HospitalInspections.org

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

1.) provide proper notice of rights in the form of required patient rights postings in 2(92 and 64) of 2 hospital departments surveyed for patient rights signage (Emergency Department and inpatient Behavioral Health).

Refer to Tag A0117

2.) A) allow patients to exercise their right to consent to or refuse treatment when being brought to the facility for preliminary examination after Apprehension by a Peace Officer in 4 out of 4 patients reviewed (Patient #52, #54, #55 and #66). The facility failed to follow procedures for involuntary detention after Apprehension by a Peace Officer without a Warrant as established in the Texas Administrative Code and Texas Health and Safety Code, preventing patients from being able to exercise their right to consent to or refuse treatment.

B.) protect the patient's right to make informed decisions in 2 (Patient #6 and #43) of 3 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.

Refer to Tag A0131


3.) ensure that patients have physical privacy to the extent consistent with their care needs during personal hygiene activities (e.g., toileting, bathing, dressing), during medical/nursing treatments, and when requested as appropriate.

Refer to Tag A0143


4.) A.) follow the patient's dialysis prescription by using the ordered BFR (Blood Flow Rate) in 3 (#5, #9, and #10) of 5 of the hemodialysis records reviewed. Patients' #5, #9, and #10 record showed treatments where the BFR (Blood Flow Rate) did not follow the patient's dialysis prescription written by the nephrologist.

B.) ensure that when facility staff members made a mistake on the inpatient portable RO machine total chlorine log that the correction to the document was done per the facility policy.

C.) ensure that that all acid jugs were labeled and that the labels were the same. Some 2K and 3K jugs were labeled with colored tape, large block labels on the front of the jugs, and some had small labels.

D.) ensure the pick-up tubes (wands) were in containers that was labeled clean and a container labeled for dirty.

E.) ensure that acid jugs were stored with caps and not the pick-up tubes (wands). Also, there was no log documenting when the acid wands were rinsed.

F.) ensure dialysis staff were maintaining a clean and sanitary environment for the acute dialysis patient.

Refer to Tag A0144



5. establish and implement an abuse protection program that included the State mandated education and training for staff that provided mental health care in a hospital. The Behavioral Health Center (BHC) of the hospital did not provide eight hours of face-to-face training covering specific topics of Abuse, Neglect, Unprofessional and Unethical Conduct to the staff.

Refer to Tag A0145


6. follow their own policy and procedure administering chemical restraints in 1 (#94,80, and 81) of 3 (#94,80, and 81) patient charts reviewed.

Nursing failed to document the psychotropic medication used for an aggressive behavior as a chemical
restraint/emergency behavioral medication. There was no documented face to face found. There was no documentation found of patient's response to the medication, or nursing assessments concerning the chemical restraint administration. There was no found vital signs in the chart in 1 (#94, 80, and 81) of 3 (#94,80, and 81) patient charts reviewed.

Nursing failed to address the patient's chemical restraint in the patients care plan in 1 (#94, 80, and 81) of 3(#94,80, and 81) patient charts reviewed.

Refer to Tag A0160


7. ensure the patients receiving restraints were not seen face to face within 1 hour after the initiation of the intervention by a physician or RN who has been trained in accordance with the requirements specified in paragraph (f) of this section in 2 (81 and 94) of 3(80,81 and 94) charts reviewed.

Refer to Tag A0178


Pharmacy Services

8). ensure 2 of 2 hospital pharmacies, (Main Hospital Pharmacy and Behavioral Health Center Pharmacy) were maintained according to acceptable United States Pharmacopeia (USP) standards. Temperatures were not monitored in medication storage rooms to ensure temperatures were maintained within the drug manufacturers' requirements for storage. The main pharmacy was not maintained in a sanitary manner.

Cross Refer to Tag A0491


9.) A.) ensure that records for scheduled medications were sufficient to trace the movement of the medication from the pharmacy to the patient in 1 procedure area (Pain Management Clinic) of 2 observed. Nursing staff were removing scheduled drugs in bulk from the locked medication storage box without signing for the medication.

B.) ensure a process was developed and implemented for the reconciliation of dispensed scheduled drugs, such as fentanyl that was to be administered as a continuous intravenous (IV) infusion, with the nursing administration flow sheet documenting the amount the patient had received along with the record of medication wasted when the medication was completed. This affected all patients receiving scheduled drugs, such as fentanyl, when they were administered as continuous IV infusions through a regular IV pump.

C.) ensure a process was developed for the prompt identification, investigation and resolution of discrepancies in scheduled drug counts in 1 of 1 incident reports reviewed that involved missing scheduled drugs. A scheduled drug had been missing for 12 days and had been reported to pharmacy 6 days later, when it was finally discovered to be missing. An investigation had not been initiated by pharmacy.

Cross Refer to Tag A0494 for detailed findings

D.) ensure a pharmacy process was developed for the dispensing of scheduled drugs for continuous intravenous (IV) infusion through regular IV pumps that provided adequate safety devices to prevent potential drug diversion during the administration process. This deficient practice had the potential to affect all patients receiving scheduled drugs as a continuous IV infusion. Continuous IV infusions of scheduled drugs were found to be easily accessed by unauthorized persons, providing the potential for drug diversion and patients not receiving the medication ordered.

E.) ensure pharmacy staff reviewed orders to ensure proper dosage for 1 (Fentanyl) of 2 medication titration order sets (titration of medications is the adjustment of medication dosage based on patient response to the medication). This practice allowed staff without prescriptive authority to determine the dosage and frequency of dosage changes to be made when patients were receiving the medication, Fentanyl, with orders for titration.

Cross Refer to Tag A0500 for detailed findings.

F.) ensure intravenous fluids were stored securely in the preoperative area of the DDC (Digestive Disease Center). Intravenous fluids were found to be stored in unlocked cabinets where unauthorized persons could potentially access them.

Cross Refer to Tag A0502.



Laboratory Services -

10.) A.) ensure lab specimens were transported safely. They failed to ensure temperatures were taken while transporting lab specimens.

B.) ensure the medication assistant that was drawing blood at the Healthy Connections lab was receiving annual competencies.

C.) ensure timely patient and physician notification was made after they were notified of potentially contaminated blood products in 2 of 2 cases that were reviewed. Two cases were sent from the blood bank revealing confirmed Hepatitis C donations were potentially administered.

Refer to A tag 0592 for additional information.



Bronchoscopy Lab - Infection Control

11.) A.) ensure that the staff who were processing bronchoscopes followed the manufacturer IFU (Instructions for use) to ensure that the bronchoscopes completed the decontamination process.

B.) ensure the facility staff who were processing the bronchoscopes followed the manufacturer IFU on the recommendations for manual flush of alcohol when processing the bronchoscopes.

C.) ensure that facility staff who were processing the bronchoscopes were trained on the correct decontamination process and use of the Medivator processing machine used to decontaminate the scopes.

D.) ensure the bronchoscopy room maintained a negative pressure. Review of the bronchoscopy procedure list for 5-1-2019 to 11-18-2019 revealed bronchoscopy procedures were done on 5 patients. Patients with known or suspected TB (tuberculosis) infection pose a significant risk of exposure to staff and other patients.

E.) ensure that air exchanges and negative pressure were monitored in the bronchoscopy decontamination processing room.

F.) ensure a sanitary environment for the provision of patient care in 3 bronchoscopy room, bronchoscopy patient supply area, and bronchoscopy decontamination room) of 3 respiratory patient care areas observed.

G.) ensure that bronchoscopy supplies were not expired and available for patient use.

H.) ensure temperatures were monitored within the facility storage rooms and an off-site warehouse located at 4815 Troup Highway that stored patient supplies, surgical supplies, Intravenous fluids, and Intravenous contrast that were available for patient use. Also, the facility failed to ensure that humidity levels were monitored in the storage rooms where sterile surgical instruments were stored.

I.) have a clear and defined separation of clean and dirty supply storage at the off-site storage warehouse.

J.) maintain a clean and sanitary environment to ensure patient's health and safety in 7 (1st floor, 2nd floor, 3rd floor, 4th floor, 5th floor, 6th floor, and an off-site storage warehouse) of 8 areas observed.

K.) ensure a process was in place to monitor patient supplies for expiration dates.

L). failed to ensure there was a facility policy/process in place for delivering time/temperature sensitive supplies to the lab.

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

M.) evaluate facility staff immunization status for designated infectious diseases, as recommended by the CDC and its Advisory Committee on Immunization Practices (ACIP).

N.) ensure the facility maintained a clean and sanitary environment for the purposes of medication storage in the Automated Pyxis systems.

O.) ensure the facility maintained a clean and sanitary condition was provided in the patient nourishment refrigerators on 6 (1st floor, 2nd floor, 3rd floor, 4th floor, 5th floor and 6th floor) of 6 floors observed.

P.) ensure the facility did not store cardboard boxes in all nursing storage closets and dietary department.

Q.) ensure the facility maintained a clean and sanitary environment in the Dietary Department.

R.) ensure the facility maintained a clean and sanitary environment in Lab #1 in 6 (main lab, phlebotomy supply cart, phlebotomy storage area, Hematology area, Chemistry area, and Transfusion area) of 6 areas observed.

S.) ensure the facility maintained a clean and sanitary environment was maintained in the Healthy Connections Lab. Also, ensure expired supplies were not stored and available for patient use in the lab.

T.) ensure the facility maintained a clean and sanitary environment was maintained at the off-site Emergency Room Lab Department. Also, the facility failed ensure lab specimens were processed in a timely manner and removed from the storage area.

U.) ensure the facility maintained a clean and sanitary environment was maintained in the Cardio Vascular (CV) Surgical Unit in 6 (Operating Room (OR) #1, OR #2, Sterile supply room, hallway of the CV OR, Electro Physiology Lab, and supply closet outside of the CVOR) of 6 areas observed.

V.) ensure the facility processed sterile surgical instruments according to the Association for the Advancement of Medical Instrumentation (AAMI) Standards.

W.) ensure a clean and sanitary environment was maintained in the Radiology Department in 6 (X-ray Room, CT Room #3, Interventional Radiology (IR) sterile storage the facility, IR Room #1, and IR Room #10) of 6 areas observed.

X.) ensure that surgical supplies in the interventional radiology department were stored in a manner to prevent cross contamination during radiology procedures in 2 (Interventional Radiology Room #1 and #10) of 2 rooms observed.

Y.) ensure the intravenous (IV) contrast was stored according to manufactures recommendations in 2 (contrast storage closet and CT Room #3) of 2 areas observed.

Refer to tag A0749 for additional information.

Surgical Services

12.) A.) ensure that tissue grafts were stored according to the manufacturer guidelines on 35 items listed on the bone freezer log.

B.) ensure the facility had a process for staff to follow on time frames for discarding grafts after being removed from the cone tissue freezer.

C.) ensure that unmonitored tissue stored outside of the bone freezer was removed from the bone freezer and was not available for implantation in a patient. One graft was implanted in a patient from the unmonitored tissue graft on 9-12-2019. There was no way to ensure the graft was maintained at the manufacturer recommended temperatures when taken out of the tissue freezer and stored in a cooler on dry ice.

D.) ensure surgical implants were not stored and available for patient use after the manufacturer expiration date. Ten (10) sterile items were on the shelf and available for patient use that were expired. Seven (7) surgical implants were on the shelf and available for patient use that were expired.

E.) ensure a sanitary environment for storage of sterile surgical supplies and patient implants in 1 (Sterile processing staging area) of 1 areas observed.

F.) ensure that sterile surgical implants/instruments were reprocessed according to the manufacturer recommendations in 3 of 3 items observed.

G.) ensure that single use/disposable items were not re-sterilized/cleaned and reused.

H.) ensure that staffing in the Sterile processing department was adequate to maintain workload and current standards of practice.

I.) to provide documentation that the filters were changed on the Endoscopy reprocessor per the IFU of the water filtration system. Also, the facility failed to provide a process for maintaining that the filters were changed every 6 months.

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

J.) ensure negative pressure was maintained in the decontamination area of the sterile processing department. There was no way to ensure contaminates from cleaning soiled surgical instruments were contained in the decontamination room.

K.) ensure there was separation of soiled/contaminated supplies and equipment from clean or sterilized equipment in a hallway in the decontamination room.

L.) ensure the temperature in the Operating Rooms, Cath Lab, Outpatient Surgical Department & Digestive Disease Center was within acceptable standards to inhibit microbial growth, reduce the risk of infection, promote patient comfort and assure the physical safety of all patients.

M.) ensure a sanitary environment for the provision of surgical services and patient care areas for 13 (Sterile Processing clean area, Sterile Processing decontamination area, OR #4, OR#5, Pre-Op area, Post-op area, Post-Op linen- equipment-supply room, anesthesia work room, Cath Lab #3, Cath Lab supply storage room, EP Lab #2, Outpatient Surgery department, and DDC (Digestive Disease Center) of 13 areas observed.

N.) ensure the intravenous fluids that were stored in the fluid warmer were stored per the facility procedure log requirements of less than or equal to 104 degrees Fahrenheit.

O.) ensure a complete Time Out was performed prior to a bronchoscopy in 1 (Patient #116) of 4 bronchoscopy charts observed. Also, the facility failed to ensure the documentation in the surgical chart for the time out was accurately completed and included all elements of a complete Time Out in 11 (Patient #'s 2, 27, 73, 74, 101, 102, 104, 105, 117, 118, & 119) of 14 patients reviewed.

P.) ensure that the patient was provided all information necessary to make an informed decision on their care in 9 (Pt #'s 22, 27, 28, 29, 73, 74, 96, 97, &105) of 9 patients reviewed.

Cross refer to Tag A0955

Based on review and interview the facility failed to:

1. provide proper notice of rights in the form of required patient rights postings in 2(92 and 64) of 2 hospital departments surveyed for patient rights signage (Emergency Department and inpatient Behavioral Health).

Refer to Tag A0117

2. A) allow patients to exercise their right to consent to or refuse treatment when being brought to the facility for preliminary examination after Apprehension by a Peace Officer in 4 out of 4 patients reviewed (Patient #52, #54, #55 and #66). The facility failed to follow procedures for involuntary detention after Apprehension by a Peace Officer without a Warrant as established in the Texas Administrative Code and Texas Health and Safety Code, preventing patients from being able to exercise their right to consent to or refuse treatment.

B) protect the patient's right to make informed decisions in 2 (Patient #6 and #43) of 3 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.


Refer to Tag A0131

3. ensure that patients have physical privacy to the extent consistent with their care needs during personal hygiene activities (e.g., toileting, bathing, dressing), during medical/nursing treatments, and when requested as appropriate.

Refer to Tag A0143

4.
A.) follow the patient's dialysis prescription by using the ordered BFR (Blood Flow Rate) in 3 (#5, #9, and #10) of 5 of the hemodialysis records reviewed. Patients' #5, #9, and #10 record showed treatments where the BFR (Blood Flow Rate) did not follow the patient's dialysis prescription written by the nephrologist.


B.) ensure that when facility staff members made a mistake on the inpatient portable RO machine total chlorine log that the correction to the document was done per the facility policy.

C.) ensure that that all acid jugs were labeled and that the labels were the same. Some 2K and 3K jugs were labeled with colored tape, large block labels on the front of the jugs, and some had small labels.


D.) ensure the pick-up tubes (wands) were in containers that was labeled clean and a container labeled for dirty.

E.) ensure that acid jugs were stored with caps and not the pick-up tubes (wands). Also, there was no log documenting when the acid wands were rinsed.

F.) ensure dialysis staff were maintaining a clean and sanitary environment for the acute dialysis patient.

Refer to Tag A0144


5. establish and implement an abuse protection program that included the State mandated education and training for staff that provided mental health care in a hospital. The Behavioral Health Center (BHC) of the hospital did not provide eight hours of face-to-face training covering specific topics of Abuse, Neglect, Unprofessional and Unethical Conduct to the staff.

Refer to Tag A0145

6. follow their own policy and procedure administering chemical restraints in 1 (#94,80, and 81) of 3 (#94,80, and 81) patient charts reviewed.

Nursing failed to document the psychotropic medication used for an aggressive behavior as a chemical
restraint/emergency behavioral medication. There was no documented face to face found. There was no documentation found of patient's response to the medication, or nursing assessments concerning the chemical restraint administration. There was no found vital signs in the chart in 1 (#94, 80, and 81) of 3 (#94,80, and 81) patient charts reviewed.

Nursing failed to address the patient's chemical restraint in the patients care plan in 1 (#94, 80, and 81) of 3(#94,80, and 81) patient charts reviewed.

Refer to Tag A0160


7. ensure the patients receiving restraints were not seen face to face within 1 hour after the initiation of the intervention by a physician or RN who has been trained in accordance with the requirements specified in paragraph (f) of this section in 2 (81 and 94) of 3(80,81 and 94) charts reviewed.

Refer to Tag A0178

Based on observation, review of documents, and interview, the facility failed to provide proper notice of rights in the form of required patient rights postings in 2 (92 and 64) of 2 hospital departments surveyed for patient rights signage (Emergency Department and inpatient Behavioral Health).

Findings included:

On the afternoon of 11-18-2019, a tour of the Behavioral Health Unit was conducted with Staff #87 and RN #58. A tour of Unit 500 revealed that the State required postings of the Patient's Bill of Rights was not present. The required bill of rights postings were not displayed on the children's, adolescents, and acute adult units either.

Interview was conducted at the time of the observation with RN #58. RN #58 confirmed that the postings had been present, but removed at the direction of the corporate staff. RN #58 stated that the Behavior Health Unit management had been told that the signage was not necessary.

Review of the Texas Administrative Code, Title 25 Health Services, Part 1 Department of State Health Services, Chapter 404 Protection of Clients and Staff - Mental Health Services, Subchapter E Rights of Persons Receiving Mental Health Services, 404.162 Patient's Bill of Rights, Teen's Bill of Rights, and Children's Bill of Rights, revealed the following:

"(f) Copies of the Patient's Bill of Rights, Teen's Bill of Rights, and/or Children's Bill of Rights must be displayed prominently at all times in all areas frequented by persons receiving services (e.g., day rooms, recreational rooms, waiting rooms, lobby areas). A sufficient number of copies will be kept on hand in each of these areas in order that a copy may be made readily available to anyone requesting one."

On 11-21-2019 at 11:35 AM, the required postings in the Emergency Department were observed to be hung on the wall at a height that made the small print unreadable. Patient #57 and Patient #58 were interviewed in the waiting area. When asked, both confirmed that they had tried to read the signs but had been unable. Patient #58 stated, "And I even got up close, but it hurt my neck trying to look up and read it that close."

Staff # 92 was interviewed at the time of observations. Staff #92 confirmed that she was unable to read the signage. The signs contained the "Notice of Health Information Privacy Practices" in English and Spanish, and the "Discrimination is Against the Law" notice in English and Spanish. The signs contained information on the patient's rights and information on how to file a complaint if the patient rights were violated.

RN #64 was interviewed on 11-21-2019 at approximately 12:15 PM. RN #64 stated that she was aware that the signage was not readable and that she was working with the hospital department that handled facility signs to have them replaced. RN #64 stated she had emailed that department with the request. Staff #64 was asked to provide copies of the correspondence as evidence of when the problem had been identified and what the resolution was going to be. No emails or evidence was provided.

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

A) allow patients to exercise their right to consent to or refuse treatment when being brought to the facility for preliminary examination after Apprehension by a Peace Officer in 4 out of 4 patients reviewed (Patient #52, #54, #55 and #66). The facility failed to follow procedures for involuntary detention after Apprehension by a Peace Officer without a Warrant as established in the Texas Administrative Code and Texas Health and Safety Code, preventing patients from being able to exercise their right to consent to or refuse treatment.

B) protect the patient's right to make informed decisions in 2 (Patient #6 and #43) of 3 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.

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


Findings for A) included:

Patient #52

Patient #52 was interviewed on the afternoon of 11-18-2019. The patient stated that he was being held against his will. Patient #52 stated that his order of detention had expired and that they would not let him leave.

RN #58 was interviewed on the afternoon of 11-18-2019. RN #58 stated that the patient had been admitted on an Emergency Detention Warrant that expired over the weekend. RN #58 explained that due to it being a weekend, the facility had until close of business on 11-18-2019 to file for an Order of Protective Custody.

Patient #52's chart was reviewed on the morning of 11-19-2019. Chart review revealed the following:
The chart contained a form titled, "Notification - Emergency Detention ... Application for Emergency Detention without a Warrant (Peace Officer Warrant)." The form showed that Patient #52 was apprehended by a Peace Officer on Thursday, 11-14-2019, at 9:30 PM and transported to an emergency department "for the purpose of conducting a preliminary examination by a physician." The facility that the patient was transported on the Peace Officer's warrant was a separate facility from UT Health East Texas - Tyler. The record showed the patient had an arrival date/time of 11-14-2019 at 10:00 PM. The physician from the separate facility's emergency department initiated the preliminary examination at 11:48PM. Review of the physician examination showed that the patient was medically cleared and the final physician's note made on the morning of Friday, 11-15-2019, stated, "Notify the police that the patient is medically clear at this time as they had previously indicated that they plan on taking him to jail once he was medically cleared." Discharge instructions were as follows:
"Possible early urinary tract infection
Bactrim DS twice daily times 10 days
Follow-up your primary care physician within 10 days
Return to the emergency room as needed for worsening"

No information was found in the preliminary examination performed based on the Peace Officer Warrant to show that Patient #52 required Emergency Admission for chemical dependency or mental health treatment. No statement from the physician making the preliminary examination in the emergency department as required by Section 462.043(b) or Section 573.022. EMERGENCY ADMISSION AND DETENTION was found in the preliminary examination. The emergency department record did not show when the patient departed the emergency department. No documentation was found in the emergency department record provided of the separate hospital's emergency department nursing or medical staff handing the patient off to the behavioral health unit staff for admission.

