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Based upon observation, record review, and interview, the Governing Body failed to


A. ensure antipsychotic medications given IM (intramuscular) or IV (intravenous) for behavioral emergencies were identified and monitored as a chemical restraint in 5 (Patient #19, #22, #23, #24, and #25) of 5 on 3 (Emergency Room, Intensive Care Unit, and Medical/Surgical Unit) of 4 Units reviewed. The facility failed to ensure the staff administering the medications were properly trained and educated. The facility failed to document assessments or reassessments of the patient before or after administering antipsychotic medications, perform de-escalation techniques before a restraint, failed to complete a 1-hour face to face, and failed to monitor the use of chemical restraints through the Quality Assessment Performance Improvement Process (QAPI).

Refer to Tag A0144 (A)


B. ensure that medications given IM (intramuscular) or IV (intravenous) and used as behavioral restraints were not ordered PRN (as needed) in 3 (Patient #19, #22, #25) of 5 patient records reviewed.

Refer to Tag A0169


C. ensure a physician or qualified Registered Nurse (RN) completed a 1-hour face to face on patients after a chemical restraint was administered for a behavioral emergency in 5 (Patient #19, #22, #23, #24, #25) of 5 patient records reviewed.

Refer to Tag A0179

The deficient practices identified 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. follow their own policy and procedure in checking bags or large purses for an infant when leaving the NICU/Nursery/Pediatric unit. The facility failed to have a quick response to lock down after a code pink (infant abduction code) was called.

Cross Refer to Tag A0144 (B)


E. ensure a properly executed informed consent was in the medical record prior to procedures being performed in the Emergency Department (ED) in 2 (Patient #20 and #21) of 2 medical records reviewed. The facility also failed to follow their own policy.

Refer to Tag A0131


F. provide the complainant with a written response of the results of the grievance investigation notice and information to allow the complainant to rebut the grievance in 8 patients (Patient #53, #55, #56, #57, #58, #60, #63, and #64) out of 20 (Patient #45 - #64) complaint/grievances reviewed.

Refer to Tag A0123

G. monitor the effectiveness, safety services, and quality of care by analyzing and tracking meaningful data in 10 (January thru November 2022) of 10 months reviewed.

Refer to Tag A0273

H. measure its success and track their performance to ensure that improvements are monitored and sustainable.

Refer to Tag A0283

I. provide an up-to-date Patient Safety Plan to ensure that clear expectations for safety are established.

Refer to Tag A0286

J. document measurable progress achieved on performance improvement projects for 10 of 10 (January thru November 2022) months reviewed.

Refer to Tag A0297

K. Based on the review of the facility's Utilization Management Plan (UMP), the facility failed to have in effect a utilization review (UR) plan that provides for review of services furnished by the facility or maintain a periodic review, as specified in the facility's UMP.

L. the Governing Body failed to ensure the Infection control professional met requirements for a facility infection control program as evidenced by no training, education, and/or certification on file. Also, the Infection Preventionist (IP) failed to ensure the performance of written policies and procedures designed to enhance infection control processes to reduce the risk of negative patient outcomes. In addition, the IP failed to perform staff surveillance to reduce the risk of healthcare associated infections and infection control activities. The IP failed to effectively and timely report to the public health agencies related to Texas notifiable conditions as required.

IP failed to report Texas Notifiable conditions for 87 of 96 communicable disease pathogen reports reviewed resulting in deficient practice in required reporting timeframe as evidenced by the following: Staff # 2 reports unable to locate all notifiable conditions for review, of the 96 located, 87 (chlamydia, gonorrhea, syphilis, HIV, and salmonella) were not reported as required to applicable public health agencies. Staff # 8 and staff # 2 report inability to locate other notifiable conditions for reporting and unaware of process (coronavirus, CRE, campylobacter, hepatitis, etc.).

Refer to Tag: A 748

M. the facility failed to ensure practices and process were in place to prevent and control infections in 14 of 14 areas reviewed for infection control in the (Emergency department (ED), Dietary, Surgical Department, nursing unit(s), Sterile storage, laboratory main, secondary lab, Respiratory, linen and laundry services, Maternal Child Health, Behavioral Health, Obstetrics, Labor & Delivery, and Neonatal Intensive Care Unit).


Refer to Tag: A 750


N. ensure the immediate use steam sterilization for autoclave #1 and #2 in the sub sterile rooms were being used only for carefully selected clinical situations, such as a dropped instrument or no replacement instrument available. Also, the facility failed to complete and record the "Flash Sterilization Log" record per the facility policy.

O. ensure that the surgeon had completed a History and Physical examination form prior to the patient having a surgical procedure. The History and Physical form was completed by the Advance Practice Nurse #41. Also, the surgeon failed to follow the facility's own Medical Staff Rules and Regulations on History and Physical examination note.


Cross Refer to Tag: A 0952

P. protect the patient's right to make informed decisions in 2 (Patient #14 and #18) of 9 surgical patients reviewed. The facility failed to ensure that patients or their representatives were provided with the risks and benefits prior to surgical procedures performed and that the informed consent had a witness signature. In addition, ensure the Patient Disclosure and Consent for Anesthesia and /or Perioperative Pain management (analgesia) was completed prior to anesthesia being performed by the anesthesiologist or physician associates on the day of surgery. Also, the facility failed to follow their own policy and procedures on Informed consent.


Cross Refer to Tag: A 0955

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

Based on document review and interview the facility failed to:


A. ensure antipsychotic medications given IM (intramuscular) or IV (intravenous) for behavioral emergencies were identified and monitored as a chemical restraint in 5 (Patient #19, #22, #23, #24, and #25) of 5 on 3 (Emergency Room, Intensive Care Unit, and Medical/Surgical Unit) of 4 Units reviewed. The facility failed to ensure the staff administering the medications were properly trained and educated. The facility failed to document assessments or reassessments of the patient before or after administering antipsychotic medications, perform de-escalation techniques before a restraint, failed to complete a 1-hour face to face, and failed to monitor the use of chemical restraints through the Quality Assessment Performance Improvement Process (QAPI).

Refer to Tag A0144 (A)


B. ensure that medications given IM (intramuscular) or IV (intravenous) and used as behavioral restraints were not ordered PRN (as needed) in 3 (Patient #19, #22, #25) of 5 patient records reviewed.

Refer to Tag A0169


C. ensure a physician or qualified Registered Nurse (RN) completed a 1-hour face to face on patients after a chemical restraint was administered for a behavioral emergency in 5 (Patient #19, #22, #23, #24, #25) of 5 patient records reviewed.

Refer to Tag A0179



The deficient practices identified 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. follow their own policy and procedure in checking bags or large purses for an infant when leaving the NICU/Nursery/Pediatric unit. The facility failed to have a quick response to lock down after a code pink (infant abduction code) was called.

Cross Refer to Tag A0144 (B)


E. ensure a properly executed informed consent was in the medical record prior to procedures being performed in the Emergency Department (ED) in 2 (Patient #20 and #21) of 2 medical records reviewed. The facility also failed to follow their own policy.

Refer to Tag A0131


F. provide the complainant with a written response of the results of the grievance investigation notice and information to allow the complainant to rebut the grievance in 8 patients (Patient #53, #55, #56, #57, #58, #60, #63, and #64) out of 20 (Patient #45 - #64) complaint/grievances reviewed.

Refer to Tag A0123

Based on review and interview, the facility failed to provide the complainant with a written response of the results of the grievance investigation notice and information to allow the complainant to rebut the grievance in 8 patients (Patient #53, #55, #56, #57, #58, #60, #63, and #64) out of 20 (Patient #45 - #64) complaint/grievances reviewed.


The findings were:
The surveyor requested to see a copy of the facility's Complaint/Grievance Policy, the facility's Complaint/Grievance Log, Patient Quality and Safety Performance Improvement Meeting Minutes for January 2022 through November 14, 2022. There were 20 complaints/grievances reviewed during the specified timeframes. Per the facility's "Complaint/Grievance Policy" on page 1 in item 6 stated, in part, "A written response of the results of a significant complaint/grievance investigation will be provided to the patient within 7 calendar days ....."

Review of the grievance investigations revealed the facility failed to provide the complainant with a written response of the results of the grievance investigation notice and information to allow the complainant to rebut the grievance in 8 patients (Patient #53, #55, #56, #57, #58, #60, #63, and #64) out of 20 complaint/grievances reviewed.

Per the facility's "Complaint/Grievance Policy" on page 1 in item 6 stated, in part, " ...another written acknowledgement with the date and resolution/response letter will be sent ...."

There was 1 (Patient #61) of the 20 that had no documented follow-up at all.

There was 1 (Patient #62) of the 20 that did not appear on the Complaint/Grievance Log at all.

An interview was conducted with Staff #3 on the afternoon of 11/17/2022. Staff #3 was questioned if she had any further evidence that the logged complaints/grievances received a follow-up by letter per their policy. Staff #3 stated, "We do not".

Based on documentation review and interview the facility failed to;

A. follow their own policy to ensure a properly executed informed consent was in the medical record prior to procedures in the Emergency Department (ED) in 2 (Patient #20 and #21) of 2 medical records reviewed.

B. ensure the physician explained the risks and benefits to the patient before administering blood or blood products in 3 (#37, #38 and #40) of 4 (#37,#38, #39, and #40) charts reviewed.

C. to ensure patients that were unable to consent for the administration of psychotropic medications were not administered the medication or had a court order to administer in 1(#30) of 1 charts reviewed.

Findings:

Patient #20
A review of Patient #20's medical record revealed Patient #20 presented to the Emergency Department (ED) on 11/07/2022 with a fractured right elbow. A review of the History documented by Physician #114 at 3:59 PM did not reveal any risk or benefits were discussed with the patient prior to the procedure.

A review of the documentation titled "History of Present Illness" by Physician #113 dated 11/07/2022 revealed, "Plan is to give conscious sedation and closed reduce the right elbow and splint. I have discussed that he will end up needing operative intervention ..." This document was not timed by Physician #113.

A review of the document titled, "Procedure Note" by Physician #113 revealed, " ...I discussed all risks, benefits, alternatives with him which include continued instability arthritis of the right elbow need for further procedure including ORIF nerve or vessel injury with reduction ..." This document was not timed by Physician #113.

With no time documented by Physician #114, this surveyor was unable to determine if Patient #20 was informed of the risks and benefits of the procedure prior to his wife signing the consent.

An Orthopedic Surgical Consent for Closed Reduction Right Elbow by Physician #113 was signed by the patients wife and witnessed by the nurse. No date or time of the signatures was documented. Physician #113 did not sign the consent.

An additional consent titled, "Consent For Special Procedure" was as follows:
"11/07/2022 6:35 PM I authorize Physician #113 and/or whomever he designates to perform the following procedure, Closed Reduction Right Elbow upon me."

The consent was signed by the patient's wife and witnessed by the nurse. There were no risk and benefits listed on this consent.


The "Consent for Anesthesia" was signed by the patients wife and witnessed by the nurse. There was no date or time documented when the consent was signed.

Patient #21
Patient #21 presented to the ED on 11/03/2022 with right hip pain after a fall. A review of the history documented by Physician #73 did not reveal that the risks and benefits of the procedure were discussed with the patient prior to the procedure.

A review of the document titled; "Consent for Special Procedure" was as follows:
"11/03/2022 2:30 AM. I authorize Physician #73 and/or whomever he designates to perform the following procedure, Closed Reduction R Hip upon me."

The consent for special procedures contained an abbreviation for "Right."

The consent was signed by the patient and witnessed by the nurse. There were no risk and benefits documented on the consent.

An "Anesthesia Preprocedure Evaluation" was created on 11/03/2022 at 2:24 AM by CRNA #115.
A review of the document titled; "Consent for Anesthesia" was as follows:
" ...The procedure or treatment, including the anticipated benefits, material risks, alternative therapies, and potential complications, was explained to the patient or the patients legal representative by___________ (left blank).
...
Anesthesia Plan: Types of Anesthesia, risks, and benefits discussed: ...Informed consent signed with the patient and all parties understand the risks and agree with anesthesia plan. All questions answered. Patient consented to blood products? Yes ..."

The consent was signed by the patient and witnessed by the nurse. However, the informed consent for blood or blood products was not documented on the procedure or anesthesia consent. There was no date or time documented when the consent was signed. There was no way to determine if the consent was signed prior to the induction of anesthesia.

An interview was conducted with Physician #12 after 10:00 AM on 11/16/2022. Physician #12 was asked if they listed the anesthesia providers name on the informed consent. Staff #12 replied, "No, we do not do that. The provider getting the consent may be different than the one giving the anesthesia. We really look at who did the pre anesthesia evaluation and usually that is the one that provided the anesthesia during the procedure."

An interview was conducted with Staff #59 in the afternoon of 11/15/2022. Staff #59 stated. "The facility consulted with an outside consultant that informed us that the "Informed Consent" document was just a piece of paper because all the informed consent information was documented by the physicians in their History and Physicals, Progress Notes, or Anesthesia Pre-procedure Evaluation. The nurses had them sign the paper. We do not rely on the consent for legal documentation."

Staff #59 confirmed there was no place for the physician or provider performing the procedure to sign the consent.

Staff #4 and #12 confirmed the findings.


A review of the facility policy titled, "Consents, General and Informed" effective date 11/2022 revealed the following:

"Informed Consents
Article 4509i of the Texas Civil Statutes provides that, before a patient or a person authorized to consent for a patient gives consent to any medical treatment that appears on the Texas Medical Disclosure Panel's list requiring disclosure, the physician must disclose to the patient, or person authorized to
consent for the patient, the risks and hazards involved in the proposed treatment.
1. For informed consents to occur, the physician must provide sufficient information to the patient, or person authorized to provide consent, to enable the patient or person to understand the facts and implications of the proposed actions and to decide whether to submit to the treatment being proposed.

2. The type of information to be disclosed and discussed with a patient includes but is not limited to the following:
a. The nature of the patient's condition;
b. The nature of the proposed care, treatment, service, medications, interventions, or the procedures to be performed;
c. The nature and probability of potential risks involved;
d. The potential benefits to be reasonably expected;
e. The potential side effects that might occur;
f. The inability of the physician to predict results;
g. The irreversibility of the procedure, if that is the case;
h. The likelihood of achieving goals;
i. The likely result of not receiving the treatment or procedure;
j. The reasonable alternatives therapies, including their risks, benefits, hazards, side
effects and potential complications;
k. When indicated, any limitations on the confidentiality of information learned from or about the patient.

3. The Titus Regional Medical Center, "Disclosure and Consent, Medical and Surgical Procedures"
form (adapted from the state required forms) shall be completed in full. No abbreviations (including physician initials) may be used anywhere on the form (patients may not understand
medical abbreviations). When possible the procedure should be written in lay terms (along with medical terminology for the procedure) to increase understanding of the intended
procedure. Copies of the required disclosures are kept on file on all nursing units.

4. Certain procedures as specified by the Texas Medical Disclosure Panel require
and specific consent forms as required by the state to be signed. These certain procedures include but may not be limited to the following:
a. Hysterectomy (Art. 4509i, §6.08.)
b. Electroconvulsive therapy (25 TAC §601 .7)
c. Radiation therapy (25 TAC §601 .5)

5. A patients consent shall be documented with sufficient clarity and detail so as to satisfy the reader that the patient was given and understood the medical information listed in item 2 above. Such documentation shall include but is not limited to the following:
a. A statement that the procedure or treatment, including the anticipated benefits,
material risks, hazards, side effects, alternative therapies and potential
complications was explained to the patient or patient's representative by the
physician or provider who provided explanation (must list name of physician or
provider);
b. A specific listing of all risks as required from time to time by the Texas Medical
Disclosure Panel, relative to the procedure to be performed;
c. General information such as the patient's name, contemplated procedure, and
provision for the disposal and/or use of tissue necessarily removed during surgery;
d. The date the patient expressly gave his or her consent;
e. The date the documentation was recorded (if different than the date of the patient
giving his consent);
f. Signature of the patient;
g. Signature of the witness to the patient's signature;
h. In the event a translator was utilized to obtain consent, the name of the translator
and language translated must also be provided.

6. Should the patient, or person authorized to give consent, have any questions or state that the medical treatment or surgical procedure has not been explained by the physician, then the responsible physician must be notified promptly. The consent form must not be signed until the patient or surrogate decision-maker has had the medical treatment or surgical procedure explained by the physician and has had any questions answered to their satisfaction and the patient or person indicates they consent to the proposed treatment or procedure.

7. The healthcare professional obtaining the patient's signature is only witnessing the fact that the patient, or appropriate other person authorized to give consent, acknowledges understanding of what the physician has explained about the medical treatment or surgical procedure that will be done and gives consent for the treatment or procedure."

Staff #4 and Staff #12 confirmed the findings.




