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Based on observation, interview, and record review, the Governing Body failed to effectively discharge its oversight responsibilities in the total operation of the hospital.

Findings included:

The Governing Body failed to:

1. ensure a physician was appointed to the medical staff and granted privileges in accordance with medical staff bylaws. A physician (SL 24) performed surgery on three (3) patients without being officially appointed or granted surgical privileges by the Governing Body.

Cross refer to Tag A0046


2. ensure services provided by a contracted dialysis company were provided in a safe and effective manner.

Cross refer to Tag A0084


3. ensure a functioning nurse call system at the Sugar Land and Tidwell locations that met all Texas Administrative Code requirements to include: audible signal at nurse station; visible signal in the corridor; and two-way communication between nursing staff and patient.

Cross Refer to Tag A0144


4. ensure a formal complaint that included serious allegations of patient neglect and safety was documented and investigated per facility Grievance policy.

Cross Refer to Tag A0118


5. ensure that individual character, competence, training, experience, and judgment were considered in the Medical Executive Committee's recommendation and Governing Body's appointment of a candidate to the medical staff.

Cross Refer to Tag A0357


6. ensure an effective nursing service to provide 24 hour patient care to meet patients need:

a. ensure the training and competency verification of its nursing staff to provide patient care: a large percentage of hospital-employed ICU RNs lacked completed skills checklists; a large percentage of agency/contracted RNs lacked documented ACLS & PALS certifications; two (2) hospital locations had nursing directors in positions in which they did not meet the educational requirements; and the main campus did not have a director of nurses or an ED nurse director.

Cross refer to Tag A0386


b. ensure adequate numbers of licensed nursing personnel to provide nursing care to 2 patients (Patient # T-34B and T-31A) as needed. Patient T-34B was a critically ill ER patient who was post- COVID and experienced a cardiac event. Facility was unable to transfer him to their inpatient ICU due to a "shortage of staff." After spending almost 22 hours in the ED, this patient died on 5/11/2021 at time of survey.

Patent T-31A was brought to the ER following a suicide attempt ; he was delusional and suffered auditory hallucinations. There were physician orders for 1:1 monitoring but documented a "seater (sic) was not available." This patient eloped from the ER with his IV catheter still in place, after spending 23 hours in the ER.


c. ensure any nursing staff was scheduled or on-site from April 24 - 30, 2020, at the Sugar Land location.

Cross Refer to Tag A0392


d. ensure the hospital's registered nursing staff evaluated the nursing care for 3 of 4 patients (Patients T-34B, T-20, T-25, and T-17) and failed to reassess the patients' vital signs according to the patients' needs and nursing standards.

Cross Refer to Tag A0395


7. ensure medical records (containing confidential & protected information) were stored in a secure location where they were protected from access by unauthorized individuals, as well as fire and water damage:

-Tidwell location: there were an estimated 14,775 medical records stored behind the hospital in two unlocked spaces: the "barn" and a boxcar.

-Red Oak location: there were an estimated 112 medical records stored in a materials management area adjacent to the operating suites, accessed from the outside of the hospital.

Cross Refer to Tag A0441


8. ensure the facility's kitchen provided food services in a sanitary environment and per the Texas Food Establishment Regulations (TFER).

Cross Refer to Tag A0619


9. ensure Tidwell and Red Oak locations met life safety requirements related to Protection From Fire. Both locations failed to meet National Fire Protection Association 101 code (2012 & 2010 editions). An Immediate Jeopardy was called at each location on different days based on findings from health surveyors and a life safety inspector on-site.

Cross Refer to Tag A0709


10. ensure a safe environment for patients: maintenance of building, safe storage of supplies, and electrical biomed inspection of patient equipment.

Cross Refer to Tags A0701 & A0724


11. ensure an active system-wide program for prevention and control of infection at all 3 locations. Governing Body failed to:

a. ensure proper PPE usage and hand hygiene by nursing staff..

b. ensure that clean linen was properly stored [not contaminated by exposure to cats and birds, dirt, dust, debris, or splashes from floor cleaning].

c. ensure operating rooms were maintained under proper humidity levels, sterile supply storage temperature and humidity was monitored.

d. ensure proper usage of multi-dose medication vials per professional standards: Tidwell, Sugar Land, and Red Oak locations.

e. ensure efficacy of surgical instrument washer was verified per policy.

f. ensure the maintenance of a sanitary environment: Emergency room, Operating rooms, Dialysis area - Tidwell

g. make certain clean patient equipment and patient supplies were stored in a manner to prevent contamination

h. ensure proper drainage of the HVAC system: open drain pipes noted in ER and COVID Units - Tidwell

i. ensure biohazard storage areas (outside) were secure and not accessible to public - Tidwell

j. ensure expired supplies were not available for patient use - Tidwell

Cross Refer to Tag A0749


12. ensure surgical services were provided in accordance with acceptable standards of practice:

The Governing Body failed to:

a. ensure the facility's surgical instrument washer was draining properly and not allowing contaminated water to remain in the washer. This prevented the washer from thoroughly cleaning the instruments prior to sterilization process & placed patients at risk of developing an infection from inadequate sterilization. An Immediate Jeopardy was called related to this deficient practice.

b. ensure the facility maintained a Flash Sterilization Log. Flash sterilization is an abbreviated sterilization process that should be tracked per professional infection control guidelines.

c. ensure the Operating Room's surgical equipment was maintained free of copious amounts of dust build-up and numerous rusted metal bases, and able to be cleaned.

d. ensure documented training and competency for the current Sterile Processing Department (SPD) technician.

e. ensure the facility's endoscope reprocessing machine was not stained and was free of copious amounts of tape, rendering the machine unable to be properly cleaned.

f. ensure the anesthesiologist performed appropriate hand hygiene; and also swabbed the rubber septum of medication vials with alcohol prior to use in the OR.

Cross Refer to Tag A0941

Based on record review and interview, the Governing Body failed to ensure that 1 (SL-24) out of 8 medical staff members' credential files reviewed had been appropriately credentialed and/or appointed to the Medical Staff in accordance with Facility Bylaws.

A physician (SL 24) performed surgery on three (3) patients without being appointed or granted surgical privileges by the Governing Body.

Findings include:

Sugar Land location:

Record review of Governing Body Bylaws dated 12/19/19 showed the following information: Only physicians, (as such terms are defined in the Medical Staff bylaws, rules and regulations) holding current Texas and DEA licenses, having been approved for Medical Staff membership and clinical privileges in the Hospital, or by other healthcare professionals authorized by the Medical Staff and the Board may be directly responsible for a patient's admission, care, diagnosis, and treatment of any medical or psychiatric problem that is present on admission or develops during the hospitalization in or at the Hospital.


During an interview on 05/14/2021 at 1:15 PM with Staff T-9, Lead Credentialing Coordinator, she and surveyor reviewed the credential file of physician (SL-24). Record review of the credential file of (SL-24) showed the following:

-A "Texas Standardized Credentialing Application," completed and signed by (SL-24) on 2/25/2020.

-A form titled: "UMMC: Plastic Surgery Privileges" showed the following "Key" at the top of the form: "[ ]- requested ; G-granted; D-denied." There were 12 different surgical privileges checked as "requested" by (SL-24). The privilege request was signed by (SL-24) on 4/19/2020; and by Staff T-95, Department Chair, on 4/22/2020. There was no documentation to show that any of the requested privileges had been granted or denied.

Staff T-9 said physician's (SL-24) application had not gone through the established appointment process. He had not been granted any surgical privileges, including temporary privileges.

Review of medical records for patient (SL-4) showed she had surgery performed by (SL-24) the Sugar Land location on 4/24/2020.

Review of medical record for patient (SL-15) showed she had surgery performed by (SL-24) the Sugar Land location on 4/27/2020.

Review of medical record pre patient (SL-16) showed she had surgery performed by (SL-24) at the Sugar Land location on 4/25/2020.

Based on observation, interview, and record review, the facility's Governing Body failed to ensure services provided by a contracted dialysis company were provided in a safe and effective manner.

The facility currently had a hemodialysis census of 4 patients.


Tidwell location

The facility's Governing Body failed to:

Implement its policy and procedure on employee orientation, to ensure contract dialysis staff received facility-based orientation in 3 of 3 contracted staff. (Contract staff T42, T100, T101)

Ensure hemodialysis machines had annual electrical safety inspections in 3 hemodialysis equipment in use at the facility. (Hemodialysis machine ID# 4KOS-P725, 6KOS-636E, Reverse Osmosis machine #67459.

Ensure hemodialysis equipment that were previously used were properly cleaned and disinfected after use.


Policy Reviewed:

Review on 05/13/2021 of the facility's current policy and procedure title: "Agency Nurse Utilization: Orientation," Policy # NSG.02.053.2. Last reviewed 04/19. I. Outcome Standards: To ensure that quality patient care is delivered, and nursing patient care standards are upheld when the hospital finds it necessary to utilize contract agency nursing staff for provision of patient care services. II. Process Standards: To facilitate the attainment of Outcome Standards: C. the agency nurse is to be given the following information: 1. Orientation packet. 2. Evaluation form: He/she will be instructed to review the material and sign her acknowledgment of this information and return it to the nursing supervisor.


Review on 05/13/2021 of contracted dialysis company #A policy and procedures titled "Safety Standards for Acute Dialysis Equipment" Policy # 2.2, Dated 12/2020. All equipment will be checked by the Chief Technician for electrical safety initially and biannually thereafter. The Chief Technician will maintain a logbook documenting the electrical safety checks. Procedure: This process for testing electrical leakage should be performed biannually, or unless specified more frequently by the manufacture.


Review on 5/13/2021 of the facility's current policy titled "Cleaning and Disinfecting of Equipment," Policy # INF.016.1, Revision 10/18; Purpose: To minimize the risk of infection to our patients, employees and visitors through thorough cleaning, disinfection and/or sterilization of environmental surfaces, patient care items and equipment. Definitions: Cleaning: the removal of all foreign material (e.g., soil organic material) from objects. Decontamination: The use of physical or chemical means to remove, inactivate or destroy blood-born pathogens on surface or items to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, us or disposal.


Findings included:

Tidwell location

Review of selected hemodialysis employee files on 05/13/2021 at 13:00 PM along with the facility's human resource specialist Employee ID # T-7 revealed no documentation was found in the employee files confirming the orientation of 3 of 3 dialysis contracted staff for dialysis company ID # A. (Employee ID #s T-42, T100, T-101)

Interview on 05/13/2021 with human resource specialist Employee ID # T-7 confirmed the above findings and stated we do not have a signed orientation checklist from them and stated it has been a challenge, they have not been wanting to come to the office. I have not been able to do the orientation. I have notified the manager of our request for their orientation.

Observation on 05/13/2021 at 12:35 PM of the renal unit located on the ICU hallway along with contract dialysis nurse manager, Employee ID# T-42, and the facility Chief Executive Office, Employee ID #-5, the dialysis room was observed to contain two Fresenius 2008 hemodialysis machines (#13 -4KOS-P725, #15 6KOS-636E), and one attached reverse osmosis (RO) water treatment unit attached to machine #13 (RO machine # 67459). The two hemodialysis machine and reverse osmosis unit did not contain any evidence of electrical safety stickers.

Interview with contract dialysis nurse manager, Employee ID# T-42 confirmed equipment was not labeled with electrical safety stickers and would contact his biomedical staff to obtain the electrical safety testing results. No evidence of electrical safety inspection of equipment was received prior to exit.

Observation on 05/12/2021 at 10:300 AM of the renal unit located on the ICU hallway along Infection Control Practitioner, Employee ID # T-1 with contract dialysis nurse, Employee ID# T-101 the dialysis room was observed to contain two Fresenius 2008 hemodialysis machines (#13 -4KOS-P725, #45 6KOS-636E), and one attached reverse osmosis (RO) water treatment unit attached to machine #13. (RO machine # 67459) in addition one portable RO water treatment unit (machine # 14).

Hemodialysis machine ID #13 was observed to have visible droplet splatter on the front surface of the machine that appeared brownish red in color, surface rust approximately 1.5 inches by 14 inches long was identified on the back lower metal portion of the machine along with multiple areas of dark sticky residue and with visible tape remained attached to the machine. Acid and bicarbonate wands were observed with a build of white debris on the connection heads of the wands. Drain hose had dark greenish black growth in hose.

Hemodialysis machine ID #45 was observed to have multiple brownish red droplet splatter on the outer side and inside surfaces on two of the front wheels, wheel canisters and wheel arm segments.

Interview on 05/12/2021 with contract nurse Employee ID# T-101 when asked if the machines had been cleaned and disinfected and if they were ready for use, Employee ID # T-101 replied that the machines had been cleaned and disinfected already and were ready for use. Surveyor pointed out the brownish red splatter on Machine ID# 13 to Employee ID # T-101 and she stated that it must have been missed, the machines are wiped down after each use. Employee ID# T-101 was then observed obtaining a disinfection wipe and the brownish red splatter was wiped and removed.

Interview on 05/13/2021 at 12:40 PM with contracted dialysis nurse manager, Employee ID# T-42 stated the machines should be cleaned and disinfected after each use. Surveyor then pointed out the brownish red droplet splatter on both machine wheel and wheel arms of hemodialysis machine ID#45. Employee ID T-42 stated that it must have been missed and that was not acceptable. Employee ID # T-42 then observed donning gloves and used a disinfection wipe and wiped away some of the droplet splatter. Nurse Manager confirmed the drain hose had a black substance inside and needed to be changed out, tape was not allowed on the machines and he would have the rust repaired on the hemodialysis machine.

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

A. ensure a functioning nurse call system at the Sugar Land and Tidwell locations that met all Texas Administrative Code requirements to include: audible signal at nurse station, visible signal in the corridor, and two-way communication between nursing staff and patient.

Cross Refer to A0144


B. ensure a formal complaint that included serious allegations of neglect was documented and investigated per facility Grievance policy - Tidwell location.

Cross Refer to A0118


C. ensure that individual character, competence, training, experience, and judgment were considered in the Medical Executive Committee's recommendation and Governing Body's appointment of a candidate to the medical staff.

Cross Refer to A0357

Based on interview and record review, the facility failed to follow its policy for investigation and resolution of grievances.

Spouse of Patient # T-53 made a formal complaint that included several allegations of neglect that was not documented or investigated.

Findings included:

Tidwell location:

Record review of facility policy titled: "Patient Complaints/Grievances,"dated 04/19, showed that:

- A grievance is a formal or informal-written or verbal grievance that cannot be resolved promptly by a staff member;

- Grievances about situations that endanger the patient such as neglect should be reviewed immediately given the seriousness of the allegation;

- Complaints regarding dissatisfaction of health care professional's/care providers will be referred to the appropriate Department Directors;.

- Complaints regarding safety/environmental issues are forwarded to the Safety Officer for review;

- The hospital will work to resolve all grievances within 7 days and provide a written response;

- If the investigation will take several days, a written response will be provided to the patient within 7 days.


On 04/27/2021 at 10:30 AM, a telephone interview was conducted with the spouse (complainant) of Patient T-53. He said "After the telephone call I made to the Social Worker, we have not heard anything from anyone at the hospital--not a phone call or a letter. We have no idea if our concerns were investigated or the outcome."

Record review on 5/11/2021 of the facility Complaint/Grievance Log for the last 12 months failed to show a documented grievance or complaint related to care and treatment of Patient T-53 in June 2020.

