HospitalInspections.org

Based on record review and staff interviews, the governing body failed to ensure:

A.
1. policies and procedures were approved by the facility governing body in 3 (Administration of Blood and Blood Products, Patient Complaints and Grievances, and Policy on Policies) of 4 (Administration of Blood and Blood Products, Patient Complaints and Grievances, Policy on Policies, and Restraint and Seclusion for Non-Behavioral Health Units.)

2. all the policies and procedures had the name of the specific facility placed on all the policies in 4 of 4 (Administration of Blood and Blood Products, Patient Complaints and Grievances, Policy on Policies, and Restraint and Seclusion for Non-Behavioral Health Units.) hospital policies.

3. the policy and procedures were clear on instruction and easily accessible to all staff in 4 of 4 (Administration of Blood and Blood Products, Patient Complaints and Grievances, Policy on Policies, and Restraint and Seclusion for Non-Behavioral Health Units.) policies.

A review of the policy and procedure Administration of Blood and Blood Products POC 47 revealed a corporate policy and an attached addendum to the corporate policy.

A review of the facility's corporate policy titled "Administration of Blood and Blood Components" dated 04/04/2023 revealed both policies are together, and the reader must separate what would be followed in corporate policy and what part of the addendum was different from the corporate policy.

A review of the corporate policy on the Administration of Blood and Blood Products revealed there were 15 pages to the corporate policy and 6 pages to the facility's addendum. The surveyor spent three hours trying to determine what the difference was between the two policies. The corporate policy referenced the Center of Medicare and Medicaid Services (CMS) and Joint Commission but did not reference The Texas Administrative Code (TAC). The facility does not use the joint commission for its deemed entity. The addendum did not reference any resources.
The corporate policy stated, "A Licensed Independent Practitioner (LIP) can order blood. This may include a nurse practitioner or physician assistant." The addendum stated only a physician must order blood.

The corporate policy stated, "a. The transfusionist will ascertain that signed consent and LIP's order have been obtained."The addendum did not state who should obtain the consent and stated to "notify the physician of patient refusal immediately." A physician must obtain blood consent to ensure the patient understands the benefits and risks of receiving blood. Neither the policy nor the addendum addressed the consent correctly.

The corporate policy stated, "a. Accurate identification and verification of the donor's blood and the intended recipient is the single most important step in ensuring transfusion safety (see Steward policy POC 19 Patient Identification). The policy refers the nurse to another policy to see how the identification process should work.
The addendum stated the blood should be checked by two nurses at the bedside.

A life-threatening reaction can occur when your ABO or Rh blood type and that of the transfused blood do not match. If this happens, your immune system attacks the transfused red blood cells. This can be life-threatening and may cause death. The nurse administering the blood would have to read the corporate policy on blood transfusions, refer to a policy on the patient identifier, and then read the addendum and hopefully not misunderstand or misinterpret the correct process that could put the patient in a life-threatening situation.

There was no evidence that the blood policy or addendum was approved by the governing body.

An interview was conducted with staff #3 and staff #4 on 4/24/24. Staff #3 stated the corporation would not allow the facility to change the policy but could add an addendum if the facility needed to clarify the corporate policy. Staff #3 confirmed that she and #4 worked on the policy addendums to try to make it part of the facility's processes but it was confusing when trying to determine a process due to both policies being available to staff. Staff #4 confirmed the corporate policy must stay intact and could not be altered. Staff #4 stated the addendums are attached to the back of the policy.

A review of the Policy on Policies stated, "Corporate Policy: Policy that is developed by the relevant stakeholder(s), approved at the Steward system level by the Clinical Excellence Committee, and forwarded to the hospitals for review and adoption. Corporate Policies are also known as system-wide policies or National Policies ...

A. General
1. Every policy is designated as either a Corporate Policy (also known as a System Wide or a National Policy) or Hospital Policy (also known as a Local Policy).

2. Each Hospital will have a designated Hospital Policy Coordinator to maintain document control inclusive of Committee minutes, policy tracking and publishing documents to policy portal.

3. All policies are reviewed at least every three years or more frequently, as required by law, regulation and/or accrediting body.

4. All policy actions (approval, review, and revision) are documented in the respective committee minutes.

5. The designated policy author/content expert/stakeholder group will be responsible to review and update a policy when applicable operations, guidelines and/or regulations change or if required by applicable law and/or regulation and/or as noted in the body of the policy.

6. Changes will be made to the original policy by using track changes function of word document to ensure review by committee members responsible for the review and subsequent implementation of the changes. Types of changes may include but are not limited to:
a. Change in regulatory requirements
b. Change in departmental operations including changes to staff resources, technology, available equipment, etc.
c. Change in evidence- based guidelines for clinical procedures

7. References will be updated to reflect the most current regulation, accrediting organization standards, author and/or publication used to complete the update. Department Manager is responsible for ensuring that only the most recent reference manual is available for use.

Revision approval date will be noted in policy update.

8. The tracked policy will be sent to all involved stakeholders identified within the Review and Approval Section of the policy with a written summary of reason for changes.

9. Once approved by the stakeholders, the tracked change policy will be sent to the appropriate approval and implementation process as noted above.

10. All previous/retired versions of the policy will be archived for at least seven years from the date of retirement of that version of the policy."

A review of the Policy on Policies RI 63 stated on the addendum that the system policy had been accepted "as is." However, there was an addendum to the policy. There was no evidence that the policy was approved by the governing body.

A review of the policy for Patient Complaints and Grievances revealed the corporate policy was 5 pages long and the addendum was 7 pages. The addendum stated on 3/22/21 "removed the TJC fax number and average of 7 days." The facility no longer uses The Joint Commission (TJC) as its deemed entity. The policy still had the joint commission information on the policy in how to make a complaint. The review and approval notes revealed there was no evidence the governing body approved the policy.

A review of the corporate policy Restraints and Seclusion for non-behavioral units revealed another state was discussed in a policy that was to be specific for this facility in Texas. The policy stated, "(Exclusion: Massachusetts does not permit Trained RNs to do Face-to-Face Evaluations.)"



B.. bio-medical staff checked for disinfectant residual after disinfecting the RO (reverse osmosis) loop every 30 days and the ultra-filter (Diasafe) was changed every 90 days according to the manufacturer's recommendations. Also, the bio medical staff failed to ensure the RO (reverse osmosis) membrane and the carbon tank were not leaking, and the water room was secured. The dialysis staff failed to disinfect the Fresenius machines every 7 days, perform chlorine checks every 4 hours, and perform chemical analysis and endotoxins as required per the AAMI guidelines. In addition, dialysis staff failed to have immunity against the Hepatitis B virus, know the Hepatitis B status of patients receiving dialysis, and obtain an order to perform hemodialysis on patients.


C.

1. ensure that chemical restraints/emergency behavioral medications (EBM) administered were identified as a chemical restraint in 3 (Patient #30, #85, and #86) of 3 patient medical records reviewed.

2. ensure staff was educated on the administration of chemical restraints/EBM for side effects, respiratory or cardiac distress, and assessment of medication effectiveness and safety after administration in 3 (Patient #30, #85, and #86) of 3 patient medical records reviewed.

3. ensure chemical restraints were added to the restraint log and monitored through Risk and Quality in 3 (Patient #30, #85, and #86) of 3 patient medical records reviewed.

4. ensure the policy and procedure gave clear guidelines on assessing and reassessing a patient after the intravenously or intramuscular (IV/IM) administration of a psychoactive drug was administered as a chemical restraint/EBM.

5. ensure a face-to-face by the provider or trained RN was completed within one hour of the administration of a chemical restraint/EBM.

Refer to Tag A0160

D. ensure 4 (Physician #45, #46, #47, and #48) of 4 physicians were granted privileges to order and administer Moderate and/or Deep Sedation in the Emergency Department to 5 (Patient #33, #34, #36, #40, and #41) of 5 patients. Also, the facility failed to follow its policy titled, "Management of Moderate and/or Deep Sedation by Non-Anesthesia Personnel".

Refer to Tag A0341

Based on review and interview the governing body (GB) failed to ensure that the physician's credential files were completed, and delineation of privileges was approved or not approved by the medical staff chair in 5 (#109, 111, 112, 26 and 27) out of 5 physician credential files.

A review of the delineation of privileges form found that it allows the physician to request what medical privileges he/she requested to perform in the facility. The physician must provide information to the medical executive credential staff and the governing body to ensure they have the education, training, and expertise to request these privileges. Once the physician has been approved by the committee and the GB then the physician can perform the services requested within the facility.


Physician #112
A review of physician #112's credential file revealed he was an orthopedic surgeon (doctors who specialize in the surgery of bones, joints, and muscles.) On 12/20/23 physician #112 requested to have locum tenes privileges (Locum tenens providers work at healthcare facilities temporarily to fill gaps in care or occupy vacant positions until a full-time provider can be found.) The facility did not have an orthopedic surgeon and needed a physician to take the orthopedic call. Physician #112 requested "Orthopedic Surgery Cognitive Privileges." There were no found privileges approved for physician #112. Physician #112 had been actively on call since 1/4/2024. A letter was found in the file from Staff #2 (CEO) that stated physician #112 was approved and privileges were granted from 1/4/24 through 12/31/2024.

Physician #111
A review of physician #111's credential file revealed he was a pulmonologist (a doctor who specializes in lung conditions). On 8/3/22 physician #111 requested the delineation of privileges to have permission to perform moderate sedation. The box stating approved on the delineation form was checked but there was no signature or date on who approved the physician to perform moderate sedation.

A review of the "Committee Approval for Medical and Allied Staff Membership and/or Privileges at Appointment/Reappointment" form revealed the medical department chair signed and dated the form on 8-17-22 but failed to check whether the reappointment was approved or not recommended. The recommendation for moderate sedation privileges was left blank.

Physician #109
A review of physician # 109's credential file revealed he was a pulmonologist (a doctor who specializes in lung conditions.) On 5/10/22 physician # 109 requested the delineation of privileges to have permission to perform moderate sedation. The box stating approved on the delineation form was checked but there was no signature or date on who approved the physician to perform moderate sedation.

A review of the "Committee Approval for Medical and Allied Staff Membership and/or Privileges at Appointment/Reappointment" form revealed the medical department chair signed and dated the form on 8-17-22) but failed to check whether the reappointment was approved or not recommended. The recommendation for moderate sedation privileges was left blank.

Physician #26 and #27
A review of physician credential files for #26 and #27 revealed they were both nephrologists (diagnose, treat, and manage acute and chronic kidney problems and diseases).

Physician #26 had completed and requested nephrology cognitive and procedural privileges on 7-22-22. There was no signature of approval for these requested privileges.

A review of the "Committee Approval for Medical and Allied Staff Membership and/or Privileges at Appointment/Reappointment" form revealed the medical department chair signed and dated the form on 8-17-22 but failed to check whether the reappointment was approved or not recommended.

Physician #27 did not have a delineation of privileges form in his file. A review of the "Committee Approval for Medical and Allied Staff Membership and/or Privileges at Appointment/Reappointment" form revealed the medical chair signed and dated the form on 8/17/22 but failed to check whether the reappointment was approved or not recommended.

An interview was conducted with Staff #82 (credential specialist) and Staff #2 (CEO) on 4/24/24 in the morning concerning the incomplete credential file of physician #112. Staff #82 confirmed the paperwork in the credential files was blank and incomplete. Staff #82 stated she had just taken the job over in September of 2023 and had not gotten to all the credential files to see what was missing and incomplete. Staff #2 stated, "I don't know how this happened." Staff #2 confirmed the credential files were missing privileges and incomplete.

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

A. a properly executed informed consent was in the medical record for 3 (Patient #25, #26, and #27) of 3 patients reviewed for a Peripherally Inserted Central Catheter (PICC Line) and 3 (Patient #33, #34, and #40) of 3 patients reviewed in the Emergency Department (ED) for procedures and procedural sedation/anesthesia. Also, the facility failed to follow its policy titled Informed Consent, General Consent to Treat, and Moderate and/or Deep Sedation by Non-Anesthesia Personnel.

Refer to Tag A 0131

This deficient practice had the likelihood of causing harm to the patients being dialyzed by exposing the patients to a chemical disinfectant used to disinfect the water loop.


B.
1. chemical restraints/emergency behavioral medications (EBM) administered were identified as a chemical restraint in 3 (Patient #30, #85, and #86) of 3 patient medical records reviewed.

2. staff was educated on the administration of chemical restraints/EBM for side effects, respiratory or cardiac distress, and assessment of medication effectiveness and safety after administration in 3 (Patient #30, #85, and #86) of 3 patient medical records reviewed.

3. chemical restraints were added to the restraint log and monitored through Risk and Quality in 3 (Patient #30, #85, and #86) of 3 patient medical records reviewed.

4. the policy and procedure gave clear guidelines on assessing and reassessing a patient after the administration of a psychoactive drug IV/IM used as a chemical restraint/EBM.

5. a 1- hour face-to-face by the provider or trained RN was completed within one hour of the administration of a chemical restraint/EBM.

Refer to Tag A 0160

The deficient practices identified under the following Conditions of Participation were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.


C. chemical restraints/emergency behavioral medication (EBM) orders were not written on a PRN (as needed) basis in 1 (Patient #31) of 1 medical record reviewed. The facility also failed to follow its policy "Restraint and Seclusion for Non-Behavioral Health Units", Policy Number POC 41.

Refer to Tag A 0169

The deficient practices identified under the following Conditions of Participation were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.


D.

1. bio-medical staff checked for disinfectant residual after disinfecting the RO (reverse osmosis) loop every 30 days. Also, the bio-medical staff failed to follow the facility policy "Hemodialysis Water Supply."

This deficient practice had the likelihood of causing harm to the patients being dialyzed by exposing the patients to a chemical disinfectant used to disinfect the water loop.


2. bio-medical staff changed the ultra-filter (Diasafe) every 90 days according to the manufacturer's recommendations for 6 of 6 Fresenius machines located in the hospital.

This deficient practice had the likelihood of causing harm to the patients being dialyzed if the preventive maintenance on the machines was not completed as required by the manufacturer guidelines.


3. bio-medical staff repaired the water leak on the RO (reverse osmosis) membrane and the carbon tank. Also, the facility staff failed to secure the water purification and storage system.

4. bio-medical staff added salt pellets to the brine tank when the salt pellets were below the full mark.

5. staff disinfected the Fresenius dialysis machines every 7 days per manufacturer guidelines.

6. staff performed chemical analysis every 6 months per the AAMI standards on the Fresenius dialysis machines.

7. staff performed endotoxins/cultures every 3 months per the AAMI standards on the dialysis machines.

8. Two (#12 and # 92) of 3 staff members working in high-risk areas (hemodialysis) were vaccinated and/or had positive immunity against the Hepatitis B virus.

9. dialysis staff were performing Total and Residual Chlorine checks every 4 hours while patients were undergoing hemodialysis treatment.

10. dialysate samples were sent to the laboratory for testing when dialysate manufacturers were changed.

11. patients were tested for Hepatitis B surface antigen before the initiation of hemodialysis treatment on 1 (Patient # 70) of 6 patient medical records reviewed. Also, the hospital failed to follow the policy, "Care of the Patient with a Positive Hepatitis B Surface Antigen (HBsAg)".

12. there was an active physician's order for hemodialysis treatment before initiating treatment in 1 (# 72) of 6 patient medical records reviewed Also, the dialysis staff failed to ensure the physician's order for treatment was followed in 2 (# 71 and # 74) of 6 patient medical records reviewed. The hospital staff failed to follow the hospital policy, "AV Fistula, Cannulating Mature Constant Sites".

13. the dialysis machines were disinfected after the treatment of a patient with an unknown hepatitis B status.


Refer to Tag A 0144

Based on document review and interview the facility failed to ensure a properly executed informed consent was in the medical record for 3 (Patient #25, #26, and #27) of 3 patients reviewed for a Peripherally Inserted Central Catheter (PICC Line), 3 (Patient #33, #34, and #40) of 3 patients reviewed in the Emergency Department (ED) for procedures and procedural sedation/anesthesia, and 4 (# 70, # 71, # 73, and # 74) of 6 patients reviewed before initiation of hemodialysis treatment.


It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, impairment and /or subsequent death.

Findings:


Patient #25

A review of Patient #25's medical record revealed Physician #84 signed a PICC Line Order dated 4/08/2024 at 6:20 PM.

(A Peripherally Inserted Central Catheter is a thin flexible tube inserted in a vein in your arm and threaded into a larger vein above the right side of your heart. It is used to give IV medications, fluids, blood transfusions, chemotherapy, and other drugs needed over a longer time).

A review of the informed consent document titled "Vascular Access" was as follows:
" ...I (we) voluntarily request Dr.(Physician #84) as my physician and such associates, technical assistants, and other health care providers as they may deem necessary, to treat my condition which has been explained to me by my physician as: (No condition was documented)

Access to a large vein to give medicines, fluids, nutrients, or blood products over a long period of time.
Other_______________________________________________
...
Placement of a peripherally inserted central catheter (PICC) ..."

