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412 MUSTANG AVENUE

DENVER CITY, TX 79323

PROPER VENTILATION, LIGHTING, AND TEMPERATURE

Tag No.: C0926

Based on review of facility documentation, observation, staff interview and accepted standard of practice, the facility failed to maintain proper ventilation and temperature control in 2 of 2 operating rooms and an autoclave (sterilization) room.

Findings were:

Review of the facility policy, "OPERATING ROOMS - TEMPERATURE, HUMIDITY and VENTILATION," effective 11/22/22, reflected in part, "POLICY: The temperature, humidity and airflow in all operating rooms shall be maintained with acceptable standards in order to inhibit bacterial growth and prevent infection, as well as promote patient comfort and safety. Relative humidity (RH) shall be maintained at 20 to 60 percent as recommended by the American National Standards Institute (ANSI), the American Society of Healthcare Engineers (ASHE) and the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE). Before establishing or re-establishing the low-end design RH levels below 30% in the OR, healthcare facility should assess the impact of lower RH on the equipment and supplies being used ... Temperature of the operating rooms shall be maintained at 68 to 75 degrees Fahrenheit (F) [FGI (Facility Guidelines Institute) 's 2014, ANSI (American National Standards Institute)/ASHRAE/ASHE Standard 170 - 2008)]. Each surgical site shall have separate temperature controls. Operating room temperatures shall be logged on a daily basis.
Airflow: The Engineering Department shall control the quality of air entering all operating rooms.
Air entering operating rooms shall be sequentially filtered through two (2) filters, the filter is rated at 85% efficiency and the second filter is rated at 85%.
A minimum of 20 to 25 total air changes per hour shall be maintained. At a minimum, 20% of incoming air shall be from the outdoors (three [3)] air changes per hour) ...
HVAC [Heating, Ventilation, and Air conditioning] Failure in the OR: All surgeries in progress shall be completed. All elective procedures shall be placed on hold until the HVAC failure has been repaired ..."

Facility logs, "2025 OR," "2025 GI," and "2025 Autoclave,"maintained in the respective rooms, documented the following parameters at the bottom of each log:
"PARAMETERS FOR OPERATING ROOM VENTILATION, AMERICAN INSTITUTE OF ARCHITECTS, 1996
Temperature 68 (degrees) F - 73 (degrees) F, depending on normal ambient temperatures
Relative humidity 30% (percent) to 60%
Air movement from "clean to less clean" areas
Air changes Minimum 15 total air changes per hour
Minimum 3 air changes of outdoor air per hour
CDC GUIDELINE FOR PREVENTION OF SSI
INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY"

Review of logs for temperature and humidity for two operating rooms, "2025 GI" and "2025 OR," and a "2025 Autoclave," room, dated January 1 through July 1, 2025, found discrepancies:
- temperature and humidity logs reflected parameters for operating room ventilation; temperature, and relative humidity; and reflected [in part], " ... Temperature 68 to 73 degrees (F), depending on normal ambient temperatures; Relative humidity 30% to 60% ...
- parameters for temperature and humidity, as documented in the facility policy, differ from parameters documented on "2025 GI," "2025 OR," and "2025 Autoclave" logs.

Based on the parameters for humidity and temperature listed on the bottom of the logs, "2025 GI," "OR" and "Autoclave" room:
- "2025 GI," operating room - Out-of-range humidity found for 71 of 127 days, on which humidity was measured; out-of-range temperature was found for 59 of 127 days, on which temperature was measured.
- "2025 OR," operating room - Out-of-range humidity for operating room, "OR" found 88 of 127 days, on which humidity was measured; out-of-range temperature for "OR" found 92 of 127 days, on which temperature was measured;
- "2025 Autoclave," room - Out-of-range humidity in "Autoclave," room was found for 109 of 127 days on which humidity was measured; out-of-range temperature in "Autoclave," room was found for 71 of 127 days on which temperature was measured;
- no documentation was provided to reflect staff action when temperature and/or humidity were out-of-range; that temperature and/or humidity was rechecked, and the problem resolved;
- temperature and humidity were not documented on weekends or holidays;
- no documentation was provided to reflect air movement and changes were evaluated.

Observation on the afternoon of 7/1/25, in the autoclave room, accompanied by Operating Room, Director (Staff #12), revealed a digital display temperature reading of 73 degrees (F) and humidity of 50%. In interview on 7/1/25, at the time of this observation, CNO (Staff #16) and Operating Room, Director (Staff #12) provided no documentation of staff corrective action for out-of-range temperature and humidity. CNO (Staff #16) confirmed temperature and humidity were not monitored on weekends/holidays and stated the facility is exploring options for monitoring systems. CNO (Staff #16) was asked about the parameters at the bottom of each temperature and humidity log, for air movement and air changes. CNO (Staff #16) was not aware of how these measures were made, or who maintained this information.

