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



A. ensure contracts/ agreements dealing with patient care were provided in a safe manner. The facility failed to ensure contracts were renewed timely in 3 of 11 contracts/agreements that were reviewed.

Refer to tag A0084 for additional information.



B. ensure they followed their own policy and procedures in identifying, addressing, and resolving complaints and grievances.

Refer to tag A0120 for additional information.


C. develop and enforce a process to ensure patients receiving psychoactive medications were provided the information necessary to make an informed decision to accept the treatment in 3 of 3 patients reviewed (Patient #62, #64, and #68) who were prescribed psychoactive medications.

Refer to tag A0131 for additional information.


D. provide a safe environment for the treatment of psychiatric patients on the Geropsych unit on the 5th floor of the main campus. Numerous ligature risks and hazards had been identified by the facility without appropriate processes put in place to mitigate the risk. Additional risks and hazards were identified during the survey.


E. ensure staff followed their policy for providing the availability of portable suction during an emergency on 2 of the 2 units (Rehab and Geropsych units on the 5th floor) required at the main hospital campus.


F. ensure the security of the dialysis supplies and products in the acute dialysis unit.

The facility's staff failed to follow the dialysis prescription for the BFR (blood flow rate) to achieve adequacy of dialysis for 6 (#4, #5, #6, #9, #10, #11) of 8 medical records reviewed. Also, the acute dialysis unit failed to follow their own policy.


The facility failed to do chlorine checks every 4 hours on 4 (#4, #8, #9, and #10) of 8 patients while patients were receiving dialysis treatments. Also, the acute dialysis unit failed to follow their own policy.


The facility failed to report a high range of the dialysate pH on 1 (#11) of 8 patients. Also, the acute dialysis unit failed to follow their own policy.

The facility failed to ensure the solution used for the independent device (Phoenix Meter) which verifies the PH and conductivity of each machine, was not used past the expiration from the date of opening as recommended by the manufacture 2 of 4 solutions observed on the tri-station. This procedure was necessary to ensure the RO water and bleach water on the tri-station was not kept over 24 hours to prevent contamination.

The facility failed to ensure dialysis staff were maintaining a clean and sanitary environment for the acute dialysis patient.


The facility failed to ensure that 4 dialysis machines (#K044, #K118. #K139, and #K12) for the months of November and December of 2018, and January 2019 were disinfected every 7 days.


The facility failed to ensure the dialysis Quality Assurance Performance Improvement (QAPI) program was developed, implemented, maintained and evaluated with focus indicators to improve the outcomes of the acute dialysis unit.

Refer to tag A0144 for additional information.


G. ensure data was collected and monitored to assure the safety of services provided by 2 of 2 unit ( Behavioral Health Unit and Dialysis) reviewed for quality indicators. The facility failed to ensure staff on the off campus and main hospital campus were aware and included in opportunities for improvement projects in 3 of 7 departments (Sleep lab, Wound Care, Dietary).


Refer to tags A0273 and A0283 for additional information.



H. ensure an organized nursing service which ensured sufficient numbers of Registered nurses in 1 of 2 emergency departments (offsite hospital ED). One of the two RNs working the ED on every shift was required to provide care of ED patients and be the house supervisor for the inpatient surgical unit, surgery department and sleep lab.

The facility failed to ensure sufficient numbers of Certified nurse aides (CNA) on the medical surgical unit, orthopedic and pediatric unit. The facility was working without any CNA's on some shift and at times 1 CNA for the entire floor according to their staffing schedules and interviews. According to staff interviews, patients activities of daily care were not provided as scheduled.

Refer to tag A0392 for additional information.



I. ensure accurate physician orders, intake and outputs, and weights were documented and monitored on 1 of 4 patients sampled for Total Parental Nutrition and (TPN) Peripheral Parenteral Nutrition (PPN) (Patient #45).

Refer to tag A0395 for additional information


J. ensure management of the Dietary department for the main hospital campus. The facility failed to ensure dietary staff had documentation of training, record keeping, used proper sanitation techniques in the kitchen and properly stored food products.

Refer to tag A0620 for additional information.


K. ensure there were emergency pull cords and code blue buttons in 2 of 3 Radiology departments ( Outpatient Radiology at the main campus and the Radiology Department at the off-site hospital campus area). In the event of a patient emergency, staff did not have accessibility to call for assistance.


Refer to tag A0701 for additional information.


L. ensure the infection control officer developed a system that maintained a clean and sanitary environment. The facility failed to maintain a sanitary hospital environment and mitigate risks of possible hospital acquired infections in 13 (Emergency Room, Laundry, Housekeeping, Maintenance,Central Supply, Inpatient Rehabilitation, Behavioral Health, Surgery, Cardiac Catherization Lab, Radiology, Lab, Pharmacy, Medical Surgical) of 13 departments.


Refer to tag A0749 for additional information.




M. ensure surgical services was organized and acceptable standards of practice were used. The facility failed to:

Change the cold disinfection solution (Rapicide PA) every 21 days per the manufacturer guidelines for the high level disinfecting of the endoscopy scopes.

Change the 1 Micron filter, .45 Micron filter, 0.2-Micron water filter, air filter, and the Carbon filter per the manufacturer guidelines for the Medivator scope reprocessor (washer).

Ensure there were qualified and trained staff at the off-site campus to wash and process endoscopy scopes for disinfection after they were used on patients.

Ensure that endoscopes stored in a drying cabinet were disinfected per AORN (Association of Registered Nurses) guidelines. The facility did not have a process to ensure that endoscopes would not be used on a patient after the recommended hanging time at the offsite campus. Also, the facility did not have a policy on endoscope storage/hang time to ensure they were not used on a patient past timelines in the AORN recommendations.

Ensure that High level disinfectant test strips were not used past the expiration date. The Rapicide PA test strips were open on 10-3-2018. The test strips have a four-month shelf life after opened. The test strips were still in use 2-12-2019; 9 days after the expiration date.

Ensure that there was separation of soiled or contaminated supplies and equipment from the clean or sterilized equipment at the offsite campus in 1 (Sterile processing department) of 1 area observed.

Ensure that Surgical Instrument sets that contained implants (Screws) were not released from the Sterile Processing department prior to the biological test resulting at the main hospital campus and the off-site hospital campus. There was no way to determine conditions were met to kill a specified amount of microorganisms for a sterilization process prior to releasing the implants to storage or the operating room for surgery.

Ensure surgical instrument sets had a visible external chemical indicator in 3 (Orthopedic/General instruments) of 3 surgical instrument sets observed. The external chemical indicator was faded and there was no way externally to determine if the items had been exposed to the sterilization process.





32143

N. have clear documentation that corporate policy and procedures for "Restraints and Seclusions" were identified for the facility and the policy and procedures were clear in the language used for that specific facility. Governing Body (GB) failed to have policies and procedures that clearly applied to that hospital in 1(Restraints and Seclusion) of 1 policy and procedures reviewed for patient safety.

Review of the policy and procedure Restraint and Seclusions revealed one process for time limits and physician renewal of restraint/seclusion orders. There were multiple states (Arizona, Arkansas, Colorado, Louisiana, Texas and Utah) listed under time limits for physician orders to be signed in a specific time frame and what to do in those states.
Under training requirements for all direct care staff the policy stated, "Training requirements for RN's authorized to conduct the 1-hour face to face evaluation (only if allowed by state regulation/hospital practice)." There was no information that specified if Texas was one of those states.

An interview was conducted with Staff #4 on the afternoon of 2/14/19. Staff #4 confimed that the policy and procedure had instruction for multiple states. Staff #4 was not aware there was no specific policy for the facility.

Based on interview and record review, the Governing body failed to ensure contracts/agreements dealing with patient care were provided in a safe manner. The facility failed to ensure contracts were renewed timely in 3 of 11 contracts/agreements that were reviewed.

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


Findings include:


Review of a sample of contracted or arrangements listed revealed the following agreements were expired:

Garner Environment Services (emergency supplies)-08/16/2018
PalAmerican Security- 09/30/2018
Sysco Houston (disaster supplies) - 12/31/2018

During an interview on 02/14/2019 after 1:00 p.m., Staff #97 confirmed the expired contracts/agreements.

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

A. provide a safe environment for the treatment of psychiatric patients on the Geropsych unit on the 5th floor of the main campus. Numerous ligature risks and hazards had been identified by the facility without appropriate processes put in place to mitigate the risk. Additional risks and hazards were identified during the survey.

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

B. follow its own policy for providing the availability of portable suction during an emergency on 2 of 2 units (Rehab and Geropsych units on the 5th floor) at the main hospital campus.

C. ensure the security of the dialysis supplies and products in the acute dialysis unit.


D. follow the dialysis prescription for the BFR (blood flow rate) to achieve adequacy of dialysis for 6 (#4, #5, #6, #9, #10, #11) of 8 medical records reviewed. Also, the acute dialysis unit failed to follow their own policy.


E. do chlorine checks every 4 hours on 4 (#4, #8, #9, and #10) of 8 patients while patients were receiving dialysis treatments. Also, the acute dialysis unit failed to follow their own policy.


F. report a high range of the dialysate pH on 1 (#11) of 8 patients. Also, the acute dialysis unit failed to follow their own policy.

G. ensure the solution used for the independent device (Phoenix Meter), which verifies the PH and conductivity of each machine, did not exceed the 24 hour period recommended by the manufacturer. The bleach container and the R/O container was not dated to know if the the solution was used beyond the 24 hour period as recommended by the manufacture. This procedure was necessary to ensure the RO water and bleach water on the tri-station was not kept over 24 hours to prevent contamination.

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


I. ensure that 4 dialysis machines (#K044, #K118. #K139, and #K12) were disinfected every 7 days for the months of November and December of 2018, and January 2019.


J. ensure the dialysis Quality Assurance Performance Improvement (QAPI) program was developed, implemented, maintained and evaluated with focus indicators to improve the outcomes of the acute dialysis unit.

K. Ensure the physician documented the need for the administration of a psychotropic medication and/or Emergency Behavioral Medication administration in 3(12, 17 and 20) of 3 charts reviewed.

Document what de-escalation techniques were used or any other alternate restraint before administering a psychotropic medication in 3(12,17, and 20) of 3 charts reviewed.

Document the patient's legal status. The facility also failed to ensure the patient had a warrant, was under police detainment, or was a forensic patient before handcuffs are used to restrain a patient in 1(17) of 3 (12, 17 and 20) patients reviewed.

Follow physician orders to remove a suicidal patient's belongings in 1(12) of 3(12, 17 and 20) patient charts reviewed.

Perform a face to face evaluation before or within 1 hour after the administration of an emergency behavioral medication in 3(12, 17 and 20) of 3 charts reviewed.

Document on the patient's status concerning his behavior or psychotropic medication administration effectiveness in 3(12, 17 and 20) of 3 charts reviewed.

There was no found documentation that the physician or nurse was monitoring the patients for QT prolongation and arrhythmias due to the administration of Intravenous (IV) Haldol in 2 (# 17 and 20) of 3 (#12, 17 and 20) charts reviewed.

Cross Refer Items A through K to Tag A0144



L. follow its own policy and procedures in identifying, addressing, and resolving complaints and grievances.

Cross Refer to Tag A0120


M. develop and enforce a process to ensure patients receiving psychoactive medications were provided the information necessary to make an informed decision to accept the treatment in 3 of 3 patients reviewed (Patient #62, #64, and #68) that were prescribed psychoactive medications.

Cross Refer to Tag A0131

Based on review and interview, the facility failed to follow its own policy and procedures in identifying, addressing, and resolving complaints and grievances.

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



Findings include:

Review of the Complaint and Grievance log revealed complaints and grievances were logged with incident reports. There was no separate log for complaints and grievances. The log was 66 pages long for one year.

An interview with Staff #5 was conducted on the morning of 2/14/19. Staff #5 reported the list does not separate the incidents from the complaints and grievances. Staff#5 was calling corporate to determine how to separate the list with no avail. In the late afternoon hours, Staff #5 was able to compile a list of complaints and grievances. Staff #5 stated the facility is changing to another system and it has been difficult to navigate through the current system. Staff #5 confirmed that the facility was unable to generate a log for Sentinel Events or Root Cause Analysis.

Review of the facility's policy and procedure "Patient Complaints and Grievance Policy Guidelines" Stated, "PROCEDURE:
GRIEVANCE OR COMPLAINT
A. In the event a verbal patient care complaint cannot be resolved at the time of the complaint by staff present, it is postponed for later resolution, is referred to other staff for later resolution, requires investigation, and/or requires further actions for resolution then the complaint is a grievance for the purposes of these requirements.
E. Complaint may become Grievance
1. Patient complaints that become grievances also include situations where a patient or a patient's representative telephones the hospital with a complaint regarding their patient care or with an allegation of abuse or neglect, or failure of the hospital to comply with one or more CoPs, or other CMS requirements.
2. Those post-hospital verbal communications regarding patient care that would routinely have been handled by staff present, if the communication had occurred during the stay/visit are not required to be defined as a grievance.
3. All verbal or written complaints regarding abuse, neglect, patient harm, or hospital compliance with CMS requirements are to be considered a grievance for the purposes of these requirements."

Review of patient complaint 1817477 on 3/4/18 revealed the complaint was logged into the computer system by a RN House Supervisor. The complaint stated, "Pt called about his treatment in the ER. States that NP and nurse were rude was told that he had bone spurs but was not given any information about what to do for them while he waited for a podiatrist."(SIC) Staff #5 was asked why this was logged as a complaint and not a grievance. Staff #5 stated that it should have been but the house supervisors put in the information and log it as a complaint. Staff #5 stated, "They do that all the time and I have to go back in and change them. Staff #5 reported that this has been a continuing problem. Staff #5 was asked if that may be an education issue and Staff #5 stated, "Yes."

Review of patient complaint 1826279 10/18/2019 stated, "Patient stated that she had a $200 watch go missing. She said the night shift nurse had taken it off to start an IV. She is unsure where it was placed after the IV insertion. She said it was gold and she has had it for years." This complaint was not resolved in a timely manner and was never changed to a grievance process and addressed as such.

Review of patient complaint 1821930197 1/11/19 stated, "Family unhappy with attending MD care of pt." This complaint was not resolved in a timely manner and was never changed to a grievance process and addressed as such.

Review of complaints and grievances from 3/18/18 to 1/11/19 revealed the process in determining what was a complaint vs a grievance was not identified and brought through the QAPI process to resolve.

An interview with Staff #5 was conducted in the afternoon of 2/14/19. Staff #5 stated the complaints and grievances were reported to Quality Assessment Process Improvement (QAPI). Review of the QAPI Meeting Minutes for September, October, November, and December of 2018 revealed there was no data or PI processes for September and October of 2018. Data was found reported in November and December but no PI processes or specific issues on lack of education of staff was identified or addressed. QAPI has not had any meetings for 2019.

Based on review of records and interview, the facility failed to develop and enforce a process to ensure patients receiving psychoactive medications were provided the information necessary to make an informed decision to accept the treatment in 3 out 3 patients reviewed (Patient #62, #64, and #68) that received psychoactive medications.

Findings included:

On the morning of 2-13-2019, the chart for Patient #62 was reviewed at the nurse station on the Behavioral Health Unit, 5th floor. Staff #102 was interviewed during the chart review. Staff #102 confirmed that the patient had been discharged from the hospital that morning. The chart was reviewed for properly executed Consent to Treatment with Psychoactive Medication forms.

A Consent to Treatment with Psychoactive Medication form was found on the chart for the medication listed as Haldol. The dosage and route of medication was not listed. The form indicated that the patient was only given an oral explanation of the medication on 2-10-2019 at 1:00 AM. The record reflected that the patient was receiving Haldol orally and as a long-acting injection, requiring two separate consents.

A Consent to Treatment with Psychoactive Medication form was found on the chart for the medication listed as Cogentin. The dosage and route of medication was not listed. The form indicated that the patient was only given an oral explanation of the medication on 2-10-2019 at 7:46 PM.

A Consent to Treatment with Psychoactive Medication form was found on the chart for the medication listed as Depakote. The dosage and route of medication was not listed. The form indicated that the patient was only given an oral explanation of the medication on 2-10-2019 at 7:46 PM.

A Consent to Treatment with Psychoactive Medication form was found on the chart for the medication listed as Trazadone. The dosage and route of medication was not listed. The form indicated that the patient was only given an oral explanation of the medication on 2-10-2019 at 7:46 PM.

A Consent to Treatment with Psychoactive Medication form was found on the chart for the medication listed as Ativan. The dosage and route of medication was not listed. The form indicated that the patient was only given an oral explanation of the medication on 2-10-2019 at 1:00 AM.

The patient signed all of the consents. An illegible signature was present on all consents in the block labeled "Physician, P.A., R.Ph., RN or LVN Giving Explanation / Position / Date/Time". Staff #102 was asked whose signature was in the block on each of the forms. Staff #102 confirmed it was a nurse's signature. The block underneath the nurse's signature was a signature block for the physician to sign within two days of the consent being signed. The physician was required to sign stating that the explanation given by someone other than the physician had been verified. The physician's signature was not present on any of the forms. Since the physician did not confirm the explanations given to the patient, there was no written information provided to the patient, and the consent did not contain the dosage or route, there was no way to confirm that the patient had received the appropriate information necessary to make an informed decision to accept treatment with these psychoactive medications.

Review of Patient #68's medication consents showed that there were 5 consents. All consents had been provided by a nurse with oral explanation only. All were missing the physician signature verifying the patient had received the correct explanation.

Review of Patient #64's medication consents showed that there were 4 consents. All consents had been provided by a nurse with oral explanation only. The physician had signed, dated, and timed three of the consents within the 2-day time frame. The fourth consent was not dated or timed to ensure the patient was not given medications for a lengthy period of time without an appropriate explanation.

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

A. provide a safe environment for the treatment of psychiatric patients on the Geropsych unit on the 5th floor of the main campus. Numerous ligature risks and hazards had been identified by the facility without appropriate processes put in place to mitigate the risk. Additional risks and hazards were identified during the survey.