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Findings;

Patient #38
Review of Patient #38's chart revealed she came into the Emergency department (ED) on 10/19/22. She required a blood transfusion, and a physician order was placed to transfuse two units of packed red blood cells. The patient was administered two units on 10/20/22 at 1:06PM and finished at 3:15PM. The second bag was hung at 4:00PM and ended at 6:30PM. Review of the chart revealed there was no found documentation from the physician in the ED or from the Hospitalist upon admission the risk and benefits of blood. Staff #77 confirmed on 11-16-22 that there was no found physician documentation of risk and benefits before administering blood.

Patient #40
The blood consent was signed by the patient on 10/19/22 at 9:53AM. The only signature on the consent was a registered nurse. There was no date or time when the nurse signed the consent. There was no place designated on the form for the physician's signature.

Review of Patient #40's chart revealed she came into the ED on 10/27/22 with a lower GI bleed. The patient was seen by the Hospitalist on the Medical Surgical Unit on 10/28/22. The patient was ordered 2 units of blood and administered. A blood consent was found signed by the patient on 10-28-22 at 11:25AM. The nurse witnessed the form but there was no date or time when the nurse signed the consent. There was no physician signature on the consent. Review of the ED note, and the Hospitalist H&P revealed there was no explanation of risk or benefits noted. Staff #77 confirmed there was no found physician documentation of risk and benefits before administering blood.

Patient #37
Review of Patient #37's chart revealed she was ordered blood on 8/7/22. The patient signed the consent on 8/7/22 at 3:32PM. There was no physician signature on the consent that the patient had received any risk and benefits concerning the infusion. Staff #77 confirmed there was no found physician documentation of risk and benefits before administering blood. Patient #37 received the blood on 8/7/22 at 3:57PM.

According to www.ncbi.nlm.nih.gov/pmc/articles/PMC1312305 "Under Texas law, "informed consent" describes the physician's duty to disclose to the patient the risks and hazards of medical care that would influence a reasonable person's decision to give or withhold consent to that treatment. (Peterson v. Shields 652 S.W.2d 929, 931 (Tex. 1983); Texas Revised Civil Statutes Annotated, art. 4590i, §§ 6.02, 6.05 (Vernon's Supp. 1999)." The patient's physician is responsible for discussing the risks and benefits of blood transfusion and for obtaining consent or documenting refusal on the consent form or medical record.

Review of the facility policy and procedure Blood and Blood Product Administration stated, " ...Planning, 7. Obtain a consent for blood transfusion OR a refusal to permit blood transfusion form from patient (Form in A forms). Scan signed form into patients Electronic Medical Record."

There was no found evidence in the policy and procedure that directed the staff to ensure the physician had explained the risks and benefits in the medical chart before administering the blood products. Review of the blood consents revealed there was no place, or designated line on the blood consents for the physician to sign.



Findings for Psychiatric Unit
Patient #30

Review of Patient #30's chart revealed he was admitted to the psychiatric unit on 11/12/22. He was admitted involuntarily due to lack of capacity to consent for psychiatric services (the mental ability to make a rational decision, which includes the ability to perceive, appreciate all relevant facts and to reach a rational judgment). Patient #30 did have an Order of Protective (OPC) Custody Warrant to hold the patient for care. There was not a medication addendum to the OPC order to force medications.

An OPC is an order issued from the Texas county judge that allows the psychiatric facility to hold the patient and provide treatment. The judge has determined that the proposed patient presents a substantial risk of serious harm may be demonstrated by the proposed patient's behavior or by evidence that the proposed patient cannot remain at liberty. If the physician determines that psychoactive medications need to be given during the patients stay, then the physician can request the order state that medications can be forced and administered without the patients consent.
Review of Patient #30's chart revealed he received Zyprexa (antipsychotic) by mouth on 11/12/22 as part of his daily medication regimen. There was no physician documentation found that the patient had clarity and was able to sign and consent to psychoactive medications. There was no consent found that the patient was able to understand and comprehend the risk and benefits of Zyprexa.

An interview was conducted with Staff #61 and Staff #79(MD) in the afternoon on 11/14/22. Staff #61 stated that she did not understand that the patient could not be given psychotic medications unless there was a written order in the OPC to administer medications. Staff #61 stated, "We have been giving patients oral medications if they had an OPC. The patient did take the medications. He is still confused." Staff #79 stated that if she determines the patient will not be able to clear up and understand medications that she will make sure that the OPC order include the administration of psychactive medications as needed.

Based on document review and interview the facility failed to:

A. recognize antipsychotic medications given IM (intramuscular) or IV (intravenous) for behavioral emergencies were identified and monitored as a chemical restraint in 5 (Patient #19, #22, #23, #24, and #25) of 5 patients on 3 (Emergency Room, Intensive Care Unit, and Medical/Surgical Unit) of 4 Units reviewed. The facility failed to ensure the staff administering the medications were properly trained and educated. The facility failed to document assessments or reassessments of the patient before or after administering antipsychotic medications, perform de-escalation techniques before a restraint, failed to complete a 1-hour face to face, and failed to monitor the use of chemical restraints through the Quality Assessment Performance Improvement Process (QAPI).

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

This deficient practice had the likelihood to cause harm to all patients receiving IM or IV antipsychotic medications. The facility policy does not recognize that emergency behavioral medications administered IM or IV for behavioral emergencies are chemical restraints. The patients receiving these medications are not monitored or assessed by the nursing staff or physicians as if they were restrained.


B. follow their own policy and procedure in checking bags or large purses for an infant when leaving the NICU/Nursery/Pediatric unit. The facility failed to have a quick response to lock down the facility after a code pink (infant abduction code) was called.


Findings:

A. A review of the restraint logs for 3 (Emergency Department, Intensive Care Unit, and the Behavioral Health Unit) of 3 Units for the months of September, October, and November of 2022 did not reveal any Chemical Restraints were administered. Staff #16 and #60 confirmed these findings.

Staff #59 and #60 confirmed no chemical restraints were administered during the months of September, October, and November of 2022. Staff #59 also confirmed there was no restraint log for the Medical Surgical Floor for review.
Staff #59 stated, "The facility policy and the State of Texas do not allow chemical restraints."

Medical record reviews were conducted on 11/15-17,2022 with Staff #4, #16, and #60.

Patient #19
Patient #19 was a 76-year-old female admitted to the facility on 11/08/2022 with a diagnosis of Dehydration.

Review of the History and Physical documented by Physician #68 on 11/08/2022 at 5:12 PM revealed she had a past medical history of hypertension, dyslipidemia, and vascular dementia. The Psychiatric behavior was documented as normal behavior.

A review of the medical record for Patient #19 revealed an order was written by Physician #68 on 11/09/2022 at 2:58 PM for Haldol (antipsychotic medication) 5mg IM (intramuscular) every 6 hours PRN (as needed) for agitation.
The medication was administered by the nurse on 11/09/2022 at 3:15 PM and 9:14 PM.

3:15 PM IM Haldol
Review of the document titled "change in status" documented by the nurse on 11/09/2022 at 2:52 PM revealed Patient #19 was "combative with family members, trying to pull IV out and trying to get into hallway. Family wants home meds resumed or something for her to relax."

Haldol 5mg IM was administered at 3:15 PM nurse. The PRN Med Reassessment was documented as "mild relief" at 3:45 PM. Vital signs; (blood pressure, respirations, temperature, oxygen level, and pulse rate) were recorded at 4:01 PM.

No documentation was found in the medical record of less restrictive measures attempted before administering the chemical restraint.

Staff #94 confirmed there was no nursing assessment documented after the IM injection of Haldol at 3:15 PM on 11/09/2022. Only the effectiveness of the medication was documented at 3:45 PM. Staff #94 stated, "That is the only documentation related to the IM injection of Haldol. There is no other documentation from the nurses regarding the IM injection of Haldol." The next nursing assessment was not documented until 11/09/2022 at 7:45 PM. The assessment was the Registered Nurse (RN) shift assessment completed by the night shift RN.

There was no documentation regarding the IM Haldol administered at 3:15 PM on Physician #68's progress note dated 11/09/2022 at 6:02 PM. Further review of the progress note documented by Physician #68 on 11/09/2022 revealed the patient's Psychiatric behavior and mood were "normal." The next physician progress note was dated 11/10/2022 at 3:04 PM.

There was no nursing or physician assessment in the medical record after the IM injection of Haldol at 3:15 PM.

9:14 PM IM Haldol
Review of the medication administration documentation revealed Haldol 5mg IM was administered at 9:14 PM by the nurse. The PRN Med Reassessment was documented at 9:44 PM by the nurse as "moderate relief." Vital signs were recorded at 9:07 PM. Only blood pressure and pulse rate were recorded at 9:16 PM. Vital signs were not taken again until 12:38 AM on 11/10/2022.

Staff #94 confirmed there was no nursing or physician documentation prior to the IM injection of the Haldol administered at 9:14 PM.

A telephone interview was conducted with Staff #94 after 10:00 AM on 11/22/2022. Staff #94 was asked if the nurses or physicians documented anything regarding the IM Haldol given at 3:15 PM and 9:14 PM on 11/09/2022. Staff #94 replied, "No, there is not anything other than the one change in status documented by the nurse on 11/09/2022 at 2:52." Staff #94 was also asked why Patient #19 received the IM injection of Haldol at 9:14 PM on 11/09/2022. Staff #94 stated, "There is no documentation by the nurses or the physicians why she needed the injection. I do not see anything. The only thing documented after either injection was the effectiveness of the medications."

Staff #94 confirmed Patient #19 was on the medical/surgical floor and not the ICU.

Patient #22
Patient #22 was admitted to the Intensive Care Unit (ICU) on 11/02/2022 at 1:13 PM with a diagnosis of Acute Pancreatitis. He was transferred to the Medical/Surgical Floor on 11/08/2022.

A review of the History and Physical (H&P) documented by Physician #69 on 11/02/2022 at 10:40 PM revealed the patient had a medical history of Atrial Fibrillation, Coronary Artery Disease, Hypertension, and Myocardial Infarction with placement of two coronary stents. "Sister claims the patient is a chronic alcoholic". A review of the physical exam revealed the patient had swelling and bruising to the right elbow, his skin was jaundiced (yellow in color) he was alert, oriented to person, place and time, mental status was at baseline, and his mood and behavior was normal. Patient #22 confirmed with the nursing staff he had a history of alcoholism.

Review of the document titled, "Provider Notification" on 11/02/2022 at 9:50 PM revealed "Patient highly confused/trying to get out of bed/low blood pressure still/PRN's given. See orders 5mg Haldol IV."

Review of the order written by Physician #69 on 11/02/2022 at 9:52 PM read, "Haldol 5mg IV Once." The medication was administered on 11/02/2022 at 10:00 PM by Staff RN #116.

A review of the document titled, "Flowsheet" on 11/02/2022 at 11:00 PM revealed the medication was effective. Vital signs (blood pressure, respirations, pulse rate, and oxygen) were monitored at 10:50 PM and 11:20 PM. No 1-hour face to face was completed.

Further review of the History and Physical documented by Physician #69 at 10:40 PM revealed the H&P was created after the 5mg Haldol was administered IV. The documentation by Physician #69 did not reference the IV Haldol or need for the antipsychotic medication.

Review of RN Staff #116 progress note dated 11/03/2022 at 3:09 AM was as follows:
" ...Patient going through worsening withdrawals throughout the night, attempting to climb out of bed and CIWA (a tool used to assess and diagnose the severity of alcohol withdraw) protocol initiated at 9:30 PM. Pt responding ok to PRNs but remains restless ..."

Patient #22 was transferred to the Medical/Surgical Floor on 11/08/2022. A review of the progress note dated 11/08/2022 at 10:02 AM by Physician #92 was as follows:

" ...Patients mental status is now back to baseline he is oriented to himself situation and location, he is now 24 hours out from any signs or symptoms of DTs. Is now been off all psychotropic medications for greater than 24 hours ..."
Physician #69 wrote an order on 11/03/2022 at 2:47 PM that read, "Geodon 10 mg IM Q 6hours PRN for agitation."

Review of the Medication Administration Record for Geodon revealed that RN Staff #117 administered Geodon 10mg IM to the left deltoid at 1:01 AM on 11/09/2022. Further review revealed RN Staff #118 administered IM Geodon to the left anterior thigh at 7:32 AM on 11/09/2022.

A review of the document titled, "Flowsheet" dated 11/09/2022 at 7:32 AM revealed Patient #22 was disoriented. Further review revealed the Alcohol Withdrawal Assessment completed at 7:32 AM read the patient was disoriented but not agitated. Reassessment of the effectiveness of the PRN Geodon was completed at 8:02 AM and documented as "Full relief obtained." No 1-hour face to face was completed.

RN Staff #117 documented a Plan of Care on 11/09/2022 at 3:02 AM. There was no documentation in the Plan of Care for the use of IM antipsychotic medications to control behaviors.

RN Staff #94 confirmed no other assessments were documented by the nurse before or after the IM Geodon administration. RN Staff #94 confirmed there was no documentation of Patient #22 being agitated prior to the administration of the IM Geodon at 1:01 AM or 7:33 AM.


Patient #23
Patient #23 was a 70-year-old female admitted to the Emergency Room on 10/19/2022 at 12:01 PM. She was transported by ambulance to the ER for Altered Mental Status with a history of Alzheimer's/Dementia. She was triaged by the nurse and vital signs were taken at 12:05 PM.

A review of the History and Physical documented by Physician #63 at 12:03 PM was as follows:
" ...EMS states the staff at the lodge called us for an unresponsive patient. When we got there she was laying on her bed and was drooling. 70-year-old female with history of Alzheimer's dementia presents by EMS from the Lodge assisted living for concern of being found unresponsive in her bed ...Patient was able to tell me her name, when asked if she has any pain in her head or her abdomen she denies. She was unable to answer other questions ...Psychiatric: Agitated, verbally and physically aggressive with staff and provider ..."

An order for Haldol 5 mg (milligrams) IV ED (Emergency Department) 1 time was written by Physician #63 on 10/19/2022 at 1:12 PM. The indication comment was documented as "prn for agitation" and the indications of use was documented as "delirium." The medication was administered IV at 1:18 PM by RN (Registered Nurse) Staff #64. There was no documentation by the nurse or physician of any de-escalation techniques attempted prior to the IV administration of Haldol.

RN Staff #64 documented on 10/19/2022 at 1:25 PM that the "Pt was climbing out of bed, assisted pt back to bed, pt to ct scan via (by) stretcher."

The patient was transported to the Radiology Department at 1:25 PM for a CT scan. There was no documentation by the nurse or physician confirming the patient was monitored for adverse reactions or effectiveness of the IV Haldol. Vital signs to include blood pressure, pulse rate, respirations, oxygen level, and temperature were documented by the nurse at 2:09 PM This was 51 minutes after the IV Haldol was administered. There was no nursing assessment documented after IV administration of Haldol. No 1-hour face to face was completed.

A review of Physician #63's documentation at 2:16 PM was as follows:

"No signs of infection on labs. Unable to obtain urinary drug screen due to patient violent behavior, she is hitting staff, yelling screaming biting. Patients daughter reports that this is her baseline. Patient is discharged back to care facility at baseline state of dementia and agitation. With a discharge diagnosis of Severe late onset Alzheimer's dementia with other behavioral disturbance ..."

Patient #63 was discharged at 2:51 PM. Vital signs to include blood pressure, pulse rate, respirations, oxygen level, temperature, and pain level were documented at 2:47 PM but no nursing assessment was complete.
Staff #4 confirmed the findings.

Patient #24
Patient #24 was a 27-year-old female admitted to the ER on 10/19/2022 at 3:10 PM. She was transported by ambulance with a police escort for altered behavior.

Nursing assessment was started by RN Staff #109 at 3:20 PM. Vital signs were taken at 3:28 PM and noted an elevated blood pressure of 133/90, increased heart rate of 105, and a low oxygen level of 94% on room air. The patient was alert but appeared agitated. Behavioral assessment was completed at 3:45 PM by RN Staff #64. The nurse documented the patient was unclean, unkempt, inappropriate dress for the situation and was found walking on highway and at Home Depot with no shoes on feet. She was also flirtatious and uncooperative.

A review of the History and physical documented by Physician #63 at 3:22 PM was as follows: " ...Patient was found walking around in a parking lot, was trying to get into a vehicle with the mom and her child. Patient is supposed to be taking Zyprexa, per report by EMT she has been off it anywhere from 1 day to 7 years. Patient is not violent. Patient denies homicidal or suicidal ideations ..."