The informed consent was signed by Patient #25 on 4/08/2024 at 2:55 PM and witnessed by Staff RN #89. Staff RN #89 failed to date and time their signature. Further review of the informed consent revealed the patient consented to blood/blood products and anesthesia. There was no documentation on the consent regarding the type of anesthesia to be administered.

A review of the PICC Line insertion note revealed RN Staff #85 placed the PICC line on 4/09/2024 at 8:57 AM. RN Staff #85 was not on the informed consent as the RN performing the procedure.


An interview was conducted with RN Staff #85 on 4/24/2024 at 9:50 AM. RN Staff #85 was asked if he had the patient sign the consent form for the PICC Line placement. RN Staff #85 confirmed the nurse on the floor gets the consent signed. RN Staff #85 was asked if he put his name on the consent form as the person placing the PICC Line. RN Staff #85 stated, "I usually put the doctor's name that orders the line and mine". RN Staff #85 was asked who explained the risks and benefits of the procedure. RN Staff #85 stated, "I talked to the patient about placing the line in their arm before we start, and I asked them if they have any questions". RN Staff #85 was asked if he explained the risks and benefits of a blood transfusion or anesthesia to the patient. RN Staff #85 confirmed he did not talk to them about blood transfusions or anesthesia risks and benefits. RN Staff #85 confirmed his name was not on the consent.

RN Staff #10 confirmed on 4/23/2024 at 10:30 AM there was no documentation in the medical record by Physician #84 confirming the risks and benefits had been explained to the patient for a PICC Line placement, blood transfusion, or anesthesia before the informed consent was signed.


Patient #26

A review of Patient #26's medical record was completed on 4/23/2024 at 10:20 AM with RN Staff #10. Record review revealed Physician #86 signed the PICC Line Order on 4/08/2024 at 2:30 PM.

A review of the informed consent document titled "Vascular Access" was as follows:
" ...I (we) voluntarily request Dr.(Physician #86) as my physician and such associates, technical assistants, and other health care providers as they may deem necessary, to treat my condition which has been explained to me by my physician as: (No condition was documented)

Access to a large vein to give medicines, fluids, nutrients, or blood products over a long period of time.
Other_______________________________________________
...
Placement of a peripherally inserted central catheter (PICC) ..."

The informed consent was signed by Patient #26 on 4/08/2024 at 5:55 PM and witnessed by Staff RN #88 (signature illegible). RN Staff #88 failed to date and time their signature. The RN witnessing the consent was the same RN placing the PICC Line, RN Staff #88. No other witness signature was documented. Further review of the informed consent revealed the patient consented to blood/blood products and anesthesia. There was no documentation on the consent of what type of anesthesia would be administered.

A review of the PICC Line insertion note revealed RN Staff #88 placed the PICC line on 4/08/2024 at 5:47 PM. RN Staff #88 was not on the informed consent as the RN performing the procedure.

RN Staff #10 confirmed on 4/23/2024 at 10:40 AM there was no documentation in the medical record by Physician #84 confirming the risks and benefits had been explained to the patient for a PICC Line placement, blood transfusion, or anesthesia before the informed consent was signed.


Patient #27

A review of Patient #27's medical record revealed Physician #87 signed the PICC Line Order on 4/07/2024. Physician #87 failed to document a time for the order.

A review of the informed consent document titled "Vascular Access" was as follows:
" ...I (we) voluntarily request Dr.(Physician #87) as my physician and such associates, technical assistants, and other health care providers as they may deem necessary, to treat my condition which has been explained to me by my physician as: (No condition was documented)

Access to a large vein to give medicines, fluids, nutrients, or blood products over a long period of time.
Other_______________________________________________
...
Placement of a peripherally inserted central catheter (PICC) ..."

The informed consent was signed by Patient #27 on 4/07/2024 at 1:45 PM and witnessed by (signature illegible). The witness failed to date and time their signature. Further review of the informed consent revealed the patient consented to blood/blood products and anesthesia. There was no documentation of what type of anesthesia would be administered.

A review of the PICC Line insertion note revealed RN Staff #88 placed the PICC line on 4/07/2024 at 4:44 PM. RN Staff #88 was not on the informed consent as the RN performing the procedure.

RN Staff #10 confirmed on 4/23/2024 at 10:45 AM there was no documentation in the medical record by Physician #84 confirming the risks and benefits had been explained to the patient for a PICC Line placement, blood transfusion, or anesthesia before the informed consent was signed.


A review of the facility policy titled, "Consent, Informed" with a final approval date of 10/05/2023 was as follows:

" ...POLICY
(Name of hospital) recognizes that every adult with decision making capacity has the right to make informed decisions regarding their care, treatment and services. The right to make informed decisions means that patients are provided with sufficient information in a manner that can be understood to permit them to make an informed and rational decision on whether to submit to a proposed course of treatment. The patient should be told the nature of the illness or condition, the general nature of the proposed treatment, the benefits, the risks, and side effects of the planned treatment, the risks of failing to undergo treatment, the likelihood of the patient achieving their goals, potential problems that might occur during recuperation and reasonable alternative treatments. Obtaining informed consent is the physician's or other qualified provider's responsibility. Documentation of the informed consent process can be completed by one of the following methods:

1. Making a summary note of the discussion and patient or their designee's agreement in the patient's medical record that the informed consent process has been completed; or
2. Making a summary note of the discussion and patient or their designee's agreement in the patient's medical record as part of the procedural note that the informed consent process has been completed; or
3. By completing or having completed a signed consent form in compliance with requirements of the Texas Medical Disclosure Panel ..."

An interview was conducted with RN Staff #10 on 4/23/2024 at 10:20 AM. RN Staff #10 was asked who discussed the risks and benefits of a PICC Line to the patients. RN Staff #10 stated, "It should be the doctor that ordered it". RN Staff #10 was asked why the physician's name was on the informed consent and not the RN completing the procedure. She replied, "The nurse puts the name of the ordering physician on the consent and then gets it signed by the patient".

RN Staff #10 confirmed the RN placing the PICC Line should not be the person witnessing the consent. She stated, "It should be the nurse caring for the patient that witnesses the consent".

In an interview on 4/23/2024 at 10:45 AM, Physician #91 confirmed his name should not be listed as the physician on the informed consent for vascular access (PICC Lines) because he would not be the provider placing the PICC Line. Physician #91 was asked if he explained the risks and benefits of a PICC Line to the patient. He replied, "Yes, I would, and I would explain to them the reason it was needed".

On 4/24/2024 at 11:00 AM CNO Staff #3 and Quality Director Staff #4 confirmed 3 (Patient #25, #26, and #27) of 3 patients reviewed did not have a properly executed informed consent for a PICC Line placement.


Patient #33

Patient #33 was admitted to the Emergency Department (ED) on 3/24/2024 at 6:43 PM with a dislocated left shoulder.

A review of the informed consent for Anesthesia revealed Patient #33 signed the consent for Moderate Sedation on 3/24/2024 at 7:32 PM and the consent was witnessed by the RN. The Anesthesia Signature was left blank.

Physician #47 administered 75 (milligrams) mg of Propofol (a general anesthetic medication) Intravenously (IV) at 7:36, 25 mg of Propofol IV at 7:38, and 75 mg of Propofol IV at 7:42 PM for a left shoulder reduction.

A review of the document titled, "Procedural Sedation Documentation" dated 3/24/2024 at 7:19 PM revealed Physician #47 explained the risks and benefits of Moderate Sedation and failed to include the risks and benefits of deep sedation with Patient #33 before the procedure began.

RN Staff #21 confirmed on 4/23/2024 at 3:00 PM that Physician #47 failed to document that he explained the risks and benefits of Deep Sedation. Also, Staff #30 confirmed on 4/29/2024 at 1:00 PM there was no informed consent for the Left Shoulder Reduction on 3/24/2024 by Physician #47 in the medical record.


Patient #34

Patient #34 was a 5 year old male admitted to the ED on 1/17/2024 at 4:49 AM with a foreign body (FB) stuck in his nose.

A review of the informed consent for Anesthesia was signed by the legally authorized representative (LAR) for Moderate Sedation and witnessed by the nurse on 1/17/2024 at 5:45 AM. The Anesthesia Provider's Signature was blank.

RN Staff #103 administered 60mg of Ketamine (a dissociative anesthetic medication) Intramuscular (IM) on 1/17/2024 at 5:46 AM for moderate sedation.

A review of the document titled, "Procedural Sedation Documentation" dated 1/17/2024 at 5:45 AM revealed Physician #47 explained the risks and benefits of Moderate Sedation and failed to include the risks and benefits of deep sedation.

RN Staff #21 confirmed on 4/23/2024 at 3:00 PM there was no informed consent for the FB Removal in the patient's medical record.


Patient #40

Patient #40 arrived at the ED on 2/05/2024 at 1:19 PM with a right wrist injury.

A review of the informed consent for Moderate Sedation revealed Patient #40 and Physician #46 signed the consent on 2/05/2024 at 4:10 PM. The RN (signature illegible) witnessed the consent on 2/05/2024 at 4:10 PM.

Physician #46 administered 50mg of Propofol IV at 4:37 PM for moderate sedation.

A review of the document titled, "Procedural Sedation Documentation" dated 2/05/2025 at 4:35 PM revealed Physician #46 explained the risks and benefits of Moderate Sedation and failed to include the risks and benefits of deep sedation.

A review of the informed consent for the procedure was as follows, " ...Procedure: Closed reduction of the right wrist with other indicated procedures ..." The informed consent was signed by the patient on 2/05/2024 at 4:10 PM and witnessed by the RN (signature illegible). The witness failed to date and time their signature.

RN Staff #21 confirmed on 4/23/2024 at 3:00 PM that Physician #46 did not sign the informed consent for the closed reduction of the right wrist and failed to document he had discussed the risks and benefits of the procedure with the patient before the consent was signed by the patient.

A review of the policy titled, "General Consent to Treat", Policy Number RI 33 with a last revised date of 10/03/2023 was as follows:

" ...The General Consent to Treat is required for routine treatment provided during emergency room visits, inpatient hospitalization and outpatient care. Furthermore, the policy advises patients of critical information before treatment is commenced in a hospital setting ...

PROCEDURE
1. Inpatient/Outpatient Procedures: Consent to Routine Treatment
A ...
B. The General Consent for Treatment for provides authority for routine diagnostic work-up and routine treatment only. Continuing treatment, invasive examinations, as well as invasive procedures, all require Specific Informed Consent (See #II below) ...

II. Informed Consent for Procedures

A. Invasive clinical procedures outside the scope of routine hospital care as required by applicable law and regulatory statute, require a detailed informed consent discussion with the patient (or the patient's surrogate decision-maker).
B. The discussion is conducted by the Licensed Provider (LP) performing the procedure or his/her designee who is a clinician directly involved in the procedure (e.g. Physician, Advanced Practice Nurse, Resident, etc.).
C. The process of informed consent is ultimately the sole responsibility of the primary practitioner completing the procedure.
D. Documentation of the informed consent process may be completed by the physician or his/her designee and should include discussion and understanding with the patient of the risks, benefits and alternative procedures or course of treatment.
E. Specific clinical procedures requiring informed consent are approved by the Medical Staff and may include the following general categories:
1. Major/minor surgical or invasive procedures. Any procedure involving general anesthesia, moderate or deep sedation, or regional blocks ..."

A review of the facility policy titled, "Management of Moderate and/or Deep Sedation by Non-Anesthesia Personnel" was as follows:

" ...Policy
Moderate or deep sedation is administered for procedures either directly by licensed independent practitioners credentialed and privileged within the department of anesthesia and/or by a qualified licensed independent practitioner who has appropriate privileges for the planned level of anesthesia ...

A. Location
The use of deep sedation for procedural interventions by non-anesthesia personnel is restricted to the ED.
...
J. Medications
Moderate and deep sedation medications may only be ordered and administered as follows:

1. Moderate Sedation
a. A physician with privileges in the administration of moderate sedation orders the medications for moderate sedation, specifying dose and route ...
2. Deep Sedation
a. An ED physician with privileges in the administration of deep sedation orders the medications for deep sedation specifying dose and route.
b ...
c. Medications include but are not limited to Ketamine (dissociative anesthetic), Etomidate (anesthetic medication), and Propofol (a general anesthetic medication) ...
d. The use of Ketamine, Etomidate (a general anesthetic medication), and Propofol is restricted to ED physicians with privileges to administer deep sedation ..."


An interview was conducted on 4/24/2024 at 9:30 AM with CNO Staff #3 and Quality Director Staff #4. CNO Staff was asked if patients are given Ketamine or Propofol should they be consented for Deep Sedation. CNO Staff #3 and Quality Director Staff #4 confirmed if patients are administered Etomidate, Ketamine, or Propofol they should be consented to Moderate and Deep Sedation according to the facility policy.



48653


Findings:

During a review of patient medical records with Staff # 98 on 04/24/2024 at 10:30 AM, the surveyor observed hemodialysis treatment was initiated before obtaining informed consent for hemodialysis treatment.


Patient # 70

Patient # 70 was admitted to the hospital on 04/08/2024 at 8:23 PM. The patient's first hemodialysis treatment was initiated on 04/09/2024 at 9:38 AM. The patient did not sign a hemodialysis informed consent until 04/09/2024 at 10:02 AM.

Patient # 71

Patient # 71 was admitted to the hospital on 03/27/2024. The patient's first hemodialysis treatment was initiated on 03/27/2024 at 11:02 AM. The patient did not sign a hemodialysis informed consent until 03/27/2024 at 11:10 AM. The physician who ordered hemodialysis treatment did not sign the informed consent. There was no documentation in the medical record that the physician discussed the risks and benefits of hemodialysis treatment before the start of treatment.

Patient # 73

Patient # 73 was admitted to the hospital on 04/02/2024 at 12:17 PM. The patient's first hemodialysis treatment was on 04/02/2024 at 2:03 PM. The patient did not sign a hemodialysis informed consent until 04/02/2024 at 2:07 PM. The physician who ordered hemodialysis treatment did not sign the informed consent. There was no documentation in the medical record that the physician discussed the risks and benefits of hemodialysis treatment before the start of treatment.

Patient # 74

Patient # 74 was admitted to the hospital on 04/02/2024 at 3:35 PM. The patient's first hemodialysis treatment was on 04/03/2024 at 9:54 AM. The patient did not sign a hemodialysis consent until 04/03/2024 at 10:30 AM. The physician who ordered hemodialysis treatment did not sign the informed consent. There was no documentation in the medical record that the physician discussed the risks and benefits of hemodialysis treatment before the start of treatment.

A review of the hospital's policy titled, "Informed Consent" with an approval date of 10/05/2023 revealed the following,

"POLICY: Wadley Regional Medical Center (WRMC) recognizes that every adult with decision-making capacity has the right to make informed decisions regarding their care, treatment, and services. The right to make informed decisions means that patients are provided with sufficient information in a manner that can be understood to permit them to make an informed and rational decision on whether to submit to a proposed course of treatment. The patient should be told the nature of the illness or condition, the general nature of the proposed treatment, the benefits, the risks, and the side effects of the planned treatment, the risks of failing to undergo treatment, the likelihood of the patient achieving their goals, potential problems that might occur during recuperation and reasonable alternative treatments. Obtaining informed consent is the physician's or other qualified provider's responsibility ..."

During an interview with Staff # 98 (Dialysis Clinical Director) on 04/24/2024 at 11:30 AM, Staff # 98 acknowledged the dialysis staff were initiating hemodialysis treatment on patients before the patients had signed a hemodialysis informed consent. Staff # 98 also confirmed the physician did not sign the hemodialysis informed consent and document the risks and benefits that had been discussed with the patient before the start of treatment.

Based on observation, record review, and interview, the hospital's:


A. bio-medical staff failed to check for disinfectant residual after disinfecting the RO (reverse osmosis) loop every 30 days. Also, the bio-medical staff failed to follow the facility policy "Hemodialysis Water Supply."

This deficient practice had the likelihood of causing harm to the patients being dialyzed by exposing the patients to a chemical disinfectant used to disinfect the water loop.


B. bio-medical staff failed to change the ultra-filter (Diasafe) every 90 days according to the manufacturer's recommendations for 6 of 6 Fresenius machines located in the hospital.

This deficient practice had the likelihood of causing harm to the patients being dialyzed if the preventive maintenance on the machines was not completed as required by the manufacturer guidelines.


C. bio-medical staff failed to repair the water leak on the RO (reverse osmosis) membrane and the carbon tank. Also, the facility staff failed to secure the water purification and storage system.


D. bio-medical staff failed to add salt pellets to the brine tank when the salt pellets were below the full mark.


E. staff failed to disinfect the Fresenius dialysis machines every 7 days per manufacturer guidelines.


F. staff failed to perform chemical analysis every 6 months per the AAMI standards on the Fresenius dialysis machines.


G. staff failed to perform endotoxins/cultures every 3 months per the AAMI standards on the dialysis machines.


H. employee health department failed 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. Two (#12 and # 92) of 3 staff members working in high-risk areas (hemodialysis) were not vaccinated and/or did not have positive immunity against the Hepatitis B virus.