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

B. follow its own policy for requiring the availability of portable suction during an emergency on 2 of 2 units (Rehab and Geropsych units on the 5th floor) at the main hospital campus.

C. ensure the security of the dialysis supplies and products in the acute dialysis unit.


D. follow the dialysis prescription for the BFR (blood flow rate) to achieve adequacy of dialysis for 6 (#4, #5, #6, #9, #10, #11) of 8 medical records reviewed. Also, the acute dialysis unit failed to follow their own policy.


E. do chlorine checks every 4 hours on 4 (#4, #8, #9, and #10) of 8 patients while patients were receiving dialysis treatments. Also, the acute dialysis unit failed to follow their own policy.


F. report a high range of the dialysate pH on 1 (#11) of 8 patients. Also, the acute dialysis unit failed to follow their own policy.

G. ensure the solution used for the independent device (Phoenix Meter), which verifies the PH and conductivity of each machine, did not exceed the 24 hour period recommended by the manufacturer. The bleach container and the R/O container was not dated to know if the the solution was used beyond the 24 hour period as recommended by the manufacture. This procedure was necessary to ensure the RO water and bleach water on the tri-station was not kept over 24 hours to prevent contamination.

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


I. ensure that 4 dialysis machines (#K044, #K118. #K139, and #K12) were disinfected every 7 days for the months of November and December of 2018, and January 2019 .


J. ensure the dialysis Quality Assurance Performance Improvement (QAPI) program was developed, implemented, maintained and evaluated with focus indicators to improve the outcomes of the acute dialysis unit.

K. Ensure the physician documented the need for the administration of a psychotropic medication and/or Emergency Behavioral Medication administration in 3(12, 17 and 20) of 3 charts reviewed.

Document what de-escalation techniques were used or any other alternate restraint before administering a psychotropic medication in 3(12,17, and 20) of 3 charts reviewed.

Document the patient's legal status. To ensure the patient had a warrant, was under police detainment, or was a forensic patient before handcuffs were used to restrain a patient in 1(17) of 3 (12, 17 and 20) patients reviewed.
Follow physician orders to remove a suicidal patient's belongings in 1(12) of 3(12, 17 and 20) patient charts reviewed.

Perform a face to face evaluation before or within 1 hour after the administration of an emergency behavioral medication in 3(12, 17 and 20) of 3 charts reviewed.

Document on the patient's status concerning his behavior or psychotropic medication administration effectiveness in 3(12, 17 and 20) of 3 charts reviewed.

Ensure the physician or nurse was monitoring the patients for QT prolongation and arrhythmias due to the administration of Intravenous (IV) Haldol in 2 (#17 and 20) of 3(#12, 17, 20) charts reviewed.



Findings for A included:


On the morning of 2-13-2019, a tour was made of the Behavior Health Unit on the 5th floor with Staff #102. This unit was identified in policies and reports as Geropsych, but currently served adult psychiatric patients, as well as geriatric psychiatric patients. The unit consisted of 11 patient rooms on the South Wing and 9 patient rooms on the West Wing. Patient rooms had Careview cameras in them that allowed staff in the nurse station to visualize the patient in the bed area of the room. The doors to the bathrooms and bathroom area were not visible on camera for patient privacy. A tour of the rooms revealed that all bathrooms and bathroom doors presented readily accessible ligature attach points for patients who may be suicidal. A simulated hanging was conducted. In the simulated hanging, it took less than 20 seconds to make a knot in a bed sheet, throw it over the top edge of the bathroom door and use the pinch point between the door and the door jamb to support full body weight.

Interview with Staff #102 revealed that the hospital had conducted risk assessments of the unit in the spring of 2018 and fall of 2018. Staff #102 stated the ligature risks, along with other risks to patient safety throughout the unit, had been identified during these assessments with mitigating plans put in place. When asked about mitigating plans for the ligature risks in the patient bedrooms, Staff #102 stated that the unit secretary watched patients through the Careview monitoring system while patients were in their rooms, a Mental Health Technician (MHT) provided a visual check on every patient every 15 minutes, and a staff member was assigned to check each location of identified risk (patient rooms, hallway, day room, quiet room, laundry room) every 15 minutes.

The census at the time was 16 patients plus one patient that was discharging. No patients were on a one staff member to one patient (1:1) level of monitoring. There was one MHT assigned to monitor the patients every 15 minutes. Staff #113 was asked about her duties as the MHT assigned to monitor 16 patients. Staff #113 stated she passed out snacks, took care of towels and linens, provided water and coffee if needed, took patient vital signs, completed computer charting, and washed patient clothing in addition to monitoring 16 patients every 15 minutes. When asked if she kept a paper record of patient locations and what they were doing/how they were behaving until she could chart in the computer, Staff #113 stated she did not have a paper record.

Patient rooms were observed to have the doors open and patients were observed to be wandering the hallway, in and out of rooms. Some patients were observed to be in their rooms with the doors closed. There was one MHT in the day room with some patients, while other patients were in the hallway or in their rooms.

Staff #114 had taken over as the monitor for the identified ligature risks. Staff #114 was observed to be standing in the hallway by the nurse station where both the South Wing hallway and West Wing hallway could be observed. When interviewed about her duties, Staff #114 stated that every 15 minutes she would go to each patient room and check the ligature risks, document the form, and then come back to the location where she could monitor the hallways.

This meant that the Unit Secretary would not be able to see the patient in the bathroom, the MHT monitoring the patients and staff member monitoring the environment could have documented at the same time, and the patient could potentially have hung themselves for 15 minutes before anyone checked on them.

Staff #117 was asked to come to the first floor conference room and assist with review of the MHT charting on 2-13-2019 at 2:45 PM. Review of the computer showed that the 15 minute checks that were to be conducted on 12 of the 16 patients on the Behavioral Health Unit had not been charted since 12:30 PM. Four of the 16 patients did not have the 15 minute checks document between 12:30 PM and 2:15 PM.

Review of Patient #63's record showed that he had been involuntarily admitted on 2-11-2019 after being determined to be a danger to himself and others. He presented from a local hospital under warrant after an attempted medication overdose. He reported hearing command voices telling him to choke others and hurt himself. The patient scored low risk on the Suicide Risk Assessment Scale. Despite attempting suicide prior to admission and being involuntarily admitted, he was placed in a room with readily accessible ligature risks without being placed on a 1:1.

Review of Patient #61's record showed that she had been voluntarily admitted on 2-12-2019 for an increased depression and anxiety with suicidal ideation. Patient #64 had told her husband she wanted to end her life by taking pills. The patient scored low risk on the Suicide Risk Assessment Scale. Despite having active suicidal ideation, she was placed in a room with readily accessible ligature risks without being placed on a 1:1. During the tour of the unit on the morning of 2-13-19, she was observed to be isolating in her room with the door closed.

Review of Patient #65's record showed that she had been voluntarily admitted on 2-12-2019 for increased depression with suicidal ideation. The patient scored as high risk on the Suicide Risk Assessment Scale. Despite reporting an increase in depression, suicidal ideation, and scoring high risk on the suicide risk assessment scale, she was placed in a room with readily accessible ligature risks without being placed on a 1:1.

Review of Patient #66's record showed that she had been voluntarily admitted on 2-7-2019 for attempting suicide by overdose after a fight with her spouse. The chart reflects that the patient and her spouse "have ongoing conflictual relationship". Her spouse dropped her off at a local store parking lot and left her there. The patient then took 10 to 15 tablets of her regular medications. The patient required stabilization in the emergency department prior to admission due to the overdose. Upon arrival to the unit, the patient was noted to be sleepy and unable to answer questions. The patient was scored as overall low risk on the Suicide Risk Assessment Scale. The assessor scored question number 2, Prior History of Suicide, as Low- Has had periods of ideation but no history of attempts or gestures. The patient should have been scored as High - One or more serious suicide attempts (e.g. requiring medical attention), with wish of success; history of suicide attempt in hospital. The assessor scored question number 3, Marital Status, as Low - Married with family experiencing moderate marital or family difficulties. The patient should have been scored Moderate - Separated, but living with someone else; Married with relationship tension. Despite making a serious suicide attempt that required medical stabilization, she was placed in a room with readily accessible ligature risks without being placed on a 1:1.

Review of Patient #67's record showed she had been involuntarily admitted on 2-13-2019 after taking an intentional overdose. The patient scored high risk on the Suicide Risk Assessment Scale. Despite being involuntarily admitted as a risk to herself after an attempted suicide and being assessed as a high risk for suicide, the patient was placed in a room with readily accessible ligature risks without being placed on a 1:1.

Staff #102 was asked why patients who were depressed and had made recent suicide attempts or had active suicidal ideation were not placed on 1:1, Staff #102 stated that patients who scored low risk on the Suicide Risk Assessment Scale were not placed on 1:1. Staff #102 stated that it was up to the physician to determine if the patient need to be on a 1:1 if the patient scored high on the Suicide Risk Assessment Scale.

Review of The Medical Center of Southeast Texas Policy Title: Patient Monitoring - Routine and 1:1 Precautions, Policy Number 33, Final Approval Date: 03/08/2016 was as follows:

Page 3 of 5

"APPENDIX A

ONE TO ONE (1:1) OBSERVATION

1:1 Observation is defined as: keeping the patient under direct visual observation at all times. This includes use of bathroom and showering. Staff utilizes one to one protocol.

Criteria for 1:1 Observation:

a. Patient recently made suicide attempt prior to admission
b. Patient is voicing suicidal ideation and has specific plans on how it would be carried out.
c. Patient is voice feelings of hopelessness and helplessness and has a history of suicide attempts in the past.
d. Patient is expressing regret that suicide attempt prior to admission failed.
e. Patient is voicing suicidal ideation and unwillingness to accept treatment.
f. Patient is expressing feelings of hopelessness and has made preparations for death (i.e. making business or insurance arrangements, etc.).
g. Presence of command hallucinations to kill self whether or not there is expressed suicidal ideation."

In addition to the ligature risks identified by the facility on their self-assessment, the following patient hazards were identified during the 2-12-2019 tour of the Geropsych unit:

A mobile computer cart was observed to be in the hallway unattended. The unattended equipment as well as the cords attached presented a hazard to psychiatric patients. The cart was plugged into the electrical wall outlet with a cord more than 12 inches long. A communication cable was plugged from the cart to an outlet in the wall with cord more than 12 inches long. The medication dispense cart had cords to various components of the computer system that were more than 12 inches long, including: Mouse, Keyboard, Monitor, Computer Drive, and Scanner.

In both the South Wing and West wing, handrails were observed to have missing end-caps that left hardware exposed for patient tampering and exposed sharp edges. A nut and washer was able to be removed by hand with little effort. Pieces of metal hardware could be used by psychiatric patients for self-harm.

Contracted maintenance staff were working on the unit and unsupervised or observed by Behavioral Health Unit staff. The maintenance staff were observed to leave their large rolling cart unattended in the hallway while they worked in the room. The cart was observed to have two pairs of vice-grip pliers accessible to patients as they walked by. These metal tools could be used by mental health patients to harm themselves or others.





Findings for B included:

On the afternoon of 2-12-2019, a tour of the inpatient rehabilitation unit on the 5th floor was made with Staff #103 and Staff #104. An Emergency Supply Crash Cart was observed. The crash cart was to be used for patient medical emergencies on the unit. The top of the crash cart had several pieces of equipment, including portable suction. Portable suction would be required for several reasons to include if a patient was unresponsive and could not clear their own airway. Staff #104 was asked to test the portable suction machine. Staff #104 discovered that an adapter needed to connect suction tubing to the machine was missing. Review of the Emergency Supply Crash Cart log revealed that there was not a place on the log that required the suction to be checked.

During interview with Staff #104, Staff #104 stated that another crash cart was available on the behavioral unit on the same floor. If suction was needed, it could be retrieved from that crash cart. Upon further inquiry, it was determined that the portable suction on the crash cart on the behavioral unit was also missing the adaptor to connect suction. It was determined that during an emergency, someone would have to bring a portable suction machine from the first floor, Respiratory Therapy Department, to the 5th floor.

On 2-13-2019, Staff #91 stated that the portable suction machines had been replaced on the crash carts on the 5th floor. During a tour of the Geropsych unit, the suction was tested. It was found during the testing that the battery pack was not holding a charge and would not work unless plugged into an outlet. However, a patient experiencing an emergency may not be near enough to an electrical outlet for the suction to be used.

A review of The Medical Center of Southeast Texas Policy Title: Emergency (Crash) Cart Exchange & Maintenance, Final Approval Date: 3/13/2018, was made as follows:

"POLICY:

Emergency (crash) carts, pediatric Broselow bags, airway/intubation bags, and the neonatal emergency boxes provide immediate availability of emergency equipment, medication, and supplies.
...

PROCEDURE:
...

3. The defibrillator is tested using the Defibrillator Testing Guidelines on the Emergency Crash Cart Checklist.

4. Emergency (crash) carts should be clean, free of dust, with only the following items externally located on the cart

Defibrillator
Three lead patient cable
External Paddles
Airway/Intubation bag - secured with lock labeled with supply expiry date
Manual resuscitation bag/mask: 1 each - adult, pediatric, infant
Oxygen Tank
CPR board
Portable Suction (Rehab & Geropsych & all location at the Beaumont Campus)
Emergency Crash Cart Checklist
Pediatric Broselow bag (Port Arthur Campus: ER Room 5, Inpatient CT, Outpatient Radiology, Day Surgery, 3rd Floor Pediatrics, PACU, and Beaumont Campus: ER, PACU, Surgery)
...

8. During the course of completing the Emergency Crash Cart Checklist if any discrepancies are found, follow the resolution process:

Problem Resolution
Expired Supplies or Medications Exchange Process
Broken Lock Exchange Process
Defibrillator Test Failure Contact BioMed & remove from service
O2 Pressure less than 1200psi Replace O2 Tank from unit or contact
Plant Ops
Missing external supply Contact central supply to replace
external supply"

The policy did not contain requirements or instructions for the testing of the portable suction, documentation of the serviceability of the suction, or process for resolution of a problem with portable suction.


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Findings include:


C. During a tour of the facility on 02/11/2019 at 3:33 PM, observed the acute dialysis unit had 2 doors to the dialysis unit. One of the doors was to the water room system The other door led directly to the dialysis supplies and products and treatment area. The dialysis unit was inside the intensive care unit. Both of the doors had key code access; which allowed Housekeeping or any department employees access into the dialysis unit and into the water system room. Observed different nursing staff entering and leaving the dialysis unit. Also, the dialysis unit was storing powdered potassium chloride and calcium additives in the cabinet. The cabinets had a locking mechanism, but the key was in the door of the cabinet which contained the potassium chloride when the surveyor entered the dialysis unit. In addition, the same access code allowed employees access to the R/O (Reverse Osmosis) water system. The key code was the same for both doors. The code was 12345* which I obtained by watching them enter the door.

This deficient practice allowed access to the jugs and allowing potassium chloride additives to be added to the open jugs or tampering with the jugs.


An interview with Staff #118 on 02/11/2019 at 3:40 PM confirmed the above findings.

D. the facility's staff failed to follow the dialysis prescription for the BFR (blood flow rate) to achieve adequacy of dialysis for 6 (#4, #5, #6, #9, #10, #11) of 8 medical records reviewed. Also, the acute dialysis unit failed to follow their own policy.

These findings had the likelihood to cause harm by causing cramping, nausea, and chest pain to all patients receiving care at the facility.

Findings include:

A review of patient #4's treatment records dated 01/22/2019, the BFR was ordered by the physician to be set at 350; however, the treatment record revealed the BFR was run at 300. There was no documentation in the treatment record to why the BFR was ran at a lower rate.

A review of patient #4's treatment records dated 01/30/19, the BFR was ordered by the physician to be set at 350; however, the treatment record revealed the BFR was run at 300. There was no documentation in the treatment record to why the BFR was ran at a lower rate.

A review of patient #4's treatment records dated 02/04/19, the BFR was ordered by the physician to be set at 350; however, the treatment record revealed the BFR was run at 300. There was no documentation in the treatment record to why the BFR was ran at a lower rate.

A review of patient #4's treatment records dated 02/06/19, the BFR was ordered by the physician to be set at 350; however, the treatment record revealed the BFR was run at 300. There was no documentation in the treatment record to why the BFR was ran at a lower rate.

A review of patient #5's treatment records dated 01/12/19, the BFR was ordered by the physician to be set at 350; however, the treatment record revealed the BFR was run at 300. There was no documentation in the treatment record to why the BFR was ran at a lower rate.

A review of patient #5's treatment records dated 01/30/19, the BFR was ordered by the physician to be set at 350; however, the treatment record revealed the BFR was run at 300. There was no documentation in the treatment record to why the BFR was ran at a lower rate.

A review of patient #5's treatment records dated 02/01/19, the BFR was ordered by the physician to be set at 350; however, the treatment record revealed the BFR was run at 300. There was no documentation in the treatment record to why the BFR was ran at a lower rate.

A review of patient #5's treatment records dated 02/06/19, the BFR was ordered by the physician to be set at 350; however, the treatment record revealed the BFR was run at 300. There was no documentation in the treatment record to why the BFR was ran at a lower rate.

A review of patient #5's treatment records dated 02/08/19, the BFR was ordered by the physician to be set at 350; however, the treatment record revealed the BFR was run at 300. There was no documentation in the treatment record to why the BFR was ran at a lower rate.

A review of patient #6's treatment records dated 02/11/19, the BFR was ordered by the physician to be set at 350; however, the treatment record revealed the BFR was run at 300. There was no documentation in the treatment record to why the BFR was ran at a higher rate.

A review of patient #9's treatment records dated 02/01/19, the BFR was ordered by the physician to be set at 400; however, the treatment record revealed the BFR was run at 350. There was no documentation in the treatment record to why the BFR was ran at a lower rate.

