HospitalInspections.org

Based on observations, staff interviews, review of one of one medical record (MR 1), and review of facility documents, it was determined that the facility failed to ensure that methods for preventing and controlling the transmission of infectious diseases within the facility are implemented as evidenced by failing to ensure methods for preventing and controlling transmission of infections within the facility are implemented for patients suspected of having or being ruled out for an airborne transmitted disease, Tuberculosis (TB), in accordance with nationally recognized guidelines and facility policy (A-0749).

Immediate Jeopardy findings were identified on 10/19/23. A patient was admitted to same day surgery on 10/12/23, with a documented history of a positive QuantiFERON test, CT (Computerized tomography) results showing possible TB, and no evidence of orders for airborne isolation precautions in the pre-operative area. The patient then had a bronchoscopy (an aerosol generating procedure) performed in a positive pressure operating room (OR) with no documented use of a High Efficiency Air (HEPA) filter unit. Review of facility policy titled, "Isolation Direct Admission Procedure for Adult Policy," indicated that if patient is suspected of having or being ruled out for airborne transmitted diseases, they must be placed in a negative pressure room or a room with a HEPA filter. The Director of Accreditation and Licensure and the Assistant Vice President of Quality and Patient Safety were informed of the IJ and provided with the IJ Template on 10/20/23 at 12:43 PM.

On 10/20/23 at 1:54 PM, an acceptable removal plan was received. Verification of the Removal Plan was performed, which consisted of a tour of the same day surgery area, observation of education to current staff in the unit, staff interviews, and facility documents review. Education review for all clinical staff including nurses and medical staff. Review of the notification to the scheduling staff of a change in process for booking bronchoscopy procedures to include escalating all bronchoscopy bookings to the OR director, who will discuss with the physician to determine the appropriate location for the procedure. The IJ was removed on 10/20/23 at 3:32 PM.

Cross Reference:
482.42(a)(2) - Infection Control Program

Based on staff interviews, a review of one of one medical record (MR1), and review of facility documents, it was determined that the facility failed to ensure the methods for preventing and controlling the transmission of infections within the facility are implemented for patients suspected of having or being ruled out for an airborne transmitted disease, such as Tuberculosis (TB), in accordance with nationally recognized guidelines and facility policy.

Findings include:

Reference: The Centers for Disease Control and Prevention (CDC), Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Settings, 2005, states, "... Environmental Controls The second level of the hierarchy is the use of environmental controls to prevent the spread and reduce the concentration of infectious droplet nuclei in ambient air. ... When surgical procedures (or other procedures that require a sterile field) are performed on patients with suspected or confirmed infectious TB, respiratory protection should be worn by HCWs to protect the sterile field from the respiratory secretions of HCWs and to protect HCWs from the infectious droplet nuclei generated from the patient. ... Postoperative recovery of a patient with suspected or confirmed TB disease should be in an AII room in any location where the patient is recovering (118). If an AII or comparable room is not available for surgery or postoperative recovery, air-cleaning technologies (e.g., HEPA filtration and UVGI) can be used to increase the number of equivalent ACH (see Environmental Controls); however, the infection-control committee should be involved in the selection and placement of these supplemental controls. ... Secondary environmental controls consist of controlling the airflow to prevent contamination of air in areas adjacent to the source (AII [Airborne Infection Isolation] rooms) and cleaning the air by using high efficiency particulate air (HEPA) filtration or UVGI."

Review of the facility document titled, " Isolation-Direct Admission Procedure for Adult Policy and Pediatric Patients with Airborne Pathogens" (dated January 28, 2019) states, "Purpose: describe the process used to directly admit adult...patients with airborne pathogens to the Medical Center, to limit risk of exposure to other patients, visitors and staff...Policy: Patients admitted...who are suspected of having , identified as having, or being ruled out for diseases transmitted by airborne route, (e.g. Tuberculosis...SARS [severe acute respiratory syndrome], Measles...) must be placed in an airborne isolation (negative pressure) room or a private room with a portable HEPA [High Efficiency Particulate Absorbing] filter unit...Equipment: 1. Portable HEPA filter units are available from engineering seven days a week, 24 hours a day..."

Review of the facility document titled, "Tuberculosis Control Program and Plan for Patient Care" (dated June 2023) states, "...Isolation of Care of Patient-Patients admitted with the diagnosis of possible or confirmed TB and all patients with...pulmonary disease of undetermined etiology are to be placed in an Airborne Infection Isolation Room (AIIR) on appropriate airborne precautions...2. in the event that a negative pressure room is unavailable, portable HEPA filters may be used...7. Discontinuing Isolation: Airborne Isolation precautions must be maintained until the isolated patient is no longer infections or until active pulmonary/laryngeal TB has been ruled out...b) patients suspected the have TB will be in airborne isolation precautions until another diagnosis has been identified..."