Review of Patient #52's chart showed that he was admitted to the behavioral health unit on 11/15/2019 at 2:49 PM. Notes from the admissions staff indicated that the physicians from the other hospital's emergency department and the Behavioral Health Unit spoke prior to the patient being transferred with a note to "consider benzo & opioid w/d K2?" This indicated the possibility that the patient's symptoms were related to Chemical Dependency.

Between 11-15-2019 when the preliminary examination by an emergency room physician at another hospital had been completed indicating the patient was to be discharged to police custody and 11-18-2019 when the court approved an Order of Protective Custody, no records were found that showed the patient should have been held involuntarily. The patient record showed that during that time period the patient had not signed for a voluntary admission and had been requesting to leave the facility. The patient record showed that there was no physician order in the patient's chart to hold the patient for involuntary commitment by court order.

No orders were found in Patient #52's chart as of 11-19-2019 to hold the patient for court ordered mental health or substance abuse treatment. An application for court ordered mental health treatment was made on 11-18-2019 and a Motion for Order of Protective Custody was signed by the courts on 11-18-2019.

An interview was conducted with Staff #87 and RN #58 on the morning of 11-19-2019. Both stated that they had been told the physician had placed an order on 11-18-2019 in the electronic medical record to hold the patient for a court Order of Protective Custody. On the afternoon of 11-29-2019 RN #58 confirmed that the order had not been properly entered into the electronic system by the physician, therefore, no order was in the patient record.

Patient #54

Patient #54's chart was reviewed on 11-19-2019. The chart revealed that on Saturday, 11-9-2019, at 2:13 AM, a peace officer from the Wood County Sheriff's Office apprehended Patient #54 to be taken to UT Health East Texas Behavioral Health. Admission paperwork showed the patient was admitted on 11/9/2019 at 3:27 AM as an involuntary patient.

The patient record showed that the preliminary examination was conducted on Saturday, 11-9-2019, at 6:57 AM. Per the physician's note, the "Assessment/Treatment Plan" included medication for depression and an alcohol detoxification protocol for alcohol withdrawal. The "Expected Length of Stay" was going to be 7 days. No physician order to hold the patient for court ordered mental health treatment or application paperwork for court ordered mental health treatment was made at the time of preliminary examination when it was determined by the physician that the patient length of stay was expected to be 7 days.

The physician's admission note contained a "Summary of Medical/Psychiatric Inpatient Criteria", but did not contain the necessary statement from the physician conducting the preliminary examination for Emergency Detention and Admission as required by the Texas Health and Safety Code for admission under emergency detention.

Review of Psychiatry Progress notes for 11-12-2019 at 9:33 AM showed that the patient reported the "Voices don't go away, even with the pills"; he was having "Persistent auditory hallucinations that are voices telling him to kill himself, telling him he is going to burn in hell"; his mental status was documented as "Suicide Risk? Yes Suicide Risk Details Suicide Plan Overdose"; "Appearance Disheveled"; and "Judgement Impaired". No information was found in the Psychiatry Progress notes that addressed the patient's readiness for discharge from emergency detention or ability to consent for voluntary admission for treatment.

The patient's record showed that the patient was allowed to sign a Post-Admission Consent for Voluntary treatment on Tuesday, 11-12-2019, at 3:00 PM. Since Monday, 11-11-2019, was a holiday, the courts were closed. Tuesday by 4:00 PM was the deadline for submitting paperwork to the court for an involuntary commitment. No paperwork had been prepared to submit to the court in time for the deadline if the patient had not signed a consent for voluntary treatment.

RN #55 assisted with navigation of Patient #54's chart. RN #55 confirmed that the only legal paperwork available was the initial paperwork initiated by the Peace Officer.

Patient #55

Patient #55's chart was reviewed on 11-19-2019. The chart revealed that on Thursday, 11-14-2019, at 9:39 PM, a peace officer from the Wood County Sheriff's Office apprehended Patient #55 to be taken to UT Health East Texas Behavioral Health. Admission paperwork showed the patient was admitted on 11/14/2019 at 10:58 PM as an involuntary patient. The physician's admission note contained a "Summary of Medical/Psychiatric Inpatient Criteria", but did not contain the necessary statement from the physician conducting the preliminary examination for Emergency Detention and Admission as required by the Texas Health and Safety Code for admission under emergency detention. No application for court order for protective custody was found in the chart.

The patient record showed that the preliminary examination was conducted on Friday, 11-15-2019 at 3:56 PM. The Psychiatric Evaluation - Admission History and Physical showed that the initial Expected Length of Stay was determined to be 5-7 days. Since the 24-hour time frame was going to expire on Friday, an order to hold the patient for court ordered treatment should have been written and the paperwork submitted prior to court office closure on Friday, 11-15-2019. Absent of a court order for further detainment, the patient should have been allowed to exercise his right to refuse or consent to inpatient treatment.

Patient #55's records showed that he was not provided the right to sign a Post-Admission Consent for Voluntary Treatment and Review of Patient Rights until Sunday, 11-17-2019, at 12:30 PM.

RN #55 assisted with navigation of Patient #55's chart. RN #55 confirmed that the only legal paperwork available was the initial paperwork initiated by the Peace Officer.

An interview was conducted with Staff #87 and RN #58 on the morning of 11-19-2019. Staff #87 and RN #58 were able to explain the difference between an Apprehension by a Peace Officer Without a Warrant (APOWW) and an Emergency Detention Warrant (EDW) signed by a magistrate or a judge. RN #58 stated she was unaware that the Case Manager that was handling involuntary admissions did not understand the difference.


Review of the Texas Health and Safety Code, Subtitle B. Alcohol and Substance Abuse Programs, Subchapter C. Emergency Detention revealed the following:

"Sec. 462.041. APPREHENSION BY PEACE OFFICER WITHOUT WARRANT.
(a) A peace officer, without a warrant, may take a person into custody if the officer:
(1) has reason to believe and does believe that:
(A) the person is chemically dependent; and
(B) because of that chemical dependency there is a substantial risk of harm to the person or to others unless the person is immediately restrained; and
(2) believes that there is not sufficient time to obtain a warrant before taking the person into custody.
(b) A substantial risk of serious harm to the person or others under Subsection (a)(1)(B) may be demonstrated by:
(1) the person's behavior; or
(2) evidence of severe emotional distress and deterioration in the person's mental or physical condition to the extent that the person cannot remain at liberty."

"Sec. 462.044. PRELIMINARY EXAMINATION. (a) A physician shall conduct a preliminary examination of the apprehended person as soon as possible within 24 hours after the time the person is apprehended under Section 462.041 or 462.043.
(b) The person shall be released on completion of the preliminary examination unless the examining physician or the physician's designee provides a written opinion that the person meets the criteria specified by Section 462.043(b)."

Criteria specified by Section 462.043(b) was as follows:
"(1) the person who is the subject of the application is a person with a chemical dependency;
(2) the person evidences a substantial risk of serious harm to the person or others;
(3) the risk of harm is imminent unless the person is immediately restrained; and
(4) the necessary restraint cannot be accomplished without emergency detention."



Review of the Texas Health and Safety Code, Subtitle C. Texas Mental Health Code, Subchapter C. Emergency Detention, Release, and Rights revealed the following:

"Sec. 573.001. APPREHENSION BY PEACE OFFICER WITHOUT WARRANT.
(a) A peace officer, without a warrant, may take a person into custody if the officer:
(1) has reason to believe and does believe that:
(A) the person is a person with mental illness; and
(B) because of that mental illness there is a substantial risk of serious harm to the person or to others unless the person is immediately restrained; and
(2) believes that there is not sufficient time to obtain a warrant before taking the person into custody.
(b) A substantial risk of serious harm to the person or others
under Subsection (a)(1)(B) may be demonstrated by:
(1) the person's behavior; or
(2) evidence of severe emotional distress and deterioration in the person's mental condition to the extent that the person cannot remain at liberty.
(c) The peace officer may form the belief that the person meets the criteria for apprehension:
(1) from a representation of a credible person; or
(2) on the basis of the conduct of the apprehended person or the circumstances under which the apprehended person is found.
(d) A peace officer who takes a person into custody under Subsection (a) shall immediately:
(1) transport the apprehended person to:
(A) the nearest appropriate inpatient mental health facility; or
(B) a mental health facility deemed suitable by the local mental health authority, if an appropriate inpatient mental health facility is not available; or
(2) transfer the apprehended person to emergency medical services personnel of an emergency medical services provider in accordance with a memorandum of understanding executed under Section 573.005 for transport to a facility described by Subdivision (1)(A) or (B).

"Sec. 573.021. PRELIMINARY EXAMINATION.
(a) A facility shall temporarily accept a person for whom an application for detention is filed or for whom a peace officer or emergency medical services personnel of an emergency medical services provider transporting the person in accordance with a memorandum of understanding executed under Section 573.005 files a notification of detention completed by the peace officer under Section 573.002(a).

(b) A person accepted for a preliminary examination may be detained in custody for not longer than 48 hours after the time the person is presented to the facility unless a written order for
protective custody is obtained. The 48-hour period allowed by this section includes any time the patient spends waiting in the facility for medical care before the person receives the preliminary examination."

"Sec. 573.022. EMERGENCY ADMISSION AND DETENTION.
(a) A person may be admitted to a facility for emergency detention only if the physician who conducted the preliminary examination of the person makes a written statement that:
(1) is acceptable to the facility;
(2) states that after a preliminary examination it is the physician's opinion that:
(A) the person is a person with mental illness;
(B) the person evidences a substantial risk of serious harm to the person or to others;
(C) the described risk of harm is imminent unless the person is immediately restrained; and
(D) emergency detention is the least restrictive means by which the necessary restraint may be accomplished; and
(3) includes:
(A) a description of the nature of the person's mental illness;
(B) a specific description of the risk of harm the person evidences that may be demonstrated either by the person's behavior or by evidence of severe emotional distress and deterioration in the person's mental condition to the extent that the person cannot remain at liberty; and
(C) the specific detailed information from which the physician formed the opinion in Subdivision (2)."

Review of the Texas Administrative Code showed the time-frame that an involuntary patient could be detained by a facility after Apprehension by a Peace Officer without a Warrant was strictly limited to 24-hours with the exception of weekends and holidays unless a further court order was obtained.

Review of Texas Administrative Code, Title 25 Health Services; Part 1 Department of State Health Services; Chapter 411 State Mental Health Authority Responsibilities;
Subchapter J Standards of Care and Treatment in Psychiatric Hospitals; was as follows:

"411.485 Discharge of an Involuntary Patient

(a) Discharge from emergency detention.

(1) Except as provided by 411.465 of this title (relating to Voluntary Treatment Following Involuntary Admission) and in accordance with Texas Health and Safety Code, 573.023(b) and 573.021(b), a hospital shall immediately discharge a patient under emergency detention if either of the following occurs:

(A) the administrator or the administrator's designee determines, based on a physician's determination, that the patient no longer meets the criteria described in subsection 411.462(c)(1) of this title (relating to Emergency Detention); or

(B) except as provided in paragraphs (2) and (3) of this subsection, 24 hours elapse from the time the patient was presented to the hospital and the hospital has not obtained a court order for further detention of the patient.

(2) In accordance with Texas Health and Safety Code, 573.021(b), if the 24-hour period described in paragraph (1)(B) of this subsection ends on a Saturday, Sunday, or legal holiday, or before 4:00 p.m. on the next business day after the patient was presented to the hospital, the patient may be detained until 4:00 p.m. on such business day.

(3) In accordance with Texas Health and Safety Code, 573.021(b), the 24-hour period described in paragraph (1)(B) of this subsection does not include any time during which the patient is receiving necessary non-psychiatric medical care in the hospital's emergency room or non-psychiatric emergency care in another area of the hospital."



32143


Patient #66

Review of Patient #66's chart revealed the patient was a 43 y/o female brought to the behavioral health unit (BHU) on 9/5/19 AT 1:03 am for psychosis. Patient #66 was brought to the unit, as an involuntary patient, under an APOWW signed by a police officer. The officer had written, "off medication for 3-4 days. Has no ate or drank anything in 2 or 3 days. Was observed walking around barefoot in the middle of the road on hot pavement." (SIC) The initial physician order written 9/5/19 at 1:03 am stated, "Emergency detention warrant (EDW) expires on 9/6/19." Patient #66 did not have an EDW but an APOWW that expired once the patient was evaluated by the physician. There was no physician order for involuntary or involuntary status nor to hold the patient for court commitment proceedings.

Review of Patient #66's chart revealed a physician order written on 9/6/19 at 10:46 am. The order stated, "have patient sign in voluntary." There were no consents signed for voluntary or involuntary in the patient's chart. Staff #88 confirmed there was no consents signed nor any documentation that the patient was aware of her status and patient rights. On 9/11/19 at 2:20 pm a physician order was found that read, "Begin Commitment Process rescind previous discharge order due to behavior emergency." Review of the chart revealed a waiver of probable cause, waiving the patients right to a hearing, on 9/11/19 and the Order of Protective Custody was signed on 9/12/19. Patient #66 was held in the facility for 6 days without notification of her status of involuntary to voluntary. There was no documentation found that Patient #66 was made aware of the request for discharge process.


41831



Findings for B) include:



A review of medical records was conducted on 11/21/19 after 9:30 a.m. in the administrative offices. The findings were as follows:


Patient # 6

A review of the medical record revealed patient # 6 was admitted to the hospital on 11/17/19 with chest pain. Review of the history and physical assessment and plan of care included a Lexiscan Cardiolite test. Review of the medical record revealed patient # 6 was scheduled to have a Cardiac Stress Test on 11/18/19. A document titled "Disclosure and Consent - Medical and Surgical Procedures - Cardiac Stress Lab," was reviewed. Review of the document revealed the patient signed the consent on 11/18/19 at 9:30 a.m., and a nurse witnessed the signature. The physician signature line was blank.

Further review of the medical record revealed no documentation that the risk and benefits of this procedure were discussed with the patient prior to her signing the consent form.



Patient # 43

A review of the medical record revealed patient # 43 was admitted to the hospital on 11/17/19 with a diagnosis of acute cerebrovascular accident (stroke) and moyamoya disease (a condition that causes a restriction of the carotid arteries that decreases blood flow to the brain). Review of the record revealed patient #43 was scheduled for a cerebral arteriogram in the Interventional Radiology department under moderate sedation on 11/19/19. This procedure allows the physician to evaluate the blood flow to the patient's brain. This procedure requires the patient be sedated.

A document titled "Disclosure and Consent - Medical and Surgical Procedures - Arteriography/Angioplasty," was reviewed. The review of this document revealed the patient's husband signed this consent form on 11/19/19 at 7:48 a.m., and was witnessed by the nurse. The physician signed this consent at 2:10 p.m., on 11/19/19. A document titled "Disclosure and Consent - Medical and Surgical Procedures - Moderate Sedation," was also reviewed. The review revealed the patient's husband signed this consent form on 11/19/19 at 7:46 a.m. Further review of this document revealed the physician signed this consent form at 2:00 p.m.

Review of a post-operative report signed by the physician at 2:54 p.m. stated "Procedure and risks and benefits were discussed with the patient and family. Informed consent was obtained." Further review of the medical record revealed no documentation that the risks and benefits of this procedure were discussed with the patient or her husband prior to him signing the consent form.

An interview with RN #66 was conducted on 11/21/19 after 9:30 a.m. RN # 66 was asked how informed consents were obtained at the facility. RN # 66 stated the physician would explain the risks and benefits of the procedures to the patient and have the patient or representative sign the consent form with a nurse to witness. RN # 66 was then asked what documentation would be expected prior to the procedure. RN # 66 stated the physician would document this discussion prior to performing the procedure.



A review of the facility policy titled "Informed Consent - Admin" with a latest review date of 11/21/18, revealed the following:

"Policy:
1) It is the policy of UT Health Tyler to fully comply with the Texas Medical Disclosure Panel's rules on informed consent for medical treatment and procedures.

2) Consent will be obtained in writing prior to performing surgical procedures, non-surgical invasive, diagnostic and/or therapeutic procedures, and all procedures in which anesthesia or sedation is used ... ... ... ..."

"Procedure:

1) It is the duty of the treating physician to obtain a patient's consent for treatment or procedure; this duty cannot be delegated nor is it eliminated, lessened, or spread by having the nurse secure the patients' signature before surgery or procedure.

2) Before a patient or person authorized to consent for a patient gives consent to any medical care or surgical procedure that appears on the Texas Medical Disclosure Panel's list requiring disclosure, the physician shall disclose to the patient or person authorized to consent for the patient:

a) the potential benefits, risks, and side effects of the patient's proposed care, treatment and services
b) the likelihood of the patient achieving his or her goals
c) any potential problems that might occur during recuperation. (See attached). Attach lists A&B

3) The informed consent process also includes a discussion about reasonable alternatives to the patient's proposed care, treatment, and services. The discussion encompasses risks, benefits, and side effects related to the alternatives, and the risks related to not receiving the proposed care, treatment and services. Also included in the informed consent process is a discussion about any circumstances under which information about the patient must be disclosed or reported. The physician documents the above discussions when signing the informed consent ....."


The facility failed to follow its own policy for obtaining informed consents prior to procedures.

Based on record review and interview, the facility failed to protect the patient's right to privacy in 1 (Patient #51) of 3 patients reviewed.

The facility failed to ensure that patients have physical privacy to the extent consistent with their care needs during personal hygiene activities (e.g., toileting, bathing, dressing), during medical/nursing treatments, and when requested as appropriate.

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


Findings include:



A review of medical records was conducted on 11/21/19 after 9:30 a.m. in the administrative offices. The findings were as follows:


Patient # 51

Review of the patient #51's medical record revealed he was admitted to the outpatient day surgery at 6:47 a.m. on 10/24/2019. Documentation revealed the patient's representative was listed as "Friend."

Review of nursing documentation from 10/24/2019 revealed an entry where the nurse stated: "Patient arrived to unit at 0726. Pt able to ambulate to bed independently. CHG bath completed by pt at bedside as per unit protocol."

CHG bath being a chlorohexidine gluconate bath to kill germs.

The above findings were verified by RN # 66 at the time of review.

Review of a document provided by the facility titled "CHG Bath Fact Sheet," revealed the following: Under section titled "Ask Patients These Questions Before Giving CHG Bath: Is the patient allergic or sensitive to lotions, creams, fragrances, perfumes (suntan lotion, aloe, etc.? Does the patient have dry skin, eczema, or naturally sensitive skin? Is the patient light-skinned (i.e. redhead or very blonde hair)? Has the patient shaved at home prior to arriving for surgery? If the patient answers YES to any of these questions, notify RN caring for patient. A site test should be administered. Check or ask patient if there are any areas of skin that are excoriated or red upon arrival to pre-op - Instruct patient to not use cloth on these identified areas; Inform RN so this can be documented on skin man; Pay close attention to folds of skin for example - under breasts, abdomen, axilla. Instruct patient to allow air circulation to these areas to promote complete dry time - under breasts, abdomen, axilla. IMPORTANT TO REMEMBER: Use laminated sheet for educating patient. Remind patient: 1. Wipes have an exfoliative nature so educate patient to gently wipe skin. 2. Please always reinforce to patient they will use all six wipes. 3. Not to use above jawline, on face, genital or rectal area."

Further review of the medical record revealed no documentation that the questions listed in the facility document titled "CHG Bath Fact Sheet," were asked or that the nurse educated the patient or caregiver on how to properly perform the "CHG" bath, or that the patient or caregiver's ability or willingness to perform the "CHG" bath was assessed.

An interview with Staff # 44 was conducted on 11/21/19 at 11:45. Staff # 44 was asked about the protocol referred to in the nursing documentation. Staff # 44 stated, there was no actual protocol, or written process regarding patient's using the "CHG Bath," only the document "CHG Bath fact sheet."

A confidential interview was conducted. It was stated when the patient arrived at the facility for his procedure, they were shown to the "intake" area. The nurse arrived at the pre-op area with a gown and four packages of antibacterial cloths to bathe the patient. The nurse pointed to a diagram on the wall that had a man with dots on it. The nurse opened one package to show the wipes and instructed the (friend) to use one wipe per dot on the man on the picture. The nurse told the (friend) to change the patient into the gown after the bath was completed. The question was asked who performed the bath and it was stated she did (the friend). The question was asked if the nurse asked the patient if he gave permission for the (friend) to perform the bath and the answer was "no," nor did the nurse ask if the (friend) was comfortable with performing the bath. The question was asked if the patient made any statements regarding the bath he received. The patient was concerned the bath had not been thorough enough. It was stated the patient, in his usual state, was alert and oriented and able to follow commands, however he had balance issues due to a previous medical condition and would not have been able to perform the bath on this day as the patient was very nervous due to the procedure he was to have.

The question was asked if the staff knew the (friend) was not a family member or primary caregiver and it was stated the patient told them when he was admitted. The question was asked what duties did the (friend) perform for the patient. It was stated the (friend) prepared meals, washed clothes, cleaned the patient's home, took him to doctor appointments and grocery shopped as needed. The question was asked if the (friend) performed any personal care needs for the patient and it was stated no he can usually performed those himself.

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


A. follow the patient's dialysis prescription by using the ordered BFR (Blood Flow Rate) in 3 (#5, #9, and #10) of 5 of the hemodialysis records reviewed. Patients' #5, #9, and #10 record showed treatments where the BFR (Blood Flow Rate) did not follow the patient's dialysis prescription written by the nephrologist.


B. ensure that when facility staff members made a mistake on the inpatient portable RO machine total chlorine log that the correction to the document was done per the facility policy.

C. ensure that that all acid jugs were labeled and that the labels were the same. Some 2K and 3K jugs were labeled with colored tape, large block labels on the front of the jugs, and some had small labels.


D. ensure the pick-up tubes (wands) were in containers that was labeled clean and a container labeled for dirty.

E. ensure that acid jugs were stored with caps and not the pick-up tubes (wands). Also, there was no log documenting when the acid wands were rinsed.

