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Tag No.: A0528
Based on interview and record review, the facility failed to ensure the Condition of Participation for Radiologic Services was met as evidenced by:
1. The facility failed to ensure limitations on access to areas containing radiologic services equipment for one of two sampled double doors to the computerized tomography scan (CT, a diagnostic imaging procedure that uses a combination of electromagnetic radiation [energy that comes from a source and travels through space] with high energy to produce images of the inside of the body), CT room located in the hallway of an emergency department, to prevent patient, visitors, and staff from opening the CT room door while patient are being scanned by the CT machine. The facility provides CT scan services to 60 - 70 patients daily.
This deficient practice resulted in an increased risk of re-exposure for the patient who is on the CT scan when the double door to the CT is accidentally opened (by ED visitors, patients, or emergency department staff) during scanning, as the scan may need to be repeated for the patient receiving the scan, and the potential to develop cancer due to radiation exposure for patients, visitors, and staff who may open the CT double door while the CT is scanning (omitting radiation when in scan mode). (Refer to A-0536)
2. The facility failed to ensure the metal joint of the arm that holds the body of a power injector of one of two sampled power injectors (devices used to inject a substance into the body in order to improve the visibility of the internal structure) in the computerized tomography's (CT, a diagnostic imaging procedure that uses a combination of electromagnetic radiation [energy that comes from a source and travels through space] with high energy to produce images of the inside of the body) room did not separate, leaving about a centimeter-wide open gap, in accordance with the facility policy and procedure.
This deficient practice poses a risk of infection and injury, Increase the risk of contamination of the injector due to the open gap, which can lead to patients developing infections. In addition, the handle of the injector may fall completely apart during the procedure when the handle is being adjusted and manipulated, which is likely to cause injury to the patient or staff. (Refer to A-537)
3. The facility failed to ensure the ceiling panel above the CT machine of one of two CT room sampled (CT 2) was not lifted leaving about an inch open gap, in accordance with the facility policy and procedure. This deficient practice poses a risk of falling debris or particles which increase the risk for infection and injury to patients and staff. (Refer to A-537)
4. The facility failed to ensure one of two CT room sampled, CT2 on the second floor did not have damage to the wall, in accordance with facility policy and procedure. The wall had a rectangular hole sized about two inches by five inches where portions of the drywall hung loosely from. The hole was located in the lower portion of the wall towards the molding where additional linear breakage where the paint in this lower portion was scraped revealing more drywall This deficient practice likely to expose patients and staff to radiation leaks when it is not inspected, monitored, and maintained. (Refer to A-537)
The cumulative effect of these deficient practices resulted in the facility's inability to provide quality health care in a safe environment.
Tag No.: A0536
Based on observation, interview, and record review, the facility failed to ensure limitations on access to areas containing radiologic services equipment due to non-functioning interlocking mechanism for one of two sampled (CT 1's) double doors to the computerized tomography scan (CT , a diagnostic imaging procedure that uses a combination of electromagnetic radiation [energy that comes from a source and travels through space] with high energy to produce images of the inside of the body), CT room located in the hallway of an emergency department, to prevent patient, visitors, and staff from opening the CT room door while patient are being scanned by the CT machine. The facility provides CT scan services to 60 - 70 patients daily.
This deficient practice resulted in an increased risk of re-exposure for the patient who is on the CT scan when the double door to the CT is accidentally opened (by ED visitors, patients, or emergency department staff) during scanning, as the scan may need to be repeated for the patient receiving the scan, and the potential to develop cancer due to radiation exposure for patients, visitors, and staff who may open the CT double door while the CT is scanning (releasing radiation when in scan mode).
Findings:
The facility installed a CT scan unit located in the ED. The CT scans double doors are in the ED hallway; the hallway is accessible to patients, visitors, and staff. There is a patient's restroom also located in this hallway. On October 1, 2023, the facility started providing CT scan services from this CT unit located in the emergency department hallway to patients in the facility.
During an observation on 5/22/24 of the CT's double door, once the door was opened, the CT scanner is about 15 feet from the door inside the CT scan room. It was observed that there was no barrier between the doorway and the CT scanner unit.
On 5/22/24 at 11:00 a.m., during an interview with the Radiology Technician (RT 1), RT 1 stated the CT department sees over 60 to 70 cases daily, they are busy. RT 1 also stated, "we complete one (one patient complete CT scan) in and one (patient) out and we already have one (patient) in on transit." RT 1 further stated he did not have knowledge that when the door to the CT scan opens the scanner will stop. RT 1 stated if the door opens during scanning the concern is radiation because scanning is on.
During an interview on 5/22/24 at 11:07 a.m. with the Manager of the Emergency Department (MED) 2, MED 2 confirmed the emergency room hallway are used by the emergency department patients, visitors, and staff. ED patient uses the restroom few doors down and across from CT double door.