Review of the documentation by RN Staff #70 on 10/20/2022 at 8:20 AM was as follows:

"Pt began to escalate and get agitated at 0738. She began yelling and stating "I do not want to stay in here. Y'all just want to lock me up and keep me locked up. I just got out of being locked up. You are treating me like a caged animal." She then slammed the cabinet door in room a few times and punch the counter a few times with her right hand. Security called to ED. She continued to yell and become agitated. PRN PO medication was offered. She refused. She then said, "I do not care I will not take any medication from y'all I have rights and I know my rights so I will not take them." When the benefits of the medication was talked to with the patient she stated, "I am not taking them, you can take me to jail because I will not take them. That's it I'm done take me to jail." She then began to respond to what appears to be auditory hallucinations stating "Troy I know that's you, I swear if these people don't go away I am going to kill every one of these motherfuckers. Troy turn on your CB radio and tune into channel 4 and I know that's you. Troy I have a 38 and I'm going to kill all these motherfuckers." Patient was at this time while stating she was going to kill everyone was doing a gun motion with her fingers and acting like she was shooting outside her door. Patient then hit the wall approximately 3-4 times with her right hand causing a small abrasion to her right pinky finger. At this time an order was obtained from the physician for IM emergency medication due to patient becoming a threat to herself. When the nurse approached the door with the medication she stated, "You better not touch me with that shit or I will stab you in the eye with the needle." She then backed into the wall and sat down. With security assistance the IM medication was given and patient did not try to fight the injection. After injection she would switch from in between crying to angry. She began to punch and kick the wall again. Nurse asked her to please stop doing this as she was going to hurt herself and we did not want her hurt. She stated, "I'm fine I am not going to be hurt by a punch I have been punch and took a chain to the face. Have you ever been punched? No? Okay." She then began saying, "I'm done like can you take me out of these blue scrubs I like orange better and think I need some orange clothes." At this she began responding to what appears to be internal stimuli and kept talking to someone named Troy. "She was stating they just want to abuse me like you. I was locked in the room. I'm tired of being locked in rooms. What happens if I do this and this what happens huh? That means I can operate a scope, if I can operate a scope that means that I can shoot and kill everyone right? Yeah. I thought so." She continued to respond like this stating the same thing over and over for an extended amount of time. All of this happened between the hours of 0738-0820. Patient was moved to OBS room with door remaining open and security at doorway."

Review of the nursing documentation on 10/20/2022 at7:55 AM was as follows:
"Discussed change in pt status with Physician #63 and that patient is at risk for injury d/t punching counter and verbally aggressive and threatening staff. Emergency medication injection orders placed due to pt refusing oral meds"

Further review of Patient #24's medical record revealed Physician #63 wrote an order on 10/20/2022 at 7:47 AM that read, "Haloperidol Lactate (Haldol) 5 mg IM ED 1 time. Patient behavior escalated, threatening to hurt staff and herself." The medication was administered by the RN on 10/20/2022 at 7:58 AM.

Also, Physician #63 wrote an order on 10/20/2022 at 7:49 AM that read, "Lorazepam (antianxiety medication) 2mg IM ED 1 time. Pt actively psychotic, threatening staff, punching wall. Concern for harm to self or others." The medication was administered by the RN on 10/20/2022 at 7:58 AM.


Review of the record revealed Patient #24 was assigned a sitter. The sitter documented on the patient every 15 minutes while in the emergency room. The sitter did not document that the patient was in restraints during the observations. Staff #70 documented the patient refused vital signs (VS) at 8:10 AM and 8:27 AM. The next set of complete vital signs, Blood Pressure, Pulse, Respirations, Temperature, and oxygen levels were documented at 8:42 AM by the Nurse.

The nurse documentations on 10/20/2022 for hourly rounding was as follows:

" ...8:10 AM Pulse: (refused) Respirations: (patient refuses VS but is breathing) No count of respirations noted.
8:12 AM the patient is currently walking around room yelling at staff. Skin tone pink, no distress noted, patient refused vitals at this time.
8:27 AM Patient continues to refuse vitals, patient continues to ambulate around room and yell at staff, skin tone pink, no distress noted.
8:30 AM Patient is currently sitting on her mattress on the floor.
8:46 AM Pt in room continues to talk to staff but in a much calmer manner ..."

Staff #4 and Staff #60 confirmed the last documentation from a physician was on 10/19/2022 at 7:44 PM by Physician #73. Patient #24 was transferred to an inpatient psychiatric facility with a diagnosis of Acute Psychosis on 10/20/2022at 5:14 PM.


Staff #4 confirmed the only de-escalation techniques documented prior to the IM injection of Haldol on 10/20/2022 was a po (by mouth) Haldol tablet that was refused by the patient at 7:47 AM. Staff #4 confirmed the ER nurses do an hourly rounding on the patients. Staff #4 stated, "The hourly rounding is a safety check and not an assessment. Depending on the severity of the patient's behaviors, our psych patients are assigned a sitter and they document on the patient every 15 minutes." Staff #4 also confirmed there was no 1-hour face to face in the medical record and our physicians know they are the ones that must do a 1-hour face to face for restraints because none of our nurses in the ER are trained to do that.

Staff #4 and #60 stated when Patient #24 received the IM injections of Haldol and Lorazepam it was not considered a restraint per the facility policy so therefore the patient was not monitored as a restraint nor was the patient placed on the restraint log.



Patient #25
Patient #25 was a 36-year-old female admitted to the ER on 11/02/2022 3:55 PM for auditory and visual hallucinations and Suicidal.

A review of the RN triage note at 4:18 PM was as follows:
" ...Pt c/o visual and auditory hallucinations that are telling her to harm herself. Pt denies the voices giving her a plan but states they want me to kill myself right now. I'm also worried something is wrong with my daughter, but the police checked on her and said she was fine. Pt. then stated I am going to rehab at Glenoaks. Patient stated hallucinations all started today. Pt stated I am seeing shadows and people."

Review of Physician #63's note dated 11/02/2022 at 4:45 PM revealed the patient had a history of depression, bipolar disorder, and anxiety and was hearing voices to kill herself. Specifically, she states the plan is to jump off of this building. She has been off medications for over a year. Currently she denies any attempt to harm herself, no ingestions, cutting, or other attempts to self-harm. She denies chest pain, difficulty breathing, abdominal pain, burning with urination, or diarrhea.

Physician #63 wrote an order on 11/02/2022 at 4:51 PM that read: Haloperidol (Haldol) Lactate 5 mg IM Q 4 hours PRN Agitation."

The medication was administered on 11/02/2022 at 10:25 PM by RN Staff #74. The medication was administered greater than 5 hours after the PRN IM Haldol was written for agitation. This allowed the nurse, Staff #74 to make a clinical decision without consulting with the physician.

Staff #4 confirmed there was no documentation for behaviors of agitation at the time of the IM administration of Haldol. Staff #4 also confirmed, per the documentation, Staff #74 administered the IM Haldol while the patient was sleeping.

Documentation by the ER sitter Staff #75 was as follows:
" ...Sitter assessment: 11/02/2022
10:01 PM- Activity: In bed, Behavior: Sleeping, Resp Check (chest rising and falling); Yes, Restraints: No.
10:15 PM- Activity: In bed, Behavior: Sleeping, Resp Check (chest rising and falling); Yes, Restraints: No
10:30 PM- Activity: In bed, Behavior: Sleeping, Resp Check (chest rising and falling); Yes, Restraints: No
10:45 PM- Activity: In bed, Behavior: Sleeping, Resp Check (chest rising and falling); Yes, Restraints: No ..."

Documentation by RN Staff #74 on 11/02/2022 was as follows:
" ...10:00 PM-Hourly Rounding-Patient resting in bed with eyes closed. No distress noted at this time.
10:25 PM-Medication Given- Haloperidol lactate injection 5 mg IM Right Ventrogluteal.
11:00 PM-Hourly Rounding-Patient is sleeping in bed. No distress noted at this time ..."

Vital signs were taken at 4:57 PM on 11/02/2022 and not again until 11/03/2022 at 8:01 AM. An admission nursing assessment was performed by the RN on 11/02/2022 at 4:32 PM. A shift assessment was documented at 7:15 PM by RN Staff #74. No nursing assessment was documented again until 11/03/2022 8:39 AM and that was a Behavioral assessment only.

Staff #4 confirmed Nursing assessments were completed on 11/02/2022 at 4:32 PM, 11/02/2022 at 7:15 PM, 11/03/2022 at 8:39 AM (behavioral assessment only), 11/03/2022 at 7:35 PM (Respiratory, Glasgow Coma Scale, and Neuro Cognitive assessment only), and 11/04/2022 at 7:25 AM (Behavioral Assessment only).

There was no nursing assessment documented post IM administration of Haldol for greater than 10 hours. Hourly rounding by the Registered Nurse was documented from 11/02/2022-11/04/2022.

An interview was conducted with Staff #4 on 11/16/2022 after 10:00 AM. Staff #4 was asked to explain the process of the hourly rounding. Staff #4 replied, "Hourly rounding is for the nurses to see their assigned patients. This is not an assessment. It is usually a brief view to ensure the patient is safe and not in any harm."

Review of the ED Course documentation by Physician #63 and #73 was as follows:
" ...11/02/2022 7:55 PM Physician #63-Urine Drug Screen positive for meth, pending 24-hour hold. Patient care transitioned to Physician #73 ...

11/03/2022 6:36 AM Physician #73-Patient is sleeping comfortably. Patient in for audio and visual hallucinations and wanting to go to Glen Oaks. She is awaiting MHMR assessment after she has had her 24 hour hold for positive UDS (urine drug screen) Lungs clear CV is regular rate rhythm. Impressions: substance abuse, hallucinations, and delusions.

11/03/2022 7:08 AM Physician #63 Received checkout from Physician #73. Anxiety, bipolar, hallucinations with voices telling her to harm herself. No plan. She wants to go to drug rehab. Positive for amphetamine, awaiting MHMR evaluation around 4:00 PM.

11/04/2022 7:00 AM Physician #73 Patient rechecked says slept well and is calmer. Still wanting to get some help with rehab. Lungs clear, RRR, Abd soft and nontender, mucosa moist, awaiting placement ..."
There was no physician assessment for greater than 7 hours post IM injection of Haldol.

Staff #4 confirmed from 11/02-11/04/2022 there was no documentation by the sitter or the nurse that Patient #25 was in restraints.

Review of the nurse's notes dated 11/04/2022 at 5:19 PM the RN documented, "Patient in ED voluntary for greater than 48 hours for psych placement. Patient denies Suicidal/Homicidal ideations and requesting to leave. Physician #63 states AMA (against medical advice) disposition. House Supervisor notified.
5:55 PM Pts mother arrived. Pt leaves AMA with form signed. Pt leaves ambulatory to ED exit with all belongings ..."
Staff #4, #16, and #60 confirmed the findings.

An interview was conducted with Staff #59 in the afternoon on 11/15/2022. Staff #59 was asked if chemical restraints were placed on the restraint log. Staff #59 stated, "We do not administer chemical restraints here at this facility. We do give emergency behavioral medications, but they are not considered a restraint so therefore they are not placed on the restraint log."

An interview was conducted on 11/15/2022 at 4:30 PM with Staff #71 and #72. Staff #71 was asked if the patients that received Chemical Restraints/Emergency Behavioral Medications (EBM) were placed on the restraint log. Staff #71 stated, "No they are not. We do not give Chemical Restraints at this hospital. The state of Texas does not allow us to give them. We do give EBM's, but they are not considered a restraint." Staff #72 was asked if the nurses monitored the patients every 15 minutes after an IM/IV antipsychotic medication was administered. Staff #72 replied, "We do hourly roundings for safety checks. Usually, the patients have a sitter, and they document every 15 minutes. The sitter documents the patient's behavior, they look to see if the patient is breathing by looking for the rise and fall of the chest, but they do not count respirations. They also document who is in the room and if the patient required any interventions, like redirection of their movement. The nurses do check the vital signs but not every 15 minutes. Sometimes the patient refuses."

Staff #71 and #72 were asked to explain the process of a chemical restraint/EBM per the facility policy. Staff #71 and #72 stated the policy does not cover chemical restraints. The policy is more directed at mechanical restraints.

Staff #59 was asked to provide a facility policy on the administration and monitoring of EBM's. Staff #59 stated, "We do not have a separate policy for that. We give EBM and they are not considered a restraint per our policy."



A review of the facility policy titled, "Standardized Use of Restraints and/or Seclusion" with a revised date of 11/2022 was as follows:
" ...DEFINITIONS:
A. Restraint: Any method (physical or chemical) of restricting a patient's freedom of movement (including seclusion), physical activity or normal access to his or her body that:
1. is not a usual and customary part of a medical diagnostic or treatment procedure to which the patient, or his or her legal representative, has consented.
2. is not indicated to treat the patient's medical condition or symptoms; or
3. does not promote the patient's independent functioning.
4. Cannot be intentionally easily removed by the patient in the same manner that it was applied
a. Types of restraints:
...2. Violent/Self Destructive Restraint: Emergency restraint use in any care setting to manage violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others.
3. Chemical Restraint: The use of a sedating psychotropic drug to manage or control behavior or restrict a patients freedom that is not a usual or customary standard of treatment for the patient's medical or psychiatric condition. The use of chemical restraint is prohibited in the state of Texas and is not used at Titus Regional Medical Center.
...
c. The administration of a psychoactive medications during an episode severe psychiatric emergency to stop ongoing attempts at self-harm or imminent threat of harm to others, ordered as a one-time dose and intended to treat the symptoms of psychiatric emergency is NOT considered a chemical restraint and referred to as the emergency administration of medication ..."





According to /www.ncbi.nlm.nih.gov/books/NBK560892/revealed the following:
"HALDOL (haloperidol) Haloperidol is the first of the butyrophenone series of major antipsychotics that is indicated for use in the treatment of schizophrenia.

Box Warning
There is an increased risk of mortality (1.6 to 1.7 times) in elderly patients with dementia-related psychosis. In seventeen placebo-controlled controlled trials, patients using atypical antipsychotic drugs for 10-weeks, death was reported in 4.5% of patients for drug-treated patients compared to 2.6% in the placebo group. Hence haloperidol is not FDA-approved for the treatment of patients with dementia-related psychosis ... there is no specific antidote, supportive treatment is the mainstay of haloperidol toxicity.

HALDOL (haloperidol) should be administered cautiously to patients: with severe cardiovascular disorders, because of the possibility of transient hypotension and/or precipitation of anginal pain. Should hypotension occur and a vasopressor be required, epinephrine should not be used since HALDOL may block its vasopressor activity and paradoxical further lowering of the blood pressure may occur. Instead, metaraminol, phenylephrine or norepinephrine should be used. When HALDOL is used to control mania in cyclic disorders, there may be a rapid mood swing to depression.

Haloperidol is one of the most commonly used antipsychotics in this world. However, since the drug can cause several side effects and is related to several toxicities after initiation, the healthcare workers must be familiar with its pharmacology, signs, and symptoms of toxicity, and management of adverse effects. In addition, a proper history and physical examination are necessary before the initiation of haloperidol in any patient. Therefore, recommended course of action when prescribing haloperidol is as follows:
The clinicians (MD, PA, NP) prescribe haloperidol for appropriate indication.
Psychiatrists are responsible for the overall care of patients on haloperidol therapy.
Pharmacists should ensure proper dosing and report back to clinicians if there are potential drug interactions.
Specialty-trained nurses should review the medicine administration record to ensure there were no administration errors.
Emergency department physicians and triage nurses are the first to respond in case of acute haloperidol overdose.
Intensivist ensures proper ICU care and monitoring while in hospital.
Severe cases of haloperidol toxicity require the consultation of a medical toxicologist."


Staff #4, #16, #59 and #60 confirmed the findings.







32143


B. A tour was taken on the Neonatal Intensive Care Unit (NICU) on the morning of 11-17-22 revealed the NICU, Nursery, nor the pediatric unit had an infant security tag or abduction alarm system, such as a bar-coding system or umbilical clamp, which triggers an alarm, locks doors, and freezes elevators if the infant comes within 4 feet of an exit or elevator.

An interview was conducted with Staff #82 (RN) on 11-17-22 at 9:40AM. Staff #82 stated that the NICU did not have any type of alarming system and if a child had been abducted, they would follow their policy and procedure. Staff #82 stated that the doors are locked at all the units and people need to be let in and out. Staff #82 stated that they have Code Pink drills often and feels like the units are secured. Staff #82 stated that if someone looked suspicious or had an extra-large bag, they would inspect it before letting anyone leave. While on the unit on 11/16/22 this surveyor saw a female leaving the un

Based on review of record and interview, the facility failed to ensure that medications given IM (intramuscular) or IV (intravenous) and used as behavioral restraints were not ordered PRN (as needed) in 3 (Patient #19, #22, #25) of 5 patient records reviewed.

This deficient practice had the likelihood to cause harm to all patients receiving IM or IV antipsychotic medications on a PRN basis. Nurses are expected to make a clinical decision when a patient can receive an IM or IV antipsychotic based on the patients behavior without consulting a physician. This places all patients at serious risk of serious harm, injury, abuse, and even death.


