls for patients promptly and courteously
* Delivers patient specimens to the lab within 30 minutes of collection.

5. Accepts responsibility for the performance of clerical duties as assigned or needed in order to deliver quality service.
* Orders, maintains, and accounts for all unit supplies to promote efficient delivery of patient
care.
* Transcribes physician orders and utilizes order management system effectively as it relates
to nursing and places for nurses to check when signing off orders.
* Maintains organized, up-to-date medical records with an adequate number of stamped
physician order sheets, progress notes, and other records in patient charts.
* Retrieves appropriate patient care forms from HBO as requested by nursing staff.
* Runs daily lab reports and places lab/x-ray reports for RNs to review. Immediately notifies RN when lab results are out of range.
* Prepares new charts and scans charts for completeness
* Discharges patients out of HBO system in a timely manner for room availability.
* Assists in controlling noise level at nurse's station and keeps desk area clean and neat."


An interview was conducted on 01/23/2024 at 9:00 AM with Staff #93. This surveyor questioned Staff #93 about why there was not a Telemetry Technician watching the cardiac monitors. Staff #93 reported that the "NICU does not use Telemetry Technicians. The nurses are responsible for watching their patient's cardiac monitors." When questioned about the patient-to-staff ratio, Staff#93 reported "The NICU staff with two patients to one nurse". Staff #93 was asked how the nurses watch the monitors continuously for each patient if that nurse may be dealing with an emergency or not available at the nurse's station. Staff #93 stated "All of the nurses help each other and watch the monitors. The nurses can pull up the telemetry on their computer screen". The nursing staff were unable to provide a process to ensure another nurse was available to monitor other NICU infants if an RN was occupied with another baby in crisis. The RN would not be able to effectively monitor any other patients during that time.

Based on document review and interview Nursing Services failed to document verbal orders from physicians for moderate sedation medications in the Radiology Department in 4 (Patient #6, #41, #42, and #43) of 4 medical records reviewed. Also, the hospital failed to ensure physicians signed verbal orders for sedation medications according to the facility's Verbal Order Policy.

Findings:

Patient #6
Patient #6 is a 77-year-old male scheduled for a Tunneled Hemodialysis Catheter Placement under moderate sedation on 1/22/2024 by Physician #123 in the Radiology department.

A review of the medical record revealed medication orders that read:

"Versed (a sedative medication) Intravenous (IV) Intra-op PRN (as needed)" on 1/22/2024 at 10:40 AM. RN Staff #75 documented the administration of Versed .5 mg (milligrams) IV at 10:40 AM and "Fentanyl (an opioid used for pain control) Intravenous (IV) Intra-op PRN (as needed)" on 1/22/2024 at 10:40 AM. RN Staff #75 documented the administration of Fentanyl 25 mcg (micrograms) IV at 10:40 AM.


Patient #41
Patient #41 was a 58-year-old male scheduled for a Tunneled Hemodialysis Catheter Placement under moderate sedation on 1/12/2024 by Physician #78 in the Radiology department.

A review of the medical record revealed medication orders that read:

"Versed IV Intra-op PRN" on 1/12/2024 at 8:39 AM. RN Staff #75 documented the administration of Versed .5 mg IV at 8:39 AM and "Fentanyl IV Intra-op PRN" on 1/12/2024 at 8:39 AM. RN Staff #75 documented the administration of Fentanyl 25 mcg IV at 8:39 AM.


Patient #42
Patient #42 was a 55-year-old male scheduled for a Tunneled Hemodialysis Catheter Placement under moderate sedation on 1/08/2024 by Physician #78 in the Radiology department.

A review of the medical record revealed medication orders that read:

"Versed IV Intra-op PRN" on 1/08/2024 at 9:20 AM. RN Staff #75 documented the administration of Versed .5 mg IV at 9:20 AM and "Fentanyl IV Intra-op PRN" on 1/08/2024 at 9:20 AM. RN Staff #75 documented the administration of Fentanyl 25 mcg IV at 9:20 AM.


Patient #43
Patient #43 was an 88-year-old female scheduled for a Percutaneous Transhepatic Biliary drainage/cholangiogram procedure in Radiology under moderate sedation by Physician #79 on 1/18/2024.

A review of the medical record revealed medication orders that read:

"Versed IV Intra-op PRN" on 1/18/2024 at 1:17 PM. RN Staff #75 documented the administration of Versed .5 mg IV at 1:13 PM. This was 4 minutes before the medication was ordered. The next medication order read, "Fentanyl IV Intra-op PRN" on 1/18/2024 at 1:40 PM. RN Staff #75 documented the administration of Fentanyl 12.5 mcg IV at 1:40 PM.

RN Staff #75 was asked If she administered the Versed before the order was given. RN Staff #75 stated, "No, I did not. This is how the computer puts it in there. There is no verbal order written so when I document the medication it puts an order there by the physician. If the administration time is different than the documentation time, then the order is documented at the same time as my documentation and not at the actual administration time."



An interview was conducted with RN Staff #75 and Staff #76 on 1/24/2024. RN Staff #75 was asked if the physician writes the orders for the sedation medications before the procedure starts. RN Staff #75 stated, "No he does not. He will tell me what medications and how much to give during the procedure. Then I document the time and dosage of the medication administration in the medical record." RN Staff #75 was asked if she wrote verbal orders for the medications she was administering and she confirmed she did not write verbal orders for the sedation medications. Still, once she put them in the EMR as administered then the physician would sign off on them.


An interview was conducted with RN Staff #75, Interventional Radiology Supervisor Staff #76, and Staff #120 on 1/25/2024 at 10:00 AM. Staff #120 was asked why there was not a verbal order in the medical records for the sedation medication. Staff #120 stated, "When the nurse administers the sedation medications and documents the time in the medical record it automatically creates a verbal order by that physician. That order goes into the physician queue for the physician to sign."

After further review and multiple medical records reviewed for the Interventional Radiology Department Staff #120 confirmed no verbal orders were documented by the nursing staff in the medical record. Therefore, no verbal orders have been countersigned by the physicians ordering moderate sedation.

Physician #89 confirmed verbal orders were not being documented and the physician responsible for the patient care was not able to countersign for the moderate sedation medications used in the Interventional Radiology Department since July 1, 2023.