F. ensure dialysis staff were maintaining a clean and sanitary environment for the acute dialysis patient.


Findings included:

A. A review of Patient #5's record revealed that the Registered Nurse did not follow the patient's dialysis prescription by using the ordered BFR (Blood Flow Rate). There was 1 of 5 treatments where the BFR (Blood Flow Rate) was ran at 300 and did not follow the patient's dialysis prescription as written by the nephrologist. The dialysis prescription for the BFR was to be ran at 350.

A review of Patient #9's record revealed that the Registered Nurse did not follow the patient's dialysis prescription by using the ordered BFR (Blood Flow Rate). There was 1 of 6 treatments where the BFR (Blood Flow Rate) was ran at 300 and did not follow the patient's dialysis prescription as written by the nephrologist. The dialysis prescription for the BFR was to be ran at 350.

A review of Patient #10's record revealed that the Registered nurse did not follow the patient's dialysis prescription by using the ordered BFR (Blood Flow Rate). There was 1 of 6 treatments where the BFR (Blood Flow Rate) was ran at 350 and did not follow the patient's dialysis prescription as written by the nephrologist. The dialysis prescription for the BFR was to be ran at 400.


An interview with Staff #1 on 11/19/18 at 10:00 AM confirmed the BFR (Blood Flow Rate) was not ran per the physician dialysis prescription.

B. A review of the document titled, "Inpatient portable RO machine total chlorine log" had several write overs on the log. The entries were totally obliterated and marked over several times.

A review of the facility's policy titled, "Medical record documentation" revealed the following:

"When an error is made in a handwritten medical record entry, the information may not be obliterated or otherwise altered by blacking out the entry with a marker, using white out, writing over the entry, etc. If the error is made when making an entry, draw a single line through the error only, leaving the remainder of the entry documented. If an error is noted after the entry is
completed, the following procedure should be used:

1. Draw a single line through entry. The inaccurate information should still be legible.
2. Write "error" near the note.
3. Enter the current date and time of the new entry.
4. Document the correct information.
5. Sign the entry."


An interview with Staff #1 on 11/19/19 at 11:45 AM confirmed the above findings and that the facility policy was not followed.

C. During a tour of the acute dialysis unit on 11/19/19, it was observed that 2K and 3K acid jugs were labeled 3 different ways. There were 2 jugs with no labels. Some of the acid jugs were labeled with green or red tape around the handle of the acid jugs; which indicated it was 2K or 3K. Another set of the acid jugs were labeled with big block labeling with a 2K or 3K. Some of the labels were small with the "Globally Harmonized system, formally Hazard materials identification system." There was no consistency in the labeling of the acid jugs.

An interview with Staff #24 on 11/19/219 at 11:00 AM confirmed the above findings.

D. During a tour of the acute dialysis unit on the morning of 11/19/19, it was observed that pick-up wands (Bicarb) were being stored in clear plastic containers. There was no label to indicate whether the wands were clean or dirty. The container was plastic and splattered with a white substance.

An interview with Staff #24 on 11/19/219 at 11:00 AM confirmed the above findings.

E. During a tour of the acute dialysis unit on the morning of 11/19/19, it was observed that acid jugs were stored with the pick-up wands. There were no caps for the jugs in the facility. Also, there was no process for rinsing the wands or cleaning of the acid containers. Using pick-ups for caps had the likelihood to contaminate the acid jugs.


A review of the facility's policy titled, "Acid Concentrate Storage and Handling" revealed the following:

"Every 30 days. the reusable concentrate container must be cleaned:

o Discard any remaining concentrate.
o Thoroughly rinse inside and outside of container with reverse osmosis (RO) or deionized (Dl) water.
* Inspect for foreign materials.
* Place on a shelf inverted to allow to dry
o Each container will be assigned and labeled with a permanent
machine identification number to facilitate the tracking of containers.
o Containers will be stored capped to prevent accumulation of dust, dirt or other contaminants.
o Containers. wands and caps that are stored will be rinsed, allowed to air dry and stored in a manner that will prevent accumulation of dust, dirt or other contaminants.
o In the store room. prior to taking container to patient station. cap must be removed, and wand must be inserted. Cap must remain in store room.
o Post treatment with wand in place, externally disinfect the container.
o Return container to store room, remove wands and cap container.
o Rinse wands and allow to dry."

An interview with Staff #24 on 11/19/19 at 11:45 AM confirmed the above findings and that the facility policy was not followed.


F. During a tour of the acute dialysis unit and the storage area on the afternoon of 11/19/19 observed the following infection control issues:

Acute Dialysis unit:

*Loose linen was in the dirty laundry cart not bagged.

*Rusty faucet at the clean sink where the tri station was located.

*Dialysis chair arms did not open for cleaning in the event of a blood spill on the chair.

*Shelves in the storage room dusty and dirty.

*Wall in the storage area had large piece of plaster missing.

*Rusted racks in the storage rooms where supplies were stored.

*Dirty dusty drawers on the in-center treatment floor and in the nurse's station.

* Cart in front of the isolation room was rusted and dirty.

* Infusion pump was stored on top of the dialysis machine.

* Floor of the dialysis unit was worn down to cement.

* IV poles were coverd in a white splatter substance and had the appearance of being unclean.

*Acid jugs dirty and not capped allowing dirt and debris to fall into jugs.

*No acid wand and jug cleaning log.

*2 acid jugs with no labels.

*Staff #8 stocking patient supplies on treatment floor from cardboard boxes.

*Staff #12 wearing mask under her chin and not changing mask between patients.

*Staff #11 wearing the same mask between multiple patients and it was not covering her nose.

*Staff #9 was observed wearing the same pair of gloves going from patient to machine and back to the patient without changing and washing his hands.

An interview with Staff #3 on 11/19/2019 at 9:30 AM confirmed the above findings.

Based on observation, interview, and review of documents, the facility failed to establish and implement an abuse protection program that included the State mandated education and training for staff that provided mental health care in a hospital. The Behavioral Health Center (BHC) of the hospital did not provide eight hours of face-to-face training covering specific topics of Abuse, Neglect, Unprofessional and Unethical Conduct to the staff.

This deficient practice has the potential for harm to all patients admitted to the BHC.

Findings included:

On 11-20-2019, personnel files were reviewed. During a review of required training, no evidence of 8 hours of face-to-face training covering Abuse and Neglect was found. Staff #85 had "Team Member Education Workbook Renewal Form" dated 10-19-2019 in his training file. The form contained the following instructions:
"Please check the items that have successfully completed as required for annual renewal:"
No items were checked, including the block for Abuse, Neglect, Illegal, Unprofessional and Unethical Conduct in Healthcare Facilities." The form was signed by RN Staff #95, Staff Development.

Interview was conducted with RN Staff #95 on the morning of 11-20-2019. RN Staff #95 explained that the employees were given a workbook upon hire to complete self-study and completed quizzes based on the self-study. Annually the employees were given a self-study packet with a quiz that covered the workbook. The Education Renewal Packet Post-Test consisted of a 32-question True/False quiz. The last page of the packet contained an Employee Self-Check Scoring Key with the following instructions to the employee:

"Use this to self-check your answers. If you find that your answer is incorrect, go back and reference the workbook for understanding. If you fail to find the explanation needed, please ask your education coordinator for further assistance in understanding the answer."

The 32-question quiz only contained 4 True/False questions about Abuse and Neglect. Review of the workbook showed that less than 2 pages were used to cover Abuse and Neglect.

RN Staff #95 stated that if an employee no longer had their workbook, they could request a new one. However, Staff #95 confirmed that a workbook and understanding of the material in the workbook was not required to complete the quizzes and obtain a passing grade as the scores were provided in the workbook packet provided to the employee.

When asked, RN Staff #95 confirmed that she was not aware that the State required 8 hours of annual face-to-face in-service training covering specific topics of Abuse, Neglect, Unprofessional and Unethical Conduct for staff that provided mental health care in hospitals. RN Staff #95 confirmed that there was no such training program developed and implemented in the Behavioral Health unit of the hospital.

UT Health Tyler Policy Code: 1600.203; Subject: BHC/Patient Abuse and Neglect was reviewed. References cited at the end of the policy include "CMS CoP: 482.13(c)(3) Tag A-0145.

However, review of the Definitions following the cited reference for "CMS CoP: 482.13(c)(3) Tag A-0145" revealed that definition for Neglect did not include the definition as provided in the cited reference. The definition for Neglect in the policy was "The absence of minimal services or resources to meet basic needs such as withholding or inadequately providing a quality standard of medical care, food and hydration, clothing, hygiene, and safe and supervised environment." The definition provided by the cited reference was, "Neglect, for the purpose of this requirement, is considered a form of abuse and is defined at the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness."

Based on chart reviews, interviews, and policy and procedures reviews the facility failed to follow their own policy and procedure administering chemical restraints in 1 (#94,80, and 81) of 3 (#94,80, and 81) patient charts reviewed.

Nursing failed to document the psychotropic medication used for an aggressive behavior as a chemical
restraint/emergency behavioral medication. There was no documented face to face found. There was no documentation found of patient's response to the medication, or nursing assessments concerning the chemical restraint administration. There was no found vital signs in the chart in 1 (#94, 80, and 81) of 3 (#94,80, and 81) patient charts reviewed.

Nursing failed to address the patient's chemical restraint in the patients care plan in 1 (#94, 80, and 81) of 3(#94,80, and 81) patient charts reviewed.

Patient #94
Review of patient #94's revealed he was a 61 y/o male admitted into the hospital on 8/12/19 at 9:30am. The patient had been found on the street with altered mental status.

Review of Patient #94's physician orders revealed an order, dated 8/14/19 at 3:10AM, for Geodon 10mg IM one time only. There was no reason noted on the physician order for the administration of a psychotropic drug.
Review of the nurse's clinical note on 8/14/19 at 3:09am stated, "____ (Patient #94) is observed to be kicking at bedrails and screaming profanities. Pt is aggressive to nursing staff despite continual attempts to reorient pt and calm him. MD paged, and one-time order received for Geodon." Review of the Medication Administration record(MAR) the RN administered the medication in the left deltoid.

The nurse had administered a chemical restraint due to aggressive behavior. There was no documented face to face found. There was no documentation found of patient's response to the medication, or nursing assessments concerning the chemical restraint administration. There was no found vital signs in the chart. There was no mention of the patient's chemical restraint in the patients care plan.



After reviewing Emergency Room charts an interview was conducted with Staff # 64 RN and #77 RN on 11/21/19 in the afternoon. Staff #64 stated that patients receiving psychotropic medications IM/IV for behavioral issues were not always being assessed as if they had received a chemical restraint. Staff #64 and 77 confirmed the chemical restraint protocol were not always being followed. Staff #64 stated that the policy and procedures were being updated and the nursing staff needed education again on chemical restraints used in the ER and hospital wide.

Review of the facility's policy and procedures Restraint and Seclusion, use of Policy # 61078 stated,
"B) Initial orders
1.) Requires an order by a Physician and allows an RN to place the patient in restraint emergently and then call for an order. All telephone orders must be personally signed, dated and timed within 24 hours of the time the order was originally issued.
3.) The Care Plan will be initiated and modified as needed."
C) Orders for Restraint or Seclusion in a Behavioral Emergency use cannot be written for a time period that exceeds the following: o 4 hrs for > 18 years old o 2 hrs for 9 - 17 years old o 1 hr for < 9 years old o Personal restraint holds have a maximum time limit of 15 minutes total. o There is no time limit for a chemical restraint in that it is a single "STAT" dose (orally, 1M or IV). However, the nurse will document every 15 minutes those applicable elements (monitoring form) for up to an hour following the administration or longer if clinically indicated to ensure stability."

Patient #80
Review of Patient #80's chart revealed he was a 13 y/o male admitted to the behavioral health unit (BHU) for mood disorder on 10/10/19 at 6:45pm. Review of the verbal physician orders revealed a restraint order for a physical hold to restraint chair and chemical restraint. The nurse documented the reason on the order was for banging on the door, attempting to breakdown door, breaking arm off chair, hitting and kicking. Medication order stated, "Thorazine 100mg IM and Ativan 2 mg IM stat."

Review of patient #80's chart revealed there was no found face to face in the chart. The nurse observations were found documented on a "restraint/Seclusion Monitoring Log." The log showed the following:

7:32pm-The patient was placed in a physical hold. The nurse had checked on the log, that the patient was offered food and fluids, while holding him, during an active behavioral emergency. The nurse documented the patient was threatening/yelling, combative, beating door, crying, and hitting/kicking.
7:33pm-The patient was placed in a restraint chair. Hygiene was checked. The nurse documented the patient was threatening/yelling, combative, and crying.
7:39pm- The patient was administered a chemical restraint. The patient had only been in the chair for 6 minutes and had not been allowed time to decompress and work through his emotions before administering the chemical restraint. The nurse documented the patient was threatening/yelling and crying. The patient had calmed down since the 7:32pm documentation.
7:50PM- The patient was assessed for release of the restraint chair. The nurse documented he was mumbling incoherently and sitting. There was no documentation of aggressive behavior, but the patient was not released.
8:00pm-The patient was released from the restraint chair. The nurse documented that he was sitting, quiet, and sleeping.
8:05pm- The nurse documented that a face to face was performed but there was no found evidence in the chart. Staff #55 confirmed there was no face to face found in the chart. The nurse documented the patient was sitting and sleeping. There was no documentation that the child was taken to his room and out of the restraint chair.
8:38pm- Nurse documented the patient was sleeping.

Review of the log stated the RN to assess every 30 minutes but the policy and procedure for restraints and seclusion stated every 15 minutes for 1 hour. The nurse failed to monitor the patient for 33 minutes from 8:05pm to 8:38pm.
Review of the care plan revealed there was no documentation of the use of restraints or the restraint process.

Patient #81
Review of Patient #81's chart revealed the patient was admitted to the BHU on 7/12/19 at 1:07pm with a diagnosis of psychosis and aggression. Review of the nurses notes dated 7/13/19 revealed the patient was "slammed her fist on the desk and got in another patients face and began challenging her." The physician was called and an order for "Thorazine 100mg IM and Ativan 2 mg IM given one time only at 1:48am in the left gluteal."

Review of Patient # 81's restraint and seclusion monitoring log were found to have RN observation at 1:48AM, 1:50AM, and 2:30AM. The nurse failed to follow the policy and procedure to assess the patient for every 15 minutes for one hour.

Review of the Patient #81's nurses notes revealed the patient was awake at 11:20am on 7/13/19 and was throwing food at patients." Pt continued to argue with peer and he began to threaten her back and posturing like he was going to hit her." The nurse documented in her notes that the physician was called, and a verbal order was given for Thorazine 100mg IM and Ativan 2 mg IM was given and administered at 11:30am. "Pt refused to lie down and let the medication work and came back up to the day area demanding another food tray .... Started banging the food cart and knocking the monitor this nurse was typing on and was unable to redirect her." The patient was then placed in seclusion for 45 minutes.

Review of Patient #81's verbal physician order for restraint and seclusion revealed type of restraint ordered was for a physical hold to Seclusion and a chemical restraint. There were no orders written for the Thorazine 100mg IM and Ativan 2 mg IM. The order was dated 7-13-19 at 12:45pm. 1 hour and 15 minutes after the patient was medicated. There was no face to face documentation found or any nursing assessments, vital signs or monitoring log.

Based on chart reviews and interviews the facility failed to ensure the patients receiving restraints were not seen face to face within 1 hour after the initiation of the intervention by a physician or RN who has been trained in accordance with the requirements specified in paragraph (f) of this section in 2 (81 and 94) of 3(80,81 and 94) charts reviewed.

Patient #81
Review of Patient #81's chart revealed the patient was admitted to the BHU on 7/12/19 at 1:07pm with a diagnosis of psychosis and aggression. Review of the nurses notes dated 7/13/19 revealed the patient was "slammed her fist on the desk and got in another patients face and began challenging her." The physician was called and an order for "Thorazine 100mg IM and Ativan 2 mg IM given one time only at 1:48am in the left gluteal."

Review of Patient # 81's restraint and seclusion monitoring log were found to have RN observation at 1:48AM, 1:50AM, and 2:30AM. The nurse failed to follow the policy and procedure to assess the patient for every 15 minutes for one hour.

Review of the Patient #81's nurses notes revealed the patient was awake at 11:20am on 7/13/19 and was throwing food at patients." Pt continued to argue with peer and he began to threaten her back and posturing like he was going to hit her." The nurse documented in her notes that the physician was called, and a verbal order was given for Thorazine 100mg IM and Ativan 2 mg IM was given and administered at 11:30am. "Pt refused to lie down and let the medication work and came back up to the day area demanding another food tray .... Started banging the food cart and knocking the monitor this nurse was typing on and was unable to redirect her." The patient was then placed in seclusion for 45 minutes.

Review of Patient #81's verbal physician order for restraint and seclusion revealed type of restraint ordered was for a physical hold to Seclusion and a chemical restraint. There were no orders written for the Thorazine 100mg IM and Ativan 2 mg IM. The order was dated 7-13-19 at 12:45pm. 1 hour and 15 minutes after the patient was medicated. There was no face to face documentation found or any nursing assessments, vital signs or monitoring log.


Patient #94
Review of patient #94's revealed he was a 61 y/o male admitted into the hospital on 8/12/19 at 9:30am. The patient had been found on the street with altered mental status.

Review of Patient #94's physician orders revealed an order, dated 8/14/19 at 3:10AM, for Geodon 10mg IM one time only. There was no reason noted on the physician order for the administration of a psychotropic drug.
Review of the nurse's clinical note on 8/14/19 at 3:09am stated, "____ (Patient #94) is observed to be kicking at bedrails and screaming profanities. Pt is aggressive to nursing staff despite continual attempts to reorient pt and calm him. MD paged, and one-time order received for Geodon." Review of the Medication Administration record(MAR) the RN administered the medication in the left deltoid.

The nurse had administered a chemical restraint due to aggressive behavior. There was no documented face to face found. There was no documentation found of patient's response to the medication, or nursing assessments concerning the chemical restraint administration. There was no found vital signs in the chart. There was no mention of the patient's chemical restraint in the patients care plan.

Based on interview and record review, the Governing body failed to ensure the Quality department involved all services. The facility failed to ensure 4 out of 23 contracted services that were reviewed had individualized performance indicators in place.


This deficient practice had the likelihood to cause harm to all patients who received these services.


Findings include:


Review of facility contracts revealed the following did not have performance indicators:

Southwestern Cerebral Circulatory Dynamics provided transcranial Doppler services
Physical, Occupational and Speech therapy- 9 agreements were provided for these services.
Ear and Hearing PA- provided newborn hearing screening
Neurodiagnostic services provided intra-operative neurophysiological monitoring


During an interview on 11/21/2019 after 8:30 a.m., Staff #12 confirmed the contracts listed were not being taken through quality and did not have performance indicators.



Review of the "Quality, Experience and Patient Safety 2019 Improvement Plan" revealed the following:
"...UTHET uses an approach to improving clinical and service quality that is based on the UTHET Operating Model and includes three key processes: measurement, analysis, and improvement. Patient care and service processes and outcomes are measured through the use of quality indicators and date collection techniques. Analysis of collected data is used to determine levels of performance and quantify variation in processes and outcomes ..."

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

A) ensure that nursing staff who were administering moderate sedation to patients had training and current competencies to administer sedation medications in 1(#38) of 3 Staff records reviewed. Also, there were 3 (#39, #50, and #111) of 7 staff members that did not have current job descriptions for the job that the employee was specifically performing. Further review of the personnel files indicated that 3 (#60, #61, and #62) of 7 nursing staff did not have the required and specific competencies for the current position that they were performing.

B) ensure that personnel files included enough documentation to assure that staff assigned to the Behavioral Health unit had the education, training, and experience necessary to provide nursing care that would meet the needs of the population served for 2 of 2 (Staff #85 and Staff #86) employee files reviewed.

These deficient practices had the likelihood to cause harm in all patients receiving care in the facility.

Findings for A) included:

A review of the personnel record for Staff #38 on November 22, 2019, after 1:00 PM only contained a test for the moderate sedation training. There was no documentation showing she had taken the competency course required by the facility's policy.


Review of the facility's policy titled, "Moderate sedation" revealed that Moderate sedation was listed as a required competency for all registered nurses administering moderate sedation.

Review of the facility policy titled, "Moderate Sedation for elective procedures" revealed the following:

"Competency related to administration of sedation must include the following:

(a) Advanced Cardiac Life Support (ACLS) and/or Pediatric Advanced Life Support (PALS) or Emergency Nursing Pediatric Course (ENPC) depending on patient population.
(b) Be familiar with this Moderate Sedation Policy
(c) Successfully complete annual competency course on sedation"


A review of the personnel record for Staff #39 on November 22, 2019, after 1:00 PM, contained a job description in her file, but there was no name on the job description to indicate it belonged to staff #39. The 2nd page had signature spot for Supervisor, Department Head and Human Resources, but the signatures were all blank.

A review of the personnel record for Staff #50 on November 22, 2019, after 1:00 PM, contained a job description in his file for when he worked as an emergency room technician. There was no current job description for his present job duties which was in the Digestive Disease Center.


A review of the personnel record for Staff #111 on November 22, 2019, after 1:00 PM, contained a job description in her file for sterile processing. There was no current job description for her present job duties which was in the Digestive Disease Center.

A review of personnel records for Staff #60, #61, and #62 on November 22, 2019, after 1:00 PM, contained no current competencies for the position that they were presently performing.

Staff #60 presently works in preoperative unit in the Ambulatory Surgery Center.

Staff #61 presently works in postoperative unit in the Ambulatory Surgery Center.

Staff #62 presently works as a circulator in the surgery department in the Ambulatory Surgery Center.

An interview with Staff #65 on 11/22/2019 after 1:00 PM confirmed the above findings.




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Findings for B) included:

Review of an employee list identified Staff #85 as a Mental Health Tech II. Review of Staff #85's employee file showed that there was no signed job description in his employee file. A form identified as "Job Description Acknowledgement" had been signed by Staff #85 on 1-9-08, over 11 years ago. The acknowledgement stated he had received a copy of a job description titled "Mental Health Tech." The form did not include a copy of the job description received.