Findings:


Patient #19
A review of the medication order written on 11/09/2022 at 2:58 PM by Physician #68 was as follows:

"Haloperidol Lactate (Haldol-antipsychotic medication) Injection 5 mg IM Q (every) 6 hours PRN agitation.

The medication was administered by the Registered Nurse (RN) on 11/09/2022 at 3:15 PM and 9:14 PM.



Patient #22
A review of the medication order written on 11/03/2022 at 10:03 AM by Physician #94 was as follows:

"Ziprasidone (Geodon-an antipsychotic medication) 10mg IM Q 6 hours PRN for agitation."

The medication was administered by RN Staff #74 on 11/09/2022 at 1:01 AM and 7:32 AM.


Patient #25
A review of the medication order written by Physician #63 on 11/02/2022 at 4:51 PM was as follows:
"Haloperidol Lactate (Haldol) 5 mg IM (intramuscular) Q 4 hours PRN agitation."
The medication was administered on 11/02/2022 at 10:25 PM by the nurse.


An interview with Staff #13 and #59 was conducted on 11/16/2022 after 12:00 PM. Staff #13 was asked if the physicians were allowed to write PRN orders for chemical restraints. Staff #13 confirmed the facility does not allow chemical restraints and they only administer emergency behavioral medications (EBM). Staff #13 stated, "The policy does not allow restraints to be written on a PRN basis. Our policy does not refer to EBM as a chemical restraint. So, when the order is written on a PRN basis the nurse does not have to consult with the provider before administering the medication as long as the administration is within the time frame and there is not a change in the patients behavior for which the medication was ordered for."

Staff #13 and #59 confirmed the medication orders for Psychotropic/antipsychotic medications given IM/IV were written on a PRN basis for Patient #19, #22, and #25.

A review of the facility policy titled, "Standardized Use of Restraints and/or Seclusion" with a revised date of 11/2022 does not recognize that Emergency Behavioral Medications are a Chemical Restraint.
The policy was as follows:

" ...DEFINITIONS:
A. Restraint: Any method (physical or chemical) of restricting a patient's freedom of movement (including seclusion), physical activity or normal access to his or her body that:
1. is not a usual and customary part of a medical diagnostic or treatment procedure to which the patient, or his or her legal representative, has consented.
2. is not indicated to treat the patient's medical condition or symptoms; or
3. does not promote the patient's independent functioning.
4. Cannot be intentionally easily removed by the patient in the same manner that it was applied
a. Types of restraints:
...2. Violent/Self Destructive Restraint: Emergency restraint use in any care setting to manage violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others.
3. Chemical Restraint: The use of a sedating psychotropic drug to manage or control behavior or restrict a patients freedom that is not a usual or customary standard of treatment for the patient's medical or psychiatric condition. The use of chemical restraint is prohibited in the state of Texas and is not used at Titus Regional Medical Center.
c. The administration of a psychoactive medications during an episode severe psychiatric emergency to stop ongoing attempts at self-harm or imminent threat of harm to others, ordered as a one-time dose and intended to treat the symptoms of psychiatric emergency is NOT considered a chemical restraint and referred to as the emergency administration of medication ...

PROCESS: ...Restraint/Seclusion Orders: Violet or Self-Destructive behavior ...
*Refer to state standards and regulations regarding who is recognized licensed practitioner and who may conduct face-to-face evaluations.

1. Time limited orders do not mean that restraint/seclusion must be applied for the entire length of time for which the order is written. Restraint/Seclusion should be discontinued as soon as the patient meets the behavior criteria for restraint/seclusion discontinuation. Standing or PRN (as needed) orders for restraint/seclusion are prohibited ..."


Staff #59and #60 confirmed policy #12679952 reflects processes for mechanical and not chemical restraints.

Based on document review and interview the facility failed to ensure a physician or qualified Registered Nurse (RN) completed a 1-hour face to face on patients after a chemical restraint was administered for a behavioral emergency in 5 (Patient #19, #22, #23, #24, #25) of 5 patient records reviewed. The facility also failed to follow their own policy.

Medical record reviews were conducted on 11/15-17, 2022 with Staff #4, #16, #60 and #94.

Findings:

Patient #19
A review of the medical record for Patient #19 revealed an order was written by Physician #68 on 11/09/2022 at 2:58 PM for Haldol (antipsychotic medication) 5mg IM (intramuscular) every 6 hours PRN (as needed) for agitation.
The medication was administered by the nurse on 11/09/2022 at 3:15 PM and 11/09/2022 at 9:14 PM.

Review of the change in status nursing documentation on 11/09/2022 at 2:52 PM revealed Patient #19 was "combative with family members, trying to pull IV out and trying to get into hallway. Family wants home meds resumed or something for her to relax." Haldol 5mg IM was administered at 3:15 PM in both buttocks by the nurse.
The PRN Med Reassessment was documented as "mild relief" at 3:45 PM.

Haldol 5mg IM was administered at 9:14 PM by the nurse. The PRN Med Reassessment was documented as "moderate relief" at 9:44 PM.

Patient #19 was chemically restrained to treat a behavioral emergency on 11/09/2022 at 3:15 PM and 11/09/2022 at 9:14 PM.

There was no documentation of a 1-hour face to face performed by the physician or a trained RN within 1 hour of administration of the chemical restraints.

Patient #22
A review of the order written by Physician #69 on 11/02/2022 at 9:52 PM read, "Haldol 5mg IV Once."
The medication was administered on 11/02/2022 at 10:00 PM by Staff RN #116.

Review of the "Provider Notification" documented on 11/02/2022 at 9:50 PM revealed a change in patient status that read, "Patient highly confused/trying to get out of bed/low blood pressure still/PRN's given. See orders 5mg Haldol IV."
Patient #22 was chemically restrained to treat a behavioral emergency on 11/02/2022 at 10:00 PM.

Further review revealed Physician #69 wrote an order on 11/03/2022 at 2:47 PM read, "Geodon 10 mg IM Q 6hours PRN for agitation."

Review of the document titled, "Medication Administration Record" for Geodon revealed that RN Staff #117 administered Geodon 10mg IM on 11/09/2022 at 1:01 AM and RN Staff #118 administered IM Geodon at 7:32.

A review of the document titled; "Flowsheet" dated 11/09/2022 at 7:32 AM revealed Patient #22 was disoriented. Further review revealed the Alcohol Withdrawal Assessment completed at 7:32 AM read the patient was disoriented but not agitated.

Patient #22 was chemically restrained to treat a behavioral emergency on 11/09/2022 at 1:01 AM and 11/09/2022 at 7:32AM.


There was no documentation of a 1-hour face to face performed by the physician or a trained RN within 1 hour of administration of the chemical restraint administered on 11/02/2022 or 11/09/2022.


Patient #23
Review of Patient #23's medical record revealed Physician #63 wrote an order for "Haldol 5 mg IV (intravenous) ED 1 time" on 10/19/2022 at 1:12 PM. The medication was administered by Staff #64 at 1:18 PM.

A history and Physical was documented by Physician #63 at 12:03 PM. A review of the Physical Exam revealed the "...patient was agitated, verbally and physically aggressive with staff and provider ..."

Patient #23 was chemically restrained to treat a behavioral emergency on 10/19/2022 at 1:18 PM.


There was no documentation of a 1-hour face to face performed by the physician or a trained RN within 1 hour of administration of the chemical restraint.


Patient #24
A review of Patient #24's medical record revealed Physician #63 wrote an order for "Haldol 5 mg IM (intramuscular) ED 1 time. Indication Comment: Patient behavior escalated, threatening to hurt staff and herself." The medication was administered by RN Staff #70 on 10/20/2022 at 7:57 AM
Also, Physician #63 wrote an order for, "Lorazepam (antianxiety medication) 2mg IM ED 1 time. Indication Comment: Pt actively psychotic, threatening staff, punching wall. Concern for harm to self or others" on 10/20/2022 at 7:49 AM. The medication was administered by RN Staff #70 on 10/20/2022 at 7:58 AM.

Patient #24 was chemically restrained to treat a behavioral emergency on 10/20/2022 at 7:57 AM.

There was no documentation of a 1-hour face to face performed by the physician or a trained RN within 1 hour of administration of the chemical restraint.


Patient #25
Patient #25 was a 36-year-old female admitted to the ER voluntary on 11/02/2022 at 3:55 PM for auditory and visual hallucinations, and Suicidal.

A review of the RN triage assessment note documented at 4:18 PM was as follows:
" ...Pt c/o visual and auditory hallucinations that are telling her to harm herself. Pt denies the voices giving her a plan but states they want me to kill myself right now. I'm also worried something is wrong with my daughter, but the police checked on her and said she was fine. Pt. then stated I am going to rehab at Glenoaks. Patient stated hallucinations all started today. Pt stated I am seeing shadows and people."

A review of Patient #25's medical record revealed an order for "Haldol 5 mg IM Q 4 hours PRN agitation" was written by Physician #63 on 11/2/2022 at 4:51 PM.

The medication was administered on 11/02/2022 at 10:25 PM by RN Staff #74. The medication was administered as an emergency behavioral medication greater than 5 hours after the PRN order was written for agitation.

Patient #25 was chemically restrained to treat a behavioral emergency on 11/02/2022 at 10:25 PM.
There was no documentation of a 1-hour face to face performed by the physician or a trained RN within 1 hour of administration of the chemical restraint.


Staff #4 confirmed there were no 1-hour face to face assessment in 5 (Patients #19, #22, #23, #24, and #25) of 5 medical records reviewed.

Based on review and interview the facility failed to;

A. monitor the effectiveness, safety services, and quality of care by analyzing and tracking meaningful data in 10 (January thru November 2022) of 10 months reviewed.

Refer to Tag A0273

B. measure its success and track their performance to ensure that improvements are monitored and sustainable.

Refer to Tag A0283

C. provide an up-to-date Patient Safety Plan to ensure that clear expectations for safety are established.

Refer to Tag A0286

D. document measurable progress achieved on performance improvement projects for 10 of 10 (January thru November 2022) months reviewed.

Refer to Tag A0297

Based on review and interview the facility failed to monitor the effectiveness, safety services, and quality of care by analyzing and tracking meaningful data in 10 (January thru November 2022) of 10 months reviewed.

The findings were:
The surveyor requested to see a copy of the facility's Quality Assessment and Performance Improvement (QAPI) Plan Program/Policy, QAPI Meeting Minutes, and Governing Board Meeting Minutes. While the facility could produce a QAPI Process/Policy and QAPI Meeting Minutes, the QAPI Meeting Minutes, the review of the QAPI meeting minutes from January 1, 2022 - November 14, 2022, it was revealed that Dietary and Respiratory were not reporting to QAPI at all. In all departments, sub committees were formed and reported to the subcommittee directors. There was no identifiable evidence that the subcommittees were collecting data but had not analyzed the data, formulated a plan, implemented a plan, monitored, or tracked the plan. Although there was a "schedule" for most departments (except for Dietary and Respiratory) for reporting to QAPI, there was no evidence found that the Medical Staff, and Governing Body had received their reports.

An interview was conducted with the Staff #11 on the morning of 11/16/2022. Staff #11 stated, "Right now we have participation in QAPI, we are invited, and we come, but we have not participated for some time now. They (referring to the QAPI members) have not yet identified what they want me to work on. It is a known problem, and they are working on it."

An interview was conducted with the Staff #3 on the afternoon of 11/17/2022. Staff #3 was asked how sub-committees were represented during QAPI meetings. Staff #3 stated, "Depending on the department, they all report to the Quality & Safety Committee, and they attend all of those meetings. Different departments report at different quarters." Staff #85 was present during the interview and stated, "We report our Quality & Patient Safety Committee meeting minutes publicly. We have a separate set of meeting notes called the "Executive Meeting Minutes" in which the numbers and statistics are recorded as well as what will be presented to the Governing Body." Staff #85 then informed this Surveyor that she would bring the meeting notes for review. The Staff #3 provided a "Quality & Patient Safety Committee 2022 Reporting Schedule" in which the Executive Meeting Minutes were not mentioned but did not provide this Surveyor with the notes. Staff #3 and this Surveyor reviewed the Quality & Patient Safety Committee Meeting Minutes. Dietary and Respiratory were not represented on the schedule, or within the minutes reviewed for January 1, 2022 through November 14, 2022. This Surveyor then asked about representation for the two departments. Staff #3 then replied, "I will add them to the schedule right now."

An interview was conducted on the morning of 11/16/2022 with the Staff #11. Staff #11 stated, "Right now we have participation in QAPI, we are invited, and we come, but we have not participated for some time now. They (QAPI members) have not yet identified what they want me to work on. It is a known problem, and they are working on it."

Staff #3 and Staff #85 were unable to clarify how meaningful data was analyzed, plans were formulated, plans were implemented, monitored, or tracked. There was no provided or found information on how this information was reported to medical staff and governing body.

Based on the review and interviews the facility failed to measure its success and track their performance to ensure that improvements are monitored and sustainable.

The findings were:
Review of the Governing Body (GB) Meeting Minutes dated August 29, 2022, stated that a Quality Improvement Safety Plan was approved. Review of the GB meeting minutes for May 31, 2022, revealed the "Quality Improvement Safety Plan" was approved. The facility was unable to provide the Quality Improvement Safety Plan or any performance improvements that had measures, plans, or evidence that it had been taken up through the reporting process from QAPI, Medical Staff, and Governing Body.

An interview was conducted with the Staff #3 and Staff #85 on the afternoon of 11/17/2022. Staff #3 and Staff #85 were asked, "Where are opportunities for improvement discussed or where is the focus on high-risk, high-volume, or problem prone areas discussed within your QAPI Meetings?" Staff #85 replied, "Those are in the Executive Meeting Minutes I am bringing you." The Executive Meeting Minutes were reviewed and there was no evidence provided on what information was being measured for success and tracked for their performance to ensure that improvements are sustained. Staff # 85 was unable to provide any further evidence.

Based on review and interview the facility failed to provide an up-to-date Patient Safety Plan to ensure that clear expectations for safety are established.

This surveyor requested to see a copy of the facility's Patient Safety Plan and Policy on the morning of 11/14/2022. Staff #3 initially stated that the facility did not have one.

An interview was conducted with Staff #3. Staff #3 was asked on the afternoon of 11/16/2022 if she was now able to provide any proof of the Patient Safety Policy or Process being discussed or approved, or any tracking information on the Patient Safety Policy or Process. Staff #3 and Staff #85 were asked, Staff #3 stated, "Let me check in some more places." Staff #3, on the afternoon of 11/17/2022, produced an old "Patient Safety Plan" and Staff #3 stated, "I found this in the archived folders. It is very old; I think the folder said 2008. It is not in the current format we use. I know we need one, so I am going to get started on reviewing this one (indicated the 2008 Patient Safety Plan) so we will have it moving forward."

Based on the review and interview the facility failed to document measurable progress achieved on performance improvement projects for 10 of 10 (January thru November 2022) months reviewed.

The findings were:
This surveyor reviewed the facility's Board of Managers Meeting Minutes, Governing Body Meeting Minutes, and Patient Quality and Safety Performance Improvement Meeting Minutes for January 2022 through November 14, 2022. The Governing Body Meeting Minutes for May 31, 2022, approved the "Patient Quality and Safety Performance Improvement requests", but neither process was outlined within the Governing Body Meeting Minutes. There was no evidence provided for what PI processes were discussed or approved, and no tracking information was found within any of the meeting notes.

An interview was conducted with the Staff #3 and Staff #85 on the afternoon of 11/17/2022, Staff #3 and Staff #85 were asked, "How are Performance Improvements (PI) audited?" Staff #3 responded, "Each PI project has a corresponding PowerPoint presentation that is presented at the QAPI Review meetings." Then Staff #85 indicated a stack of PowerPoints that Staff #3 had provided. This Surveyor then asked if the Executive Meeting Minutes would reflect their review within them. Staff #85 responded, "Yes, they are represented there." However, Staff #85 provided a copy of the Governing Board Meeting Minutes for January 1, 2022, through 11/14/2022. Staff #85 indicated a portion annotating that the Executive Meeting Minutes were reviewed in the Governing Board Meeting Minutes. Staff #85 was unable to clarify verbally or with written documentation how meaningful data was analyzed, plans were formulated, plans were implemented, monitored, or tracked. There was no provided or found information on how this information was reported to the medical staff and governing body.

Based on record review and interview the facility's process for transporting medications and biologics supplied to offsite clinics, did not ensure the safety and security of the medications.The facility failed to secure medications in 2 of 2(Intensive care Unit and OB C-section Room #2) units.