A review of the facility policy titled, "Verbal/Telephone Orders", Policy Number: 3.140 with a reviewed date of 3/2018 was as follows:

" ...II. OBJECTIVE/S: This policy delineates the Christus Health Associates that are qualified to receive verbal/telephone orders, the individuals from which verbal/telephone orders may be received, and the process for recording, transcribing, transmitting, and authenticating verbal/telephone orders with the goal-maximizing patient safety ...
V. PROCESS:
A. Verbal Orders ...
2. All verbal orders must be documented in the medical record.
...
D. Authentication
1. The provider must authenticate all verbal and/or telephone orders within the statutory guidelines (Texas: 96 hours, New Mexico: 72 hours, and Louisiana: within 10 days) ..."

Based on a review of facility documentation and an interview with staff, the facility failed to ensure that medical records were promptly completed, consistent with hospital policies and procedures.

Findings were:

A review of delinquent medical records on 1-24-24 revealed that 39 of 432 providers had medical records that had not been completed, with an overall delinquency rate of 19%.

Facility policy HIM-PP-22 titled "Content and Timely Completion of the Medical Record" states, in part:
"OBJECTIVE:
To assure that medical records will be completed in a timely manner.
POLICY:
The Medical Record must contain information to justify admission and continued Hospitalization to support the diagnosis and describe the patient's progress and response to medications and services.
All entries must be legible and complete. They must be authenticated and dated promptly by the person (identified by name and discipline) who is responsible for ordering, providing, or evaluating the service furnished. The author of each entry must be identified and authenticate his or her entry. Authentication may include signatures and written initials.
PROCEDURE:
All records must document the following as appropriate:
A. Discharge Summary
a. Must be completed within 30 days of discharge.
b. A discharge Summary is required on all inpatient and Observation stays with the exception of observations of 48 hours less. For an observation visit less than 48 hours, a final progress note will be accepted.
B. History and Physical:
1. A History and Physical Examination must be performed within thirty (30) days before or twenty-four (24) hours after admission and always prior to an operative or high-risk procedure requiring anesthesia services.
2. For medical history and physical examinations completed within 30 days prior to admission or admission, an update documenting any changes in the patient's condition is required within twenty-four (24) hours after admission or admission or prior to surgery or a procedure requiring anesthesia services. The update must state "no change" in the patient's history and physical condition and must be documented, authenticated, dated and timed if no change in the patient's history and physical is determined.
3. A History and Physical can be handwritten, computer generated or dictated and transcribed. All handwritten History and Physicals must be legible.
4. History and Physical must be authenticated, dated and timed by the dictating/responsible provider.
5. Concurrent History and Physical Review - If the History and Physical is not in the legal patient record within twenty-four (24) hours after admission, a dictation deficiency is automatically assigned to the admitting physician.
C. Consultation Report:
1. A Consultation Report must be dictated, computer generated or handwritten ( if legible) when a consultant sees a patient.
2. Consultation report should contain concise summaries of examination of the patient and the record, impression or diagnosis and recommendation for subsequent management within the scope of the consultation request.
3. Consultation report must be authenticated, dated and timed by the consulting physician.
D. Operative Report:
1. The surgeon should enter a brief description of the procedure and significant findings in the Postoperative Progress Note immediately after the surgery and before the patient is transferred to the next level of care when the Operative Report is not documented immediately following the surgery. If the practitioner performing the operation or high-risk procedure accompanies the patient from the operating room to the next unit of care, the report can be written, computer generated or dictated in the new unit or area of care.
2. The patient's medical record documents all operative or high-risk procedures and/or the administration of moderate or deep sedation/anesthesia by the operating surgeon; dictation of the operative report should be completed within twenty-four (24) hours following the procedure."

The above was confirmed in an interview with staff #89 on 1-24-24.

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


A. Maintain the condition of the dietary area to ensure the safety and well-being of patients and staff.

Refer to tag 701

B. Promptly dispose of, or properly store decommissioned office chairs, tables, hospital beds, rails, and miscellaneous metal

Refer to tag 713

C. Ensure the emergency generator started for testing

Refer to tag 724

D. Designate or determine who would monitor the "day-to-day" maintenance of the negative pressure rooms. Also, the facility staff failed to monitor and document the negative pressure room that showed 12 air exchanges each hour and verified an air filtration rate of at least 95% per policy, "Tuberculosis Control Plan". In addition, the facility staff failed to provide negative pressure room settings data to the Infection Control Committee to support that they were monitoring and maintaining negative pressure rooms.

Refer to tag 726

Based on observation, record review, and interview, the maintenance department failed to maintain the condition of the dietary area to ensure the safety and well-being of patients and staff.

Findings Include:

A tour with Staff #37, Staff #42, and Staff #43 of the dietary area at Hospital #1 was conducted on January 22, 2024, at 9:30 AM.

Two floor drains in the preparation area near the sinks were not functioning properly.

* The first drain was not level with the floor, resulting in standing water around it. Staff #43 reported that they had requested the repair of the first drain for seven years, but it had not been addressed due to old plumbing and pipes that needed fixing.

* The second drain was obstructed and had been sealed with cement.

A review of the work order log from July 1, 2023, through January 23, 2024, showed that staff in the dietary department had reported "clogged floor drains" 46 times in six months. The staff requested a shop vac to vacuum the continued drain problems. The work order requests revealed that the floor drain behind the server line had sewer water coming up, kitchen floor drains were clogged and backing up, the floor drain backing up into the baker's area, and the kitchen sewer backed up. All work orders were closed and marked as completed.

The dishwashing room had an electrical closet that was being used to store mops, buckets, and water hoses. An orange electrical cord was plugged in and wrapped around the door handle. The electrical cord was observed draped over the door leading outside the electrical room and was wrapped around storage shelves near the electrical closet. Also, staff members were using this room to charge their cell phones.

Staff #43 reported that the electrical room was opened frequently because water would come out from the floor, requiring it to be shop vacuumed often. Also, the tiles in the ceiling at the back right corner were hanging and not secure which was a risk for rodents to enter the dietary area.