According to an article entitled "Relative Humidity Levels in the Operating Room Joint Communication to Healthcare Delivery Organizations 2015," it was stated [in part]: "Relative humidity may affect the operation of some electro-medical equipment used in the OR, particularly with older model electro-medical equipment. This equipment may malfunction unexpectedly. Too low humidity levels may also impact calibration. Larger electrostatic discharge (ESD) pulses may create a risk of destruction of parts, premature failure, and erratic behavior of software that is "confusion" from ESD pulses. And, in an environment where humidity is low, a person can more easily become "charged" and receive an electrostatic shock when coming in contact with medical equipment."

INFECTION PREVENT & CONTROL ORG & POLICIES

Tag No.: C1204

Based on interviews and facility documents, the facility failed to have an individual who is qualified through training or certification in infection prevention and control, responsible for the infection prevention and control program.

Findings were:

In an interview on the afternoon of 7/1/25, in a facility conference room, Infection Control & Employee Health Nurse, Staff #8, reported he/she held neither credential nor certification in Infection Prevention and Control. " ... I have participated in online Association for Professionals in Infection Control and Epidemiology (APIC) conferences and have reached out to professional contacts for information ..."

In an e-mail communication on 7/1/25, Staff #15 confirmed no infection control certification or training was documented in Infection Control & Employee Health Nurse (Staff #8's) personnel file.

In an interview on the afternoon of 7/1/25, Chief Executive Officer (Staff #1) stated, "Traditionally, the Governing Body does not appoint that position [referring to the Infection Control & Employee Nurse]. [Staff #8] was interviewed and hired by two Chief Nursing Officers (CNOs), 2 years ago. We have tried to get outside mentorship, and [Staff #8] participated on a Zoom call a couple of times and was told about APIC."

Review of a job description, "Infection Control & Employee Health Nurse," signed by Staff #8, undated, documented [in part],
" ... DEPARTMENT: Nursing JOB SUMMARY: Oversees all infection control and prevention related activities within the organization ... Responsible for all functions of the employee health program and for providing clinical employee health services ...
JOB QUALIFICATIONS ... D. Experience: 1. Prior Work Experience: Three years of professional nursing experience in a clinical setting and one year in a nursing supervisory role preferred. 2. Technical Training: Current Cardiopulmonary Resuscitation (CPR) certification, Advanced Cardiac Life Support (ACLS), Pediatric Advanced Life Support (PALS) ... ESSENTIAL DUTIES AND RESPONSIBILITIES ... C. Will be required to establish standard methods of care, utilizing evidence-based practice and best practice standards... E. Responsible for policies and procedures within the organization related to infection control and employee health ... L. Responsible for coordinating the infection control program which includes surveillance; analysis of data; developing reports, policies, and procedures ... O. Coordinate with the Infection Prevention and Control Committee to determine the direction of surveillance activities and actively evaluate effectiveness of the Infection Prevention and Control Plan annually ... R. Develop and implement continuously improved patient care procedures and control mechanisms related to quality, compliance, and infectious diseases ... OTHER SIGNIFICANT REQUIREMENTS: ... E. Performs duties in related departmental functions as directed by the Chief Nursing Officer or Department Supervisors ..."

Neither credential [training and education] nor certification [competency] in Infection Prevention and Control were described as qualifications a candidate must meet for the position of Infection Control & Employee Health Nurse.

LEADERSHIP RESPONSIBILITIES

Tag No.: C1225

Based on observation, interview, review of facility documents, and review of acceptable standards of practice, the facility failed to maintain a clean and safe environment in patient areas, including temperature and humidity control for 2 of 2 operating rooms and an autoclave room (a room in which surgical equipment and supplies were sterilized); monitor temperature and humidity on holidays and weekends; document staff action to report and resolve out-of-range temperature and/or humidity levels; ensure trained and qualified persons in infection control roles, with continuous nursing supervision and oversight; and develop, implement and enforce a plan to monitor surgical patients, utilizing appropriate criteria, current tools, and monitoring methods for prevention, identification, and reporting of surgical site infection.

Findings were:

A tour of the facility on the morning of 6/30/25, accompanied by Chief Executive Officer (CEO), Staff #1, revealed:
- uncovered linen (towels) were observed on a shelf in a therapy treatment room, in a storage area, and in a linen supply room. Clean linens were not stored in a manner to prevent contamination by dust and debris.
- cardboard boxes, containing supplies, were observed in storage and supply rooms. Corrugated boxes cannot be cleaned and may house and provide a food source for pests.