Findings included:

An interview was conducted on 11/17/2022 in the pharmacy with Staff # 55. Staff # 55 reported that offsite clinics picked up medication orders from the pharmacy and transported the medications back to the clinics. Staff # 55 described the process as follows: The clinic will send an e-mail requesting the needed medications and vaccines. The pharmacy staff then prepare the order and print an invoice for the order. The medications are then placed in a clear, plastic, zip-top bag and placed in a central location in the hospital pharmacy until pick up. The clinic manager or designee then come to the hospital pharmacy to pick up the medications at which time they are handed the clear, plastic, zip-top bag and sign the invoice. They are then given a copy of the invoice and a copy is placed in a file in the pharmacy. Staff # 55 reported there was no reconciliation process after the medications left the hospital. Staff # 55 reported there was no locking device or tamper resistant seal on the clear, plastic, zip-top bag. Staff # 55 reported the medications were transported in the clinic staff's personal vehicle and not one provided by the clinic or hospital.


The facility was asked for the policy for transporting and releasing medications to offsite facilities and no such policy was provided.


An interview with # 26 and # 52 on 11/17/2022, confirmed the process described by Staff # 55 was correct and confirmed the facility had no specific policy for the process as described.


32143


Findings included:

A tour was taken on the Intensive Care Unit (ICU) on 11-16-22. A drawer was opened in the patient supplies area near the medication cabinet. A large wooden key ring was found with 4 keys attached. Staff #94 was asked what the keys went to and she stated it goes to the locked narcotic box inside the refrigerator. Staff #94 stated the nurse would have to sign into the medication cabinet to open the refrigerator. Review of the medications in the refrigerator revealed there was numerous medications that were not narcotics. The nurse could sign out for another medication and have the key to open the locked box. There would be no evidence on who opened the narcotic box. This would allow for drug diversions to happen.

A tour was taken on 11-14-22 in the c-section room #2 of the OB Department. The anesthesia medication and supply cart was open. Medications for anesthesia was unsecured and could be transported out of the room easily. Staff # 77 confirmed the cart should be locked.

Based on observation, record review and interview, the Dietary Director/Executative Chef, failed to ensure all food served to patients was prepared in a safe and sanitary environment.

This deficient practice had the likelihood to potentially expose all patients within the facility to food borne diseases that could cause severe illness and/or death.

Findings included:

Observations made during a tour of the facility's kitchen on 11/14/2022, found temperature logs for warming cabinets, cooling tables, refrigerators and freezers used to store food had not been consistently checked to ensure they remained at proper temperatures to prevent food borne illnesses. Observations made during this tour also revealed general unsanitary conditions, expired milk in the milk cooler, the milk cooler also had a foul odor. In the bulk cooler a tray with a cardboard box was found with meat thawing, on top of the box was another package of meat thawing and the box was sitting in a pink liquid coming from the meat sitting on top of it. There was a crack in the ceiling above the clean side of the dishwasher and clean dishes were sitting under the crack.

The above observations were made in the presence of staff #19, # 22 and # 23, and all findings were confirmed at the time of observation on 11/14/2022 at 12:30 PM.

Observations made during a follow-up tour of the facility's kitchen on 11/15/2022 found temperature logs for warming cabinets, cooling tables, refrigerators and freezers used to store food had not been checked for that day. The environment was unsanitary and dirty, equipment identified as unusable was available for use at the time of observation. The issues identified on the previous day with the cleanliness and sanitation of the kitchen was still present during this tour. Also, a cart with two stainless pans had thawed chicken in them, and it was observed the plastic wrap used to cover the pans was loose and the pans were open. Staff # 22 stated the chicken was going to be used for service that day and was about to be cooked. Upon closer inspection, it was found by the surveyor both pans of chicken had passed the use by date on the pans. One date showed the chicken expired on 11/12/2022 in one pan and 11/13/2022 on the other.

Staff # 22, # 23, # 85 and # 87 confirmed all findings at the time of observation on 11/15/2022 at 9:45 AM.

A review of the facility policy titled, "Kitchen Sanitation," with an approval and effective date of 08/2022 revealed:

"Policy: Food and Nutrition Services maintains a comprehensive kitchen sanitation program and current Safety Data Sheets for approved chemicals used in cleaning and sanitizing.

Purpose: To promote a clean safe and effective environment and to prevent the transmission of disease-carrying organisms ....

4. Management conducts Food and Safety Standards Reviews and Sanitation Self-Inspections weekly. Safety inspections conducted per FDA and Texas Department of Health standards to monitor the effectiveness of the Kitchen Sanitation Program."

A review of the job description for the Director of Nutritional Services revealed this position is responsible for overseeing food preparation and sanitation standards in the Nutritional Services Department.

Based on the review of the facility's Utilization Management Plan (UMP), the facility failed to have in effect a utilization review (UR) plan that provides for review of services furnished by the facility or maintain a periodic review, as specified in the facility's UMP.

The findings were:
On the morning of 11/14/2022, this Surveyor requested to see the facility's Utilization Management Plan (UMP). Per facility's UMP policy, the Utilization Review Committee must:
" Meet quarterly and be reviewed at least annually
" Recommended changes in Hospital procedures/medical staff practices
" Over/under utilizations of
- hospital services
- special data trends
- referrals
" include information on length of stay
" readmissions within 30-days
" short stay-less than 2 midnights
" extended lengths of stay
" adverse determinations
" setting PI goals at least annually
" process errors
This Surveyor reviewed the facility's Quarterly Utilization Review Committee Meeting Minutes (URCMM) for the facility 7/28/2022 and 5/16/2022. No Quarterly or Annual Utilization Review Committee Meeting Minutes prior to 5/16/2022 for the year of 2022 were provided and could not be found as of the afternoon of 11/16/2022. The details of the discussions held during the URCMM were not found. There were no numbers related to special data, trends, referrals, lengths of stay, extended lengths of stay, readmissions within 30-days, adverse determinations, process errors, or Performance Improvement (PI) goal progress.

An interview was conducted on the afternoon of 11/16/2022 with the Staff #59. Staff #59 was asked for the URCMM prior to 5/16/2022, she stated, "We do not have anything prior to show you. We had turnover and we are just getting back on track with our URC meetings. The notes from 5/16/22 are the first ones we have for this year."

Based on observation, record review, and interview:

A. the Governing Body failed to ensure the Infection control professional met requirements for a facility infection control program as evidenced by no training, education, and/or certification on file. Also, the Infection Preventionist (IP) failed to ensure the performance of written policies and procedures designed to enhance infection control processes to reduce the risk of negative patient outcomes. In addition, the IP failed to perform staff surveillance to reduce the risk of healthcare associated infections and infection control activities. The IP failed to effectively and timely report to the public health agencies related to Texas notifiable conditions as required.

IP failed to report Texas Notifiable conditions for 87 of 96 communicable disease pathogen reports reviewed resulting in deficient practice in required reporting timeframe as evidenced by the following: Staff # 2 reports unable to locate all notifiable conditions for review, of the 96 located, 87 (chlamydia, gonorrhea, syphilis, HIV, and salmonella) were not reported as required to applicable public health agencies. Staff # 8 and staff # 2 report inability to locate other notifiable conditions for reporting and unaware of process (coronavirus, CRE, campylobacter, hepatitis, etc.).

Refer to Tag: A 748

B. the facility failed to ensure practices and process were in place to prevent and control infections in 14 of 14 areas reviewed for infection control in the (Emergency department (ED), Dietary, Surgical Department, nursing unit(s), Sterile storage, laboratory main, secondary lab, Respiratory, linen and laundry services, Maternal Child Health, Behavioral Health, Obstetrics, Labor & Delivery, and Neonatal Intensive Care Unit).


Refer to Tag: A 750

Based on observation, record review, and interview, the Governing Body failed to ensure the Infection control (IC)professional met requirements for a facility infection control program as evidenced by no training, education, and/or certification on file. A review of the employee file did not reveal a certification, infection control training, and or relevant education. Staff # 56 confirmed that the appointed IC did not have any training, education, and/or certification. Also, the Infection Preventionist (IP) failed to ensure the performance of written policies and procedures designed to enhance infection control processes to reduce the risk of negative patient outcomes. In addition, the IP failed to perform staff surveillance to reduce the risk of healthcare associated infections and infection control activities.

Upon review of the last quarter of reportable conditions provided by staff # 2, the IP failed to report Texas Notifiable conditions for 87 of 96 communicable disease pathogen reports reviewed resulting in deficient practice in required reporting timeframe as evidenced by the following: Staff # 2 reports unable to locate all notifiable conditions for review, of the 96 located, 87 (chlamydia, gonorrhea, syphilis, HIV, and salmonella) were not reported as required to applicable public health agencies. Staff # 8 and staff # 2 report inability to locate other notifiable conditions for reporting and unaware of process (coronavirus, CRE, campylobacter, hepatitis, etc.).

Based on observation, record review, and interview, the facility failed to ensure practices and process were in place to prevent and control infections in 14 of 14 areas reviewed for infection control in the (Emergency department (ED), Dietary, Surgical Department, nursing unit(s), Sterile storage, laboratory main, secondary lab, Respiratory, linen and laundry services, Maternal Child Health, Behavioral Health, Obstetrics, Labor & Delivery, and Neonatal Intensive Care Unit).

During a tour of the facility from 11/14/2022 to 11/17/2022 the following infection control findings were observed:

Hand hygiene

Upon Infection Control facility assessment on 11/16/22 at 9:34 AM a code was called to room 418, observed sixteen personnel enter the room with only one performing hand hygiene. Another 3 persons entered the room without hand hygiene while 5 left the room without performing hand hygiene. Only infection control hand hygiene audit from September 2022 reports 85% compliance with hand hygiene. During environmental rounding in the emergency department on 11/16/2022 at 140025 identifiable opportunities or indications were observed for appropriate hand hygiene by hospital (ER nurses, physicians, and phlebotomist, as well as emergency medical services personnel) only 2 opportunities for hand hygiene were followed. Observed staff leaving room with gloves on and returning to patient room with same gloves.

Observed venipuncture

On 11/15/2022 at 2:44 PM in the secondary lab, observed staff # 21 perform a venipuncture without performing hand hygiene and contaminating gloves. Staff # 21 left tourniquet on patient wrist for over 3 minutes, contaminated venipuncture site with contaminated gloved hand. When staff # 21 removed the needle, staff did not apply direct pressure or gauze to site; thus, allowing blood to drip from patient on the chair and floor. Staff # 21 then proceeded to use contaminated gloves to get supplies from the drawer and contaminated all supplies with a bloody glove. Staff did not label or verify patient when labeling tubes at the bed or chairside. Staff walked the blood samples into another room to label with contaminated gloves and utilized the computer. Patient replaced contaminated tourniquet into the drawer where clean supplies are supposed to be maintained. During an interview with staff # 8, stated, "yes, I knew we were gonna get called on for the tourniquet reuse."

Emergency Department

Entrance into the ED observed wheelchairs and searing that was dirty as evidenced by unknown dried substances on chairs, soiled tissue in a chair. There were no readily available disinfectant wipes. During initial tour with RN # 4 it was reported that there is no process to define if chairs have been disinfected between use. ED entrance and waiting area observed tear and shredding of floor tile, revealing subfloor with trapped dirt and grime. Observed chair with hole and scratches penetrating the vinyl, resulting in risk of healthcare associated infections (HAIs) or transmission.

Table in the ED entrance noted sticky black residue on edge trapping particles, fibers, and hair.

ED cubby or cubicle with cabinet in by triage (outside of the ED), observed multiple jugs of open disinfect and hand sanitizer in open cabinet with various other spray bottles empty. ED cabinet outside of triage, observed grossly dirty shelving as evidenced by black discoloration with debris, brown sticky stains with rings resembling a coke can, open box of gloves and gloves in the sticky residue. Observed hand sanitizer on wall with dirty sticky adhesive.

During initial ED tour, observed in exam 1 a dirty computer on wheels as evidenced by dust and debris on the computer screen and keyboard. Exam 1 in ED observed open 2x2s in a bin, staff # 4 reports they are used for intravenous access removal and wounds. Two packages of defibrillator pads beyond expiration date. Exam 1 ED observed open multipacks of cardiac electrodes in dirty blue bin as evidenced by layers of dust. ED Exam 1 observed stretcher mattress with adhesive residue in multiple areas and tears in outer linin, preventing proper disinfection and posing high risk of HAIs and/or pathogen transmission, i.e., clostridium difficle infection (CDI). Exam 1 base of stretcher revealed dislodged Velcro with adhesive resulted in adhered debris, fibers, hair, dirt. Observed base of stretcher with multiple exposed areas with rust and dried unknown brown substances.

Trauma room observed open or exposed 2x2s in dirty bin as evidenced by layers of gray/white dust. Trauma room observed top of metal cart with sticky adhesive residue, glucometer case with used and bloody chemstrip (strip utilized to test blood sugar levels from pricking the finger for capillary blood. ED Observed a laundry hamper with a signed attached with large peeling tape, the tape had adhered debris, dirt and dust. Observed a dirty or soiled glove in the isolation cart in the room, as well as an expired Adult respiratory mask. ED continued, observed bloody alcohol prep crusted and dried inside the top drawer of working supply cart. Observed an uncovered Bair hugger, staff #4 reports the process to ensure it is clean or disinfected and ready for a new patient, it would be covered with a green clear bag. Continue in the ED, trauma room, observed airway bag on crash cart not labeled with a date when last checked. Signs on the wall partially adhered with silk tape. Open razors in top of procedure cart, unsecured or packed in a safe place. ED Trauma room continued, observed surgical equipment expired and outer surface degraded. Observed laundry hamper with adhesive and trapped debris, dust, unknown sticky substance around top lid.

ED medication area, middle of nurse's station with recent large leak and staff # 4 reported the destruction of the pyxis machine. Ceiling tiles are grossly stained and continues to be changed weekly due to ongoing pipe issues above the ED. Continue with medication prep area in the ED, observed sink with dark brown and yellow stains, cluttered cabinets with medications of single use as multi-use, blood transport containers, open wound dressing supplies, lids to various cups, hydrogen peroxide, medical equipment and staff # 4 reports unsure what is clean or dirty. Continue with medication prep area in the ED, observed single use tincture of benzoin for multiple patient use, bin container with blood on the bin, crushed dirty or stained brown cup, lancets, and lubricant. Observed a cloth gait belt (used to assist with patient transfers), staff # 4 reports unsure if clean or dirty. A cloth transfer or gait belt cannot be utilized on multiple patients, as it cannot be disinfected. Medication prep area in the ED continues, observed tape or adhesive on doors and walls, extremely cluttered drawers with single use patient items partially utilized (coban or elastic bandage, a variety of tape rolls, thermometers (oral and tympanic), broken thermometer, syringes, a partial log of open 2 x 2s, tourniquets, etc. Staff # 4 reports unsure what is clean or dirty. Medication prep area continued, observed expired tongue blade in wrapper for patient use, cluttered drawer overfilled with patient supplies, syringes, angiocatheters, culturettes, and specimen containers. Observed expired supplies as evidenced by date. Medication prep area continued in the ED, observed glass ampule of medication in back of cluttered drawer unlocked, copious tape or adhesive on cabinets, walls, and doors, as well as dirty cabinets as evidenced by black and brown stains. Continue with medication prep area in the ED, observed various food items in drawers and shelving next to blood vacutainer tubes for patient use and under ice/water machine. Observed brown liquid stain under cabinet for pipes of water/ice machine with plastic tub to catch potential water next to blood vacutainer tubes and other patient supplies. Medication preparation area in the ED continued. Observed open multiuse 2x2 "According to facility policy use of Elsevier education and clinical guidelines, a sterile and/or individually wrapped 2 x 2 is best practice for use on invasive procedures (insertion and removal of SPCs)." Observed cluttered drawer with various papers, manuals, cotton tip applicators, and various patient supplies.

Public restroom in the ED, observed hand soap container connected to the wall held together by large pieces of silk and paper tape. Observed large pieces of paper tape holding paper towel dispenser to the bracket.

ED exam room 12, observed open 2 x 2s in a bin. Noted defibrillator time incorrect when a strip was run. Observed open tears in mattress of stretcher exposed dense foam, high risk for HAI transmission. Noted dried brown substances on bed frame, observed cracks and rust on bed frame, unable to disinfect.

ED, crash cart (Zoll monitor) time incorrect. Observed hole in ceiling with exposed pipe in patient room.

ED Exam room 8, observed vinyl chair with wood arms, chair vinyl with multiple tears in vinyl, exposed padding risk of HAIs. Wooden arms of chair with scratches and inability to disinfect related to wood and not protected with polyurethane. Observed multiple intrusions into wall plaster with peeling layers of buckled paint.

ED Exam 9 observed vinyl chairs with tears through the vinyl. Noted Larger recline vinyl chair with holes and tears in vinyl. Arms of chair with sticky worn residue.