Observed an eyewash station in the dietary area with a constant stream of water. Surveyor asked dietary staff to address the stream of water coming from the faucet and the staff reported it was broken.

Surveyor observed in the grill area, a large 5-gallon bucket that was about ¾ full of brown discolored water found below the sink. The water had leaked from the sink into the bucket, and there were discolored towels and trash around the bucket. Maintenance staff notified Staff #37 that the leak would not be fixed until the other leaks in the hospital were resolved.

Upon reviewing the work order log for the dates between July 1, 2023, and January 23, 2024, it was found that the dietary department staff had reported the "sink repairs" 11 times. All 11 work orders were closed and marked as completed.

The coolers located in the grill area had gaskets around their doors which were shredded and torn. Furthermore, there were visible traces of grease and food particles on the inside of the doors. Hanging down from the cooler fan, there were electrical wires inside the food cooler. Behind the cooler, a wadded-up blue and white paper towel was wrapped around a wire near the heating coils, which could increase the risk of a fire hazard.

Upon reviewing the work order log provided between July 1, 2023, and January 23, 2024, it was discovered that the dietary department staff had reported twice about the need to replace the seals around the coolers. The work order log indicates that the issue was resolved, with the work order being closed and marked as completed.

The light bulb fixture in the daily use cooler located in the preparation area was hanging by its wires, which were duct taped to prevent the bulb from falling into the food.

The light bulbs above the grill were not functioning.

The surveyor observed a pipe on the exterior part of the meat cooler, which was meant for draining and defrosting. The pipe was found to be hanging above a preparation table and was not connected to anything. Dietary staff reported the reason for the defrost pipe being unhooked was that floor drain #2 was obstructed by concrete.

While touring the dietary area, the dietary team was informed of all the findings that were discovered. Staff #37 and Staff #43 reported that multiple work orders had been submitted for cooler gaskets, an eyewash station faucet, and floor drains that were not draining. Emails would be sent from the maintenance department stating that the work orders had been completed. Staff #43 confirmed that the cooler gaskets, eyewash station, and floor drains have been not fixed.

A tour with Staff #40, Staff #43, Staff #65, and Staff #86 of the dietary area at hospital #2 was conducted on January 24, 2024, at 9:00 AM.

Observed in the preparation area there was a stand-alone freezer where the patient's ice cream and popsicles were stored. The freezer had a heavy frost buildup.

During the inspection, the surveyor observed that the baseboards appeared to have pulled away from the wall and the wall plaster was cracked and peeling. Also, the door frame had a rust-like appearance.

An interview with Staff #40 on January 24, 2024, at 3:00 PM in the conference room confirmed that the maintenance department failed to complete work orders that had been submitted which addressed safety issues in the dietary department.

Based on observation and interview the facility failed to promptly dispose of, or properly store decommissioned office chairs, tables, hospital beds, rails, and miscellaneous metal on the afternoon of 01/23/2024.

Findings Include

On the afternoon of 01/23/2024, a tour of the back entrance service area of the hospital, which is the loading dock. The apron of the dock was being used to store decommissioned hospital furniture (chairs, coffee tables, over-bed tables, hospital beds, and rails). Other unidentified metal for disposal was observed in the concrete yard area. A front-end loader was being operated to place the unidentified metal onto a trailer. The volume of discarded furniture and equipment was more than could be counted.

The surveyor stated, "This must have taken a while to accumulate?" Staff #100 stated, "Yes, daily, broken furniture and equipment are removed from the building".

The facility staff was unable to voice or demonstrate the process for prompt removal of decommissioned furniture and equipment.

Based on observation, and interview hospital facility #2 failed to ensure the emergency generator started for testing during the survey observation date 01/24/2023.

On the morning of 01/24/2024 the survey team met with facility staff # 87, the maintenance staff. Staff #87 was asked to demonstrate the function of the emergency generator. Staff #87 opened the generator doors and pressed the start switch. The generator failed to start. Staff #87 attempted the switch several times without igniting the generator. Staff #87 left the generator and entered the building to ensure all breakers were functioning. He returned to the generator and pressed the ignition switch and again the generator failed to ignite.

Staff #87 phoned the maintenance department of facility#1 and spoke with a maintenance co-worker who instructed him to manipulate the switch, as the switch fuse might be faulty. Staff #87 manipulated the switch and the generator ignited as desired.

Staff # 87 confirmed the fuse was not making consistent contact. Staff #87 was asked by the surveyor, "You are going to have that fuse replaced, correct? Staff #87 stated Yes, ma'am".

Maintenance supervisor, staff #100, and VP of Operation staff #40 witnessed the initial test failure of the emergency generator for facility #2.

Based on observation, record review, and interview the facility failed to designate or determine who would monitor the "day-to-day" maintenance of the negative pressure rooms. Also, the facility staff failed to monitor and document the negative pressure room that showed 12 air exchanges each hour and verified an air filtration rate of at least 95% per policy, "Tuberculosis Control Plan". In addition, the facility staff failed to provide negative pressure room settings data to the Infection Control Committee to support that they were monitoring and maintaining negative pressure rooms.

Findings Include:

During a tour of Hospital #1 on January 24, 2024, at 2:00 PM with Staff #5, Staff #38, Staff #39, and Staff #40.

During an interview with Staff #39 on January 24, 2024, at 1:00 PM, it was stated that the maintenance department checks negative pressure rooms with a vaneometer (portable test equipment that indicates airflow) twice a year. Additionally, nursing performs tissue tests (If air pressure is appropriately negative, the tissue will be pulled TOWARDS the room demonstrating an acceptable airflow) when isolated patients occupy these rooms. During the interview, Staff #39 demonstrated the use of the vaneometer. Surveyor asked about the parameters, Staff #39 replied, "I just make sure the needle swings towards the door, I don't look at the number on the meter." However, Staff #39 did not demonstrate or acknowledge the electronic room monitoring system used to ensure that there are 12 air exchanges per hour or that the pressure differentials are sufficient to prevent airborne particles from exposing other patients or staff members.