A review of patient #10's treatment records dated 11/26/18, the BFR was ordered by the physician to be set at 350; however, the treatment record revealed the BFR was run at 300. There was no documentation in the treatment record to why the BFR was ran at a lower rate.

A review of patient #11's treatment records dated 11/26/18, the BFR was ordered by the physician to be set at 250; however, the treatment record revealed the BFR was run at 350. There was no documentation in the treatment record to why the BFR was ran at a higher rate.

A review of patient #11's treatment records dated 11/28/18, the BFR was ordered by the physician to be set at 250; however, the treatment record revealed the BFR was run at 350. There was no documentation in the treatment record to why the BFR was ran at a higher rate.


A review of the policy titled, "Prescription Verification and Safety Checks" revealed the following:

"Policy:

7. The following prescription parameters indicate a complete physician order and will be
documented on the treatment flow sheet prior to treatment initiation:
Date treatment to be performed
Dialyzer make and model
Dialysate Composition
- Potassium
- Calcium
- Sodium Dialysate
- Bicarbonate
Blood Flow Rate or Blood Flow Range Orders as below
Blood Flow at _______ mL/min
If unable to maintain flow due to inadequate vascular access patency, patient intolerance (i.e. chest pain, access discomfort) or elevated venous pressure, adjust blood flow between _____mL/min to _____ mL/min
If blood flow cannot be maintained within this range, maintain the blood flow you can achieve and notify the physician.
Update the blood flow order after speaking with the physician
Dialysate flow rate
Duration of treatment"

An interview with Staff #40 on 02/13/2019 at 2:00 PM confirmed the above findings and that the facility failed to follow the acute dialysis policy.


E. the facility failed to do chlorine checks every 4 hours on 4 (#4, #8, #9, and #10) of 8 patients while patients were receiving dialysis treatments. Also, the acute dialysis unit failed to follow their own policy.


A review of patient #4's treatment records dated 02/11/19, chlorine checks were not done every 4 hours. The first chlorine check was done at 5:20 AM the patient completed his dialysis treatment at 9:30 AM, there was no second chlorine check done. The second check should have been done at 9:20 AM.

A review of patient #8's treatment records dated 02/01/19, chlorine checks were not done every 4 hours. The first chlorine check was done at 5:55 AM the patient started the dialysis treatment at 5:54. Staff failed to do the chlorine check prior to patient starting the treatment.

A review of patient #9's treatment records dated 02/01/19, chlorine checks were not done every 4 hours. The first chlorine check was done at 5:55 AM the patient started the dialysis treatment at 7:15 AM. Patient #9 completed his treatment at 10:30 AM. The second chlorine check should have been done at 9:55 AM.


A review of patient #10's treatment records dated 11/26/18, chlorine checks were not done every 4 hours. The first chlorine check was done at 10:15 AM the patient completed his dialysis treatment at 2:32 PM, there was no documented second chlorine check done on the acute hemodialysis flow sheet.

A review of the policy titled, "TOTAL CHLORINE MONITORING OF PORTABLE
REVERSE OSMOSIS (RO) WATER TREATMENT SYSTEMS" revealed the following:

"PURPOSE: To establish total chlorine testing is regularly performed and that patients are dialyzed only with water having chlorine/chloramine levels within the limits
specified by the Association for the Advancement of Medical Instrumentation (AAMI).

NOTE: The terms mg/L and parts per million (ppm) are interchangeable, that is 1 mg/L
equals 1 ppm.

POLICY:

1. DaVita hospitals/facilities measure Total Chlorine to verify that levels are less than or
equal to 0.1 ppm (< 0.1 ppm) as specified by AAMI.

2. Total Chlorine testing is performed prior to treatment and every four (4) hours after the initial test while dialysis quality water is being utilized. A final Total Chlorine test is recommended to be performed at the end of the treatment day to verify that the portable
carbon tank/filters have not exhausted."


An interview with Staff #40 on 02/13/2019 at 2:00 PM confirmed the above findings and the acute dialysis unit failed to follow the policy.

F. the facility failed to report a high range of the dialysate pH on 1 (#11) of 8 patients. Also, the acute dialysis unit failed to follow their own policy.


A review of patient #11's treatment records dated 11/23/2018 revealed the dialysate pH was 7.7. The normal range is 6.9-7.6. There was no documented evidence that Staff #38 reported or recheck the elevated PH prior to starting the patient on dialysis.


A review of the policy titled, "Prescription Verification and Safety Checks" revealed the following:

"Independent Meter and machine conductivity:
Compare independent meter reading with machine reading
Manual pH
Acceptable reading: 6.9 - 7.6. Check independent pH with approved test method
for final dialysate."

An interview with Staff #40 on 02/13/2019 at 2:00 PM confirmed the above findings and the acute dialysis unit failed to follow the policy.


G. ensure the solution used for the independent device (Phoenix Meter), which verifies the PH and conductivity of each machine, did not exceed the 24 hour period recommended by the manufacturer. The bleach container and the R/O container was not dated to know if the the solution was used beyond the 24 hour period as recommended by the manufacture. This procedure was necessary to ensure the RO water and bleach water on the tri-station was not kept over 24 hours to prevent contamination.

This deficient practice had the likelihood to cause harm to all patients by failing to ensure the meter was properly calibrated to measure conductivity of the water and dialysate.

During a tour of the acute unit on 02/13/2019 at 1:30 PM the following was observed:

The RO water and the bleach water containers on the tri-station were not dated so there was no way to know if the solution being used was within the 24-hour window.

An interview with Staff #38 on 02/13/2019 at 1:30 PM confirmed the above findings.


H. the facility failed to ensure dialysis staff were maintaining a clean and sanitary environment for the acute dialysis patient.


During a tour of the acute dialysis unit on 02/11/2019 in the afternoon observed the following infection control issues:

1. A plastic drain tube with a black substance lying across the sterile gowns on a stainless steel cart.

2. There was a yellow plastic container which was dry rotted and broke off on to the sterile patient supplies.

3.The sterile dialysis tubing was below the bicarb containers that were shipped in from the outside in cardboard box. Sterile dialysis tubing should be stored above the clean supplies (bicarb containers).

4.The bottom shelf where sterile tubing was located was covered in dust and dirt.

5. The wheel caster on the stainless steel patient supply cart was dry rotted and falling off into the floor.

6. Observed on the top shelf of the stainless steel cart was a cardboard box on the shelf with the sterile patient supplies and sterle supplies were below the card board box.

Card board boxes harbor parasites, insects, and microorganisms.
"External shipping containers have been exposed to unknown and potentially high microbial contamination. Also, shipping cartons, especially those made of corrugated material; serve as generators of and reservoirs for dust." (AAM1 ST46-Section 5.2 Receiving items).


An interview with Staff #40 on 02/13/2019 at 3:40 PM confirmed the above findings during the tour of the acute dialysis unit.


I. ensure that 4 dialysis machines (#K044, #K118, #K139, and #K12) were disinfected every 7 days. for the months of November and December of 2018, and January 2019.

1. Machine #K044 in the month of November 2018 was not bleached after unknown status of Hepatitis B before next patient use. Also, the facility failed to bleach on 11/24/18 which would have been the 7th day, machine #K044 was not bleached until 11/25/18. In the month of December 2018 on 12/14/18 Staff member #38 conducted the vinegar cycle, but failed to document the heat disinfection on #K044. Further review of machine #K044 in the month of January 2019; the machine was not bleached after unknown status of Hepatitis B before next patient use. Also, on the logs there were numerous write overs and mark outs making it difficult to determine the times the bleaching had occurred.


2. Machine #K118 in the month of November was not bleached every 7 days prior to use. The facility failed to bleach on 11/23/18. The machine was not bleached until 11/28/18. Also, on the logs there were numerous write overs and mark outs making it difficult to determine the times the bleaching had occurred.


3. Machine #K139 in the month of December 2018 was not bleached after unknown status of Hepatitis B before next patient use. Also, the facility staff failed to document any type of disinfection after the patient had been dialyzed on 12/14/18, 12/17/18, and 12/19/18. There was inconsistency in the documentation of the Hepatitis B immunity; some of the staff would write "IM" and some would document "SUS".


4. Machine #K12 in the month of December was not bleached every 7 days prior to use. The facility failed to bleach on 12/24/18. The machine was not bleached until 12/31/18. Also, on the logs there were numerous write overs and mark outs making it difficult to determine the times the bleaching had occurred.


An interview with Staff #40 on 02/13/2019 at 2:00 PM confirmed the above findings.


J. ensure the dialysis Quality Assurance Performance Improvement (QAPI) program was developed, implemented, maintained and evaluated with focus indicators to improve the outcomes of the acute dialysis unit.


A review of the QAPI meeting minutes for November and December 2018 did not address the issues with the disinfection logs

Based on review of records and interview, the facility failed to maintain an effective an ongoing quality assessment and performance improvement program. The facility failed to:


A. ensure data was collected and monitored to assure the safety of services provided by 2 of 2 unit ( Behavioral Health Unit and Dialysis) reviewed for quality indicators.

Refer to tag A0273 for additional information.


B. ensure staff from the off campus and main campus hospitals were aware and included in opportunities for improvement projects in 3 (Sleep lab, Wound Care, Dietary) of 7 (Housekeeping, Telemetry, Laboratory and Radiology) departments since April 2018, 10 months.

Refer to tag A0283 for additional information.

Based on review of records and interview, the facility failed to ensure data was collected and monitored to assure the safety of services provided by 2 of 2 unit ( Behavioral Health Unit and Dialysis) reviewed for quality indicators.

On the afternoon of 2-14-2018, a review was made of quality data for the Quality Control Program. No quality tracking data was found concerning services provided by the Behavioral Health Unit.

On the morning of 2-15-2018, and interview was conducted with Staff #4. Staff #4 was advised that no tracking data was found. Staff #4 confirmed that the Behavioral Health Unit was not tracked for the measure of quality indicators.


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A review of the QAPI meeting minutes for November and December 2018 did not address the issues with the disinfection logs, R/O machine logs, conductivity and PH discrepancies, staff not following the dialysis prescription, the numerous write overs and mark outs on the logs and treatment flow sheets during the investigation survey. The QAPI meeting minutes discussed treatment volume and statistics. There was no evidence that the dialysis staff were involved in the quality meeting.

An interview with Staff #40 and #118 on 02/14/2019 at 9:00 AM confirmed the QAPI meetings did not address the above findings.

Based on observation, record review, and interview, the Hospital (off campus and main campus) failed to ensure the department staff of the hospital were aware and included in opportunities for improvement projects in 3 (Sleep lab, Wound Care, Dietary) of 7 (Housekeeping, Telemetry, Laboratory and Radiology) departments since April 2018, 10 months.

This deficient practice had the likelihood to effect all departments and patients of the hospital.


Findings included.


#1 Sleep lab on the off-site hospital campus.
On the morning of 2/12/2019, the tech, staff #35, who was available for interview, confirmed she was educated to her job duties and responsibilities toward the patients, but was unable to speak to what project improvement the sleep lab staff might be working on.

Interviews with wound care staff #119,on the afternoon of 2/13/2019 on the main campus, confirmed she thought the department director kept Quality data but she did not know for sure what it was.

Interview with the dietary director, staff #52, on the morning of 2/14/2019 on the main campus, confirmed she was keeping data. She was checking food tray temps and refrigeration logs. Interview with kitchen staff revealed they did not know what quality indicators were or what the data collected for them was.

On the afternoon of 2/13/2019 in the board room of the main campus, an interview with the Director of Quality services confirmed she was aware that departments within the hospitals services were not educating their staff as to what a project improvement was or what their department was working to improve. She indicated it had been identified earlier. When asked if it had been long enough to expect that department staff would understand and be aware of their individual improvement projects she replied "yes". The Director further explained the department managers had been instructed to educate their staff regarding project improvement for each department.


Ten (10) months had passed since becoming aware of the failure of the department managers to educate their staff to the Quality program, indicators and improvements projects. The failure persisted. No documentation was provided to indicate staff education, awareness or accountability was being collected, tracked, and analyzed.

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

A. ensure an organized nursing service which ensured sufficient numbers of Registered nurses in 1 of 2 emergency departments (offsite hospital ED). One of the two RN's working the ED on every shift was required take care of ED patients be the house supervisor for the inpatient surgical unit, surgery department and sleep lab.

B. ensure sufficient numbers of Registered nurses to provide care and supervise licensed vocational nurses on the medical surgical unit, orthopedic and pediatric unit.

C. ensure sufficient numbers of Certified nurse aides (CNA) on the medical surgical unit, orthopedic and pediatric unit. The facility was working without any CNA's on some shift and at times 1 CNA for the entire floor according to their staffing schedules and interviews. According to staff interviews patients activities of daily care were not provided as scheduled.

Refer to tag A0392 for additional information.

D. ensure accurate physician orders, intake and outputs and weights were taken and followed on 2 of 4 patients sampled for Total Parental Nutrition and (TPN) Peripheral Parenteral Nutrition (PPN) (Patient #'s 1 and 45).

Refer to tag A0395 for additional information

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

A. ensure sufficient numbers of Registered nurses in 1 of 2 emergency departments (offsite hospital ED). One of the two RN's working the ED on every shift was required take care of ED patients be the house supervisor for the inpatient surgical unit, surgery department and sleep lab.

B. ensure sufficient numbers of Registered nurses to provide care and supervise licensed vocational nurses on the medical surgical unit, orthopedic and pediatric unit.

C. ensure sufficient numbers of Certified nurse aides (CNA) on the medical surgical unit, orthopedic and pediatric unit. The facility was working without any CNA's on some shift and at times 1 CNA for the entire floor according to their staffing schedules and interviews. According to staff interviews patients activities of daily care was not provided as scheduled.


This deficient practice had the likelihood to cause harm to all patients presenting and residing on these units.


Findings include:


ED at the off-site hospital campus


During an observation on 02/12/2019 after 8:30 a.m., two Registered nurses (RN) were working in the Emergency department. During the observation one of the nurses was observed to leave the unit.

During confidential interviews it was revealed that the nurses in the ED were working as charge nurse, taking patients and functioning as the house supervisor for hospital. They also were responsible for the 17 bed inpatient unit, sleep lab, and surgical area. When it was busy in the ED it was hard.

There are no nurses working in the sleep lab. When there was an emergency like a code the ED nurses would have to take over for them.

That it was dangerous for ED nurses to be working as the house supervisor also because a trauma could come in the ED at any time.

Review of "ER schedule" from January 27th-February 11,2019 and the Emergency Department Staffing Worksheet revealed the following:

2 Registered nurses (RN) working 7:00 a.m.- 7:00 p.m. shift;
2 Registered nurses (RN) working 7:00 p.m.- 7:00 a.m. shift;
1 Technician working from 1:00 p.m.-1:00 a.m. shift.

Review of the ED census during this same timeframe was from 14- 38 patients per day. There were cases such as chest pain, head injuries, transient ischemic attack, dehydration, acute pharyngitis, shortness of breath, minor motor vehicle accidents, congestive heart failure and seizures listed on the sheet occasionally.

There was no documentation of who would cover the ED when one of the RN's were called off the unit to take care of concerns in other parts of the hospital.




Medical/surgical, orthopedic and pediatric unit at main hospital campus


During confidential interviews the following was reported about staffing;

The nurse to patient ratio was 1:6 and they used 1-2 nurses aide on a shift.

The nurses are taking 4-6 patients and it is not always on the acuity of the patients. There are a lot of total care patients with blood infusing. Sometimes that makes it difficult. There was one CNA for 4 wings. The CNA's help with activities of daily living, turning and repositioning and bathing. The baths are passed to the night shifts when the day shift can not get them.

The nurses are taking 5-6 patients and sometimes they have 0-2 CNA's working. Patient baths are not always done. Sometimes they are passed on to the night shift.

We need more CNA's and the patients are complaining. There was usually 1 CNA, but there was supposed to be 2. They are not able to get baths done. They are passed off the night shift or gotten the next day.

Sometimes the CNA's are taking 30 plus patients. This had been a problem since January 2018. The baths cannot be given sometimes. Sometimes just the bedbound total care patients get baths. Sometimes patients that are a two person assist are turned by one person because of the staffing problems. The CNA's are tired and worn out.

Sometimes there was one CNA on the unit. There are problems with RN's not covering the halls where LVN's are working. When the nurses are stopping to assist with care it causes delays in other care. The charge nurses try to get some of the baths. When they cannot be done they explain to the patients that they will get them on the night shift. They encourage the family members to be involved and help them with the care.

Not knowing about the staffing matrix for the units.



Review of staffing matrix that was being used revealed the following:

A nurse to patient ratio of 1:5 on days and nights.
One CNA up to 10 patients; 2 at 11 plus patients on days and night shifts.



Review of staffing schedules from 02/06-12/2019 revealed the following days or nights was short a nurse:

02/06/2019 (days and nights)
02/09/2019 (days)
02/11/2019 (nights)

From 02/06-12/2019 the following days or nights was short CNA's:

02/06/2019 (one for 3 hours on days)
02/07/2019 (no CNA on days and one short on nights)
02/08/2019 (short by one for 3 hours on days and short one on nights)
02/09/2019 (days and nights)
02/10/2019 (days)
002/11/2019 (days and nights)
02/12/2019 (short by one for 3 hours on days)
Staff #59 confirmed the staffing numbers.

Review of the nursing staffing Advisory committee minutes revealed the last documented meeting was June 27, 2017 (over 1 ½ years ago). According to the minutes there had been in a change in the staffing ratio for ortho patients. 'Total joints require a lot of care. Decreased Ortho's and total joints to 4 to 1.."

During an interview on 02/15/2019 after 8:30 a.m., Staff #3 provided another staffing matrix which was different from what was being used. The matrix did not give directives on decreasing staffing when nurses had total joint patients. Staff #3 reported that the facility had been having staffing committee meeting, but had not documented anything since June 2017 (over 1 ½ years ago).