Staff #85's most recent job evaluation had been completed on 6-1-2018. Since that time he had received two Counseling Notices (disciplinary action), one on 8-28-2018 and one on 8-16-2019.

Staff #85 had "Team Member Education Workbook Renewal Form" dated 10-19-2019 in his training file. The form contained the following instructions:

"Please check the items that have successfully completed as required for annual renewal:"

The form contained 32 check boxes that covered the required annual training. No items were checked. The form was signed by RN Staff #95, Staff Development.

Interview was conducted with RN Staff #95 on the morning of 11-20-2019. RN Staff #95 explained that the employees were given a workbook upon hire to complete self-study and completed quizzes based on the self-study. Annually the employees were given a self-study packet with a quizzes. Answers to the quizzes were provided so that the employee could score their own quizzes. The last page of the packet contained an Employee Self-Check Scoring Key with the following instructions to the employee:

"Use this to self-check your answers. If you find that your answer is incorrect, go back and reference the workbook for understanding. If you fail to find the explanation needed, please ask your education coordinator for further assistance in understanding the answer."

RN Staff #95 stated that if an employee no longer had their workbook, they could request a new one. However, Staff #95 confirmed that a workbook and understanding of the material in the workbook was not required to complete the quizzes and obtain a passing grade as the scores were provided in the workbook packet provided to the employee.


Interview was conducted with Staff #88 and RN Staff #58. Both confirmed that Staff #85 was providing the patients being voluntarily admitted with copies of their patient rights and explaining those rights to the prospective patients.

Review of Staff #85's training file showed that he had not taken the required Pre-Admission Screening Assessment (PASA) or the required education/credentials per the Texas Administrative Code to provide patients seeking voluntary admission with their patient rights. Staff #88 and RN Staff #58 both confirmed this.

Review of Staff #86's file contained similar findings. There was no signed job description, only a Job Description Acknowledgement for the position of a Mental Health Tech I from 1-04-2008. The last annual evaluation was from 9-15-2017. The file contained 2 Counseling Notices, (disciplinary action), dated 11-29-2017 and 7-16-2018. No current annual training was found in her training file.

Based on the review of the employee file, the surveyor could not determine what the required duties were for Staff #85 and #86, what education and training was required for those positions, and if Staff #85 and Staff #86 were qualified to perform the duties of those positions.

Based on observation, review of records, and interview, the facility failed to ensure nursing staff followed physician orders in the initiation of 1 (Fentanyl) of 2 titratable medications reviewed for Patient #56.



Findings included:

Patient #56 was observed to be receiving the pain medication, Fentanyl, through a continuous intravenous (IV) infusion on the morning of 11-21-2019.

Review of the physician order for the medication in the electronic medical record was as follows:

"Fentanyl 2000 mcg (microgram) in NS (normal saline) intravenous; Starting dose: 25mcg/hr (micrograms per hour) @titratemL/Hour; Titrate to Ramsey Scale of 2; Max = 200 mcg/hr"

RN Staff #57 was interviewed on the morning of 11-21-2019. RN Staff #57 explained that the nurse assessed the patient using criteria from the Ramsey Scale. A score of 2 showed the patient was lightly sedated.

Review of the initiation of the order showed that the medication had been started at a rate of 50 mcg/hr on the previous shift. RN Staff #57 reviewed the nursing notes, orders, and flow sheet to see if there was clarification of why the medication was started at double the ordered rate. No information was found in the electronic record that explained why the nurse starting the medication did not follow the physician's order.

Based on interview, observation and record review, the facility failed to have a policy to instruct nursing staff on how to administer pre-printed orders for biological's such as total parenteral nutrition (TPN) 3 of 3 patients (#38, #39 and #40).


This deficient practice had the likelihood to effect all patients of the facility who received TPN.



Findings included


Patient #38

On 11/20/2019 in the afternoon, the electronic medical records (MR) for patients (Pt/pt) #38,#39, and #40 were reviewed with the assistance of staff #66.

Pt #38 was admitted 10/28/2019. Received an order for TPN. The preprinted order read "Give bag 1 over a 24 hour period". "Give 2-3-4 in 24 hours".

Interview with Staff #66 explained it was "understood that each bag of TPN would run separately over a 24 hour period. Staff #66 confirmed the order was confusing.



Patient #39

Pt #39 was admitted 9/30/2019. On 10/4/2019 TPN orders were entered by the physician on the MR to run over 18 hours. Review of the Pharmacy record read, "deliver over 24 hours". A request for the facility's titration policy revealed the facility had no approved titration policy for the nursing staff to refer to when physician orders did no match pharmacy orders.


Patient #40

Pt #40 received 2 separate bags of TPN. The physician orders were not clear as to the time frame the TPN was to be administered. The facility had no approved titration policy for nursing staff to refer to.

On 10/29/2019, an interview with staff #44, confirmed the facility's lack of a titration policy had been identified. The proposed policy had not yet gone to Governing Body/Medical Staff for approval. The facility had no policy instructing nursing or physician staff on approved IV titration rates.

Based on document review and interview the facility failed to ensure the content of the verbal order for sedation medications was clearly communicated and documented between the Registered Nurse and the Physician in 6 (Patient #33, #34, #76, #77, #78, and #79) of 6 medical records reviewed.


This deficient practice had the likelihood to cause harm to all patients receiving moderate sedation in the Pain Management Clinic if the verbal order for sedation medications was not complete. Without complete documentation of verbal orders with date, time, dosage, and route the Registered Nurse could possibly give the wrong medication or dose causing serious harm or even death to a patient.


Findings include:


PATIENT #33

Patient #33 was a 66-year-old female admitted to the Pain Management Department for an outpatient procedure on 11/20/2019.

A review of the document titled, "SEDATION/VITAL SIGNS/ORDER RECORD" revealed the following:

" ...Date 20-Nov-19 IV Medications V.O. From Dr. and Repeated: Staff #114 ..."

The Registered Nurse documented medications given as follows:

" ...MEDICATIONS ADMISISTERED: Versed IV 2mg/14:56 ..."

Staff #114 did not document an attestation statement confirming the sedation medication given during the procedure was verbally ordered or sign a completed verbal order taken by the Registered Nurse. Further review of the medical record did not reveal a written order by Staff #114 for the medication given by the Registered Nurse during the procedure. Also, the Registered Nurse failed to document the total amount given to Patient #33 during the procedure.




PATIENT #34

Patient #34 was an 81-year-old male admitted to the Pain Management Department for an outpatient procedure on 11/20/2019.

A review of the document titled, "SEDATION/VITAL SIGNS/ORDER RECORD" revealed the following:

" ...Date 20-Nov-19 IV Medications V.O. From Dr. and Repeated: Staff #114 ..."

The Registered Nurse documented medications given as follows:

" ...MEDICATIONS ADMISISTERED: Versed IV 1mg/14:17 and Fentanyl IV 50mcg/14:17 ..."

Staff #114 did not document an attestation statement confirming the sedation medication given during the procedure was verbally ordered or sign a completed verbal order taken by the Registered Nurse. Further review of the medical record did not reveal a written order by Staff #114 for the medications given by the Registered Nurse during the procedure.

The Registered Nurse failed to document a complete verbal order for the sedation medications given during the procedure.



PATIENT #76

Patient #76 was a 68-year-old male admitted to the Pain Management Department for an outpatient procedure on 11/20/2019.

A review of the document titled, "SEDATION/VITAL SIGNS/ORDER RECORD" revealed the following:

" ...Date 20-Nov-19 IV Medications V.O. From Dr. and Repeated: Staff #114 ..."

The Registered Nurse documented medications given as follows:

" ...MEDICATIONS ADMISISTERED: Versed IV 2mg/16:10 and Fentanyl IV 50mcg/16:10 and Fentanyl 50mcg/16:20 ..."

Staff #114 did not document an attestation statement confirming the sedation medication given during the procedure was verbally ordered or sign a completed verbal order taken by the Registered Nurse. Further review of the medical record did not reveal a written order by Staff #114 for the medications given by the Registered Nurse during the procedure.

The Registered Nurse failed to document a complete verbal order for the sedation medications given during the procedure.



PATIENT #77

Patient #77 was a 31-year-old female admitted to the Pain Management Department for an outpatient procedure on 11/20/2019.

A review of the document titled, "SEDATION/VITAL SIGNS/ORDER RECORD" revealed the following:

" ...Date 20-Nov-19 IV Medications V.O. From Dr. and Repeated: Staff #99 ..."

The Registered Nurse documented medications given as follows:

" ...MEDICATIONS ADMISISTERED: Versed IV 2mg/14:30 and Fentanyl IV 100mcg/14:30 ..."

Staff #99 did not document an attestation statement confirming the sedation medication given during the procedure was verbally ordered or sign a completed verbal order taken by the Registered Nurse. Further review of the medical record did not reveal a written order by Staff #99 for the medications given by the Registered Nurse during the procedure.

The Registered Nurse failed to document a complete verbal order for the sedation medications given during the procedure.




PATIENT #78

Patient #78 was a 62-year-old female admitted to the Pain Management Department for an outpatient procedure on 11/20/2019.

A review of the document titled, "SEDATION/VITAL SIGNS/ORDER RECORD" revealed the following:

" ...Date 20-Nov-19 IV Medications V.O. From Dr. and Repeated: Staff #99 ..."

The Registered Nurse documented medications given as follows:

" ...MEDICATIONS ADMISISTERED: Versed IV 2mg/14:46 and 1mg/14:55. Fentanyl IV 50mcg/14:46 ..."

Staff #99 did not document an attestation statement confirming the sedation medication given during the procedure was verbally ordered or sign a completed verbal order taken by the Registered Nurse. Further review of the medical record did not reveal a written order by Staff #99 for the medications given by the Registered Nurse during the procedure.

The Registered Nurse failed to document a complete verbal order for the sedation medications given during the procedure.




PATIENT #79

Patient #79 was a 56-year-old male admitted to the Pain Management Department for an outpatient procedure on 11/20/2019.

A review of the document titled, "SEDATION/VITAL SIGNS/ORDER RECORD" revealed the following:

" ...Date 20-Nov-19 IV Medications V.O. From Dr. and Repeated: Staff #99 ..."

The Registered Nurse documented medications given as follows:

" ...MEDICATIONS ADMISISTERED: Versed IV 2mg/15:19 and Fentanyl IV 50mcg/15:19 ..."

Staff #99 did not document an attestation statement confirming the sedation medication given during the procedure was verbally ordered or sign a completed verbal order taken by the Registered Nurse. Further review of the medical record did not reveal a written order by Staff #99 for the medications given by the Registered Nurse during the procedure.

The Registered Nurse failed to document a complete verbal order for the sedation medications given during the procedure.



An interview was conducted with Staff #37 on 11/22/2019 after 9:00 AM. Staff #37 was asked how do you confirm the medications given by the Registered Nurse during the procedure were ordered by the physician. Staff #37 replied, "The Registered Nurse documents the medications given to the patient on the record." Staff #37 was asked to locate the verbal order written by the nurse for the medications given within Patient #34's medical record. Staff #37 stated, "There is no specific verbal order written by the nurse. I see what you mean now. We will have to be more specific on the verbal orders for the nurses to give the medications."


Staff #37 and #63 confirmed the above findings.

Based on observation, interview, and document review the facility failed to provide blood and blood transfusion products according to their written policy, and failed to establish a method for periodically observing the patient after the initiation of the transfusion in 3 of 3 patients (#40, #41 and #115) who received blood transfusions or blood transfusions components.

This deficient practice had the likelihood to effect all patients of the facility.


Findings included.


On 11/19/2019 patient #118 was observed at the initiation of receiving a transfusion of Fresh Frozen Platelets, (FFP). The Registered Nurse (RN) #18, was observed taking the first set of vitals signs prior to initiation of the FFP. The second set of vitals signs were taken 15 minutes after the insertion of the new intravenous line, designated for the FFP, was spiked and hung. The FFP were not warmed. The platelets were sluggish and RN #18 used 10 minutes for manipulation of the line and positioning of the patients arm, where the insertion sight was, to gain consistent flow of the platelets. A rate was not checked to establish the initial rate. The RN appeared satisfied, that the line where the FFP was infusing, was open and with no occlusion.

The second set of vitals signs was taken and recorded with only 5 minutes of actual platelet infusion time. RN #18, and the unit charge nurse, instructed the patient and her family member to report any nausea, tightness in her chest, increase of temperature and other symptoms of transfusion reaction. RN #18 exited the patient's room. These instructions were witnessed by staff #17 the unit manager and the surveyor, who exited after RN #18.

In the hallway, RN #18 was asked how did she intend to monitor pt #115 and the FFP being infused? She indicated she would be in the close proximity of patient #115. When asked what did she consider "close proximity", she replied she would be out of sight of pt #115, while providing care to her other patients, whose rooms were near pt #115. She indicated she would check in on pt #115. The finale set of vitals signs were recorded at the completion of the infusion.

The unit manager was asked what was the process for evaluation or assessment of the patient during the infusion. The manager confirmed the RN stay in the area of the hallway near the patient during infusion but she likely would be managing patients during the same time and check in on the patient.

A review of the facilities policy for, "Blood/Blood Components Transfusion", follows;
Policy 200.051 effective date 1991

J. 4) Start the transfusion slowly at approximately 2 ml (milliliter liter) per minute for the first 15 minutes.

k. During the first 15 m minutes of the transfusion the nurse will remain in close proximity to be able to observe the patient for catastrophic transfusion reactions such as, hemolysis, anaphylaxis or bacterial contamination and document in the nurse's notes. The nurse should continue periodically observe the patient during the transfusion and for an hour after completion.

After RN #18 exited patient #115, a conversation with staff #17, the manager, confirmed patient #115, who was a chemo patient, appeared very ill and uncomfortable during the initiation of the FFP transfusion. The question was directed to the manger, that why would vey ill patient who already feels sick be tasked with notifying her nurse, if she recognized, she was feeling worse.

If vitals signs were only taken before the transfusion, at the 15 minute infusion point and at completion of the infusion, what was the process for evaluation the patient between those times of pt/nurse interactions? Why would an ill patient be tasked with the responsibility of notifying the RN should delayed transfusion reactions symptoms occur.

RN#17, stated, I understand your point.

There was no process established for "continued periodic observation", of patients receiving blood or blood opponent transfusions. There was no method to determine the safe 2 milliliter rate for the first 15 minutes of the transfusion.

Further review of patient medical records (pt #40 and #41) who received blood or blood component transfusions revealed the same form had been used. Vital signs were recorded prior to the infusion, 15 minute into the transfusion and at the completion of the transfusion.

Pt #41 had a sudden elevation in temperature. No harm occurred the RN stopped the transfusion and initiated the proper interventions. Documentation did not indicate at what time during the infusion the reaction was identified.

Based on document review and interview the facility failed to ensure a complete and/or updated History and Physical was in the medical record prior to the start of a procedure in the Pain Management Clinic in 4 (Patient #34, #76, #78, and #79) of 6 medical records reviewed.

This deficient practice had the likelihood to cause harm to all patients undergoing procedures in the Pain Management Clinic by not attesting the history and physical was up to date with the patients current medical conditions.

Findings include:


PATIENT #34

A review of Patient #34's medical record revealed Staff #114 did not update the history and physical (H&P) prior to the start of the procedure. The signed H&P by Staff #114 was dated 10/22/2019 2:16 PM.

A review of the document titled, "PAIN MANAGEMENT CENTER PRE-SEDATION HISTORY AND PHYSICAL" was as follows:

" ...H&P-Unchanged from full H&P on chart (completed within 30 days prior to procedure)

H&P-H&P with changes as documented below ..."

Staff #114 failed to document if there were any changes to Patient #34's medical history prior to the procedure on 11/20/2019.

A review of the H&P dated 10/22/2019 did not indicate Patient #34 had a medical emergency prior to the procedure.




PATIENT #76

A review of Patient #76's medical record revealed Staff #114 did not update the history and physical prior to the start of the procedure. The signed H&P by Staff #114 was dated 10/29/2019 10:18 AM.

A review of the document titled, "PAIN MANAGEMENT CENTER PRE-SEDATION HISTORY AND PHYSICAL" was as follows:

" ...H&P-Unchanged from full H&P on chart (completed within 30 days prior to procedure)

H&P-H&P with changes as documented below ..."

Staff #114 failed to document if there were any changes to Patient #76's medical history prior to the procedure on 11/20/2019.

A review of the H&P dated 10/29/2019 did not indicate Patient #76 had a medical emergency prior to the procedure.



PATIENT #77

A review of Patient #77's medical record revealed Staff #99 did not document an update to the history and physical prior to the start of the procedure. The signed H&P by Staff #99 was dated 11/19/2019 at 1:39 PM.

A review of the document titled, " ...PAIN MANAGEMENT CENTER PRE-SEDATION HISTORY AND PHYSICAL was as follows:

H&P-Unchanged from full H&P on chart (completed within 30 days prior to procedure)

H&P-H&P with changes as documented below ..."

Staff #99 failed to document if there were any changes to Patient #77's medical history prior to the procedure on 11/20/2019.

A review of the H&P dated 11/19/2019 did not indicate Patient #77 had a medical emergency prior to the procedure.



PATIENT #78

A review of Patient #78's medical record revealed Staff #99 did not update the history and physical prior to the start of the procedure. The signed H&P by Staff #99 was dated 11/13/2019 at 1:04 PM.


A review of the document titled, "PAIN MANAGEMENT CENTER PRE-SEDATION HISTORY AND PHYSICAL" was as follows:

" ...H&P-Unchanged from full H&P on chart (completed within 30 days prior to procedure)

H&P-H&P with changes as documented below ..."

Staff #99 failed to document if there were any changes to Patient #78's medical history prior to the procedure on 11/20/2019.

A review of the H&P dated 11/13/2019 did not indicate Patient #78 had a medical emergency prior to the procedure.


During an interview on 11/22/2019 after 9:00 AM, Staff #37 confirmed the above findings.

Based on document review and interview the facility failed to ensure an informed consent was completed as ordered by the physician in 3 (Patient #33, #34, and #79) of 6 medical records reviewed.



Findings include:



PATIENT #33

Patient #33 is a 66-year-old female admitted for an outpatient procedure to the Pain Management Department on 11/20/2019.

A review of the document titled "Pain Management Outpatient Physician Order Sheet was as follows:

" ...Consent for left C3,4,5,6 Cervical MBB's ..." (Injections for pain into the neck area)

Staff #114 signed and dated the order on 11/20/2019 at 1:27 PM.

A review of the document titled, "DISCLOSURE AND CONSENT MEDICAL AND SURGICAL PROCEDURES PAIN MANAGEMENT" revealed Patient #33 was consented for a "Left Cervical Medial Branch Clocks". There were no documented levels on the informed consent as order by Staff #114.



PATIENT #34

Patient #34 is an 81-year-old male admitted for an outpatient procedure to the Pain Management Department on 11/20/2019.

A review of the document titled "Pain Management Outpatient Physician Order Sheet was as follows:

" ...Consent for left L4-5, L5-S1, TFESI ..." (Injections for pain into the lower back)

Staff #114 signed and dated the order on 11/20/2019 at 1:49 PM.

A review of the document titled, "DISCLOSURE AND CONSENT MEDICAL AND SURGICAL PROCEDURES PAIN MANAGEMENT" revealed Patient #34 was consented for a "Selective Lumbar Epidural Steroid Injection-Left". There were no documented levels on the informed consent as order by Staff #114.



PATIENT #79

Patient #79 is a 56-year-old male admitted for an outpatient procedure to the Pain Management Department on 11/20/2019.

A review of the document titled "Pain Management Outpatient Physician Order Sheet was as follows:

" ...Consent for CMBB B C4-C6 ..." (Injections for pain into the neck area)

Staff #99 signed and dated the order on 11/20/2019 at 3:00 PM.

A review of the document titled, "DISCLOSURE AND CONSENT MEDICAL AND SURGICAL PROCEDURES PAIN MANAGEMENT" revealed Patient #79 was consented for a "Cervical Medial Branch Blocks Bilateral". There were no documented levels on the informed consent as order by Staff #99.


An interview was conducted on 11/22/2019 after 9:00 AM with Staff #37. Staff #37 was asked why there were no specific levels for the spinal injections listed on the informed consent. Staff #37 said, "Well sometimes they have to enter at a different level on the spine to get to where they need to inject the steroids or sometimes they use a catheter to get there." Staff #37 reviewed the Physician Order Sheet with this surveyor and confirmed the physician required specific levels on his order sheet.


Staff #37 and #63 confirmed the above findings.

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


A) ensure 2 of 2 hospital pharmacies, (Main Hospital Pharmacy and Behavioral Health Center Pharmacy) were maintained according to acceptable United States Pharmacopeia (USP) standards. Temperatures were not monitored in medication storage rooms to ensure temperatures were maintained within the drug manufacturers' requirements for storage. The main pharmacy was not maintained in a sanitary manner.

Cross Refer to Tag A0491 for detailed findings for A).

B) ensure that records for scheduled medications were sufficient to trace the movement of the medication from the pharmacy to the patient in 1 procedure area (Pain Management Clinic) of 2 observed. Nursing staff were removing scheduled drugs in bulk from the locked medication storage box without signing for the medication.

C) ensure a process was developed and implemented for the reconciliation of dispensed scheduled drugs, such as fentanyl that was to be administered as a continuous intravenous (IV) infusion, with the nursing administration flow sheet documenting the amount the patient had received along with the record of medication wasted when the medication was completed. This affected all patients receiving scheduled drugs, such as fentanyl, when they were administered as continuous IV infusions through a regular IV pump.

D) ensure a process was developed for the prompt identification, investigation and resolution of discrepancies in scheduled drug counts in 1 of 1 incident reports reviewed that involved missing scheduled drugs. A scheduled drug had been missing for 12 days and had been reported to pharmacy 6 days later, when it was finally discovered to be missing. An investigation had not been initiated by pharmacy.

Cross Refer to Tag A0494 for detailed findings for B), C), and D).