A review of the CDC guidelines revealed the following:

"C.I. Air-Handling Systems in Health-Care Facilities
B. 2. Monitor areas with special ventilation requirements (e.g., AII or PE) for ACH, filtration, and pressure differentials.21, 120, 249, 250, 273-275, 277, 333-344 Category IB, IC (AIA: 7.2.C7, 7.2.D6)
* Develop and implement a maintenance schedule for ACH, pressure differentials, and filtration efficiencies using facility-specific data as part of the multidisciplinary risk assessment. Take into account the age and reliability of the system.
* Document these parameters, especially the pressure differentials."

An interview was conducted with Staff #38 and Staff #40 in a conference room on 1/24/2024 at 3:00 PM to discuss the findings from the tour and the interview with Staff #39. Staff #38 and Staff #40, both acknowledged that the policy for the Tuberculosis Control Plan was vague and needed to be clearer as to how often negative pressure rooms should be checked and whose responsibility it would be. During this interview, preventative maintenance reports were obtained. Preventative maintenance records revealed that negative pressure rooms were being done monthly by the maintenance department but did not show any specific parameters other than saying it was completed. There was no way to determine if this was hospital #1 or hospital #2 or which department in each hospital this preventative maintenance report was being conducted.

A review of the facility's policy titled, "Tuberculosis Control Plan #IC-PP-49", revised date 8/08/2023 revealed the following:

"Responsibility:

Supervisory responsibility for the TB Control Program shall be assigned to the hospital Infection Control Committee. The Infection Preventionist shall act as a designee of the Committee to implement the Program on a day-to-day basis. The Infection Preventionist shall enlist the assistance of physicians, the Safety Officer, the Manager of Plant Operations, etc. as needed to implement and maintain the TB Control Program. ...

Engineering/Environmental Controls:

AIR should be negative pressure to adjacent areas, have at least 12 air changes per hour, directly exhausted to the outside, and are equipped with negative pressure monitors ..."

Interviews with Staff #38 and Staff #40 confirmed that the Tuberculosis Control Plan Policy and process failed to show any details as to what department would oversee the monitoring of negative pressure rooms. Also, the preventative maintenance reports failed to include details of what hospital or department the testing was being done, what the pressure differentials were during the testing, or if there were any pressure failures during monitoring.


48749

Based on observations, interviews, and review of documentation the facility failed to ensure the infection prevention and control program maintained a clean and sanitary environment to avoid sources and transmission of infection in the following departments Hospital #1, Dietary, Labor and delivery, Post- Partum, Main Warehouse, Medical, surgical, cardiovascular ICU's, Central supply Cath Lab, Out Patient Cancer Treatment Area, Out Patient Oncology, Out patient Imaging. Hospital #2- Dietary, Medical Surgical Floor, Laboratory.

Refer to Tag A0750

Based on observations, interviews, and review of documentation the facility failed to ensure the infection prevention and control program maintained a clean and sanitary environment to avoid sources and transmission of infection in the following departments Hospital #1, Dietary, Labor and delivery, Post- Partum, Main Warehouse, Medical, surgical, cardiovascular ICU's, Central supply Cath Lab, Out Patient Cancer Treatment Area, Out Patient Oncology, Out patient Imaging. Hospital #2- Dietary, Medical Surgical Floor, Laboratory.

Findings included:

Tour of the facility and observation of patient care by surveyor staff revealed infection control issues and issues of maintaining a clean and sanitary environment:Tour of the laboratory area of the main campus on 01/22/24 identified the following issues:
* Missing and chipped laminate was observed on several counters throughout this area, making thorough cleaning of the surface impossible. In interview on 01/23/24 the laboratory director verified that at the time of the tour on 01/2224, no work orders had been placed to address the missing and chipped laminate on the counters in the laboratory.

Tour of the outpatient cancer treatment area on 01/23/24 identified the following issues:
* The True beam room had a cabinet where IT had relocated wiring through cabinet. The wiring was through a hole (approximately 4 inches in circumference) that was open into the wall, creating a potential entry point for dust, dirt, and pests. At the time this was noted a work order had not been completed for this issue. A backboard was also observed stored on the floor in this room, presenting a risk of cross contamination.
* Dust was observed on the light fixture in Exam room #3. This room also contained an exam table that had a sticker in place on the metal frame. Stickers and tape prevent surfaces from being cleaned effectively.

Tour of the outpatient oncology area on 01/23/24 identified the following issues:
* Room #1 had debris noted in the exam table drawer, indicating ineffective cleaning of this area.
* Room #4 had dust noted inside a cabinet, indicating ineffective cleaning of this area.
Tour of the outpatient endocrinology area on 01/23/24 identified the following issue:
* Light fixtures in the area, contained what appeared to be multiple dead bug carcasses.

Tour of the Outpatient Imaging Centers on 0/24/24 identified the following issues:
* The hallway outside the MRI had a ceiling tile with a discolored water stain around it approximately 5" diameter in size. Ceiling tiles with water stains can harbor mold and may crumble, contaminating items below.
* A patient nutrition refrigerator had debris visible on the shelves containing liquid nourishment for patients.
Tour of the Atlanta Laboratory area on 0/24/24 identified the following issues:
* There was missing and chipped laminate noted on several counters throughout this area, making thorough cleaning of the surface impossible.

The above findings were verified on tours with staff members #6, 9, and 90.

Facility based policy #13 for OPS-Environmental/Custodial Services entitled, "Office Areas/Ancillary Areas" stated in part,
"General Cleaning & Disinfection

Daily ...
· Clean all visible ledges and surfaces 6' (six feet) and under ...
· HEALTHCARE: Clean all examination rooms or treatment rooms and tables, changing cleaning cloths after each room ...

Weekly ...
· Detail areas include high ledges (door closes, tops of shelf units, bookcases, etc.), ceiling corners and light fixtures, air vents, window blinds; carpet edges; and areas under and behind larger, harder-to-move equipment.
· Carpet edges and all areas above 6' (six feet) must be cleaned weekly with a high-dusting tool or a stiff brushing tool for carpeted edges."

Several surveyors note that the canisters used for the pneumatic tube system to send laboratory specimens appeared dirty at several locations throughout the facility, with visible dirt and debris present. In interview on 01/23/24, the lab director verified there was no cleaning schedule or process for ensuring the canisters are cleaned routinely.