ED Designated Sexual Assault and/or safe room. Observed inside of cabinets paper torn and taped. Observed Tape used to secure a storage bin and written on for remote. Observed grossly saturated with disinfect, did not allow proper dwell time prior to returning mattress to base of stretcher. Observed dislodged Velcro on mattress with dirt, fibers, hair trapped into adhesive.

Public restroom outside of Exam room 9 observed toilet caulk and ceramic broken and/or separated from the wall. Observed paper taped to wall, dirty adhesive foam under soap dispenser with dirt and debris, fibers. Observed black coiled hair on and in sink, as well as black curly or coiled hairs on toilet lid and opening.

ED Exam 10 observed intrusions into wall through sheetrock and plaster. Observed mattress with adhesive residue resulted in debris and dirt adhered. Observed tears through vinyl of stretch (mattress), exposed porous padding observed, risk of HAIs (CDI). Observed intrusions into wall through sheetrock and plaster, peeling paint exposed sheetrock. Observed tears through vinyl of stretch (mattress), exposed porous padding observed, risk of HAIs (CDI).

Soiled utility room observed broken cabinet doors not intact, door hardware missing, broken equipment stored with cleaning equipment. Soiled utility room observed multiple opened spray bottles with buckets open and unknown liquid.

Clean utility room observed with broken equipment, broken cabinet door hardware. Clean utility room with gross brown and yellow sticky adhesive in drawer with package of pepper adhered in drawer with goggles. Clean utility room observed broken hardware on drawers with copious sticky adhesive and trapped dirt, debris and fibers. Observed broken drawer front on cabinet next to patient equipment and storage of patient supplies. Observed broken and missing cabinets hardware, sterile obstetrics basin with dried dead bugs and packaging disturbed. Clean utility room observed sticky adhesive on equipment (bedside commode) with adhered fibers, hairlike structures, dirt and debris. Observed storage room bins with floating dirt and particles of white and brown in bottom of bins or storage containers.

Combination employee/patient/visitor bathroom in the ED with personal employee supplies of lotion, toothpaste, aerosol sprays, hydrogen peroxide, soap, specimen containers, gauze, and personal employee information. Observed plug-in aromatic diffuser with burned liquid on top.

Storage room observed storage bins with floating dirt, fibers, hairs, plastic pieces or shavings, and dust in storage bins for patient supplies.

Facility unable to produce policy on curtain changing and or process for disinfection.

Facility unable to produce policy or process on how and where to treat a positive mycobacterium tuberculosis patient in the Emergency department secondary to no available negative pressure or AIIR rooms (only available on the 4th floor). Facility policies (Vacating patient rooms after PUI 11211046 and Transmission based precautions 12687224) do not include transport guidelines, process for protecting patients, visitors, and or staff.

Secondary Laboratory

Refrigerators located in labs were found to be dirty with dust, hair, sticky residue in various colors and debris. External refrigerators in both labs with tape and adhesive residue exposing to pathogen growth. Tissue refrigerator frozen with excess of ice and frost, freezer items discolored reflecting frozen, thawed, and refrozen.

Stat Lab (Secondary lab site ER/Outpatient) absolute disarray with personal phlebotomy carts covered in adhesive and gauze secured with tape, open contaminated 2x2s and cotton balls, single use tape adhered to carts and used on multiple patients (in and out of patient rooms) bottom of carts with multiple tips of gloves and dirt, dust, and sticky residue. Staff report reuse of tourniquets, reports they wipe the tourniquet with sani-wipes. Unknown curtain changing or cleaning policy. Observed two patient phlebotomy chairs side by side with no patient privacy between chairs, staff confirms outpatients and emergency room patients are brought to lab for venous collection. Observed large oscillating fan in patient care area covered in dust and debris. Noted a patient and staff refrigerator consumed in dirt and unknown sticky residue. Observed multiple boxes of cereal and open food products in lab and patient care area, staff report they store their food in the refrigerator, warm their food in microwave and eat in the lab. Upon arrival 11/15/2022, noted only tape and gauze removed from the phlebotomy containers. Containers continue to be covered in adhesive with dirt, also noted open butterfly needles and staff states, "that is my cart and it is ready to go draw blood."

No sanitation process or policy for pneumatic tube system, as well as no log for contamination of spilled body fluids from collection and diagnostic testing. Secondary Lab/Outpatient in the ED, staff # 5 and staff # 6 report unknown process for pneumatic tube system disinfection. Facility produced no policy or clinical guidelines on process for pneumatic tube system disinfection or response to contamination of specimen spills.

Secondary lab observed storage filing cabinet covered in black stains, tears in laminate exposed particle wood.

Secondary (outpatient) lab in the ED observed patient venipuncture supplies in bathing tub with carboard divider secured with large silk tape, silk tape discolored beige brown and adhered with fibers and dirt. Observed patient venipuncture supplies in portable tubs, patient supplies (venipuncture needles and butterfly needles open from package exposing access device to contamination), observed silk tape discolored beige brown and adhered with fibers and dirt, gauze secured to handle with paper tape, rolls of paper tape adhered to tub for multi-use between patients (reported by staff # 5 and staff # 6). Observed paper cut-outs adhered to carts with employee names. Secondary (outpatient) lab in the ED observed patient venipuncture supplies in portable tubs, patient supplies for venous collection observed blood, dirt, dust, and residual adhesive in tubs. Staff # 5 and staff # 8 unable to describe process or produce policy on disinfection of carts taken from patient-to-patient rooms (transmitting pathogens HAIs). Secondary lab observed intrusion into wall paint, plaster, sheetrock, and corner metal with black stains and decaying plaster. Secondary labs with portable patient venipuncture supplies, unclean as evidenced by adhesive residue, open supplies, unable to verbalize disinfection process. Staff #5 reports reused tourniquets. Observed staff # 6 enter the lab with blood filled vacutainers mixed with clean supplies and not in biohazard bags. Secondary labs with portable patient venipuncture supplies, unclean as evidenced by adhesive residue, open supplies, unable to verbalize disinfection process. Observed label machine in tub, staff # 8 reports no process to known when label makers are disinfected between patient use. Observed crusted dried blood base of vacutainer holder cage. Secondary lab in outpatient receiving area with corrugated shipping boxes, stored equipment, and readily available patient information. Secondary lab in outpatient receiving area with corrugated shipping boxes, stored equipment, open jar of 2 x 2s, silk tape on cabinet laminate corner to secure broken piece. An additional cabinet corner with missing laminate and exposed particle board. Observed drawer with opened butterfly needles for venous collection. Staff #6 reports they take them out of the sealed packages for easy access. Observed corner of cabinet with broken and missing laminate exposed particle board, observed faded and discolored orange tourniquet tied to a label maker staff # 6 reports it goes from room to room and unable to discuss disinfection process. Observed oscillating fan in patient car area, fan covered in dirt, dust and next to patient care equipment. Observed personal perfumed lotion on counter in lab outpatient patient area. Observed boxes of cereal in cabinets, a microwave, employee personal items (purses) unsecured in the patient care area, bowls, cups, and oatmeal. Observed two refrigerators, staff # 5 reports one is for staff and one for patients. No found log for temperature or disinfection process. Observed inside of refrigerators with copious dust, dirt, hair, unknown sticky substances. Observed black sticky substance on floor between refrigerators of secondary lab with trapped fibers and long black hairs. Noted an open butterfly needle connected to a 10 ml syringe on top of tub, staff # 5 reports they open the supplies before going into patient area to collect blood.

Main lab

Microbiology Hood was dirty with debris and tape and tape residue externally. Internal or under Hood noted dried residue unknown source, dirt, debris, as well as rings of liquid dried.

Storage rooms cluttered and overstocked with multiple boxes on the floor, stacks of papers, stacks of trash cans, plastic tubs, wire hangers, hole in the floor for a conduit up into the ceiling. Storage area overcrowded with stacks of boxes, equipment, broken equipment, dirt, and ceiling pieces on the carpeted floor.

Laboratory observed drawers with diagnostic testing supplies in drawers with trash, dirt, dust, and debris. Observed stacks of papers with patient identifiers in cabinets with lab testing equipment. Noted computer work areas covered in dust.

Main laboratory observed cabinets in chemistry testing area filled with broken equipment, unused equipment, boxes and bins. Noted static guard air spray behind chemistry machines, staff # 8 reports it is for employees clothing. Observed large oscillating fans with dust and dirt on blades in lab testing area.

Main laboratory chemistry testing area observed PCR machines (six or more) reported by staff # 8 as decorated for Halloween with construction paper and tape. Observed dust balls on floor, sticky residue with black on floor, observed corner of workspace broken through laminate exposed particle board.

Observed cardboard and Styrofoam secured in refrigerator with yellow discolored masking tape, Styrofoam covered in dark brown and yellow stains with sticky substance splattered inside of refrigerator.

Microbiology area observed workspace desk with broken laminate and exposed particle wood, microbiology hood with copious adhesive and white smeared stans, stainless steel under hood with crusted dried rings where samples are tested. Microbiology Hood observed stainless steel under hood with crusted dried rings where samples are tested, top of hood covered in thick layer of dust, notes adhered with tape on hood.

Main laboratory observed noted adhered with tape, crusted and unknown sticky brown adhesive on floor. Observed wads of electrical cords and extension cords on floor covered in dirt, dust, floors with gray crusted and dried substances. Observed sink area with dried white crystalized areas behind faucet. Observed sink with gross discoloration and stains, black crusted dried substances. Staff # 8 reports unsure of disinfection process.

Observed broken and peeling laminate from corner of workstation, trash bags full of aluminum receptacles, staff # 8 reports saving for recycling. Laboratory refrigerators observed with adhesive tape and residual. Observed open pipe above filing cabinet adhered with tape and filing cabinet covered in dirt, dust, white unknown pieces, inside of refrigerator with dirt, dust, paper, yellow sticky substances.

5th Floor

5th floor Medication Room 4 drawer cabinet and floor covered in a dried white substance.

Room 533 observed patient cabinet with rusted area from paint peeling on the floor, bathroom with toilet separated from the wall with gap in caulking. observed missing molding with exposed porous particle board. Observed the wall above patients' bed with peeling paint through the sheetrock. Observed wall with peeling paint through the sheetrock, exposed sheetrock and doorframe separated from wall. Noted single use fabric gait belt, staff # 2 reports room ready for next patient; unsure if the gait belt is used or clean.

Hallway 5th floor observed peeling paint from doors, exposed and rusted metal, observed broken hand railing, open end with missing cap. Observed isolation cart with rusted bottom drawer. Hallway scale (multi-patient us), no way to identify if clean, no available disinfectant to sanitize.

Room 522 observed wooden chair with exposed porous wood worn away polyurethane.

Room 532 observed television cable and plug secured to wall with patient paper tape. Noted wood on chair with intrusions through polyurethane and exposed porous wood.

5th floor Nourishment Room open to patients, families, and staff, observed plastic tubs with tape and adhesive residue, sticky clear substance dried to interior and exterior with condiments in them, observed drawers with utensils in bins with dust and dirt, empty plastic bags, dried yellow substance. Observed partially open lower cabinets below sink secured with zip tie and noted broken key lock, cabinet with trash, empty plastic bottles. Observed handheld can opener with paper trash, lids for cups, Whataburger ketchup packets. Staff # 2 reports unsure how or when cleaned/disinfected. Observed ice/water maker dirty as evidenced by dried white film and crystals on base, air filter covered in dirt and dust. Observed dried brown stains sticky to bottom of refrigerator inside. Noted package of sour cream adhered to bin. Observed tape adhered to inside of refrigerator to secure drawers and dividers. Observed patient snacks with patient identifiers on stickers.

Scales on floor in patient rooms, observed floor stand digital scales. Staff # 2 reports no process to identify if scales are cleaned between patients.

4th Floor

4th Floor observed patient room doors with peeling paint. Community patient shower observed dirt, dust, dust balls, brown stains, gray sticky residue and dirt adhered to caulk.

4th floor nourishment room open for patients, family or visitors, and staff as reflected on the laminated sign. Observed exterior door with peeling paint and exposed metal, peeling paint and exposed metal and rust to cabinets, microwave interior dirty with brown stains, rusted interior door of microwave. Observed tape residue on exterior cabinets, rust and brown dried secretions to inside of drawers, peeling paint and separated caulk from laminate. Observed laminate not adhered to corner of countertop, exposed porous wood. Observed freezer with frost and brown, red discoloration. No observed log for ice/water maker.


29191

Pain management Procedure Room:

Observed the mattress on the pain management table had numerous tears in external protective layer of mattress, exposing the porous internal cushion, unable to disinfect with tears through protective mattress covering resulting in the likelihood for hosting bacterial or pathogen growth and healthcare associated infection(s).

The crash cart in the pain management post operative area had large spots of paint missing on the outside which exposed metal and rust which makes unable to be cleaned and disinfected.


Surgical Department:

Initial facility tour of the surgical department was on 11/14/2022 at 11:45 AM with the Director of Surgical Services # 40.

Pre-Operative Room #5 observed an Ambu-Bag X 2 with yellow discolored wrapping stored under the sink. The shelf under the sink had dust and dirt particles. The brown molding was peeling away from the top cabinet. The lower cabinet had molding missing, and the exposed particle board was showing. The molding that had fallen off the lower cabinet was found in the drawer.

Pre-Operative Room #7 observed large amount of calcium build- up on the shelves under the sink and the hinges to the door had large amount of calcium build-up. There was rust particles and exposed particle board showing on the shelves.

Pre-Operative Room #9 observed adhesive tape holding the molding in place. Adhesive tape is
unable to be disinfected related to adhesive residue trapping pathogens and/or bacteria. The shelf under the sink had dust and dirt particles.

Pre-Operative Room #10 observed a large roll of paper towels that was sitting under the sink. The shelf under the sink had dust and dirt particles. The middle shelf had exposed particle board showing. Raw wood cannot be cleaned or disinfected.

Pre-Operative Room #12 observed large amount of calcium build-up on the shelves under the sink. The shelf under the sink had dust and dirt particles.

There was a large metal gray cabinet in the hallway of the pre-operative area. The cabinet stored sterile surgical supplies. On the bottom of the cabinet was rolls of kerlix gauze and rolls of silk tape sitting directly on metal.

In operating room #4 observed rust on the operating room table (Skytron). The anesthesia machine had an Yankauer suction clamped off, but open to air with no cover. There was no way to know if the suction set-up was clean or dirty. The anesthesia supply cart had rust on the drawers.

In operating room #4 observed the anesthesia machine had an Yankauer suction clamped off, but open to air with no cover. There was no way to know if the suction set-up was clean or dirty. The drawers in the anesthesia machine had open oxygen tubing coiled inside with other packages of oxygen tubing. Also, drawers in the anesthesia machine had dust and dirt particles. The anesthesia supply cart had dust, hair, and dirt particles in the drawers. The surveyor picked up a package of intravenous tubing and there was long black hair on the package. The outside of the blue metal anesthesia supply cart had numerous spots of rust. Observed a large black bucket sitting directly on the floor beside the anesthesia machine with oxygen mask and two Yankauer suctions with tubing in packages. The bucket had dust and dirt particles with caps off medication vials and caps off intravenous tubing. The bucket that was carrying anesthesia supplies had an unclean appearance.

The crash cart in the surgical area had large spots of paint missing on the outside which exposed metal and rust which makes unable to be cleaned and disinfected.

Sterile Supply Area:

The flooring where sterile instruments are stored had missing floor tile and chips out of the floor. The flooring where the moving wire racks of surgical instruments are located had dark blackish run marks in the flooring. The floors in the sterile instrument storage had an unclean appearance.

Post Operative Care Area: (PACU)

The curtains (Cube Care) hanging in PACU were not dated as to when the curtains were hung. There was a place to document on the curtains for the day, month, and year.

Observed an intravenous pole that had rusted caster wheels in thew PACU area.

An interview with Staff #40 (Director of Surgical Services) on 11/14/2022 at 3:30 PM confirmed the infection control issues found in the surgical area and in pain management area.


40989

An observation tour of the Labor and Delivery Unit was conducted on 11/15/2022 at 9:40 AM with Staff #7, #60, and #76. The following was observed.

C-Section Operating Room #1

Staff #7 and Staff #76 confirmed the operating room (OR) was ready for a patient and that it had been terminally cleaned. The OR was used for newborn delivery by means of a cesarean section (C-sections). The anesthesia circuit (a system of tubing, reservoir bag, and valves used to deliver oxygen and anesthetic gases from the anesthesia machine to the patient and removal of carbon dioxide) was attached to the machine with the oxygen on and filling the reservoir bag. Staff #7 could not confirm nor deny if the circuit was clean. Next to the anesthesia machine was a red reusable sharps container. The container was used to dispose of needles, broken glass, and surgical blades. On the bottom of the cart a white dried liquid, dirt, and dust was noted. Beside the bin on the floor was a capped needle and trash. Next to the anesthesia machine was a mobile cart used to store supplies for the anesthesia department. On the top of the cart were needles syringes, and rolls of tape. The shelf that stored the tape was dirty with trash and dust. A slide out tray on the side of the cart was noted to have dried white liquid, dirt, dust, and debris next to the endotracheal tubes ready for patient use.