E) ensure a pharmacy process was developed for the dispensing of scheduled drugs for continuous intravenous (IV) infusion through regular IV pumps that provided adequate safety devices to prevent potential drug diversion during the administration process. This deficient practice had the potential to affect all patients receiving scheduled drugs as a continuous IV infusion. Continuous IV infusions of scheduled drugs were found to be easily accessed by unauthorized persons, providing the potential for drug diversion and patients not receiving the medication ordered.

F) ensure pharmacy staff reviewed orders to ensure proper dosage for 1 (Fentanyl) of 2 medication titration order sets (titration of medications is the adjustment of medication dosage based on patient response to the medication). This practice allowed staff without prescriptive authority to determine the dosage and frequency of dosage changes to be made when patients were receiving the medication, Fentanyl, with orders for titration.

Cross Refer to Tag A0500 for detailed findings for E) and F).

G) ensure intravenous fluids were stored securely in the preoperative area of the DDC (Digestive Disease Center). Intravenous fluids were found to be stored in unlocked cabinets where unauthorized persons could potentially access them.

Cross Refer to Tag A0502 for detailed findings for G).

Based on observation and interview, the facility failed to ensure 2 of 2 hospital pharmacies, (Main Hospital Pharmacy and Behavioral Health Center Pharmacy) were maintained according to acceptable United States Pharmacopeia (USP) standards.

This deficient practice placed all patients receiving medications from the pharmacies at risk.

Findings included:

On the morning of 11-20-2019, a tour of the Behavioral Health Center (BHC) pharmacy was made with Staff #90. Staff #90 was asked how temperature was monitored in the pharmacy and the pharmacy medication storage rooms on the units. Staff #90 confirmed that temperature was not monitored and that the pharmacy did not track temperatures to ensure temperatures in medication storage areas were within a predetermined range based on the medications stored. Staff #90 confirmed that over the summer, the air conditioning system had failed and the building had been warmer than normal. Staff #90 confirmed that there were no records available to show that medication stored in the building had not exceeded temperatures recommended by the manufacturer beyond allowable excursion times.

A tour of the main hospital pharmacy was made on 11-21-2019 with Staff #91. During the tour, the pharmacy was observed to have cracked and broken floor tiles leading into the sterile compounding area. Staff #91 confirmed that no work order had been submitted to repair these tiles. There was a visible buildup of dirt in the cracked and broken areas of tiles, as well as in corners and around the door and threshold areas.

The pharmacy was observed to be crowded with limited workspace. Sinks next to workspaces did not have barriers to prevent splash onto the work surfaces next to them. The laminate area behind the sink and along the backsplash was observed to be dirty with build-up along the seams of joined laminate.

The bottom shelf of a refrigerator was observed to have a puddle of liquid with dark matter in it surrounding a center shelf-support. Staff #91 stated he believed that it was a stain. Upon wiping with a white cleaning cloth, it was confirmed to be liquid with dark matter in it and not a stain. Sliding door tracks were observed to have a buildup of dirt and debris. Staff #91 was unable to tell the surveyor when the refrigerators were last cleaned.

Pumps that administer tube feeding solutions to patients and pumps used by patient to self-administer doses of pain medication [Patient Controlled Analgesia (PCA) pumps] were observed on shelves in the back of the pharmacy. A cart with cleaning supplies was observed next to carts with frozen medications that were in the process of thawing.

Interview with Staff #91 at the time of the tour revealed that pumps were picked up by pharmacy staff from soiled utility rooms on the patient floors and brought into the pharmacy for cleaning. They were unwrapped and cleaned on the cart that was beside the carts used for thawing medications and across from refrigerators that medications were stored. Pumps brought in to the pharmacy area had the potential to come from patient rooms who were in isolation due to various infections. This process had to potential for the spread of harmful bacteria, viruses, or other microorganisms that could cause disease throughout the hospital, as medications from the main pharmacy go throughout the hospital.

During interview with Staff #91, Staff #91 confirmed that the main pharmacy and other locations in the hospital where drugs were stored were not being monitored to ensure that medications were being stored within a predetermined range based on the medications stored.

Review of USP 36 Good Storage and Shipping Practices <1079>

"Scope

Good storage and distribution practices apply to all organizations and individuals in any aspect of the storage and distribution of all drug product, including but not limited to the following:
...
Pharmacies including but not limited to retail, compounding, specialty, mail order, hospital, and nursing home pharmacies

...
Storage in Buildings and Facilities

Drug product storage areas are required to maintain the product temperature between the limits as defined on the product label. Buildings and facilities used for the warehousing, storage, and/or holding of drug products should be of adequate size for their intended use. These facilities should be adequate to prevent overcrowding. The building and facility should be designed to control environmental conditions where necessary and should be made of readily or easily cleanable materials. Sanitation and pest control procedures should be written, indicating frequency of cleaning and the materials and methods used. The pest-control program should ensure the prevention of contamination as well as the safe use of pesticides. Records of all cleaning and pest-control activities should be maintained."

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

A) ensure that records for scheduled medications were sufficient to trace the movement of the medication from the pharmacy to the patient in 1 procedure area (Pain Management Clinic) of 2 observed.

B) ensure a process was developed and implemented for the reconciliation of dispensed scheduled drugs, such as fentanyl that was to be administered as a continuous intravenous (IV) infusion, with the nursing administration flow sheet documenting the amount the patient had received along with the record of medication wasted when the medication was completed. This affected all patients receiving scheduled drugs, such as fentanyl, when they were administered as continuous IV infusions through a regular IV pump.


C) ensure a process was developed for the prompt identification, investigation and resolution of discrepancies in scheduled drug counts in 1 of 1 incident reports reviewed that involved missing scheduled drugs.


Findings for A) included:

On the morning of 11-20-2019, the Pain Management clinic was observed to have a locked narcotic box. A count of narcotics in the box showed there were 25 vials of the medication, Fentanyl. There were 10 vials of the medication, Demerol. There was not any of the medication, Versed.

According to the Pain Management Sedation Narcotic Count Sheet there should have been 95 vials of thee medication, Fentanyl. Additional records showed that another 25 vials of Fentanyl had been delivered that morning, for a total of 120 vials that should have been present. The Pain Management Sedation Narcotic Count Sheets showed that there should be 17 vials of Demerol and 45 vials of Versed.

RN Staff #59 and Staff #61 were asked if they could account for the missing medication. RN Staff #59 stated that only nurses that worked in the procedure rooms had keys to the narcotic boxes. He explained that in the morning they removed the narcotics and took them to the procedure rooms they were assigned to and locked them in another box until it was time to administer to the patient. Neither RN Staff #59 or Staff #61 were able to tell me what medications were in which procedure room. RN Staff #59 stated he would have to physically go to each room and do a count to find out where the medications were. There was not a record of who removed the scheduled drugs or where they had taken them. Staff #59 stated at the end of the day nursing staff compare what was returned to the box with patient procedure records to ensure the medications could be accounted for. However, during the period of time between removing the medications in the morning and the final count in the evening, records could not trace the movement of the scheduled medications throughout the department or trace who was responsible for them.

Review of Policy Number: 48380, Title: Medication Administration, Section: Narcotics, "3) Narcotics should be signed for at the time removed from the narcotic box and charted on the MAR/Patient Care Record immediately after administration." showed the facility policy was not being followed.


Findings for B) included:

During observation rounds on the morning of 11-21-2019 in the Trauma Intensive Care Unit (ICU), Patient #56 was observed to have an intravenous (IV) medication for pain, Fentanyl, being administered. RN Staff #57 was the nurse assigned to the patient. During interview, RN Staff #57 explained that narcotic medications administered through a regular IV pump were documented on a flow sheet. When asked if two nurses were required to reconcile what was dispensed with the total amount of medication administered on the flow sheet and documented medications wasted, a process similar to narcotics administered through a patient controlled analgesia (PCA) pump, RN Staff #57 stated they were not.

Interview was conducted with Staff #91 on the afternoon of 11-21-2019. Staff #91 confirmed that there was not a process to reconcile the medication dispensed with the documented amount administered per the nursing flow sheet and the documented waste amount to ensure medication was administered as ordered and not being diverted.


Findings for C) included:

On 11-22-2019, pharmacy incident reports were reviewed with Staff #91 to determine if further action not identified on the reports had been taken. An incident with the scheduled drug, suboxone had been identified and reported on 11-12-2019. The event description was as follows:

"There was a discrepancy in the Pyxis (a machine used for dispensing medications) that was discovered this morning. The discrepancy occurred on 11/06/19. An additional dose of suboxone was removed and misplaced, causing an inventory discrepancy. The whereabouts of the medication is unsure due to the event occurring a week ago. The pharmacy told myself and the charge nurse to go ahead and resolve the discrepancy and complete a trideo. (incident report)"

The report did not contain any further information as to an investigation, follow-up, action taken, or resolution. Interview with Staff #91 confirmed that he is the person in the pharmacy that receives the incident reports. Staff #91 confirmed that he had not taken action to investigate this incident report.

Based on observation, review of records, and interview, the facility failed to

A) ensure a pharmacy process was developed for the dispensing of scheduled drugs for continuous intravenous (IV) infusion through regular IV pumps that provided adequate safety devices to prevent potential drug diversion during the administration process. This deficient practice had the potential to affect all patients receiving scheduled drugs as a continuous IV infusion.

B) ensure pharmacy staff reviewed orders to ensure proper dosage for 1 (Fentanyl) of 2 medication titration order sets (titration of medications is the adjustment of medication dosage based on patient response to the medication).

Findings for A) included:

During observation rounds on the morning of 11-21-2019 in the Trauma Intensive Care Unit (ICU), Patient #56 was observed to have an intravenous (IV) medication for pain, Fentanyl, being administered. The bag of medication was observed to be hanging from an IV pole in the patient's room. The bag was not observed to have any safety device that prevented access to the bag of medication and tubing. The bag was connected to standard tubing. The tubing was run through a standard IV pump that was used to pump the medication into the patient's vein at a controlled and pre-set rate. The pump from the tubing was connected to a catheter that had been placed into a vein in the patient.

The room was observed to have curtains that could be pulled closed to provide patient privacy during patient care.

This set-up had the potential for drug diversion in multiple ways. Once the curtain was pulled, the bag could be removed from the IV pole. The tubing could be disconnected from the bag and medication removed from the access port where the tubing had been connected to the bag. The tubing could be then replaced without detection.

The regular IV tubing had access ports so that medications could be injected or removed. These ports were located above the pump and below the pump. Both access ports could be used to removed medication with a syringe from the medication bag and tubing. If a small amount was removed below the pump, the medication count on the pump would not be affected. If medication was removed from the port above the pump, a compatible fluid could be added to the line to replace the volume of medication removed. This would also result in the pump count not being affected.

During interview with RN #57 and Staff #91, it was discovered that there was not a reconciliation process for the medication dispensed from pharmacy, the medication administered through the pump and documented on the flow sheet, and the medication wasted. (Cross Refer to Tag A0494 for detailed findings)

By not using devices to prevent access to the medication bag and tubing and not reconciling the medication dispensed with the documented amounts of administration on the nursing flow sheet and the waste records, the potential existed for the diversion of patient medication by unauthorized persons.


Review of Policy Number 48380, Medication Administration, showed that the Objective was "To establish guidelines for safe and timely administration of medications." Under the section for Administration and Documentation of Medication, no procedures were found for documenting the administration of narcotics on the nursing flow sheet and reconciling with the physician order for amount dispensed and the waste record. The Narcotics section of the policy stated, "6) Licensed personnel is responsible for returning the narcotic sheet (yellow) to Pharmacy upon completion of narcotic, discontinuation of medication and/or upon discharge of patient. Any narcotic not used will be returned with the yellow sheet within 72 hours of stopping narcotic." Interview with Staff #91 confirmed that the yellow sheet was not used to reconcile the administration of narcotics on the nursing flow sheet with the physician order for amount dispensed and the waste record.

Findings for B) included:

Patient #56 was observed to be receiving the medication, Fentanyl, through a continuous intravenous (IV) infusion on the morning of 11-21-219. Review of the physician order for the medication in the electronic medical record was as follows:

"Fentanyl 2000 mcg (microgram) in NS (normal saline) intravenous; Starting dose: 25mcg/hr (micrograms per hour) @titratemL/Hour; Titrate to Ramsey Scale of 2; Max = 200 mcg/hr"

RN Staff #57 was interviewed on the morning of 11-21-2019. RN Staff #57 explained that the nurse assessed the patient using criteria from the Ramsey Scale. A score of 2 showed the patient was lightly sedated. The patient was receiving 25 mcg/hr at that time. When asked how much RN Staff #57 would adjust the medication if the patient needed more to achieve a score of 2, the nurse stated, "I would probably go up 5 mcg/hr to 30." RN Staff #57 confirmed that the orders provided in the physician's titration order set did not include how much the medication could be increased or decreased by, or how often the increases or decreases could be made to achieve a Ramsey Score of 2. RN Staff #57 confirmed that nurses must use nursing judgement to determine the dosage of medication to give.

Interview was conducted with Staff #91 on 11-22-2019. Staff #91 confirmed that the order set did not contain the correct information for dosage adjustments amounts and time intervals. Staff #91 confirmed that the Ramsey Scale of 2 was to be used as an indication that the dosage needed to be adjusted, and not a substitute for a dosage or frequency of adjustments.

This practice left nursing staff to use nursing judgement to determine the dosage of medication to give and the frequency to increase or decrease the medication. This act was not within a nursing scope of practice.

Review of the Texas Nurse Practice Act was as follows:
"(2) Professional nursing means the performance of an act that requires substantial specialized judgment and skill, the proper performance of which is based on knowledge and application of the principles of biological, physical, and social science as acquired by a completed course in an approved school of professional nursing. The term does not include acts of medical diagnosis or the prescription of therapeutic or corrective measures. Professional nursing involves:
...
(C) the administration of a medication or treatment as ordered by a physician, podiatrist, or dentist;"

Based on observation and interview, the facility failed to ensure intravenous fluids were stored securely in the preoperative area of the DDC (Digestive Disease Center).

This deficient practice had the likelihood to allow unauthorized employees to have access to the intravenous fluids.

Findings include:

During an observation on 11/20/2019 after 2:30 PM, intravenous fluids were found stored in a plastic cabinet with approximately 3 shelves that had a pull-up door with a lock. The lock on the pull-up door was taped and appeared to be broken. The 3 shelves were packed with intravenous fluids. The intravenous fluids were not stored in a secure manner. Anyone passing through the preoperative unit would have access to the intravenous fluids.

Staff #36 confirmed the observations.

Based on observation and interview, the facility failed to follow its own policy regarding storage of contrast media. Contrast materials were left unlocked and accessible to patients and staff in the ERCP (Endoscopic Retrograde Cholangio-Pancreatography) room.

This deficient practice had the likelihood to put all patients at risk for harm due to contrast being left unlocked and able to be tampered with.

Findings included:

On a tour of the ERCP room on 11/20/19 at 2:30 PM found 12 bottles of Isovue-300 in an unlocked cabinet. This practice allowed anyone entering the ERCP room access to the contrast.

A review of the facility's policy titled," Contrast Media" revealed the following:

"POLICY:
In compliance with regulatory agencies, contrast is to be handled in a safe methodical secure fashion.

2) Security:
a) Contrast is stored in a locked space ..."


An interview with Staff #62 on 11/20/19 at 2:30 PM confirmed the above findings.

Based on interview and record review, the facility failed to maintain adequate laboratory services to meet patient needs in 3 of 3 labs reviewed (Main campus, Healthy connections and Off-site Campus). The facility failed to:



A. ensure lab specimens were transported safely. They failed to ensure temperatures were taken while transporting lab specimens.



During an interview on 11/19/2019 after 8:30 a.m., Staff #42 said he was over the lab couriers. Staff #42 said the couriers were keeping the labs in coolers during transportation. The couriers were supposed to take the temperatures prior to putting a lab specimen in the cooler and then every two hours. The room temperatures were supposed to be 15-25 degrees Celsius and the refrigerated temperature was supposed to be 2-8 degrees Celsius. Staff #42 said the 12 midnight to 7 a.m., STAT(immediate) lab couriers were through another contracted service. Staff #42 said he wasn't sure if they were logging their temperatures.

During an interview on 11/20/2019 after 1:40 p.m., Staff #12 provided the following courier sheets and confirmed they were not completed:

Review of lab courier sheets dated 11/11-15/2019 revealed lab being transported, but there was no documentation of temperatures being taken.

Review of a lab courier sheet dated 11/16-17/2019 revealed staff failed to consistently record temperatures prior to placing specimens in coolers and every two hours.


Review of a facility's policy named "TRANSPORT OF SPECIMENS TO THE LABORATORY" dated 12/22/2015 revealed the following:

"Proper transport of specimens to the laboratory is required for optimum growth of microorganisms and to prevent deterioration of all specimen types."


B. ensure the medication assistant that was drawing blood at the Healthy Connections lab was receiving annual competencies.


Review of a competency form for Staff #113 revealed it was dated 08/02/2018.

During an interview on 11/18/2019 after 12:44 p.m., Staff #19 said Staff #113 does almost all of the blood draws. Staff #19 said she did the last competency in 2018 and had not done one since then. When questioned about how often she was supposed to do the competency. Staff #19 said she "don't know".


C. ensure timely patient and physician notification was made after they were notified of potentially contaminated blood products in 2 of 2 cases that were reviewed. Two cases were sent from the blood bank revealing confirmed Hepatitis C donations were potentially administered.

Refer to A tag 0592 for additional information.

Based on interview and record review, the facility failed to ensure timely patient and physician notification was made after they were notified of potentially contaminated blood products in 2 of 2 cases that were reviewed.

This deficient practice had the likelihood to cause harm to all patients who received blood products.


Findings include:




Review of the lab's "NOTIFICATION LETTERS/LOOK BACK" log revealed the following:


The blood bank sent a letter to the facility dated 07/18/2019 revealing a confirmed Hepatitis C donation was potentially administered. The facility's notification to the patient's physician was 09/03/2019 (over 45 days later).

The blood bank sent a letter to the facility dated 06/14/2019 revealing a confirmed Hepatitis C donation was potentially administered. The facility's notification to the patient's physician was 07/19/2019 (over 30 days later).


During an interview on 11/18/2019 after 1:28 p.m., Staff #11 confirmed the timeframe's and that the physician notification was made late. Staff #11 said that their timeframe started when they received the letter from the blood bank (after the supplement test results). Staff #11 said they had 28 days to make physician notification. Staff #11 was asked what was done when they saw there was a problem with the late physician notifications. Staff #11 said nothing had been done.

During an interview on 11/18/2019 after 1:44 p.m., Staff #12 said that the information regarding the late physician notifications was not being looked at by Quality.


Review of a facility's policy named "Look Back Quarantine Procedure" dated January 02,2019 revealed the following:


"..Notification of prior recipients who have received seronegative or untested blood from a donor later found to be confirmed positive for anti-HIV-1/2, HRLV-I/II, HBsAg, anti-HBc, or anti-HCV is referred to as "look-back".."
4. Physician notification will not take place until the results of the supplemental (additional, more specific) tests for HIV or HCV have been received from the blood center. Notification of the supplemental test results must be received within 45 days of the test. The Transfusion Service Manager will monitor the Notification Letter Log to verify that results are received within the timeframe.
5. Draft letter to be sent to patient's physician within 28 days of supplemental test results. Restate information included in the blood supplier notification letter with special emphasis regarding the potential for transmitting the virus including the need for testing and counseling.."

Based on observation, interview and record review the facility failed to maintain the walk -in freezer in the dietary department and the dish room of the dietary department in safe and sanitary working condition, from June 2019 through November 22, 2019.

This deficient practice had the likelihood to effect all patients of the facility.

Findings included.

Walk-in freezer:

On 11/18/2019 a tour of the dietary department revealed the single walk-in freezer with significant frost build-up on the ceiling, heavy frost and stalactites were visible on steel freezer racks and ice was beginning to form around the floor edges. The freezer door was closed when the freezer was approached but condensation was observed around the glass window and water was dripping down the front of the door. Upon opening the door the heavy plastic curtain which protect and reduces the exchange of inside and outside temperature was missing. This plastic guard separates the cold air from the warm air when the door must be opened to retrieve frozen food for meal preparation.

Interview with the dietary manager, Staff #30, and assistant chef #31, confirmed they had been observing frost build up and stalactites forming on the racks for close the 3-4 months. Both of these employees confirmed they had reported this problem to the plant operations department.

Both the manager and assistant chef confirmed the patient food supply was frozen safely, but it was becoming difficult for the staff to safely remove the food from the densely frozen sections of the freezer. The floor was becoming slick with ice, the racks had heavy frost and stalactites's that made removing boxed meat dangerous.

On the late morning of 11/18/2019, a conversation with the plant operations Director confirmed he was aware of the frost and ice build up in the interior of the walk in freezer. He confirmed his staff had looked at the freezer to investigate the problem. A request was made to look at the electronic communications for a time line and interventions that had been attempted. The plant operations manager indicated the gasket had been ordered for replacement and a heavy plastic curtain that protected the interior from warm air when the door was opened had also been ordered.

On 11/21/2019 a review of the available work orders were provided for review. The documentation indicated a plant operations technician had work orders from the dietary department, freezer, on the following days. Initial date of request and completion date.

Requested 10/8/2019, "(sic) knocked out what ice I could. this problem has been discussed with (Dietary Manager) the door to freezer is left open and moisture is getting in. the only way to get rid of all the ice would be to empty the walk in and shut down to thaw and dry out walls and floor, there is so much water in there now". Completed 10/10/2019 at 9:19 AM.

Requested 11/1/2019 at 8:47 AM, "(Sic) talked to (Assistant Chef), and they are going to have to empty freezer and thaw. then let dry before we can put back into service. All curtains are missing from the door and the door is always being left open. I will order new curtains. addendum: "try to order curtains for door. Waiting to hear back from them". Completion date 11/8/2019, no time documented.

Requested, 11/6/2019, no time documented, "Scrapped (Sic) ice in walk in freezer". Completion date 11/6/2019, 12:30 PM.