Observation in a medication room, on the morning of 6/30/25, accompanied by Chief Nursing Officer (CNO), Staff #16, revealed:
- a sharps disposal container, which held discarded needles and/or other medical devices that go into skin), atop a counter. The portals in the top of the sharps disposal container were in the open position. Open portals potentially exposed nursing staff' fingers/hands to needle sticks.
- a spray bottle containing liquid which was identified as an environmental cleaning solution; a stick deodorant, intended for individual use; and travel-size bottles of hygiene products were observed on/near a shelf in a shower room, located on the medical/surgical hallway.

In interview at the time of the observation on 6/30/25, CNO (Staff #16) reported the shower room is used by patients who may have mobility issues. Staff #16 confirmed the spray bottle may contain a liquid that should not come into contact with skin and/or mucous membranes; and that personal use hygiene items, which could potentially transmit germs and bacteria from one patient to another, would be removed from the shower room.

In interview on the afternoon of 7/1/25, in a facility conference room, Infection Control & Employee Health Nurse (Staff #8), when asked to describe the facility's infection surveillance, prevention and control, and antibiotic use activities, reported the hospital followed CDC (U.S. Centers for Disease Control and Prevention) and APIC (Association for Professionals in Infection Control and Epidemiology) standards. Staff #8 was asked for documentation of surveillance activities and stated, "I've been trying to determine how to do my surveillance and get it onto paper. I know it's something we are supposed to be doing, and I just need to get it together to get it done." Infection Control & Employee Health Nurse (Staff #8) stated, "Infections would be reported in Quality Assurance Performance Improvement (QAPI) meetings. Staff #8 revealed:
- infection control environmental rounds were not scheduled;
- he/she had no audit tools for infection control/environmental rounds;
- education was provided to hospital and clinic staff; however, Staff #8 did not consistently document staff participation;
- he/she did not review logs which documented temperature and humidity readings for the facility's two operating rooms and autoclave room; and that out-of-range temperature and humidity readings would be reported to maintenance staff;
- surgical patients were monitored for infection at their clinic appointment, following their surgery;
- 30-day, 60-day, and 90-day surveillance of surgical patients (inpatients and outpatients) was not conducted; and
- the facility's infection control plan had not been updated since 2019.
When asked for documentation of infection surveillance, prevention and control, and antibiotic use activities, Staff #8 stated, "... provided a computer-generated "NHSN (National Healthcare Safety Network) 13.2.06 View Monthly Reporting Plan," for April 2025, in which the facility identified procedure-associated modules for cesarean section and abdominal hysterectomy were performed by the facility; however , no patient-specific information was provided.

In interview on the afternoon of 7/1/25, CNO (Staff #16) described persistent problems with the facility's air handlers [air handling units condition, clean, and circulate air and are crucial for maintaining a healthy and safe environment].

Observation on the afternoon of 7/1/25, in the autoclave room, accompanied by Operating Room, Director (Staff #12), revealed a digital display temperature reading of 73 degrees Fahrenheit (F) and humidity of 50%. In interview on 7/1/25, at the time of this observation, CNO (Staff #16) and Operating Room, Director (Staff #12) provided no documentation of staff corrective action for out-of-range temperature and humidity. CNO (Staff #16) confirmed temperature and humidity were not monitored on weekends/holidays and stated the facility is exploring options for monitoring systems. CNO (Staff #16) was asked about the parameters at the bottom of each temperature and humidity log, for air movement and air changes. CNO (Staff #16) was not aware of how these measures were made, or who maintained this information.

Review of the facility policy, "OPERATING ROOMS - TEMPERATURE, HUMIDITY and VENTILATION," effective 11/22/22, reflected in part, "POLICY: The temperature, humidity and airflow in all operating rooms shall be maintained with acceptable standards in order to inhibit bacterial growth and prevent infection, as well as promote patient comfort and safety. Relative humidity (RH) shall be maintained at 20 to 60 percent as recommended by the American National Standards Institute (ANSI), the American Society of Healthcare Engineers (ASHE) and the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE). Before establishing or re-establishing the low-end design RH levels below 30% in the OR, healthcare facility should assess the impact of lower RH on the equipment and supplies being used ... Temperature of the operating rooms shall be maintained at 68 to 75 degrees (F) [FGI (Facility Guidelines Institute) 's 2014, ANSI (American National Standards Institute)/ASHRAE/ASHE Standard 170 - 2008)]. Each surgical site shall have separate temperature controls. Operating room temperatures shall be logged on a daily basis.
Airflow: The Engineering Department shall control the quality of air entering all operating rooms.
Air entering operating rooms shall be sequentially filtered through two (2) filters, the filter is rated at 85% efficiency and the second filter is rated at 85%.
A minimum of 20 to 25 total air changes per hour shall be maintained. At a minimum, 20% of incoming air shall be from the outdoors (three [3)] air changes per hour) ...
HVAC [Heating, Ventilation, and Air conditioning] Failure in the OR: All surgeries in progress shall be completed. All elective procedures shall be placed on hold until the HVAC failure has been repaired ..."