Based on record review and interview, the hospital's Main campus failed to insure the nursing staff assessed and evaluated patients who received Total Parental Nutrition and Peripheral Parenteral Nutrition, by failing to record intake and output consistently and failed to record patient weight consistently as ordered by the physician for 2 of 4 patients whose medical record was reviewed. Patient #45 for Total Peripheral Nutrition (TPN) and patient #1 for Peripheral Parenteral Nutrition (PPN).


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


Findings included.


On 2/13/2019 on the telemetry unit, interview with staff #16 revealed the RN staff administered both TPN (total peripheral nutrition administered via larger veins, subclavian and for long term) and PPN (peripheral Parenteral nutrition administered for shorter length of time into smaller vein) when ordered by the physician. A review of patient (Pt/pt) #45 indicated TPN was ordered 2/9/2019. The order was for TPN to run via intravenous (IV) catheter at 60 CC's (Cubic centimeters) per hour. The order also included instruction for weight (wt) to be recorded and, intake and output (I&O) to be recorded each shift. Staff #16 indicated the pharmacy mixture was sent out twice a day at 12 hours shifts.

The TPN and PPN solution was good for 24 hours and may be removed from the refrigerator 4-6 hours prior to administration. It takes 2-3 hours for TPN to obtain room temperature. (Reference Johns Hopkins Medicine Total Parenteral Nutrition Administration)

Staff RN #16 confirmed the TPN came from the pharmacy in 1000 CC bags. At 60 cc an hour the patient would receive 720 cc's in twelve hours. If continually running the patient would require 16.6 hours to receive all of one 1000 cc bag . Staff RN #16 confirmed the delivery of a new bag every 12 hours was problematic as over the course of time the bags were not being hung timely.

Upon review of pt #45's medical record (MR) it was discovered that intake and output was not consistently being recorded every shift (12 hours) and weight was not being recorded daily. There was no evidence the nurse notified the physician of the limited collection of I&O and no awareness that weight had not been recorded.

With the assistance of staff #16 the MR for pt #1, who received PPN, was reviewed. Pt #1 also had physician orders for I&O every shift and weight daily. The documentation was lacking consistent I&O. Some shifts recorded it some shift failed to record the I&O. No wt's were identified in the MR. Again there was no evidence the nursing staff had identified the risk of the lack of I&O and the failure to record daily weight for a patient who was receiving PPN.

Staff RN #16 confirmed the Nursing and Registered Dieticians were aware of this problem and the issue was identified in the newly implemented electronic medical record system. The new system failed to include prompts or order sets for I&O and weight. The order set that was in the new system had to be reordered daily. If the physician failed to re-order or failed to include in the order I&O and weight, the RN would not see it or be reminded to complete the assessment for I&O and weight.

On 2/14/2019 in the conference room, an interview with staff Registered Dietician (RD) # 121 confirmed she was aware of the problem and she agreed the new Electronic medical record was the issue. They (RD, Registered Pharmacist, RN, Medical Doctors) were all aware and frustrated, and had not come up with a way to ensure the order would be safely followed to include the full dose ordered, I&O and weight would be monitored, analyzed, recorded, and reported to the physician if inadequate or abnormal. Staff #4 was also present for this discussion.

During the above interview a request to review the written policy for the nursing staff for administration of TPN and PPN was requested. The RD confirmed there was no policy for the instruction of the RN for administration of TPN and PPN. Without a policy and incomplete order sets, documentation of evaluation and assessment of the patient was incomplete.

Based on record review and interview, the facility failed to ensure that all patient medical record entries must be legible, complete, dated, timed.

The dialysis flow sheets and disinfection logs were not legible and without write-overs or crossed out entries. Also, the offsite Emergency Department campus failed to document the severity index level and who administered an anesthetic agent to a patient. Furthermore, the facility failed to ensure accurate documentation of physician orders, intake and outputs and weights on 2 of 4 patients sampled for Total Parental Nutrition and (TPN) Peripheral Parenteral Nutrition (PPN) (Patient #'s 1 and 45), at the Main hospital campus.

This deficient practice had the likelihood to cause harm by flowsheet data being difficult to read and leading to misinterpretation of data.

Findings included:

During record review of the hand written dialysis treatment sheets, 7 of 8 patient charts reviewed had entries that were either written over or crossed out without initialing.

Dialysis patient #4 had 11 write-overs and crossed out entries on 10 treatment sheets.

Dialysis patient #5 had 17 write-overs and crossed out entries on 20 treatment sheets.

Dialysis patient #6 had 2 write-overs and crossed out entries on 2 treatment sheets.

Dialysis patient #8 had 1 write over in 1 treatment sheet.

Dialysis patient #9 had 1 write-over on 1 treatment sheet.

Dialysis patient #10 had 1 write-over on 1 treatment sheet.

Dialysis patient #11 had 4 write-overs and crossed out entries on 4 treatment sheets.

A review of the disinfection and RO (reverse osmosis) system logs revealed numerous write overs.

An interview with Staff #40 on 2/14/19 at 9:30 AM confirmed the above findings and verified DaVita Dialysis had no policy on legible documentation.



10135


ED on the offsite hospital campus

Review of the Emergent department (ED) record on Patient #31 revealed she was a 46 year old female who presented to the ED on 02/12/2019 at 6:40 a.m.. Patient #31 amputated the tip of her left index finger on a kitchen door.

Patient #31 was assessed as having a pain level of 10 (0 meaning no pain and 10 meaning severe pain). Patient #31 was assessed as being an acuity level of 3 (severity index meaning non-urgent).
The physician medically screened Patient #31 at 7:04 a.m., and assessed her as being an emergent level (severity index meaning a level 1).

Nursing failed to accurately document the severity index level on Patient #31.

Review of ED procedure notes revealed Patient #31 had a repair of the finger. There was documentation that the anesthetic agent Lidocaine 1 percent was used.

Review of the medication detail sheet revealed a nurse performed and verified the medication. There was no other documentation in the chart to indicate the physician administered the anesthetic agent.

During an interview on 02/12/2019 after 11:00 a.m., Staff #47 reported that the physician gave the anesthetic and that nursing was not allowed to give anesthetics. Staff #47 confirmed she could not find the documentation in the chart the physician gave the anesthetic agent during the repair.



28659

On 2/14/2019 an interview with staff #122, the Medical Records (MR) Director of the main hospital campus indicated unawareness of the incomplete MR for TPN (total Parenteral nutrition) and PPN (peripheral Parenteral nutrition) patients #1 and #45.

During the interview, the MR Director indicated that reading through the medical record for failed nursing documentation had not previously been on her staffs list of review topics. However she understood that when a physician leaves a written order for data to be collected, evaluated and recorded, and the MR reflected the collection, evaluation and recording of the desired information was not present, the MR was incomplete.

Staff #122 confirmed the requested information was not present in the medical record for patients #1 and #45.

Based on interview and observation, the facility's medical staff failed to provide a policy for the safe destrucion of medication no longer in use and failed to provide a policy for the accurate utilization of patient's private medication, when required to be given to the patient while in the hospital on 2 of 2 campuses, the main and off site campus, for 8 months (August 2018 through February 2019)




This process had the likelihood to effect all patients of the hospital.



Findings included.

#1
On 2/12/2019 in the morning, at the nurses station, an interview with staff Registered Nurse (RN) #46, confirmed the nursing staff disposed of unused medications by dropping them into a red biohazard sharps container that was kept in the locked medication room. The RN further explained the process was known to the pharmacist and she had been educated to the process when hired, approximately 8 months ago. The staff RN confirmed she had never considered that the plastic containers could be cut into and solid medication could be removed and stolen.

The Quality Director, staff #4, confirmed the process observed on the off campus site was the process utilized on the main campus. A printed hand-out of the proposed drug destruction process that the pharmacy had recommended for use was provided. The process would fully adulterate any medication placed within the bottle.

The new system called, "RX Destroyer", contained a solution that would coat the medication when gently mixed in the bottle. The manufacturer's instructions recommended, at the least two times a day mixing and coating drugs dropped into the bottle. The bottle was understood to be full when the fill line reached 2 inches from the top of the bottle. The bottle would then be placed in a secure location for pick-up and full destruction.

Admininstrative staff #120 at the off site campus, confirmed the new drug destruction process had not been implemented, although two containers were identified mounted in departments but were later removed, and that staff had not been trained on the new process prior to approval. The adminstrative staff were unsure if the new process was in the process of Governing Body approval. The administrative staff confirmed a policy was not yet available for review.

On 2/12/2019 in the conference room an interview with staff, Registered Pharmacist #60, revealed, the drug (destruction) trial initiative was brought to the hospital from corporate. It was her understanding it was to be implemented. She indicated ALL STAFF training occurred the first week of February. She further indicated, it may or may not have gone to Governing Body or Medical Staff for approval.


#2
Interview with staff RN #46 also confirmed, on occasion patient's private medication was brought from home and used if the patient was admitted for inpatient stay and the hospital pharmacy did not have the medication in stock.

Further staff #46 indicated the patient medication would be sent to the pharmacy for proper identification and labeling and returned to the patient surgical unit (PSU). When asked if the patients medication was counted when brought in and counted when the patient was discharged she said "no".

The hospital had no system in place to ensure that patient private stock medications, brought from home, were utilized properly. There was no method of accountability to indicate how many doses were present on admission and therefore the hospital staff could not verify the correct medication count upon discharge.

Staff #46 indicated upon discharge the medication would simply be returned to the patient.

Based on observation and interview, the facility failed to follow its own policy regarding storage of CT (cat scan) contrast. Contrast materials were left unlocked and accessible to patients and staff in the CT 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 CT room on 2/12/19 at 9:30 AM the keys were found in the cabinet that contained the CT contrast. The cabinet was open and allowed anyone entering the CT room access to the contrast.

The facility policy titled," Drug Product Storage" states:

"POLICY:
There will be procedures to be followed regarding the storage and stocking of any drugs or drug
products in the Imaging Department.

C. All contrast materials used for radiologic studies are stored and secured in Imaging or in
Pharmacy. These contrast materials are located in the CT room and clean utility store
room in the imaging core. All storage areas containing contrast material will be locked
during the hours that the department is closed for routine business. The contrast
materials are packaged and stored in unit doses. The Imaging Staff is responsible for
maintaining these contrast materials, checking for expired items, and disposal of any out
of date or improperly labeled materials by returning them to the Pharmacy."

An interview with Staff #11 on 2/12/19 at 9:30 AM confirmed the above findings.

Based on observation, interview, and record review, the manager of the Dietary department for the main hospital campus failed to, 1) have management training, 2) provid hands on dietary training for the dietary staff (electronic education only), 3) ensure safe refrigeration temperatures of refrigeration units used for patient nutritional snacks, 4) ensure the sanitation of utensils used in the dietary department and 5) ensure proper storage and preparation of food products intended for patient use.

refer to Tag A 0620

Based on observation, interview, and record review, the manager of the Dietary department for the main hospital campus failed to, 1) have management training, 2) provide hands on dietary training for the dietary staff (electronic education only), 3) ensure safe refrigeration temperatures of refrigeration units used for patient nutritional snacks, 4) ensure the sanitation of utensils used in the dietary department and 5) ensure proper storage and preparation of food products intended for patient use.

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


Findings included.


On the late morning of 2/14/2019 a walking tour of the dietary department of the main campus identified the following:

1. Evidence of leaking seals (dark amber grease baked into the glass) on the inside of the double paned glass of the oven doors, making the oven door impossible to clean and sanitize.
2. Eight (8) muffin tins and 9 corn bread tins exhibited dark black carbon build up making them difficult to sanitize.
3. An opened bag of frozen shrimp, without use by or opened date affixed on the package, was identified in the walk-in freezer.
4. Frozen sausage, in a card board box, was left open to air in the walk-in freezer.
5. Two (2) trays of bread dough for dinner rolls were stored open to air and were loosely covered with parchment paper in the walk in freezer.
6. The stand mixer was covered with a torn black bag. When the bag was removed a basting brush was found beneath the back of the mixer.
7. A new employee was observed wiping a wet container with a cloth. The cloth had the potential to leave fabric residue behind. Dishes, pots, pans, etc should be turned so they can drain and air dry.
8. Kitchen staff were observed plating noon trays on the line. Below the line were shipping boxes of fruit and fruit cups. Staff was observed reaching into the shipping boxes removing fruit or fruit cup and placing the item on the patient tray and moving the tray down the line.
9. Six (6) shipping boxes which contained disposable plates and cups were stored with the content visible, with only walking distance between the boxes and the tray line where food was being plated.

After the tours, an interview with the dietary manager, staff #52 indicated the most recent Environment of care (EOC) rounding was completed in September, more than 4 months ago.

The Dietary manager was asked if she did inservice training. She replied all staff took on-line training when hired. When asked if she ever conducted actual hands on staff training specific to meal sanitation and preparing of food she said not really but she did inservice monthly.

The refrigeration logs were reviewed and it was discovered during the conversation, that the refrigerators on the individual patient units, were monitored for correct temperature by the kitchen staff. The manager was asked how did she use the temp logs? She was asked if she turn them in for quality data, she replied, "I don't do much with them. I just collect them and store them". The logs were reviewed and a number of out of range temperatures were identified. The manager was asked what happened when the refrigerator temperature was out of range, especially if patient nutritional supplements were being stored in the frig, She replied, "Well they usually just adjust the temp of the refrigerator". She confirmed she did not follow-up on it.

The Dietary manager was asked what was her department collecting for Quality review. After some thought she replied "Food Temperatures for trays". She indicated she had been checking them since she had moved into the position, 6 months or so. The manager admitted she didn't understand how project improvement was determined or how to choose what data should be collected, analyzed and tracked.

The Dietary manger was asked if she had received any specific training or instruction intended to guide her in managing her estimated 50 employees (the department was 2 positions short) and meeting the patient nutritional demands. She replied no, but she was working in the kitchen prior to the previous manager leaving. She had been moved into that position.

The dietary manager was asked if she had been provided any recommended dietary training to manage the department, provided any training manual such a the food handlers requirement guide, or other job specific training? She said, no but all her staff had obtained their food handlers certificates.

Based on review of records and interview, the facility failed to ensure that cases identified as extended stays per the Utilization Review Plan were reviewed by the Utilization Review Committee for 22 out of 27 occasions when patients had a length of stay of 30 days or greater.

Findings included:

On the morning of 2/12/2019, Policy Title: Utilization Review Plan, Final Approval Date: 11/20/2018, was reviewed. The policy contained the following requirements for reviewing extended stays:

"6. Extended Stay Review:
a. Extended stay is defined as any case with a length of stay that exceeds 30 days.

b. The Case Management Department will conduct an extended stay review for all patients who fall into the extended stay criteria and forward this review to the UR Committee.

c. The Managers will document all reviews in the Case Management electronic documentation system and label these reviews as extended stays.

d. The UR Committee members will review the case management notes and criteria and make a determination as to the medical necessity of the extended stay. If the UR Committee determines that the extended stay is not medically necessary, the attending physician and the patient will receive written notification of this decision within 2 days from the date of determination.

e. If the attending physician does not respond nor contest the findings of the UR Committee's decision the findings are deemed to be final.

f. If the attending physician contests the UR Committee's findings and presents additional information related to the patient's need for the extended stay, at least one additional physician member of the UR Committee must review the case. If the two physicians of the UR Committee determine that the patient's stay is not medically necessary after considering the additional information presented, their determination is deemed to be final.

g. A written notice of the decision will be sent to the attending physician, the patient, and to the Chief Executive Officer of the hospital within 2 days after a final decision is made.

h. A (sic) no time may a non-Physician member of the UR Committee make a medical necessity determination for the appropriateness of extended stay.

i. Following the UR Committee review and determination that an admission or extended stay is justified an extended stay review will be conducted every 7 days thereafter.
i. Note: There are 5 working/business days in a given week identified Monday - Friday. When a holiday falls on a working/business day, the holiday is not counted as a working/business day.

j. Adverse Determination
i. Screening by the non-Physician reviewer indicates that the admission or continued stay is not medically necessary based upon the criteria used, the case is referred for physician review (physician advisor, medical consultant, physician liaison to the medical staff). The physician will determine if the case meets medical necessity criteria. If the physician reviewer determines that the case is medically necessary, the non-physician reviewer will set the next review date per the UR plan.
ii. If the physician reviewer determines that the case does not meet medical necessity criteria, this determination will be referred to the practitioner or practitioners responsible for the care of the patient in order to obtain additional information to substantiate medical necessity and care being provided.
iii. Before making a determination that an admission or continued stay is not medically necessary, the UR committee must consult the practitioner(s) responsible for the care of the patient and afford the practitioner(s) the opportunity to present their views. If the practitioner(s) are unable to provide additional information to substantiate medical necessity, or fail to do so, the case will be referred to the UR Committee for review.
iv. If the committee decides that admission to or continued stay in the hospital is not medically necessary, written notification must be given, no later than 2 days after the determination is made, to the hospital Chief Financial Officer, the patient, and the practitioner(s) responsible for the care of the patient."

On the morning of 2/12/2019, an interview was conducted with Staff #13 and Staff #14. Staff #13 was asked to provide evidence of extended stay reviews for all of 2018. Staff #13 stated that those patients who had a 30-day length of stay were sent to a physician reviewer. Staff #13 stated that the patients who were admitted to the Behavioral Health unit were not included in this process. Staff #13 provided copies of a form titled, "Secondary Physician Review Form" for 5 inpatient medical stays. One of the forms did not have any patient identification information on it so was unable to determine the patient that had been reviewed.

Review of the hospital provided reports for patients who had a 30-day length of stay or greater showed that there were 27 patients with a length of stay of 30 days or longer. Staff #13 stated she had no evidence that the other 22 cases had been reviewed by the Utilization Review Committee.

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


A. ensure that the emergency pull cords and code blue buttons were in the Outpatient Radiology at the main campus and the Radiology Department at the off-site hospital campus area. If there was a patient emergency the staff did not have accessibility to call for assistance during an emergency.