I. dialysis staff failed to ensure Total and Residual Chlorine checks every 4 hours while patients were undergoing hemodialysis treatment.

J. dialysis staff failed to ensure dialysate samples were sent to the laboratory for testing when dialysate manufacturers were changed.

K. staff failed to ensure patients were tested for Hepatitis B surface antigen before the initiation of hemodialysis treatment on 1 (Patient # 70) of 6 patient medical records reviewed. Also, the hospital failed to follow the policy, "Care of the Patient with a Positive Hepatitis B Surface Antigen (HBsAg)".

L. staff failed ensure there was an active physician's order for hemodialysis treatment before initiating treatment in 1 (# 72) of 6 patient medical records reviewed Also, the dialysis staff failed to ensure the physician's order for treatment was followed in 2 (# 71 and # 74) of 6 patient medical records reviewed. The hospital staff failed to follow the hospital policy, "AV Fistula, Cannulating Mature Constant Sites".

M. staff failed to ensure the dialysis machines were disinfected after the treatment of a patient with an unknown hepatitis B status.


Findings:

A.

A review of the water loop disinfection log for the months of February, March, and April 2024 revealed the biomedical staff did not document the disinfection residual was clear after the water loop had been disinfected.
A review of the water disinfection log had no place to document the residual was clear after the bio-medical had disinfected the water loop.

A review of the policy titled; "Hemodialysis Water Supply" revealed the following:

"POLICY
Water supplied to the Hemodialysis machine must meet the Association for the Advancement of Medical Instrumentation (AAMI) standards for water for Hemodialysis (at a minimum standard of RD62:2006).
SCOPE
This policy applies to the Hemodialysis Staff.
PROCEDURE
The bacterial quality of both the water and the dialysate will be checked monthly.
Each time the treated water system and distribution piping are disinfected, the dialysis machines will be put into Rinse program. This allows the disinfectant chemical to feed through the inlet system. The water will be tested for residual disinfectant prior to use for dialysis."

An interview with Bio-medical technician #12 on 04/24/2024 at 11:00 AM confirmed the disinfectant residual was not being documented on the water loop disinfection log and that there was no place on the log to document that the disinfectant was clear before the patients were dialyzed. Also, Staff #12 confirmed that the facility's policy "Hemodialysis Water Supply" was not being followed.

B.

During a tour of the dialysis department on 04/24/2024 at 10:00 surveyor observed that the Diasafe filters on the back of the 6 Fresenius dialysis machines were last changed on September 7, 2023.

A review of the "Dialysis Diasafe Filter Change Log" showed the last time the Diasafe filters were last changed was January 4, 2023. Patients were currently being dialyzed on the machines.

A review of the Operator's instructions for the 2008H and 2008K with "Diasafe" filters revealed the following guidelines:

"Replace the DIASAFE filter at least every 90 days (3 months). After replacing the DIASAFE filter, perform either the automated test function or a manual pressure holding test AND then perform the DIASAFE filter integrity test."


An interview with Staff #56 on 04/24/2024 at 11:00 AM confirmed the Diasafe filters had not been changed since September 2023. Also, Staff #56 confirmed that the Diasafe filters were not being documented as changed on the "Dialysis Diasafe Filter Change Log."

C.

During a tour of the dialysis department water room on 04/24/2024 at 10:00 AM surveyor observed an orange discolored liquid running down the side of the RO (reverse osmosis) membrane. Also, there was clear liquid running down the side of the carbon tank. Also, during the tour of the purification water system observed the door and entrance to the room where the water room was located were left open to unauthorized users.

An interview with Staff #12 on 04/24/2024 at 10:00 AM was asked if the housekeeping cleans the water room location. Staff #12 stated, "Yes."

A review of the ANSI/AAMI RD52:200 Environment: secured & restricted guidelines revealed the following:

"The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system."


An interview with Staff #12 and #56 on 04/24/2024 at 10:00 AM confirmed that the RO (reverse osmosis) membrane and the carbon tank were leaking. The carbon tank was last changed out by a private company on 2/11/2024 and it had been leaking since that date per Staff #56. Staff members #12 and #56 could not speak to how long the RO (reverse osmosis) membrane had been leaking. Also, Staff #12 confirmed the water purification system was not restricted to authorized users.

D.

During a tour of the dialysis department water room on 04/24/2024 at 10:00 AM with Staff #12 and #56 the surveyor observed that the brine tank salt pellets were below the halfway mark. The salt pellets were below the water level and a black substance floating on top of the water level.

A review of the ANSI/AAMI RD62 revealed the following:

"The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head."

An interview with staff #12 and #56 on 04/24/2024 at 10:00 AM confirmed that the salt pellets were below the halfway mark and there was a black substance floating on top of the water.

E.

A review of the "Dialysis Machine Check log" for the months of February, March, and April 2024 revealed that the 6 Fresenius dialysis machines were not being disinfected every Tuesday per the hospital policy. Staff documented disinfection was performed on a Monday one week and the next week the machines would be disinfected on a Tuesday. There was no consistency with the machines being disinfected on a Tuesday per the hospital policy.

A review of the hospital policy titled, "Guidelines, Staff General" revealed the following:

"Policy:

1. Acid rinse followed by heat disinfection is to be done on all dialysis machines on Sunday, Monday, Wednesday, and Friday after each treatment day.
2. Bleach rinse is to be done on Tuesday, followed by heat disinfection.
3. Bleach rinse concentration is 6.125% (76 ml of R/O water to 244 ml of bleach).
4. No reuse of artificial kidneys.
5. Staff must record vital signs, venous pressure, blood flow, and speed at least every 30 minutes during Hemodialysis.
6. Arteriovenous grafts and fistulas are not to be cannulated unless protective face masks are worn.
7. No eating or drinking in Hemodialysis Unit.
8. All patients are to be weighed pre and post dialysis weights should be done using the same method of scales."

An interview with Staff #12 on 04/24/2024 at 1:30 PM confirmed the staff were not bleaching the 6 Fresenius machines every Tuesday per the hospital policy "Guidelines, Staff General."

F.

A review of the logs for chemical analysis of the RO system (Reverse Osmosis), six (6) Fresenius dialysis machines, and four (4) Tablo dialysis machines were last performed on 01/31/2022. There were no other logs found for the chemical analysis.

A review of the AAMI guidelines requires the following for chemical analysis:
"(24) Samples of product water used for dialysis shall be submitted for chemical analysis every six months, and after a change of the reverse osmosis membranes, and shall demonstrate that the quality of the product water used to prepare dialysate, concentrates from powder, or to reprocess
dialyzers for multiple use meets §4.1.1 (concerning Maximum level of chemical contaminants in water) of the American National Standards Institute, Water Treatment Equipment for Hemodialysis Applications, RD52:2004 Edition, published by the AAMI."

An interview with Staff #12 on 04/24/2024 at 1:30 PM confirmed that the last chemical analysis was performed on 01/31/2022 and that there has been no further chemical analysis performed.

G.

A review of the "Microbiology Sampling Form for Dialysis Machines and RO Water" logs for endotoxins of the RO system (Reverse Osmosis), six (6) Fresenius dialysis machines, and four (4) Tablo dialysis machines for the months of February, March, and April 2024 were being performed but not consistently every quarter. There was no schedule as to when each machine and the RO water would have samples drawn to check for endotoxin levels.

A review of the AAMI guidelines requires the following for endotoxins:
"For newly installed bicarbonate concentrate mixing and delivery systems, weekly testing shall be conducted for one month to verify that bacteria and endotoxin levels are consistently within the allowed limits. Responsible facility staff shall develop a schedule to ensure each hemodialysis
machine is tested quarterly for bacterial growth and the presence of endotoxins."

An interview with Staff #12 on 04/24/2024 at 2:00 PM confirmed that the machines and the RO system were not being sampled every quarter for endotoxin levels.


A review of the hospital's "Infection Prevention and Control Plan 2024" revealed,

OBJECTIVE: There is an effective organization-wide program for the surveillance, prevention, and control of infections at Facility A. A coordinated process is used to reduce the risks of endemic and epidemic healthcare-acquired infections in patients and healthcare workers ...
Infection Preventionist and Employee Health are responsible for many other activities to prevent and control infection transmission in the hospital and outpatient areas ...
8. Dialysis Water Reports A report from Biomedical Engineering about sterility monitoring of dialysis water and dialysate is provided quarterly to the Patient and Environmental Safety Committee and bimonthly to the Infection Prevention and Control Committee through IC PI Trending report."




48653



Findings:


H.

The unknown immunity status of staff members could result in the transmission of the hepatitis B virus between patients and staff members. Two (#12 and # 92) of 3 staff members working in high-risk areas (hemodialysis) were not vaccinated and/or did not have positive immunity against the Hepatitis B virus.

This deficient practice had the likelihood to result in harm to staff members working in high-risk areas of the hospital due to failure to monitor hepatitis B immunity and vaccination status.


Staff # 12

A review of Staff # 12's personnel file revealed Staff # 12 received a booster dose of the Hepatitis B vaccine on 10/17/2023. Staff # 12 had a nonreactive HBV (Hepatitis B Virus) surface antibody result on 11/27/2023 indicating Staff # 12 had no immunity to the Hepatitis B virus. Staff # 12 did not sign a declination form demonstrating refusal of additional vaccines.

Staff # 92

A review of Staff # 92's personnel file revealed Staff # 92 received a complete Hepatitis B vaccine series in 1983. Staff # 92 did not have titers drawn. There was no evidence of positive immunity for Staff # 92.

A review of the hospital policy titled, "Employee Health Records" with an approval date of 04/06/2023 revealed,

"POLICY: Employee health records will be maintained on each employee in the Employee Health Office. These records include, but may not be limited to: Records of immunizations, tests performed, and the pre-employment health assessment ...
Hepatitis B: Observe universal blood/body precautions. All personnel who are at risk for blood/body fluid exposure should take the Hepatitis B immunization ..."

A review of the hospital's "Infection Prevention and Control Plan 2024" revealed,

OBJECTIVE: There is an effective organization-wide program for the surveillance, prevention, and control of infections at Wadley Regional Medical Center. A coordinated process is used to reduce the risks of endemic and epidemic healthcare-acquired infections in patients and healthcare workers ....
Infection Preventionist and Employee Health are responsible for many other activities to prevent and control infection transmission in the hospital and outpatient areas.
1. Employee Health Reports: A report regarding measures taken by Employee Health in response to employee work-related exposures to infectious agents, sharp injuries, and the status of prophylactic vaccination programs is presented to Infection Prevention and Control Committee bi-monthly."

There was no documentation provided to the surveyor to support the hospital's Infection Control Committee was made aware of Staff # 12's and # 92's immunity status against the Hepatitis B virus while working in a high-risk area.

During an interview with Staff # 93 on 04/23/2024 at 2:30 PM in the administrative conference room, Staff # 93 acknowledged staff members were working in high-risk areas (hemodialysis) with unknown immunity status to Hepatitis B virus. Staff # 93 confirmed Staff # 12 had not signed a declination form demonstrating refusal of the vaccine series.


I.
This deficient practice had the likelihood of resulting in a patient undergoing hemodialysis treatment being exposed to high levels of chlorine. Exposure to high levels of chlorine in treatment water can cause oxygen desaturation and hemolytic anemia.

A review of the hospital's "Hemodialysis Chlorine Monitoring Log" for January, February and April of 2024 revealed the dialysis staff did not check chlorine every 4 hours on the following dates:

January 15th, 2024
Chlorine checks were performed at 8:30 AM and 1:50 PM.

January 17th, 2024
Chlorine checks were performed at 8:00 AM and 2:00 PM.

January 20th, 2024
Chlorine checks were performed at 7:00 AM and 12:00 PM.

January 24th, 2024
Chlorine checks were performed at 7:00 AM, 11:00 AM, and 9:30 PM.

January 25th, 2024
Chlorine checks were performed at 1:00 AM and 6:55 AM.

January 27th, 2024
Chlorine checks were performed at 7:10 AM and 3:20 PM.

February 5th, 2024
Chlorine checks were performed at 6:45 AM, 11:20 AM, and 4:30 PM.

April 4th, 2024
Chlorine checks were performed at 7:00 AM, 11:00 AM, and 8:45 PM.

A review of the hospital policy, "Free Chlorine/Total Chloramines Test" with an approval date of 02/01/2024 revealed,

"POLICY: The performance of carbon beds is monitored by measuring the total chlorine concentration in the water exiting the first carbon bed.
Testing for Total Chlorine and Residual Chlorine should be performed at the beginning of each treatment day prior to the patient's initiating treatment and every 4 hours while in use. Results should be recorded on the Total Chlorine and Residual Chlorine Log ..."

During an interview with Staff # 12 on 04/23/2024 in the dialysis treatment suite, Staff # 12 acknowledged there were many treatment days when chlorine was not checked every 4 hours during a patient's treatment.


J.
During a tour of the hospital's dialysis suite on 04/23/2024 at 3:30 PM, the surveyor observed 2 different manufacturers of acid concentrate stored in the dialysis suite supply room. The surveyor observed jugs of Citrasate 45X acid solution and jugs of Naturalyte 45X acid solution stored together on the same shelf.

During an interview on 04/23/2024 at 3:35 PM, Staff # 3 reported both manufacturers of acid were being used and the staff were not aware samples were to be sent to the laboratory for testing when changing between the 2 manufacturers on the same dialysis machine.

K.
This deficient practice had the likelihood of resulting in patients and staff members being exposed to the Hepatitis B virus due to the unknown and potentially positive Hepatitis B status of the patient undergoing hemodialysis treatment.

A review of Patient # 70's medical records with Staff # 98 (Hemodialysis Clinical Director) revealed the following,

Patient # 70 was admitted to the hospital on 04/08/2024 at 8:23 PM. The patient's first hemodialysis treatment of this admission was on 04/09/2024 at 09:38 AM. There was no record of a Hepatitis B surface antigen drawn during this admission. The last Hepatitis B surface antigen resulted as negative on 09/01/2023 at 3:30 PM.

A review of the hospital's policy, "Care of the Patient with a Positive Hepatitis B Surface Antigen (HBsAg)" with an approval date of 09/07/2023 revealed the following,

"POLICY: The HBsAg status of all patients should be ascertained prior to treatment by either a written report from the referring center (including the most recent date testing was performed), verbal notification from the physician, or serologic test. If hepatitis status is unknown by either of these methods, the patient should be treated as a suspect for HBsAg until serologic status is determined. The HBV serologic status should clearly be documented on dialysis records and reports should be readily available in the electronic medical record for review. All healthcare personnel assigned to these patients, as well as the Infection Preventionist, should be aware of the patient's serologic status.

SCOPE: This policy applies to the hemodialysis staff.

PROCEDURE: The hemodialysis staff will ascertain the HBsAg status of all patients prior to initiation of hemodialysis and document it on the hemodialysis plan of care prior to each patient treatment."

During an interview with Staff # 98 on 04/24/2024 at 10:30 AM, Staff # 98 acknowledged the dialysis staff were not always obtaining a Hepatitis B surface antigen prior to initiating treatment on the patients. Staff # 98 acknowledged Patient # 70 never had a Hepatitis B antigen drawn during the 04/08/2024 hospital visit.

L.

Patient # 72

During a review of medical records with Staff # 98 on 04/24/2024 at 10:30 AM the surveyor noted the dialysis staff had initiated hemodialysis treatment on Patient # 72 before the physician placed the orders for hemodialysis into the electronic medical record.

Patient # 72 was admitted to the hospital on 04/02/2024 at 5:26 AM. The patient's first hemodialysis treatment was on 04/02/2024 at 10:30 AM. Staff # 104 initiated the hemodialysis treatment.
The physician did not enter an order for hemodialysis treatment into the electronic medical record until 04/02/2024 at 10:58 AM.

In an interview with Staff # 104 on 04/24/2024 at 10:40 AM, Staff # 104 stated, "I took the order over the phone from the doctor and then started treatment, but I did not document that I got the order over the phone and entered the order after treatment began".

Patient # 71

Patient # 71 was admitted to the hospital on 03/27/2024. The patient's first hemodialysis treatment was on 03/27/2024 at 11:02 AM.

The physician ordered a blood flow rate (BFR) of 400 ml/min (milliliters per minute) and a dialysate flow rate (DFR) of 300 ml/min.

Staff # 104 documented the following at the start of the patient's hemodialysis treatment:
"Blood Flow Rate: 400 ml/min
Dialysate Flow Rate: 400 ml/min"

Staff # 104 did not follow the physician's orders for BFR and DFR.

Patient # 74

Patient # 74 was admitted to the hospital on 04/02/2024 at 3:35 PM. The patient's first hemodialysis treatment was on 04/03/2024 at 9:59 AM.

The physician ordered a blood flow rate of 400 ml/min and a dialysate flow rate of 500 ml/min.