10/30/2019, no time documented, "(Sic) knocked off what I could. this is an ongoing problem with the door left open and air getting in and freezing up. have talked to (dietary Manager) and ordered new door curtain". Completion date 11/10/2019 10:18.



On 11/7/2019 the plant operations technician documented the following, "Curtain strips 3 boxes of 6 strips". This purchase order was not signed by a department manager indicating the order was approved or actually ordered.

On 11/18/2019, The operations technicians submitted the following order.
Door gasket
Door heater
Door heater cover
Window heater

This order was signed and dated 11/18/2019.



Dish room:

On 11/18/2019 the dish room was toured during the morning while the breakfast dishes were being prepped to place in the automated dish machine. The ceiling was observed with black spots over every ceiling tile in the room. The manager, staff #30, was asked what was the black spots and the reply was, "mold". The room was a large self contained work area where all dirty food trays entered via one door. The pots and pans were also pre scrubbed in this area. The ceiling was observed to be "raining" condensed moister. The Air conditioning vents were large enough for cold air to come in, however there was no return air intake and venting mechanism, which would pull the humid air out of the dish room and vent it to outdoor air, identified in the room.

Dirty dishes were placed into a conveyor type carriage that constantly moved the dished through a rectangular cleaning shoot. The long conveyor shoot passed through a wall and exited the other side of the wall clean and dry where a facility employee placed the clean dishes and utensils in the their place. When the dish washing machine was shut down at the end of the cleaning process a large amount of heavy steam was discharged into the room. A deep layer of steam was visible at the ceiling. Employees were observed attempting to mop the floors and keep them as dry as possible, while they worked in this room.

Interview with the Dietary manager and assistant chef confirmed they had asked the maintenance department to investigate the air entering the room and both staff pointed to the large directional air conditioning vent in the ceiling. Moister was observed dripping off the vents. Both staff were asked if an architect or someone with expertise in this area had been consulted. They both stated to their knowledge "No".

On 11/19/2019 this room was revisited by the surveyor and mold was still visible on the ceiling tiles.

On 11/20/2019 a member of the facility's management team was made aware of the dish room mold.

On 11/21/2019 the room was observed with clean ceiling tiles. An investigation in to the resolution of the excessive moisture in this room had initiated.

Based on observation, interview, and record review, the facility failed to ensure the facilities and equipment were maintained in a manner to promote patient safety in (decontamination, sterile processing staging area, post-op linen-equipment-supply room) of 3 areas observed.

This deficient practice had the likelihood to cause harm to all patients.


During an observation tour on November 19-22, 2019 the following was observed:

DECONTAMINATION AREA
There was a power strip cord laying unsecured on the base of an IV pole that was used to store a computer for the sterile processing technician to access the sterile processing instrument tracking program. The power strip outlet had three power cords plugged into it. The power strip outlet was covered in dust, dirt, and debris.

STAGING AREA
There was a power strip cord hanging freely on a metal rack storing surgical equipment. The power strip outlet had two power cords plugged into it.

There was a power strip cord laying unsecured on top of a plastic cart. The power strip outlet had four power cords plugged into it.

There was a power strip cord laying unsecured on a metal rack storing surgical batteries for battery powered equipment. The power strip outlet had six power cords plugged into it.

POST-OP LINEN-EQUIPMENT-SUPPLY WORK ROOM
There was a power strip cord on the floor next to the supply metal cart. The power strip outlet had six power cords plugged into it.


Staff #41 confirmed the above findings on the power strip cords.


A review of the NFPA 99 guidelines revealed the following:

"Use of extension cords in Operating Rooms: The code states that the power cord from the device must be "continuous and without switches from appliance to the attachment plug" (NFPA 99 7-5.1.2.5). This has been interpreted as forbidding extension cords in anesthetizing locations. The only exception is a permanently mounted power cord on a movable equipment assembly on a rack or table."

Based on observation, interview, and record review, the facility failed to provide a sanitary environment to prevent sources and transmission of infections. The facility failed to:



A. ensure that the staff who were processing bronchoscopes followed the manufacturer IFU (Instructions for use) to ensure that the bronchoscopes completed the decontamination process.

B. ensure the facility staff who were processing the bronchoscopes followed the manufacturer IFU on the recommendations for manual flush of alcohol when processing the bronchoscopes.

C. ensure that facility staff who were processing the bronchoscopes were trained on the correct decontamination process and use of the Medivator processing machine used to decontaminate the scopes.

D. ensure the bronchoscopy room maintained a negative pressure. Review of the bronchoscopy procedure list for 5-1-2019 to 11-18-2019 revealed bronchoscopy procedures were done on 5 patients. Patients with known or suspected TB (tuberculosis) infection pose a significant risk of exposure to staff and other patients.

E. ensure that air exchanges and negative pressure were monitored in the bronchoscopy decontamination processing room.

F. ensure a sanitary environment for the provision of patient care in 3 bronchoscopy room, bronchoscopy patient supply area, and bronchoscopy decontamination room) of 3 respiratory patient care areas observed.

G. ensure that bronchoscopy supplies were not expired and available for patient use.

H. ensure temperatures were monitored within the facility storage rooms and an off-site warehouse located at 4815 Troup Highway that stored patient supplies, surgical supplies, Intravenous fluids, and Intravenous contrast that were available for patient use. Also, the facility failed to ensure that humidity levels were monitored in the storage rooms where sterile surgical instruments were stored.

I. have a clear and defined separation of clean and dirty supply storage at the off-site storage warehouse.

J. maintain a clean and sanitary environment to ensure patient's health and safety in 7 (1st floor, 2nd floor, 3rd floor, 4th floor, 5th floor, 6th floor, and an off-site storage warehouse) of 8 areas observed.

K. ensure a process was in place to monitor patient supplies for expiration dates.

L. failed to ensure there was a facility policy/process in place for delivering time/temperature sensitive supplies to the lab.

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

M. evaluate facility staff immunization status for designated infectious diseases, as recommended by the CDC and its Advisory Committee on Immunization Practices (ACIP).

N. ensure the facility maintained a clean and sanitary environment for the purposes of medication storage in the Automated Pyxis systems.

O. ensure the facility maintained a clean and sanitary condition was provided in the patient nourishment refrigerators on 6 (1st floor, 2nd floor, 3rd floor, 4th floor, 5th floor and 6th floor) of 6 floors observed.

P. ensure the facility did not store cardboard boxes in all nursing storage closets and dietary department.

Q. ensure the facility maintained a clean and sanitary environment in the Dietary Department.

R. ensure the facility maintained a clean and sanitary environment in Lab #1 in 6 (main lab, phlebotomy supply cart, phlebotomy storage area, Hematology area, Chemistry area, and Transfusion area) of 6 areas observed.

S. ensure the facility maintained a clean and sanitary environment was maintained in the Healthy Connections Lab. Also, ensure expired supplies were not stored and available for patient use in the lab.

T. ensure the facility maintained a clean and sanitary environment was maintained at the off-site Emergency Room Lab Department. Also, the facility failed ensure lab specimens were processed in a timely manner and removed from the storage area.

U. ensure the facility maintained a clean and sanitary environment was maintained in the Cardio Vascular (CV) Surgical Unit in 6 (Operating Room (OR) #1, OR #2, Sterile supply room, hallway of the CV OR, Electro Physiology Lab, and supply closet outside of the CVOR) of 6 areas observed.

V. ensure the facility processed sterile surgical instruments according to the Association for the Advancement of Medical Instrumentation (AAMI) Standards.

W. ensure a clean and sanitary environment was maintained in the Radiology Department in 6 (X-ray Room, CT Room #3, Interventional Radiology (IR) sterile storage the facility, IR Room #1, and IR Room #10) of 6 areas observed.

X. ensure that surgical supplies in the interventional radiology department were stored in a manner to prevent cross contamination during radiology procedures in 2 (Interventional Radiology Room #1 and #10) of 2 rooms observed.

Y. ensure the intravenous (IV) contrast was stored according to manufactures recommendations in 2 (contrast storage closet and CT Room #3) of 2 areas observed.

Refer to tag A0749 for additional information.

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

A. ensure that the staff who were processing bronchoscopes followed the manufacturer IFU (Instructions for use) to ensure that the bronchoscopes completed the decontamination process.

B. ensure the facility staff who were processing the bronchoscopes followed the manufacturer IFU on the recommendations for manual flush of alcohol when processing the bronchoscopes.

C. ensure that facility staff who were processing the bronchoscopes were trained on the correct decontamination process and use of the Medivator processing machine used to decontaminate the scopes.

D. ensure the bronchoscopy room maintained a negative pressure. Review of the bronchoscopy procedure list for 5-1-2019 to 11-18-2019 revealed bronchoscopy procedures were done on 5 patients. Patients with known or suspected TB (tuberculosis) infection pose a significant risk of exposure to staff and other patients.

E. ensure that air exchanges and negative pressure were monitored in the bronchoscopy decontamination processing room.

F. ensure a sanitary environment for the provision of patient care in 3 bronchoscopy room, bronchoscopy patient supply area, and bronchoscopy decontamination room) of 3 respiratory patient care areas observed.

G. ensure that bronchoscopy supplies were not expired and available for patient use.

H. ensure temperatures were monitored within the facility storage rooms and an off-site warehouse located at 4815 Troup Highway that stored patient supplies, surgical supplies, Intravenous fluids, and Intravenous contrast that were available for patient use. Also, the facility failed to ensure that humidity levels were monitored in the storage rooms where sterile surgical instruments were stored.

I. have a clear and defined separation of clean and dirty supply storage at the off-site storage warehouse.

J. maintain a clean and sanitary environment to ensure patient's health and safety in 7 (1st floor, 2nd floor, 3rd floor, 4th floor, 5th floor, 6th floor, and an off-site storage warehouse) of 8 areas observed.

K. ensure a process was in place to monitor patient supplies for expiration dates.

L. failed to ensure there was a facility policy/process in place for delivering time/temperature sensitive supplies to the lab.

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

M. evaluate facility staff immunization status for designated infectious diseases, as recommended by the CDC and its Advisory Committee on Immunization Practices (ACIP).

N. ensure the facility maintained a clean and sanitary environment for the purposes of medication storage in the Automated Pyxis systems.

O. ensure the facility maintained a clean and sanitary condition was provided in the patient nourishment refrigerators on 8 (1st floor, 2nd floor, 3rd floor, 4th floor, 5th floor, 6th floor, ER, and behavioral health unit) of 8 floors observed.

P. ensure the facility did not store cardboard boxes in all nursing storage closets and dietary department.

Q. ensure the facility maintained a clean and sanitary environment in the Dietary Department.

R. ensure the facility maintained a clean and sanitary environment in Lab #1 in 6 (main lab, phlebotomy supply cart, phlebotomy storage area, Hematology area, Chemistry area, and Transfusion area) of 6 areas observed.

S. ensure the facility maintained a clean and sanitary environment was maintained in the Healthy Connections Lab. Also, ensure expired supplies were not stored and available for patient use in the lab.

T. ensure the facility maintained a clean and sanitary environment was maintained at the main ER and off-site Emergency Room Lab Department. Also, the facility failed ensure lab specimens were processed in a timely manner and removed from the storage area.

U. ensure the facility maintained a clean and sanitary environment was maintained in the Cardio Vascular (CV) Surgical Unit in 6 (Operating Room (OR) #1, OR #2, Sterile supply room, hallway of the CV OR, Electro Physiology Lab, and supply closet outside of the CVOR) of 6 areas observed.

V. ensure the facility processed sterile surgical instruments according to the Association for the Advancement of Medical Instrumentation (AAMI) Standards.

W. ensure a clean and sanitary environment was maintained in the Radiology Department in 6 (X-ray Room, CT Room #3, Interventional Radiology (IR) sterile storage the facility, IR Room #1, and IR Room #10) of 6 areas observed.

X. ensure that surgical supplies in the interventional radiology department were stored in a manner to prevent cross contamination during radiology procedures in 2 (Interventional Radiology Room #1 and #10) of 2 rooms observed.

Y. ensure the intravenous (IV) contrast was stored according to manufactures recommendations in 2 (contrast storage closet and CT Room #3) of 2 areas observed.

Z. ensure the behavioral health unit was properly cleaned and in dayrooms, patient rooms, and general areas.


Findings Include:

During an observation tour on November 18, 2019 after 12:30 p.m. the following was observed:

A. BRONCHOSCOPE PROCESSING

During an observation tour on December 18, 2019 after 12:30 p.m., the following observations were made:
Staff #57 was processing a bronchoscope in the decontamination room. Staff #57 demonstrated the manual washing of the scope and explained the process. Staff #57 was asked to explain the process for placing the scopes in the Medivator processing machines. Staff #57 stated, "After the scopes are manually cleaned we place the scopes in the machine. A test strip is completed on all cycles prior to running the cycle." There was a scope in the Medivator processor at the time of the demonstration. Staff #57 was asked to provide the log for the scope decontamination. Review of the log revealed that the scope that was currently being processed in the machine showed a complete on the log. Staff #57 was asked to explain how the log book was completed prior to the scope completing the decontamination process. Staff #57 stated, "This log entry is completed prior to starting the decontamination process." Staff #57 was asked how the staff determined if the scope completed the decontamination cycle. Staff #57 stated, "Well the cycle lights will light up on the particular cycles and the alarm will alarm if the scope doesn't complete the cycle. Staff #57 stated, "Well there isn't really an indicator light or a print out. We do complete a RUHOF ATP Lab Quality control test (a swab test used to verify if there is any contaminates left in the internal channels of the scope) quarterly and we have not had any positive results." Staff #57 was asked if there was any way the staff at the facility could confirm the completion of the decontamination process for bronchoscopes. Staff #57 stated, "I don't know of anything specific."

Review of the manufacturers IFU for Medivator CER-1/CER 2 revealed the following:

"The LED's will blink, indicating the phase. When the cycle is complete, the LED's will remain on ..."
During a phone call with Medivator customer service on 11-19-2019 at 9:39 a.m. the following was revealed:
Staff #109 was asked what indicator the Medivator processor machine with a serial number of 2C189281-23 would be to indicate cycle completion. Staff #109 stated, "The processor will beep when the cycle is complete."

Staff #57 confirmed she was not aware of the cycle completion beep.

Staff # 55 confirmed the above findings on the Medivator processing and decontamination of bronchoscopes.

B. MANUAL FLUSHING OF THE ALCOHOL PORT ON BROCHOSCOPES DURING DECONTAMINATION PROCESSING

An observation of the decontamination process of a bronchoscope on 11-18-2019 after 12:30 p.m. revealed the following:

Staff #57 was processing a bronchoscope in the decontamination room. Staff #57 demonstrated the manual washing of the scope and explained the process. Staff #57 explained that the alcohol port was manually flushed during the process. Staff #57 stated, "We flush 30 cc per bronchoscope during the decontamination process."

Review of the manufacturer IFU for Medivator CER-1 & CER -2 revealed the following:

" ...5.10 instructions for Alcohol Flushing Port
3. Fill the Alcohol Flushing Adapter with 60 cc of fresh 70% isopropyl alcohol by drawing the alcohol into the syringe through the vertical tubing ...
5. ...For one endoscope or for smaller endoscopes such as bronchoscopes 60 cc is sufficient ..."
Staff #57 confirmed that the facility was not using the recommended amount of alcohol to be instilled into the flushing port for decontamination of bronchoscopes.

C. STAFF TRAINING ON PROCESSING BRONCHOSCOPES

During an interview on 11-19-2019 after 9:00 a.m., Staff #57 was asked who completed her training on using the above listed Medivator for processing bronchoscopes. Staff #57 stated, "A previous employee trained me, and I train all the staff." Staff #57 was asked if she had completed any training from Medivator or had been trained by anyone that was trained by Medivator to operate the Medivator decontamination processors. Staff #57 stated, "No, I haven't."

Staff # 55 confirmed there was no training on file for any of the respiratory staff that were operating the Medivator decontamination processor machines. Staff #57 also confirmed the staff was not decontaminating the bronchoscopes according to the manufacturer IFU. Refer to above listed deficiencies.

D. NEGATIVE PRESSURE IN BRONCHOSCOPY ROOM

During an observation tour on 11-18-2019 after 12:30 p.m. the following observations were made:

Staff #55 was asked if the pressure for the bronchoscopy room was monitored. Staff #55 stated, "No. We requested a monitor, but they put the sensor in the wrong room."
Review of the facility document titled, "Ventilation Evaluations" provided by facility maintenance revealed the last time the negative pressure was checked was 3-25-2019. Staff #55 confirmed the negative pressure was not continuously monitored.

Review of the bronchoscopy procedure list for 5-1-2019 to 11-18-2019 revealed bronchoscopy procedures were done on 5 patients with known or suspected TB (tuberculosis). Those infections pose a significant risk of exposure to staff and other patients.

Staff #55 confirmed the staff did not check the room pressure prior to completing bronchoscopy on TB suspected or confirmed patients.

Review of the facility policy titled, "6009 Air Pressure Relationships Policy" with an approval date of 9/1/2019 revealed the following:

"ii. The following areas will be monitored by the staff and/or electronic monitors on a continuing basis and report to the Plant Services any time it is suspected that the air pressure relationship is not correct:
1. Surgery
2. Bronchoscopy including the scope cleaning room.
3. Pharmacy"


E. MONITORING OF AIR EXCHANGES AND NEGATIVE PRESSURE IN THE BRONCHOSCOPY DECONTAMINATION ROOM.


During an observation tour on 11-18-2019 after 12:30 p.m. the following observations were made:

Staff #55 was asked if the pressure and air exchanges were monitored in the bronchoscopy decontamination room. Staff #55 stated, "I'm not really sure, facility maintenance employees monitor that." Review of the facility document, "Ventilation Evaluations" dated March 25, 2019 did not have any notation of the bronchoscopy decontamination room.

On November 19, 2019 after 9:00 a.m. Staff #55 confirmed the pressure and air exchanges were not monitored in the bronchoscopy decontamination room according to facility maintenance staff.

F. SANITARY ENVIRONMENT

During an observation tour on 11-18-2019 after 12:30 p.m. the following observations were made:

BRONCHOSCOPY ROOM
There was a filing cabinet to the right of the door when entering the bronchoscopy room. The top of the cabinet was covered in dust and dirt. There was a basket of papers that contained patient information unsecured. On top of that basket there was a patient foam positioner. There were two bottles of cleaning supplies and trash bags. The area was in disarray. Sitting next to the filing cabinet there was a storage cabinet. On top of the storage cabinet there was a corrugated cardboard box that contained sterile chest tubes. The box of chest tubes was sitting on top of a box of ink cartridges for the printer. There was a cardboard cylinder leaning on the storage cabinet and sitting on the floor. The cylinder was coated in dust. There was a box of open bronchoscopy supplies that had water stains on it. Staff #57 stated, "We only use those supplies for training." The box of supplies was in the bronchoscopy room were sterile procedures are performed. The floor between the file cabinet and storage cabinet was covered in dust, dirt, and debris. There was trash in the corner (end caps, paper, and plastic connectors).

On top of the crash cart there was a plastic bin containing electrodes. The bin was coated in dust, dirt, and debris.
In a drawer of one of the cabinets, there was a corrugated cardboard box that contained multiple open sterile supplies (Intubating stylets, and other bronchoscopy supplies). Staff #57 stated, "Those are training supplies." The supplies were in the bronchoscopy room were sterile procedures were performed. In the same drawer there was a bag of suckers and Pop Tarts.

In another drawer, there eight sterile surgical instruments in peel packs (pouches used to sterilize instruments). The sterile surgical instruments were stored in the same drawer with electrical outlet cords, biohazard bags, and ballpoint pens.

In another drawer, there were packages of sterile fiberoptic swivel adapters. The base of the drawer in which the sterile packages were in was coated with dust, dirt, and debris.

In another drawer, there were sterile endotracheal tubes (a tube inserted into the trachea for the primary purpose of establishing and maintaining a patent airway) sitting on top of empty non-sterile pathology slide containers and biohazard bags.

In another drawer, there was sterile suction tubing that had been removed from the package and stored in the drawer. The drawer was full of unpackaged sterile suction tubing. Staff #57 confirmed the tubing came in a package and it was removed from the package prior to storing in the cabinet drawer.

In another drawer, there was Intravenous Sodium Chloride stored. The base of the drawer was covered in dust, dirt and debris.

Underneath the cabinet in an open area, there was a copy supply box that stored bronchoscopy reports with patient information unsecured. Next to that box, there was a multi-Lumen Central Venous Kit (sterile supply) on the floor. The floor was covered in dust, dirt, and debris. There was a metal stool next to the sterile supply coated in rust, dirt, and debris. There were electrical cords that had been taped together. The tape was peeling loose and was covered in dust.

On the cabinet top above the drawers, there was a box of sterile supplies (IV tubing, and suction tubes). The box was corrugated cardboard.

In another drawer there was mixture of sterile saline syringes used to flush a patient's IV tubing stored with lotion and office supplies (pens, highlighters, markers).

In another drawer, there was sterile IV extension tubing stored with food product (Chocolate covered pretzels).

The anesthesia cart was overstocked in bins that contained sterile supplies (IV catheters). Sterile packages were stored in a manner that could cause damage to the packages and contamination. There was a corrugated cardboard box containing sterile syringes on the top of the anesthesia machine. There were electrode pads attached to the cables and hanging on the anesthesia machine. There was no way to determine how long the electrodes had been on there or if the electrodes were clean. There was an oxygen adapter tubing opened, out of the manufacturer package and attached to the anesthesia machine. There was suction tubing opened, out of the manufacturer package and attached to the anesthesia machine. In the drawers of the anesthesia machine there were sterile esophageal temperature probes stored on top of equipment cables, blood pressure cuffs, and other equipment. The sterile temperature probe packages were stored bent and curled up in a manner that could compromise sterility of the item. The floor behind the anesthesia machine was covered in dust, dirt, and debris. There was a bottle of ketamine (anesthetic drug used for sedation, pain relief, and memory loss) in a drawer of the anesthesia cart. The bottle was listed as a multiuse vial. The vial was not dated with an opening date and there was no way to determine when it expired.