Facility based policy #LAB/LG-PP-13.6 entitled "Pneumatic Tube System" stated in part,
"3. Emergency Procedures
A. Reporting a leak or spill
1. If a user discovers a leak of body fluid or blood on the outside of the zip lock bags or the carrier, or inside the carrier bin, the user must immediately complete all the following steps ...

d. Disinfect all carriers affected by wiping down with disinfectant wipes, let sit for 15 minutes then wash with hot water."



32143

A tour was conducted in the central supply warehouse on 1-24-24 at 10:45 AM with staff #2 (RN), staff #59 (RN scribe), and staff # 97 (materials management supervisor). The following items were found.

Loading Dock

Multiple boxes (15-20) containing medical supplies were found sitting on the dock in the rain. The boxes were wet. 3 of the boxes contained sterile surgical supplies.

Main Warehouse

The main warehouse floors were littered with paper, dirt, dust, and general trash under the rolling carts holding the boxed supplies.

50 bottles of Similac baby formula were found unboxed in a plastic container with no lid. The container was sitting on the bottom shelf of a metal cart. Underneath the cart was a lot of dirt, dust, and debris. The bottles had fine dust and particles on them. Staff #97 confirmed that these bottles would go to the nursery and NICU.

Boxes of needles, gowns, and electrodes were found open and exposed to dirt in the warehouse.

Staff #97 confirmed there were no temperature or humidity checks done in the main warehouse. Staff #97 confirmed that the floors are swept with a dry broom and no mopping is done in the main warehouse.

An interview with staff # 97 was conducted during the tour on 1-24-24 at 10:55 AM. Staff # 97 stated that the warehouse was not controlled for temperature or humidity. Staff #97 stated that there were surgical supplies that had temperature parameters in the warehouse but could not state how long they had been sitting in the warehouse before being unpacked.

Unboxing Room for Medical Supplies (middle room between the warehouse and clean central supply)

Unboxed sterile supplies were found sitting next to and against dirty boxes that had not been unboxed.

Clean Central Supply

Once the boxes are emptied from the middle room the supplies are brought into the clean central supply room. The room was very large and had multiple racks and shelves filled with supplies. On one end of the room was supplies and on the other end of the room was sterile processing. There was no wall or curtain to separate the central supply from sterile processing.

Two rolling racks that held sterile medical supplies were rolled away from the wall. Dirt, a broken wheel, and medical supplies were found on the floor under the supply rack. Staff #17 (cs tech) stated on 1-24-24 @ 11:10 AM that housekeeping comes in and cleans the floor but never pulls any of the racks out to clean under them.

An interview with staff #116 (material management) confirmed that they had not been checking for temperatures or humidity and were not aware that she should be until a survey told her earlier the day before. Staff #116 had a thermometer in the large room. She stated that she did not have a process but found a form on the website for the hospital system. The thermometer that was being used was not adequate to check the temperature of such a large area.

Cardiovascular Intensive Care Unit- (CVICU) Supply Room
Medical Intensive Care Unit
Surgical Intensive Care Unit

A small room was found on the units that were being used to store sterile and non-sterile medical supplies. The rooms were extremely hot. The rooms not only contained supplies but also a commercial ice and water machine that was putting off a large amount of heat with no air return found. Staff #2 stated there was no other place to put the ice machines. The rooms were not being monitored for temperature or humidity and the staff was not able to guarantee the integrity of the supplies in the rooms.

The facility failed to ensure the clean and sterile supplies were being properly monitored for temperature and humidity. Staff #2 confirmed that the facility was not obtaining temperature or humidity checks. Staff #2 confirmed the facility deemed entity was Joint Commission. According to https://www.jointcommission.org/standards/standard-faqs/ambulatory/environment-of-care-ec/000001275/ the standards stated, "ASHRAE Standard 170- 2008 Table 7.1 ventilation requirements for sterile storage in CENTRAL MEDICAL AND SURGICAL SUPPLY areas includes the following:
Positive air pressure relationship to adjacent areas
Minimum outdoor air exchange 2 per hour
Minimum total air exchange 4 per hour
Maximum relative humidity 60%
Temperature range 72 to 78 F or 22 to 26 C. "



48749

During a tour of the facility's Labor and Delivery Department on 01/22/2024 at 10:15 AM with Staff #2 and Staff #56, the following infection control issues were identified:

Labor and Delivery:

*Observed multiple holes on the fitted bed sheet of patient-ready room N250.

*Observed blood on the handle of the stirrup and the footrest of a patient-ready bed in delivery room N250.

*Observed black-colored stains on the mattress and side table of the Isolette (clear plastic enclosed crib that maintains a warm environment for a new baby and isolates from germs) in room N250.

*Observed chipping and peeling of the laminate on the cabinets and table in patient room N250.

*Observed brown-colored stains on the water jets of the bathtub and there was visible gray or black staining noted on the bottom of the bathtub in patient room N250.

*Observed the laminate was chipped and peeling on several areas of the counter at the nurse's workstation in labor and delivery.

*Observed the patient nutritional freezer was iced over and not defrosted in labor and delivery.

*Observed a pneumatic compression pump (a device that helps move fluid out of an area of the body with excess fluid) and a PC infusion pump (a monitoring system that delivers fluids in large or small amounts and may be used to deliver nutrients or medications) untagged as clean in the clean equipment room.

*Observed a freezer located in the labor & delivery department medication room was iced over and not defrosted.

*Observed the pyxis (an automated medication dispensing system) refrigerator located in the labor and delivery medication room was found to have dirt and debris built up on the bottom shelf.

Postpartum:

*Observed black-colored stains and scratches to the fiberglass on the floor of
the shower located in room 278.

*Observed there was an IV (intravenous) pole found with black-colored, sticky material on the base. The infusion pump was noted to not have a clean tag to indicate ready for use in room 278.

* Observed visible black, sticky material on the pillowcase and there was hair-like material noted on the fitted bed sheet of patient-ready room 278.

*Observed visible chipping and cracking of the drywall in room 278.

*Observed a trash can filled with isolation material in the anti-chamber of an unoccupied negative air pressure room 274.

*Observed a rip in the vinyl cushion of the chair in isolation room 274.