Staff # 106 documented the following at the start of the patient's hemodialysis treatment:
"Blood Flow Rate: 500 ml/min
Dialysate Flow Rate: 400 ml/min"

Staff # 106 did not follow the physician's orders for BFR and DFR.

A review of the hospital policy, "AV Fistula, Cannulating Mature Constant Sites" with a final approval date of 02/01/2024 revealed the following,
"PROCEDURE:
1. Verify order ..."

During an interview with Staff # 98 on 04/24/2024 at 10:45 AM, Staff # 98 acknowledged the dialysis staff had not followed the physician's order for hemodialysis and did not ensure the order for hemodialysis was entered into the electronic medical record prior to starting hemodialysis treatment.

M.

This deficient practice had the likelihood of resulting in the transmission of the Hepatitis B virus to other patients receiving hemodialysis at the hospital.

During a review of medical records for Patient # 73, the surveyor noted the patient was admitted on 04/02/2024 at 12:17 PM. The patient's first hemodialysis treatment was on 04/02/2024 at 2:03 PM. The patient was treated on hemodialysis machine # 4242.
The patient's Hepatitis B status did not result until the day after treatment on 04/03/2024 at 2:20 AM.

A review of the "Dialysis Machine Check Log" for April of 2024 revealed machine # 4242 underwent a bleach disinfection on 04/02/2024. However, there is no time documented. It is unknown if the machine was bleached after Patient # 73's hemodialysis treatment.

An interview with Staff # 98 on 04/24/2024 at 11:45 AM confirmed the dialysis staff were not aware of the patient's hepatitis B status and did not document the time the machine underwent disinfection. Staff # 98 was unsure when Machine 4242 underwent bleach disinfection and Staff # 98 agreed a time of disinfection should have been documented.

Based on document review and interview the facility failed to:

A. ensure that chemical restraints/emergency behavioral medications (EBM) administered were identified as a chemical restraint in 3 (Patient #30, #85, and #86) of 3 patient medical records reviewed.

B. ensure staff was educated on the administration of chemical restraints/EBM for side effects, respiratory or cardiac distress, and assessment of medication effectiveness and safety after administration in 3 (Patient #30, #85, and #86) of 3 patient medical records reviewed.

C. ensure chemical restraints were added to the restraint log and monitored through Risk and Quality in 3 (Patient #30, #85, and #86) of 3 patient medical records reviewed.

D. ensure the policy and procedure gave clear guidelines on assessing and reassessing a patient after the intravenously or intramuscular (IV/IM) administration of a psychoactive drug was administered as a chemical restraint/EBM.

E. ensure a face-to-face by the provider or trained RN was completed within one hour of the administration of a chemical restraint/EBM.

The deficient practices identified under the following Conditions of Participation were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.

Findings:


Patient #30 was a 41-year-old female who arrived at the Emergency Department (ED) by Emergency Medical Services (EMS) on 1/16/2024 at 3:36 AM with complaints of Auditory Hallucinations.

A review of the ED triage assessment documented by RN Staff #117 on 1/16/2024 at 3:46 AM was as follows:

"Visual and auditory hallucinations that started a few hours ago. States history (hx) of schizophrenia but does not take medication for it. Was choking self in front of Emergency Medical Services (EMS)."

Nurse Practitioner (NP) #113 gave a verbal order on 1/16/2024 at 3:37 AM for Geodon (antipsychotic medication) 20 milligrams (MG) intramuscular (IM).

The medication was administered by RN Staff #117 on 1/16/2024 at 3:41 AM.

Further review revealed NP #113 entered medication orders into the electronic medical record (EMR) on 1/16/2024 at 3:37 AM that read, "Benadryl (an antihistamine medication that can cause drowsiness) 50 mg IM once and Ativan (a sedative medication) 2 mg IM once".

The medication was administered to Patient #30 on 1/16/224 at 4:19 AM by the nurse.

A review of the documentation by NP #113 on 1/16/2024 at 5:36 AM was as follows:

"Patient was treated here earlier for some sort of seizure activity and is reported as she had been out of her Keppra for a month. She was treated and observed for a period of time and then discharged home. EMS returned her a little later for a psychotic-type episode, she is confrontational and combative and was given Geodon, Benadryl, and Ativan for her highly agitated state on arrival. She is medically cleared at this time for psychiatric evaluation."

A review of the documentation by RN Staff #118 dated 1/16/2024 at 4:50 AM was as follows:

" ...Upon arrival patient was initially arguing with staff and EMS during transfer to bed from EMS stretcher. Patient behavior escalated to her attempting to strangle herself stating that she was having auditory hallucinations. She then threatened several staff members verbally. Patient stopped strangling herself after med administration ..."

Patient #30 was placed on a 1:1 observation on 1/16/2024 at 3:36 AM after arriving at the hospital for safety.

On 4/23/2024 after 1:00 PM, RN Staff #7 confirmed patients who were suicidal were placed on a 1:1 observation for safety per the hospital protocol after the CSSR (Columbia Suicide Risk Scale is a risk assessment tool used to determine the patient's severity of suicide risks) brief assessment was completed. RN Staff #7 stated, "The nurses can automatically place them on a 1:1 without a physician order depending on their CSSR Screening results. Staff members were then assigned to complete safety checks on the patient every 2 hours and document their findings in the medical record".

Vital signs were assessed on 1/16/2024 at 3:46 AM and were as follows:

"Temperature (T) 97.7, Pulse (P) 60, Respirations (R) 21, Oxygen 98%, and Blood Pressure (BP)140/80".

On 4/23/2024 after 1:00 PM RN Staff #7 confirmed there were no further documented vital signs until 5:01 AM. The last set of vital signs was taken 1/16/2024 at 2:40 PM when the patient was discharged.


An interview was conducted with RN Staff #7 on 4/23/2024 after 1:00 PM. RN Staff #7 was asked how often the patient gets vital signs assessed after receiving a chemical restraint/EBM. RN Staff #7 stated, "They have to be seen by the physician within 1 hour after the medication is given and vital signs are taken by the nurse then".

An interview was conducted with RN Staff #7 on 4/23/2024 after 1:00 PM. RN Staff #7 confirmed there was no documentation in the medical record that vital signs were taken every 15 minutes for an hour after the chemical restraint/EBM was administered. Also, RN Staff #7 confirmed there was no documentation of the respiration count, O2 (oxygen) saturation, or that the physician was notified staff was unable to obtain the vital signs due to the patient's agitation.

Patient #30 was discharged from the ED on 1/16/2024 at 2:40 PM.

An interview was conducted with RN Staff #7 on 4/23/2024 after 1:00 PM. RN Staff #7 was asked who completed the 1-hour face-to-face assessment after a chemical restraint/EBM was administered to patients in the ED during a behavioral emergency. She stated, "If we had to give a chemical restraint, it would be the physician, but we do not give chemical restraints. That happens very rarely". RN Staff #7 was asked if the Registered Nurses (RN) were allowed to do a 1-hour face-to-face after a chemical restraint/EBM. RN Staff #7 confirmed only physicians were allowed to complete the 1-hour face-to-face assessment.

RN Staff #3 and RN Staff #7 confirmed Patient #30 was given a chemical restraint/EBM due to a behavioral emergency and there was not a 1 hour face-to-face documented by a physician within an hour of the initiation of the restraint. Also, it was confirmed there were no less restrictive interventions documented before the chemical restraint/EBM was administered.



Patient #85

Patient #85 was a 62-year-old female who arrived at the ED on 3/31/2024 at 11:23 AM by Emergency Medical Services (EMS) after an attempted suicide by self-strangulation.

A review of the ED documentation dated 3/31/2024 by Physician #47 was as follows:

" ...Medical Decision Making (MDM) narrative:
MDM: The patient initially was reasonably cooperative. Medical screening workup ordered. Labs and scans reviewed and patient deemed medically stable for mental health evaluation. While awaiting mental health evaluation, the patient became extremely agitated. She was standing in the room screaming at the top of her lungs, constantly yelling f*** you at the nursing staff. She struck 1 of the nurses, she went to the nurse server (sic) was trying to rip the doors open. There was no calming the patient or talking her down. She continued to become more and more aggressive and severely agitated. Emergency Detention (ED) requested on the patient. IM Geodon (an antipsychotic medication) and Ativan ordered TO TREAT THE PATIENT'S SEVERE AGITATION, NOT AS A CHEMICAL RESTRAINING AGENT. She will need to calm down significantly before we can obtain a mental evaluation ..."

A review of the orders dated 3/31/2024 by Physician #47 was as follows:

On 3/31/2024 at 2:25 PM, a verbal order was given by Physician #47. The verbal order was as follows: "Restraint Psych Violent/Self Destruct Every (Q)15M (every 15-minute monitoring)".

On 3/31/2024 at 2:27 PM Physician #47 wrote an order for Geodon 10 mg IM Once: The medication was administered on 3/31/2024 at 2:33 PM by RN Staff #114.

On 3/31/2024 at 2:27 PM Physician #47 wrote an order for Ativan 2 mg IM Once. The medication was administered by RN Staff #114 on 3/31/2024 at 2:31 PM.

There was no clinical indication documented on the written medication orders for Geodon and Ativan.

An interview was conducted with RN Staff #7 on 4/23/2024 at 1:00 PM. RN Staff #7 was asked to explain the verbal order for "Restraint Psych Violent/Self Destruct. RN Staff #7 stated the Q15M was for the observation levels of the patient monitoring. They get documented on an observation sheet every 15 minutes".

Further review of the medical record revealed Patient #85 was placed in bilateral soft wrist restraints on 3/31/2024 at 2:25 PM.

Vital signs (Temperature, Pulse, Blood Pressure, Respirations, and Oxygen saturation) were assessed at 2:25 PM and no reassessment until 4:54 PM. RN Staff #7 confirmed there were no vital signs assessed after the chemical restraint/EBM was administered for more than 2 hours. Also, RN Staff #7 confirmed there was no documentation of the respiration count, O2 (oxygen) saturation, or that the physician was notified staff was unable to obtain the vital signs due to the patient's agitation.

An interview was conducted with RN Staff #7 on 4/23/2024 after 1:00 PM. RN Staff #7 was asked if the patients receiving chemical restraints/EBMs were placed on a restraint log and monitored through Risk and Quality. RN Staff #7 confirmed they were not placed on a restraint log, and nothing was reported to Quality regarding restraints.
After multiple requests for the ED restraint log, RN Staff #7 confirmed there was no restraint log for the ED for the past 3 months.

RN Staff #3 and RN Staff #7 confirmed Patient #85 was given a chemical restraint/EBM due to a behavioral emergency and there was not a 1 hour face-to-face documented by a physician within an hour of the initiation of the restraint.


32143


Findings:

A review of patient # 86's chart revealed she came to the ER on 2/2/24 with suicidal ideations.

A review of the physician notes dated 2/2/24 stated, "____ (patient #86) is an 18-year-old lady who presents to the emergency department today for the reported chief complaint of behavior problems and suicidal ideation. Reportedly she threatened to kill herself with a pencil. Upon her arrival at the emergency department, ____ (patient #86) became aggressive and combative. She started hitting, kicking, and scratching at the nursing staff. She also bit a paramedic on the wrist. She was initially administered IM Ativan which did not seem to have much effect. For safety purposes, she was ultimately administered Geodon 20 mg IM in order to control her agitated delirium."

A review of the chart revealed on 2/2/24 at 11:11 AM that the patient was agitated, inappropriate, and abusive.
A review of the physician's order revealed that Ativan/Lorazepam (sedative) 2 mg IM was ordered on 2/2/24 at 11:32 AM and administered at 11:33 AM. The Geodon (Ziprasidone 20 mg IM was ordered on 2/2/24 at 11:54 AM and administered at 11:58 AM. There was no documentation or indication on the order for the use of a chemical restraint/ emergency behavioral medication.

There was no nursing documentation on the effectiveness of the medication. There was no nursing documentation of a patient assessment with vital signs until 2/2/24 at 19:00 (7:00 PM), 7 hours later. There was no documentation of chemical restraint/emergency behavioral medication nor was the facility policy and procedure followed for a face to face.

A review of the policy and procedure, "Restraint and Seclusion for Non-Behavioral Health Units" revealed there were 11 pages of a corporate policy that was not within the scope of the facility's current practice. The policy also had a hospital addendum. The addendum stated the policy was adopted with variations. The addendum was 4 pages long and the nurse would have to read the policy and then try to determine what part of the policy had an addendum to provide appropriate care.

An interview with Staff # 7 RN stated that the ER did not have a restraint log because they did not have restraints. Staff #7 stated they never use physical restraints in the ER, and they don't administer chemical restraints/emergency behavioral medications. Staff #7 was shown patient #86's chart and shown the patient was given psychotropic medications intramuscularly due to agitation, combativeness, and physical harm to medical staff. Patient #86 was having a behavior that needed to be controlled to prevent harm to self and others. Staff #7 stated that it was not a restraint. She was treated for a psychiatric Illness. There was no documentation that the patient was assessed by a psychiatrist or was being treated for any specific treatment or disease process. Staff #7 was asked again why the patient received the medications. Staff #7 stated, "to stop her behavior. She was screaming, kicking, and hitting staff." Staff #7 failed to identify what a chemical restraint/emergency behavioral medication was and was not aware of the policy and procedures for restraints.

A review of the corporate policy had a section for violent medication restraints. The policy stated, "The order must include the ...reason for restraint and seclusion ...for medication restraints, a violent restraint order, a complete medication order, and a physical hold order (if indicated.) Must perform a face-to-face within 1 hour of restraint and document. Under monitoring assessment and interventions, the policy stated, "patient response within 1 hour, Physical and psychological status q 15 minx4, circulation and skin check q 15 min ... vital signs q 15 minx4 EVEN IF SLEEPING. If agitated, obtain O2 sat and RR at minimum. If unable notify MD."

An interview was conducted with Staff # 3 on 4/25/24. Staff #3 stated, "The policy was complex and difficult to get through sometimes, but it comes down to the fact they just didn't follow the policy."

Based on record review and interview the facility failed to ensure restraint orders were not written on a PRN (as needed) basis in 1 (Patient #31) of 1 medical record reviewed. The facility also failed to follow its policy "Restraint and Seclusion for Non-Behavioral Health Units", Policy Number POC 41.

The deficient practices identified under the following Conditions of Participation were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death.

Findings:

A medical record review for Patient #31 was conducted on 4/23/2024 at 1:00 PM with RN Staff #10.

Patient #31 was an 88-year-old female admitted to the hospital on 2/01/2024 with a diagnosis of Dementia with behavioral disturbances.

A review of History and Physical dated 2/01/2024 documented by Physician #115 was as follows:

" ...Assessment and Plan
Impression:
Altered Mental Status
Metabolic encephalopathy
Dementia with behavioral disturbances ...
As needed Geodon 10 mg for agitation ..."


A review of the medication order dated 2/01/2024 at 9:17 AM by Physician #115 was as follows:

"Geodon (an antipsychotic medication) 10 milligrams (mg) Intramuscular (IM) Q6H (every 6 hours) PRN (as needed) for Agitation. Total doses 3".
A review of the Medication Administration Record (MAR) revealed that 10 mg of Geodon was administered IM to Patient #31 on 2/05/2024 at 12:24 PM by RN Staff #116.


A review of the documentation dated 2/05/2024 at 12:49 PM by RN Staff #116 was as follows:

"Patient has been uncooperative and agitated throughout the AM. Multiple attempts made to administer AM medications were unsuccessful. Patient using profanity towards nurse staff. Patient refusing to eat lunch. Attempts made to assist patient with patient care needs and patient kicking and hitting at nurse. PRN Geodon given per (Medication Administration Record) MAR".



A review of the Medline Plus website was as follows:
https://medlineplus.gov/ency/article/003212.htm

"Agitation

Agitation is an unpleasant state of extreme arousal. An agitated person may feel stirred up, excited, tense, confused, or irritable.

Considerations:

Agitation can come on suddenly or over time. It can last for a few minutes, for weeks, or even months. Pain, stress, and fever can all increase agitation.

Agitation by itself may not be a sign of a health problem. But if other symptoms occur, it can be a sign of disease.

Agitation with a change in alertness (altered consciousness) can be a sign of delirium. Delirium has a medical cause and should be checked by a health care provider right away."

While there is an objective scale of agitation developed for patients who are sedated, there is not one for patients who are not sedated. There were no objective criteria or scale that distinguished what agitation was. This required the nurse to assess the patient and decide when to medicate the patient without objective guidelines. Based on the order parameters, the patient could have been medicated for shouting at the staff or demanding that she wanted to go home. Without objective parameters, the nurse must decide what agitation means to the nurse and what behaviors to give medication for every 6 hours without a physician assessment of the behaviors to ensure something hasn't medically changed and the least restrictive intervention was used. As Geodon has no reversal agent, once given, the patient must wait for the effects to wear off.


