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Based on observation, document review, and interview, in one (1) of 11 medical records (MR) reviewed the facility failed to implement physician ordered Airborne isolation for a patient with concern for tuberculosis (TB) and cohort the tuberculosis (TB) patient per facility policy (Patient #21).

This failure placed patients, visitors, and staff at risk for exposure to an airborne communicable disease.

Findings:

See Tag 0749

Based on observation, document review, and staff interview, the facility (a) failed to monitor and maintain the operating room (OR) temperature and relative humidity in accordance with its policy and procedures and according to the "Facility Guidelines Institute" acceptable standards of practice and (b) failed to implement its policy and procedure for out-of-range temperature and relative humidity for out-of-range parameters.

Findings:
The facility failed to monitor and maintain the operating rooms (OR) temperature and relative humidity in accordance with its policy and procedures and according to Table 7-1 Facility Guidelines Institute 2018 Guidelines and ANSI/ASHRAE/ASHE 170 (Ventilation of Health Care Facilities). The acceptable range for Relative Humidity (RH) according to Facility Guidelines Institute is 20-60%.
High humidity increases the risk for microbial growth in procedure areas as well as areas where sterile supplies are stored.

See Tag 0951

Based on observation, document review, and interview, in one (1) of 11 medical records (MR) reviewed the facility failed to implement physician ordered Airborne isolation for a patient with concern for tuberculosis (TB) and cohort the tuberculosis (TB) patient per facility policy (Patient #21).


Findings:

Review of the facility's Policy and Procedure titled, "Management of Isolation and Multi Drug Resistant Organisms (MDROs)," revised 12/01/23 states:

"POLICY:
Patients with suspected or confirmed pulmonary tuberculosis (TB) will be placed on airborne isolation ideally, in a negative pressure room, or-one equipped with HEPA filtration (high-efficiency particulate air filter can theoretically remove at least 99.97% of dust, pollen, mold, bacteria, and any airborne particles with a size of 0.3 microns) if a negative pressure room is unavailable at the earliest possible moment and remain on isolation until the isolation order is lifted, based on SBH (St Barnabas Hospital) Health System TB (tuberculosis) guidelines, and input from Infection Control and the infectious diseases consultant.

PURPOSE:
To provide guidance on isolation practices and limit transmission of tuberculosis (TB) throughout SBH (St Barnabas Hospital) Health System. This policy supersedes all other policies on tuberculosis.

I. Administrative Considerations
The following administrative considerations are to be made in cases where suspected or confirmed (tuberculosis) TB patients are placed, on airborne isolation:

Prioritization of Patients
When isolation rooms are not available for all patients, and there is absolutely no alternative but to prioritize patients, the following guidelines can be used to assign AFB (Acid-Fast Bacillus (AFB) sputum tests to identify specific bacteria, such as Mycobacterium tuberculosis) isolation rooms:

Those patients who cannot be placed in an AFB isolation room should, at a minimum, be placed in a private room equipped with a HEPA filter, with the door remaining closed at all times.

Cohorting
The sharing of rooms by (tuberculosis) TB patients is generally not advisable and rarely done however may be considered in extenuating circumstances if the following conditions can be documented:

-Both patients are known to be infected with drug susceptible organisms, or both patients' organisms are known to have the same resistance pattern, and
-Both patients are responding to treatment.


Tuberculosis (TB) patients may not share rooms under the following circumstances:
-A patient suspected of having tuberculosis (TB) will never be placed in a room with a patient known to have tuberculosis (TB).
-Two patients suspected of having tuberculosis (TB) will not share the same room.
-Patients with unknown or pending susceptibility results will not share a room with anyone.

Authority
Clear lines of authority will be established in order to coordinate the initiation, maintenance and termination of airborne isolation.

-Infection Control personnel will coordinate all airborne isolation activity.
-Infection Control personnel will be notified of all patients admitted with suspected or confirmed infectious tuberculosis (TB).
-Initiation and enforcement of airborne isolation procedures is the responsibility of all involved hospital staff in conjunction with infection control personnel."