During an interview on 5/13/2021 at 2:10 PM with Staff T-84, Social Worker, she said, she would check her notes; the patient's name sounded familiar. Staff T-84 returned to interview and said, she remembered speaking with the spouse of Patient T-53. She said, she did not remember all of the issues but did recall he said the call light and toilet were not working. There were other concerns. At the time, the former CNO was handling complaints. Staff T-84 said, she handed off the concerns to the former CNO to address. Staff T-84 was unable to locate a documented grievance or any documentation regarding an investigation of the care & treatment concerns related to Patient T-53.

During an interview on 5/14/2021 at 11:10 AM with the CEO, she said, because the former CNO addressed the issues immediately--this was not considered a grievance. Surveyor informed the CEO that allegations (verbal or written) of abuse or neglect were considered grievances by CMS.

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

a) The nurse call system in 6 of 6 hospital rooms was operational and provided two-way voice communication between the patient room and the nursing staff at the unit's nursing station;

b) The nurse call system in 5 of 5 preoperative patient rooms was operational and provided an audible signal when engaged;

c) The nurse call system in 8 of 8 PACU [Post Anesthesia Care Unit] bays was operational and provided an audible signal when engaged; and

d) 2 of 2 patient bathrooms between the preoperative and postoperative areas had an emergency call system.

These failures created an unsafe setting. Emergency circumstances require dependable means of communication in order to quickly request aid. A swift response could make the difference in a life-threatening situation. Having access to dependable means of communication could ultimately save the lives of those in need.


Findings included:

Record review of policy # ADM.01.030.1, "Patient Rights Policy," revised 4/2019, showed:

I. OUTCOME STANDARD. To improve care, treatment, services and outcomes, the Hospital recognizes and respects the rights of each patient ... A. Policy ... 17. The right of the patient to receive care in a safe setting. 18. The right of the patient to be free from all forms of abuse. "


Sugarland location.

Record review of Texas Administrative Code, Title 25, Part 1, Chapter 133, Subchapter, Rule §133.162, showed: "A nurses regular calling system is intended for routine communication between each patient and the nursing staff. Activation of the system at a patient's regular calling station will sound a repeating (every 20 seconds or less) distinct audible signal at the nurse station, indicate type and location of call on the system monitor, and activate a distinct visible signal in the corridor at the patient suites door ... The audible signal shall be canceled and two-way voice communication between the patient room and the nursing staff shall be established at the unit's nursing station when the call is answered by the nursing staff."

During a tour of the inpatient unit, and preoperative and post-operative areas, on 5/13/2021 at 4:00pm, the following observations were made, and interviews conducted:


a) Inpatient Unit.

There were 5 patient rooms on the inpatient unit. The rooms did not have an operable wired nurse call system.

In an interview with Staff # SL-17 (RN) on 5/13/2021 at 4:20pm, she stated:

" The patient bedrooms did not have a wired nurse call system;

" The nurse call system was a wireless battery-operated call button;

" The call button was given to the patient upon arrival to the unit;

" There is an audible signal at the nurse's station when the call button is activated; and

" The nurse call system did not provide two-way voice communication between the patient and the nurse.


The call button consisted of a round pendant suspended from a thin piece of twine. Staff # SL-17 (RN) took a pendant from the 5 or 6 pendants at the nurse's station. She pushed the center of the pendant to activate the call system; nothing happened. She returned that pendant and took a second one. When she pushed the center of that pendant, the alarm was activated at the nurse's station as a low chime.

In an interview with Staff # SL-17 (RN) and Staff # SL-7 (Medical Assistant), they were asked how they would know if a patient pushed the call button and it did not alarm at the nurse's station. They did not have an answer.

In an interview with Staff # SL-12 (DPO) on 5/13/2021 at 4:15pm, he stated, the twine that was secured to the call button penchant could be easily broken and once broken, the call button could be easily misplaced or lost in the bed linen by the patient.

Record review of a follow-up email with Staff # T-43 on 5/19/2021 at 3:53pm, she stated that the policy for nurse call was not located during the week of the survey.


b) Preoperative Area.

Each bed in all 6 rooms had a wired bedside call button system. When the button was pushed, a light on the ceiling outside the patient's room lit up. There was no audible signal at the nurse's station.

In an interview with Staff # SL-14 (RN preop) on 5/13/2021 at 4:00pm, she stated, there was no audible signal at the nurse's station, adding, "There's USUALLY someone at the nurses' station."


c) PACU.

There were cubicle privacy curtains suspended from ceiling tracks around all 8 beds in the PACU. Each bed had a wired bedside call button system. When the button was pushed, a light on the ceiling just outside of the privacy curtain at the foot the patient's bed lit up. There was no audible signal at the nurse's station.

In an interview with Staff # SL-15 (RN-PACU) on 5/13/2021 at 4:15pm, she stated there was no audible signal at the nurse's station, adding that in other facilities she had worked, there was an audible signal. She also stated that the privacy curtains were open unless the patient needed privacy. She concluded by saying she might have more than one patient at a time.

Record review of "Drawn Curtains, Muted Alarms, and Diverted Attention Lead to Tragedy in the Post Anesthesia Care Unit", an article by Matthew Grissinger, RPh, FASCP [Registered Pharmacist, American Society of Consultant Pharmacists], showed: "In a PACU, where nurses are rarely far from the patient's bedside, staff may have a good-faith, but mistaken, belief that the risk associated with muting alarms is not significant ... [A]larms that are inaudible, and a blocked line of sight for observing patients, invite untoward clinical events." [From the United States National Library of Medicine, National Institute of Health, Pharmacy and Therapeutics, June 2016, 41(6): pp. 344-35]


d) Patient Bathroom.

In an interview with Staff # SL-14 (RN preop) on 5/13/2021 at 4:05pm, she stated the bathroom located between the preoperative unit and PACU was a patient bathroom.

There was no emergency call system in the bathroom.

In an interview with Staff # SL-12 (DPO) on 5/13/2021 at 4:05pm, he stated there should be an emergency call system in the bathroom. He also stated there was another bathroom for patients that did not have an emergency call system.

Further interview with Staff # SL-14 (RN preop) on 5/13/2021 at 4:05pm, she stated, "We tell the patients not to lock the door." She also stated there should be an emergency call system in the bathroom.


23032


Based on observation, interview, and record review, the facility failed to ensure the patients recieve care in a safe setting. The facility failed to implement an effective process for patients to call for assistance in case of an emergency in 2 of 3 patient hallways observed [400 & 500 hallways-which is the COVID Unit]. The facility failed to ensure:

a ) the nurse call alarm at the nurses station was consistently audible or present;

b) a policy was established to include required volume parameters to be maintained;

c) training was provided to nursing staff on recently installed nurse call system.


Findings included :

Tidwell location:

Record review of Texas Administrative Code, Title 25, Part 1, Chapter 133, Subchapter, Rule §133.162, showed: "A nurses regular calling system is intended for routine communication between each patient and the nursing staff. Activation of the system at a patient's regular calling station will sound a repeating (every 20 seconds or less) distinct audible signal at the nurse station, indicate type and location of call on the system monitor, and activate a distinct visible signal in the corridor at the patient suites door ... "

a) Audible and absent alarms :

Observation # 1 on 05/13/2021 at 9: 15 AM by 2 surveyors ( A & B) on the COVID Unit showed the following:

-The call system was activated by Surveyor A in rooms 415, 418, and 421, she was accompanied by Staff T-46, RN. Surveyor-B remained at the nursing station. Surveyor B heard one low-volume beep when the alarm for room 421 was activated. Otherwise, no alarms were heard by Surveyor B. No staff responded to the one beep.

-Staff T-44, Engineering Manager, arrived at the nurses' station shortly thereafter to help explain the system. He asked staff to activate the call light in a nearby patient room. There was a very low-volume beep that continued approximately every 10 seconds. Surveyor B stated that the volume was very low. Staff T-44 stated, "Yes, unless you're right here, you wouldn't hear that ..."

Observation # 2 on 05/14/2021 at 8:45 AM at the COVID Unit nurses station was conducted by Surveyor A, accompanied by Staff T-44, Engineering Manager.

interview with Staff-T-44 , he stated the following:

- the facility had this Dukane call system for 20 years. When a new nurse call system was installed on the 100 hall, parts were taken from that system to revamp this Dukane system.

- it was installed in the COVID Unit about 4 weeks ago.

- Unlike the other 2 newer call light systems ; the staff can control the volume on this system.

Staff T-44 explained the Dukane menu options and how to scroll through the choices.

The volume settings ranged from 6 to 63. Observation of the current volume setting was 20. Staff T-44 confirmed that 20 was low and difficult to hear. He said he was not aware of any required volume setting.

Staff T-44 raised the volume setting to 60. There was not a big difference in the sound from 20 to 60--but some difference was noted

Record review of the call light system's operations manual "Dukane Communications System: ProCare 6000/Model 4A3610B," failed to show a recommended volume setting in order to maintain a safe and audible sound.


b) Policy:

The facility was unable to produce a nursing policy/procedure specific to the newly refurbished & installed Dukane Communication System- to include any required volume parameters to be maintained.


c) Training :

Immediately following the call light observation on 5/13/2021 at 9:30 AM, Staff T-47 said she had not received training on the nurse call system. Surveyor-A requested any nursing training on the call light system in use in the COVID Unit. None was provided prior to survey exit.

Based on record review and interview, the facility failed to ensure that individual character, competence, training, experience, and judgment were considered in the Medical Executive Committee's recommendation and Governing Body's appointment of a candidate to the medical staff for 7 of 7 clinicians (Staff # T-72 through T-78).

Tidwell location.

Findings included:

Record review of Governing Body Bylaws, Doctors Hospital 1997, L.P. d/b/a United Memorial Medical Center Tidwell, last reviewed December 19, 2019, showed, "Section 2. Appointment, Reappointment ... [A]ll applications for appointment and for reappointment to the Medical Staff ... the Medical Staff shall ensure:
a. That criteria for selection include individual character, competence, training, experience, and judgment."


Record review of the credentialing files of 7 of 7 clinicians included:

Staff # T-72 (MD - Medical Doctor), T-73 (NP - Nurse Practitioner), T-74 (MD), T-75 (CRNA - Certified Register Nurse Anesthetist), T-76 (PA - Physician Assistant), T-77 (MD), and Staff # T-78 (MD).

Further review of the Professional Reference Questionnaire did not include all aspects of the criteria for selection (individual character, competence, training, experience, and judgment).

In an interview with Staff # T-9 on 5/14/2021 at 3:00pm, she stated the Professional Reference Questionnaire needed to be revised to align with the Governing Body Bylaws and regulations.

Based on record review, interview, and observation, it was determined that the hospital failed to have an effective nursing service to provide 24-hour nursing services for all areas of the hospital.

1) The hospital failed to ensure that training and competency verification of its nursing staff to provide patient care. Twenty-nine percent of hospital-employed licensed intensive care unit (ICU) nurses did not have their competencies evidenced by a current skills check list at the time of survey. Forty-two percent of the contracted agency nurses working at the hospital lacked evidence of the adult advanced life support certificate (ACLS) required by the hospital for its intensive care unit personnel. Ninety percent of contracted agency nurses did not have evidence of the required pediatric life support certification (PALS) despite a pediatric patient population at the time of survey. Eleven percent of agency nurses lacked evidence of basic life support (CPR) competence; two of four nurses were scheduled to work at the time of survey. Three agency nurses (eight percent) did not have a skills check list on file.

In addition, two out of three hospital campuses had personnel in director position who did not have the educational prerequisites to function in those positions, and the main campus did not have a Director of Nursing at the time of survey.

This failure placed the hospital at risk of lack of qualified leadership and personnel to deliver efficient nursing care and ensure compliance with standards of nursing practice.

Cross refer A0386


2) The hospital failed to provide adequate numbers of licensed nursing personnel in the hospital's intensive care unit and emergency department for two patients who had sought emergency care and required inpatient treatment. In the ED, Patient T-34B experienced a cardiac event, suffered from serious breathing problems related to his previously diagnosed COVID disease, and required admission to critical care. The intensive care unit had a shortage of nurses. Patient T-34B remained in the ED for close to 22 hours and died on 05/22/21 at the time of survey.

Patient T-31A had attempted suicide and was brought to the hospital ED as a serious risk of harm to himself by emergency services. The patient suffered from hallucinations and delusions and required close staff supervision. One-to-one staff was not available to observe the suicidal patient. Twenty-three hours into his stay, Patient T-31A, suicidal with impaired memory and orientation, left the ED with his intravenous catheters in place without staff's knowledge of the patient's whereabouts.

Cross refer A0392


3) The hospital's licensed ED nursing staff failed to evaluate the nursing care for four patients and did not reassess the patients according to their needs and nursing standards. Patients T-34B, T-20, T-25, and T-17 had been emergently treated for their breathing problems related to their COVID illness and/or Pneumonia. Despite the serious patient conditions and final critical care hospital admissions, the patients' vital signs were not checked for up to two hours.

Cross refer A0395

Based on record review and interview, the hospital failed to have a nursing service that provided types and numbers of nursing staff necessary to provide nursing care on all areas of the hospital.

1) Seven of 24 hospital-employed intensive care unit (ICU) registered nurses (or 29 percent) did not have a completed skills check list; 6 out of the remaining 17 hospital-employed licensed ICU nurses had skills check lists dated 2019 or before. One registered nurse's skills had not been assessed or verified in five years.

2) Fifteen of 35 hospital-contracted agency nurses (or 42 percent) did not have the required adult advanced cardiac life support (ACLS) certificate required by the hospital for its intensive care unit personnel. Thirty-two of 35 agency nurses (or 91 percent) did not have the specialty certification for pediatric life support (PALS) as required by hospital registered nurse (RN) job description although the hospital had a pediatric surgical patient at the time of survey. Four of 35 agency nurses lacked evidence of basic life support (CPR) competence; two agency nurses without evidenced CPR certification were scheduled to work at the time of survey. Three agency nurses did not have a skills check list on file.

3) An agency nurse during his initial work assignment at the main campus did not have a hospital-based preceptor.

These failures could place the hospital at risk to have agency nurses take care of critically ill patients in the hospital's intensive care unit without hospital verified and/or evidenced proficiency.


4) The medical center's Red Oak and Sugar Land campuses had nursing director personnel who did not have the educational prerequisites to function in those positions according to their job description. The main campus did not have a Director of Nursing at the time of survey.

5) The main campus Emergency Department (ED) did not have a nurse director

6) The hospital did not have a staffing committee to evaluate nurse sensitive indicators nor a staffing plan at the time of survey.

These failures placed the hospital at risk of lack of qualified leadership and personnel to deliver efficient nursing care and ensure compliance of standards of nursing practice.


Findings included

1) Personnel files were reviewed with Personnel T-7 on 09/12/21 at 1010. Personnel T-7 stated that three out of five ICU assigned RNs (T-29, T-31, and T-48) did not have the required skills checks demonstrated. Personnel T-7 stated ICU RN T-46's skills were last demonstrated in 2016.

Record review of the 05/13/21 hospital provided registered nurse (RN) employee list reflected the hospital had 24 RNs on their payroll.

Further record review of the employee list reflected:

a) one nurse (T-60) had a nursing license with an 10/31/2020 expiration date on file

b) seven RNs (T-29, T-53, T-60, T-61, T-62, T-63, T-66) did not have a completed skills check list on file

c) six of 17 RNs (T-18, T-55, T-64, T-65, T-67, and T-68) had skills check lists dated 2019 or earlier and had not been updated annually.