According to the United States Pharmacopia<797> Resource Guide, dated 2013 revealed the following: Page 22
"Multiple-dose vials are designed for use beyond a single dose. Unless otherwise specified by the manufacturer, the maximum beyond-use date after initial puncture is 28 days."

The bins storing medications in the anesthesia cart were covered in dirt, dust, and debris.
In another drawer of the anesthesia cart, there was IV saline and sterile Tegaderm dressing in the same drawer with an unsterile surgical instrument and a box of batteries. There were 4x4 sponges stored in a bin inside a drawer of the cart. The sponges were stored in an open fashion uncovered. The sponges were exposed to build up of dust, dirt, and contamination.

BRONCHOSCOPY PATIENT SUPPLY AREA
There were patient bronchoscopy supplies stored in corrugated boxes. There were boxes of sterile supplies (Medtronic catheters, biopsy forceps, surgical gloves and aspiration needles) stored on a shelf approximately 2 inches from the ceiling. There was an oxygen tubing hanging from a metal bracket. Staff #57 stated, "We used to use that to hang the radiology gowns on. We don't use it anymore, I don't know why it is still hanging there." There were two PleurX starter kits sent home with patients sitting on the floor. The kits contained drainage containers for draining and collecting fluid from chest tubes. There was a stretcher that had stretcher head boards stored on top of it. The headboard metal posts that attached the board to the stretcher were coated in rust.

There was a metal cart used to store Laser supplies. The cart had a bin that contained Defogger Anti Fog Kits. The manufacturer package stated, "Do not reuse". The bin had 3 bottles that had been open and removed from the manufacturer package. Staff #57 was asked if the facility reused the defogger. Staff #57 stated, "Yes". The top of the cart was coated in dust, dirt, and debris.

BRONCHOSCOPY DECONTAMINATION ROOM
There was a blue PPE (Personal Protective Gown) hanging from a clip on the wall. The gown was out of the package. PPE gowns are not reusable. There was an open package of sterile gauze sponges sitting on the cabinet next to the Medivator processor. There were bronchoscope cleaning brushes in a biohazard bag in the cabinet. The brushes are used to clean the channels inside the bronchoscope. The brushes were labeled as single use. There was no way to tell if the brushes had been used. Staff #57 stated, "I do not know if they are used. We don't use that type of brush anymore. I don't know how long they have been there." There was an anesthesia scope in a plastic bin on top of the cabinet. The box was labeled biohazard, dirty. Staff #57 was asked how long the scope had been there and who brought the scope in. Staff #57 stated, "I do not know. The operating room is supposed to notify our department if they bring anything up here to be processed.

Review of ANSI/AAMI S179:2017 - Comprehensive guide to steam sterilization and sterility assurance in health care Facilities (Engineering department) revealed the following:

"11 Storage and transportation

11.1 Sterile storage Sterile items should be stored under environmentally controlled condition that reduces the potential for contamination ...

Supplies should be removed from external and web-edged shipping container before transport to any restricted area ..."

11.1.l Storage Facilities (Engineering department)

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."

Review of the AORN (Association of perioperative Registered Nurses) 2019 Perioperative Standards and Recommended Practices, Guidelines for Sterilization, revealed the following:

" ...Recommendation IV.c. Supplies and equipment should be removed from external shipping containers and open-edged corrugated cardboard boxes before transfer to the sterile storage area or point of use.

External shipping containers and open-edged cardboard boxes may collect dust, debris, and insects during shipment and may carry contaminants into the surgical suite ..."


G. EXPIRED BRONCHOSCOPY PATIENT SUPPLIES

During a tour on November 18, 2019 after 12:30 p.m. the following was observed:

BRONCHOSCOPY ROOM

The following supplies were found in the bronchoscopy room expired:
1. Graspit Forceps expired 11-2013; over 6 years ago.
2. Tracheal Tube exchanger X2 expired 9-2016; over 3 years ago.
3. Ardnt Endobronchial Blocker Set expired 11-2018; over 1 year ago.
4. Precisor Hot biopsy forceps expired 1-2017; over 2 ½ years ago.
5. Arrow Vessel Catheterization Kit expired 6-30-2018; over 1 year ago.

BRONCHOSCOPY PATIENT SUPPLY STORAGE AREA

6. Sure Fit Dual Dispersive Electrode Pad
7. Precisor Broncho Pulmonary Biopsy Forceps X 3 expired 2-2019; over 9 months ago.
8. Medtronic Core Cath 2.75 expired 12-27-2018; almost 1 year ago.
9. Cordis Power Flex P3 expired 7-31-2019; almost 4 months ago.



40989



Findings include:



H. An observation tour of the facility was conducted on 11/18/2019 after 9:00 AM with Staff #51. The following was observed:

1st FLOOR CENTRAL SUPPLY

The central supply room was observed storing patient supplies ready for use. Multiple wire racks were observed storing sterile instrument trays in large plastic bins and sterile surgical supplies. Approximately 14 plastic storage bins were used storing sterile instrument trays to be used outside of the operating room for procedures. 3 plastic bins were observed storing single surgical instruments in peel packs. surgical sutures were observed stored on the metal carts.

An interview conducted with Staff #60 was conducted on 11/18/2019 after 9:00 AM. Staff #60 was asked how he monitored and maintained the temperature in the central supply room. Staff #60 replied he did monitor the temperature in the room nor did he monitor the humidity. Staff #60 was asked if he was aware the temperature and humidity needed to be monitored. Staff #60 stated, "We talked about doing it and then we were told that it was an overkill and Joint Commission said that we only had to monitor if there was a bulk of supplies being stored in one area."


4TH FLOOR 4WB/4WC CRITICAL IMC UNIT

Observed in the clean supply room were sterile instrument trays in a hard-plastic bins and sterile supplies readily available for patient use. Staff #51and the Unit Manger were asked if the temperature and humidity were monitored in the supply room. Triple Lumen Catheter Trays (large catheter to be used for those with poor IV Access or critically ill patients) were stored and per the manufacturing guidelines noted on the outside of the sterile package, reads temperatures not to exceed 86 degrees F or fall below 59 degrees Fahrenheit. Sterile Thoracentesis Trays were observed with a label reading to maintain the temperature of the item between 68077 degrees Fahrenheit. The unit manager stated, "No we do not monitor the temperature and humidity in the closet." The unit manager was asked if she was aware there was sterile items in the closet that have to remain within a certain temperature range. The unit manger replied, "No."



3WB/3WC SURGICAL ICU

During an observation of the clean supply rooms on the 3rd floor of the facility it was noted sterile supplies and sterile instruments were stored and readily available for patient use. Confirmed by Staff #51 that no temperatures or humidity's were being monitored to ensure sterile supplies did not exceed the manufacturing guidelines for temperature and the sterile instruments were kept within the standard and recommended guidelines for temperature and humidity ranges to ensure patient safety.


A review of the AORN Perioperative Standards and Recommended Practices,

" ...Temperature should be maintained at a maximum of 75 degrees F in sterile storage areas.

Relative humidity should be maintained at a maximum of 60% in Sterile Storage areas.

Low humidity increases the risk of electro static 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 ..."


Staff #51 confirmed the above findings.



OFF-SITE SUPPLY WAREHOUSE


An observation tour was conducted at the off-site supply storage warehouse on 11/19/2019 after 8:00 AM with Staff #34 and #36. This surveyor observed sterile surgical supplies with storage temperatures listed on the external packaging, Intravenous (IV) fluids, IV contrast (used for X-ray procedures), and infant formulas. Staff #34 was asked if the temperature was monitored inside the warehouse and documented. Staff #36 stated, "Only the IV fluids are monitored for temperature."

An interview was conducted with Staff #110 on 11/19/2019 after 8:00 AM. Staff #110 was asked if the temperature was monitored in the warehouse to ensure no items exceeded or fell below the manufacturing guidelines to ensure sterility and patient safety. Staff #110 said, "We do monitor the IV fluids. We have a temperature gauge right below the IV fluids and it is logged in the book." Staff #110 was asked to provide the book for review. A review of the temperature logs revealed the temperature was documented twice a day, Monday through Friday and no documentation on the weekend. There was no way for the facility to be alarmed if the temperature exceeded the high or low storage temperatures per the manufacturers guidelines. The logs further revealed the last temperature documented was in the AM on 9/12/2019. Staff # 110 was asked if she knew the recommended temperature ranges, what to do, or who to notify if the temperature was out of range. Staff # 110 said, "No." Staff #110 confirmed the only temperatures that were being documented were pertaining the IV fluids stored in the warehouse.


I. During the observation tour it was confirmed by Staff #110, #34, and #36 there was no separation between the clean and dirty storage of supplies. External shipping boxes were stored next to sterile surgical supplies in the same area. The dock, where packages were received and distributed to additional facilities was an open area leading to a central storage area storing clean supplies mixed with opened external shipping boxes.

A review of ANSI/AAMI 2017 standards was as follows:


Review of ANSI/AAMI S179:2017 - Comprehensive guide to steam sterilization and sterility assurance in health care Facilities (Engineering department) revealed the following:

"...11 Storage and transportation

11.1 Sterile storage Sterile items should be stored under environmentally controlled condition that reduces the potential for contamination ...

Supplies should be removed from external and web-edged shipping container before transport to any restricted area


11.1.l Storage Facilities (Engineering department)

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..."


Staff #34, #36, #110 confirmed the above findings.

Staff #44 confirmed there was no temperature or humidity monitored throughout the hospital in any supply/storage closet on any nursing/patient floors.



J. An observation tour was conducted with Staff #51 on 11/18/2019 after 8:00 AM. The following was observed:


1st FLOOR

At the Cardiac Registration Center check in desk, the corner of the wall nearest the floor was missing paint and exposing the sheetrock. The porous surface could not be sanitized properly to ensure patient safety and prevent the spread of infectious diseases.


PATIENT ROOM #1103

This room was cleaned and sanitized and available for a new patient admit. The recliner when pulled to the recline position exposed a dried white liquid. Behind the blinds and in front of the window was soiled with dust and dirt. The ceiling tiles above the sink, displayed multiple brown spots/stains. The IV pole was heavily soiled with white spots that appeared to be dried liquid. The corner behind the IV poles was soiled with a heavy buildup of dirt, dust, and debris. The caulking behind the sink was noted to have a dark brown color embedded into the caulk.
There was no cover seen over the AC control mounted on the wall exposing the metal dials possibly placing patients, staff, and visitors in danger.


MEDICATION ROOM

Inside the medication was a pill crusher used to crush medications for a patient. The pill crusher was visibly noted to be heavily soiled with dirt, dust, and debris. A potential of cross contamination to patient medication.


CENTRAL SUPPLY

Inside the central supply storage room was supplies for multiple departments in the hospital. Isolation carts, sterile supplies, sterile surgical instruments, emergency intubation boxes, and patient supplies. There was no splash guard noted on the bottom of multiple wire racks storing patient supplies. This allows for dirt, dust and water during cleaning to splash directly onto patient items possibly damaging the integrity of the packaged items. External shipping boxes were stored on the shelves next to patient supplies increasing the risk of cross contamination from external contaminates and insects within the webbed edge container. Multiple surgical instruments that were peel packed were found stored in plastic bins. The hinged instruments were found in the closed position and not open. The plastic bins were soiled with dirt, dust, and debris. An interview was conducted with Staff #60 on 11/18/2019. Staff #60 was asked if he knew he could not store sterile instruments or supplies next to external shipping boxes." Staff #60 stated, "No." Staff #60 was asked if the central supply room was only used for clean supplies. Staff #60 replied, "Yes that is all we keep in here. We don't keep a lot of stuff in her just some incase the units need it right now. We get out supplies from the warehouse where everything gets delivered."

Staff #51 and #60 confirmed the above findings.


2nd FLOOR

MEDCATION ROOM

Upon observation of the patient medication refrig

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

A. ensure that tissue grafts were stored according to the manufacturer guidelines on 35 items listed on the bone freezer log.

B. ensure the facility had a process for staff to follow on time frames for discarding grafts after being removed from the cone tissue freezer.

C. ensure that unmonitored tissue stored outside of the bone freezer was removed from the bone freezer and was not available for implantation in a patient. One graft was implanted in a patient from the unmonitored tissue graft on 9-12-2019. There was no way to ensure the graft was maintained at the manufacturer recommended temperatures when taken out of the tissue freezer and stored in a cooler on dry ice.

D. ensure surgical implants were not stored and available for patient use after the manufacturer expiration date. Ten (10) sterile items were on the shelf and available for patient use that were expired. Seven (7) surgical implants were on the shelf and available for patient use that were expired.

E. ensure a sanitary environment for storage of sterile surgical supplies and patient implants in 1 (Sterile processing staging area) of 1 areas observed.

F. ensure that sterile surgical implants/instruments were reprocessed according to the manufacturer recommendations in 3 of 3 items observed.

G. ensure that single use/disposable items were not re-sterilized/cleaned and reused.

H. ensure that staffing in the Sterile processing department was adequate to maintain workload and current standards of practice.

I. to provide documentation that the filters were changed on the Endoscopy reprocessor per the IFU of the water filtration system. Also, the facility failed to provide a process for maintaining that the filters were changed every 6 months.

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

J. ensure negative pressure was maintained in the decontamination area of the sterile processing department. There was no way to ensure contaminates from cleaning soiled surgical instruments were contained in the decontamination room.

K. ensure there was separation of soiled/contaminated supplies and equipment from clean or sterilized equipment in a hallway in the decontamination room.

L. ensure the temperature in the Operating Rooms, Cath Lab, Outpatient Surgical Department & Digestive Disease Center was within acceptable standards to inhibit microbial growth, reduce the risk of infection, promote patient comfort and assure the physical safety of all patients.

M. ensure a sanitary environment for the provision of surgical services and patient care areas for 13 (Sterile Processing clean area, Sterile Processing decontamination area, OR #4, OR#5, Pre-Op area, Post-op area, Post-Op linen- equipment-supply room, anesthesia work room, Cath Lab #3, Cath Lab supply storage room, EP Lab #2, Outpatient Surgery department, and DDC (Digestive Disease Center) of 13 areas observed.

N. ensure the intravenous fluids that were stored in the fluid warmer were stored per the facility procedure log requirements of less than or equal to 104 degrees Fahrenheit.

O. ensure a complete Time Out was performed prior to a bronchoscopy in 1 (Patient #116) of 4 bronchoscopy charts observed. Also, the facility failed to ensure the documentation in the surgical chart for the time out was accurately completed and included all elements of a complete Time Out in 11 (Patient #'s 2, 27, 73, 74, 101, 102, 104, 105, 117, 118, & 119) of 14 patients reviewed.

P. ensure that the patient was provided all information necessary to make an informed decision on their care in 9 (Pt #'s 22, 27, 28, 29, 73, 74, 96, 97, &105) of 9 patients reviewed.

Cross Refer to Tag A 955


Findings Include:

A. TISSUE GRAFT STORAGE

During a tour on November 19, 2019 after 10:00 a.m. the following observations were made:
A Bone/Tissue freezer was stored in the Sterile processing department. Staff #53 was asked who monitored the tissue freezer for temperature and tracking the grafts when they were removed and returned. Staff #53 stated, "We monitor the temperature, but I don't know anything about the grafts. We don't even have a key." Staff #53 was asked who was responsible for tracking the grafts when they were removed. Staff #53 stated, "I really don't know." Staff #43 stated, "Staff #50 can answer your questions, I'll call him down."

During an interview with Staff #50 on November 19, 2019 after 10:00 a.m., Staff #50 was asked to explain the process for monitoring tissue graft temperature when the grafts were removed from the bone/tissue freezer. Staff #50 stated, "well we really don't have a process. For example, about a week ago, we defrosted the bone tissue freezer. We removed all the grafts and stored them on dry ice for about 8 hours. When the freezer was defrosted and back up to temperature we put the grafts back in." Staff #50 was asked how the facility monitored the temperature of those grafts while they were outside of the bone/tissue freezer. Staff #50 stated, "Well we just made sure they were still frozen. We don't have a thermometer to monitor those temperatures."

Review of an initial list provided by the facility on November 19, 2019 revealed thirty - five (35) tissue grafts shown to have been removed on November 11, 2019 by Staff #50 during a defrost process and placed on dry ice unmonitored for 8 hours.

Review of an attestation provided by the facility on November 20, 2019 after 9:00 a.m. from Staff #50 revealed the following:

Staff #50 stated, "On November 11, 2019 at 1400 I removed 25 bone and tissue products from the Fisher Scientific Isotemp Freezer model #8966 (Biomed #49162). The attached list contains all the items removed. The listed items were placed on 45 pounds of dry ice obtained from .... And placed inside 2-IGLOO coolers for 6.5 hours while the freezer could be thawed .... At 2030 the tissue and bone were placed back in the bone tissue freezer, intact and frozen ...."

Staff #50 confirmed the facility did not monitor temperature of the tissue/grafts while it was outside of the bone/tissue freezer.

Review of the facility document, "Titled Bone Freezer Log" revealed the operation range for Bone Freezer was -18 degrees to -80 degrees Celsius.

Review of the facility policy titled, "Procedures to Acquire, Receive, Store, and Issue tissues" with an effective date of 6-18-2019 revealed the following:

"12. Continuous temperature monitoring will be maintained for all tissue storage refrigerators and freezers. This equipment should be calibrated annually by BioMed ...

13.Storage equipment must have an alarm system that is continuously monitored and that alarms when the temperature is not within the acceptable range ..."

There was no way to ensure the grafts/tissue were maintained at the manufacturer temperature recommendations without monitoring the temperature.

B. TIME FRAMES ON DISPENSING AND RETURNING TISSUE TO THE BONE/TISSUE FREEZER

During an interview with Staff #50 on November 19, 2019 after 10:00 a.m., Staff #50 was asked to explain the process for monitoring tissue graft temperature when the grafts were removed from the bone/tissue freezer. Staff #50 stated, "well we really don't have a process." Staff #50 was asked to explain what guidelines the operating room followed when a graft was removed and not used. Staff #50 stated, "We don't really have one." Staff #50 was asked how long grafts could remain out of the freezer before they should be discarded. Staff #50 stated, "Well if they still have crystals on them, we just put them back in the freezer."

Review of an IFU for "Life Net Health Allograft Bio-Implant" which was one of the grafts in the bone/tissue freezer revealed the following:

" ...Once the bio-implant is thawed, it must be used during the current procedure or discarded. Do not refreeze or refrigerate the bio-implant after thawing has begun ..."

The facility did not have any processes for the operating room staff to follow on removing tissue from the freezer. There was no accountability to ensure tissue that had been removed from the bone/tissue freezer was acceptable to return to the freezer and stored for use on another patient.

C. TISSUE STORED OUTSIDE OF THE BONE/TISSUE UNMONITORED AND IMPLANTED INTO A PATIENT.

Review of an attestation provided by the facility on November 20, 2019 after 9:00 a.m. from Staff #50 revealed the following:

Staff#50 stated, "On November 11, 2019 at 1400 I removed 25 bone and tissue products from the Fisher Scientific Isotemp Freezer model #8966 (Biomed #49162). The attached list contains all the items removed. The listed items were placed on 45 pounds of dry ice obtained from .... And placed inside 2-IGLOO coolers for 6.5 hours while the freezer could be thawed .... At 2030 the tissue and bone were placed back in the bone tissue freezer, intact and frozen ...."

Staff #50 confirmed the facility did not monitor temperature of the tissue/grafts while it was outside of the bone/tissue freezer.

Review of the facility document titled, "Tissues implanted since bone freezer defrosted on 11-11-2019" revealed the following:

Patient #107 had Primagen allograft Tissue implant X2 implanted on 9-12-2019 during a surgical procedure of Laminectomy Lumbar with decompression.

Staff #44 confirmed the tissue implanted into Patient #107 was one of the grafts that was removed from the bone/tissue freezer on November 11, 2019 and stored on dry ice in a cooler with no temperature monitoring.

D. SURGICAL IMPLANTS AND SUPPLIES THAT WERE EXPIRED AND, ON THE SHELF, AVAILABLE FOR PATIENT USE.

STAGING AREA - STERILE PROCESSING DEPARTMENT

EXPIRED ITEMS:

1. Right/Left IBO Blade Set expired 3-1-2015; over 4 years ago.
2. Right/Left IBO Blade Set expired X 6 expired 1-1-2018; over 1 ½ years ago.
3. Right/Left IBO Blade Set expired 1-1-2019; over 10 months ago.
4. Reciprocator Blade expired 2-2018; over 1 ½ year ago.
5. Reciprocator Blade expired 8-2019; over 3 months ago.
6. Micro Sagittal Blade expired 3-1-2019; over 8 months ago.
7. Medtronic Drill Bit expired 10-10-2019; expired over 1 month ago.
8. Prolaryn Gel Injectable Implant expired 6-23-2019; over 6-23-2019.
9. Beaver Myringotomy Blade X3 expired 4-2019; over 7 months ago.
10. Beaver Myringotomy Blade X1 expired 6-2019; over 5 month ago.
11. Evolve Radial Head Implant X 3 - expired 7-2019; over 4 months ago.
12. Evolve Radial Head Implant X 1 9-2019; over 2 months ago.
13. Wright Evolve Radial Head implant expired 2-28-2019; over 9 months ago.
14. OrthoMesh Resorbable Mesh Straight expired 10-2012; over 7 years ago.
15. Denver Ascites Shunt expired 9-30-2019; over 2 months ago.

OPERATING ROOM 4

1. Xeroform Occlusive Gauze strip overwrap X 3 expired 5-2018; over 1 ½ year ago.
2. Central Venous Catheter Kit expired 4-30-2019; over 7 months ago.


E. SANITARY ENVIRONMENT FOR STORAGE OF STERILE SUPPLIES AND PATIENT IMPLANTS

During an observation tour on November 20, 2019 after 9:00 a.m. the following was observed:

STAGING AREA

There were bins stored on metal racks that contained sterile surgical orthopedic/general instruments. The base of the bin was coated in dust, dirt, and debris.