Facility logs, "2025 OR," "2025 GI," and "2025 Autoclave,"maintained in the respective rooms, documented the following parameters at the bottom of each log:
"PARAMETERS FOR OPERATING ROOM VENTILATION, AMERICAN INSTITUTE OF ARCHITECTS, 1996
Temperature 68 (degrees) F - 73 (degrees) F, depending on normal ambient temperatures
Relative humidity 30% (percent) to 60%
Air movement from "clean to less clean" areas
Air changes Minimum 15 total air changes per hour
Minimum 3 air changes of outdoor air per hour
CDC GUIDELINE FOR PREVENTION OF SSI
INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY"

Review of logs for temperature and humidity for two operating rooms, "2025 GI" and "2025 OR," and a "2025 Autoclave," room, dated January 1 through July 1, 2025, found discrepancies:
- temperature and humidity logs reflected parameters for operating room ventilation; temperature, and relative humidity; and reflected [in part], " ... Temperature 68 to 73 degrees (F), depending on normal ambient temperatures; Relative humidity 30% to 60% ...
- parameters for temperature and humidity, as documented in the facility policy, differed from parameters documented on "2025 GI," "2025 OR," and "2025 Autoclave" logs.

Based on the parameters for humidity and temperature listed on the bottom of the logs, "2025 GI," "OR" and "Autoclave" room:
- "2025 GI," operating room - Out-of-range humidity found for 71 of 127 days, on which humidity was measured; out-of-range temperature was found for 59 of 127 days, on which temperature was measured.
- "2025 OR," operating room - Out-of-range humidity for operating room, "OR" found 88 of 127 days, on which humidity was measured; out-of-range temperature for "OR" found 92 of 127 days, on which temperature was measured;
- "2025 Autoclave," room - Out-of-range humidity in "Autoclave," room was found for 109 of 127 days on which humidity was measured; out-of-range temperature in "Autoclave," room was found for 71 of 127 days on which temperature was measured;
- no documentation was provided to reflect staff action when temperature and/or humidity were out-of-range; that temperature and/or humidity was rechecked, and the problem resolved;
- temperature and humidity were not documented on weekends or holidays;
- no documentation was provided to reflect air movement and changes were evaluated.

In review of a job description (undated), "Infection Control & Employee Health Nurse," stated [in part]: ... ESSENTIAL DUTIES AND RESPONSIBILITIES ... O. Coordinate with the Infection Prevention and Control Committee to determine the direction of surveillance activities and actively evaluate effectiveness of the Infection Prevention and Control Plan annually ..."

The CDCs, NHSN (National Healthcare Safety Network), Surgical Site Infection Event (SSI)," dated January 2025, found at cdc.gov, included definitions, detailed information, and requirements, and stated [in part], "Settings: Surveillance of surgical patients will occur in any inpatient facility and or hospital outpatient procedure department (HOPD) where the selected NHSN operative procedure(s) are performed ... Requirements: Perform surveillance for SSI following at least one NHSN operative procedure category (using the associated NHSN operative procedure codes) as indicated in the Patient Safety Monthly Reporting Plan (CDC 57.106) ... All procedures included in the NHSN monthly surveillance plan are monitored for superficial incisional, deep incisional, and organ/space SSI events and the type of SSI reported must reflect the deepest tissue level where SSI criteria are met during the surveillance. An SSI event is attributed to the facility in which the NHSN operative procedure is performed ... Surveillance Methods: SSI monitoring requires active, patient-based, prospective surveillance. Concurrent and post-discharge surveillance methods should be used to detect SSIs following inpatient and outpatient operative procedures for example, these methods include review of medical records or surgery clinic patient records ...
- Visit the ICU and wards - talk to primary care staff
- Surgeon surveys by mail or telephone
- Patient surveys by mail or telephone ...
Any combination of these methods or other methods identified by the facility with the capacity to identify all SSIs is acceptable for use; however, NHSN criteria for SSI must be used ..."

No information was provided to support the facility identified or provided information to the Governing Body to promote and ensure:
- trained and qualified persons in infection control roles, with continuous nursing supervision and oversight;
- a clean and safe environment in patient areas; including environments which require control of temperature, humidity; air movement; and air exchange (i.e., operating and sterilization rooms);
- concurrent and post-surgical surveillance of surgical inpatients and outpatients, utilizing appropriate criteria; current tools and monitoring methods for prevention; identification; and reporting of surgical site infection.