A review of the facility policy titled, "Restraint and Seclusion for Non-Behavioral Health Units", Policy Number POC 41, with a revised date of 3/07/2023 was follows:

" ...Policy
It is the policy of Steward Health Care that all patients have the right to be free from restraints or seclusion of any form, imposed as a means of coercion, discipline, convenience or retaliation by staff. As such, efforts are ongoing to afford patients care in a restraint-free and seclusion-free environment. Hospital leadership is responsible for creating a culture that supports a patient's right to be free from restraint or seclusion Restraint or seclusion use is limited to instances when there is imminent risk of harm to the patient or others and only when other less restrictive measures have failed, or after a determination that such alternatives would be inappropriate or ineffective under the circumstances. In addition, under no circumstances should restraints be used for staff convenience, to coerce or discipline the patient, or as a method of retaliation ....

TEXAS
Attachment B: Nursing Restraint Guide ...

Order obtained prior to administration. Each new medication restraint requires a new order.
No PRN orders. No standing orders ..."


An interview was conducted with RN Staff #10 on 4/23/2024 at 1:00 PM. RN Staff #7 confirmed the medication was ordered as a PRN medication for agitation and it was administered to control the patient's behavior. RN Staff #10 was asked if PRN orders for antipsychotics were allowed to be written by the physicians. RN Staff #10 stated, "No they cannot be written PRN to control a patient's behavior". RN Staff #10 confirmed the corporate policy for restraint and seclusion was 11 pages. RN Staff #7 stated, "At the end of the corporate policy was an addendum that included multiple attachments that were specific to Texas law and our hospital on restraint and seclusion. You have to look through a 27-page policy to determine what is required for this hospital and for the State of Texas. Also, RN Staff #10 confirmed there was no 1 hour face-to-face completed by the physician after the chemical restraint/EBM was administered ".

Based on document review and interview the Medical Staff failed to ensure 4 (Physician #45, #46, #47, and #48) of 4 physicians were granted privileges to order and administer Moderate and/or Deep Sedation in the Emergency Department to 5 (Patient #33, #34, #36, #40, and #41) of 5 patients. Also, the facility failed to follow its policy titled, "Management of Moderate and/or Deep Sedation by Non-Anesthesia Personnel".

Refer to Tag A 0341

It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, impairment and /or subsequent death.

Based on document review and interview the Medical Staff failed to ensure 4 (Physician #45, #46, #47, and #48) of 4 physicians reviewed were granted privileges in the Emergency Department (ED) to order and administer moderate and/or Deep Sedation to 5 (Patient #33, #34, #36, #40, and #41) of 5 patients. Also, the facility failed to follow its policy titled, "Management of Moderate and/or Deep Sedation by Non-Anesthesia Personnel".



It was determined that these deficient practices posed an Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, impairment, and /or subsequent death.

Findings:

A review of medical records was conducted on 4/23/2024 and 4/24/2024 with Staff #3, Staff #7, and Staff #83.

Patient #33
Patient #33 was a 26-year-old male who presented to the ED on 3/24/2024 at 18:43 (6:43 PM) with a dislocated left shoulder. A review of the ED document by Physician #47 was as follows:
" ...Medical Decision Making (MDM) Patient given initial Dose of 75 mg (milligrams) of Propofol (a general anesthetic medication) with some relaxation however the patient did not relax enough to accomplish reduction. Additional 25 mg given in(sic) the patient became somewhat combative. A repeat 75 mg was given with good response. Patient tolerated well ..."

A review of Physician #47's written orders were as follows:
"...3/24/2024 at 7:12 PM-Propofol 100 mg IV Once and 3/24/2024 at 7:32 PM-Propofol 100 mg IV Once..."

A review of the Procedural Sedation Document revealed Physician #47 administered 75 mg of Propofol IV at 7:36 PM, 25 mg of Propofol IV at 7:38 PM, and 75 mg of Propofol at 7:42 PM".

A review of the nursing documentation dated 3/24/2024 at 7:50 PM by RN Staff #49 was as follows:
" ...Moderate sedation performed for left shoulder dislocation with Physician #47 at the bedside. Total of 175 mg Propofol administered by Physician #47 in 3 doses ..."


Patient #34
Patient #34 was a 5-year-old male admitted to the ED on 1/17/2024 at 4:50 AM with a foreign body (FB) in his nose. A review of the ED document dated 1/17/2024 at 5:35 AM by Physician #47 was as follows:

" ...MDM: The child is very apprehensive and this is a wax foreign body which is body temperature and therefore very soft. Previous attempts to remove this were unsuccessful. I gave mom the option of going to ENT today or for us to perform procedural sedation and with the child being still to see if we have a better chance of removing this foreign body. Mom elected procedural sedation. The patient is being set up for procedural sedation and monitoring ...

Procedural Sedation
Indication for Procedural Sedation: FB Removal
Medication Administration: Nurse administered ...
Informed consent for Mod/Deep Sedation signed: Yes
Informed consent for Procedure signed: Yes ..."

A review of the Procedural Sedation Document revealed 60 mg of Ketamine (dissociative anesthetic) was administered on 1/17/2024 at 5:46 AM by Physician #47.

A review of the document titled; "Anesthesia Permit" revealed Patient #34's legal representative consented to moderate sedation.


A review of the credential file of Physician #47 was completed with Staff #82 and Staff #3 on 4/24/2024 after 10:00 AM. The review revealed Physician #47 did not have approved privileges for moderate and/or deep sedation. Also, Physician #47 only requested privileges for moderate sedation, and no deep sedation privileges were requested. Further review of the credential file revealed Physician #47 did not have an attestation by his Department Chair stating they had monitored his moderate and deep sedation outcomes and attested to the competence of the provider. Also, there was no completion of the moderate or deep sedation packet, including policy, medication protocol, attestation, and successful completion of an examination as required for these privileges for his re-appointment dated 10/01/2023-09/30/2025.

During an interview on 4/24/2024 at 11:00 AM Chief Nursing Officer (CNO) Staff #3 and President #2 confirmed Physician #47 did not have privileges to order and/or administer moderate or deep sedation in the ED.


Patient #36
Patient #36 was a 19-year-old male who arrived at the ED by ambulance on 2/23/2024 at 3:55 PM for left shoulder pain. An X-ray on 2/23/2024 confirmed a left anterior shoulder dislocation without fracture.

A review of the procedural sedation documentation dated 2/23/2024 at 5:29 PM by Nurse Practitioner (NP) #81 revealed Patient #36 received 50 mg of Propofol IV for sedation to perform a left shoulder reduction (a procedure to return the shoulder to its normal position without surgery).

Further review revealed Physician #45 wrote an order for 50 mg of Propofol IV for procedural sedation on 2/23/2024 at 4:37 PM. A Review of the Procedural Sedation documentation did not reveal a time the medication was administered or who administered the medication.




A review of the credential file of Physician #45 was completed with Staff #82 and Staff #3 on 4/24/2024 after 10:00 AM. The review revealed Physician #45 requested privileges for moderate and deep sedation. The Department Chair recommended the approval on 10/03/2023 but failed to write an attestation statement that he monitored his moderate and deep sedation outcomes and attested to the competence of the provider.

Also, there was no confirmation of completion of the moderate or deep sedation packet, including policy, medication protocol, attestation, and successful completion of an examination as required for these privileges for his re-appointment dated 10/01/2023-9/30/2025.

During an interview on 4/24/2024 at 11:00 AM CNO Staff #3 and President #2 confirmed Physician #45 did not have the proper credentials/privileges to order and/or administer moderate or deep sedation in the ED.


Patient #40
Patient #40 was a 33-year-old male who presented to the ED by ambulance on 2/05/2024 at 1:19 with right wrist pain. An X-ray on 2/05/2024 confirmed a right distal radius fracture.

A review of the procedural note on 2/05/2024 by Physician #46 read, "Procedural Sedation". Physician #46 wrote an order on 2/05/2024 at 4:14 PM for Propofol 100 mg IV Once. A review of the Procedural Sedation documentation revealed that 50 mg of Diprivan (Propofol) was administered IV at 4:37 PM for procedural sedation.


A review of the credential file of Physician #46 was completed with Staff #82 and Staff #3 on 4/24/2024 after 10:00 AM. The review revealed Physician #46 did not request privileges nor was he approved for moderate or deep sedation in the ED for his reappointment dated 10/01/2023-9/30/2025.

During an interview on 4/24/2024 at 11:00 AM CNO Staff #3 and President #2 confirmed Physician #46 did not have the proper credentials/privileges to order and/or administer moderate or deep sedation in the ED.


Patient #41
Patient #41 was a 19-year-old male who arrived at the ED on 3/10/2024 at 12:35 PM complaining of Left Shoulder pain. An X-ray was completed on 3/10/2024 and confirmed a left shoulder dislocation.
A review of the procedure note documented by Physician #48 dated 3/10/2024 revealed 80 mg of Ketamine was administered IV for procedural sedation. A review of the medication orders revealed Physician #48 ordered 80 mg of Ketamine IV once on 3/10/2024 at 1:15 PM.

A review of the credential file of Physician #48 was completed with Staff #82 and Staff #3 on 4/24/2024 after 10:00 AM. The review revealed Physician #48 did not request privileges nor was he approved for moderate or deep sedation in the ED for his reappointment dated 10/01/2023-9/30/2025.

During an interview on 4/24/2024 at 11:00 AM CNO Staff #3 and President #2 confirmed Physician #46 did not have the proper credentials/privileges to order and/or administer moderate or deep sedation in the ED.


An interview was conducted with Staff #4, Staff #3, and Staff #82 on 4/24/2024 at 11:00 AM. Staff #82 was asked if she was aware the ED Physicians did not have moderate and/or deep sedation privileges. Staff #82 confirmed she was not aware. Staff #4 confirmed Staff #82 was new to the position. Staff #3 was asked to review Policy Number POC 42 titled, "Management of Moderate and/or Deep Sedation by Non-Anesthesia Personnel" and confirm if the required documentation (confirmation of completion of the moderate or deep sedation packet, including policy, medication protocol, attestation, and successful completion of an examination) was missing from 4 (Physician #45, #46, #47, and #48) of 4 physicians files reviewed. Staff #3 stated, "Yes, it is not there but I assure you this will be corrected, and the proper privileges with approval and all required documentation will be placed in the physician's credential files." Staff #3 was then asked to confirm if the medications Ketamine, Etomidate, and Propofol were considered deep sedation drugs, and if used by the physicians for procedural sedation, would that require the physicians to have deep sedation privileges? Staff #3 stated, "Yes per the policy if Ketamine, Etomidate (an anesthetic medication used for the induction of general anesthesia), or Propofol are used for sedation the physician must have deep sedation privileges before ordering and/or administering".


A review of the facility policy titled, "Management of Moderate and/or Deep Sedation by Non-Anesthesia Personnel" was as follows:

" ...Policy
Moderate or deep sedation is administered for procedures either directly by licensed independent practitioners credentialed and privileged within the department of anesthesia and/or by a qualified licensed independent practitioner who has appropriate privileges for the planned level of anesthesia ...
A. Location
The use of deep sedation for procedural interventions by non-anesthesia personnel is restricted to the ED.
B. Oversight. ...
C. Procedure for Privileging and Skill Competency

1. MODERATE SEDATION
a ...
b. Continuation of privileges is decided at the time of recredentialing if the following information is provided:
*Board Certification or Board Eligibility in Emergency Medicine or Anesthesia or current Advanced Cardiac Life Support (ACLS) certification or Pediatric Advanced Life Support (PALS) certification.
*Attestation by the Department Chair that they have monitored sedation outcomes, and they attest to competence.
*Current successful completion of the Moderate Sedation Training packet (includes policy, medication recommended protocol, attestation, and examination).

2. DEEP SEDATION
a. Only Emergency Medicine physicians may request privileges to administer deep sedation ...
b ...
c ... Continuation of privileges is decided at the time of recredentialing if the following information is provided:
*Board Certification or Board Eligibility in Emergency Medicine or have current ACLS certification or PALS certification.
*Attestation by the Department Chair that they have monitored individual's deep sedation outcomes.
*Attestation of current completion of the Deep Sedation Training packet for both pediatrics and adults (includes policy, medication recommended protocol, attestation, and examination) ....

J. Medications
Moderate and deep sedation medications may only be ordered and administered as follows:

1. Moderate Sedation
a. A physician with privileges in the administration of moderate sedation orders the medications for moderate sedation, specifying dose and route ...

2. Deep Sedation
a. An ED physician with privileges in the administration of deep sedation orders the medications for deep sedation specifying dose and route.
b ...
c. Medications include but are not limited to Ketamine (dissociative anesthetic), Etomidate (anesthetic medication), and Propofol ...
d. The use of Ketamine, Etomidate, and Propofol is restricted to ED physicians with privileges to administer deep sedation ..."


During an interview on 4/24/2024 at 12:52 PM, Staff CNO #2 and Staff President #2 confirmed 4 (Physician #45, #46, #47, and #48) of 4 physicians did not have the proper credentials to order and/or administer moderate or deep sedation. Also, CNO Staff #3 and Staff President #2 confirmed the facility failed to ensure privileges were approved according to the facility policy.

Based on record review and staff interview the hospital failed to ensure the dialysis department had, at a minimum, 2 trained Registered Nurses readily available to provide direct patient care to patients receiving hemodialysis. Also, the hospital failed to have a staffing matrix and plan for the dialysis department.

This deficient practice had the likelihood of resulting in a delay in hemodialysis patient care and/or an incomplete dialysis treatment. Dialysis patients who do not complete or miss treatment are at an increased risk of electrolyte imbalances which can cause heart arrhythmias, cardiac arrest, and death.

A review of daily staffing assignments for the dialysis department was conducted with Staff # 98.

April 11th, 2024

Staff # 104 (Dialysis Registered Nurse) was clocked in from 6:27 AM to 2:19 PM.
Staff # 105 (Dialysis Registered Nurse) was on call and clocked in from 7:02 AM to 5:04 PM.

Staff # 105 was treating patients in the dialysis unit alone without assistance from an additional qualified and trained registered nurse from 2:19 PM to 5:04 PM. There were no other trained registered nurses in the hospital to assume hemodialysis care in the event Staff # 105 became incapacitated or had to leave the hospital emergently.

April 17th, 2024

Staff # 104 was clocked in from 6:30 AM to 2:50 PM. Staff # 104 clocked back in at 3:35 PM until 9:54 PM.
Staff # 105 was clocked in from 7:06 AM to 2:50 PM.

Staff # 104 was treating patients in the dialysis unit alone without assistance from an additional qualified and trained registered nurse from 3:35 PM to 9:54 PM. There were no other trained registered nurses in the hospital to assume hemodialysis care in the event Staff # 104 became incapacitated or had to leave the hospital emergently.

During an interview with Staff # 98 on 04/24/2024 at 11:00 AM, Staff # 98 acknowledged the dialysis staff needed additional support from a trained and qualified registered nurse who could be readily available to assume care of a hemodialysis patient if needed. Staff # 98 confirmed there were days in April 2024 when only 1 qualified and trained registered nurse was available to provide care to hemodialysis patients in the hospital.

Based on observation, record review, and staff interviews:

A. the hospital failed to ensure patients with a physician's order for "Continuous Telemetry Monitoring" were continuously monitored by a trained and qualified staff member. The hospital failed to follow the policy, "Cardiac Monitoring and Telemetry Utilization".

Findings:

During a tour of the Emergency Department with Staff # 7 on 04/22/2024 at 4:35 PM, the surveyor observed there were no qualified and trained staff members monitoring the patient's cardiac rhythms located on the cardiac monitoring screen within the nurses' station area.

Patient # 22

Patient # 22 was admitted with coffee ground emesis, hypotension, electrolyte abnormalities, and aspiration pneumonia. Patient # 22 was classified to be in "serious condition, requiring critical care time" by the Emergency Room Physician.

A review of Patient # 22's orders revealed Physician # 47 (Emergency Room Medical Director) placed the following order,
"Continuous Cardiac Monitor, CONTINUOUS/Start: 04/22/2024 at 4:26 PM"

During an interview with Staff # 90 on 04/22/2024 at 4:35 PM, the surveyor asked if there was a staff member assigned to monitor the cardiac rhythms at the nurses' station. Staff # 90 stated, "No, the charge nurse and other nurses are at the nurses' station and will listen for alarms and respond if necessary but there is no one who continuously monitors the rhythms. We do not have a monitor tech in the emergency department".

During an interview with Staff # 107 (cardiac monitor tech) on 04/23/2024 at 10:30 AM, the surveyor asked Staff # 107 if they were able to monitor patients on a continuous cardiac monitor in the Emergency Department. Staff # 107 stated, "No, we cannot remotely monitor those patients because of something with the hospital's zoning. The Emergency Department uses a different system than the rest of the hospital."