Refer to Tag A0701


B.1. perform fire drills at 1(wound care clinic) out of 2 (wound care clinic and sleep lab) offsite outpatient departments.

2. have documentation of employees participating in fire drills in 2 (1/19 and 2/19) out of 3 (12/18, 1/19, 2/19) months reviewed.

Refer to Tag A710




C. 1. ensure the facilities and equipment were maintained in a manner to promote patient safety in 4 (Operating Room 4, Cardiac Cath Lab hallway, and Cardiac Cath lab Procedure Room 1&2) of 4 areas observed.

2. maintain a locked and secured area for medical gases. The facility failed to maintain the general maintenance on the large oxygen tanks and the metal frame work supporting the copper pipes and shut off valves.

3. ensure that a process was developed, enforced and staff were trained in the safe use of the clothes dryer on the Behavioral Health Unit on the 5th floor.

Refer to Tag A0724

Based on observation and interview, the facility failed to ensure that the emergency pull cords and code blue buttons were in the Outpatient Radiology at the main campus and the Radiology Department at the off-site hospital campus area. If there was a patient emergency, the staff did not have accessibility to call for assistance during an emergency.

This deficient practice had the likelihood to put all patients at risk for serious harm due to not being able to reach the emergency pull cord in an emergency.

Findings include:

Outpatient Radiology Department:

In the Outpatient Ultrasound room on 2/12/19 at 9:30 AM, the emergency pull cord was draped up and over a sign on the wall making it inaccessible to a patient lying on the floor. Also, in the Outpatient Radiology waiting room restroom, the emergency pull cord was only approximately 2 inches long making it inaccessible to a patient lying on the floor.

An interview with Staff #25 on 2/12/19 at 10:00 AM confirmed the above findings.




40989


Radiology Department at the off-site hospital campus:


During an observation tour of the Radiology Department at the off-site campus on 2/12/2019 after 2:00 PM with Staff #96 the following was observed:

In the examination room that was used for Computed Tomography (a machine that uses a combination of x-rays and computers to create pictures of internal organs, bones, and other tissue), there was no emergency call system in place that staff could use to call for assistance during a patient emergency. There was no Code Blue emergency button in the room.

There was a patient restroom located next to the CT (Computed Tomography) room. On the inside of the restroom there was no emergency call system in place for patients to use if assistance was needed.

During an interview with Staff #96 on 2/12/2019 after 2:00 PM, Staff #96 was asked what Staff #96 would do in the event of an emergency? Staff #96 stated, "We have to walk back over to the phone and page overhead for help." Staff #96 also stated, "There was no emergency call button in any of the rooms since the building was built."

Staff #96 was asked how the patients would call for assistance from the restroom if they needed assistance or had an emergency. Staff #96 confirmed there was no call system in the patient restroom for patients to use. Staff #96 also confirmed there was no way for Staff to determine a patient needed assistance or had an emergency without direct observation of the patient in the restroom.

Based on review and interview the facility failed to:

1. perform fire drills at 1(wound care clinic) out of 2 (wound care clinic and sleep lab) offsite outpatient departments.

2. have documentation of employees participating in fire drills in 2 (1/19 and 2/19) out of 3 (12/18, 1/19, 2/19) months reviewed.


1. Review of the fire drills performed for 2018 and 2019 revealed there was no fire drills performed at the offsite wound care clinic. The wound care clinic has three operational hyperbaric chambers.

According to National Fire Protection Association (NFPA) Chapter 14 spells out safety procedures and precautions for hyperbaric chambers:

"Hyperbaric oxygen therapy (HBO2) involves breathing near 100 percent oxygen in an environment in which the atmospheric pressure is raised to three times higher than normal, in either a multi-person or a single-person chamber.
According to a 1997 study published by the Undersea and Hyperbaric Medical Society, from 1923 to 1996, 77 deaths resulted from 35 fires in clinical hyperbaric chambers. Fires and explosions in HBO2 facilities worldwide have been caused by static electricity, electrical devices, chemical hand warmers, and other sources.
However, the risk of fire in a hyperbaric chamber or environment is a major concern for several reasons. Fires begin under three conditions, adequate fuel, sufficient oxygen, and a source of ignition. Therefore, by definitions these chambers are a high oxygen environment in which fuel is always present in the form of cloth, paper, etc. In turn, the potential fire risk is always present during treatment. Furthermore, fast evacuation is not possible due to the nature of the pressurized chambers and it is also difficult to rapidly ventilate the smoke and fumes that come along with fires."


2. Review of the policy and procedure "Fire Prevention" revealed:

"1.) Fire drills will be held one per quarter per shift in different zones.
4.) The drills will be evaluated and critiqued and presented to the Safety (EOC) Committee.

Respiratory Therapy 1.) Therapist or technicians on duty will report to the scene of the fire. Maintenance proceeds to the scene of the fire. All maintenance staff should carry a fire extinguisher to the scene of the fire. Maintenance to determine extent of the fire and inform PBX Operator to call Fire department when necessary.

Security 1.) When a fire alarm is activated after hours during weekends or anytime on weekends and holidays, the Security Guards will proceed to the fire scene."

Review of the fire drills conducted at the main campus revealed the fire drills conducted in December of 2018 had been documented and a sign in sheet was attached. The employees involved in the drill had signed in to show participation in the drill.

Review of the fire drills documented for 1/2019 and 2/2019 revealed there was no sign in sheets. There was no documentation that the required personnel were present for the drill.

An interview was conducted with Staff #28 in the afternoon of 2/12/19 concerning fire drills. Staff #28 stated, "We have not been doing fire drills at the wound care clinic. We will start doing them now." No plan was offered in how the drill will be conducted and how the Hyperbaric chambers would be considered. Staff #28 stated that she did not have sign in sheets attached to the drills for 1/19 or 2/19 drills.

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

1.) ensure the facilities and equipment were maintained in a manner to promote patient safety in 4 (Operating Room 4, Cardiac Cath Lab hallway, and Cardiac Cath lab Procedure Room 1&2) of 4 areas observed.



2.) maintain a locked and secured area for medical gases. The facility failed to maintain the general maintenance on the large oxygen tanks and the metal frame work supporting the copper pipes and shut off valves.


3.) ensure that a process was developed, enforced and staff were trained in the safe use of the clothes dryer on the Behavioral Health Unit on the 5th floor.


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



During an observation tour on 2-13-2019 after 10:30 AM, the following was observed at The main hospital campus:


OPERATING ROOM 4

There were exposed wires on an electrical power cord that was hanging from the ceiling in OR 4. The black coating covering the wires had pulled away from the plug at the point where the plug and cord attach; exposing the electrical wires. The electrical cord with the exposed wires had an extension hooked into the plug that allowed the electrical plug to be utilized in the operating room.

There was an electrical cord with an extension hooked into it that was hanging down on the floor behind two stepping stools. The cord had been tucked behind the stepping stools, and the stepping stools were pushed against the wall. The electrical cord was in an upright position between the wall and the stepping stool.

In an interview with Staff #95 on 2-13-2019 after 10:30 PM, Staff #95 said the operating room had been in use for patient care until the morning of 2-13-2019. Staff #95 said the room had been closed for an unrelated problem.

Staff #95 confirmed the above findings.


During an observation tour on 2-14-2019 after 11:00 AM, the following was observed at The Main Campus.


CARDIAC CATH LAB

There were three Pacemaker Programmer/tester/implantable machines stored in a cove located in the Cardiac Cath lab department. The pacemaker machines were all from different manufacturers. One machine was from Abbott, one was from Medtronic, and the third one was from Boston Scientific. None of the pacemaker machines had been checked by the biomedical department for electrical safety. There were no Preventative Maintenance stickers on the machines.

In an interview with Staff #76 on 2-14-2019 after 11:00 AM, Staff #76 was asked how long the pacemaker machines had been in the facility. Staff #76 said the machines had been there as long as she could remember, over 10 years. Staff was asked if the machines were being used on patients. Staff #76 confirmed they were.

There was a Volcano Ultrasound machine stored in a cove next to the pacemaker programming/testing machines. There was a Phillips Health Care Equipment sticker on the machine with an ID #66877685 on the sticker. There was a sticker on the machine labeled, "Lease/Rental". There was a date on the machine of 12-2017 as the last date checked by a tech with the initials HR. The expiration date was 12-2018; almost two months ago. Staff #76 confirmed the dates on the ultrasound machine.

In an interview on 2-14-2019 after 11:00 AM, Staff #98 was asked who was responsible for checking equipment that was brought into the facility. Staff #98 said it was the Bio-Medical department's responsibility. Staff #98 confirmed that the pacemaker programmer/testers did not have any Preventative Maintenance check or electrical safety check. Also, Staff #98 confirmed that the Volcano ultrasound machine was due for inspection 12-2018; almost 2 months ago.


Review of the "Multi-Vendor Biomed Operations Policy Manual 5100-011, Rev K. Chapter 18, Inventory and Incoming Inspections" revealed the following:

" ...Permanent equipment shall receive a permanent ID tag. Short term rental and non-hospital owned equipment shall receive a uniquely numbered yellow inventory sticker; this assigns it a control number beginning with T, identifying it as temporary equipment.
...Short term rental, and non-hospital owned (to include evaluation, patient and physician owned)
...Perform electrical safety and performance test or verify that a current PM and safety has been completed by the vendor ..."


CARDIAC CATH LAB PROCEDURE ROOM 1&2

There was a power strip cord on the floor next to an IV pole in Procedure room 1. The power strip outlet had two power cords plugged into it.

There was a power strip cord on the floor next to an IV pole and Cath Lab supply cabinet in Procedure room 2. The power strip outlet had two power cords plugged into it.

In an interview with Staff #76 on 2-14-2019 after 1100 AM, Staff #76 confirmed the power strip outlet cords were laying on the floor. Staff #76 said the electrical power strip cords were mounted on the IV poles previously and she wasn't sure why they were removed from the poles.


Review of the NFPA 99 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."





32143



During a tour of the facility on 2/12/19 the following issues were found:

Outside of the loading dock area a fenced area was found holding oxygen bottles and other gases. The area was found unlocked and unsecured.

2 large industrial oxygen tanks were found to be in a fenced concrete area. The oxygen tanks had copper lines and shut off values that joined and came together to a main shut off valve. The metal frame holding the pipes was heavily rusted on the bottom of the frame. Large pieces of metal were missing causing the framework to be weak and fragile. The 2 large oxygen tanks were rusted and needed general maintenance.


36827



On the morning of 2-13-2019, a tour of the Behavioral Health Unit on the 5th floor was made with Staff #102. A laundry room was observed to contain a washer and dryer for cleaning and drying patient clothing. The dryer was observed to have a large amount of lint in the lint trap. The top edge of the lint was light in color with another layer of dark colored lint over it.

Interview was conducted with Staff #102 at the time of the tour. Staff #102 stated the Mental Health Technicians (MHT) were responsible for washing and drying the patient's clothing.

Staff #113, MHT, was interviewed at the time of the tour. Staff #113 was asked if she had any specialized training for processing laundry or had any policies. Staff #113 stated the only training she had was from the nursing staff. When asked to describe her training, Staff #113 stated she had been told to get a paper bag, put the patient's room number on the bag, and put the patient's clothing in the bag. She had been told to always finish the laundry she started on her shift and to make sure the patient got all of their belongings back. Staff #113 stated, "That's about it."

Staff #113 didn't relay any information about checking the washer and dryer for safety of use prior to using, cleaning out the dryer lint trap to prevent lint build up between use that could potentially start a fire, or how to clean the equipment between uses.

Review of the policies table of content for the Behavioral Health Unit did not show any policies pertaining to the laundering of patient clothing. Staff #4 was asked on the afternoon of 2-13-2019 for policies pertaining to the laundering of patient clothing. No policies were alleged or provided.

Training for staff on the Behavioral Health Unit was reviewed with Staff #91 on the afternoon of 2-14-2019. No evidence of training for processing patient laundry, to include care of the equipment, was found.

Based on review, observation, and interviews the facility failed to maintain a sanitary hospital environment and mitigate risks of possible hospital acquired infections in 13 (Emergency Room, Laundry, Housekeeping, Maintenance,Central Supply, Inpatient Rehabilitation, Behavioral Health, Surgery, Cardiac Catherization Lab, Radiology, Lab, Pharmacy, Medical Surgical) of 13 departments.

Refer to Tag A0749

Based on review, observation, and interviews, the facility failed to ensure the infection control officer developed a system that maintained a clean and sanitary environment. The facility failed to maintain a sanitary hospital environment and mitigate risks of possible hospital acquired infections in 13 (Emergency Room, Laundry, Housekeeping, Maintenance,Central Supply, Inpatient Rehabilitation, Behavioral Health, Surgery, Cardiac Catherization Lab, Radiology, Lab, Pharmacy, Medical Surgical) of 13 departments.



Findings include:

A tour was conducted with Staff #63,7,62,64,65, and 28 on 2/12/19.

Emergency Room:
The public restroom was heavily soiled. The commode was soiled on the base and bowl with hair, dried urine, and unidentifiable black substance around the base. The floor was soiled with dirt, dust, hair and a sticky substance.
A shop vacuum was found sitting next to the x-ray equipment in the hallway. The shop vacuum was heavily soiled with dirt and had a hand made handle made out of frayed duct tape.

Seven rolling IV poles were found with rusted bases, wheels, and chipped paint in the clean storage.
Three bedside commodes were found to be rusted on the legs and metal frames in the clean storage.
The soiled utility room was found to have open biohazard trash within touching distance of the dirty laundry. Soiled bedside commodes were found stacked up against the laundry.

Main Laundry Storage Area:
There was no adequate storage for the bins in the laundry room. Shelves of patient gowns, sheets, and pads were found sitting uncovered. The items were exposed to dirt and dust off of the soiled floor. 4 carts were found with scrub/uniforms, used in surgery and obstetrics. The uniforms were uncovered and exposed on open carts with soiled laundry bins pushed up against them.

Racks of drapes and mesh hanging room dividers were found uncovered. Pillows, a rolling stool, and a bottle of liquid was sitting on top of a rack. So many containers were crammed in the room the surveyor was unable to get to the back of the room to inspect the racks against the wall. Surgical towels and patient towels were found unwrapped and exposed to dust and debris.

Biohazard Room:
A room was found in the first floor hallway with clean biohazard trash containers and unused sharps containers. The clean supplies were found stored in the same room with the soiled laundry waiting for pick up. An employee's jacket was found laid across a soiled trash can next to the clean supplies.

An interview was conducted with staff #7 in the morning of 2/12/19. Staff #7 reported that there was no space for the laundry storage and that's why it was sitting in the hallway when surveyors arrived. Staff #7 was not aware he could not store soiled laundry with clean supplies. Staff #7 stated, "We will try to find another place for the dirty laundry to go before pick up."

Outside Walkway for Loading Dock and Trash:
A uncovered concrete walkway was found leading to the trash bins. Outside the door of the walkway broken dustpans and brooms were found lying on a water hose. 2 Rolling 30-gallon trash cans were found upside down on the walkway. The trash barrels had been cleaned and were drying according to Staff #7. The base on the wheels were heavily soiled with dirt, hair and mold.

7 large, plastic, blue, rolling containers were sitting on the walkway. Inside the open containers were bags of dirty laundry. Some of the laundry was bagged and some of the bags were open. The laundry had been exposed to the rain and was wet. There was standing water in the bins. The laundry was not covered or protected to prevent the spread of infection.

A large commercial trash compactor was found sitting at the end of the walkway. The ground around the compactor was found to be littered with trash, wood pieces, and metal objects.
Next to the compactor was an industrial metal trash container. The container had no cover and was opened to elements and surroundings. Trash bags, card board, soda bottles, and food was found in the open container. The bottom of the container had a rusted out bottom with large holes. The trash was not protected from rodents or bugs. The trash was not contained and was allowed to spill out onto the hospital parking lot during the rain.


Maintenance Department:
In the maintenance department, the framework to the water pumps, were heavily rusted. Maintenance failed to maintain a clean work area around the pumps.




Cooling Tower Area:
2 - 5 gallon buckets were filled with rain water sitting outside in the cooling tower area. Water sitting stagnate can be a vessel for waterborne diseases.


Central Supply:
Sitting outside the loading dock, on a wooden pallet, 8 cardboard boxes of soap was found. The boxes were wet and trash was found sitting on top of the boxes.

The central supply room holds medical supplies and items needed for hospital use. Opened boxes of medical supplies were exposed to soiled shipping boxes and some items were found sitting on top of soiled boxes.

An interview was conducted with staff #66 and #63 in the afternoon of 2/12/19. Staff #66 reported that the supplies are brought to the loading dock and unpacked as needed. Staff #66 was asked what area was designated dirty and what area was designated for clean. Staff #66 reported there was no designated clean or dirty area in the central supply area. Staff #63 confirmed there was no dirty, to clean, to patient system in the central supply area. Staff #63 stated, "It just needs to be reorganized. We need to make sure the areas are designated to prevent clean items from mixing in with dirty items."


36827

Finding for the Inpatient Rehabilitation Unit included:

On the afternoon of 2-12-2019, a tour of the inpatient rehabilitation unit on the 5th floor was made with Staff #103 and Staff #104.