There were bins that contained sterile supplies (Stopcock, Aspiration Needle, Uterine Manipulator, Thermoguard dispersive pads). The base of the bins was coated in dust, dirt, and debris. The Aspiration Needles were longer than the bin used to store them and were touching the metal carts stored behind them.

There were several instrument sets (Stryker Bone Scoop, Acromed Extraction Set, Baby Fznoche, Mitek Mini Anchor Set,) that had a faded external chemical indicator on the set. The external chemical indicator was faded and there was no way externally to determine if the items had been exposed to the sterilization process.

Review of the AORN (Association of perioperative Registered Nurses) 2019 guidelines revealed the following:

"V. Chemical indicators specific to the sterilization method selected should be used with each package.
Chemical indicators are used to verify that one or more of the conditions necessary for sterilization have been achieved within each package. External and internal CIs do not verify sterility of the contents.

V.a A CI should be placed on the outside and inside of every package to be processed unless the internal indicator is readable through the package material. External CIs are used to verify that the package has been exposed to the sterilization process. External indicators are intended to differentiate processed packages from unprocessed packages. Internal CIs are used to verify that the sterilant has reached the contents of the package and that critical variables of the sterilization process have been met. The number of critical process variables that are monitored with an internal indicator is dependent on the specific type of internal indicator that is used.

V.a.1. A class I CI (i.e., process indicator) should be placed externally. Examples of process indicators are indicator tape and indicator labels."


There was a closed cabinet that contained Medtronic tissue/grafts. Inside the closed cabinet the following was stored:

1. There was a package of Medtronic Grafton DBM. The package listed the required temperature storage as 15 degrees - 30 degrees Celsius.
2. There was a package of Medtronic Grafton Plus DBM Paste. The package listed a required temperature storage of 15 degrees to 30 degrees Celsius.

Staff #50 was asked if the facility monitored the temperature inside the cabinet. Staff #50 said, "No. All the grafts are ambient, they don't require monitoring" Staff #50 was asked to confirm the temperature requirements listed on the package. Staff #50 confirmed the temperature requirements listed on the above tissue grafts. Staff #50 confirmed the facility was not monitoring the temperature as required per the manufacturer guidelines.

There was a Stryker IM Nail Cart that had sterile and non-sterile instruments stored in the same drawer. The base of the drawer was covered in trash, dust, dirt, and debris. In the bottom drawer of the cart there were sterile orthopedic implants. The base of the bin storing the sterile implants was covered in dust, dirt, and debris.

There was a bin that contained orthopedic Alphatec sterile and non-sterile instruments stored together in the same bin.

There was a metal rack that stored bins containing sterile instruments (Stryker Instruments & Alphatec) in peel packs (Surgical pouch used to sterilize instruments). The peel packs (Sterilization packs) were stacked up and packed tightly in the bins. The packages were stored in a manner that would allow crush, bend, and puncture of the package compromising the sterility of the item.

Review of ANSI/AAMI S179:2017 - Comprehensive guide to steam sterilization and sterility assurance in health care Facilities (Engineering department) revealed the following:

"11 Storage and transportation

11.1 Sterile storage
11.1.l Storage Facilities (Engineering department)

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."


There was a metal rack that stored sterile Stryker drills on the bottom shelf. There was no a splashguard on the shelf. There was no way to protect the sterile instruments from contaminates/splashes when the floor was being mopped.


F. REPROCESSING OF STERILE SURGICAL IMPLANTS/ INSTRUMENTS

During an observation tour on November 20, 2019 after 9:00 a.m. the following observations were made:
There were three (3) sterile peel packs that contained Synthes 3.5 locking plug implants. The facility did not have an IFU (Instructions for Use) at the facility and could not obtain one from the Synthes representative.

There were two laryngeal stents in sterile peel packs. They were sterilized by ETO (Ethylene Oxide) sterilizer. Staff #53 stated, "They had to be sterilized over 10 years ago. We don't even have a sterilizer like that anymore."
There was no way to determine if the implants were sterilized per manufacturer instructions.
Staff #53 confirmed the above information of reprocessing/sterilizing surgical implants/instruments.

G. SINGLE USE/DISPOSABLE ITEMS

There was an Odontoid Threaded Guidewire sterilized and in a surgical peel pack in the staging area available for patient use. The peel pack had been put into a plastic container that was labeled with information for another implant. The information had been partially marked out on the label of the plastic container. Staff #53 stated, "I don't know, but I'm guessing it was put into that container to protect it. Staff #53 was asked if the facility had an IFU on processing of the guidewire. Staff #53 stated, "I will look." Information provided later revealed the following:
An information sheet from Medtronic stated, "Moist Heat or Steam Sterilization". There were no parameters listed.
Staff #53 stated, "The Odontoid wire found in the staging area is no longer made by Medtronic." The current wires are single use and cannot be sterilized."

Two Basix Inflation Syringes were found stored in clear zip lock bag in the respiratory department. The two syringes were in a drawer and available for patient use. Staff #55 was asked what the syringes were used for. Staff #55 stated, "They are used in respiratory cases to check valve placement in patients with a pneumothorax (a collapsed lung)." Staff #55 was asked what process the facility used to clean the syringes between patients. Staff #55 stated, "We just wipe them down with the Sani-Wipes." Staff #55 was asked to provide the manufacturer IFU for the syringe.

Review of the manufacturer IFU revealed the following: "Sterile. Use once and destroy." Staff #55 confirmed the syringe was a single use item.

There was a metal cart used to store Laser supplies. The cart had a bin that contained Defogger Anti Fog Kits. The manufacturer package stated, "Do not reuse". The bin had 3 bottles that had been open and removed from the manufacturer package. Staff #57 was asked if the facility reused the defogger. Staff #57 stated, "Yes".

H. STERILE PROCESSING STAFFING

During a tour on November 19- 20, 2019 the following was revealed:

The sterile processing decontamination had one tech working in the area. There were tables piled with dirty instruments waiting to be washed. Staff #53 was asked if the facility normally had only one tech working in the area. Staff #53 stated, "Yes usually. We try to send more help when we can, but our workload had really increased so we don't have extra help usually."

Observations of the staging area in sterile processing revealed unsanitary environment where patient supplies, implants, surgical instruments were stored. Staff #53 was asked if the staff in sterile processing were responsible for maintaining the staging room as well. Staff #53 stated, "Yes". Staff #53 was asked if the sterile processing department had enough staff to maintain the workload and current standards of care. Staff #53 stated, "No. I have asked for additional help, but it has not been approved."

Review of a facility document titled, "Executive Summary- SPD Tech I position with a date of 8-29-2019" revealed the following:

" ...This workload is contributing to consistently high OT...

RECOMMENDATION
Our recommendation is two-fold: First we need to add 2 FTE (Full time employee) to reduce OT ...
Second, we need to add 2 FTE's to the 2nd (11am - 7pm) and 3rd (10:30 p.m. to 7:00 a.m. shifts in preparation for 15% volume increase ..."
Staff #53 confirmed the above request had not been approved since submitting over 3 months ago.


J. NEGATIVE PRESSURE IN STERILE PROCESSING DECONTAMINATION AREA

On November 19, 2019 after 1:00 p.m. the following was revealed:

There were two entry/exit doors for the decontamination room. The first door was entry and exit to the surgery department. The second door was entry/exit to the facility hallway. Staff #53 stated, "The second door is used by other departments transporting contaminated instruments for reprocessing, instrument representatives picking up loaner instrument sets, and housekeeping picking up contaminated trash and linen."

Staff #53 was asked if the pressure was monitored in the decontamination room. Staff #53 stated, "Yes on the first door into surgery there is a monitor." Staff #53 was asked if second door for the facility entry was monitored. Staff #53 stated, "No we do not have a monitor on that door. We don't check that side."

There was no way to ensure contaminates from cleaning soiled surgical instruments were contained in the decontamination room.

Review of the AORN (Association of perioperative Registered Nurses) 2019 guidelines revealed the following:

"Table 3
Heating, Ventilating, and Air Conditioning Design Parameters

Sterile Processing decontamination room - Pressure Relationship to Adjacent Areas: Negative"


K. SEPARATION OF SOILED/CONTAMINATED SUPPLIES AND EQUIPMENT FROM CLEAN/STERILIZED EQUIPMENT IN DECONTAMINATION

During a tour on November 19, 2019 after 1:00 p.m. the following was observed:

There was a hallway of the sterile processing decontamination room that opened to the facility side. On one side of the hallway there was a metal cart that had PPE's (Personal Protective Equipment), disinfectant bottles, and other decontamination area supplies. Next to those supplies was another metal cart that stored clean metal case trays. Next to that, there was another metal cart that stored clean loaner surgical instruments. Staff #53 said the loaner instruments were put there for the instrument representatives to pick up. On the other side of the hallway, in the same area there was contaminated surgery trash, contaminated surgery linen, biohazard medical device collection bins, and biohazard medical waste boxes. There was no barrier to separate the above listed items. Staff #53 was asked why the above listed items were stored in the same area together. Staff #53 stated, "Well I was told the facility stored everything in here because they did not have any other place to store it. We consider everything in this room dirty." Staff #53 was asked if the case metal case trays and loaner surgical instruments had been decontaminated prior to placing in the room. Staff #53 stated, "Yes." Staff #53 was asked if the metal case trays and surgical instruments would be considered clean or dirty. Staff #53 stated, "I guess they would be clean, but we always put them in the washer before using them." Staff #53 was asked if the loaner instruments that were sent outside of the facility from that room with the instrument representative were clean and decontaminated. Staff #53 stated, "Yes they are."
Staff #53 confirmed the above findings on separation of clean/sterilized supplies and equipment from contaminated/soiled supplies and equipment.


L. TEMPERATURE AND HUMIDITY

The facility failed to ensure the temperature in the Operating room (OR) was within acceptable standards to inhibit microbial growth, reduce the risk of infection, promote patient comfort and assure the physical safety of all patients. The temperature was out of range for 40 of 53 days reviewed. There was no documentation on the log to indicate corrective action taken and the temperature on follow up after corrective action was done.


Review of the Temperature Logs for October 1 to November 22, 2019 revealed the following:

EP LAB 1
The temperature was documented out of range 38 of 53 days reviewed.
The humidity was documented out of range 30 of 53 days reviewed.

EP Lab 2
The temperature was documented out of range 39 of 53 days reviewed.
The humidity was documented out of range 30 of 53 days reviewed.

The EP labs are procedure rooms; however, the facility is performing sterile surgical cases (Pacemaker/Defibrillator cases) in the rooms.


OR #1
The temperature was documented out of range 40 of 53 days reviewed.

OR#2
The temperature was documented out of range 37 of 53 days reviewed.

OR #3
The temperature was documented out of range 41 of 53 days reviewed.

OR #4
The temperature was documented out of range 1 of 53 days reviewed.

OR #5
The temperature was documented out of range 31 of 53 days reviewed.

OR #6
The temperature was documented out of range 40 of 53 days reviewed.

OR#7
The temperature was documented out of range 38 of 53 days reviewed.

OR#8
The temperature was documented out of range 32 of 53 days reviewed.

OR#9
The temperature was documented out of range 33 of 53 days reviewed.

OR#10
The temperature was documented out of range 34 of 53 days reviewed.

OR#11
The temperature was documented out of range 25 of 53 days reviewed.

OR#12
The temperature was documented out of range 32 of 53 days reviewed.

CYSTO ROOM 1
The temperature was documented out of range 13 of 53 days reviewed.

CYSTO ROOM 2
The temperature was documented out of range 2 of 53 days reviewed.

CATH LAB
There was no documentation to show that the Cath Lab Temperature and humidity was monitored on a continuous basis.


Review of the AORN Perioperative Standards and Recommended Practices,

"Temperature should be maintained between 68 degrees Fahrenheit (F) to 75 degrees Fahrenheit (20 degrees to 23 C) within the operating room suite. Procedure rooms should be maintained between 70 degrees F to 75 degrees F. Temperature should be maintained at a maximum of 75 degrees F in sterile storage areas.
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 electro static 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."

Review of the facility document titled, "Room temperature and Humidity" revealed the ranges on the log did not reflect current AORN standards.


M. SANITARY ENVIRONMENT

During an observation tour on November 19-20, 2019 the following observations were made:

STERILE PROCESSING CLEAN AREA
Two autoclaves observed in the sterile processing clean area were coated with a limescale build up and rust. Staff #53 stated, "I have been working on getting a contract worked out with Steris to come out and clean the autoclaves, but it has not been completed yet." Staff #55 was asked when the last time the autoclaves had been cleaned. Staff #55 stated. "about a year ago."
There was a storage room in sterile processing area that stored patient care supplies, PPE (Personal Protective Supplies), and sterile processing supplies such as instrument wraps. There were two corrugated boxes. One corrugated box stored external chemical tape tolls. These tape indicator rolls are used on the outside of wrapped surgical items to verify the package has been exposed to the sterilization process. The second corrugated cardboard box contained printer parts left by the IT department after repair of a printer.

DECONTAMINATION AREA
There was a metal cart that had PPE's disinfectant bottles, and other decontamination area supplies. The cart was coated in rust. There was a drain in front of the washers. The drain had a buildup of a black substance in the base. There were metal bases used to store washer racks had a buildup of a white substance and rust on them.

There was an IV (Intravenous pole) that housed a computer for the SPD tracking program in the decontamination area. The pole was coated with dust, dirt, and debris.

OPERATING ROOM 4

There were three opened and partially used bottles of 70% Alcohol stored in a cart in the room. The bottles did not have an open or expiration date listed on the bottle.

There was a bag of Intravenous (IV) Saline that had been spiked with tubing attached hanging on the auto transfusion machine. Staff #52 confirmed the last case done that machine was set up in for use was November 7, 2019; 13 days prior. Staff #52 stated, "I cannot be sure when the IV Bag and tubing were left there, but that was the last case." Staff #52 was asked if hanging the open saline bag and tubing was the facility procedure. Staff #52 stated, "No. We were trained to discard it after end of the case we are in."

There was an open bag of electrodes in the anesthesia cart. There was no way to determine how long the bag had been opened or a way to ensure the electrodes were not dried out. The package states, "Do not use if the package is opened or damaged." The crevices of the keyboard on the anesthesia machine was coated in dust, dirt, and debris. There was a metal rack inside the operating room that had sterile surgical supplies (suture, staplers, stapler reloads, malecot catheters, Ioban drapes, and sternal wires) stored on it. The supplies were not covered. Staff #40 confirmed the rack stayed in the room during surgical procedures. There was no way to ensure the supplies were not splashed/contaminated during surgical cases.

During an observation of an operating room cleaning in OR #2 on November 20, 2019 after 1:30 p.m., it was observed the operating room table mattress was not cleaned underneath the mattress. Staff #40 was asked if the facility process was to clean underneath the mattress. Staff #40 confirmed it was. There was rust on the wheel posts of the operating room bed.

There was a patient roller board used in Operating Room #1. The Vinyl covering had cracks and tears in it. The roller board was used to move a patient whose diagnosis was osteomyelitis. There was no way to properly clean the roller board with cracks and tears in the vinyl.

OPERATING ROOM 5

There was a cart in the room that stored patient supplies. The top of the cart was coated in dust, dirt, debris and hair. The bins in the cart and in the room that stored sterile and non-sterile supplies were coated in dust, dirt, and debris. There were three opened and partially used tubes of K-Y Jelly. The tubes are single use. The foil seals had been broken and removed from the inside of the lid. There were several silver colored ceiling tiles in the room that had rust stains on them. The air conditioning vent was covered in dust, dirt, and debris. There was a glass cabinet door that had splashes of a white substance. Inside the cabinet the metal shelves were coated in dust, dirt, and debris. The shelves were storing sterile surgical drapes and gowns, suction tubing, and dressing sponges. There was pink suction connector tubing on the floor underneath the linen hamper. Staff #40 confirmed the room had been cleaned.

The anesthesia cart had suction tubing that had been open and was attached hanging on the cart. The anesthesia circuit was opened and out of the manufacturer package and attached to the machine. There was no way to ensure the supplies were clean.

During a tour on November 21, 2019 after 10:30 a.m. the following observations were made:

PRE-OP

The computer cart base was coated in dust. The crevices in the keyboard on the nurse's computer was coated in dust, dirt, and debris. In the nurse's supply cart, there was an open package of gauze sponges. The sponges were stored in an open

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

A. ensure that all practitioners who were performing surgery were listed on the informed consent in 1 (Pt #28) of 9 patients reviewed. There was no way to ensure the patient was fully informed what practitioner would be performing their surgery.

B. ensure that patients were provided all information necessary to make an informed decision on their care in 9 (Pt #'s 22, 27, 28, 29, 73, 74, 96, 97, &105) of 9 patients reviewed.


This deficient practice had the likelihood to cause harm to all patients having surgery and/or anesthesia at the facility.



Findings Include:

During a patient tracer observation on 11-20-2019 after 1:30 p.m. for Patient #28 the following was observed:
Staff #107 was in the procedure room as an assistant for the physician during the procedure. Patient #28 was in operating room for Lumbar two through Sacral one hardware removal. Review of the surgical consent did not list Staff #107. Staff #40 was asked what part of the surgery Staff #107 performed. Staff #40 stated, "she just helps the doctor with whatever he needs." Staff #40 was asked if Staff #107 performed any of the invasive part of the procedure i.e.; cutting, tying, burning, or removing of tissue. Staff #40 confirmed they did. Staff #40 stated, "Staff #107 is not a hospital employee. She is employed by the physician." Staff #40 was asked if the patient was informed of the assistant's role in the procedure. Staff #40 stated, I assume the physician told them, but I don't know." Staff #40 was asked if the facility physicians used assistants regularly at the facility. Staff #40 stated, "There are only two private first assistants that I know of. We have employed first assistants, but they do not perform any invasive part of the procedure." Staff #40 was asked if any of the first assistants who perform any invasive part of the surgical procedures were listed on the surgical consents. Staff #40 confirmed they were not.

There was no documentation in the medical record to ensure the patient was fully informed of all practitioner's that would be performing/assisting in their surgery.

Review of surgical medical records from November 19-22, 2019 revealed the following:

Patient #'s 22, 27, 28, 29, 73, 74, 96, 97, &105 had an anesthesia consent signed by an anesthesiologist. The anesthesia consent did not indicate what provider would be administering the anesthesia during the procedure.
Review of the medical records Pt #'s 22, 27, 28, 29, 73, 74, 96, 97, &105 revealed CRNA (Certified Registered Nurse Anesthetists) were administering anesthesia during the procedures.

An interview with the Chief of Anesthesia confirmed the CRNA's who are administering the anesthesia are not listed on the consent and the patients are not informed who will be providing the anesthesia.

Staff #41 confirmed the above findings on the anesthesia consents.

Based on document review and interview the facility failed to follow their own policy to ensure patients safety who were receiving moderate sedation had a documented ASA Level (physical status assessment) by the physician prior to procedures requiring moderate sedation in 3 (Patient #33, #34, and #76) of 6 medical records reviewed.


ASA Physical Status Assessment Levels are as follows:

ASA1-Normal/Healthy
ASA2-Mild Systemic Disease
ASA3-Severe Systemic Disease
ASA4-Severe Systemic Disease, Threat to Life"
ASA5-Moribund
ASA E-Emergency


This deficient practice had the likelihood to cause harm to all patients receiving moderate sedation. Not assessing patients for the correct ASA level could lead to respiratory problems and possible death from the moderate sedation medications.


Findings include:


PATIENT #33

Patient #33 is a 66-year-old female admitted ON 11/20/2019 to the Pain Management Department for an outpatient procedure.

A review of the History and Physical (H&P) dated 111/12/2019 by Staff #114 revealed Patient #33 had a history of Depressive disorder, Ovarian cyst, and Insomnia.

A review of the document titled, "PAIN MANAGEMENT CENTER PRE-SEDATION HISTORY AND PHYSICAL" revealed Staff #114 failed to document the ASA level of Patient #33.




PATIENT #34

Patient #34 is an 81-year-old male admitted ON 11/20/2019 to the Pain Management Department for an outpatient procedure.

A review of the History and Physical (H&P) dated 10/22/2019 by Staff #114 revealed Patient #34 had a history of Chronic Pain, Spinal Stenosis of lumbar region, Lumbar post-laminectomy syndrome, Coronary Artery Disease, Diabetes, and Hypertension.

A review of the document titled, "PAIN MANAGEMENT CENTER PRE-SEDATION HISTORY AND PHYSICAL" revealed Staff #114 failed to document the ASA level of Patient #34.



PATIENT #76

Patient #76 is a 68-year-old male admitted ON 11/20/2019 to the Pain Management Department for an outpatient procedure.

A review of the History and Physical (H&P) dated 10/22/2019 by Staff #114 revealed Patient #76 had a history of Chronic Pain, GERD, and Skin Cancer.

A review of the document titled, "PAIN MANAGEMENT CENTER PRE-SEDATION HISTORY AND PHYSICAL" revealed Staff #114 failed to document the ASA level of Patient #76.




A review of the facility titled," Moderate Sedation Policy Number 3-15" was as follows:


" ...7.0 Patient Selection, Assessment, and Preparation:

7.3 The proceduralist with moderate sedation privileges will perform and document a pre-sedation assessment including ASA classification and airway assessment. Assignment of the ASA classification is evidence of review of the patient's medical history ..."


An interview was conducted with Staff #34 on 11/22/2019 after 9:00 AM. Staff #37 was asked if he was aware of the policy and what the documentation requirements were for moderate sedation. Staff #37 said, "Yes, I'm aware of all the requirements." Staff #37 was presented three medical records for review and was asked why the physician was not documenting the ASA Levels on the patients receiving moderate sedation. Staff #37 replied, "They are supposed to be, and the nurse is supposed to be checking that before they go to the room for the procedure and any medication is given."


Staff #37 and #63 confirmed the above findings.