During an interview on 05/13/21 at 0940 Personnel T-7 confirmed the above findings.

Record review of the daily staffing sheet dated 05/11/21 at 7 AM reflected Personnel T-18 was scheduled to work.


2) Record review of the hospital Criteria-Based Job Description/Registered Nurse ICU reflected requirements that included current Cardiopulmonary Resuscitation (CPR) certificate, ACLS, and PALS certification within 3 months of employment, and "must be able to provide nursing care to patients of all ages...must cross train and then be willing to float to other nursing departments as needed..."

Record review of the 05/14/21 hospital-provided list of agency nurses' competencies reflected the hospital had 35 agency nurses on file. The list reflected that

a) 32 out of 35 nurses (or 91 percent) did not have the PALS certificate. The list included agency RNs T-50, T-88, and T-92.

b) 15 out of 35 agency nurses (or 42 percent) did not have the required Advanced Cardiac Life support (ACLS) certification. The list included RNs T-92 and T-50.

b) 4 out of 35 nurses (or 11 percent) did not have a current Basic Life Support (BLS/CPR) on file. The list included agency RNs T-92 and T-50.

c) 3 out of 35 nurses (or 8 percent) did not have a skills check list on file to evidence. Those nurses included agency RNs T-88, T-92, and T-102.

Record review of the hospital-provided nurse assignment sheet dated 05/11/21 at 1900 reflected agency RNs T-50, T-88, and T-92 were scheduled to work.


Hospital administrative nurse T-6 was asked about hospital-assigned agency nursing competencies during an interview on 05/10/21 at 1445. Personnel T-6 stated, the agencies provided the nurse competency check list and "if they [the agency nurses] are not competent per agency, they will get trained."

During an interview on 05/11/21 at 1100 Hospital Personnel T-10 confirmed that agency nurses did not get checked off by the education department.

Intensive Care Unit Patient Census dated 05/12/21 at 0836 reflected, the unit had 12 patients with diagnoses that included Coronary Artery Disease, Congestive Heart Failure, Drug Overdose, Upper Gastrointestinal Bleeding, Abnormal Troponin, Myocardial Infarction, Sepsis, Abnormal CT. All patients had been admitted prior to 05/11/21.

Record review of the hospital's Surgery Schedule dated 05/11/21, Patient T-16, a 5-year old patient, was scheduled to undergo a right ear tympanoplasty (a surgical technique to repair a defect in the tympanic membrane with the placement of a graft).


During an interview on on 05/12/21 at 1315, Hospital administrative Personnel was asked about the required PALS certification in the RN job description and stated she was working on having it removed because of the usual adult hospital patient population.


3) During an interview on 05/11/21 at 1110 Hospital Personnel T-11 stated that agency RN T-51's first hospital assignment was on 02/02/21.

Record review of the hospital-provided staffing sheet dated 02/02/21 at 1845 reflected the names of four RNs scheduled for the hospital's ICU including RN T-51. Hospital Personnel T-11 stated on 05/11/21 at 1110 that all four nurses were from a staffing agency and agreed that RN T-51 was not oriented to the unit by a hospital-based staff member.


4) Record review of the application file of Hospital Director of Nursing T-103, hired on 04/14/21, was reviewed with Hospital Personnel T-5 on 05/13/21 at 1515. The document reflected the applicant had an associate degree in nursing. Personnel T-5 acknowledged the finding.

On 05/13/21 at 1700, Hospital Director of Nursing T-93's file was reviewed with Hospital Personnel T-7 who confirmed that Personnel T-93 had an associate degree of nursing, was not enrolled in a Master of Science in Nursing Program and did not have any supervised hours with a Master's prepared preceptor.


Record review of the criteria-based job description signed by Hospital DON T-93, undated, revised on 11/08/19, reflected the position required a Bachelor of Science Degree and "desired" a Master's degree. The position assumed "a primary role in ensuring the delivery of high quality, efficient nursing care...ensures compliance of standards of nursing practice..."


During an interview on 05/11/21 at 1430, Hospital Personnel T-43 stated there was not a Director of Nursing at the main campus at that time.

Hospital Nurse Administrative Personnel T-6 was asked about a current Director of Nursing (DON) at the main campus during an interview on 05/12/21 at 1315 and stated that there was none at that time.


5) During interview on 05/12/21 at 1050, Hospital Personnel T-49 was asked about a nursing director in the hospital's Emergency Department. T-49 denied there was a manager or director and stated Personnel T-27 "helped out."

Record review of T-27's job description signed by the employee, undated, revised 09/28/16 reflected the job summary to be "responsible for evaluating, reviewing, analyzing trauma charts and maintenance of reported data entered in the Texas Trauma Registry...supervised by Trauma Coordinator/Director of Emergency Department..."


6) Hospital Administrative Personnel T-6 was asked about the hospital's nurse advisory staffing committee to evaluate nurse sensitive indicators during an interview on 0512/21 at 1015. Personnel T-6 stated there was no staffing committee. Later, during an interview on 05/12/21 at 1315, Personnel T-6 stated denied the hospital had a nurse staffing plan.

Based on record review and interview, the hospital failed to have adequate number of licensed nursing personnel to provide nursing care to 2 of 10 patients (Patient # T-34B and T-31A) as needed.

1) Patient T-34B sought emergency care the morning of 05/10/21 for breathing problems related to his previously diagnosed COVID disease. The patient's vital signs were elevated and the physician recommended urgent inpatient admission in view of the patient condition that was compounded by a critically elevated Troponin level and a physician-suspected cardiac infarction. Admission orders to inpatient treatment were written approximately five hours after the patient's ED arrival; no bed was available at that time. Over the following six hours, Patient T-34B's heart rate fluctuated between 150 and 160 beats per minute, his oxygen levels desaturated to 87 percent, and the patient became restless. Emergency Department (ED) staff called the admitting station to give the patient's report, but the assigned nurse was unavailable. Still in the ED 15 hours after his initial ED presentation, Patient T-34B became confused. Twenty hours into the patient's ED stay, the nursing supervisor informed the ED staff that the ICU had a shortage of staff that morning. Patient T-34B remained in the ED for another hour and 53 minutes during which he was noted to be confused and pulled out his IV catheters. Patient T-34B finally became unresponsive and diaphoretic. The patient died in the hospital's ED on the morning of 05/11/21 at the time of survey.


2) Patient T-31A had been brought to the hospital's emergency department by peace officers after taking an unknown number of pills in a suicide attempt the early afternoon on 04/01/21. He was considered to be a substantial risk of serious harm to himself and threatened to leave and take more drugs. The patient was delusional and suffered from auditory hallucinations with impaired orientation and memory. Nursing noted he was on a one-to-one observational level. Eighteen hours into his ED stay, Patient T-31A was placed close to the nurses' station for constant observation. Approximately 20 minutes later, nursing moved the patient back in one of the ED rooms with the order to monitor him; there was no sitter available. On 04/02/21 at 1439, approximately 23 ½ hours after the patient's initial presentation to the ED, Patient T-31A, a suicidal patient with impaired memory and orientation, was able to leave the ED with staff's unawareness of the patient's whereabouts. Patient T-31A still had his intraveneous catheter in place at the time of departure.


Findings included:

1) Patient T-34B's Emergency Department Nursing Medical Record dated 05/10/21 at 0927 reflected the patient was triaged. The patient's chief complaint was shortness of breath (SOB). The patient was not accompanied by anyone. His SOB was "mild to moderate severity" and was accompanied by a cough that had started that morning. The patient had a fever since the previous night. Patient T-34B had been seen at a specialty clinic "this am" and was noted with oxygen levels at 90 percent on room air and was sent to the ED.

Patient T-34B's triage assessment reflected the patient was "alert, no acute distress (NAD), patent airway...normal breathing pattern...dry skin: pink, warm. Awake, alert, and oriented as to person, place, and time. Calm; cooperative."

Record review of Patient T-34B's triage vital signs reflected his blood pressure was 147/97 mmHg, his temperature was 102.7-degree Fahrenheit. The patient had a pulse of 140 beats per minute (bpm) and was breathing at a rate of 20 respirations per minute (rpm). The patient reported a zero on the 1-10 pain scale and had no allergies. The patient's medical history included high blood pressure. Airborne, contact, and droplet precautions were initiated, and the patient was placed on a stretcher in a negative pressure room.

Record review of Patient T-34B's Physician Reevaluation and Observation document dated 05/10/21 at 1600 reflected that the patient needed "to go to the Covid unit right away...[Patient T-34's] condition id [sic] compounded by the fact that he is going through an evolving infarct...already has several stents in his coronary arteries."

Record review of Patient T-34B's ED Nursing Notes dated 05/10/21 at 0937 reflected the physician examined the patient. At 1323, the ED reported a critical Troponin level of 0.043 nanogram per milliliter (ng/mL) for Patient T-34B. Admission orders were written at 1414 and room assignment was done at 1520 "...room not available ...once room is clean and available, we will bring patient..." At 1805 Patient T-34'Bs blood pressure was "elevated" and his oxygen level "desaturated to 87 percent;" the patient received a nonbreathing mask with oxygen administration. On 05/10/21 at 1845, Patient T-34'Bs heart rate was noted to fluctuate between 150 and 160 bpm. At 2026, Patient T-34B's heartbeat fluctuated between 148 and 160 bpm and the patient was "restless." Staff noted they "called station 4 for report but assigned nurse unavailable..."

Record review of Patient T-34B's ED Nursing Notes dated 05/11/21 at 0011 reflected the patient "remained restless...HR [hear rate] 150 to 154 on IV [intravenous] drip." At 0415, Patient T-34B was noted to be "confused, climbed out of bed to beside commode..."

Patient T-34B's ED Nursing Notes dated 05/11/21 at 0515 reflected ED staff "called the supervisor regarding transfer to ICU and also confused and unstable condition. The supervisor informed me that they have shortage of staff this morning." At 0620, Patient T-34B "pulled both IVs out." At 0635, Patient T-34B was "unresponsive, diaphoretic, color flushed, code blue called and ACLS protocol initiated..." At 0705, Patient T-34B was "pronounced dead..." At 0932, staff spoke to the admitting physician to inform him that the patient "was never taken to a room because of nursing shortage and was pronounced deceased in the ER at 0705 this morning..."


During an interview on 05/12/21 at 1315, Hospital administrative Personnel T-6 came to the ED with shortness of breath and received breathing treatments. The patient was not "sustaining oxygen levels." Personnel T-6 stated that "there was no reason not to take the patient to ICU."


2) Patient T-31A's Notification of Emergency Detention dated 04/01/21 at 1450 reflected a peace officer had "reason to believe that...[Patient T-31A] evidences a substantial risk of serious harm to himself...or others..." after the patient was "found sitting by a dumpster showing signs of distress...he took a large quantity of unknown blue pills...trying to kill himself."


Nursing Notes dated 04/01/21 at 1542 reflected Patient T-31A's psychiatric assessment; the patient was noted to be delusional, threatening, with auditory hallucinations, anxious mood and suicidal thought content with impaired orientation and memory.

Patient T-31A's Emergency Department Physician Medical Record dated 04/01/21 at 1608 reflected the patient had arrived at 1524 with a chief complaint of overdose and suicidal ideation. The physician noted the severity of the patient's present illness.

Nursing Notes dated 04/01/21 at 1616 reflected that the Patient T-31A was "on continuous monitoring 1 to 1." Notes dated 04/02/21 at 0100 and 0400 reflected that the patient had a "sitter at bedside." Notes dated 04/02/21 at 0841 reflected Patient T-31A was "placed by the nurses' station for 1-1 [sic] ...very abusive and threatening to hit..." Nineteen minutes later, on 04/02/21 at 0900, nursing notes reflected that Patient T-31A was "placed back in room 4 per ERP (Emergency Room Physician) and order to do rounds on him because hospital did not have a seater [sic] for him." At 1243 nursing noted that "continuous monitoring [was] in place..." At 1405, Patient T-31A was "on stretcher in no acute distress." Thirty-four minutes later, on 04/02/21 at 1439, nursing documented that Patient T-31A "possibly eloped...not in room..." At 1440 the nurse noted that they "came to check on...[Patient T-31A] and was not in room. Gown was on bed and belongings were not on the table on the hallway...possible [sic] left with IV catheter on since it was not found in room..."


Physician Encounter Summary dated 04/02/21 at 1439 reflected Patient T-31A's final diagnoses that included Depression, Marijuana Use, and Amphetamine in Urine.


The physician's Reevaluation and Observation documentation dated on 04/02/21 and 0831 reflected that Patient T-31A wanted to leave the room "but was told he could not do so...does not want to be in this hospital...boasting that he will take more drugs when he leaves here and no one can stop him...continues to threaten he would leave if he could not go to a psyche [sic] hospital...pt was advised that we are even keener than him to get him to a proper institution..."

Physician Discharged Instructions dated 04/02/21 at 1439 reflected Patient T-31A "eloped."

The patient incident was discussed on 05/12/21 at 1315 with Hospital administrative Personnel T-6.


37490

Based on interview and record review, the facility failed to show any nursing staff working April 24, 2020 - April 30, 2020, at its Sugar Land location.

Findings include:

Record review of facility policy titled: Department Staffing Guidelines, dated 4/19 showed the following information:

B. Emergency Room:

FTE Allotment: Three licensed nurses on duty at all times (must have 2 RN), additional staff as needed 1 PCA and 1 US


D. Medical/Surgical

FTE Allotment: Minimal 2 licensed nurses (must have 1 RN on duty at all times), 1:6 Nurse patient ratio ...


UMMC Census Based Staffing Grid (page 4/5 of 5) shows *all units must be staffed with no less than 2 RNs at all times regardless of census and acuity.

Record review of the emergency room patient log for 4/24-30/2020 revealed no patients were seen.


During an interview with hospital Director of Operations (SL-3) on 5/11/2021 at 1:05 PM, she stated that the hospital remained open during the entire course of the pandemic. Surgeries were cancelled when the Governor's mandate to not have elective surgeries was in effect but, the in-patient and emergency room stayed opened and were always staffed. When asked to provide a copy of the nursing schedule for the last week in April, she stated that due to staff turnover, she did not have a copy of that schedule. When asked to provide time clock data for the nursing staff during the same time period, she stated that there was a new time system in place, and she could not retrieve the data. She stated that Human Resources could provide the information.


Interview with human resource staff (T-7) on 5/12/2020 at 12:20 PM, she stated that the timeclock data for the nursing staff at the Sugarland location 4/24-30/2020 could not be retrieved.

Based on record review and interview, the hospital's registered nursing staff failed to evaluate the nursing care for 3 of 4 patients (Patients T-34B, T-20, T-25, and T-17) and failed to reassess the patients' vital signs according to the patients' needs and nursing standards.

1) Patient T-34B sought emergency care the morning of 05/10/21 after his positive COVID-19 test a week earlier. Despite the patient's evolving cardiac infarct, oxygen level fluctuation, elevated body temperature, and increased heart rate up to 160 beats per minute during his approximately 21-hour Emergency Department (ED) stay, his vital signs were taken with intervals up to close to two hours between reassessments shortly before the patient died.

2) Patient T-20 was hospital admitted from the Emergency Department with diagnoses that included COVID on 03/28/21. The patient was critically ill; the physician noted she might die. Despite the patient's low oxygen level and elevated temperature upon ED arrival, her vital signs were measured at every two hours before the patient was transferred to the inpatient unit.