During a tour of the Emergency Department (ED) on 07/22/2024 at approximately 2:15PM, with Staff V, ED charge nurse, it was observed patients were separated in cubicles with blue curtains. Staff V, ED charge nurse, when asked why the curtains had different colors stated, "the darker blue curtains are where isolation patients are kept when there are no isolation rooms available." A patient was observed in cubicle 9 (Patient #21) and Staff V stated the patient was on airborne isolation. The surveyor observed the curtain was not completely closed around the cubicle and there were patients in the adjacent cubicles 8 and 10. Per Staff V, these patients in cubicles 8 and 10 were not on isolation.
It was also observed that there was no signage for Airborne Isolation at cubicle #9.

Review of the medical record (MR) for Patient #21 identified: the patient presented to the ED on 07/22/2024 at 10:13AM via EMS (Emergency Medical Services) with complaints of shortness of breath, chest pain, productive cough blood tinged for 2 days, hypertensive, tachycardic, tachypneic and hypoxic. Physician, Staff S assessment at 10:50AM includes past medical history: acute kidney failure, anemia, diabetes mellitus type 2, nicotine dependence, tuberculosis (TB) positive 1996, pneumonia x 2, and asthma. Physician ordered Airborne isolation at 10:29AM for abnormal chest x-ray with concern for tuberculosis (TB), labs, AFB (Acid-Fast Bacillus sputum tests to identify specific bacteria, such as Mycobacterium) culture, ECG (electrocardiogram, a quick test to check the heartbeat).

During interview on 7/22/2024 at 2:15PM, Staff V, ED Charge Nurse, reported they have two isolation patients, one in cubicle 9 on airborne isolation and one in cubicle 15 on contact isolation. They currently have 2 isolation rooms which are in use therefore the patients in cubicles 9 and 15 have to be mixed in with the rest of the ED patients. Staff V, further stated, normally, patients on isolation in the main ED is given an isolation cart, a mask, along with a HEPA (high efficiency particular air) filter until a room is identified for isolation. Staff V acknowledged and it was observed that there was no HEPA filter with the patient on airborne isolation in cubicle 9. Staff V further acknowledged she was informed of the need for an airborne isolation room however none was available, and she did not inform her supervisor. When asked how this affects the two adjacent patients, in cubicle 8 and 10, to cubicle #9, staff V, stated she was unable to comment.

During interview on 7/22/2024 at 3:00PM, Staff X, Infection Control Director, verbalized what the protocol for patients on airborne isolation included, a negative pressure room, isolation cart for staff with supplies, a sign placed outside of the room, if an isolation room was not available a HEPA filter should be placed with the identified patient. Staff X further stated, when a patient is placed on airborne isolation, the Electronic Medical Record (EMR) will flag the order and that's how the department is notified. Staff X acknowledged there was no HEPA filter in cubicle #9 for the patient that was on airborne isolation at the time of observation.

During interview on 7/22/2024 at 3:15PM, Staff R, RN for patient in cubicle 9, acknowledged patient was on airborne isolation however there were no rooms available, and it was reported to the charge nurse per protocol.
During interview on 7/22/2024 at 3:20PM, Staff S, ED attending for patient in cubicle 9, reported patient in cubicle 9 has an abnormal chest X-ray and an order for airborne isolation was placed. Acknowledged he is aware there were no isolation rooms available, and acknowledged the unavailability of the room was never bumped up the chain of command.

Based on observation, document review, and staff interview, the facility (a) failed to monitor and maintain the operating room (OR) temperature and Relative Humidity (RH) in accordance with its policy and procedures and according to Facilities Guidelines Institute (FGI) 2018 Guidelines and (b) failed to implement its policy and procedure for out-of-range temperature and relative humidity for out-of-range parameters.

Findings include:

Table 7-1 Facility Guidelines Institute (FGI) 2018 Guidelines and ANSI/ASHRAE/ASHE 170 (Ventilation of Health Care Facilities). The acceptable range for Relative Humidity (RH) according to Facility Guidelines Institute is 20-60%.