Room #512 was identified as a terminally cleaned room (ready to receive a patient). The patient bed had linens on it. The white lines were observed to have black smudge marks on them. The sheets were removed to expose the mattress. The mattress was observed to be soiled with dirt and debris on it. The mattress was lifted to expose the metal bed frame underneath. The metal bedframe was observed to be rusting in areas and soiled with dirt and debris. The hinged bracket that controlled the side rail was observed to have dark matter collected in the plastic grooves. The hinge area was observed to have a dried matter on it. The bedside table, top drawer, was observed to have a dried spill inside the drawer. A small couch that made out to a bed was observed in the room. The arms of the couch had large nicks in the finish. The exposed material underneath was a porous material. Porous surfaces absorb dirt and bacteria and cannot be adequately cleaned between patients. The couch was made of cleanable material; but was observed to have dirt collected in the pleats of the material. The cushions were removed from the couch. The area underneath the cushions was observed to have hair, dirt, and debris. One of the back-rest cushions that had been removed was observed to have a dried spill that ran down the cushion and had dried on the bottom edge of the cushion. The bathroom shower area was observed to have a shower chair covered in plastic to indicate it had been cleaned. The plastic was removed and the chair turned over. The underside of the chair was observed to be visibly soiled. The corner of the bathroom between the toilet and wall was observed to be visibly soiled. The caulking between the toilet and floor was observed to be degraded and missing in places. The area between the old caulking and toilet base was observed to be visibly soiled.

The soiled utility room was observed to contain regular trash and biohazard trash. - The trash container had been recently emptied and replaced. The empty replacement container still had trash in it from another area of the hospital. It contained food boxes, medications, and unused needles in the package. Items for staff and patient use were observed to be stored in the contaminated room. Items included a box of Christmas cards, the back cover for a portable wound vacuum (used to help with wound healing), single-patient-use stethoscope (used to listen to heart and lung sounds), single-patient-use thermometer, and isolation gowns for use when a patient has an infection. The room was observed to have a liquid-waste disposal system (commonly referred to as a hopper) that resembles a toilet. The hopper was observed to have standing water in it with a yellow ring buildup at the water line. The walls of the room were observed to have scuffs and gouges in them that exposed the porous wallboard beneath the finish. The porous material was able to absorb dirt, moisture, and bacteria and provided a place for potentially infectious bacteria to be harbored and spread from. Plastic signs used to warn the public about slip hazards on wet floors were being stored in the biohazard room, potentially allowing the spread of infection.

An alcove off of the hallway was observed being used to store wheelchairs readily available for patient use. Four of the wheelchairs were checked and found to contain patient items from previous use in the pockets of the chair, including a Valentine's Day Card, a pair of hospital-supplied non-slip socks, a compact disc containing patient medical records from another facility, and oxygen tubing. One chair was found to have the metal seat frame visibly dirty.

The medication room contained a small medication refrigerator underneath a counter. The top door edge and seal was observed to have white granules and dust on it. Trash was observed on the floor between the refrigerator and the wall. An empty medication capsule was found on the bottom door shelf and top door shelf along with white granules.

Clean-supplies storage bins were observed to be dusty and dirty. Clean-supplies storage cart was observed to be dirty.


Findings for the Behavioral Health Unit included:

On the morning of 2-13-2019, a tour was made of the Behavior Health Unit on the 5th floor with Staff #102. This unit was identified in policies and reports as Geropsych, but currently served adult psychiatric patients, as well as geriatric psychiatric patients.

The Soiled Utility / Biohazard Room was observed. The walls of the room were observed to have scuffs and gouges in them that exposed the porous wallboard beneath the finish. The porous material was able to absorb dirt, moisture, and bacteria and provided a place for potentially infectious bacteria to be harbored and spread from. A broom and dustpan used throughout the unit were observed to be stored in the room with trash and potentially infectious biohazard material. Dining room food trays were observed to sitting on top of a soiled linen cart and next to an open container used for biohazard waste. These trays were waiting to be picked up and taken back to the kitchen. An eyewash station with disposable bottles of eyewash liquid were stored on the wall in a manner that left the bottles exposed to the room with the trash, dirty linen, and biohazard waste.

A mobile medication dispense computer cart was observed to be sitting the hallway unattended. The keyboard and keyboard tray were observed to be visibly soiled with dust and dried spilled material.

Hand rails on the walls in the South Wing and West Wing were observed to have the endcaps missing. The handrails contained a buildup of dirt and debris inside of the handrails.

A laundry room was observed to contain a washer and dryer for cleaning and drying patient clothing. The top of the washer was observed to be visibly soiled when the lid was raised. The dryer lint trap was observed to have a large amount of lint in it. The inside of the dryer door and seal had fibers and lint particles on it.

Interview was conducted with Staff #102. Staff #102 stated the Mental Health Technicians (MHT) were responsible for washing and drying the patient's clothing.

Staff #113, MHT, was interviewed. Staff #113 was asked if she had any specialized training for processing laundry or had any policies. Staff #113 stated the only training she had was from the nursing staff. When asked to describe her training, Staff #113 stated she had been told to get a paper bag, put the patient's room number on the bag, and put the patient's clothing in the bag. She had been told to always finish the laundry she started on her shift and to make sure the patient got all of their belongings back. Staff #113 stated, "That's about it."

Staff #113 didn't provide any information on how to ensure patient clothing was being properly sanitized either by the detergent being used or the temperature of the water. Staff #113 did not provide any information about the cleaning and care of the washer and to prevent

Review of the policies table of content for the Behavioral Health Unit did not show any policies pertaining to the laundering of patient clothing. Staff #4 was asked on the afternoon of 2-13-2019 for policies pertaining to the laundering of patient clothing. No policies were alleged or provided.

Training for staff on the Behavioral Health Unit was reviewed with Staff #91 on 2-14-2019. No evidence of training for processing patient laundry, to include care of the equipment, was found.

Room 535 was identified as a terminally cleaned room that was ready to receive a patient. The pillowcase was removed from the pillow. The impermeable cover of the pillow was observed to be torn. This would prevent proper sanitization of the pillow between patients and allow bacteria and infectious material to collect and be spread from patient to patient. The bed sheet was observed to have black particles on it.

A patient nutrition area was located at one end of the nurse station. The refrigerator that contained patient food and drink was observed to have dirt particles collecting in the folds of the door seal. When the refrigerator door was opened, the floor could be observed to be heavily soiled. A blue plastic bin inside the door was observed to be soiled. The shelf that the blue plastic bin was sitting on was soiled. The bottom interior shelf was visibly soiled with a dried purple substance and other matter. The crisper drawers contained dirt and debris. The shelf under the crisper drawers was soiled with hair and debris. The edge of the crisper drawer had a dried purple substance on it. The counter top next to the patient drinking cups appeared to be stained. When the counter stain was lightly wiped with a damp Sani-Cloth, the blue stain came off easily onto the cloth. The open stack of patient drinking cups was in close proximity to the automatic hand sanitizer dispenser, allowing for possible chemical contamination of drinking cups. A cabinet was used to store patient food items. Bins inside the cabinet used to store patient food items were visibly soiled with dried food matter, dust, and dirt. The inside walls, doors, and shelves in the cabinet were visibly soiled with dried spills and dirt. A jar of instant ice tea mix was observed on a shelf. The lid was visibly soiled. Approximately ¾ of the jar content had been used. The container did not have any identification of when the jar had been opened or how long the opened jar had been on the shelf.


The Clean Equipment Room was observed. A gait-belt used to assist patients who have a difficult time walking was observed to on a cart with equipment ready for use. The gait-belt was visibly stained and dirty. A plastic container attached to a machine used for checking vital signs was observed to have dried matter in the bottom of the container. Two machines for checking blood pressure were ready for use. Both had single-patient-use blood pressure cuffs attached. Both cuffs were observed to be dirty. Staff #20 confirmed that the staff had been using the cuff between patients instead of single-patient-use. A rolling tank holder used to transport oxygen bottles was observed to be rusted and dirty at the base and the attaching bracket. Rusted surfaces trap bacteria and moisture, providing a surface for bacteria to grow. A rolling cart used to transport patient belongings was available for use. The top and bottom shelf was observed to be visibly soiled with dried spill, dust and dirt.

Room 528 was originally designed to be a room to isolate patients with airborne infectious diseases. The room had an "ante-room" designed for staff to be able to enter and put on protective equipment. A patient had been admitted to the room the previous day. The ante room was found to have unlocked drawers in it. Inside of one of the drawers was trash, dirt, and a Styrofoam cup with a lid on it. The lid was removed to observe the content. The cup had contained a liquid that appeared to have been approximately half full based on the dried ring of substance around the cup. The cup had been in the drawer long enough that the liquid had all evaporated and left a dried dark brown substance in the bottom of the cup. The locked cabinet doors were visibly dirty with dirt and dust build-up in the recessed handles. The ante-room walls were observed to have large religious drawings on them in pencil.


39801

During an observation tour on 2-12-2019 after 8:30 AM, at the offsite campus, the following was revealed:


STERILE INSTRUMENT STORAGE ROOM
There were bins that stored sterile surgical instruments with a buildup of dust, dirt and debris.

OPERATING ROOM 1
There were two Carbon Dioxide tanks stored on a cart used for laparoscopic procedures that were coated in rust.

ANESTHESIA WORK ROOM
There were corrugated boxes stored in a drawer. The boxes contained the surgical instrument alligator clips in one box, and a peripheral nerve stimulator in another box.

OPERATING ROOM 3
There were two Carbon Dioxide tanks stored on a cart used for laparoscopic procedures that were coated in rust.



During an observation tour on 2-13-2019 after 9:00 AM, at the Main Hospital Campus, the following was revealed:


PACU (POST ANESTHESIA CARE UNIT)
There was suction tubing stored hanging from the suction canisters. The suction tubing was open and exposed to external contaminates.


OPERATING ROOM 4
There were step stools stored against the wall that were covered in a coat of dust, dirt, and debris. There was a bottle of Flumazenil (A Benzodiazepine antagonist indicated for the reversal of the sedative effects of benzodiazepines) stored in the Pixis (Medication Dispensing Unit) that expired 10/2018; 4 months ago. There was an Intravenous Bag of Lactated Ringers Injection solution that expired 10-2018; 4 months ago.

STORAGE ROOM FOR OR ROOMS 5-8
In the Supply/Equipment/Instruments for OR 5-8, there was a rack holding OR positioners and equipment. The bottom shelf had a plastic liner with cracks and peeling paint. This rack was in a room with sterile surgical instruments. There was a rack holding OR positioners and equipment. The prone positioner had cracks and tears in the outside vinyl covering. On one side of the prone positioner there was a flap that opened up. The inside of the flap had a white cloth covering the positioner pillow that was permeable and would allow irrigation fluids and bodily fluids to be absorbed. The vinyl coverings on the wedge positioners were cracked and torn which would allow fluid and bodily fluids to seep inside.

There were three metal carts used to store surgical cases that had been pulled and put into the carts for the next day. The bottom rail of the metal cart had cracks and a buildup of dust, dirt, and debris around the edges. There was rust on the wheel casters.

OR HALLWAY
There was an orthopedic fracture table used in surgical cases to position patients. The foot holder was stained with a brownish color. The inside of the foot positioner was made of a permeable cloth that would allow liquids and bodily fluids to soak into the cloth. The bottom base of the orthopedic fracture table used in surgical cases to position patients was coated in dust, dirt, and debris. The surveyor was able to write a letter in the dust build up on the base. The base of an IV (Intravenous) pole was coated in dust and dirt. The pole was stored in the OR hallway.

EVS (ENVIRONMENTAL SERVICES STORAGE ROOM) IN THE OR HALLWAY
A bin in the Environmental Services storage room located in OR Hallway was coated in dust and debris. A vinyl cover that covered a metal rack containing cleaning supplies located in the environmental services room had cracks and peeling on the vinyl coating. The wheel casters were covered in rust. There was a drain in the floor. The drain and floor around the drain, were coated in a black substance along with dust, dirt, and debris.

SUPPLY ROOM FOR CYSTOSCOPY SUPPLIES
There was a basket of Saline irrigation used in surgical cases that was stored on top of a counter top next to Sani-Wipes (Detergent used to sanitize surfaces in the OR). Surgical supplies used in cystoscopy procedures were stored in a cabinet under the counter. In the back of the cabinet there was an electrical outlet. There was also an opening in the back wall that had plumbing exposed. Below the plumbing valve there was a hole in the wall that appeared to be a drain hole.

GI LAB PROCEDURE ROOM
A storage cart in an endoscopy procedure room had missing chips of paint and rust on the cart. The wheel casters were coated in rust.

CARDIAC CATH LAB PROCEDURE ROOM 1
The trash bin had an open lid exposing the procedure room to contaminates from the trash. The floor in Cath Lab procedure room #1 had paint that was peeling and chipped. The linoleum floor was separated from seams exposing the subfloor in Cath Lab procedure room #1. There were carts with wheel casters covered in rust. There was a crate labeled Biomedical waste. The crate was being used to dispose of non-biomedical waste. The can was used as a trash can. There was a patient roller board that had cracks and tears in the vinyl covering. The plastic covering on medical radiology equipment was cracked and missing pieces of plastic.

CARDIAC CATH LAB STORAGE ROOM
There was a linen cart that stored patient linen and gowns. The cover for the cart was too small to cover the entire cart; thus exposing the linen to external contaminates. There was a cart used to store patient Linen rolls and patient gloves. The cart was coated in rust. The wheel casters were coated in rust, dirt, and debris.

LAUNDRY AND LINEN - OR SCRUBS

During an observation tour on 2-14-2019 after 2:00 PM, the following was observed:

There was a cart located in the hallway of the 1st floor labeled as Linen Services that contained trash and cardboard boxes. There was a linen cart in the hallway that contained bags of Operating Room scrubs. The bags that stored operating room scrubs had tears in them exposing the scrubs to outside contaminates. In the EVS Linen and Laundry storage room, there were Operating room scrubs stored on carts uncovered. Also, in the EVS Linen and Laundry room, there were Operating room scrubs stored in a cardboard box. There were large linen transport carts that stored linen/laundry in the room. The linen/laundry were stored in thin clear plastic bags. There was no external cover for the cart.

Staff #7 said the facility used a contract vendor for laundry and linen. Staff #7 said the facility had recently changed to this contract vendor. Staff #7 was asked to demonstrate the flow of linen and laundry into the facility. Staff #7 said the contract trucks bring the laundry and linen to the back dock. The contract linen company employees unload the linen carts to the back dock. The carts are then taken to the EVS Linen and Laundry room to be stored. During the observation tour, there were no deliveries of laundry and linen for observation.

During an interview with Staff #7 on 2-14-2019 after 2:00 PM the following was revealed:

Staff #7 said the facility did not have any policies or procedures that addressed how linen was transported to and from the facility. Staff #7 was asked how the facility ensured that laundry and linen was transported in a sanitary manner. Staff #7 said the contract company provided the facility an agreement and guarantee when the contract was signed. Staff #7 said the facility had not incorporated Laundry & Linen into their QAPI (Quality Assurance/Performance Improvement) as of 2-14-2019. Staff #7 said the contract was new and the facility was trying to incorporate evaluations, but had not completed that as of 2-14-2019.



29191

ULTRASOUND DEPARTMENT:

A tour of the ultrasound department with Staff #68 on 02/12/2019 at 3:11 PM the following findings were observed:

1. The transvaginal probes were being stored in a plastic bag in drawer of a brown plastic cabinet in the ultrasound room.

The storage of transvaginal probes was evidence-based national guidelines, such as the ANSI/ AAMI ST58:2013 "Chemical Sterilization and High-level Disinfection in Health Care Facilities"

"Store the device in a manner that will protect from damage or contamination and that is consistent with national guidelines and manufacturers' recommendations such as hanging vertically in a cabinet and storing in a clean environment."

If there is any moisture on the probes, condensation can occur inside the plastic bags and microbial growth could occur.

A porous surface, like wood, holds moisture and dirt and would promote microbial growth and mold.

An interview with Staff #68 on 02/12/2019 at 3:11 PM confirmed the above findings.


40989

An observation tour was conducted on 2/12/2019 after 9:00 AM at the off- site campus with Staff #3 and Staff #87, the following findings were observed.


STERILE SUPPLY ROOM
Multiple black plastic bins, used to store sterile supplies and equipment, were noted to have dirt and dust lining the inside and outside of the bins.


OPERATING ROOM #1
A patient moving device (roller), secured to the wall by a metal rack was observed to have tears on the vinyl covering preventing adequate sanitation of the roller.


DECONTAMINATION ROOM
There was an empty metal rack mounted to the wall above the sink. Staff #87 was asked what it was used for. Staff #87 said it holds a biohazard bin. The metal rack was noted to have several rust colored stains. Above the empty metal rack, the wall was soiled with brown colored stains and six holes exposing the sheetrock. Sheetrock cannot be adequately sanitized to prevent the spread of infections.


SUB-STERILE ROOM LABELED 1144
1. Inside of the drawers were heavily soiled with dust, dirt, and debris.
2. The corner of the wall was noted to have chipped paint exposing the sheetrock.

Staff #3 and Staff #87 confirmed the findings.



On 2/13/2019 after 9:00AM an observation tour was conducted at the main hospital campus in the Surgical Services department with Staff #19 and Staff #24.

HALLWAY COVE IN THE SURGERY DEPARTMENT
There were sliding metal shelves that stored clean patient supplies. On the top shelf was a corrugated box stored next to clean patient supplies.

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 ..."



Review of ANSI/AAMI ST79:2017 revealed the following:

"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 ..."


OPERATING ROOM #1
1.There was a blue metal cart that held a Valleylab generator for a cautery device (a machine used to cauterize bleeding vessels and cut through tissue). The cart was heavily soiled with dirt, dust, and debris. The cart also was noted to have chipped paint exposing the bare metal. The wheel casters were noted to have a rust colored stain and heavily soiled with dirt, dust and debris.

2. The mobile white stand used to hold four suction canisters was soiled with brown colored dirt, dust, and debris on the base.

3. 2 of 2 rolling chairs had chipped paint and rust on the base. The chairs were heavily soiled with dirt, dust and debris.

4. The mattress on the operating table was torn in several places exposing the material under the vinyl covering. The frame was noted to have chipped paint exposing the metal. The Velcro attached to the bed that secures the mattress in place was noted to be soiled with a reddish/brown stain and covered heavily in dirt, dust and debris.