3) Patient T-25 was emergently evaluated on 04/28/21 at 1140 for her complaints of shortness of breath. The patient's diagnoses that included Community-Acquired Pneumonia, Chronic Obstructive Pulmonary Disease, and Emphysema required inpatient hospitalization and intensive care. Despite the severity of Patient T-25's illness, the patient's vital signs were checked only three times during the patient's four-hour and 20 minute ED stay.

4) Patient T-17 was brought to the hospital's ED per emergency medical services on 02/15/21 for complaints of shortness of breath. The patient had been hospitalized for his COVID illness earlier that year and was noted with a very low blood pressure on ED admission and stay. There was no documented evidence that nursing evaluated the patient's blood pressure for more than two hours between 1310 and 1530.


Findings included:


1) Patient T-34B's Emergency Department Nursing Medical Record dated 05/10/21 at 0927 reflected the patient was triaged. The patient's chief complaint was shortness of breath (SOB). His SOB was "mild to moderate severity" and was accompanied by a cough that had started that morning. The patient had a fever since the previous night. Patient T-34B had been seen at a specialty clinic and was sent to the ED.


Record review of Patient T-34B's triage vital signs dated 05/10/21 at 0927 reflected his blood pressure was 147/97 mmHg, his temperature was 102.7-degree Fahrenheit. The patient had a pulse of 140 beats per minute (bpm) and was breathing at a rate of 20 respirations per minute (rpm). The patient's medical history included high blood pressure.

Patient T-34B's Physician Reevaluation dated 05/10/21 at 1600 reflected a cardiology consult request. The physician noted that Patient T-34B's condition was "...compounded by the fact that he is going through an evolving infarct...already had several stents in his coronary arteries."

Record review of Patient T-34B's ED Nursing notes dated 05/10/21 at 1805 Patient T-34B's blood pressure was "elevated" and his oxygen level "desaturated to 87 percent;" the patient received a nonbreathing mask with oxygen administration. On 05/10/21 at 1845, Patient T-34B's heart rate was noted to fluctuate between 150 and 160 bpm. At 2026, Patient T-34B's heartbeat fluctuated between 148 and 160 bpm and the patient was "restless."

Record review of Patient T-34B's ED Nursing Notes dated 05/11/21 at 0011 reflected the patient "remained restless...HR [heart rate] 150 to 154 on IV [intravenous] drip." At 0415, Patient T-34B was noted to be "confused, climbed out of bed to beside commode...had large diarrhea..."

Patient T-34B's ED Nursing Notes dated 05/11/21 at 0515 reflected the patient's "confused and unstable" condition.

Patient T-34B's ED Nursing Notes dated 05/11/21 at 0635 reflected the patient was "unresponsive, diaphoretic, color flushed, code blue called and ACLS protocol initiated..." At 0705, Patient T-34B was "pronounced dead."


Record review of Patient T-34B's ED Vital Signs Documentation reflected the patient's vital signs were taken 25 times between his initial triage upon ED entry on 05/10/21 and immediately preceding his death on 05/11/21 at 0705. Staff recorded vital signs on 05/10/21 at 0927 (triage), 1038, 1112, 1128 1238, 1323, 1345, 1511, 1536, 1709, 1805, 1807, 1845, 1856, 1920, 2009, 2100, 2225, 2320, and on 05/11/21 at 0100, 0150, 0359, 0558, 0614, and 0645.

Vital Signs documentation dated 05/10/21 at 1128 reflected the patient's heart rate to be 154 beats per minute (bpm). Vital signs did not get checked again for one hour and ten minutes until 1238 when the patient's heart rate was 152 bpm. Forty-five minutes later, at 1323, Patient T-34B's heart rate was still elevated to 151 bpm.

Record review of Patient T-34B's vital signs in the ED dated 05/10/23 at 2320 reflected the patient's heart rate to be elevated to 152 bpm. The heart did not get checked until one hour and 40 minutes later on 05/11/21 at 0100; at that time, the patient's heart rate was still 150 bpm. Approximately three hours before the patient expired, his vital signs did not get measured for one hour and 59 minutes between 0359 and 0558; the patient's heart rate was 142 bpm at 0359 and 155 bpm at 0558 on 05/11/21.

Record review of Patient T-34B's Physician Orders dated 05/10/21 at 1029 reflected a radiology order for a computer tomography of the chest. The reason was noted a positive COVID test "a week ago."

The above findings were reviewed during an interview on 05/12/21 at 1315 with Hospital Administrative Personnel T-6 who stated it was the expectation to evaluate the critically ill patient's vital signs "every 15 minutes."


2). Patient T-20 sought emergency care on 03/28/21. Her chief complaint was Shortness of Breath; the patient's blood oxygen level upon arrival was critically low at 76 percent according to the triage vital signs timed at 1715.

Record review of the ED Nursing Medical Record dated 03/28/21 reflected the patient's vital signs were taken at 1720, at 1931, and at 21:26 and reflected the patient's elevated body temperature and respiratory rate.

Patient T-20's Discharge Instructions and Patient Disposition documentation dated 03/28/21 at 1839 reflected the patient was admitted in "serious condition" to the hospital's COVID unit.

Patient T-20's Physician History and Physical Examination document dated 03/28/21 at 2200 reflected the patient's extensive COVID Pneumonia. The document reflected a hand-written note that the patient "may die."


3) Patient T-25's Emergency Department Physician Medical Record dated 04/28/21 reflected the patient arrived at the hospital's ED at 1140 with a chief complaint of shortness of breath. Diagnoses included Left Lower Lobe Pneumonia, Chronic Obstructive Pulmonary Disease (COPD) exacerbation, and Hypoxemia (low blood oxygen). The patient's disposition for admission to the Intensive Care Unit (ICU).

Triage vital signs dated 04/28/21 at 1145 reflected the patient had a temperature of 100.1 degree Fahrenheit. Her pulse was elevated to 101 beats per minute (bpm), her respirations were 24 per minute. Patient T-25 complained of pain of 8 and a 1 to 10 scale.

Nursing Medical Record dated 04/28/21 at 1345 and 1600 reflected Patient T-25 had elevated respirations, pulse and pain.

Patient T-25's Physician History and Physical dated 04/28/21, untimed, reflected the patient's 88/56 mmHg, and her respirations were 34 breaths per minute.


4) Patient T-17's Emergency Department Nursing Medical Record reflected the patient presented to the ED on 02/15/21 with complaints that included Shortness of Breath. The patient's triage vital signs dated 02/15/21 at 0927 included the oxygenation level of 88 percent on room air and his blood pressure was low. The nurse documented the patient's oxygen level at 0930. The patient's vital signs were taken at 1029 when the patient's blood pressure (BP) was 85/56 mmHg, at 1215 (BP of 88/53mmHg), at 1310 (BP of 90/60 mmHg), at 1530 (BP of 87/55 mmHg), at 1628 (BP of 91/54 mmHg) and at 1742 (BP of 96/60 mmHg).

Patient T-17's Emergency Department Physician Medical Report dated 02/15/21 at 0855 reflected the patient had "already tested positive for COVID in January and was hospitalized...back then..." The patient's disposition was the hospital's COVID unit.

Record review of Patient # T-17's Physician History and Physical Examination dated 02/15/21 reflected the patients diagnoses that included Early Respiratory Failure and Orthostatic Hypotension; the patient had a history of COVID and Lymphoma.


During an interview on 05/10/21 at 0915, Hospital Personnel T-27 reviewed the charts of Patient T-20, T-25, and T-17 together with the surveyor and acknowledged the findings.


Record review of the hospital-wide Policy # NSG.02.103.4 titled Assessment and Reassessment dated 04/2019 reflected "all patients receiving inpatient, outpatient or ER services will have an initial assessment and appropriate follow-up assessments based upon their individual needs." The policy specifies for the Emergency Department staff that "reassessments are performed by an RN and physicians ...as indicated by the patient's condition and/or treatment" (page 10).


Record review of the Texas Board of Nursing Scope of Practice reflected "The comprehensive assessment is the first step and lays the foundation for the nursing process. The comprehensive assessment is the initial and ongoing, extensive collection, analysis and interpretation of data. Nursing judgment is based on the assessment findings ..."
(https://www.bon.texas.gov/practice_bon_position_statements_content.asp#15.28).

Based on observation, staff interviews, and a review of facility documentation, the staff failed to ensure that multi-dose vials of patient medications were discarded after 28 days from opening and first use. The safety of medications in multi-dose vials used past 28 days of opening may be compromised, thus potentially endangering patient health and recovery.

Red Oak location:

Findings were:

Hospital policy #PHA.TX.065 entitled "Medication Use Process: Administration - Medication Expiration Dating," last revised 7/11, included the following:
"Outcomes Standards:

1. To identify a standardized expiration (beyond use) dating policy for drugs used in this facility after initial use ...

Process Standards:

Dating of sterile containers as follows: ...

2. Multi-Dose (i.e., preserved Vials - 28 days (not to exceed manufacturer's expiration date) ..."


During a tour of the hospital nursing unit on the morning of 5/10/21 with Staff #RB2, hospital Director of Nursing, the following medications were found available for patient use, opened, and with no marked date to indicate when they were opened or when they should be discarded:

#1 vial of Humulin R U-100 insulin (100 unit/mL)

#1 multi-dose vial of Ascorbic Acid injection (500mg/mL)


With no evidence of when the vials were opened or to be discarded, there was no way to determine if the medications were still safe for patient use.


The Centers for Disease Control and Prevention, Injection Safety article (available at https://www.cdc.gov/injectionsafety/providers/provider_faqs_multivials.html), includes the following:

Medication vials should always be discarded whenever sterility is compromised or cannot be confirmed. In addition, the United States Pharmacopeia (USP) General Chapter 797 [16] recommends the following for multi-dose vials of sterile pharmaceuticals:

- If a multi-dose has been opened or accessed (e.g., needle-punctured), the vial should be dated and discarded within 28 days unless the manufacturer specifies a different (shorter or longer) date for that opened vial ..."

Based on observation, record review, and interview, the facility failed to ensure there was an effective medical record service that maintained physical and administrative responsibility for medical records. The facility failed to:

A. ensure medical records were stored in a secure location where they were protected from access by unauthorized individuals, as well as fire and water damage:

1.Tidwell location: there was an estimated 14,775 medical records stored behind the hospital in two unlocked spaces: the "barn" and a boxcar.

2. Red Oak location: there was an estimated 112 medical records stored in a materials management area adjacent to the operating suites, accessed from the outside of the hospital.

Examples of confidential patient information accessible at both locations included: patient's medical history and treatment, along with demographic information (name, date of birth, address, phone number, social security number), and emergency contact information.

Cross Refer to A0441


B. ensure medical records were complete. Three (3) of 20 patient records reviewed failed to contain an Operative Report-Sugar Land location.

Cross Refer to A0449

Based on observation, record review, and interview, the facility failed to ensure medical records were properly stored in a secure location where they were protected from access by unauthorized individuals, as well as fire and water damage. A random sampling of medical records from the estimated 14,775 charts showed that 12 of 12 records (Patient # T-40 through T-51) contained the patient's medical history, diagnosis, and medical care/treatment, along with demographic information (name, date of birth, address, phone number, social security number), emergency contact information, and, when applicable, insurance information).


Tidwell Location.

Findings included:

Record review of the HIPAA Journal [ https://www.hipaajournal.com/what-is-considered-protected-health-information-under-hipaa/ ] Copyright © 2014 - 2021, showed:
"Under HIPAA, protected health information [PHI] is ... individually identifiable information relating to the past, present, or future health status of an individual that is created, collected, or transmitted, or maintained by a HIPAA-covered entity in relation to the provision of healthcare, payment for healthcare services, or use in healthcare operations (PHI healthcare business uses).

"Health information such as diagnoses, treatment information, medical test results, and prescription information are considered protected health information under HIPAA, as are national identification numbers and demographic information such as birth dates, gender, ethnicity, and contact and emergency contact information. PHI relates to physical records ...

"The HIPAA Security Rule requires covered entities to protect against reasonably anticipated threats to the security of PHI. Covered entities must implement safeguards to ensure the confidentiality, integrity, and availability of PHI ...

"HIPAA requires physical, technical, and administrative safeguards to be implemented ... Physical safeguards for PHI data include keeping physical records and electronic devices containing PHI under lock and key. Administrative safeguards include access controls to limit who can view PHI information and security awareness training."


Record review of Policy # HIM.018.109.1, "Confidentiality of Medical Records Authorized Access," reviewed 04/2016, showed: "There will be established guidelines for determination of authorized access to patients' medical records ... The following individuals will be permitted access to patient medical records for purposes of care and treatment of patients, review activities, and research which Administration and the Medical Staff have authorized: ... Medical Staff Practitioners ... Nursing Department - direct patient care providers ... Admissions Department ... ancillary departments ... Business Office ... monitoring departments ... [and] contracted services as required by their job functions. Employees should be able to provide proper identification, as well as provide a valid reason as to the review."


Record review of Policy # HIM.018.009.2, "Protection / Prevention Against Loss and Destruction," revised 05/2010, showed: "The hospital is responsible for safeguarding both the medical record and its informational content against loss, defacement, tampering, and from use by unauthorized individuals. Particular emphasis is given to protection from fire and water ... To prevent theft, records are maintained in secured areas with access limited to Health Information Management department employees and those employees (House Supervisors) charged with record retrieval after hours."


Record review of Policy # HIM.018.095.1, "Filing, Storing, and Retrieving of Off-Site Patient Records," revised 05/2010, showed: " ... charts are sent to off-site storage as needed when charts need to be purged."


During a tour of the facility on 5/10/2021 at 9:45am, it was observed that several staff were going in and out of a metal building behind the hospital. The building had a large front door that was open. This opening was large enough to accommodate the unloading of equipment and supplies as is seen on a loading dock.


In an interview with Staff # T-44 (EM - Engineering Manager) on 5/10/2021 at 9:45am, he stated that the building was referred to as "the barn" and housed used equipment and housekeeping supplies.


Further observation of the building showed, there was a washing machine and dryer to the immediate left just inside the front door. The building contained used hospital beds, chairs, electronic equipment, tools, and an assortment of utensils and gadgets. To the back of the space was a metal fence and gate. Inside the gate was bottled water and housekeeping supplies. In addition, there was a climate-controlled room with linens, towels, and gowns. Staff # T-44 (EM) stated that the laundry equipment was used by the housekeepers. He also stated, he had access to this building. He was asked to identify the individuals observed coming and going, He identified them as Staff # T-96 (Contractor), Staff # T-97 (Contractor), Staff # T-98 (Contractor), Staff # T-99 (Engineer Technician), and Staff # T-85 (Housekeeping Supervisor).

Continuing with the tour, it was observed that there were piles of boxes on the second story. The boxes were stacked three to six high. Some rows were three to four boxes deep. The depth of many of the rows could not be determined without manually moving many of the boxes. Upon closer examination of the boxes, the surveyor found that almost all these boxes were filled with medical records. Several of the boxes had hospital financial information; others had letters informing physicians of possible termination of admitting privileges due to delinquent medical records. With the randomness of the stacks and the rising temperature inside the building, it was not possible to get an exact number of boxes containing medical records.

There were also pieces of medical records piled into boxes on the first floor. Several of the boxes were overflowing onto the floor. These records were not complete medical records, but random pieces of the medical record. These records, ranging from Medication Administration Records to consent forms to clinical assessments, contained the patient's name and other

The surveyor asked that a representative from Health Information Management be summoned. Staff # T-79 (Medical Records Supervisor) arrived.