*Observed two PC infusion pumps (a monitoring system that delivers fluids in large or small amounts and may be used to deliver nutrients or medications) were found untagged as clean in the clean equipment room.

During a tour of the facility's Cardiovascular Intensive Care Unit on 01/24/2024 at 09:30 AM with Staff #2 and Staff #56, the following infection control issues were identified:

Cardiovascular Intensive Care Unit (CVICU):

*Observed in the clean utility room where sterile supplies were stored, the temperature was very hot. There was an ice machine noted in the room and the room did not have temperature and humidity control.

*Observed a hole in the wall and the drywall was cracked and broken in CVICU room 324.

During a tour of the facility's Central Supply on 01/24/2024 at 11:00 AM with Staff #2 and Staff #56, the following infection control issues were identified:

Central Supply:

*Observed a buildup of dust and debris on the floor under the bottom shelf holding supplies.

*Observed a buildup of dirt and material on the floor between the shelves and around the border of the walls.

*Observed a buildup of dust and debris on the shelves holding sterile supplies.

*Observed open cardboard boxes stored on the shelf above sterile supplies.

*Observed boxes of sterile supplies sitting on the loading dock exposed to the rain and temperature.

During a tour of the facility on 01/23/2024 at 12:00 PM with Staff #2 and Staff #56, the following infection control issues were identified:

Medical-Surgical Floor- Second Campus:

*Observed a brown liquid dried to the side rail of a bed in a patient-ready room 504.

*Observed chipping and peeling on the laminate of the cabinets in room 504.

*Observed brown rust-like stains on the bottom of the shower chair in room 504.

*Observed tears in the seat cushion and peeling laminate on the chair in the isolation room.

*Observed two pre-made patient meals were found to be expired in the nutrition room.

*Observed the laminate covering was stained, broken, and lifted away from the countertop in the nutrition room.







49344

On January 22, 2024, at 9:30 AM. a tour of the dietary area at Hospital #1 was conducted with Staff #37, Staff #42, and Staff #43.

During the inspection of the meat cooler, the following items were observed:

* The surveyor observed a large puddle of what appeared to be a bloody drainage on the floor.
* Powdered gravy stored in a bowl was found to have an expiration date of January 6, 2024.
* The French toast mix that was stored in a bowl had an expiration date of January 5, 2024.
* An unlabeled container of "brown gravy" was observed and confirmed by Staff #37.

During the inspection of the produce cooler, the following items were identified:

* A container of mushrooms was found with dates marked on it. The dietary staff was unable to determine if the dates indicated the day of the produce's arrival or if was it the expiration date. Staff #37 reported that dietary staff members have neglected to change the labels that indicate when the food arrived or expired.

* Observed a container of bell peppers that had holes in the saran wrap, with no expiration date on the label.

A review of records in the dietary area of Hospital #1 revealed no evidence that the soda fountain spigots in the retail area of the dietary department had been cleaned or maintained.

Food cooler in the grill area, the surveyor observed bags of food that contained french fries, tater tots, and onion rings that were left unsealed. These food items were spilling onto the floor of the cooler. Also, the surveyor observed dark-colored fluid spillage beneath the food cooler.


At 12:00 PM, during a dietary tray pass in Hospital #1, Staff #45 was observed passing trays to patient rooms while leaving the door of the tray cart open. The surveyor asked about the open door after the second tray was passed, Staff #45 acknowledged that it should be kept closed between dietary tray passes.

An interview with Staff #40 and Staff #43 on January 22, 2024, at 3:00 PM in the conference room confirmed that the findings during the tour of the dietary area of Hospital #1 failed to maintain a clean and sanitary environment to avoid patients being served spoiled food.

A tour with Staff #40, Staff #43, Staff #65, and Staff #86 of the dietary area in Hospital #2 was conducted on January 24, 2024, at 9:00 AM.

During an inspection of the large freezer, it was discovered that an unpackaged piece of fish was found on the food rack.

An interview with Staff #86 in the Kitchen of Hospital #2 on January 24, 2024, at 9:15 AM, stated that during the cleaning of the freezer, the "housekeeper found an unpackaged piece of fish under the rack on the floor. The housekeeper placed that fish on the frozen food rack and forgot to dispose of it." Also, there were several containers and bags of unprepared food in the freezer that appeared to have freezer burn.

The air conditioner vent cover was black in color, dusty, and dirty in appearance with a buildup of grease. Staff #86 reported that the vent does not receive regular maintenance or cleaning.

A review of records in the dietary area of Hospital #2 revealed no evidence that the soda fountain spigots in the retail area of the dietary department had been cleaned or maintained.

An interview with Staff #40 and Staff #43 on January 24, 2024, at 11:00 AM in the conference room confirmed that the findings during the tour of the dietary area of Hospital #2 failed to maintain a clean and sanitary environment.


47892

Findings;

A tour was conducted on 1/22/2024 at 1:00 PM of the Cath Lab (catheterization laboratory is a procedure room where minimally invasive tests and procedures are performed to diagnose and treat cardiovascular disease) department, it was observed in Cath Lab #2 that there was a build-up of dust and debris on the bottom of each sterile supply cabinet. Also, a build-up of dust and debris was found in the small refrigerator in Cath lab #2.

In an interview on 1/22/2024 at 1:25 PM, Staff #16 agreed that dust and debris were found at the bottom of each sterile supply cabinet and at the bottom of the small refrigerator.

Based on observation, record review, and interview, the facility's surgical staff failed to:

A. ensure the immediate use of steam sterilization for autoclaves #8 and #9 in the sub-sterile rooms was being used only for carefully selected clinical situations, such as a dropped instrument or no replacement instrument available. Also, the facility failed to complete and record the "Flash Sterilization Log" record per the facility policy.

It was determined that this deficient practice posed an Immediate Jeopardy to patient health and safety and placed all patients having a Surgical procedure in the facility at risk for the likelihood of harm, serious injury, and possibly subsequently death.

B. address the temperature and humidity in the twelve surgical operating rooms and the two surgical instrument room areas that were out of range for November 2023 through January 25, 2024.

C. ensure sterility of transesophageal echocardiography (TEE) scope, which is a scope that is used for echocardiography to assess the structure and function of the heart, and to ensure the HEPA filter was changed every six months in the GUS System (This system is a manual high-level disinfection for endoscopes).