An interview with Staff #24 was conducted on 2/13/2019 after 9:00 AM. Staff #24 was asked if the soiled Velcro was covered with dried blood. Staff #24 could not confirm nor deny if the stain was dried blood.


Staff #19 and Staff #24 confirmed the findings.


POST ANESTHESIA CARE UNIT (PACU)
The Malignant Hyperthermia Cart was noted to have 2 expired patient care items. A Foley Catheter with an expiration date of 07/2018 and a Multi-Lumen CVC, (Central Venous Catheter) kit expired 12/2018.

Staff #70 confirmed the findings.

ENDOSCOPY 4
1. A three tier rolling metal cart was noted to have rust, dirt, dust, and debris. The sides and front of the cart had several areas of green paint. The wheel casters were heavily soiled with dirt, dust, and debris.

Staff #24 confirmed the findings.


40990

OUTPATIENT RADIOLOGY:

On a tour of the Outpatient Radiology area on 2/12/19 at 9:35 AM with Staff #8, #11, and #25 the following findings were observed:

1. In the Cat Scan (CT) imaging room stacks of partially covered linen were located on top of a refrigerator and on top of a warmer both in close proximity to where the patient would lie on the table for a procedure.

2. In the CT room a rolling bedside table had rust on the legs and wheels.

3. In the CT room old broken tiles were located under the sink.

4. Water stained ceiling tiles were located in the Control Room, Patient Restroom, and Ultrasound Room.

5. A water leak with a corroded pipe under the sink was found in the Ultrasound Room.

6. Dead bugs were found on the floor in the Radiology Reading Room
.
7. Dirty floor with bugs and trash found in the MRI Computer Room.

8. Dusty old fans with the last dated PM of 8/17 were found in the Radiology Reading Room.

9. Broken tile lifting off of the floor were found in the X-ray room.

10. The" in-use" light cover above the X-ray room door was detaching from the electrical box.

11. Paint peeling off of wall in CT and MRI control area leaving exposed sheet rock.


An interview with Staff #25 on 2/12/19 at 10:00 AM confirmed the above findings.



10135

LAB AT OFFSITE HOSPITAL CAMPUS

During an observation on 02/12/2019 after 10:30 a.m., a door to a room was labeled as being a Biohazard area. There was a sign on the door that read "DANGER FORMALDEHYDE Potential Cancer Hazard.."

A shower station was in the room and the floor of the shower was soiled with brown build-up. A container of unused blood vacutainer tubes, a box of open clean gloves and a container with patients' specimens were stored on a cart in the room.

Another cart was pushed against this cart of supplies which contained a box of formaldehyde solution Formalin.
Staff #57 confirmed the observation and reported that the patients specimens on the cart were going to be sent out to the Main campus to be resulted.

There was no separation of clean and dirty.


EMERGENCY DEPARTMENT AT OFFSITE HOSPITAL CAMPUS

Respiratory carts containing clean supplies were stored in a room off the ED.
Unbagged oxygen regulators were stored in the carts on top of clean supplies. There was no way to tell if they were clean or not.


ED CRASH CART AT THE OFF-SITE HOSPITAL CAMPUS

Unbagged oxygen regulators and laryngoscope handle were stored in the carts with clean supplies. There was no way to tell if they were clean or not.

Staff #47 confirmed the observations.



PHARMACY AT THE OFF-SITE HOSPITAL CAMPUS

A storage room contained cardboard boxes which had shipping labels on them. The boxes contained the following:

Bags of sterile intravenous fluids;
Boxes of Ominipaque which is a sterile contrast used for x-rays;
Boxes containing antibiotics. Some of the bags of antibiotics had been removed from the shipping boxes and

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

A. change the cold disinfection solution (Rapicide PA) every 21 days per the manufacturer guidelines for the high level disinfecting of the endoscopy scopes.

B. change the 1 Micron filter, .45 Micron filter, 0.2-Micron water filter, air filter, and the Carbon filter per the manufacturer guidelines for the Medivator scope reprocessor (washer).

C. ensure there were qualified and trained staff at the off-site campus to wash and process endoscopy scopes for disinfection after they were used on patients.

D. ensure that endoscopes stored in a drying cabinet were disinfected per AORN (Association of Registered Nurses) guidelines. The facility did not have a process to ensure that endoscopes would not be used on a patient after the recommended hanging time at the offsite campus. Also, the facility did not have a policy on endoscope storage/hang time to ensure they were not used on a patient past AORN recommendations.

E. ensure that High level disinfectant test strips were not used past the expiration date. The Rapicide PA test strips were open on 10-3-2018. The test strips have a four-month shelf life after opened. The test strips were still in use 2-12-2019; 9 days after the expiration date.

F. ensure that there was separation of soiled or contaminated supplies and equipment from the clean or sterilized equipment at the offsite campus in 1 (Sterile processing department) of 1 area observed.

G. ensure that Surgical Instrument sets that contained implants (Screws) were not released from the Sterile Processing department prior to the biological test resulting at The main hospital campus and the off-site hospital campus. There was no way to determine conditions were met to kill a specified amount of microorganisms for a sterilization process prior to releasing the implants to storage or the operating room for surgery.

H. ensure surgical instrument sets had a visible external chemical indicator in 3 (Orthopedic/General instruments) of 3 surgical instrument sets observed. The external chemical indicator was faded and there was no way externally to determine if the items had been exposed to the sterilization process.



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



Findings Include:


During an observation tour on 2-12-2019 after 2:00 PM the following was observed:


Review of the facility document titled. "Filter Change Log - Off Site Campus" revealed the following:

A. The last disinfectant change for the Rapicide PA was 8-27-2018, almost 5 ½ months ago. According to the Manufacturer IFU (Instructions for Use) the Rapicide should be changed at a maximum of every 21 days.
Review of the Endoscopy Schedule for the offsite campus revealed that 41 endoscopy procedures as of 2-12-2019 had been performed since the Rapicide PA detergent expired. The Rapicide PA was changed 8-27-2018 and expired 9-17-2018.


B. The last 1 and .45-micron filter changes noted were 8-14-2018, almost 5 months ago. According to the Manufacturer IFU these filters should be replaced every 3 months.

The last 0.2 Micron filter change noted was 4-20-2018; almost 10 months ago. According to the Manufacturer IFU this filter should be replaced every 6 months.

The last Waterline Disinfection (Internal Water Filter) Change noted was 4-20-2018. According to the Manufacturer IFU this filter should be replaced every 6 months.

The last Air Filter change was 9-20-2018, almost 4 ½ months ago. According to the Manufacturer IFU this filter should be changed every 3 months.

The last Disinfectant Filter change was noted on 11-25-2018, almost 2 ½ months ago. There was no documentation that the filter had been cleaned since that time. According to the manufacturer IFU this filter should be cleaned monthly and replaced when needed.



Review of the IFU (Instructions for Use) from Medivator for "DSD Edge" revealed the following:

" ..... TASK 3. Check the expiration date of the Rapicide PA Part A&B, to confirm it is within the acceptable use date. ACTION Once opened, Rapicide PA Part A&B can be used up to a maximum of 21 days, but only if it passes the MRC (Minimum Recommended Concentration). Replace if expired or below MRC ..."

" .... TASK 7. Review the Filter Change Log to confirm all filters are being changed at the required pressure or time intervals.

ACTION-
1 and .45-micron External Water Filters - Replace every 3 months or when water pressure of 40 psi cannot be maintained.


0.2-micron absolute internal water filter - Replace every 6 months. Must perform water line disinfection upon filter replacement.

Air Filters - Replace every 3 months

Active Vapor Management Filter - Replace every 6 months.

Disinfectant Mesh Filters (1 per side) Clean monthly, replace when needed."


C. On an observation tour of the endoscopy decontamination room on February 12, 2019 after 2:00 PM, it was noted that there were no staff at the offsite campus who had knowledge and training in cleaning and disinfection of endoscopy scopes and equipment.

In the endoscopy decontamination room there were two Medivator processers (Endoscope Processors). Both of the processors contained endoscopy scopes. Side A was flashing an unknown alarm when observed. One scope was observed laying on top of the counter partially covered in a blue pad. The scope was labeled soiled. Staff #86 was asked how long the scopes had been stored in this fashion. Staff #87 said she didn't know for sure. Staff #87 was asked if there had been any endoscopy procedures on 2-12-2019. Staff #87 said there had been no endoscopy procedures on 2-12-2019. According to the Medivator processing logs, the last date endoscopes were processed were 2-11-2019. Staff #87 confirmed there were endoscopy cases on 2-11-2019. Staff #87 said Staff #88 had just started at the facility on 2-11-2019 and should be down to get them processed.

During an interview with Staff #88 on 2-12-2019 after 2 PM, Staff #88 said she had no knowledge of the endoscopy scopes that were in the decontamination room. Staff #88 was asked if she had been trained on processing endoscopes. Staff #88 said she had not. Staff #88 said she had not previously worked in endoscopy and did not have any knowledge on the process of decontamination, detergent changes, or filter changes.

During an interview with Staff #86 on 2-12-2019 after 2 PM, Staff #86 was asked if anyone at the facility had knowledge of the endoscopy decontamination process. Staff #86 said the Sterile processing technician had quit the day before and he was the only one who was knowledgeable. Staff #86 said it is the SPD (Sterile processing department) technician's responsibility to clean/reprocess scopes. Staff #86 was asked if he was aware that Staff #88 had no knowledge in this process. Staff #86 confirmed he did not.


D. The facility did not have a process to ensure that endoscopes were used on patients after the recommended hanging time at the offsite campus.

During an observation tour on 2-12-2019 after 2 PM, an endoscope (Scope #8555) was observed hanging in a drying cabinet. The date listed on the reprocessing label attached to the scope showed a date of 2-1-2019 as the last date the scope was reprocessed. The endoscope label indicated the scope had been hanging in the cabinet for 11 days, 6 days past the AORN recommendation. Staff #87 was asked if there was a process at the facility used to ensure the scopes were reprocessed within the AORN recommendations for hang time in a drying cabinet. Staff #87 confirmed she did not know.


Review of the Endoscopy Policies and Procedures did not reveal any policy that addressed how long endoscopes could be stored/hanging in a cabinet if not used prior to reprocessing.


Review of the AORN (Association of perioperative Registered Nurses) Perioperative Standards and Recommended Practices revealed the following:

"Recommendation IX

Flexible endoscopes should be stored in a manner that protects the device from damage and minimizes microbial contamination ....

IX.b. Flexible endoscopes should be reprocessed before use if unused for more than five days. In research studies, flexible endoscopes cleaned and processed as recommended and stored by hanging in closed cabinets have been shown to grow organisms after five days of no use"


E. The facility was using High level disinfectant test strips that were past the expiration date.

On 2-12-2019 observed disinfectant test strips currently in use in the endoscopy decontamination room at the offsite campus that were expired. The Rapicide PA test strips were open on 10-3-2018. The test strips have a four-month shelf life after opened. These test strips were still in use 2-12-2019, 9 days after the expiration date.

Review of the Medivator Processing Log for 2-11-2019 at the offsite campus revealed three endoscopy scopes that had been processed using expired test strips. Scope # 828, 901 and 908 were processed on 2-11-2019. The test strips 4-month expiration date noted on the log was 2-4-2019; 7 days prior. Staff # 86 confirmed the finding.


F. There was an incomplete separation of soiled/contaminated supplies and equipment from the clean/sterilized supplies and equipment at the offsite campus in 1 (Sterile processing department) of 1 area observed.

During an observation tour on 2-12-2019 after 8:30 AM, observed a window that was used to pass through cleaned surgical instruments from decontamination area to clean/preparation room. There were instrument sets sitting on the counter underneath the window that prevented the window from being closed. There were several instrument sets on the counter under the window and stacked up on the counter behind the window. There were also several instrument sets sitting on the rack in front of the automated washer waiting to be processed. There was an instrument set sitting on top of a black plastic container that was located in the clean/processing room. Staff #86 said the container was a cover for part of the water filtration system used in the Operating room. There were water tanks and plumbing behind that black container. There was a wire rack in the decontamination area that contained sets of clean instruments. The wire rack was sitting across from the sink area in the decontamination room. The sink area was used to clean/wash contaminated surgical instruments.


Staff #88 was asked how long the window had been open. Staff #88 said she had only been working there two days; but it had been open since she started. Staff #88 said there was very limited room in the clean/processing room to complete the process of wrapping and preparing instruments for sterilization. Staff #88 said she was the only one working in sterile processing and she had not gotten to all the instruments yet. Staff #88 said the workload was "A lot" for one person. Staff #88 said she had been sent from the main campus to help after the sterile processing technician walked out. Staff #88 said the processes at the offsite campus were very time consuming and did not mirror the main campus sterile processing.


Review of the AORN 2019 recommendations, "The Guideline for Cleaning and Care of Surgical Instruments" revealed the following:

"Instruments should be cleaned and decontaminated in an area separate from locations where clean items are handled.

Physical separation of decontamination areas from areas where clean items are handled minimizes the risk of cross-contamination. Cross-contamination can result when soiled items are placed in close proximity to clean items or are placed on surfaces upon which clean items are
later placed. Droplets and aerosols created during cleaning of soiled instruments can cause cross-contamination of any nearby clean items or surfaces."



G. Surgical Instrument sets that contained implants (Screws) were released from the Sterile Processing department prior to the biological test resulting at The main hospital campus and the off-site hospital campus. There was no way to determine conditions were met to kill a specified amount of microorganisms for a sterilization process prior to releasing the implants to storage or the operating room for surgery.


OFF SITE CAMPUS
During an observation tour on 2-12-2019 after 8:30 AM, there was a surgical case noted to be set up in an Operating Room at the offsite campus. The sterile field had been opened and included open sterile instruments and supplies. Staff #87 was asked what case the room had been set up for. Staff #87 said the case had been set up for Patient #35. Patient #35 was scheduled for "Left - Shortening osteotomy 2nd Digit with AO Fixation, Arthroplasty proximal interphalangeal joint with digifuse 2nd digit, fluoroscopy/C-Arm." Staff #87 was asked if the instruments that had been opened on the sterile field included the implants that would be used for the case. Staff #87 said she was not sure but would find out. Staff #87 left area, returned a few minutes later and said the instrument set opened on the sterile field did contain the implants.

Review of the document titled, "Steam Sterilization" in the sterile processing department revealed the following:
Load 3 listed an instrument set, "Mini Monster 2.5 and 2.0". Staff #87 confirmed this was the set that contained implants and was open on the sterile field. There was no documentation noted on the log for when the biological test was taken out of the Incubator or the result of the biological test.
Staff #88 said she had looked at the biological test result in the morning but had not had time to write the results down. Staff #88 was asked if anyone had spoken to her prior to the instrument set being removed from sterile processing. Staff #88 confirmed they had not.

During an interview with #90 on 2-12-2019 after 1:50 PM the following was revealed:
Staff #90 was asked if she was the RN assigned to the case for Patient #35. Staff #90 confirmed she was. Staff #90 was asked if she had opened the case including the instrument sets with the implants. Staff #90 said she helped the scrub for the case open everything and get ready for the case. Staff #90 was asked if she confirmed the biological was negative prior to taking the implant set out of sterile processing. Staff #90 said, "No. We just have to make sure the result is negative prior to bringing the patient to the room." Staff #90 was asked what would happen if the biological was positive. Staff #90 said, "The staff would break everything down and reopen the case. It is not uncommon to have to break a case down."
During an interview with Staff #94 on 2-12-2019 after 2:00 PM, Staff #94 confirmed per policy and recent training, the staff was instructed to confirmed biological test results prior to leaving the central processing area with any instrument set that contained implants.


MAIN HOSPITAL CAMPUS
On February 13, 2019 after 2:00 PM while reviewing the document titled, "Sterilizer Load Report" dated 2-1-2019 with a completion time of 6:15 PM the following was revealed:
The load contents showed an instrument set, "Synthes 3.5 Cannulated Set-001" on the load. The instrument set contains implants (Screws) in the set. The Load Report did not have a biological test noted on the record.
An interview with Staff #95 on 2-13-2019 after 3:00 PM confirmed no biological test was run on the Cannulated Screw set. Staff #95 was asked if the implants had been used on a patient. Staff #95 said she would go pull the set from the shelf and look at the date. The date noted on the Cannulated screw set was 2-1-2019 at 4:05. Staff #95 confirmed the set had not been used on any patient. Staff #90 took the set to sterile processing to be reprocessed with a biological test.

Review of the Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79 2012 Guidelines revealed the following:


"10.6 Routine load release

10.6.1 Process monitoring devices
Every sterilization load containing implants should be monitored with a POD containing a BI (an El challenge test pack). A Class 5 Integrating CI should be included in this PCD. Implants should be quarantined until the results of the BI testing are available (CDC, 2008).

10.6.3 Release criteria for implants

As with all cycles, an experienced, knowledgeable person should review the sterilizer chart or printout at the end of the sterilization cycle, as well as the results of other indicators that have been used to monitor the sterilization process. The load should be quarantined until the results of the BI testing are available (CDC, 2008).

Releasing implants before the El results are known is unacceptable and should be the exception, not the rule. When documented medical exceptions dictate (e.g., the need for trauma-related orthopedic screw-plate sets), it could be necessary to release an implantable device before the El results are known. In this case, the release of the device before the El results are known should be documented; the El result obtained later should also be documented. (See Annex L for examples of an implant log and an exception form.) It is critical that this
documentation be fully traceable to the patient. Emergency situations should be defined in written guidance developed in consultation with infection prevention and control, the surgeon, and risk management. Steps should be taken to reduce the frequency of emergency release of implantable items. For example, ongoing periodic reviews of the exception forms and implant logs could reveal consistent patterns of events that are causing emergency release and that could be corrected."


Review of the facility policy titled, "Sterilization of Medical Devices" with a final approval date of 1-8-2019 revealed the following:

" ...C. all sterilized implants will not leave the SPD area until a BI is completed except in emergency situations ..."