A review of the hospital policy, "Cardiac Monitoring and Telemetry Utilization" with a revision date of 1/11/2022 revealed,

"POLICY: Cardiac telemetry is used when there is evidence of benefit for the patient and alignment with goals of care. Telemetry is discontinued when the benefit is achieved or if it is no longer achievable.
PURPOSE: Utilization of telemetry needs to balance the likelihood of benefit with the risk of overutilization and clinical alarm fatigue
SCOPE: This applies to all patients receiving electrocardiographic monitoring outside the ICU.
PROCEDURE ...
B. Initiation and discontinuation of telemetry
1. Patients assigned to telemetry must have a telemetry order from an LIP (licensed independent provider) including the indication.
C. Management of Patients on Telemetry ...
1. All patients admitted to telemetry have:
a. A patent peripheral intravenous IV or IV infusion
b. Vital signs are assessed at least every 8 hours unless otherwise ordered.
2. RN verification of monitor patterns are documented in the electronic health record (EHR) every shift and more frequently if dysrhythmia or clinical status dictates ...
6. Patients who are transported away from the telemetry unit and need continued monitoring are either accompanied off the unit by RN or qualified licensed personnel, or remotely monitored where available ..."

During an interview with Staff # 7(Emergency Room Clinical Director) on 04/23/2024 at 10:40 AM, Staff # 7 acknowledged there were patients with continuous cardiac monitoring orders who were not being continuously monitored by a trained and qualified staff member. Also, Staff # 7 confirmed the telemetry monitor tech for the hospital cannot monitor patients in the emergency room remotely.



28659


B. the hospital failed to identify Registered Nurses (RN) from Licensed Vocational Nurses (LVN) on the staffing matrix/grid. RN scope of practice differs from LVN scope of practice regarding responsibilities of patient care. The staffing patterns could not be established safely by the charge nurses for patient care from March of 2024 through April 24, 2024.


Findings:


On 04/24/2024 in the board room of the facility an interview with the Staffing Coordinator #108, confirmed a staffing matrix/grid was being used to staff the step down unit. The matrix/grid identified all nurses by a total number of nurses who would be available to provide patient care during each shift. The matrix/grid failed to separate or otherwise identify the number of RN's and the number of LVN's providing care during the shift.

TEXAS BOARD OF NURSING: LICENSED VOCATIONAL NURSE SCOPE OF PRACTICE.

"The scope of practice for an LVN must be directly supervised by a RN, Physician Assistant, Physician, Dentist or Podiatrist. The LVN is responsible for providing safe, compassionate, and focused nursing care to assigned patients with predictable heath care needs."

Without identifying RN from LVN ratios, the facility could not ensure the charge nurse would know how to assign patients safely to the RN or to the LVN. LVN's are allowed to manage pt's with predictable health care needs. A LVN may not make decision independently for an unstable patient.

The Staffing Coordinator #108, confirmed, "We employee 3 LVN's on the step-down unit. and the RN to LVN ratio was not identified on the grid."

Based on record review and interview, the nursing staff failed to follow the intravenous iron sucrose (Venofer) guidelines for 1 (#9) of 1 patient receiving an iron infusion.

Findings included:

A review of patient #9's medical record revealed that the patient was receiving a Venofer (iron) infusion. A review of the medical record revealed that Patient #9 received one set of vital signs at the beginning of the iron infusion. Also, the iron infusion of Venofer 200 mg was ordered to run over 60 minutes per the iron infusion guidelines. The iron infusion was started at 12:19 PM and completed at 1:00 PM which was less than 60 minutes.

Vital signs taken at 10:58 AM
Temperature 98.6
Blood Pressure: 133/70
Pulse: 83
Respirations: 20

Iron infusion was started at 12:19 PM.

There were no other vital signs taken during the infusion. At discharge partial vital signs were taken as blood pressure and pulse before the patient left the facility.

Blood pressure: 110/68
Pulse: 64

A review of the facility's policy titled, "Intravenous Iron Sucrose (Venofer) Guidelines" revealed the following:

"P&T Approval:
Indication:
Iron sucrose (Venofer®) is indicated for the treatment of iron-deficiency anemia in chronic renal failure, including non-dialysis-dependent patients (with or without erythropoietin} and dialysis-dependent patients receiving erythropoietin therapy. Iron sucrose has an unlabeled indication of cancer/chemotherapy-associated anemia.

Iron sucrose 100- 200 mg in 100 ml of normal saline infused over at least 60 minutes.

Note: Hypersensitive episodes may occur if the drug is administered too rapidly.

Patient Monitoring:

Anaphylactic reactions to iron sucrose are usually evident within a few minutes after starting the infusion and close observation is necessary to ensure recognition.

Blood pressure should be taken and documented at the following intervals

* Prior to administration
* If patient has never received iron sucrose before, check vital signs every
10 minutes x 3
* At 15 minutes after starting infusion
* End of administration

If at any time during the intravenous administration of iron sucrose a hypersensitivity reaction is suspected, immediately stop the infusion, and notify the physician."

An interview was conducted with Staff #19 on 04/22/2024 at 1:00 PM. Staff #19 confirmed that only one set of vital signs was taken during the infusion and that the iron infusion was administered in 41 minutes. Also, Staff #19 confirmed the staff failed to follow the "Intravenous Iron Sucrose (Venofer) Guidelines".

Based on record review and staff interviews, the facility's staff failed to ensure the physician's order for the administration of blood/blood products included a transfusion rate and/or duration in 4 (#67, #68, # 69, #76) of 4 patient medical records reviewed. Also, the facility failed to have a clear policy regarding the administration of blood/blood products.

Findings:

The facility had two separate policies regarding blood/blood product administration, the corporate policy, and the facility addendum revealed inconsistencies in their process for blood/blood product administration.
Due to the inconsistencies in the 2 policies and the physician's ordered time range of 2-4 hours, it was unclear to the Registered Nurse what rate the transfusion should run at.


Patient #67

A review of the electronic health record (EHR) for Patient #67 revealed that the Physician ordered 1 unit of RBCs (red blood cells) with a duration of less than 2 hours on 04/17/2024 at 10:26 AM.
The Physician's order did not include a transfusion rate.
Per the administration record, the transfusion was not initiated until 1:20 PM and completed at 4:00 PM. The transfusion duration was 2 hours and 40 minutes.

Patient # 68

A review of the EHR for Patient #68 revealed the physician ordered 2 units of RBCs to be infused with a duration of 2-4 hours. The Physician's order did not include a transfusion rate.

Patient # 69

A review of the EHR for Patient #69 revealed that the Physician ordered 2 units of RBCs over 2-4 hours on 04/17/2024 at 7:07 AM. The Physician did not include a transfusion rate.


Patient # 76

A review of the EHR for Patient # 76 revealed on 04/21/2024 at 7:40 AM, the Physician ordered 2 units of RBCs over 2-4 hours. The Physician did not include a transfusion rate in the order.



A review of the facility's corporate policy titled "Administration of Blood and Blood Components" dated 04/04/2023 states:

"7. Patient Monitoring
a. The first 10 to 15 minutes of any transfusion are the most critical.
b. Non-emergent transfusions are started slowly at 120ml/hour, under close observation of the qualified transfusionist.
c. If no evidence of a reaction is noted within the first 15 minutes, the flow is increased to ensure the product is infused within the ordered duration time period.
d. Vital sign measurements are taken and documented baseline (prior to the start of transfusion), 15 minutes after the start of transfusion, any time throughout the transfusion if warranted by clinical observation of the patient, and at the end of transfusion.
e. At the end of the transfusion the patient is assessed for evidence of a transfusion reaction.
f. Date and time the transfusion was ended is recorded.

8. Time Limits\
a. Refer to Nursing Skills/Procedure reference text for blood administration rates.
b. The blood transfusion is completed in 4 hours or less.
c. The blood bank is notified when it is anticipated that transfusion cannot be completed in 4 hours.
d. The medical director may decide whether or not to continue the transfusion, weighing donor exposure risk and bacteremia."

A review of the facility's addendum to the corporate policy, titled "Administration of Blood and Blood Components" dated 05/23/2023 states:

"8. Obtain baseline vital signs and document on the Issue Transfusion form or in the electronic health record. Need baseline vital signs in to assist with monitoring of patient, fluid and electrolyte balance, and event of blood reaction.

9. Connect the blood product to the IV set and clamp off the normal saline. Open blood flow clamp and regulate the flow or administer blood via syringe pump by disconnecting syringe with normal saline and connecting syringe with blood to platelet infusion set primed with normal saline. The flow rate for elective blood transfusion is usually set so the transfusion of one unit of blood is accomplished within two hours. In the event the patient has a "cold agglutinin", the lab may request the blood to be infused with a blood warmer.

10. The RN is to observe for signs of reaction. The transfusion officially begins when the blood enters the patient's veins.
NOTE: Signs/symptoms of transfusion reaction are listed on the unit issue/transfusion form. Most reactions occur within the first 15 minutes of the transfusion."

An interview was conducted with Staff # 3 on 04/23/2024 at 4:00 PM. Staff #3 was questioned on the process of blood administration. Staff # 3 reported the nurses infuse the blood within the duration time. We don't have a transfusion rate; the nurse can adjust with the pump.

Based on record review and staff interview, the hospital's emergency room staff failed to ensure vital signs were obtained and documented according to each patient's Emergency Severity Index (ESI) level on 4 (# 20, # 21, # 22, and # 24) of 8 patient medical records reviewed. Also, the hospital staff failed to follow the policies, "Patient Assessment, Reassessment and Documentation of Care in the Emergency Department" and "Emergency Department Nursing Triage".

This deficient practice had the likelihood of resulting in a delay in care and treatment due to the emergency room staff not obtaining and documenting the patient's vital signs promptly.

All healthcare staff involved in the patient's treatment and care were not able to monitor and provide the appropriate medical care because they did not have the most up-to-date information, including the patient's vital signs.

A review of patient medical records was conducted in the Emergency Room with Staff # 104 on 04/23/2024 at 2:00 PM.

Patient # 20

Patient # 20 was admitted to the Emergency Department on 04/22/2024 at 8:37 PM with complaints of syncope (passing out). The patient was rated as an ESI level 3.

The patient had 1 set of vital signs documented during the entire Emergency Department visit. The following vital signs were documented:

"8:42 PM: Heart Rate: 97 H, Respirations 22, Blood Pressure: 128/63, Pulse Oxygen Saturation: 100 % on Room Air."

There were no other vital signs documented during the patient's Emergency Department visit on 04/22/2024.
The patient was discharged from the Emergency Department to go home on 04/22/2024 at 10:23 PM.

Patient # 21

Patient # 21 was admitted to the Emergency Department on 04/03/2024 at 9:36 PM with complaints of a headache following a car wreck. The patient was rated as an ESI level 3.

The patient had 1 set of vital signs documented during the entire Emergency Department visit.

The following vital signs were documented:
"9:41 PM: Heart Rate: 82, Respirations: 18, Blood Pressure: 134/82 H, Pulse Oxygen Saturation: 100 % on Room Air."

The patient was discharged from the Emergency Department to go home on 04/04/2024 at 12:26 AM.

Patient # 23

Patient # 23 was admitted to the Emergency Department on 04/22/2024 at 4:17 PM with complaints of rectal bleeding. The patient was rated as an ESI level 2.

The patient had 2 sets of vital signs documented during the entire Emergency Department visit.
The following vital signs were documented:

"4:29 PM: Heart Rate: 95 H, Respirations 23, Blood Pressure: 90/79 L, Pulse Oxygen Saturation: 96%
6:34 PM: Heart Rate: 17 L, Respirations 18, Blood Pressure: 99/64 L, Pulse Oxygen Saturation: 100 % on 2 liters via nasal cannula"

The patient was transferred to the ICU (Intensive Care Unit) on 04/22/2024 at 7:43 PM. There were no vital signs documented prior to the transfer to the ICU.

Patient # 24

Patient # 24 was admitted to the Emergency Department on 04/23/2024 at 5:25 AM with complaints of rectal bleeding and syncope (passing out). The patient was rated as an ESI level 2.

The patient had 1 set of vital signs documented during the entire Emergency Department visit.

The following vital signs were documented:
"5:24 AM: Heart Rate: 77, Respirations: 19, Blood Pressure: 154/73 H, Pulse Oxygen Saturation: 96 % on Room Air"

The patient was transferred to the hospital's telemetry unit on 04/23/2024 at 6:13 AM. There were no vital signs documented prior to the transfer to the telemetry unit.


A review of the hospital policy, "Patient Assessment, Reassessment and Documentation of Care in the Emergency Department" with a revision date of 06/14/2022 revealed,
"POLICY: This policy outlines the standards for patient assessment, reassessment, and documentation of care in the Emergency Department.
SCOPE: This policy applies to all patients in the Emergency Department.
PROCEDURE:
A. Triage Assessment
1. Upon initial contact with a registered nurse, a brief, rapid assessment is completed.
B. Primary Assessment
1. Vital Signs
2. Columbia Suicide Severity Rating Scale
3. Allergies
4. Height and Weight
5. Home Medication List
6. Glasgow Coma Score
7. Medical History including immunization status and last menstrual period
C. Secondary Assessment
1. Focused Assessment of chief complaint
2. Fall Risk Assessment and Intervention
D. Reassessment
1. Vital signs are repeated when abnormal, clinically indicated, and prior to admission, or transfer. The minimum frequency of vital signs for active ED patients is every 4 hours and for ED-boarded patients is every shift. The LIP should be notified of any abnormal vital signs ..."

A review of the hospital policy, "Emergency Department Nursing Triage" with a revision date of 06/14/2022 revealed,
"POLICY: The Emergency Department registered nurses who have met the clinical competencies will perform triage assessments, provide first aid, and assign a severity index using the mot recent version of the AHRQ, Emergency Severity Index (ESI).
PROCEDURE:
1. All patients receive a rapid triage assessment including:
A Chief complaint
B. Allergies
C. Vital signs, including temperature, pulse, respirations, blood pressure, and pain intensity.
d. Other information, if appropriate, may include oxygen saturation, last menstrual period, past medical history, and weight.
2. Whenever possible patients are immediately placed into open treatment spaces and triage is performed at the bedside.
3. First aid measures including, but not limited to, applying dressings, ice packs, splinting, and elevation are initiated.
4. The registered nurse may approach a designated LIP regarding orders for any patient requiring urgent medications.
5. Patients are triaged into one of five Emergency Severity Index (ESI) levels and triage algorithm.
Level 1: Patients who require immediate evaluation and treatment with the use of many resources.
Level 2: Patients who require evaluation and treatment as soon as possible with reassessment as needed requiring multiple resources.
Level 3: Stable patients who could wait for evaluation and treatment requiring multiple diagnostic and therapeutic resources.
Level 4: Stable patients who could wait for evaluation and treatment requiring one therapeutic diagnostic resource.
Level 5: Stable patients who could wait for evaluation and treatment and require minimal or no resources.
6. If a patient has been assessed as ESI level 1 or 2, the patient is brought to the ED treatment area expeditiously and an ED attending is notified."

An interview with Staff # 7 (Emergency Department Clinical Director) on 04/23/2024 at 2:30 PM confirmed the Emergency Department staff were not obtaining and documenting the patient's vital signs according to the hospital's policies.

Based on record review, observation, and staff interviews:

A. the facility failed to ensure policies and procedures were implemented and enforced

(Refer to A0749).

B. the facility failed to maintain a clean and sanitary environment and infection control rounds in 8 (Emergency Department, Intensive Care Unit, Linen Storage, Dietary/Caferteria Department, Surgery Department, Cath Lab, Labor and Delivery, and the Step-Down Unit) of 8 Departments observed.

(Refer to A0750).

C. the facility failed to ensure policies and procedures adhered to nationally recognized guidelines when there was no active surgical site infection surveillance

(Refer to A0772).

Based on observation, record review, and interview, the staff failed to monitor temperature and humidity in the following 5 of 5 areas: Emergency Room, Labor and Delivery, Operating Room, Step-down Unit, and Intensive Care Unit. Also, the staff failed to follow the hospital's policy titled: "Air Handling, Ventilation, and Indoor Air Quality".

Findings:

During an interview on 4/23/2024, at 1:39 PM with Staff #9, the surveyor asked about how the temperature and humidity were monitored. Staff #9 presented a log of departments that are monitored daily as well as a log of departments that are monitored weekly. Staff #9 was asked how it is determined what departments are monitored and how it is determined why some departments have only a temperature or humidity checked, and not both. Staff #9 stated "I follow Texas Health and Human Services TAC 25 133.169 (c). I take this monitoring very seriously, but the people who work in the departments every day are the ones who are more accurate about it being too hot or too cold. So, if they tell me it is too hot, I will run to the department and check the temperature. I have not had any problems so far." Staff #9 reported that not all rooms were being monitored for temperature and humidity.

During the interview with Staff #9, it was confirmed that the following 18 rooms/departments were checked for humidity daily, but not temperature: Sterile Hallway, Sterile Hall Operating Room (OR) 1-4, Sterile Hall (OR 5), Sterile Hall (OR 5-8), Sterile Hall Store Rooms 1-3, Sterile Storage, Cart Room, PACU/Recovery, Perfusion Pump Room, Heart Supply Room by OR 9, Sterile Supply By OR 10, Day Surgery/Behind Desk, Decontamination Between Room 2/3, Labor and Delivery Room (LDR) Sterile Hall, LDR OR sterile clean supply, LDR Clean supply, OR Anesthesia Supply, C Section Clean Supply.