Staff # T-79 (Medical Records Supervisor), Staff # T-44 (EM) and Staff # T-5 (CEO) were interviewed on 5/10/2021 at 10:10am.

Staff # T-79 stated she did not know the boxes of medical records were being stored in the barn. She also stated that the facility had failed to comply with HIPAA [Health Insurance Portability and Accountability Act], adding that confidentiality of the records had been compromised.

All three interviewees stated that these medical records should be stored in a locked area that limited access of the records to authorized personnel only.

Staff # T-5 (CEO) stated, "I am in awe. I didn't know." She also stated the records were in the barn because they needed to be scanned. She later stated they had already been scanned. (It was determined from a random sampling that the records had indeed been scanned into the facility's electronic medical record system.)

Staff # T-44 (EM) stated he estimated there to be "a few hundred boxes," adding that there could be 300 or more boxes of medical records.

Staff # T-79 (Medical Records Supervisor) stated she agreed with Staff # T-44's estimation.


Following these findings, it was noted that there were five boxcars behind the hospital. The first boxcar was unlocked. Inside the boxcar were 291 more boxes of medical records. It was estimated that there were over 591 boxes between the barn and the boxcar (300 in the barn and 291 in the boxcar). A random selection of boxes showed there to be an average of 25 medical records per box for a total of 14,775 records.

Twelve random charts were pulled from several of the boxes of medical records. These included Patient # T-40, T-41, T-42, T-43, T-44, T-45, T-46, T-47, T-48, T-49, T-50, and # T-51. Record review of the 12 random medical records showed documents containing of each patient's medical history, diagnosis, and medical care / treatment, along with demographic information (name, date of birth, address, phone number, social security number), emergency contact information, and, when applicable, insurance information.



32870

Based on observation, staff interviews, and facility documentation review, the hospital failed to ensure the confidentiality of patient medical records as approximately 112 records were stored in the hospital central supply area in unlocked containers. This made the protected health information, as well as additional more personal patient information, available to any staff or other individuals entering the area. Consequences of breached patient information can include financial and psychological harm, fraud, and identity theft.

Findings were:

Red Oak Location:

Facility policy #ADM.01.124.1 entitled "Retention, Storage and Destruction of Records," last reviewed 4/19, included the following:

"This policy is intended to provide guidance regarding the storage of all records, including letters, memoranda, medical records, accounting source documents, etc. This policy applies to all UNTIED [sic] MEMORIAL MEDICAL CENTER (the "Hospital") entities, including hospitals, clinics, and corporate offices. All UNITED MEMORIAL [sic] MEDICAL CENTER facilities will comply with state and federal laws and regulations regarding the manner in which medical records are stored.

II. POLICY

To facilitate the attainment of Outcome Standards: ...

1. It is the Hospital's policy to apply effective and cost efficient management techniques to maintain complete, accurate, and high quality records. Records are retained in accordance with all applicable laws and regulations and this policy.

2. Records that have satisfied their required period of retention will be destroyed in an appropriate manner.

3. Records will be managed responsibly, and retention schedules and destruction procedures and methods will be developed applicable to the Hospital's records.

4. All Hospital employees and agents are responsible for ensuring that all records are created, used, maintained, preserved, and destroyed in accordance with this Records Management policy.

5. Vital and official records will be retained and protected to ensure the Hospital's continued operations in the event of a natural or man-made disaster.

6. Event of a natural or man-made disaster [sic].

7. Records containing confidential and proprietary information will be securely maintained, controlled and protected to prevent unauthorized access.

8. All records generated and received by the Hospital are the property of the Hospital. No Hospital employee, by virtue of his or her position, has any personal or property right to such records even though he or she may have developed or compiled them.

9. The unauthorized destruction, removal or use of such records is prohibited.

10. No one may falsify or inappropriately alter information in any record or document.

11. CEOs shall designate an individual to be responsible for implementing and maintaining the Hospital's records management programs at their facilities in accordance with this policy ..."

Based on interview and record review, the facility failed to ensure operative reports were completed in 3 of 20 records reviewed (SL-4, SL-15 and SL-16).

Sugar Land location.

Findings include:

Review of medical records for patient (SL-4) showed no operative report for surgery performed by MD(SL-24) the Sugar Land location on 4/24/2020.

Review of medical record for patient (SL-15) showed no operative report for surgery performed by MD (SL-24) the Sugar Land location on 4/27/2020.

Review of medical record for patient (SL-16) showed no operative report for surgery performed by MD (SL-24) at the Sugar Land location on 4/25/2020.


Review of facility policy titled: Delinquent Medical Record Policy, dated 5/14/2019 showed the following:

The incomplete medical record is considered delinquent after thirty (30) days after discharge. This includes all dictation, written notes, that are not authenticated by signatures, dates and times.

Health Information Management (HIM) staff will provide to each physician a letter bi-monthly, documenting all incomplete and delinquent records.
The data and delinquency percentage will be added to the HIM Management Stats Delinquency Rate Grid. It will be checked for accuracy and reported. This report will be presented to medical staff meetings as well as MEC and Governing Board.


Interview with staff (SL-4) on 5/11/2021 at 1:00PM, she stated that a copy of the letter could not be provided. Due to staff turnover, there is no documentation other than a note in the scheduling system that MD (SL-24) had been contacted to complete his operative reports.

Based on observation, interview, the Tidwell facility provided policy, and the Texas Food Establishment Regulations (TFER) the facility's kitchen failed to provide food services in a sanitary environment when the following was found:

An opened mayonnaise container, with no date when opened

Ice build-up in the freezer

2 wet towels, laying on the counters

Rusted shelving in the walk-in refrigerator

An unlabeled chemical in the food preparation area

Dust build-up on food services trays

A scoop in a food bin

Food debris on the meat slicer

A cloth, uncleanable, pastry bag

A blue drape, covering linens, was dragging on the floor, and collecting dirt


Finding included:

Tidwell location:

Observation on 5/10/21, at 10:00 am, in the facility's kitchen revealed the following:

An opened mayonnaise container, with no date when opened

Ice build-up in the freezer

2 wet towels, laying on the counters

Rusted shelving in the walk-in refrigerator

An unlabeled chemical in the food preparation area

Dust build-up on food service trays

A scoop in the food bin

Food debris on the meat slicer

A cloth, uncleanable, pastry bag

A blue drape, covering linens, was dragging on the floor, and collecting dirt


Review of the facility provided policy Cleaning Procedures (dated 4/19) reflected, "To maintain the cleanliness and sanitation in modern-restaurant kitchens and dining rooms must be cleaned frequently and regularly ...

A slicer should be cleansed after each use. Special care has to be taken when cleaning slicer after raw meats have been cut. (Bacteria from raw meat could be transferred to cooked meat if slicer is not cleaned properly) ..."


Review of the Texas Food Establishment Regulations reflected, "228.66(a)(1)(D) Food protected from cross contamination by storing the food in packages, covered containers, or wrappings, 228.68(d)(1)(A) Cloths in-use maintained dry, 228.113(1) Food-contact surfaces clean to sight and touch, 228.117 Utensils and food-contact surfaces of equipment shall be sanitized before use after cleaning."

During an interview, on 5/10/21, in the facility's kitchen, Staff# T24 confirmed the findings and stated, "I tell them to clean as you go."

Based on observation, interview, and record review, the facility failed to ensure that each location was constructed and maintained in a manner to ensure the safety of the patients. The facility failed to:

A. meet life safety requirements related to Protection From Fire at the Tidwell and Red Oak locations. Both locations failed to meet National Fire Protection Association 101 code (2012 & 2010 editions):

1.Tidwell location: there were multiple plastic barriers placed in corridor openings that led to patient rooms on the COVID Unit. These plastic barriers obstructed the view of the EXIT signs and impeded egress to fire exits. This deficient practice placed 13 patients and unknown numbers of staff at risk for smoke inhalation, entrapment, and possible death in the case of a fire. An immediate jeopardy was called on 5/11/2021.

2.Red Oaks location: A 40-foot by 105-foot materials management space was built adjacent to the surgical services department as an add-on to the original hospital. There was a shared wall that was not fire rated. This new addition was never recorded by the facility on the Life Safety floor plans. Numerous combustible items were stored in the space including corrugated cardboard and medical records; along with an accelerant (gas-powered pressure washer that contained gas). There were no secured fire extinguishers located in this addition. These deficient practices could result in serious injury, serious harm, serious impairment, or death in the case of a fire. An immediate jeopardy was called on 5/13/2021.

In addition, the 40-foot by 105-foot materials management space had only one door for egress, located on one of the 40-foot walls.

Cross Refer to A0709


B. ensure the hospital environment was maintained in a manner to safeguard the safety & well-being of the patients.

1. Red Oak location: There was a gasoline powered pressure washer with gasoline in the tank present stored in the hospital supply room. The gasoline is a flammable liquid and presented a safety and fire hazard for patients or staff in the facility.

2.Tidwell location: Ceiling tiles were not properly maintained throughout the facility; the facility did not maintain the required 18 inches of clearance between fire sprinkler heads and storage of supplies in the Health Information Management Department.

Cross Refer to A0701


C. ensure proper maintenance and inspection of patient care equipment and supplies. Crash carts -two (2) contained expired medications and fluids; one (1) had a nonfunctioning laryngoscope: Tidwell location. Electrical biomedical inspections were not performed on patient equipment at Tidwell location (hemodialysis machines) and Sugar Land location (sequential compression devices).


Cross Refer to A0724

Based on observation and staff interview, the facility failed to ensure a safe setting for patients in the facility as there was a gasoline powered pressure washer with gasoline in the tank present in the hospital storage and supply room. The gasoline in the tank is a flammable liquid and presents a safety and fire hazard for patients or staff in the facility.

Findings included:

Red Oak location:

During a tour of the facility the afternoon of 5/10/2021, a Honda Ryobi GCV 3300 PSI gasoline powered pressure washer was observed by the survey team in the facility storage/hospital supply room. The surveyor opened the gas tank and observed liquid in the gas tank.

In an interview with Staff RB4, Director of Plant Operations, on 5/10/2021 at 3:59 pm in the facility storage/hospital supply room, he confirmed the presence of the gas-powered pressure washer in the hospital supply room and also confirmed that the pressure washer had gasoline in the tank.

During a subsequent interview with Staff RB4 on 5/12/2021 at 5 pm in the facility conference room, he stated that the gas-powered pressure washer should have been stored in a different location with other maintenance equipment and should not have been in the hospital supply room.


35028


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

a) Ceiling tiles were properly maintained throughout the facility; and

b) The clearance between the sprinkler head and the top of a shelving unit was 18 inches or more for 1 of 8 storage units in the Health Information Management Department.


Findings included:

Tidwell location.

a) - ceiling tiles

During a tour of the facility with Staff T-44 (EM - Engineering Manager) on 5/10/2021 at 10:00am, several ceiling tiles had been removed or displaced (education room and the entrance). Numerous tiles were misaligned or had gaps throughout the facility. Several of the areas noted included the lobby, the emergency department, and hallway to medical records. Several ceiling tiles had been removed or displaced, and numerous tiles were misaligned or had gaps throughout the facility.

In an interview with Staff T-44 (EM) on 5/10/2021 at 10:00am, he stated workers had removed or displaced the tiles and failed to replace them. He also stated that properly installed ceiling systems allow smoke detectors, heat detectors, and fire sprinklers to operate correctly in the event of a fire. They also provide a barrier to the spread of smoke and fire.


b) - Health Information Management (HIM) storage

During a tour of the facility with Staff T-44 (EM) on 5/10/2021 at 10:00am, a room (part of the HIM Department) was observed to have shelving units on three of the walls. The shelving units housed medical records. On top of the shelves were boxes of supplies. Some of the supplies almost reached the ceiling.

In an interview with Staff T-44 (EM) on 5/10/2021 at 10:00am, he stated the supplies should not be stored on the top shelf of the shelving units, adding that this was a fire hazard. He also stated that there needed to be an 18-inch clearance because of the sprinkler head.

Record review of the NFPA 13 Standard for the Installation of Sprinkler Systems, 2019 edition, 10.2.8 - Clearance to Storage; 10.2.8.1: The clearance between the deflector and the top of storage shall be 18 inches (450mm) or greater. Failure to follow this NFPA regulation can impact the sprinkler's spray pattern, thus creating a life safety issue should a fire erupt.

Based on observation, interview, and record review, the Tidwell location failed to meet the Life Safety Code NFPA-[2012 edition] by placing multiple plastic barriers in corridors. These barriers obstructed the view of the EXIT signs and impeded egress to fire exits.

This deficient practice placed 13 patients and unknown numbers of staff at risk for smoke inhalation, entrapment, and possible death in case of a fire (Patient # 38, 39, 55, and Patients # 57 thru 66).

Citing 2 of 3 patient hallways observed (400 & 500 hallways)


Findings included:

Tidwell location:

Record review of Life Safety Code NFPA (2012) showed the following:

"4.5.3.2 Unobstructed Egress. In every occupied building or structure, means of egress from all parts of the building shall be maintained free and unobstructed. Means of egress shall be accessible to the extent necessary to ensure reasonable safety for occupants having impaired mobility."


Record review of facility policy titled "SAFETY MANAGEMENT PLAN", dated 10/2020, showed:

Delineated Responsibilities of the Environment of Care Committee: - Safety inspections will be conducted on a regular basis with (sic) all patient care areas.

Fire and Life Safety: "Each building in which patients are either housed or treated is in compliance with appropriate provisions of the current edition of the Life Safety code of the National Fire Protection Association or equivalent protection is provided and documented..."


Observation on 05/10/2021 at 9:30 AM showed two(2) plastic barriers that completely covered the entrance to the COVID Unit ( 400/500 hallways). Each had a zippered opening. Light could be seen coming through the barrier on the right but images could not be seen. The plastic barrier on the left was completely white and not transparent.

These two (2) plastic barriers were affixed to the side walls and the ceilings with tape and plastic devices with screws. The barrier on the right side had a sign attached to it that read: "COVID-19."


Observation after entering the plastic barrier on the right showed an enclosed space with with plastic barriers on both sides. The plastic was semi-opaque; light could be seen but images not easily made out. There was a sink, soap, trash can, and paper towel dispenser located inside this space. This space opened onto the COVID Unit nursing station.

Continued observation after exiting this plastic zippered space showed a central nursing station. To the right of the nursing station was a plastic zippered barrier; to the left of the nursing station was an additional zippered plastic barrier.


Interview at the time of observation with Staff T-106, house supervisor, she said, the plastic barrier to the right was the 400 hallway with 8 patients; the plastic zippered barrier to the left led to the 500 hallway, with 5 patients. Surveyors were unable to see anything but light through the plastic barriers on both hallway entrances. There were no EXIT lights visible though the plastic barriers which lead directly to the patient rooms on the 400 and 500 hallways.

Several patient rooms (500, 501, 502, 503, 505, and 507) on the 500 hallway had doors that were open to the hall. These rooms also had individual zippered plastic barriers located within about 4 feet inside the room entrance. Interview at the time of observation with Staff T-69, RN, he could not explain the reason the zippered plastic barriers were in place.


During an interview on 05/11/2021 at 5:30 PM with regulatory Life Safely inspector on-site -- he said, he made rounds with the Staff T-44, facility Engineering Manager. Life Safely inspector said, his findings showed the required clear and unobstructed path of travel from any point in the building was not maintained throughout the building where plastic barriers were observed, specifically cited were stations 4 and 5 ( covid ward ) where 15 covid patients resided at the time of the survey. These plastic barriers not only impeded a clear and unobstructed path to an exit but also impacted clear and full view to an exit sign. Plastic barriers also posed the potential for fumes and smoke in case of fire.