Findings Included:


A.

A review of the record titled, "Flash Sterilization Log" for autoclaves #8 and #9 revealed that complete instrument sets were being sterilized in the immediate use steam sterilization (IUSS) autoclaves which are 4-minute steam and 1-minute dry time. A full set of instruments should be run on a 4-minute steam and a 20-minute dry time.

During a tour on 1/23/24 at 1:30 PM it was observed on the IUSS log that a Neck Pan with 8 instruments was run on the IUSS cycle, which was 4-minute steam and 1-minute dry time.

During a tour on 1/23/24 at 1:30 PM, sterilizer #8 was open with a curette inside that had been sterilized on the IUSS setting. Staff member #12 had not placed a patient identification sticker on the log. The staff members were filling the log out inconsistently. There was no information on the load record for the curette instrument.

A review of the Facility's policy titled; "Sterile Processing Department" dated effective 6/2020 revealed the following:

"...Objective:
To ensure cleanliness and sterility of instrumentation, supplies, and equipment processed in steam or Ethylene oxide (ETO) sterilizer, along with VPROMAX system.

Policy:

It is the goal of CHRISTUS St. Michael (CMS) to prevent infection and to protect employees from infectious material by practicing proper decontamination cleaning and sterilization procedures in caring for instruments and equipment.

Assurance of sterilization in steam and ETO autoclaves is confirmed through the use of Integrators next to each item sterilized. The Integrator is documented to be equivalent to and to parallel the same thermal death curve as a biological, with an immediate readout. Other sterilization monitoring devices such as Biologicals will act only as a secondary source to support overall sterilizer performance.

Assurance of sterilization in Steris units is confirmed through use of biological and Chemical indicators. These procedures are to be performed only by persons specifically trained to do them. The same system of testing and documentation will be used housewide, as approved by the Infection Control Committee.

Procedure:

IV. IMMEDIATE USE STEAM STERILIZATION (IUSS)

A. Immediate Use Steam Sterilization
Immediate use steam sterilization will not be the primary means to sterilize sets or single items. The only acceptable reasons to use immediate use steam sterilization are:

1. In an emergency situation.
2. Dropped items.
3. Items that have had the packaging compromised. Any items that receive immediate use steam sterilization and do not meet these criteria must have the reason(s) why the item had immediate use sterilization cycle used documented on the Daily Flashing documentation Record..."

A review of this policy revealed that the facility's surgical staff was not following its policy.


Upon a review of the 2017 "Association for the Advancement of Medical Instrumentation" ANSI/AAMI ST79:2017, the guidelines revealed the following:

"...ANSI/AAMI ST79:2017 -- Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

13 Process monitoring, testing, and quality control

13.3 Product identification and traceability

13.3.1 General considerations

Each item or package intended for use as a sterile product should be labeled with a lot control identifier to allow full traceability of that item to the patient; alternately, an instrument tracking system may be used. Each load should have a load control record that includes a detailed content list, including specific identification of sets and the contents of sealable pouches.

13.3.2 Package labeling and expiration dating, if applicable
Each item or package intended for use as a sterile product should be labeled with a lot control Identifier prior to sterilization. The lot control identifier should identify:

a) the sterilizer identification number or code.
b) a detailed list of the contents (e.g., identification of multiple sets and the contents of paper-plastic pouches).
c) the person who assembled the package.
d) the date of sterilization.
e) the cycle number (cycle run of the sterilizer); and
f) the patient, if applicable, Items processed for immediate use should include a patient identifier..."

An interview was conducted with Staff #12 on 1/23/24 at 2:30 PM. Staff # 12 was asked if they should be running 9 instruments on an IUSS setting. Staff #12 stated, "This is the setting they told me to use for this set of instruments." When asked where the documentation was for the curette that had been flashed on IUSS, Staff #12 stated "I just haven't had time to put the information on the log".

An interview was conducted with Staff #17 and #18 on 1/23/24 at 2:50 PM. They were asked why operating room staff would run 9 instruments on an IUSS setting of 4-minute steam and 1-minute dry time. Staff #17 stated, "There is a to-follow case for the same surgeon doing the same procedure. Those are the surgeon's special instruments that the surgeon uses on both cases he is doing today".

An interview was conducted with Staff #91 on 1/23/24 at 2:55 PM. Staff #91 was asked if operating room staff should be processing 9 instruments on an IUSS cycle. Staff #91 stated, "They should not be flashing (using IUSS) at all".



B.

A review of the daily temperature and humidity records were as follows:

November 2023 Daily Temperature and Humidity:

1. Operating Room 1: there were 30 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
2. Operating Room 2: there were 30 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
3. Operating Room 3: there were 29 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
4. Operating Room 4: there were 30 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
5. Operating Room 5: there were 29 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
6. Operating Room 6: there were 30 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
7. Operating Room 7: there were 29 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
8. Operating Room 8: there were 29 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
9. Operating Room 9: there were 29 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
10. Operating Room 10: there were 18 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
11. Operating Room 11: there were 30 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
12. Operating Room 12: there were 30 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
13. Instrument Room 1: there were 29 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
14. Instrument Room 2: there were 29 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.

There were no notations that the staff had reported the out-range temperature and Humidity.

December 2023 Daily Temperature and Humidity Record:

1. Operating Room 1: there were 26 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
2. Operating Room 2: there were 25 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
3. Operating Room 3: there were 26 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
4. Operating Room 4: there were 27 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
5. Operating Room 5: there were 29 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
6. Operating Room 6: there were 18 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
7. Operating Room 7: there were 14 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
8. Operating Room 8: there were 28 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
9. Operating Room 9: there were 15 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
10. Operating Room 10: there were 11 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
11. Operating Room 11: there were 30 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
12. Operating Room 12: there were 30 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
13. Instrument Room 1: there were 22 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
14. Instrument Room 2: there were 29 of 30 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.

There were only 6 of 330 notations made by the staff who had reported the out-range temperature and Humidity.