During a concurrent observation and interview on 5/22/24 at 11:12 a.m. with the Director of Business Development in front of the double door of the CT room within the ED hallway, the CT double door opened when the automatic door push plate on the left side of the door was pressed, overriding the locking mechanism on the door.
During an interview on 5/22/24 at 1:22 p.m. with the Senior Project Manager stated there is an interlock mechanism installed in the CT room door that will shut down the CT scan when the door is open.
During an interview on 5/23/24 at 1:17 p.m., the Executive Director, Performance Excellence (EDPE) stated the facility contacted the representative for the CT unit located in the ED, and she was informed the interlock mechanism was not activated. The representative from the CT scan manufacturer tested the door, and the scanner did not shut down.
During an interview on 5/23/24 at 1:55 p.m. with the physicists and Radiation Safety Officer (Phys 1), Phys 1 stated when a person enters the CT room when the CT is scanning, there will be radiation exposure. Phys. 1 further stated that the expectation is that when an interlocked mechanism is in place, it should be connected and working.
During a review of the facility's policy and procedure (P&P) titled, "Radiation Safety Policy," dated September 2023, the P&P indicated, "To assure all members of the public and care delivery team are properly protected from ionizing radiation commensurate with the scope and extent of the use of Xray producing equipment within the facility. Properly designed facilities allow for a much higher degree of safety than can be obtained by dependence on administrative rules and procedures in inadequate facilities... While good design can never eliminate the possibility of accidental radiation exposure, the possibility and magnitude of such accidents can be greatly reduced. Proper facility design is also the most effective approach in reducing unnecessary occupational exposures. Proper attention to the radiation protection and control aspects of facility design can also minimize operating difficulties imposed because of radiation exposure or safety problems... Radiological Controls: Additional controls are frequently part of the facility design to protect radiation workers and the public. All such controls are to be observed and followed...Personnel not necessary to the procedure are removed from the room during the Xray exposures."
Tag No.: A0537
Based on observation, interview, and record review, the facility failed to:
1. Ensure one of two sampled metal joint of the arm that holds the body of a power injector (device use to inject a substance into the body in order to improve the visibility of internal structure during a procedure that uses a type of high-energy radiation) in the computerized tomography scan (CT, a diagnostic imaging procedure that uses a combination of electromagnetic radiation [energy that comes from a source and travels through space] with high energy to produce images of the inside of the body) room did not separate leaving about a centimeter opened gap in accordance with the facility policy and procedure.
2. Ensure the ceiling panel above the CT machine of one of two CT room (CT 2) sampled was not lifted leaving about an inch open gap in accordance with the facility policy and procedure.
3. Ensure one of two sampled CT room, (CT 2) on the second floor did not have damage to the wall in accordance with the facility policy and procedure. The wall had a rectangular hole sized about two inches by five inches where portions of the drywall hung loosely from. The hole was located in the lower portion of the wall towards the molding where additional linear breakage where the paint in this lower portion was scraped revealing more drywall.
These deficient practices posed a risk of infection and injury to patients and staff. The gap in the ceiling could pose a risk of falling debris or particles. There is potential contamination of the injector due to the open gap, which can lead to patients developing infections. The handle of the injector may fall completely apart during the procedure when the handle is being adjusted and manipulated. The gap in the ceiling could pose a risk of falling debris or particles, potentially causing harm to both patients and staff. The damage wall to the CT room may expose patients and staff to radiation leaks when it is not inspected, monitored, and maintained.
Findings:
1.During a concurrent observation and interview on 5/22/24 at 11:35 a.m. with the Radiology technician (RT) 3 and Executive Director, Performance Excellence (EDPE) in the CT room on the second floor, the metal joint of the arm that holds the body of a power injector (device use to inject a substance into the body in order to improve the visibility of internal structure during a procedure that uses a type of high-energy radiation) was observed separated leaving about a centimeter opened gap. RT 3 stated for equipment that has gap, staff will place a work order (a paper or digitized document that provides request for maintenance details on equipment, tools, or jobs) so it would get fix. RT 3 stated he was not aware that a work order has been entered.