During an interview on 05/11/2021 at 7: 40 PM with Staff T- 5, facility CEO, she said the plastic barriers were initially put up to provide isolation and comply with CDC recommendations, which kept changing. She went on to say the barriers helped the staff feel safe, many people remain afraid to work around COVID-19.

An immediate Jeopardy was called related to the above findings on 5/11/2021.


35028


Based on observation, record review, and interview, the facility failed to ensure that the environment was maintained in such a manner that the safety and well-being of patients was assured as required by NFPA 101 (2012 edition) and NFPA 10 (2010 edition). This was evidenced by:

a) At the Red Oaks location, a 40-foot by 105-foot materials management space was built adjacent to the surgical services department as an add-on to the original hospital. The wall was not fire rated. This new addition was never recorded by the facility on the Life Safety floor plans. Numerous combustible items were stored in the materials management space. There were no secured fire extinguishers. There was no fire risk assessment that included this space. An immediate jeopardy was called on 5/13/2021.

b) In addition, the 40-foot by 105-foot materials management space had only one door for egress, located on one of the 40-foot walls.

Findings included:

Red Oak location.

a) and b) - the materials management space.

The Red Oak location was toured on 5/12/2021 at 11:30am. Staff RB4 (DPO- Director of Plant Operations) guided the tour. During a tour of the outside of the facility, the surveyors entered a large storage area, identified by Staff RB4 (DPO) as a materials management storage area. He stated:

" The space was approximately 40-foot by 105-foot; and

" There was only entrance into / exit out of the space.

The door into the space was in the middle of on one of the 40-foot walls. Windows that had been blackened out, ran much of the length of the 100-foot wall to the left of the entrance.


Staff RB4 (DPO) stated:

" This space was an add-on to the original hospital;

" The addition "happened when the building was changing hands" and he was not aware of any architectural oversight or approval of the construction;

" This new addition was never recorded by the facility on the Life Safety floor plans;

" Surgical suites were on the other side of the windows;

" The exterior wall of the operative suites was now the interior wall of both the operative suites and this storage space; and

" He did not know the fire rating of sealant around the windows.

Staff RB4 further stated that the building needed another door and that there were items stored in the space that were combustible.


Further observation showed numerous combustible items stored in this materials management space - items such as medical records, numerous corrugated boxes filled with supplies, and plastic wrapping. (Several surveyors had found a Honda Ryobi GCV 3300 PSI gas-powered pressure washer with fuel in the gasoline tank on the evening of 5/10/2021.) There were no secured fire extinguishers.


Record review of the floor plan for the Red Oak facility (Northside Surgical Hospital - Phase 2 by Kaim Associates, Inc., dated 8/17/2015, showed the first and second floor life safety plan. The above-mentioned materials management space was not documented on this life safety plan.

Based on observation, review of documentation, and interviews with staff, the facility failed to properly maintain patient care equipment to ensure safety and quality of supplies and equipment.

Findings:
Tidwell location:

1. Emergency crash carts were not maintained and inspected in a manner that ensured the safety and quality of supplies and equipment in the carts.

2. Electrical safety inspections were not completed as required on hemodialysis equipment.


Policies Reviewed:

Review on 05/11/2021 of the Facility's current policy and procedure titled "Medication Use Process; Dispensing - Emergency Crash Cart Medication System", Policy ID # PPHA.TX.100, Revision date 1/07. Outcome Standards: The Pharmacy Department, in collaboration with Nursing and Material Management, develops and maintains the procedures to assure availability, control and security of emergency medications located throughout the facility. The carts are stocked with medications and supplies that are available in unit-dose, age-specific, and ready-to-administer forms whenever possible as deemed necessary by the hospital leadership in conjunction with members of the medical staff and licensed independent practitioners.

Process Standards:

1. An adequately stocked mobile crash cart or emergency drugs box is kept in each patient care area.

2. It is the responsibility of the charge nurse or his/her designee to check the cart/box on every 24 hours to ensure the integrity and readiness of the cart/box and its contents.

3. A Pharmacist or his/her designee checks each cart/box monthly to ensure that the cart is locked and within acceptable expiration date.

4. At the end of the code: Pharmacy will remove the used Crash Cart to Pharmacy. The medications will be removed from the cart and cart transported to Materials Management. A new cart will be exchanged. The medication drawers will be cleaned, reconciled, and replaced in the new Crash Cart. Pharmacy will update the Crash Cart Long with soonest expiring dates, unique number of the red (numbered) security seal, date the red seal is replaced and the initials of the person updating the cart. Materials Management is responsible for disassembling the Crash Cart, cleaning reassembling and reconciling all supplies on the cart.


Review on 5/13/2021 of the facility's current policy titled "Cleaning and Disinfecting of Equipment", Policy # INF.016.1, Revision 10/18; Purpose: To minimize the risk of infection to our patients, employees and visitors through thorough cleaning, disinfection and/or sterilization of environmental surfaces, patient care items and equipment. Definitions: Cleaning: the removal of all foreign material (e.g., soil organic material) from objects. Decontamination: The use of physical or chemical means to remove, inactivate or destroy blood-born pathogens on surface or items to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, us or disposal.


Review on 05/13/2021 of contracted dialysis company #A policy and procedures titled "Safety Standards for Acute Dialysis Equipment" Policy # 2.2, Dated 12/2020. All equipment will be checked by the Chief Technician for electrical safety initially and biannually thereafter. The Chief Technician will maintain a logbook documenting the electrical safety checks. Procedure: This process for testing electrical leakage should be performed biannually, or unless specified more frequently by the manufacture.


Review on 05/13/2021 of contracted dialysis company #A policy and procedures titled "Safety Standards for Acute Dialysis Equipment" Policy # 2.2, Dated 12/2020. All equipment will be checked by the Chief Technician for electrical safety initially and biannually thereafter. The Chief Technician will maintain a logbook documenting the electrical safety checks. Procedure: This process for testing electrical leakage should be performed biannually, or unless specified more frequently by the manufacture.


Findings:

Observation on 05/10/2021 at 9:30 AM of the Intensive Care Unit (ICU) along with charge nurse, Employee ID# T-4, and Infection Control Practitioner, Employee ID T-1, two emergency crash carts were observed.

Emergency Crash Cart # 11 the following was identified:

Cardiac defibrillator/monitor was observed on a metal shelf attached to the top portion of the crash cart. Rust was observed on top surface of the metal shelving unit resulting in an exposed uneven porous surface that could not be properly disinfected. Cart canister rollers with visible rust and cart base and legs with multiple paint chips and rust.

1-liter bag of 0.9% Sodium Chloride Injection, Baxter, Lot # 1321166, Expiration Date April 21, 2021

1-liter bag 5% Dextrose, Baxter, Lot # Y317669, Expiration date March 2021

Crash cart contained 1 bag of 5% Dextrose 500 ml, cart supply list documents cart should contain 5 bags of 5% Dextrose 500 ml.


Emergency Crash Cart #2 the following was observed.

Cardiac defibrillator/monitor was observed on a metal shelf attached to the top portion of the crash cart. Rust was observed on top surface of the metal shelving unit resulting in an exposed uneven porous surface that could not be properly disinfected. Cart canister rollers with visible rust and cart base and legs with multiple paint chips, rust and cracks in the plastic on base of unit.

1-laryngoscope light not functioning.

1-250 ml 0.9 Sodium Chloride, Baxter, Lot #Y321166, Expiration date April 2021

Contained 1 bag of 5% Dextrose 500 ml, cart supply list documents cart should contain 5 bags of 5% Dextrose 500 ml.

7- Epinephrine1:00,000 Abboject on cart. Emergency cart should contain 8 Epinephrine 1:000 Abbojecct


Interview on 05/10/2021at 11:30 AM with Intensive Care Unit charge nurse, Employee ID# T-4 confirmed the above findings and stated the nursing staff does an inspection of the exterior of the cart and test the Cardiac defibrillator/monitor and suction machine daily, but they do not open up the crash cart and check for expired medications. Employee ID# T-4 stated it is the pharmacy who checks the medication and expired items in the cart. Charge nurse stated once they open the cart, pharmacy is notified, and they replace it with a new cart. If the cart has not been used in 30 days, then the pharmacy replaces the cart and checks it.

Charge nurse confirmed the cart could not be properly disinfected with rust and paint chips on the surface of the cart.


Interview with on 05/11/2021at 11:30 AM with facility's Pharmacist, Employee ID # T-16 confirmed it is the pharmacy's responsibility to check all medications for expiration dates in the crash carts after each time they have been opened and brought back to pharmacy, or if cart has not been used we check them monthly for expiration dates.. Pharmacist stated the pharmacy technician checks the crash carts medications for expiration dates and fills out expiration drug forms and the Pharmacist double checks and signs off on it. Pharmacist stated it must have just got missed.


Observation on 05/13/2021 at 12:35 PM of the renal unit located on the ICU hallway along with contract dialysis nurse manager, Employee ID# T-42 and the facility Chief Executive Office, Employee ID #-5 the dialysis room was observed to contain two Fresenius 2008 K hemodialysis machines (#13 -4KOS-P725, #15 6KOS-636E), and one attached reverse osmosis (RO) water treatment unit attached to machine #13. (RO machine # 67459). The two hemodialysis machine and reverse osmosis unit did not contain any evidence of electrical safety stickers.


Interview with contract dialysis nurse manager, Employee ID# T-42 confirmed equipment was not labeled with electrical safety stickers and would contact his biomedical staff to obtain the electrical safety testing results. No evidence of electrical safety inspection of equipment was received prior to exit.


37490

Based on Observation, interview, and record review, the facility failed to ensure patient care equipment had electrical safety checks in 3 of 5 pre-op rooms (room #1, room #4, and room #5).

Sugar Land location.

Findings include:

Record review of facility policy titled: "Facility and Medical Equipment Management Plan," dated 1/2019 showed the following information:

9. Facility in medical equipment is maintained, tested, and inspected

a. Facility and biomedical engineering establishes and maintains a current, accurate and separate inventory of all equipment included in the program of planned inspections or maintenance. The inventory includes equipment owned by UMMC, leased and rented equipment and personally owned equipment.

b. Facility in biomedical engineering manage is the program of planned inspection and maintenance. All equipment in the program is tested for performance and safety prior to initial use on patients.


Observation on 5/11/2021 at 10:27 AM in the pre-operative area revealed the following:

-Two (2) sequential compression devices (SCDs) in pre-op room #1 without evidence of biomedical engineering check.

-one (1) SCD in pre-op room #4 without evidence of biomedical engineering check.

-one (1) SCD in pre-op room #5 without evidence of biomedical engineering check.


Interview with staff (SL-10) at the time of observation stated that all equipment should have a biomedical sticker on it showing that it was inspected. She confirmed that the identified SCD machines were missing stickers.

The surveyor requested alternate evidence to show if the devices had been inspected, none was provided.

Based on observation, interview, and record review, the facility failed to implement an active system-wide program for surveillance, prevention, and control of infection in 3 of 3 facility locations (Tidwell location, Red Oak location, and Sugar Land location).

Findings included:

The following infection prevention and control issues were identified during the survey process conducted at all 3 hospital locations on May 10-14, 2021. The hospital failed to :

A. Ensure proper PPE usage by nursing staff on the COVID Unit and by OR personnel - Tidwell.

B. Ensure staff utilized appropriate hand hygiene -Tidwell

C. Ensure that clean linen was properly stored [not contaminated by exposure to cats and birds, dirt, dust, debris, or splashes from floor cleaning] - Tidwell.

D. Ensure 2 of 4 operating rooms maintained humidity levels between 20 and 60 % - Red Oak location.

E. Ensure proper usage of multi-dose medication vials per professional standards: Tidwell, Sugar Land, and Red Oak

F. Ensure temperature & humidity was monitored in the sterile supply room: Sugar Land

G. Ensure efficacy of surgical instrument washer was verified per policy - Sugar Land

H. Ensure mop-heads used to clean patient rooms were properly washed - Tidwell

I. Ensure the maintenance of a sanitary environment: Emergency room, Operating rooms, Dialysis area - Tidwell

J. Make certain clean patient equipment was stored in a manner to prevent contamination - Tidwell.

K. Ensure proper drainage of HVAC system: open drain pipes noted in ER and COVID Units - Tidwell

L. Ensure biohazard storage areas (outside) were secure and not accessible to public - Tidwell

M. Ensure expired supplies were not available for patient use - Tidwell

N. Ensure patient supplies were stored in a manner to prevent contamination- Tidwell and Red Oak

O. Ensure external shipping boxes were not located in the pharmacy - Red Oak

Based on observation, interview, and record review, the facility failed to employ methods to prevent and control infections as stated in facility policies and professional guidelines.

Citing 2 of 2 hallways observed [400 & 500 hallways--which is the COVID Unit.]

The facility failed to ensure:

a. Staff demonstrated proper PPE usage;

b. Staff utilized proper hand hygiene per policy;

c. Linen was stored in a manner to prevent contamination;

d. Patient equipment was stored in a manner to prevent contamination. Clean and dirty equipment was stored together.


Findings included:

Tidwell location :

a. Record review of CDC Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic," June 19, 2020, recommended "Implement Universal Source Control Measures: HCP should wear a facemask at all times while they are in the healthcare facility..."

Record review of CDC "Facemasks Dos & Don'ts for HCP," dated 6-2-2020 showed : "...Put your face mask on so it fully covers your mouth and nose. Don't wear your face mask under your nose...under your chin..."

Observation on 5/10/2021 at 9:30 AM during initial tour of the COVID Unit, showed Staff T-47, RN , wearing her face mask pulled below her nose. She corrected this when prompted by surveyor.

Observation on 5/14/2021 at 8:45 AM in the COVID Unit nursing station showed Staff # T-82 , RN, not wearing any type of face mask.


b. Record review of facility policy titled "Hand Hygiene including Surgical Antisepsis,"dated 4/19, showed hands should be decontaminated after removing gloves.

Observation from the hallway outside room 416 on 05/10/2021 at 9:40 AM showed Staff T-81 , Registered Nurse (RN), providing care to a patient on a ventilator. Staff T-81 removed her contaminated gloves and donned a clean pair. Staff-81 failed to sanitize her hands between glove changes. She immediately exited the room into the hall, wearing the 2nd pair of gloves.


c. Record review of facility policy titled "Storage, Collection and Transportation of Linen," dated 01/2021, read: All linens will be stored in a manner that prevents the transmission of microorganisms to other patients and areas..

Observation on 05/10/2021 between 9:30 AM and 10:15 AM showed clean linen stored on metal carts with wheels. One cart each on the 400 and the 500 hallways ( COVID Unit).

The metal carts on each unit were filled with patient gowns, sheets, towels, and blankets. Each cart was covered with a bed-sheet [not a non-permeable barrier]. Each of the wire carts was open on the bottom shelf; no plastic protective barrier in place.

On the 400 hallway, the linen cart was located immediately outside room 410, against the wall. The bed sheet covering the cart was pulled back, further exposing the linen to contamination by any staff who might walk by.

During an interview with Staff T-69, RN, at the time of observation, he said this was not the appropriate way to store linen and that it could become contaminated. He stated he "just heard the linen carts were being moved into a room."


d.. Record review of facility policy titled "Equipment Distribution and Tracking," dated 04/19, showed staff "will cover and place discontinued equipment in the designated area on the station for for Materials Management to pick up...Materials Management will properly clean and inspect equipment ...cover and return to designated area storage..." The facility did not have an infection control policy specific to clean/dirty equipment storage.