Review of facility's policy and procedure manual for "Temperature and Humidity Control in the Operating Environment" dated 1/16, it states:

The Relative Humidity (RH) of air should be between 30-60% within the operating room.
a) Each OR's temperature, humidity, and pressure will be recorded on the Temperature and Humidity log by nursing staff and validated by a member of the Department of Engineering.
b) If the Parameters remain out of range despite interventions from the Engineering, infection control will be consulted to do a risk assessment. Then Clinical team will decide if the procedures can continue.

On 7/10/24, between 11:00 AM and 12:00 PM during the tour of the operating room (OR) suites, the Relative Humidity (RH) readings, immediately after surgery, were observed on the thermostat wall device as: in OR 4 - RH 75%, and OR 5 - RH 67%. According to the FGI 2018 edition, the acceptable range for RH within the operating room is 20-60% and the temperature is 68-75 degrees F (20-23 degrees C).

On 7/10/2024 at 2:00 PM, review of the operating room Daily Temperature and Relative Humidity Log revealed that the relative humidity for OR rooms #3, #4, and #5 were 70%, 75%, and 67% respectively.
A concurrent review of patient surgery log on 7/10/2024 revealed that the facility performed procedures/surgery in these operating rooms with relative humidity above acceptable ranges.

During an interview on 7/12/24 at 11:30 AM, Staff A, Chairman, the Department of Anesthesiology, and Staff B, Chief Quality Officer, acknowledged the findings and stated, "The facility uses the ORs even when the RH is higher than the acceptable range."

Review of the facilities OR Daily Temperature and Relative Humidity Log dated 7/1/2024 to 7/10/2024, revealed no documented evidence of comments/interventions to address out-of-range parameters specifically Humidity. No documented evidence of escalation to Nursing Infection Control for risk assessments.

Similar findings on out-of-range Humidity readings were identified in the review of the OR Daily Temperature and Humidity Readings log, dated April 2024 to July 2024, Examples:
On 7/9/24: OR 4 - RH 64%, OR 5- RH 63%; morning before surgery
On 7/7/24: OR 4 - RH 63% OR 5 - RH 63%; morning before surgery
On 6/14/24: OR 1- RH 66%, OR 2- RH 69%, OR 3- RH 71%, OR 4- RH 74%, OR 5- RH 74% and OR 6- RH 71% morning before surgery
On 5/29/24: OR 3- RH 71% morning before surgery
On 5/21/24: OR 4- RH 70% and OR 5- RH 68% morning before surgery
On 4/12/24: OR 2- RH 65%, OR 3- RH 66%, OR 4- RH 73%, OR 5- RH 74% and OR 6- RH 65% morning before surgery
A concurrent review of the patient surgery log revealed that the facility performed procedures/surgery in these operating rooms with a relative humidity that were out of range for days between April 2024 to July 2024.
There was no documented evidence, that the facility implemented corrective actions for out-of-range relative humidity or any evidence of clinical risk assessments, prior to conducting surgeries and utilizing the OR suites when the Relative Humidity readings were out of range.
These findings were acknowledged by Staff A, Chairman, the Department of Anesthesiology, Staff B, Chief Quality Officer, and Staff C, Senior Director of Facilities who were present during the tours.

During a tour of the Central Sterile, on 7/12/24 at 11:45 AM, it was noted that the sterile storage area Relative Humidity (RH) was 61%. Staff C, Senior Director of Facilities validated the finding at the time of the tour.
Review of the Daily Temperature and Humidity log for the Central Sterile area dated, July 2024, confirmed the findings. Similar findings of out-of-range Relative Humidity readings were identified for the following days,
On 7/12/24 at 8:00 AM - RH 61%
On 7/11/24 at 8:00 AM- RH 65%
On 7/10/24 at 8:00 AM- RH 62%
On 7/9/24 at 8:00 AM - RH61%
These findings were confirmed during interview with Staff A, Chairman, Department of Anesthesiology, and Staff C, Senior Director of Facilities on 7/12/24.