This deficiency was cited during the visit with an exit date of 12/10/2018 and had not been corrected by the facility's plan of correction completion date of 2/9/2019.



H. The offsite campus sterile instrument room had surgical instrument sets stored on a shelf ready for patient use that did not have any visible external chemical indicators in 3 (Orthopedic & General equipment) of 3 surgical instrument sets observed. The external chemical indicator was faded and there was no way externally to determine if the surgical instruments had been exposed to the sterilization process. Also, the facility was storing an equipment plug in a sterile peel pack that had not been sterilized with sterile equipment.

During an observation tour on 2-12-2019 after 8:30 am, three orthopedic/general instruments were observed on a shelf in the sterile equipment room. The external chemical indicator was faded and not visible. Staff #86 said the facility had been having problem with some of the indicator tape fading. Staff #86 was asked what was being done at the facility to correct the problem. Staff #86 said that when any sets/instruments were observed with faded tape they would be reprocessed. Staff #87 was asked to open one of the sets that would not be needed for that day to confirm the internal indicator results. When the set was opened it contained an "Emulator Class 6 STEAM" indicator. The indicator said the circle should turn green when all parameters for STEAM sterilization are met. The color noted on the circle of the indicator in the package was faded green/grey color. Staff #87 said the facility did not use these indicators presently. Staff #87 said the indicator looked like it passed; however, they did not have any guide to use to compare it to.

There was a plug stored in a surgical peel pack (Package used to sterilize instruments) that was labeled "goes with sigmoidoscope". The package was open. Staff #87 confirmed the item had not been sterilized. Staff #87 said the plug went with the sterile instrument set it was sitting with. The unsterile item was stored on top and next to sterile instruments on a shelf in the Sterile Instrument Room.


I. ensure that 1 (Staff #76) of 1 Cath Lab technician had documented training and competencies to scrub sterile cases and monitor patients during Cath Lab Procedures. Also, the facility failed to include those duties in Staff #76's job description


On 2-14-2019 after 2:00 PM while reviewing employee files with Staff #91 and #92, it was noted that the facility was utilizing staff that did not have current competencies to scrub sterile procedures and monitor patients during cardiac catheterization procedures at the Main hospital campus. Also, the facility failed to include scrubbing sterile cases and patient monitoring duties in Staff #76's job description.

During an interview with Staff #76 on 2-14-2019 while on an observation tour of the Cardiac Catheterization lab, Staff #76 said her job was Clinical Coordinator but she also functioned as a scrub technician on cardiac catheterization procedures and monitored patients.

A review of Staff #76's employee file showed a position title of "Department Coordinator". The job description did not list any skills that included scrubbing or monitoring patients. The last job description noted in the employee file that listed technical skills for setting up sterile field and instruments for designated procedures was dated 7-26-2009. This job description did not list patient monitoring as a technical skill.


A review of the facility "Competency Checklist for Staff #76 revealed the following:

"Assisting with Cath Lab Diagnostics and Interventional Procedures - Cath Lab Specials Tech Competency ..."

The Cath lab "Specials Tech Competency" did not document competency in scrubbing a sterile case or patient monitoring.

During an interview on 2-14-2019 after 2:00 PM, Staff #12 confirmed that Staff #76 was currently scrubbing cardiac catheterization procedures and monitoring patients during cardiac catheterization procedures.



J. ensure the physician marked a surgical site according to facility policy in 1 (Patient #35) of 1 patient observed

During a tracer observation at the Offsite campus on 2-12-2019 after 9:00 AM, the facility did not ensure physician #89 marked a surgical site according to facility policy in 1 (Patient #35) of 1 patient observed.

On 2-12-2019 after 9:00 AM, Physician #89 marked the left foot for Patient #35. Patient #35 was scheduled for "Left - Shortening osteotomy 2nd Digit with AO Fixation, Arthroplasty proximal interphalangeal joint with digifuse 2nd digit, fluoroscopy/C-Arm" Observation of the physician marking after he left the bedside revealed what appeared to be a check mark. Staff #87 and #90 looked at the marking and confirmed the marking appeared to be a check mark. There were no physician initials marked on the left foot surgical site.


Review of the facility policy and procedure Review of the facility policy titled, "Universal Protocol" with a final approval date of 10/26/2017 revealed the following:

"Site Marking: The purpose of site marking is to clearly identify, without ambiguity or doubt, the intended site of the procedure. Site marking is done by the proceduralist using his/her initials. The method of marking and the type of mark will be clearly defined in writing and consistent throughout the organization ..."



K. complete an update to the history and physical, to include changes in the patient's condition prior to the surgical procedure on patient records reviewed. Also, the surgeon failed to follow the hospital policy titled, "History and Physical Examination".

Cross Refer to Tag: A 0952 for additional information

Based on record review and interview, the surgeon failed to complete an update to the history and physical, to include changes in the Patient's condition prior to the surgical procedure on 4 (Patients #'s 53,54,55, & 56) of 4 patient's medical records reviewed. Also, the surgeon failed to follow the hospital Medical Staff Rules and Regulations for updating History and Physicals prior to any procedures.

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


Findings Include:

PATIENT #53

A review of Patient #53's record revealed there was no history and physical update documented from the surgeon prior to the patient having a surgical procedure on 2/13/2019. Review of the facility document titled, "History and Physical Update" showed that Staff #98 electronically signed the document on 2-13-2019 at 8:58 AM. Staff #98 did not document an updated examination of the patient to include any changes in the patient's condition. A review of the history and physical did not indicate a medical emergency.


PATIENT #54

A review of Patient #54's record revealed there was no history and physical update documented from the surgeon prior to the patient having a surgical procedure on 2/7/2019. Review of the facility document titled, "History and Physical Update" showed that Staff #98 electronically signed the document on 2-7-2019 at 10:51 AM. Staff #98 did not document an updated examination of the patient to include any changes in the patient's condition. A review of the history and physical did not indicate a medical emergency.

During an interview with Staff #8 on 2-14-2019 after 10:00 AM, Staff #8 said physicians are required to document review of the current History and Physical and reassessment of the patient's condition on the update note. Staff #8 confirmed the Physician #98 did not document this review/assessment for Patients #53 and #54.



40989


Patient #55

A review of Patient #55's record revealed there was no history and physical update documented from the surgeon prior to the patient having a surgical procedure on 2/13/2019. A review of the document titled, "History of Present Illness," revealed a signature by Staff #58, dated and timed on 2/13/19 at 14:00. Staff #58 did not document an updated examination of the patient, to include any changes in the patient's condition. A review of the history and physical did not indicate a medical emergency.


Patient #56

A review of Patient #56's record revealed there was no history and physical update documented from the surgeon prior to the patient having a surgical procedure on 2/13/2019. A review of the history and physical document revealed Staff #101 signed, dated, and timed the encounter on 2/13/2019 at 9:15AM. Staff #101 did not document an updated examination of the patient, to include any changes in the patient's condition. A review of the history and physical did not indicate a medical emergency.


Review of the Medical Staff Rules and Regulations for Medical Record Documentation Requirements, Section 5 History and Physical revealed the following:

" ...5.3 Recent History and Physical
If a complete History and Physical (H&P) was performed within thirty (30) days prior to the patient's admission by a medical staff AHP member with appropriate privileges, a copy of the H&P may be used; however, the H&P must still be updated within 24 hours of admission but prior to any procedure. The updated note in the Medical Record must indicate the recent History & Physical was reviewed, the patient was examined, and that "no change" has occurred in the patient's condition since the H&P was completed. Any changes identified must be documented."

Based on record review and interview, the physician and the anesthetist failed to conduct a complete post anesthesia assessment for 3 (Patient #'s 36, 52, and 55) of 3 patient records reviewed. The Post anesthesia evaluation did not address all elements of a post anesthesia assessment that conformed with current standards of anesthesia care to include; respiratory function, cardiovascular function, mental status, temperature, pain, nausea and vomiting, and postoperative hydration.


This deficient practice had the likelihood to cause harm for all patients receiving anesthesia at the facility.

Findings include:


PATIENT # 52

Review of the surgical record for Patient #52 on 2-14-2019 after 10:00 AM with Staff #8 revealed the following:

Patient #52 was a 74-year-old male who had an Esophagogastroduodenoscopy on 2-13-2019. The patient was discharged on 2/11/2019 at 1153 AM. The Post anesthesia assessment was dated 2-13-2019 at 12:41. The Post anesthesia note did not address nausea and vomiting or postoperative hydration.

In an interview with Staff #45 on 2-12-2019 after 9:50 AM, Staff #45 said anesthesia was required to see the patients prior to the patient leaving PACU (Post anesthesia Care unit). Staff #45 said anesthesia will see the patient, reassess the vitals, pain level, fluid status, temperature, and any deficits neurologically.

In an interview with Staff #69 and Staff #70 on 2-12-2019 after 1130 AM, Staff #69 and Staff #70 said PACU staff are required to have anesthesia see any patient prior to them leaving the PACU area. Staff #69 and #70 said they use the ALDRETE scale (A method used to determine if a patient is ready to be discharged to a less intensive area of the hospital after recovery) to assess the patient's readiness for discharge. Staff #69 & #70 said once the patient was ready for discharge, the staff from PACU will notify anesthesia staff and they would reassess the patient prior to the patient's discharge.




40989

A review of surgical records for Patient #'s 36 & 55 were conducted on 2/14/2019 after 11:00 AM. Staff #70 & Staff #95 assisted with the reviews.


Findings Include:


PATIENT #36

Patient #36 was a 66 year old female who had a Left Ulnar Nerve Transposition and left carpal tunnel release on 2-12-2019.


The Pre anesthesia Vital Signs/Physical Examination documented on 2/12/19 at 06:24 AM were as follows:

Vital signs
Heart Rate 68 bpm (beats per minute)
SBP (Systolic Blood Pressure) 125
DBP (Diastolic Blood Pressure) 70
Spo2 (Oxygen level) C 68
Respiratory Rate 18 br/min (breaths per minute)
Temperature 36.4 Celsius

Pain: 2/12/19 at 6:22 A.M. - Pain: Yes -5 out of 10 (0 being the least and 10 being the worse)


The Post Anesthesia Vital Signs/Physical Examination on 2/12/19 at 06:24 AM were as follows:

Vital signs
Heart Rate 68 bpm (beats per minute)
SBP (Systolic Blood Pressure) 125
DBP (Diastolic Blood Pressure) 70
Spo2 (Oxygen level) 100%
Respiratory Rate 18 br/min (breaths per minute)
Temperature 36.4 Degree Celsius


Pain: 2/12/19 at 6:22 AM- Pain: Yes -5 out of 10 (0 being the least and 10 being the worse)

Assessment:
Mental Status: Alert
Respiratory function: 15 breaths/min
Respiratory function: oxygen 5 l/min (liters per minute), via simple mask
Cardiovascular function: 73 beats per minute

There was no documentation of nausea/vomiting or post-operative hydration.


The Pre-Anesthesia assessment and Post-Anesthesia mirrored each other and were documented at the same time. The patient went into the Operating Room at 7:06 AM. The Patient was taken to the Post Anesthesia Care Unit at 8:32 AM.

Review of the facility document titled, "Anesthesia Records" with a subject listed as "Post anesthesia Evaluation IASIS" was documented by Staff #93. The document was electronically signed and dated 2/12/19 at 08:40 AM. The post anesthesia evaluation documented by Staff #93 revealed the same assessment findings and times as the pre anesthesia evaluation.

The Post Anesthesia assessment was documented over two hours prior to the patient's surgery completion time.


An interview conducted with Staff #'s 70 _ on 2/14/2019 after 11:00 AM Staff revealed the following:

Staff#70 was asked to review the electronic medical record for the Post Anesthesia evaluation that was documented. Staff #70 was asked if the time and assessments documented in the electronic medical record for the post-anesthesia assessment mirrored the time and assessments on the pre-anesthesia assessment. After review of the post-anesthesia assessment in the electronic medical record, Staff #70 confirmed the above findings. Staff #70 was asked if the electronic medical record showed any documentation of a post-anesthesia assessment completed on Patient #36 after the surgical procedure was complete. Staff #70 stated, "I do not know if it is accurate because we are having computer problems, but this is all that I can see." Staff #95 confirmed the findings.




PATIENT #55

Patient #55 was a 72 year old female who had a Laminectomy Lumbar four-Lumbar five on 2-13-2019.

Review of Patient #55's surgical record did not reveal any documentation of a Post-Anesthesia assessment.

Staff #70 was asked if the electronic record for Patient #55 had any documentation that anesthesia staff conducted a post-assessment after the patient's surgery was performed. Staff #55 was unable to locate a post anesthesia evaluation for Patient #55 in the electronic medical record.

Staff #70 stated, "I do not see a post anesthesia evaluation at all in Patient #55's surgical record."

Staff #70 confirmed the surgery record was a closed record, and was not pending any anesthesia documentation.



Review of the facility Medical Staff Rules and Regulations, Section 3.4, Post-Operative Care revealed the following:

" ...3.4.2 The anesthesiologist or CRNA shall maintain a complete anesthesia record to include evidence of pre-anesthesia evaluation, plan, re-assessment immediately prior to induction, and post anesthetic follow-up of the patient's condition ..."


Review of the "Practice Guidelines for Post Anesthetic Care an Updated Report by the American Society of Anesthesiologists Task Force on Post Anesthetic Care", dated 2013 revealed the following:

"Guidelines

I. Patient Assessment and Monitoring

Perioperative and post anesthetic management of the patient includes periodic assessment and monitoring of respiratory function, cardiovascular function, neuromuscular function, mental status, temperature, pain, nausea and vomiting, fluid assessment, urine output and voiding, and drainage and bleeding."

Based on interview and record review, the facility failed to ensure outpatient services were provided in accordance with acceptable standards of practice.

The facility failed to implement 3 out of 6 of their outpatient behavior health policies that were reviewed. The facility failed to implement their policies regarding safe transportation, assessment of suicide, and handling medical emergency incidents.

This deficient practice had the likelihood to cause harm to all patients receiving outpatient behavior health services.

Findings include:





Review of a policy named "Safe Transport of Clients" dated 03/13/2018 revealed the following:

"a. Competencies focusing on vehicle operation, inspection, orientation and trouble shooting will be maintained by the Program Director and will be completed upon hire and at least annually thereafter.
b. All employees driving the facility's transportation vehicle will complete an initial competency assessment as well as annual reassessment on driver safety ...
f. Employees will utilize the "Weekly Inspection Checklist" accordingly ...."

Review of personnel documents revealed the three transporters were Staff #83 with a hire date of 02/11/2011, Staff #84 with a hire date of 10/09/2017 and Staff #85 with a hire date of 04/16/2007.

During an interview on 02/14/2019 after 2:13 p.m., Staff #82 confirmed the hire dates and reported not having documentation of the annual competencies/ reassessments or the weekly checklist. Staff #82 provided the surveyor a weekly checklist dated 2017.





Review of a policy named "Assessment of Potential for Suicide, Homicide and Self -Harm" dated 03/13/2018 revealed the following:

"..E. If client is assessed to be acutely suicidal or homicidal, the attending psychiatrist must be advised immediately.
After appropriate arrangements are made by the respective program staff and the client agrees, the client is to be sent voluntarily, via ambulance, police or other means (with accompanying staff) to the designated inpatient facility.
G. The Program Director and the Medical Director will be notified.
H. Documentation will be detailed with language quoted by client as well as action taken,etc.."

Review of the clinical record on Patient #57 revealed he was a 44 year old male who presented to outpatient services on 01/07/2019. According to documentation Patient #57 "attempted suicide, per report, last night by taking all of his medications.." There was documentation in the notes that there was a discussion with Patient #57 about his suicidal thinking and was "taken to ER for medical evaluation and psych evaluation.."

There was no documentation in the record that Patient #57 agreed to be sent to the ER and there was no documentation of the Program Director's notification.

During an interview on 02/14/2019 after 2:13 p.m., Staff #82 confirmed the missing documentation.




Review of a policy named "Medical Emergencies" dated 03/13/2018 revealed the following:

POLICY
Medical emergencies will be responded to in a timely and appropriate manner.

The responsible nurse will document all detail of the incident both in the client's medical record and in an incident report.


Review of the clinical record on Patient #58 she was a 51 year old female who had outpatient services on 10/10/2018.

According to documentation in the notes Patient #58 was taken to the ER and was not responding. Patient #58 passed out on the van ride home. The paramedics were called and Patient #58 was transported to the ER.

Review of hospital emergency room records dated 10/10/2018 revealed Patient #58 had a seizure in the van.
There was no detailed documentation of what all occurred.

During an interview on 02/14/2019 after 2:13 p.m., Staff #82 confirmed they had not completed an incident report because it occurred on the van.

Based on review and interview the facility failed to develop, implement, and enforce policies and procedures to ensure that a sexual assault survivor who presents to the hospital following a sexual assault is provided appropriate care.


This deficient practice had the likelihood to cause harm to all sexual assault victims presenting to the Emergency department.

Findings include:



Review of the policy and procedures revealed there was no policy for treating a sexual assault victim in the Emergency Department (ED).

An interview was conducted with Staff #29 and Staff #91 in the afternoon of 2/13/19. Staff #29 stated that if a sexual assault victim comes to the ED they are given the choice to transfer to a facility that has a Sexual Assault Nurse Examiner (SANE). If the patient refuses to go then they conduct the exam at the facility. Staff #91 reported that the nurses would do the evidence collection. Staff #91 stated that she did an in-service with the nurses on how to perform the exam. Staff #91 stated she just opened up the box and did a power point on the instructions inside. Both staff members confirmed there was no written plan or policy and procedure. Staff #29 was unable to show the surveyor a plan on storing evidence and how the chain of evidence would proceed. Staff #29 stated, "We just give it to the officer after we are done." Staff #29 was asked what the process was if the patient did not want to call the police. Staff #29 was not aware the patient had that choice. Staff #29 confirmed there was no plan for evidence storage or removal.