Staff #9 confirmed that the decontamination room was checked daily for temperature, but not humidity.

Staff #9 confirmed that the following 13 rooms/departments are checked weekly for humidity, but not temperature: Clean Supply room 1st floor, Emergency Room clean supply room, Step Down Unit -C clean supply 1, Step Down Unit - B clean supply, Intensive Care Unit clean supply, Overflow Clean Supply room, Nursery clean supply room, cesarean section clean supply room, L&D clean supply room, 3A clean supply room, 4A clean supply room, 4S clean supply room, 4N clean supply room.

Staff #9 confirmed that the Labor and Delivery Rooms 1- 11 are checked weekly for temperature, but not humidity.

A review of the facility's policy titled, "Air Handling, Ventilation, and Indoor Air Quality" revised date 4/04/2023 revealed the following:

"Policy

The Utility Systems Management Program for Steward Health Care System Hospitals and their licensed entities shall include the correct design, installation, and maintenance of the hospital's air handling and ventilation
system serving areas specifically designed to control airborne contaminants.

In critical care areas designed to control airborne contaminants (such as biological agents, gases, fumes, dust), the ventilation system provides appropriate pressure relationships, air-exchange rates, filtration efficiencies,
temperature and humidity.

This policy cross-references Infection Control Risk Assessment (ICRA) for construction, Renovations, and Projects. To address the potential infection risks to patients, visitors, and staff associated with renovation, repair, and construction projects and to provide guidelines for the prevention of environment-associated infections.

The Indoor Air Quality (IAQ) Program for Steward Health Care System complies with Occupational Safety and Health Administration (OSHA) requirements.

The hospital maintains ventilation, temperature, and humidity levels suitable for the care, treatment, and services provided. Areas used by patients are clean and free of offensive odors ...

...8. Temperature and Humidity Monitoring Requirements for Storage of Sterile Supplies:

...c. Moisture is a major cause of contamination. Too much or too little environmental humidity can adversely affect package seals and the adherence of sterilization indicator tape and other labels, causing packages to become unsealed or making it impossible to verify that packages have been in the sterilizer.
d. Temperature and relative humidity will be managed through an electronic monitoring system or manual measurements and recorded daily in areas where large volumes of sterile supplies are stored. A process will be in place for monitoring these areas when the space is closed ..."

An interview with Staff #5 (Infection Control Coordinator) on 4/23/2024 at 1:39 PM confirmed that Staff #9 was not following the hospital's policy "Air Handling, Ventilation, and Indoor Air Quality".

Based on observations, record review, and staff interviews, the facility failed maintain a clean and sanitary environment to avoid sources and transmission of infection in 8 of 8 departments which included the Emergency Department, Linen Storage, Dietary/Cafeteria Services, Labor and Delivery, Intensive Care Unit, Step Down Unit, Surgery Department, and Heart Catheterization Lab. Also, the facility staff failed to follow the policy titled, "Infection Prevention & Control (IP) Plan."

Findings:

Emergency Department:

During a tour of the Emergency Department on 4/22/2024 at 11:09 AM with Staff # 7 and Staff # 90, the following infection control issues were observed:

* The floor at the entrance of the walk-in was damaged, with lifted laminate flooring, causing there to be seperation in the tile for dirt, dust, and trash particles to collect.

* There was damaged laminate (1"x1") with exposed wood on the check-in counter.

* There was a linen cart in the main hallway of the emergency room. Linen cart cover had frayed fabric leaving clean linens to be exposed to contaminates from hallaway traffic and housekeeping sweeping and mopping.

* The barrier on the bottom shelf of the linen cart was cracked and chipped, leaving the clean linen exposed to contamintes from housekeeping sweeping and mopping.

* Trauma light in Trauma Room # 1 was covered in a layer of dust and debris.

* The nurses station had damaged laminate on the nursing counter with exposed wood (0.5" x 1").

* Accu-Chek docking station was covered in tape residue and dust.

* There was dirt and dust and other debris on the glucometer.

* Glucometer test strips were not labeled with the date that they were opened.

* There was hair and dirt found in the medication refrigerator.

* Patient nutrition was stored in the same area as the dirty hair clippers.

* The sink in the medication preparation area had dust, dirt, and a build-up of white residue around the faucet where the water comes out.

* The Code Cart in Trauma Bay # 5 was found to have a build-up of heavy layers of dust and dirt on the inside of the cart.

* A used stylet (a slender medical probe or device used to facilitate tracheal intubation) was found laying on top of sterile patient supplies in the hallway outside of Trauma Bay #5.

* Obsrvered patient nutrition stored with sterile supplies.

* Observed dust and dirt build-up in the bins where sterile patient supplies are stored.

* There was dust build-up on the overhead light in ED room # 7.


Linen Storage:

During a tour of the linen storage on 4/22/2024 at 2:52 PM with Staff #5 and Staff #9, the following infection control issues were observed:

*Observed an open ceiling with exposed lights and pipes covered in dust above 12 racks of clean linen that were uncovered and exposed. An interview with Staff #9, Director of Plant Operations reported the exposed lights and vents are only dusted once a year.

Dietary Department:

During a tour of the dietary department on 04/22/2024 at 9:34 AM with Staff #5 and Staff #6 the following safety and infection control issues were observed:

*The floor of the walk-in coolers and freezer had a build-up of dirt and other unknown substances.

* The dish wash room floor was covered in debris and unknown substances.

* Multiple tiles are cracked and chipped throughout the kitchen, storage areas, dishwashing room, and retail area.

* Observed black substance in the walk-in freezer of the wall where food was stored.

* Food cart used to transport clean food trays dust, with debris, and other unknown substances inside the kitchen prep area.

* Wheels of carts used to store clean kitchen pans and utensils found inside the kitchen prep area were covered in a black substance.

* The gasket on the bottom of the freezer door on the produce cooler side was loose and dragging on the floor.

* Tiles missing around the base of the produce cooler with exposed holes that increase the risk of pests and rodents entering the facility

* There are missing tiles on the baseboard in the kitchen near the prep area and refrigerator, leaving the drywall exposed. There is also a brown substance on the wall in the same area.

* The dry storage area for paper products had holes in the ceiling with a red substance that cannot be cleaned.

* The kitchen's room service sink had a brown-yellow discoloration and a dripping faucet.

* Observed 2 of 12 plates from the dishwasher on the clean side had food residue dried on them.

* The splash guard on the dishwasher was discolored and had a build-up of brown residue


Cafeteria:

During a tour of the public cafeteria on 04/22/2024 at 10:27 AM with Staff #5 and Staff #6, the surveyors observed the following:

* The cappuccino machine had a brown hard build-up inside the door where the powdered/flavored product is dispensed.

* Drywall exposed near the air intake vent

* Baseboard separated and found on the floor near the air intake vent.


A review of the hospital policy titled, "Infection Prevention & Control (IP) Plan" with a revision date of 3/28/2024 revealed the following:

" POLICY:
The goal of the Infection Prevention & Control Program is to decrease the risk of acquisition and transmission of healthcare-acquired infections in the patient and employee population. Infection prevention & Control at WRMC is an important consideration in every decision and plan. Infection Prevention & Control must be an integral responsibility of all personnel, medical staff, students, and volunteers. Infection control policies are based on recognized guidelines, applicable laws, and regulations, and address measures to prevent the transmission of infections among patients, employees, medical staff, volunteers, visitors, and the public.
Policies have been developed that define surveillance, prevention, and control measures in all patient care, support, and services areas, and identify methods effective in reducing the risk of transmission of microorganisms while increasing patient safety.
Policies are reviewed and revised by Infection Preventionist and contributing departments per hospital policy. New and revised policies are approved by the Infection Prevention & Control Committee. Hospital-wide policies include those that are general and are followed throughout the hospital; these policies are in the Infection Prevention & Control Manual.
Department specific policies include policies for tasks or infection control measures unique to a particular area. Many infection prevention & control approved practices are integrated in department policies that are kept by the manager of the department, and Infection Preventionist is consulted for input and revisions.

SCOPE: This policy applies to all organization wide.

Oversight of Infection Prevention & Control
One full-time Infection Preventionist oversees the Infection Prevention & Control Program. Qualified and maintained, the IPC implements and manages this program at WRMC. Infection Preventionist reports to the Director of Quality Services.
The Infection Prevention & Control Committee reviews and approves all policies and procedures related to infection surveillance, prevention, and control activities in all departments/services and assists with the development and approval of infection prevention & control activities and the surveillance program ...
* ...Replacement of equipment, ( old, uncleanable pots/pans), as needed .
* Rust mitigation and removing items from service, as appropriate .
* Replacing or removing from service items that have rips, tears, uncleanable stains, unsealed porous surfaces.
* In collaboration with Plant Ops, prioritize environmental factors such as physical penetrations and general maintenance servicing along with pest control scheduling/utilization. This measure includes all ICRAs for any construction and/or repairs. All efforts will be on-going with periodical evaluation to determine effectiveness and make adjustments as necessary ..."

An interview with Staff #5, Infection Control Coordinator, on 04/25/2024 at 2:45 PM, confirmed that there was no active surveillance or effective collaboration with unit directors and acknowledged that the hospital had infection control issues found in 8 of 8 departments which included the Emergency Department, Intensive Care Unit, Linen Storage, Dietary/Cafeteria Department, Surgery Department, Cath Lab, Labor and Delivery, and the Step Down Unit.



48749


Labor and Delivery Unit (L&D)

During a tour of the Labor and Delivery Unit (L&D) on 04/22/24 at 9:30 AM with Staff #8 and Staff #16 the following infection control issues and issues of maintaining a clean and sanitary environment were identified:

Findings:

* There was dirt and dust debris on the bottom shelf inside the Pyxis (Medication machine that provides secure medication storage on patient care units) located in the neonatal intensive care unit. There was an unknown white substance dried on the outside of the glass doors of the Pyxis.


* In the L&D triage room, there was dust build-up on the base of a patient stretcher. The chairs had cracks and holes in the vinyl of the seats.


* In L&D patient room #3, the clear coat on the wood drawers of the Isolette (a clear plastic enclosed crib that maintains a warm environment for a new baby) and the cabinets was noted to be chipped and peeling. The wallpaper was noted to be rippled at the baseboard and separated from the wall below the window. The door entering the room was noted to be splintered or cracked above the handle.

* In the Pediatric Cart at the nurse's station, the following items were expired:

Three blue top blood collection tubes with an expiration date of 10/31/2023.
Two lavender top blood collection tubes with an expiration date of 12/31/2023.
One Foley catheter with an expiration date of 11/30/2023.

* In Feeding Room B, the bathroom was noted to have an accumulation of an unknown black substance in the cracks of the floor tiles and the tiles along the border near the floor.

* Outside of the L&D Unit, in the main hallway, there were several areas noted to have an unknown dried black or brown colored substance on the floor.

An interview was conducted with Staff # 8 and Staff #16 on 04/22/24 at 3:00 PM confirmed that there were infection control issues in the L&D department.

Intensive Care Unit

During a tour of the Intensive Care Unit on 04/23/24 at 10:00 AM with Staff#8 and #98 the following infection control issues and issues of maintaining a clean and sanitary environment were identified:


Findings:


* During a tour of the Intensive Care Unit on 4/23/2024 at 10:29 AM with Staff #54, the following infection control issues were observed:

* PICC (peripheral inserted central catheter) Insertion cart had dust and rust build-up on the topof te cart.

* PICC Insertion cart bins containing alcohol wipes were covered in a thick layer of dust.

* Drawer 1 of PICC line cart had 20 needles that expired on 4/01/2024

* Damaged couches (2) and chairs (3) in the ICU waiting room with cracks and tears in the vinyl of the seats and the fabric on the bottom is hanging on to the floor.

* In the clean supply room, multiple ceiling tiles were noted to have an unknown, brown-colored stain. Also, there was a build-up of dust in the air vent.

* In the biohazard room, there was an unknown black substance dried on the floor. Also, there were blood droplets next to the doorway. The Hopper (Sink used to dispose of liquid chemical waste) was noted to have multiple intravenous bags (IV) with medication labels, hanging from the handles next to the faucet. The IV tubing was hanging down inside the bowl of the Hopper. The water inside the bowl was yellow in color and there was a brown stain circling the porcelain on the inside of the Hopper.

* In the medication room, there was dust and debris build-up on the bottom shelf inside the Pyxis refrigerator.

An interview was conducted with Staff # 8 and Staff # 98 on 04/23/24 at 11:30 AM confirmed that there were infection control issues in the ICU department.


Step-Down Unit

During a tour of the Step-Down Unit on 04/23/24 at 2:20 PM with Staff #8 and #10 the following infection control issues and issues of maintaining a clean and sanitary environment were identified:

Findings:

* In the medication room, there was dust and debris build-up on the bottom shelf inside the Pyxis refrigerator.

* Patient rooms 226 and 227 were noted to have dried brown colored stains on the mattresses. Also, there was a build-up of dust in the air vents.

An interview with Staff #8 and Staff # 10 on 04/23/24 at 3:30 PM confirmed that there were infection control issues in the facility's Step-Down Unit.



47892


A tour of the Surgical Services Department was conducted on 4/22/2024 at 9:30 AM with RN Staff #39 and #40. The following was observed.

Findings:


Operating Room (OR) #9

* On the back side of the mayo stand (a standing tray used to place sterile instruments on during a surgical procedure) was a dried reddish-brown substance. On the feet of the mayo stand, metal was exposed. The metal surface cannot be disinfected to prevent the spread of infectious diseases.
* A small metal table had a white sticky residue on the surface.
* A belt used for patient safety while on the operating table had a white sticky residue.
* The pad on the Operating table had a white sticky residue to the top of the pad.
* Observed on the floor next to the surgical bed there was a dried orange/brown stain.

Storage Closet for Orthopedics

In this storage closet was a Fracture Table (table that patients are placed on to surgically repair broken bones).
The pad on the fracture table had an old sticky residue on the surface and the foot of the table was rusted and had chipped paint exposing the metal surface in multiple places. The top of the pedestal of the fracture table had chipped paint exposing the metal surface in multiple places. The sacral (lower back) positioner had a Velcro strip covered with dry brown residue and the back plate had chipped paint in multiple places. Also, the bottom of the metal pedestal had chipped paint and rust. The metal surface cannot be disinfected to prevent the spread of infectious diseases.

An interview was conducted with RN Staff #39 and RN Staff # 40 on 4/22/2024 after 10:00 AM. RN Staff #39 and RN Staff #40 confirmed these findings in OR 9 and the Storage Closet for Orthopedics.

Cath Lab Department

A tour of the Cath Lab Department (Cardiac Catheterization lab is a specialized medical laboratory in which doctors perform testing and procedures to diagnose and treat cardiovascular conditions) was conducted on 4/24/2024 at 9:30 AM with Radiology Technician (RT) Staff #36. The pad on the Cath Lab table had multiple small pin holes in the underside of the pad where a solution of some form had soaked into the inner cushion causing a blue/purple discoloration on the pad.

An interview was conducted with RT Staff #36 on 4/24/2024 after 9:30 AM. RT Staff #36 confirmed the findings on the Cath Lab table pad.

Based on observation, record review, and staff interview, the hospital's Infection Control Program failed to:

A. ensure active surveillance for SSI (Surgical Site Infections) for all patients undergoing surgeries in the facility (inpatient and outpatient).

B. follow-up on potential and identified surgical infections for 7 (Patient # 42, 43, 44, 45, 46, 47, 48) of 7 patient records reviewed for readmission after surgery.

Findings:

A. In an interview at 9:05 am on 4/24/24, staff #5, infection control coordinator, reported that she sent letters to each of the surgeons to follow-up on SSI, but surgeons would not respond; she also stated her case managers help her with abstractions (the process of capturing and identifying clinical data elements related to quality improvement), she monitors the readmissions of surgical patients, and she has a list of surgical patients for each month. When discussing the IC Plan regarding SSI that state only certain procedures are monitored for SSI, she reported those are the only ones that get reported to NHSN (National Healthcare Safety Network's), but all surgeries were monitored for SSI.
At 11:28 am, she came back and reported that she had not sent the letters out, she did not have a list of surgical cases performed, and she has not been monitoring for SSI appropriately, she provided the surveyor an email from corporate describing SSI surveillance and admitted she wasn't following it.

B. In an interview on 4/24/2024 at 2:00 PM, Staff #39 stated "Over the past week, I have been communicating with Staff #5 via email due to a lack of response and follow-up from previous weeks. The purpose of these emails was to provide evidence that patients with identified infections who were readmitted post-operation were being reported as per the Infection Control Program Plan."