Review of facility document titled, "Standard and Transmission Based (Isolation) Precautions for Inpatients and Outpatients" (dated February 10, 2022) states, "...1. Airborne: An airborne infection isolation room (AIIR) (negative pressure) or a room with a portable HEPA filter will be utilized...Outpatients with suspect Airborne infections (e.g., TB...), in general shall not be scheduled for outpatient Ambulatory visits in areas that do not have negative pressure rooms..."

On 10/19/23 at 10:24 AM, during a tour of the Same Day Surgery (SDS) unit in the presence Staff (S)2, (Director of Quality and Standards) and S3 (Assistant Vice President (AVP) of perioperative services), S3 stated that Room #18 was the only negative pressure isolation room on the unit and that Rooms #18-#21 were "flex" rooms [meaning they can be used as both pre-op and post-op rooms].

During a tour of the Endoscopy suite at 11:26 AM, in the presence of S2, S3, S4 and S6 (Registered Nurse), two bronchoscopy suites (negative pressure procedure rooms) were observed. During an interview, S6 stated that inpatient isolation patients are brought directly to the bronch rooms and that outpatient isolation patients will be boarded in SDS Room #18.

A review of patient #1 (P1)'s medical record on 10/19/23 at 1:09 PM, revealed the following:

Documentation in the History and Physical dated 9/25/23 at 4:22 PM, by S20 stated, "...Impression and Plan...never smoker with recent [positive] quantiferon gold [a blood test to detect infection with tuberculosis] and imaging showing b/l [bilateral] avid nodules concerning for infectious process, possible TB..." Documentation in the Operative Report dated 10/12/23 at 1:41 PM by S20 stated, "...Indications: the patient...was referred to me with bilateral upper lobe nodules concerning for tuberculosis..."

On 10/12/23 at 10:00 AM, P1 was admitted to SDS by S21 (RN) for an outpatient bronchoscopy procedure [an aerosol generating procedure that lets the doctor visualize the patients air passages and lungs with a bronchoscope (a small camera that is located at the end of a flexible tube to diagnose lung disease)]. There was no documented evidence that isolation precautions were implemented in while the patient was in the Pre-operative area.

A review of the Physician's Operative note indicated that on 10/12/23 the patient had a bronchoscopy procedure in the OR with bronchoalveolar lavage [a saline solution is put through the bronchoscope to wash the airways and capture fluid samples for testing] and washings [the bronchial (lung tissue) is scraped to obtain tissue for testing], for lung nodules. Upon further review of the intra-operative record, there was no documented evidence that a HEPA filter was used during the procedure.

Review of the Anesthesia Record revealed the procedure was conducted in the OR room #20.

Review of the perioperative documentation by S22 (RN) in the PACU (Post Anesthesia Care Unit) indicated that the patient was placed on isolation precautions in PACU.

During an interview with S3 it was stated that HEPA filters are used in all the OR's when bronchoscopies are performed. Upon request the facility was unable to provide logs for, or documentation of HEPA filter use.

Review of facility policy titled, " OR/Procedure Rooms Air Changes, Temperature and Humidity Checks" dated 1/9/2023 states, "...III. Background: Procedure rooms need to be maintained in accordance with ASHRAE [American Society of Heating, Refrigerating and Air-Conditioning Engineers] 170, FGI [Facilities Guidelines Institute] and JCAHO [The Joint Commission] guidelines. The following guidelines are used: Procedures Rooms / OR Room Class B &C...Room Pressure - Positive..." Bronchoscopy Rooms West Wing...Room Pressure - Negative..."

Review of facility policy titled, " Negative Air Pressure Monitoring: Airborne Infection Isolation Rooms" dated January 31, 2017 states, "...8. If no other negative pressure room is available, A HEPA filter machine may be utilized. Obtain through the Engineering Department..."

Review of facility document titled "Operating Rooms Annual / Quarterly Check" for dated January 2023, February 2023, May 2023, and August 2023, revealed the room pressure for OR room #20 as "+" (positive).

During an interview at 3:24 PM, S11 (RN) stated that bronchoscopies are "often" done in the OR and that a HEPA filter (a high-efficiency particulate absorbing filter that trap small, harmful particles) should be in the room at the head of the bed, near anesthesia. S11 continued to state that to obtain a HEPA filter, staff will contact [name of company] and they will bring it to you. This was confirmed by S12 (respiratory therapist) at 3:31 PM.

Upon review of the facility document of the OR Log indicated that there were six bronchoscopy cases performed in the OR for the month of October.

On 10/20/23 at 11:00 AM, S1, S2, and S3 confirmed that P1 was not placed on airborne isolation precautions in accordance with facility policy and procedure; and that evidence of the utilization of a HEPA filter during the bronchoscopy in a positive pressure room was not available.