Observation on 05/10/2021 at 10:00 AM showed Room 424 with a sign on the door that read "Clean Equipment." The following was observed inside the room:

- several IV (intravenous) poles covered in plastic;

- a wire shelving unit that held a monitor/defibrillator, IV pump, and a telephone - all 3 were uncovered.

-immediately adjacent to this wire shelving unit, there was a bedside commode (covered in plastic) and two (2) IV pumps on poles - uncovered.


During an interview immediately after this observation with Staff T-85, Housekeeping Supervisor, she said, clean equipment was covered with plastic. If not covered, it was considered dirty.


During an interview on 05/11/2021 at 10:15 AM with Staff T-1, Infection Control Practitioner, she said the following:

- staff should perform hand hygiene after removing contaminated gloves;

- linen should not be stored in wire carts with a bed-sheet covering. The facility had dedicated linen carts with proper impermeable coverings to prevent contamination.

-clean and dirty patient equipment should not be stored together. Dirty equipment should be taken to "dirty utility room " to be picked up for proper disinfection.


28141

Based on record review, observation, and interview, the hospital failed to employ methods for preventing and controlling the transmission of infections within the hospital.

1) The Emergency Department (ED) supply room had a string of dried yellow liquid on the wall across from shelves with open supplies. Shortly after the surveyor observation, a housekeeper used a floor mop to scrub the wall.

2) Biohazard material were stored in two unlocked outside containers open to unauthorized and/or public access.


Findings included:

Tidwell location:

1) Observations in the inside the Emergency Department located supply room on 05/12/21 at 1130 reflected open containers with supplies which included a package of 2x2 gauze pads, a package of disposable under pads ("chucks"), and an opened sleeve of plastic cups.

A line of yellow drainage was observed on the light-blue painted wall across the supply shelf.

Personnel T-1 and T-27 witnessed and acknowledged the above findings. Personnel T-27 stated at that time that she had previously placed a work order to have the drainage removed.


Observations on 05/12/21 at 1140 reflected an unidentified housekeeper entered the room. She had a mop placed on the floor. She then lifted the mop off the floor and started to scrub the wall where the yellow liquid was.

Personnel T-1 acknowledged that the floor mop should have not been used on the wall.

Review of the hospital infection control plan policy # INF.001.7 noted that the surveillance activities to control and prevent infections included regular rounding in patient and non-patient areas (page 8).


2) Observations on 05/13/21 at 1120 reflected a trailer in the hospital parking lot across the barn. The trailer was labeled "Biohazard" and "authorized staff only." The trailer had a padlock not snapped into the locked position.

At that time, Hospital Personnel T-44 was asked about the padlock. Hospital Personnel T-44 snapped the padlock into the locked position and stated that housekeeping had their office "right there" and pointed to the barn. There was no housekeeping staff observed there at that time. Hospital T-44 was asked about the contents of the trailer and responded that the trailer was "for needles and anything biohazard."

Observations on 05/13/21 at 1130, a blue wooden shed was observed attached to the hospital and facing Stuebner Airline Road. The shed was labeled "Biohazard." It was unlocked and potentially accessible to unauthorized persons.

Housekeeping Personnel T-40 was observed leaving the hospital and dumping trash into the trash bins outside the door. Personnel T-40 was asked about the blue shed and stated she did not know.


28422


Based on observation and an interview with staff, the facility infection control program failed to employ methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings.

Findings were:

Red Oak Location

During a tour on 5-12-21, 16 external shipping boxes were discovered within the pharmacy. External shipping boxes have the potential to bring insects, bacteria, and other outside contaminants into the facility from the inside of delivery trucks, warehouses, sidewalks, and any other places the box may have touched during manufacture and transport. These insects, bacteria, and other outside contaminants have the potential to cause disease and infection.

The above was confirmed in an interview with staff #RS-2 on 5-12-21.


30124

Based on observation, interview, and record review, the facility failed to ensure its policy and procedures were instituted in that expired supplies were readily available for use resulting in an unsanitary environment and health risk to the patients and staff. Facility has a current census of 24 patients.

Tidwell location.

The facility failed to ensure:

Blood collection tubes were not available for use after expiration date.

Blood collection set were not available for use after expiration date.

Dialysis line recirculation connectors were not available for use after expiration date.


Police Reviewed:

Review on 05/14/2021 at 2:00 PM of the facility's current policy titled "Sterile Manufactured Supplies Expiration Process"; Policy # MMT.026.204.0; Last reviewed 05/2019. Purpose: Manufacturer sterilized items must not be used after the marked expiration date.

Procedure:
1. All sterile items throughout the hospital must be checked for expiration dates on a routine basis. This is the responsibility of each department; however, the Materials Management Department retains oversight responsibility.

2. Items that have reached the marked expiration date will be immediately removed from patient care areas and returned to Materials Management Department.

Responsibility:

1. All hospital personnel must check the expiration dates on sterile items that they are using for patient care. Outdated items should not be used.

2. Each department must have a method of regularly checking their sterile supplies for outdates and documenting it.


Review on 05/24/2021 at 2:30 PM of Manufacturer recommendations from BD Vacutainer Evacuated Blood Collection System "from www.bd.com website. BD vacutainer tubes are evacuated tubes with color coded stoppers. Most tubes contain additives in varying concentrations depending on the amount of vacuum and the required additive to blood ratio for the tubes ......Do not use tubes after their expiration date. Tubes expire on the last day of the month and year indicated."


Observation on 05/12/2021 at 10:30 AM of the renal unit located on the ICU hallway along Infection Control Practitioner Employee ID # T-1 and with contract dialysis nurse, Employee ID# T-101 the dialysis room was observed, and the following expired items were identified.

3- winged blood collection sets expiration date 07/30/2020

35 - single use recirculation connectors expiration date 01/32/2021

13 - BD collection green top blood collection tubes, Lot # 9126508, 6 ml blood tubes, expiration date 10/31/2020

4 - BD collection blue top blood collection tubes, Lot # 9095757, 4 ml blood tubes, expiration date 08/31/2020

2 - BD collection tiger top blood collection tubes, Lot # 931152, 8.5 ml blood tubes, expiration date 10/31/2020


Interview with on 5/12/2021 at 10:45 AM with Infection Control Practitioner,Employee ID # T-1, cfirmed the above finding and stated she was unaware of the expired supplies in the dialysis unit and stated the supplies should not be available for use and should have been disposed been discarded.


44054

Based on facility tour, observation, policies and procedures, and staff interview the facility failed to monitor and maintain operating room (OR) suites temperature and humidity within accepted standards of practice

Findings include for Red Oak Location

*Two out of four OR suites found with multiple documented humidity levels above 60%.

-Facility's Humidity/Temperature SRG.036.101.0 policy (effective 8/99) states "To provide a safe operating room environment according to infection control and electrical safety requirements. Humidity shall be kept at a range of 30 to 60 degrees at all times to reduce the possibility of electrostatic sparks."


*Facility failed to document corrective action addressing out of range humidity

-Facility's Infection Control: Temperature and Humidity SRG.036.076.0 policy (effective 8/99) states, "If there is any deviation from recommended temperature or humidity reading do the following: . . .if humidity is >60% notify Engineering to rectify the problem."

Validated findings with Red Oak OR director during OR tour.


























35028


Based on observation, record review, and interview, the facility failed to ensure methods for preventing and controlling the transmission of infections were being followed. Specifically, the facility failed to ensure that:

" 4 of 8 healthcare workers (Staff # T-57 (RN - ICU), T-69 (RN - ICU), T-72 (MD), and Staff # T-105 (MD) at the Tidwell location wore facial masks while in the nurse's station on the COVID unit;

" 1 of 1 portable metal wire shelving unit on the COVID unit at the Tidwell location had a splash guard on the bottom shelf where patient gowns had been stored;

" Condensation from the HVAC system was properly channeled to a drainpipe; and

" Foam pillows used to position patients undergoing ultrasound scans were properly stored in 1 of 1 bathroom in the Ultrasound Department at the Red Oak location.


Findings included:

Tidwell location.

Facial masks.

Record review of the facility's document, "Hospital Preparedness and Response to Pandemic COVID-19," (no date), showed: "II. Respirator of Face Mask: Put a respirator or face mask (if respirator is not available) before entry into patient room or care area."

During a tour of the COVID unit on 5/11/2021 at 1:00pm, it was observed that eight staff members were in the nurse's station. Four of the staff members did not have their masks fully covering their mouth and nose. The masks were pulled under their chin. Staff # T-57 (RN - ICU) saw me observing them. She pulled her mask up over her mouth and nose and instructed Staff # T-69 (RN - ICU) and Staff # T-72 (MD) to put on their masks. Staff # T-105 (MD) had left the nurse's station.

In an interview with Staff # T-57 and Staff T-69 on 5/11/2021 at 1:00pm, they stated they knew that they were supposed to be wearing their mask.

Record review of CDC Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic," June 19, 2020, recommended "Implement Universal Source Control Measures: HCP should wear a facemask at all times while they are in the healthcare facility..."

Record review of CDC "Facemasks Dos & Don'ts for HCP," dated 6-2-2020 showed: "...Put your face mask on so it fully covers your mouth and nose. Don't wear your face mask under your nose...under your chin..."


Splash guard.

During further observation, a portable metal wire shelving unit near the nurse's station was seen. There was no splash guard on the bottom shelf. Patient gowns were on the bottom shelf.

In an interview with Staff T-44 (EM) on 5/11/2021 at 1:15pm, he stated there should be a splash guard on the bottom shelf of the metal wire shelving unit.


HVAC drain.

During observation in the Emergency Department on 5/11/2021 at 10:00am, the patient bathroom had a PVC pipe sticking out of the ceiling over the lavatory. Water was dripping from the pipe.

In an interview with Staff T-44 on 5/11/2021at 10:00am, he stated the water was condensation from the HVAC system, adding that this system was in place when he was hired on.



Red Oak location.

Foam pillows Ultrasound Department.

During a tour of the Ultrasound (US) Department at the Red Oak location on 5/12/2021 at 10:00am, two foam pillows were found on the floor of a bathroom.

In an interview with RR1 (US technician) on 5/12/2021 at 10:00am, she stated the foam pillows should not be on the bathroom floor.


37490


Based on observation, interview, and record review, the facility failed to employ methods to prevent and control infections as stated in facility policies and professional guidelines.

a. Staff failed to utilize proper hand hygiene per policy in 1 of 2 hallways observed [400 hallway--which is the COVID Unit.] Tidwell location.

b. Staff failed to ensure proper storage of soiled linen in "The Barn". Tidwell location.

c. Staff failed to ensure proper storage of clean linen located in "The Barn." Tidwell location.

d. Staff failed to ensure proper cleaning of microfiber mop heads in 1 of 1 facility laundry processing area in "The Barn." Tidwell location.

e. Staff failed to monitor temperature and humidity in 1 of 1 sterile supply storage areas. Sugar Land location.

f. Staff failed to document efficacy of 1 of 1 instrument washer. Sugar Land location.

g. Staff failed to ensure multi- dose vial medications were used according to acceptable standards of practice for multi-dose items in 3 of 8 clinical settings (ER, OR #1 and OR#4). Sugar Land location


Findings include:

Tidwell location:

Record review of facility policy titled "Hand Hygiene including Surgical Antisepsis," dated 4/19, showed hands should be decontaminated after removing gloves and after having contact with a patient's intact skin (e.g. when taking a pulse or blood pressure, and lifting a patient).

Observation on 5/10/2021 at 9:55 AM in the 400 hallway showed staff (T-104) in patient's (T-62) room (door open) performing ultrasound with gloves on, she then exits the room while pushing the ultrasound machine into the hallway wearing the same gloves. She then proceeded to use her cellular phone in the hallway and spoke to the surveyor at this time.

At the time of observation, ultrasound staff (T-104) stated that she had just performed an arterial and venous doppler ultrasound on patient (T-62). She stated that she does not clean the machine before entering another patient room, and that she will clean it when she gets in the next patient's room. She stated that she was going to be performing the same procedure on patient (T-57).
Ultrasound staff (T-104) at 9:58 continued using her cellular phone with contaminated gloves from patient (T-60) then entered patient's (T-57) room.


Record review of facility policy titled "Storage, Collection and Transportation of Linen", dated 1/2021 showed the following:

All linen will be stored, handled, transported and processed in a manner that prevents the transmission of microorganisms.

1. Soiled Linens will be stored in a separate, well ventilated area in covered hampers or carts.

2. The clean linens will be stored in a clean, dry area.


Observation on 5/10/2021 at 11:51AM revealed two (2) uncovered linen carts filled with full yellow biohazard linen bags in an unsecured building located directly behind the facility called "The Barn."

During an interview with staff (T-43) at the time of observation, she stated that this is dirty linen waiting to be picked up. The dirty linen is picked up on Tuesdays and Fridays.

Observation on 5/10/2021 at 11:53 AM in "The Barn" revealed a cart containing clean linen with plastic cover ripped open and exposed linen in the cart. Two (2) cats were observed sitting and laying on shelving within the barn. Staff (ID T-44) was observed petting the cats. Bird droppings were observed on fixtures throughout the barn.

Interview with staff (T-44) on 5/10/2021 at the time of observation revealed that birds often get into the barn and fly around.

Observation on 5/10/2021 at 11:55 AM in "The Barn" revealed a secure room that housed "clean" linen. Some linen was in plastic wrapping, some was not. Patient gowns were located on the unlined bottom shelf with strings touching the ground. There were drink containers located on some of the shelving. The shelves had a layer of dirt when surveyor ran their hand across them. The floor showed visible dirt and cobwebs were visible along the walls and ceilings.

Interview with Infection Preventionist (T-1) at the time of observation stated that this is not the expectation. She confirmed the room is not clean and that all linen in the room should be covered.

Record review of facility provided Laundry Guide for Rubbermaid HYGEN Microfiber cloths and mops showed that bleach is required at 50-150ppm².

Observation on 5/10/2020 at 12:00 PM in "The Barn" revealed a washer and dryer with a dirty linen hamper next to it.

At the time of observation engineering staff (T-44) stated that the only laundry done onsite is the microfiber mop heads. He stated that the water temperature would never get hot enough, so the housekeeping staff use the chemical disinfection method.

Interview with housekeeping supervisor (T-85) on 5/10/2021 at 12:05 PM stated that the washer temperature reached about 100°F. We use bleach to disinfect the mop heads. We do not measure how much bleach we add, we just pour some in depending on how many mop heads are in the load.

Interview with Infection Preventionist (T-1) on 5/12/2021 at 10:20 AM when questioned about the above observations she stated, "I am sorry to hear about these instances. That is not the expectation and that is a big violation."


Sugar Land location:

Record review of facility policy titled: "Humidity/ Temperature," dated 4/19 showed the following:

1. The humidity should be kept at a range of 30 to 60°at all times

2. The temperature shall be kept at a range of 68° to 73° at all times


Observation on 5/11/2021 at 1059 AM in the sterile supply storage area showed last documented temperature and humidity to be on 5/6/2021.

Interview with charge nurse (SL-8) at the time of observation stated that the temperature and humidity checks should be done daily and are done by the inpatient staff at night. They must have missed this one.

Observation in the sterile processing department on 5/11/2021 at 11:05 AM showed staff (SL-9) wrapping a clean instrument set in preparation for use.

