Observations:
Based on review of facility documents, observation, and staff interview (EMP), it was determined the facility failed to ensure Procedure Rooms were monitored for temperature and humidity levels.
Findings include:
On February 27, 2025, a review of the facility policy "Environmental Standards" without an approved or revised date revealed "The ventilation system will ensure that a controlled and regularly inspected filtered air supply is provided in the facility as designated below ... Procedure Room ... Operating Room ..."
Review of facility documents "Temperature/Humidity Logs" on February 27, 2025, revealed in Procedure Room One (1) and Procedure Room Two (2) the temperature and humidity were not on the log for being monitored and logged daily.
On February 27, 2025, observation of Procedure Room One (1) and Procedure Room Two (2) revealed both Procedure Rooms are not being monitored for temperature and humidity levels.
Interview with EMP1 on February 27, 2025, confirmed information provided above is complete and accurate.
| | Plan of Correction - To be completed: 03/17/2025
The Board of PA Eye & Ear Surgery center approved the below Environmental Standards policy on 3/11/2025. This specifies the temperature and humidity requirements for all clinical spaces in the facility according to AORN standards.
POLICY: The ventilation system will ensure that a controlled and regularly inspected filtered air supply is provided in the facility, as designated below.
PROCEDURE: Temperature and humidity will be maintained at the recommended levels:
- Operating Room
o Temperature of 68 to 75 degrees Fahrenheit
o Humidity of 20% to 60%
- Procedure Room
o Temperature of 70 to 75 degrees Fahrenheit
o Humidity of 20% to 60%
- Clean Utility (clean workroom)
o Temperature of 68 to 73 degrees Fahrenheit
o Humidity maximum 60%
- Sterile Storage
o Temperature maximum of 75 degrees Fahrenheit
o Humidity maximum of 60%
- Soiled Utility (decontamination room)
o Temperature of 60 to 73 degrees Fahrenheit
- Pre-Operative & PACU
o Temperature of 70 to 75 degrees Fahrenheit
o Humidity of 20 to 60%
- Temperature should be maintained between 68 to 75 degrees Fahrenheit in the operating rooms, however, as permitted within the ASHRAE 170 Table footnote (o), "Surgeons or surgical procedures may require room temperatures, ventilation rates, humidity ranges and/or distribution methods that exceed the minimum indicated ranges".
- The operating room (OR) humidity level must be appropriate for the surgical and anesthesia equipment and supplies stored in the OR. Supplies, which require a different level of humidity per manufacturer Directions for Use (DFU) may be stored outside of the OR until they are used. Personnel will be aware of DFUs specific to OR equipment and supplies, and in particular know what environmental humidity requirements are specified in the DFUs. When the temperature is >75°F (>23°C) and/or the RH is <20% and >60% a risk assessment should be conducted. Low Humidity increases the risk of electrostatic charges, which pose a fire hazard in an oxygen-enriched environment or when flammable argents are in use and increase the potential for dust. There may also be a potential for increased spread of infection. When there is High humidity, this increases the risk of microbial growth in procedures areas as well as areas where sterile supplies are stored. In addition to humidity, excessive temperature can also contribute to bacterial growth and can lead to patient/staff discomfort.
- These temperature and humidity parameters will be monitored and logged daily.
- If adjustments are necessary to maintain the specified levels, the parameters will be rechecked within 30 minutes. If the temperature and humidity levels are not within the recommended range after the 30 minutes, a decision to delay or cancel cases will be made based on a risk assessment. In the event the temperature or humidity exceeds recommended ranges while the case is in progress, the Clinical Director will be notified. An Incident Report will also be completed. Following cases will not proceed until satisfactory resolution of the temperature and/or humidity. Elevated monitoring data will be reported on a quarterly basis to the QAPI Committee and Governing Body.
- Emergency power source will be sufficient to provide necessary lighting and power when usual electrical supply is interrupted.
- Air flow will be maintained at the recommended levels:
o The restricted area should have a positive pressure relationship to the adjacent areas.
o The pressure relationship of the semi-restricted area to the adjacent area should be based on the use of the area:
Operating room – positive
Procedure room – positive
Clean/sterile storage – positive
Soiled workroom/decontamination room – negative
o Since the OR is the cleanest environment in the facility, all adjacent rooms should be negative to the OR.
- These parameters should be monitored and logged monthly to ensure proper pressure.
- An annual air balance test should be completed by contracted vendor and kept on file.
References:
ANSI/ ASHRAE/ ASHE Standard 170-2021: Ventilation of Health Care Facilities. American Society for Healthcare Engineering of the American Hospital Association.
Guidelines for Design and Construction of Hospitals. St Louis, MO: Facility Guidelines Institute (FGI); 2022.
Guidelines for Design and Construction of Outpatient Facilities. St Louis, MO: Facility Guidelines Institute (FGI); 2022.
Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. Centers for Disease Control and Prevention guideline for the prevention of surgical site infection, 2017. JAMA Surg. 2017;152(8):784-791.
State Operations Manual Appendix L – Guidance for Surveyors: Ambulatory Surgical Centers. Rev. 206. 06-17-22. Centers for Medicare & Medicaid Services.
An updated surgelog temperature and humidity log will be in place by 3/21/2025 to ensure that all spaces are in compliance with the parameters recorded in this policy. The lead Pre-Operative RN , the Clinical Director or the Administrator will audit the tracking of temperature and humidity in Surgelogs on a weekly basis.
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