January 2024 Daily Temperature and Humidity Record:

1. Operating Room 1: there were 15 of 25 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
2. Operating Room 2: there were 16 of 25 days where the temperature was out of range and 3 out of 25 where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
3. Operating Room 3: there were 17 of 25 days where the temperature was out of range and 2 out of 25 where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
4. Operating Room 4: there were 18 of 25 days where the temperature was out of range and 3 out of 25 where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
5. Operating Room 5: there were 23 of 25 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
6. Operating Room 6: there were 18 of 25 days where the temperature was out of range and 2 out of 25 where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
7. Operating Room 7: there were 11 of 25 days where the temperature was out of range and 2 out of 25 where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
8. Operating Room 8: there were 23 of 25 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
9. Operating Room 9: there were 6 of 25 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
10. Operating Room 10: there were 6 of 25 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
11. Operating Room 11: there were 25 of 25 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
12. Operating Room 12: there were 25 of 25 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
13. Instrument Room 1: there were 24 of 25 days where the temperature was out of range and 1 out of 25 where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.
14. Instrument Room 2: there were 25 of 25 days where the temperature was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.

There were only 35 of 252 notations made by the staff who had reported the out-of-range temperature and humidity for the sterile processing and decontamination area.


Review of the AORN Perioperative Standards and Recommended Practices,

"Temperature should be maintained between 68 degrees F to 75 degrees Fahrenheit (20 degrees to 23 C) within the operating room suite. General work areas in sterile processing should be maintained between 68 degrees to 73 degrees F.

Relative humidity should be maintained between 20% and 60% within the perioperative suite, including operating rooms, recovery areas, cardiac catheterization rooms, endoscopy rooms, instrument processing areas, and sterilizing areas, and should be maintained below 60% in sterile storage areas.

Low humidity increases the risk of electrostatic charges, which pose a fire hazard in an oxygen-enriched environment or when flammable agents are in use, and increases the potential for dust. High humidity increases the risk of microbial growth in areas where sterile supplies are stored, or procedures are performed.

Humidity should be monitored and recorded daily using a log format or documentation provided by the HVAC (heating, ventilation, and air conditioning) system.

Temperature should be monitored and recorded daily using a log format or documentation provided by the HVAC (heating, ventilation, and air conditioning) system."


A review of the Facility's policy titled; "Environment of Care: OR Temperature and Humidity" effective date 9/2023 revealed the following:

"...Objective:

To establish guidelines for the recommended room temperature and humidity in the Operating Room (OR).

Temperature: The Temperature range in a restricted are (Operating Room) should be 68* F to 75* F but the range may be intentionally adjusted for a limited time based on the individual needs of the patient, such as pediatric surgical patients of patients undergoing procedures that require intentional hypothermia, may require that the room temperature be adjusted outside of the recommended range.

Humidity: The recommended range for Humidity in the operating room is 20% to 60%. The thermostat in the room can be regulated to maintain humidity in this range.

Procedure:

Temperature and Humidity will be monitored daily in each Operating Room and documented on the Temperature/Humidity log in each room. When humidity is out of the recommended 20% to 60% range, adjustments will be made to the room thermostat. Increasing the temperature on the thermostat should lower the humidity. If temperature or humidity does not adjust within 30 minutes notify Plant Operations by calling 2800 and request a P-1 Work Order. If temperature or humidity continues to be out of range despite intervention by Plant Operations subsequent cases in the Operating Room should be moved to another room with the correct temperature and humidity level..."

The facility's surgical staff did not follow their policy.

In an interview Staff #17 and #18 agreed that The Daily Temperature and Humidity Records were out of range.


C.

While observing the process for cleaning and disinfection of the TEE scope on 1/22/2024 at 2:30 PM, Staff #20 drooped the processor adaptor of the scope on the floor of the scope cleaning room. Staff #20 picked the adaptor up off the floor continued to coil the scope and placed it in a plastic tub for transfer to the drying cabinet. Dropping the connection on the floor and then picking it up from the floor contaminated the TEE scope. In effect, the scope needed to be reprocessed. Also, the bin that was to be used for transporting the scope to the drying cabinets was not labeled that it had been cleaned and was ready for use to transport a clean TEE scope. There was no way of knowing if the transport bin was clean and disinfected.

An interview with Staff #20 on 1/22/2024 at 2:30 PM revealed that Staff #20 was unsure if the transport bin was clean. When Staff #20 was asked if the scope was considered clean after picking the adaptor up from the floor with sterile gloves and continuing to coil the disinfected scope. Staff #20 confirmed the TEE scope was contaminated and needed to be reprocessed.

The GUS system is used to disinfect the TEE scope. This system is a manual high-level disinfection for endoscopes. This system contains a HEPA filter to protect staff from the toxic fumes of the Metracide OPA used to disinfect the scope. The HEPA filters need to be changed every six months according to manufacturer guidelines. Staff #17 was unable to produce documentation showing that the HEPA filter had ever been changed in the GUS system that was used in the scope cleaning and processing room.

In an interview on 1/25/2024 at 2:30 PM Staff #85 stated, "We cannot get documentation on the GUS System filter change." Staff #2 and #17 confirmed that the filter had not been changed and that there was no evidence found of when the HEPA filter had been changed.

Based on observation and interview the facility failed to ensure the emergency generator for facility #2 was maintained in operational status on 01/24/2024.


Findings include.


On the morning of 01/24/2024 the survey team met with facility staff # 87, the maintenance staff. Staff #87 was asked to demonstrate the function of the emergency generator. Staff #87 opened the generator doors and pressed the start switch. The generator failed to start. Staff #87 attempted the switch several times without igniting the generator. Staff #87 left the generator and entered the building to ensure all breakers were functioning. He returned to the generator and pressed the ignition switch and again the generator failed to ignite.

Staff #87 phoned the maintenance department of facility#1 and spoke with a maintenance co-worker who instructed him to manipulate the switch, as the switch fuse might be faulty. Staff #87 manipulated the switch and the generator ignited as desired.

Staff # 87 confirmed the fuse was not making consistent contact. Staff #87 was asked by the surveyor, "You are going to have that fuse replaced, correct? Staff #87 stated Yes, ma'am".

Maintenance supervisor, staff #100, and VP of Operation staff #40 witnessed the initial test failure of the emergency generator for facility #2.