Interview with staff (SL-9) at the time of observation stated that the instrument set had gone through the washer that morning. When asked how he knows that the washer is working properly, he stated that he performs a TOSI® test each morning. When asked if he had documented the results of the TOSI® test that day, he stated "yes".

Record review of TOSI® test log showed two (2) entries dated February 2021.


Record review of facility policy titled: "Medication use process: administration, medication expiring and dating," dated 7/11 showed the following information:

2. Multi-dose (i.e. preserved) vials- 28 days (not to exceed manufacturer's expiration date.

3. Refrigerated multi-dose vials if left at room temperature after opening vials should be discarded according to stability data from manufacturer. Neuromuscular blocking agents used in OR are cisatracurium (21 days), succinylcholine (14 days), rocuronium and pancuronium bromide (30 days).


Review of Centers for Disease Control and Prevention (CDC) guidelines for multi dose vials states the following: Multi-dose vials should be dedicated to a single patient whenever possible. If multi-dose vials must be used for more than one patient, they should only be kept and accessed in a dedicated clean medication preparation area (e.g., nurses' station), away from immediate patient treatment areas. This is to prevent inadvertent contamination of the vial through direct or indirect contact with potentially contaminated surfaces or equipment that could then lead to infections in subsequent patients. If a multi-dose vial enters an immediate patient treatment area, it should be dedicated for single patient use only. Examples of immediate patient treatment areas include operating and procedure rooms, anesthesia and procedure carts, and patient rooms or bays.


Observation in the ER treatment room on 5/11/2021 at 9:45 AM revealed an open vial of 1% Xylocaine 500mg/50mL with 5/22 written on the vial.

During an interview with ER nurse at the time of observation, when asked what the date written on the vial was, she stated the expiration date. She then proceeded to point at the manufacturer's expiration date of 5/2022 and said, "see." She could not state the date of when the medication had been opened.


Observation on 5/11/2021 in operating room #4 at 10:48 AM in the anesthesia cart revealed the following:

-One (1) vial of opened, dated 5/27/21 vial of succinylcholine chloride injection 200/10mL

-One (1) vial of opened, dated 5/26/21 vial of rocuronium bromide injection 50mg/5mL


Observation on 5/11/2021 in operating room #4 at 10:57 AM in the anesthesia cart revealed the following:

-One (1) vial of opened 1% Lidocaine Injection 200mg/20mL, dated 5/20/2021

-One (1) vial of opened, dated 6/3/21 vial of succinylcholine chloride injection 200/10mL


Interview with charge nurse (SL-8) at the time of observation stated that he was not sure when the medications had been removed from the refrigerator or opened. He also stated that he was unaware of CDC recommendations of multi dose vials in direct patient care areas.

Tidwell location:

The Tidwell facility failed to meet the Condition of Participation for Surgical Services as evidenced by:

- The facility's instrument washer was not draining well, allowing contaminated water to remain in the washer, preventing the washer from thoroughly cleaning the instruments prior to sterilization process; this places patients at risk of developing an infection from inadequate sterilization.

- An OR staff member was observed outside the facility wearing operating room attire, the staff then entered the OR, without removing the contaminated attire, this places patients at risk of developing an infection from environmental contaminates.

- The facility did not have a Flash Sterilization Log; the staff were unable to provide a list of the items that were flashed sterilized and the frequency; this places patients at risk of developing an infection from an abbreviated sterilization process.

- The facility was routing, non-operating room personnel, equipment, and supplies through the OR's pre-operative patient area, placing patients at risk of infection from environmental contaminants.

- The Operating Room had surgical equipment with copious amounts of dust build-up and numerous rusted metal bases, making the equipment uncleanable, placing patients at risk of infections from environmental contaminants.

- The facility could not provide evidence of training or a job description for the facility's current Sterile Processing Department (SPD) technician, placing surgical patients at risk of infection from contaminated surgical instruments.

- The facility's endoscope machine was covered in tape, which cannot be cleaned, and the Facility's endoscope washers had yellow stains and drips on the inside and outside of the scope washer as well as tape surrounding the front lids and sides, placing patients at risk of infections from uncleanable surfaces.

- The facility's Anesthesiologist did not perform proper hand hygiene practices during a surgery, when she touched gastric bile with gloved hands, removed the gloves and did not wash her hands prior to putting on new gloves, and removed the dust caps from 2 medication bottles and did not sanitize the rubber septum prior to accessing them with a needle during a surgery. This places patients at risk of infections from biological and environmental contaminates.

Refer to A0941

Tidwell location:

Based on observation, interview, manufacturer's equipment manuals, the facility's Surgical department failed to provide a safe surgical service environment as evidenced by:

a.) The facility's instrument washer was not draining well, allowing contaminated water to remain in the washer, preventing the washer from thoroughly cleaning the instruments prior to sterilization process; this places patients at risk of infection from inadequate sterilization.

b.) The facility could not provide evidence of training or a job description for the facility's current Sterile Processing Department (SPD) technician. (Staff#T-23)

c.) The facility did not have a Flash Sterilization Log; the staff were unable to provide a list of the items that were flash sterilized and the frequency; this places patients at risk of infection and prevents the facility from being able to track for post-operative infections related to the abbreviated sterilization process.

d.) The facility was routing, non-operating room personnel, equipment, and supplies, through the OR's pre-operative patient care area placing patients at risk of infection from environmental contaminants.

e.) The facility's Operating Rooms had surgical equipment with copious amounts of dust build-up, creating an unsanitary environment. There were numerous pieces of equipment with rusted metal bases, making the equipment uncleanable, and a used respiratory mask and tubing was left in OR#1, placing patients at risk of infections from environmental contaminants.

f.) An OR staff member was observed outside the facility wearing operating room attire, the staff then entered the OR, without removing the contaminated attire, this failure placed patients at risk of infection from environmental contaminants.

g.) The facility's endoscope machine was covered in tape, which cannot be cleaned, and the Facility's endoscope washers had yellow stains and drips on the inside and outside of the scope washer as well as tape surrounding the front lids and sides. There was a brown stain running down the side of the endoscope washer. These findings place patients at risk of infections.

h.) The facility's Anesthesiologist did not perform proper hand hygiene practices during a surgery when she touched gastric bile with gloved hands, removed the gloves and did not wash her hands prior to putting on new gloves, and removed the dust caps from 2 medication bottles and did not sanitize the rubber septum prior to accessing them with a needle; this places patients at risk of infections from biological and environmental contaminants.


Findings include:

a.) An observation on 5/11/21, at 10:00 am, in the facility's sterile processing department, revealed the facility's surgical instrument washer with two full trays of surgical instruments waiting to be unloaded. Further observation revealed, the facility's instrument washer had approximately 2 inches of water sitting at the bottom of the washer. Once the washer was opened and the removable rack was rolled out, a dark brown fibrous material was observed to be stuck to the wheels of the washer's racks, and the drain contained copious amounts of surgical debris.

On 5/11/21 at 10:00 am, during an interview in the facility's sterile processing department, when asked about the water sitting in the washer, Staff #T-23, Sterile Processing Technician (SPD) confirmed the water in the bottom of the washer and stated, "That was from last night, it was my last wash ...Biomed came in to fix it ..."

On 5/11/21, during an interview in the facility's board room, Staff #T-5, CEO, was informed of the standing water in the washer and the immediate jeopardy risk posed by the contaminated water preventing the washer from thoroughly cleaning the instruments prior to the sterilization process.

On 5/11/21 at 10:00 am, during an interview in the facility's board room, when asked if he was aware of the washer not draining, Staff #T-39, Environment of Care Director stated, "It started last week. I think it's the pump. I checked the drain, it's not draining. I can manually override the computer and make it drain." Staff #39 confirmed he was not checking on the washer.

During an interview, on 5/13/21 at 4:00 pm, in the facility's sterile processing department, Staff#T-33, BioMed technician stated, "The Getinge rep came last night and said there isn't anything wrong with the washer. It's reaching 194°F (Fahrenheit) for the wash and 140°F for the rinse. I've run it a few times and it is draining."

An observation on 5/13/21 at 9:00 am, in the facility's sterile processing department, again, revealed 2 inches of water sitting at the bottom of the facility's instrument washer. Surveyor informed Staff #T-23, SPD of the finding. Staff #T-23 confirmed the finding and stated, "Those were from last night, I haven't used it yet."

On 5/13/21 at 9:10 am, this surveyor informed Staff #T-35, BioMed of the standing water. Staff #T-35 confirmed he had not been in to check the washer. Staff#T-23 stated, "We thought we had fixed it."

On 5/13/21, during an interview in the facility's board room, Staff #T-5, CEO stated, "We think it is a leaking valve. They're fixing it now."


b.) On 5/11/21 at 10:00 am, during an interview in the facility's sterile processing department, when asked how had she been trained to work in the Sterile Processing Department, Staff #T-23, Sterile Processing Technician (SPD), stated, "I am a surgical scrub tech. The person that did the processing got sick, I said, 'I'll give it a shot.' She showed me how to do it. I'll do anything to help."

On 5/13/21 at 9:10 am, in the facility board room, surveyor requested Staff#T-23's job description and training. Staff # T-7, HR confirmed, Staff #T-23 did not have a job description or documented training for the Sterile Processing position stating, "I only see it for the surgical scrub tech."


c.) On 5/11/21, during a tour of the facility's sterile processing department, when asked if the facility performs flash sterilization. Staff #T-23, SPD tech stated, "Yes, we do it if we don't have enough instruments and the cases are back to back or if something is dropped." When asked how the facility documents which instruments had been flashed sterilized, Staff#T-23 stated, "We just write if it was a flashed load; we write it on the back of the temperature strip." Staff #T-23 confirmed the facility was not documenting who the patient was, what, and why the instrument was flashed; the information was not shared with the Quality Committee or the Infection Control Committee.


d.) An observation, on the morning of 5/13/15, outside the facility's pre-operative unit, revealed an 8.5 x 11-inch sign stating in part, "OPERATING ROOM PERSONNEL ONLY Do Not Enter."

An observation, on the morning of 5/13/21, in the facility's pre-operative unit, revealed the following activity occurred while a patient was present in the Pre-operative unit:

Staff #T-31, housekeeper transporting a large linen-cart through the Pre-operative unit. When asked why she came through the Pre-operative unit, Staff T-31 stated, "The 300- unit hall is closed, this is how I was told to come."

Staff #T-32, administrator assistant, carry a purse and walking through the Pre-operative unit when asked why they came through the Pre-operative unit, Staff T-33 stated, "They told us to come this way."

Staff# T-33, Chart Extractor, carrying a box of medical records from the outside storage barn. When asked why they came through the Pre-operative unit, Staff T-33 stated, "It's closer."

Staff #T-1, Infection Control Nurse, carry a purse and walking through the Pre-operative unit, when asked why she came through the Pre-operative unit, Staff# T-1 stated, "This is the only way to come in. When we first started using the OR there weren't that many cases. The 300-hall was the Covid unit and we didn't want people going through there ...We are waiting for the 300-hall to be terminally cleaned so we can open it back up."

During an interview on the afternoon of 5/13/21, in the board room, Staff#T-5, CEO when asked about staffs walking through the Pre-operative unit stated, "The 300 Hallway used to be the Covid unit. When we moved the patients off the unit, we wanted to paint and patch walls...I can open it up."


e.) Review of the facility provided Environmental Cleaning Intraoperative Areas including Operating and Procedure Rooms Policy (dated 4/19) reflected, "Clean and disinfect all exposed surfaces, including wheels and casters, of all items with a facility-approved disinfectant and low-linting cloth, according to the manufacturer's written instructions for use, including

o Anesthesia carts and equipment (lV pumps)-OR Tech Only

o Anesthesia machines-OR Tech Only

o lV Poles o OR beds o Reusable table straps o OR , attachments (eg, arm boards, stirrups, head rests)

o Positioning devices (eg, viscoelastic polymer rolls, vacuum pack positioning devices)

o Patient transfer devices (eg, roll boards)

o Overhead procedure lights

o Tables and Mayo stands

o Mobile and fixed equipment (eg, suction regulators, medical gas regulators, imaging viewers, viewing monitors, radiology equipment, electrosurgical units, microscopes, robots, lasers)

o Storage cabinets, supply carts and furniture

o Light switches

o Door handles and push plates o Telephones and mobile communication devices

o Computer accessories (eg, keyboard, mouse, touchscreen)

o Chairs, stools and step stools o Trash and linen receptacles.


Observations, on the morning of 5/11/21, during a tour of the facility's surgery department revealed OR#1 and #2 had surgical equipment with copious amounts of dust build-up and rusted metal bases.

An observation, on the morning of 5/12/21, during a tour of the facility's surgery department revealed a respiratory mask and tubing, with condensation, that had been left in OR#1 from the previous day's surgery.

During an interview, on the morning of 5/12/21, in the facility's OR#1, Staff#T-1, Infection Control nurse, stated, "The room should be terminally cleaned, they shouldn't leave dirty items in the room.


f.) Review of the facility provided policy Operating Room Dress Code (dated 4/19) reflected, " ...Scrub clothes must not be worn outside the hospital for any reason ..."

An observation on the morning of 5/10/21, in the facility's parking lot, revealed, Operating Room (OR) Staff T-19, wearing operating room attire (surgical gown, gloves, face shield, surgical mask, and a hair bouffant.) Staff#T-19 was observed moving his vehicle. Staff#T-19 then entered the OR and went into OR #2, without removing the contaminated attire. Staff #T-19 came out of OR#2 and proceeded to the surgical scrub sink, he had removed the gown and gloves in OR #2.

During an interview on the morning of 5/10/21, when asked if it was okay to wear the operating room attire outside of the facility, Staff #T-19, stated, "I should have changed my attire."


g.) On 5/11/21, during a tour of the facility's endoscope department revealed an endoscope tower cart with copious amounts of clear tape attached to the sides. The Facility's endoscope washers had yellow stains and drips on the inside and outside of the scope washer as well as tape surrounding the front lids and sides. There was a brown stain running down the side of the endoscope washer. Staff#T-30 Endoscope tech, was able to wipe the brown stain off the side of the washer; she could not remove the stain from the inside of the washer.

During an interview on the afternoon of 5/11/21, in the facility's endoscope department, Staff #T-30, endoscopy technician, confirmed the finding and stated, "I don't know why the tape is on the washer ...We are planning on getting a new machine."

During an interview, the afternoon of 5/11/21, in the facility's endoscope department, when asked if the manufacturer had been contacted to ensure the scope washer was not affected by the yellow interior staining, Staff #T-20, OR Director stated, "No."


h.) Review of the 2010 American Society of Anesthesiology (ASA) guidelines support swabbing vial tops. "Use aseptic technique, including use of an alcohol swab or appropriate disinfectant, to cleanse the vial's rubber septum before entering ..."

An observation, on the morning of 5/11/21, in the facility's OR#1 suite, revealed Staff#T-22, Anesthesiologist, pop off the dust caps for 2 bottles of medication. Staff#T-22 drew up the medications without sanitizing the medication's rubber septum. During the surgery a gastric tube was inserted through the patient's mouth and the tubing was placed to suction out the excess bile. Dark green gastric bile started dripping onto the OR floor. Staff #T-22, placed a towel on the floor, to catch the spill, and placed plug into the leaking gastric tube port. Staff #T-22 removed her gloves and put on new clean gloves. Staff #T-22 did not wash her hands between the glove changes.

During an interview, in the operating room, Staff#T-20, OR Director stated, "She should have sanitized her hands.