On 4/24/2024 at 2:07 PM in the Board Room, a review of six patient records that were readmitted with surgical site infections (SSIs) revealed:

Patient #42

A review of the record for Patient #42 revealed the patient had a surgical procedure to remove the gallbladder on 3/29/2024, returned to the emergency room on 4/06/2024, and admitted to the Intensive Care Unit with a diagnosis of "Septic Shock". This patient required Intravenous (IV) antibiotics and fluids. There was no evidence of tracking, trending, or follow-up per the Infection Prevention and Control Plan the hospital has in place which included evaluating policies, procedures, and practices, looking for preventable risk factors and eliminate infections by reducing risk factors.

Patient #43

A review of the record for Patient #43 revealed the patient had a left toe amputation and debridement due to gangrene on 3/29/2024. On 4/01/2024 the left foot was amputated. The patient went for a follow-up visit with the orthopedist and was readmitted to the hospital on 4/18/2024 due to a post-operation wound infection. There was no evidence of tracking, trending, or follow-up per the Infection Prevention and Control Plan the hospital has in place.

Patient #44

A review of the record for Patient #44 revealed the patient was admitted on 3/23/2023 with a fractured ankle. On 3/24/2024 the patient had a repair of the fracture with an external fixator with four compartment fasciotomies done. On 3/29/2024 patient went back to the operating room for a skin graft and was discharged on 4/01/2024. The patient was readmitted on 4/08/2024 due to severe pain in the left ankle and subsequently had it removed. During the admission, it is noted that the patient has drainage and infection to the skin graft area and required IV antibiotics. There was no evidence of tracking, trending, or follow-up per the Infection Prevention and Control Plan the hospital has in place.

Patient #45

A review of the record for Patient #45 revealed the patient was admitted on 3/20/2024 for a removal of an external fixation on the right ankle. On 4/16/2024, patient was readmitted for cellulitis involving the incision. Patient required IV antibiotics. There was no evidence of tracking, trending, or follow-up per the Infection Prevention and Control Plan the hospital has in place.

Patient #46

A review of the record for Patient #46 revealed the patient was admitted on 4/02/2024 for infected hardware of the right lower leg (hardware placed several years ago). Discharged on 4/08/2024. The patient was readmitted on 4/16/2024 for cellulitis at the surgical site and required IV antibiotics. There was no evidence of tracking, trending, or follow-up per the Infection Prevention and Control Plan the hospital has in place.

Patient #47

A review of the record for Patient #47 revealed the patient was admitted on 3/02/2024 with a left distal radius fracture and discharged on 3/14/2024. The patient was readmitted on 4/13/2024 with an external fixator in place and infected pins, requiring IV antibiotics. There was no evidence of tracking, trending, or follow-up per the Infection Prevention and Control Plan the hospital has in place.

Patient #48

A review of the record for Patient #48 was initially admitted to the hospital on 2/07/2024 with a 12-millimeter obstruction stone in the left proximal ureter. On 2/08/2024 Patient #48 had a cystoscopy and retrograde pyelogram showing a large stone filling defect within the mid ureter. A left ureteric stent was placed. The patient was treated with IV antibiotics and discharged home on 2/13/2024. Patient had a follow-up cystoscopy with left ureteroscope stone extraction with laser lithotripsy and stent placement on 3/07/2024. On 4/03/2024, an attempted percutaneous nephrostomy placement with Interventional Radiology was terminated because the ureteroscope could not pass. On 4/05/2024 patient was discharged home on oral antibiotics. The patient presented to the emergency department on 4/11/2024 with a diagnosis of "sepsis secondary to urinary tract infection". The patient was admitted to the ICU, requiring IV antibiotics and fluids. There was no evidence of tracking, trending, or follow-up per the Infection Prevention and Control Plan the hospital has in place.


A review of the 2024 Infection Prevention & Control Plan revealed the certain procedures that are monitored which include, Total Knee Replacement, Total Hip Replacement, lower limb vascular surgeries, colon or large intestine surgeries and hysterectomies. The data from these procedures, according to the plan, state there will be a "monthly report of surgical procedures", which could not be provided.


A review of the hospital's Infection Prevention and Control 2024 Plan revealed:

Policy:

"The goal of the Infection Prevention & Control Program is to decrease the risk of acquisition and transmission of healthcare-acquired infections in the patient and employee population. Infection Prevention & Control at WRMC is an important consideration in every decision and plan. Infection Prevention & Control must be an integral responsibility of all personnel, medical staff, students, and volunteers. Infection control policies are based on recognized guidelines, and applicable laws and address measures to prevent the transmission of infections among patients, employees, medical staff, volunteers, visitors, and the public. Policies have been developed that define surveillance, prevention, and control measures in all patient care, support, and service areas, and identify methods effective in reducing the risk of transmission of microorganisms while increasing patient safety ...

Surgical Site Infections

Prevention of surgical site infections is a high priority. Ongoing comprehensive monitoring for specific high-level, high-volume procedures is recommended ...The most current guidelines of the NHSN SSI modules are followed.

...Objectives:

...3. To evaluate procedures, policies, and practices, looking for preventable risk factors when infection trends are identified.
4. To eliminate infections by reducing risk factors."

A review of the National Healthcare Safety Network's (NHSN) guidelines revealed:

"SSI monitoring requires active, patient-based, prospective surveillance. Post-discharge and ante-discharge surveillance methods should be used to detect SSIs following inpatient and outpatient operative procedures. These methods include, 1) direct examination of patients' wounds during follow-up visits to either surgery clinics or physicians' offices, 2) review of medical records or surgery clinic patient records, 3) surgeon surveys by mail or telephone, and 4) patient surveys by mail or telephone (though patients may have a difficult time assessing their infections). Any combination of these methods is acceptable for use; however, CDC criteria for SSI must be used."

In an interview on 4/24/2024 at 3:15 PM Staff #5, stated, "I get emails from the staff that help me with infection control monitoring, and I quickly look at them, but I don't do anything with the information from emails because I don't own them." The surveyor asked if any readmission cases was traced to see if there was a potential problem in the surgical department or other risks that could be identified. Staff #5 stated, "No, I have not done a "Crash Analysis Form" in years. We have had zero infections." The surveyor asked if there was any tracking or trending done on surgical cases. Staff #5 stated, "No, with all due respect, I do not do any tracking or trending on surgical cases. I know I should be, but I am not. I don't even get follow-ups from the doctors to let me know if the patients are having complications, so that makes it much more difficult, and I just don't have the time to do it."

In an interview on 4/24/2024 at 3:40 PM with Staff #40 (Surgical Director) stated, "I have not been informed of any surgery readmissions. This is concerning because when we have potential problems, we want it addressed immediately even if it means changing vendors for supplies or getting refreshers on education concerning sterile processes or any identified problems. I will be looking in to how I can start doing my own tracking and trending of SSI's. I don't know how I will do it, but it needs to be done and a better plan in place."

Based on observation, record review, and interview the Surgical Services Staff failed to:

A. ensure all expired patient supplies were removed from service in 2 (Anesthesia Supply Room and Sterile Supply Room) of 2 areas observed. Also, the facility failed to follow its policy titled, "Inventories Department: Finance & Accounting, Supply Chain Management".

B. ensure the Medivators DSD EDGE (a high-level disinfectant washer used to reprocess flexible endoscopes) water filters were changed according to manufacturer guidelines.

C. ensure a proper surgical time-out was performed before the surgical incision was made in 1 (Patient #60) of 1 patient observed. Also, the facility failed to follow its policy titled, "Universal Protocol for Correct Person, Correct Procedure, Correct Site Verification".

Refer to Tag A0951


Findings:

A.

A tour of the Surgical Services Department was conducted on 4/22/2024 at 9:30 AM with RN Staff #39 and #40. The following was observed.

Anesthesia Supply Room

In the back of the room, hanging on the wall was one 5.0 Glide Scope (a scope used to assist when placing a breathing tube in a patient) that had an expiration date of 7/08/2023 and two Glide Scopes that had an expiration date of 2/03/2024. The glide scopes were readily available for patient use by the anesthesia department.


Sterile Supply Room

In the Sterile Supply Room were two carts used to store patient supplies. One was a Pediatric Cart and the other was a Trauma Cart.

The Pediatric Cart stored supplies for pediatric surgical patients. Inside the cart were two 1.5 Laryngeal Mask Airways (LMA- a temporary airway used during anesthesia). One LMA expired on 6/28/2023 and one expired on 3/08/2022, a pediatric CO2 detector (detects the amount of carbon dioxide in a patient during surgery) had an expiration date of 03/27/2024, IV (intravenous) tubing with an expiration date of 09/25/2023, and a 5.0 oral/nasal tracheal tube cuffless (a tube placed in a patient's airway via the nose or mouth to assist with breathing) with an expiration date of 10/25/2023

The Trauma Cart (cart used to store patient supplies that it is readily available in the event of an emergency surgical procedure) was found to have multiple expired supplies. Inside the cart was Protex 6.5 sterile gloves with an expiration date of 02/29/2024, Protex 8.5 sterile gloves with an expiration date of 03/31/2024, 2-0 Vicryl suture (surgical stitch) with an expiration date of 01/31/2024, and two 4-0 Prolene suture with an expiration date of 03/31/2024.

An interview was conducted on 4/22/2024 after 9:30 AM with RN Staff #40. Staff #40 confirmed that all expired supplies needed to be removed from service.


A review of the facility policy titled, "Inventories Department: Finance & Accounting, Supply Chain Management" Policy Number FIN 22 with a last revised date of 10/04/2022 was as follows:

" ...Policy
Inventory counts will be performed twice a year, in October and April and guidelines will be established to assign the responsibility to control and safeguard inventories to ensure the proper accounting of inventories with the Company's consolidated financial statements.
...
B. Inventory Management and Control
...
4. Departments will review products for expiration dates on a monthly basis, products expiring within 90 days should be flagged to be used first. Products that are expected to be slow moving and cannot be returned should be offered to other Steward Facilities and the product number and quantity of items transferred should be reported to and approved by the Corporate Materials Manager. The quantity and value of expired products should be documented annually and reported to the local finance manager. Expired products that are not kept for teaching purposes should be disposed of in accordance with department policy. ..."

Further review of the Corporate Policy revealed the facility had several addendums to the policy.
A review of the facility's addendum policy titled, "PAR Level/Cart Replenishment", with a final Approval Date of 9/01/2022 was as follows:

" ...Policy
This policy is to provide information organization-wide regarding PAR location and Stock replenishment activities.
Scope
This policy applies to all Staff organization-wide.
Procedure
1. Each care unit will have a defined PAR (maximum stock level) supply compliment.
...
6. Items will be restocked at par location and rotated back forward in the order to reduce risk of expiration. ..."


A review of the facility's addendum policy titled, "Supply Storage-General Storeroom" with a final approval date of 7/11/2023 was as follows:

" ...Policy
This policy is to provide information regarding supply storage and access in the General Storeroom.
Scope
This policy applies to all Materials Management Staff and the other authorized personnel organization-wide who have access to Storeroom.
Procedure
...
5. Items that are within one week of expiration will be reported to the Purchasing Manager for prospective replacement. ..."

After further review of the facility's Corporate Policy and the Hospital Addendum policy, it was revealed that they were not the same and the policy failed to give clear direction on how to manage supplies. RN Staff #40 confirmed the corporate policy and the addendums to the policy were not being followed by the Surgical Services Staff.



B.

A review of the manufacturing guidelines filter change log for the Medivators DSD Edge revealed the Medivators system contains 3 disposable water filters, 1 Micron filter, 0.45 Micron filter, and 0.2 Micron filter, and a reusable mesh disinfectant filter.

The 1 Micron filter and the 0.45 Micron filter should be replaced every 3 months or when the water pressure is below 40 PSI (pounds per square inch).

The 0.2 Micron Filter should be replaced every 6 months.

The reusable mesh disinfectant filter should be disinfected every month.



In an interview on 4/22/2024 at 2:30 PM, Staff #9 confirmed that the 1 Micron filter, 0.45 Micron filter, and 0.2 Micron filter had not been changed since 6/23/22. There was no documentation when the reusable mesh filter was disinfected.

Based on observation, document review, and interview the facility failed to ensure a proper surgical time-out (a procedure when the entire surgical team reviews the patient's identity, the procedure, and the surgical site before the surgical incision or the start of a procedure) was performed before the surgical incision was made in 1 (Patient #60) of 1 patient observed. Also, the facility failed to follow its policy titled, "Universal Protocol for Correct Person, Correct Procedure, Correct Site Verification".


Findings:

During an observation on 4/23/2024 after 8:30 AM in the operating room (OR), it was observed that the surgical staff failed to perform the surgical time out per the facility policy.

Physician #50 and RN Scrub Staff #63 placed sterile drapes over Patient #60. RN Scrub #60 passed surgical cords off the sterile field to RN Staff #62 to connect to the surgical equipment.RN Staff #62 then moved to the head of the bed and began the time-out procedure. During the surgical time-out, RN Scrub #63 continued to retrieve instruments and equipment from the back table (table with all sterile instruments needed for a surgical procedure) and place them on the sterile field (the designated area in the OR that has been prepared to be free of bacteria and particles). During the confirmation of the patient's name and date of birth by RN Staff #62, no other surgical team member confirmed the patient's identity by a patient identifier. There was no verbal communication or agreement on the procedure to be performed between the surgical team members and the surgical team members failed to stop all activities during the surgical time-out.

During an interview with RN Staff #40 on 4/23/2024 after 9:30 AM, RN Staff #40 confirmed that all steps of the surgical time-out were not performed as required to ensure patient safety before the start of a surgical procedure.


Review of the facility's corporate policy titled, "Universal Protocol for Correct Person, Correct Procedure, Correct Site Verification, Chapter", Provision of Care, Policy# POC 23, Origination Date: 10/16/2012, Last Revised 3/23/2021 was as follows:

"Policy
An identification and verification Process for patients undergoing invasive procedures will be performed:
At time of scheduling of procedure (when applicable)
During the pre-procedure patient assessment (when applicable)
When marking the procedure site
Immediately before the procedure is started
This process includes verification of correct patient, correct procedure and correct site (level and laterality).

Scope
The invasive/surgical procedure Universal Protocol will be implemented in all patient care areas.

Definition
Time out: The active communication process among all team members of the invasive/surgical team in the location where the procedure will be done, just before starting the procedure. ...

J. "TIME OUT" IMMEDIATELY BEFORE STARTING THE PROCEDURE: See ATTACHMENT A for SAMPLE TIME OUT FORMS
1. Fire Risk Assessment is performed/documented by the procedure team as part of the Time Out immediately prior to the start of the procedure. ...
2. "Time out" must be conducted in the location where the procedure will be done, immediately before starting the procedure and restarted from the beginning anytime there is an interruption prior to the start of the procedure.
3. Time out will occur after induction with the patient fully prepped and draped. The site marking must be visible.
4. The physician responsible for the surgery/procedure is responsible for the "time-out".
5. The circulating nurse/lead staff member will initiate and prompt all team members during the "Time-out".
6. "Time-out" must include the entire procedure/operative team using active communication.
7. "Time-out" or "pre-procedural stop" will require all individuals present in the room to stop what they are doing and a team member (the RN) will provide a final verification of each of the following elements:
a. Skin prep dried before draping.
b. correct patient identity verified by hospital approved identifiers using patient identification wristband.
c. Agreement on the procedure to be performed.
d. Confirm correct procedure with consent form and patient identifiers.
e. Confirmation that the correct side and site marked, and the mark is clearly visualized.
f. Correct position.
g. Relevant images and results are properly labeled and appropriately displayed.
h. Confirmation of availability of required implants/special equipment/stents.
i. The need to administer antibiotics or fluids for irrigation purposes is documented.
j. For all cases when flammable germicides or antiseptics are used during surgeries utilizing electrosurgery, cautery, or laser the following is required and reviewed during the "Time Out":
*Packaging is nonflammable.
*Applicators are in unit dose.
*Application site is dry prior to draping and use of surgical equipment- pooling of solution has not occurred or has been corrected.
*Prep-soaked materials should be moved to a waste receptacle, at least 3 feet away from the ignition source- DO NOT REMOVE FROM THE OR ROOM to ensure ALL counts are completed and reconciled and the patient has been transferred out of the room.
k. Change of circulating personnel in the room will require a time out between those individuals to verify patient identity and procedures being performed.
8. All time-outs will utilize a "Time-out" scripting
9. "Time-out" must include the entire procedure/operative team using active communication.
10. if the time out is interrupted prior to completion, it must be repeated from the beginning.
11. Any Discrepancies in staff response during "time-out" must be addressed, resolved and documented prior to starting the procedure.
12. The time out will be documented in the procedure note, or electronic medical record.
13. Instruments will not be passed to the physician until "time-out" is completed.
14. The physician is responsible for reading and interpreting the radiographic films to be used during the procedure and that the films have been placed correctly for the patient." ...

In an interview on 4/23/2024 after 2:30 PM, RN Staff #40 confirmed that they did not follow their policy for the surgical time-out procedure.