Near the corner of the wall closest to the anesthesia cart, the laminate was pulling away from the sheetrock leaving an open area unable to be sanitized.

A blue bear hugger (a piece of equipment attached to a warming blanket to keep patients warm) was covered with heavy dirt, dust, debris, and a dried white liquid. Inside the storage compartment of the bear hugger was a sterile suction catheter used to suction a patient's secretions.

On top of a rolling table was a blue bin used to store emergency intubation supplies and a glide scope (equipment used for difficult intubations). The blue bin was heavily covered with dirt and dust. The OR table mattress was removed, and moisture was still present from the germicidal disinfectant used to clean the table. Without the proper drying time and covering of a wet surface, this created a moisture rich environment with the potential for bacterial growth. The velcro that attaches the mattress pads to the table was full of lint and unable to be sanitized. Open holes on the table, (holes placed in the table from the manufacturer to be able to use a riser) were rusted.

The metal door frames exiting the operating room had chipped paint and exposed the metal surface. This prevented the door frames from properly being sanitized to control the spread of infectious diseases.

C-Section Operating Room #2

The anesthesia cart used to store supplies for patient use was rusted below the bottom drawer and around both sides of the cabinet exposing the metal surface. The metal surface could not be sanitized to mitigate the spread of infectious diseases. The wheel covers were soiled with dirt and dust. The handle on the cart was rusted and exposing the metal beneath the paint.

The Conmed generator (a generator that is used to control bleeding by the connection of a cautery pencil coming from the sterile filed) had a brown colored stain resembling rust on the bottom shelf inside and out. All four wheel casters were rusted.

The mattress pads on the OR table had tears in the cover that allowed for body fluids and liquids to soak into the material that could lead to the spread of infectious diseases or hospital acquired infections. Once the mattress pads were removed the Velcro that adheres the mattress pads to the table was heavily soiled with lint and a tan colored dried liquid. Once the kidney rest was flexed (a bend in the OR table at a patients waistline) rust, dirt, dust, and debris was noted. The table frame beneath the mattress was noted with chipped paint exposing the metal.

An interview was conducted with Staff #7 on 11/5/2022 after 9:40 AM. Staff #7 was asked if the ORs went through a terminal cleaning in the evening. Staff #7 stated, "Yes, they do. We clean them after each procedure and then a terminal cleaning g

Based on observation, record review, and interview, the facility's governing body failed to:

A. ensure the immediate use steam sterilization for autoclave #1 and #2 in the sub sterile rooms were being used only for carefully selected clinical situations, such as a dropped instrument or no replacement instrument available. Also, the facility failed to complete and record the "Flash Sterilization Log" record per the facility policy.

B. to address the temperature and humidity in the surgical operating rooms, sterile processing and decontamination area that were out of range for the months of August, September, October, and thru November 10th of 2022.

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

Findings Included:



A review of the record titled, "Flash Sterilization Log" for autoclave #1, and #2 revealed the log indicated that complete instrument sets were being sterilized in the immediate use autoclaves. Staff members were not placing patient identification stickers on the log. The staff members were filling the log out inconsistently.

A review of the log for Autoclave #1 for the month of November 2022 revealed the following instruments were used on immediate use steam sterilization cycle.


11/03/2022 Dental set was used on the immediate use steam sterilization cycle. There was no load sticker to know which load was being sterilized.

11/08/2022 Dr Bove Lap Appy "Sonicision" instruments were used on the immediate use steam sterilization cycle. On load #3 the CI result was not marked pass or fail.


11/10/2022 Dental set was used on the immediate use steam sterilization cycle 3 different times. At 9:53 AM, 11:20 AM and 12:53 PM. On load #5 the CI result was not marked pass or fail.

11/11/2022 Dental set was used on the immediate use steam sterilization cycle 3 different times. At 9:50 AM, 10:59 AM and 1:02 PM. On load #3, #4, and #5 the CI result was not marked pass or fail.


11/14/2022 Dr Jensen's Extra instruments was used on the immediate use steam sterilization cycle. There was no load sticker to know which load was being sterilized. Also, on the same load the CI result was not marked pass or fail.

A review of the log for Autoclave #2 for the month of November 2022 revealed the following:

11/01/2022 "Holep" Tray of instruments was used on the immediate use steam sterilization cycle. On load #4 the CI result was not marked pass or fail.


11/14/2022 Dr. Cuenca set and Dr. Cuenca extra instrument x 1 was used on the immediate use steam sterilization cycle. There was no patient name on the log to know which patient the instruments were being used on.


A review of the Facility's policy titled; "Immediate Use Steam Sterilization" dated effective 08/2022 revealed the following:

"Purpose:
To insure patient safety when it is necessary to sterilize surgical instruments for immediate-use and to describe the required documentation for immediate-use sterilization. Manufacturer's written instruction will be obtained and followed prior to immediate use steam sterilization.

Definition:
Immediate-use steam sterilization (IUSS) should not be used for purposes of convenience or as a substitute for insufficient instrumentation. Immediate-use steam sterilization should be kept to a minimum and should be used only in urgent clinical situation.

Intended Use:
Flash Pak is a reusable rigid container system to be used during immediate use steam sterilization (IUSS). It is intended to enable sterilization of the enclosed devices and prevent recontamination during immediate transport to the point of use. The container is compatible with gravity-displacement steam sterilization using a 10-minute cycle at 270*F (1 32° C) for porous items and items with lumens or a 3-minute cycle at 270*F (132° C) for nonporous items like routine metal instruments. The container is also compatible with pre-vacuum steam sterilization using a 4-minute cycle at 270*F (132° C) for porous items and items with lumens or a 3-minute cycle for nonporous items like routine metal instruments.

Flash Pak® is recommended for sterilization of lumens with the following limits: gravity-displacement (5.5mm inner diameter or larger and up to 184mm in length), pre vacuum (1mm inner diameter or larger and Up to 203mm in length.)

Documentation:
A Sterilization Log is kept for each immediate-use steam autoclave. (See documentation page). The case, patient information (patient sticker) and instruments ran through immediate-use steam sterilization will be documented in the logbook as well as sterilization parameters and the load/cycle#. The paper strip from the autoclave will be placed in the sterilization logbook on the corresponding page of documentation.
NOTE: IF THE STEAM CHEMICAL INTEGRATOR HAS NOT ADEQUATELY CHANGED, OR IF ANY OF THE STERILIZATION PARAMETERS HAVE NOT BEEN MET:
Do not use items from the load in question
Place a sign on the autoclave sterilizer indication that it is OUT OF ORDER.
Report the situation to the SPD Lead tech and the Clinical Coordinator, Charge Nurse, and Director
Use another autoclave to re-sterilize the load
Document that instruments from this load were not used."

A review of the perioperative standards and recommended practices "Association of Perioperative Registered Nurses" revealed the following:

"Recommendation VII
Immediate use steam sterilization (IUSS) should be kept to a minimum and should be used only in selected clinical situations and in a controlled manner.
Immediate use steam sterilization may be associated with increased risk of infection to patients. Time constraints may result in pressure on personnel to eliminate or modify one or more steps in the cleaning and sterilization process. The term flash sterilization has historically been used to describe steam sterilization of unwrapped items intended to be used immediately. Flash sterilization cycles have traditionally been either 3 or 10 minutes of exposure, depending on the nature of the device being sterilized or the type of cycle indicated, minimal or no dry time, and no cooldown, thereby making the entire cycle time shorter than the cycle times for wrapped or terminally sterilized items. However, current manufacturer's instructions for use may require a variety of cycle times and the use of single wrappers or flash containers as opposed to sterilizing unwrapped items. The term "flash sterilization" no longer serves to describe the various steam sterilization cycles and processes that are used to process items that are not intended to be stored for later use. For this reason, the more appropriate term is IUSS.

VII. a. Immediate use steam sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization. Immediate use steam sterilization should not be used as a substitute for sufficient instrument inventory."
According to the American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation (AAMI) ST79:2017- Comprehensive guide to steam sterilization and sterility assurance in health care facilities revealed the following:

"2 Definitions and abbreviations
2.50 immediate-use steam sterilization (lUSS) Sterilization method that involves the shortest possible time between a sterilized item's removal from the sterilizer and its aseptic transfer to the sterile field. Immediacy implies that a sterilized item is used during the procedure for which it was sterilized and in a manner that minimizes its exposure to air and other environmental contaminants. A sterilized item intended for immediate use is not stored for future use nor held from one case to another. Immediacy, rather than being defined according to a specific time '. frame, is established through the critical analysis and expert collaboration of the health care team. Immediate-use steam sterilization (IUSS) should not be used for purposes of convenience or as a substitute for insufficient instrumentation. Instrument inventories should be sufficient to meet anticipated surgical volume and to ensure that there is enough time to complete all critical elements of reprocessing. Immediate-use steam sterilization should be kept to a minimum and should be used only in urgent clinical situations."

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

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

13 Process monitoring, testing, and quality control

13.3 Product identification and traceability

13.3.1 General considerations

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

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

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

An interview with Staff #40 and #43 on 11/14/2022 at 2:00 PM stated, "We are flashing full instrument sets because we don't have enough sets for some of the surgeons working at the facility." Staff #43 confirmed the sterilization logs were not being completed with patient names, load stickers, and CI results being documented as a pass or fail.



B. A review of the facility's log titled, "OR TEMP LOG" revealed temperature and humidity for August, September, October, and thru November 10th of 2022 revealed the following:

August 2022 Operating Room TEMP LOG:

There were 23 of 31 days with temperatures out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.

August 2022 Operating Room Humidity LOG:

There were 23 of 31 days where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.

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

September 2022 Operating Room TEMP LOG:

Temperatures were out of range every day that surgical cases were performed in month of September. Twenty-one (21) of 30 days with temperatures out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.

September 2022 Operating Room Humidity LOG:

There were 21 of 30 days where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.

Staff #44 had made notifications on the OR Temp log that the temperature and humidity was out of range the whole month of September 2022.


October 2022 Operating Room TEMP LOG:

Temperatures were out of range every day that surgical cases were performed in month of October. Twenty-two (22) of 22 days that surgical cases were performed the temperatures were out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.

October 2022 Operating Room Humidity LOG:

There were 10 of 22 days where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.

There were two notations that the staff had reported the out range temperature and Humidity.


November 1-10th 2022 Operating Room TEMP LOG:

There were 10 of 10 days with temperatures out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.

November 1-10th 2022 OR Humidity LOG:

There were 10 of 10 days where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.

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

A review of the facility's log titled; "Sterile Processing Area" revealed the following:

September 2022 Sterile Processing Area

There were 14 of 20 days with temperatures out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.


There were 2 of 20 days where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.


October 2022 Sterile Processing Area

There were 17 of 20 days with temperatures out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.


There were 3 of 20 days where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.

November 1-10TH 2022 Sterile Processing Area

There were 6 of 10 days with temperatures out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.

There were 2 of 10 days where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.

A review of the facility's log titled; "Decontamination Area" revealed the following:

September 2022 Decontamination Area

There were 20 of 20 days with temperatures out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.


There were 5 of 20 days where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.


October 2022 Decontamination Area

There were 19 of 19 days with temperatures out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.


There were 13 of 19 days where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.

November 1-10TH 2022 A Decontamination Area

There were 11 of 11 days with temperatures out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.

There were 4 of 11 days where the humidity was out of range per the AORN (Association of Perioperative Registered Nurses) guidelines.

There were no notations that the staff had reported the out-range temperature and humidity for sterile processing and decontamination area.


Review of the AORN Perioperative Standards and Recommended Practices,

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

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

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

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

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


A review of the Facility's policy titled; "Infection Control in the Surgical Suite" effective date 1/2022 revealed the following:

"Purpose:
To promote effective infection control procedures in the surgical suite.
IX. Environmental Cleaning in the Surgical Department
XIII. Pressure Differential and Air Exchange
a. The operating room maintains the following
1. Adequate air exchanges per hour to remove microorganisms in the room
(at least 15 air changes per hour)
2. Temperature range of 68-75 degrees F (20-24 degrees C)
3. Humidity control of 20-60 %
4. Humidity and temperature will be checked and recorded by maintenance
each morning prior to surgery."

A review of the of the Surgical/Procedural executive committee meeting minutes dated August 2022 and November 2022 revealed no documentation about the high usage of IUSS (immediate use stream sterilization) process. There was no drill down to track or analyze the issues causing the immediate use sterilization to have such a high usage in the facility. There was no written plan or process to address the high usage of immediate sterilization. There was no discussion of the out-range temperature and humidity for the operating rooms.

A review of the surgical clinical indicators that was reported to the quality department from the surgery department revealed no indication that the immediate use sterilizations was a quality issue that needed to be addressed.


An interview with Staff #40 on 11/15/2022 at 3:00 PM confirmed temperature and humidity was monitored, but the out of range had not been addressed by the Governing Body.

C. ensure the Endoscope Cleaning log was completed by the facility staff.

A review of the endoscope cleaning log for the month of November 2022 revealed the following:

11/03/2022 there were no initials of the staff member that had performed the cleaning and disinfection of the scope.

11/09/2022 there were no initials of the staff member that had performed the cleaning and disinfection of four different scopes. Also, on 11/09/2022 the leak test and manual cleaning was not documented as completed.

11/14/2022 there were no initials of the staff member that had performed the cleaning and disinfection of four different scopes. Also, on 11/14/2022 the leak test and manual cleaning was not documented as completed.

A review of the Facility's policy titled; "High Level Disinfectant Cidex OPA Policy and Procedure" effective date 10/2022 revealed the following:

"Policy:
It is the policy of TRMC that all high-level disinfectants be utilized in a safe and effective manner.

15. Document results in Cidex OPA Logbook etc."

An interview with Staff #48 on 11/14/2022 at 11:30 AM confirmed that staff initials and the cleaning and disinfection processes of the scopes had been left blank on the log.


D. ensure that the surgeon had completed a History and Physical examination form prior to the patient having a surgical procedure. The History and Physical form was completed by the Advance Practice Nurse #41. Also, the surgeon failed to follow the facility's own Medical Staff Rules and Regulations on History and Physical examination note.


Cross Refer to Tag: A 0952

E. protect the patient's right to make informed decisions in 2 (Patient #14 and #18) of 9 surgical patients reviewed. The facility failed to ensure that patients or their representatives were provided with the risks and benefits prior to surgical procedures performed and that the informed consent had a witness signature. In addition, ensure the Patient Disclosure and Consent for Anesthesia and /or Perioperative Pain management (analgesia) was completed prior to anesthesia being performed by the anesthesiologist or physician associates on the day of surgery. Also, the facility failed to follow their own policy and procedures on Informed consent.


Cross Refer to Tag: A 0955



40989


F. ensure the surgical and obstetrical department provided a clean and sanitary environment.

During an observation tour of the Labor and Delivery Unit with Staff #7, #60, and #76 on 11/15/2022 at 9:40 AM the following was observed.


Between Operating Room (OR) #1 and OR#2 was a room used for sterile and unsterile supply storage. Upon entering the room from OR#1 was a large, enclosed cabinet with a mix of sterile and unsterile items. Sterile items were instruments, foley catheters, sutures, surgical prep trays, surgical dressings, surgical gowns, surgical gloves, surgical packs, and sterile light handle covers. A large warmer used for blankets and fluids was also in the room. The warmer has the potential to emit heat that could compromise the integrity of the sterile packaging.

Inside the upper cabinet were suture boxes. Unsterile empty plastic bags used to hold contaminated surgical sponges and multiple preference cards (specific surgeon requests) for surgeons were lying on the shelf in front of the sutures. An open box of "O PDS" suture expired on 10/31/2022 that was readily available for patient use. The cabinet below this was missing a door. There were two shelves in this cabinet. On the first shelf was a hard casket containing sterile surgical instruments. On the bottom shelf was wrapped sterile instruments that were partially outside the shelf overhanging the floor. Beside the instruments were 4 hard plastic containers with a sheet of paper on the inside. Staff #7 stated, "These count sheets are no longer used like this. We used to sterilize the count sheets like this, but we no longer do this anymore. The count sheets are inside the instrument trays now. I don't know why these are even here." The sterile instruments stored on the bottom shelf were not stored in a way to prevent contamination from the cleaning agents used when the floor was cleaned.

In another lower cabinet, the broken door was placed inside the bottom shelf on top of a sterile instrument tray. Under the sterile instrument tray was an unsterile clear plastic bag that contained plastic lids for suction cannisters.

Sterile instruments that were packaged and sterilized individually (peel packed) were being separated by manilla folders and stored in a blue plastic bin. The blue bin was noted with dirt and dust.

In the upper cabinet, wrapped sterile instrument trays were stored next to an unsterile white cannister holder. The cannister holder is used in the OR to hold suction cannisters. Two of the upper cabinet doors and one lower cabinet door could not be closed because the stored items would not allow for closure.

In the hallway was a metal storage cabinet that had multiple shelves with a glass front. Sterile surgical packs containing surgical drapes, sterile table covers, sterile hand towels, and x-ray detectable sponges were stored on the same shelf as unsterile suction cannister lids.

An interview was conducted with Staff #7 on the morning of 11/15/2022. Staff #7 was asked if the temperature and humidity was monitored and recorded for the storage of sterile items in the room between the OR's or the sterile items in the hallway. Staff #7 stated. "No, we do not monitor them. There is no thermometer in this room or in the hallway."

During an interview on 11/15/2022 after 10:00 AM, Staff #76 was asked if the OR temperature and humidity was monitored and documented. Staff #76 stated, "There is a thermometer on the wall." Again, Staff #76 was asked if the temperature and humidity was documented daily. Staff #76 stated, "No, we do not have a log. We can call Plant Operations to adjust the temperature if we need to." Staff #76 stated that the temperature and humidity was monitored by the Plant Operations department. Staff #76 was then asked if the Plant Operations notified the Unit when the temperatures were out of range. Staff #76 confirmed Plant Operations did not call the Unit daily to inform the staff of the temperature or humidity. Staff#7 said, "We assume the temperature and humidity ranges are good and if they are not then plant operations will adjust them."

Staff #76 confirmed the labor and delivery staff did not document the temperature and humidity in OR #1, OR#2, or the sterile storage area daily.

Staff #40 confirmed the OB C-Section Rooms did not fall under the Surgical Services responsibility. Staff #40 stated, "They are responsible for their own temp and humidity logs. We do not have anything to do with that department."

Without staff being aware of the temperature and humidity in the OR's and sterile storage areas, this placed all patients at risk for infections, serious harm, and or death. A low humidity can increase the risk of fire when in combination of an oxygen rich environment and electric cautery (an instrument used to control bleeding) use. Without knowing the temperature and humidity for sterile storage areas, the sterility of individual packages and sterile instruments sets cannot be confirmed and placed the patient at risk of a hospital acquired infection.


A review of the AAMI guidelines for sterile storage are as follows:

" ...ANSI/AAMI S179:2017 - Comprehensive guide to steam sterilization and
sterility assurance in health care facilities
11 Storage and transportation

' 11.1 Sterile storage

11.1. Storage facilities

Sterile items should be stored under environmentally controlled conditions in a manner that reduces the
potential for contamination.

Sterile storage areas should be kept clean and dry.

Sterile items should be
1) stored far enough away from the floor, the ceiling, and outside walls to allow for adequate air circulation,
ease of cleaning, and compliance with local fire codes;

2) stored at least 8 to 10 inches above the floor, at least 18 inches below the ceiling or the level of the
sprinkler heads, and at least 2 inches from outside walls;

3) stored in such a way that wrapped packages are not stored beneath rigid sterilization containers on the
same shelf; and

4) positioned so that packaging is not crushed, bent, compressed, or punctured and so that their sterility is
not otherwise compromised.

Access to the sterile storage area should be restricted to authorized personnel.

Sterile Items, including those packaged in rigid sterilization container systems, should not be stored next to or
under sinks, under exposed water or sewer pipes, or in any location where they could become wet.
Sterile items should not be stored on floors, on windowsills, or in areas other than designated shelving,
counters, or carts. For safety and ease of handling, heavy instrument trays should be stored on middle shelves;
transport trays with solid or perforated bottoms may be used to prevent tears in wrappers during handling. (See
also section 3.3.6.4,)

The wrap manufacturer's IFU should be consulted for guidance on stacking trays,

Closed or covered cabinets are recommended for sterile storage. Open shelving may be used, but requires
special attention to traffic control, area ventilation, and environmental services,

Shelving, carts, and bins used for sterile storage should be maintained organized, clean, and dry, The bottom
shelf of storage carts or shelving should be solid. The shelving or carts should be designed for the weight and
configuration of the load ..."

Staff #7, #60, and #76 confirmed the findings

Based on record review and interview, the facility failed to ensure a history and physical was documented on the patient's record and/or an update to the history and physical prior to surgery and/or procedure on 1 (#13) of 9 records.

This deficient practice had the likelihood to cause harm to all patients receiving surgical and invasive procedures at the facility with no history and physical by the surgeon prior to surgery.

Findings Include:

A review of the medical records revealed the following:

A review of patient #13's medical record revealed the history and physical was completed by the Advance Practice Nurse #41 on 11/07/2022 at 7:15 AM. The document contained a statement written by the Advance Practice Nurse #41. "Dr._______ (#62) and I have discussed treatment options with her at length, and she wants to proceed with total ankle replacement. Dr. _______(#62) and I have also discussed all risks, benefits, alternatives with her which include but not limited to bleeding, pain, infection, nerve or vessel injury, continued pain, stiffness, loosening of the prosthesis, need for revision or further surgery. She understands all these and wishes to proceed. We will follow up with her postoperatively." There was no electronic signature by Surgeon #62 on the History and Physical. The only electronic signature on the History and Physical was by the Advance Practice Nurse #41. There was no entry in the medical record made by Surgeon #62 referencing the History and Physical prior to the surgery.

An interview with Staff #48 on 11/16/2022 at 3:00 PM confirmed the above findings from the patient's medical record.

Based on record review and interview, the facility failed to

A.) protect the patient's right to make informed decisions in 3 (Patient #14, #18, and #32) of 10 surgical patients reviewed. The facility failed to ensure that patients or their representatives were provided with the risks and benefits prior to surgical procedures performed. Also, the facility failed to follow their own policy and procedures on Informed consent.

B.) ensure the informed consent had a witness signature.

C.) ensure the Patient Disclosure and Consent for Anesthesia and /or Perioperative Pain management (analgesia) was completed prior to anesthesia being performed by the anesthesiologist or physician associates on the day of surgery.

This deficient practice had the likelihood to cause harm to all patients receiving surgical and analgesia procedures at the facility.

Findings included:



A. A review of Patient #14's record revealed:

A review of the facility's document titled, "Cardiology Procedural Admission Note" on 11/15/2022 at 9:48 AM, revealed there was no risk and benefits explained to the patient by Physician #65 prior to the procedure. Procedure was a Synchronized electrical cardioversion, TEE guided. Reason for procedure was Atrial fibrillation.

A review of Patient #18's record revealed:

A review of a physician note discussing the Bronchoscopy procedure on 10/14/2022 at 11:41 AM, the risk and benefits were written in the note; "After the risks benefits alternatives of the procedure were discussed informed consent was signed the patient was transported to the endoscopy suite where routine EKG pulse ox and blood pressure monitoring was applied. Conscious sedation was achieved using Versed 2 mg IV x 1 and fentanyl 50 mcg IV x 1. Local analgesia was accomplished with a Trans cricothyroidotomy junction of 2% lidocaine into the trachea." The Bronchoscopy procedure started at 11:14 AM. The note was signed by Physician #66 at 11:41 AM after the procedure had been completed, which then explained the risk and benefits.



B. A review of Patient #18's record revealed:

There was no witness signature to Patient #15 signing the informed consent on 11/10/2022 at 8:30 AM for a esophagogastroduodenoscopy (EGD).


C. A review of Patient #12's record revealed:

The "Anesthesia Preprocedure Evaluation" was created on 11/14/2022 at 2:06 PM by Anesthesiologist #51 and under the "Anesthesia Plan" "Informed Consent: Informed consent signed with the Patient and all parties understand the risks and agree with anesthesia plan. All questions answered. Patient consented to blood products? Yes" Then on 11/15/2022 at 7:45 AM a note was edited by Anesthesiologist #51 and under the "Anesthesia Plan" "Informed Consent: Informed consent signed with the Patient and all parties understand the risks and agree with anesthesia plan. All questions answered. Patient consented to blood products? Yes"

There was no way to know when the patient was advised of the risk and benefits of anesthesia and the informed consent was signed by the patient due the document was edited with different times making the same statement by
Anesthesiologist #51.

A review of Patient #13's record revealed:

The "Anesthesia Preprocedure Evaluation" was created by Anesthesiologist #51 on 10/03/2022 at 9:39 AM and under the "Anesthesia Plan" "Informed Consent: Informed consent signed with the Patient and all parties understand the risks and agree with anesthesia plan. All questions answered. Patient consented to blood products? Yes"
Then on 11/04/2022 at 7:54 AM a note was edited by Anesthesiologist #51 and under the "Anesthesia Plan" "Informed Consent: Informed consent signed with the Patient and all parties understand the risks and agree with anesthesia plan. All questions answered. Patient consented to blood products? Yes" Again on 11/07/2022 at 6:51 AM a note was edited by Anesthesiologist #51 and under the "Anesthesia Plan" "Informed Consent: Informed consent signed with the Patient and all parties understand the risks and agree with anesthesia plan. All questions answered. Patient consented to blood products? Yes"

There was no way to know when the patient was advised of the risk and benefits of anesthesia and the informed consent was signed by the patient due the document was edited with different times making the same statement by
Anesthesiologist #51.

A review of Patient #15's record revealed:

The "Anesthesia Preprocedure Evaluation" was created by Anesthesiologist #51 on 10/27/2022 at 12:50 PM and under the "Anesthesia Plan" "Informed Consent: Informed consent signed with the Patient and all parties understand the risks and agree with anesthesia plan. All questions answered. Patient consented to blood products? Yes" Then on 11/09/2022 at 8:54 AM a note was edited by Anesthesiologist #51 and under the "Anesthesia Plan" "Informed Consent: Informed consent signed with the Patient and all parties understand the risks and agree with anesthesia plan. All questions answered. Patient consented to blood products? Yes" On 11/10/2022 at 8:47 AM a note was edited by Certified Registered Nurse Anesthetist (CRNA) # 67 and under the "Anesthesia Plan" "Informed Consent: Informed consent signed with the Patient and all parties understand the risks and agree with anesthesia plan. All questions answered. Patient consented to blood products? Yes"

There was no way to know when the patient was advised of the risk and benefits of anesthesia and the informed consent was signed by the patient due the document was edited with different times making the same statement by
Anesthesiologist #51 and CRNA #67.


A review of Patient #17's record revealed:

The "Anesthesia Preprocedure Evaluation" was created by Anesthesiologist #51 on 11/13/2022 at 8:22 PM and under the "Anesthesia Plan" "Informed Consent: Informed consent signed with the Patient and all parties understand the risks and agree with anesthesia plan. All questions answered. Patient consented to blood products? Yes" The note leads the surveyor to question, was Anesthesiologist #51 interviewing the patient at 8:22 PM at night. Then on 11/14/2022 at 12:24 PM a note was edited by Anesthesiologist #51 and under the "Anesthesia Plan" "Informed Consent: Informed consent signed with the Patient and all parties understand the risks and agree with anesthesia plan. All questions answered. Patient consented to blood products? Yes"

There was no way to know when the patient was advised of the risk and benefits of anesthesia and the informed consent was signed by the patient due the document was edited with different times making the same statement by
Anesthesiologist #51.


A review of the facility policy titled, "Consents, General and Informed" effective date 11/2022 revealed the following:

"Informed Consents
Article 4509i of the Texas Civil Statutes provides that, before a patient or a person authorized to consent for a patient gives consent to any medical treatment that appears on the Texas Medical Disclosure Panel's list requiring disclosure, the physician must disclose to the patient, or person authorized to
consent for the patient, the risks and hazards involved in the proposed treatment.
1. For informed consents to occur, the physician must provide sufficient information to the patient, or person authorized to provide consent, to enable the patient or person to understand the facts and implications of the proposed actions and to decide whether to submit to the treatment being proposed.
2. The type of information to be disclosed and discussed with a patient includes but is not limited to the following:
a. The nature of the patient's condition;
b. The nature of the proposed care, treatment, service, medications, interventions, or the procedures to be performed;
c. The nature and probability of potential risks involved;
d. The potential benefits to be reasonably expected;
e. The potential side effects that might occur;
f. The inability of the physician to predict results;
g. The irreversibility of the procedure, if that is the case;
h. The likelihood of achieving goals;
i. The likely result of not receiving the treatment or procedure;
j. The reasonable alternatives therapies, including their risks, benefits, hazards, side
effects and potential complications;
k. When indicated, any limitations on the confidentiality of information learned from or about the patient.
3. The Titus Regional Medical Center, "Disclosure and Consent, Medical and Surgical Procedures"
form (adapted from the state required forms) shall be completed in full. No abbreviations (including physician initials) may be used anywhere on the form (patients may not understand
medical abbreviations). When possible the procedure should be written in lay terms (along with medical terminology for the procedure) to increase understanding of the intended
procedure. Copies of the required disclosures are kept on file on all nursing units.
4. Certain procedures as specified by the Texas Medical Disclosure Panel require
and specific consent forms as required by the state to be signed. These certain procedures include but may not be limited to the following:
a. Hysterectomy (Art. 4509i, §6.08.)
b. Electroconvulsive therapy (25 TAC §601 .7)
c. Radiation therapy (25 TAC §601 .5)
5. A patients consent shall be documented with sufficient clarity and detail so as to satisfy the reader that the patient was given and understood the medical information listed in item 2 above. Such documentation shall include but is not limited to the following:
a. A statement that the procedure or treatment, including the anticipated benefits,
material risks, hazards, side effects, alternative therapies and potential
complications was explained to the patient or patient's representative by the
physician or provider who provided explanation (must list name of physician or
provider);
b. A specific listing of all risks as required from time to time by the Texas Medical
Disclosure Panel, relative to the procedure to be performed;
c. General information such as the patient's name, contemplated procedure, and
provision for the disposal and/or use of tissue necessarily removed during surgery;
d. The date the patient expressly gave his or her consent;
e. The date the documentation was recorded (if different than the date of the patient
giving his consent);
f. Signature of the patient;
g. Signature of the witness to the patient's signature;
h. In the event a translator was utilized to obtain consent, the name of the translator
and language translated must also be provided.
6. Should the patient, or person authorized to give consent, have any questions or state that the medical treatment or surgical procedure has not been explained by the physician, then the responsible physician must be notified promptly. The consent form must not be signed until the patient or surrogate decision-maker has had the medical treatment or surgical procedure explained by the physician and has had any questions answered to their satisfaction and the patient or person indicates they consent to the proposed treatment or procedure.
7. The healthcare professional obtaining the patient's signature is only witnessing the fact that the patient, or appropriate other person authorized to give consent, acknowledges understanding of what the physician has explained about the medical treatment or surgical procedure that will be done and gives consent for the treatment or procedure."

An interview with Staff RN #48 on 11/16/2022 at 3:00 PM confirmed the above findings with Informed consents.




32143


Review of Patient # 32's chart revealed she was admitted to the OB department for a c-section on 11/14/22. There was no physician signature for the surgical consent. Review of the chart revealed there was no evidence found of the physician explaining to the patient risks and benefits before the surgical procedure.

An interview was conducted with Staff #77 on 11-16-22. Staff #77 stated that the nurse was supposed to review the chart and verify that the physician had documented in the history and physical, that risk and benefits were explained to the patient, before having the patient sign the surgical consent. Staff # 77 confirmed that there was no evidence of documentation that the patient received her risk and benefits before surgery.

Based on observation, record review, and interview, the Governing Body failed to ensure the emergency room staff performed Emergency Severity Index (ESI) scoring per established guidelines for best practice by the Emergency Nurses Association (ENA), including a combination of education, training, and assessment of Emergency Care.

Review of 17 of 80 emergency department medical records revealed the emergency severity index scoring (ESI) for patients were scored on a lesser acuity level than clinically indicated.

A review of the facility's' ESI and/or triage guidelines revealed the following:

The Emergency Severity Index (ESI) is a five-level emergency department (ED) triage algorithm that provides clinically relevant stratification of patients into five groups from 1 (most urgent) to 5 (least urgent) based on acuity and resource needs, developed by the Agency for Healthcare Research and Quality or AHRQ for Emergency Nurses Association {ENA}). Seventeen of the 80 ED charts reflected a much higher ESI level indicating a lower level of care when the patients status was indicative of a much higher need for assessment, interventions, and disposition.. ESI level for triage is critical to ensure quality patient care in a timely matter.

Interview with staff # 4 on 11/14/2022 at 10:00AM revealed staff are initially or upon hire given a book from emergency nurses association (ENA) on triage with ESI 5 tier system; however, there was no on-going education, training, or reviews for employee accuracy and efficacy.