During an interview on 5/23/24 at 10:15 a.m. with the Director of Facilities (DF), DF stated the power injector in the CT room on the 2nd floor has been fixed permanently. DF stated staff from his department will check and monitor doors, negative pressure rooms, hazard in corridor, lighting, water temperature and critical areas , "but we don't look at that equipment, this is not for facilities to maintain"
During a review of the facility's policy and procedure (P&P) titled, "Medical Equipment management Plan (MEMP)," dated 3/14/2024 the P&P indicated, "The MEMP has been designed, established, and implemented to ensure appropriate utilization of medical equipment and effectively reduce the risk of patient, visitor and/or staff injury by:
Selecting and acquiring medical equipment that meets the needs of the facility, Incorporating a process of assessment to minimize the physical risk of equipment through inspections, testing and maintenance. Incorporating effective monitoring and follow-up on equipment hazard notices, recalls, and incidents involving equipment management problems, failures...Organizational Responsibility: Clinical Engineering (CE) is responsible Developing, reviewing, and maintaining the MEMP and supporting policies. Ensuring the MEMP is carried out at each Hospital, Medical Center, and accredited satellite location. Educating CE Managers on the MEMP and related policies... How to obtain repair services. Clinical users are informed during orientation how to obtain repair services from CE Departments. Clinical Department managers ensure that staff members are trained on procedures for requesting equipment repair services..."
During a review of the facility's policy and procedure (P&P) titled, "Work Order Processing Procedure," dated December 1999, the P&P indicated, "To ensure appropriate routing and response to emergency calls, routine repair, and corrective maintenance requiring schedule. Urgent Requests:
Emergency requests shall be requested via the switchboard operator. These requests will be accepted only under the following conditions:
a. A condition exists with potential to adversely affect the safety of the environment of any patient, visitor, or staff member.
b. A condition exists that needs to be corrected within 5 minutes, e.g. flood situations, smoking, or burned electrical receptacle.
Work Request: Work order request forms shall be filled out for any request that does not require attention within 24 hours. These requests include but no limited to desk adjustments, hanging of pictures, bulletin boards and other repairs. Also use the work order request form for minor construction requests (projects less than $1000 in scope) such as; adding a shelf, adding an electric outlet..."
2. During a concurrent observation and interview on 5/22/24 at 11:35 a.m. with the Radiology technician (RT) 3 and Executive Director, Performance Excellence (EDPE) in the CT room on the second floor, the ceiling panel above the CT machine was lifted, there was an opened gap about an inch between the ceiling frame and the ceiling panel. RT 3 stated he is unsure why the ceiling was lifted. RT3 confirmed that the ceiling should not be lifted and stated a work order should have been place when staff observed a ceiling panel is open.
During an interview on 5/23/24 at 10:15 a.m. with the Director of Facilities (DF), DF stated he is not sure why the ceiling panel was open; maybe someone open the ceiling panel to fix something and didn't close it properly.
During a review of the facility "Safety Surveillance Survey," dated 4/3/24 (more than 48 days has passed) listed under "Item Inspected - Ceiling tiles are present and free of water marks or breakage" this area was left blank, there was no check mark indicating yes or no incompliance.
During an interview on 5/24/24 at 9:20 a.m. and on 5/24/24 at 10:20 a.m. with the Executive Director, Performance Excellence (EDPE), requested the facility's policy and procedure on environmental care and maintenance, such as checking ceiling tiles. The EDPE did not provide the policy and procedure.
3. During a concurrent observation and interview on 5/22/24 at 11:35 a.m. with the Radiology technician (RT) 3 and Executive Director, Performance Excellence (EDPE) at the entrance to the CT room on the second floor, the outside wall on the right of the CT had damages. There was a large cabinet about six feet tall and about five feet wide placed against this wall leaving a gap about 12 inches between the cabinet and the wall. In this gap an emergency shut off valve for oxygen and vacuum is located. Below this gab, the wall had a rectangular hole sized about two inches by five inches where portions of the drywall hung loosely from. The hole was located in the lower portion of the wall towards the molding in three feet by four-inch area of additional linear breakage where the paint in this lower portion was scraped revealing more drywall. RT3 stated he is unsure if a work order has been requested for the wall damage.
During an interview on 5/23/24 at 9:30 a.m. With the Interim Director of Radiology (IDR), IDR stated he is unsure if a work order for the damage wall to the CT on the second floor was requested; however, stated the wall is now (on 5/23/24) being repair.
During an interview on 5/23/24 at 10:15 a.m. with the Director of Facility (DF), DF stated the wall to the CT room on the second floor has been repaired and the painting process would start today. DF stated, "The (wall's) lead barrier to the wall was not damage." DF stated, "All staff are responsible to put in a work order if they notice something (equipment or area requiring repair), the entire team will tract it." DF stated, "The expectation is the core leaders will report any door, window, or structure issues."
During a review of the facility's policy and procedure (P&P) titled, "Medical Equipment management Plan (MEMP)," dated 3/14/2024 the P&P indicated, "The MEMP has been designed, established, and implemented to ensure appropriate utilization of medical equipment and effectively reduce the risk of patient, visitor and/or staff injury by:
Selecting and acquiring medical equipment that meets the needs of the facility, Incorporating a process of assessment to minimize the physical risk of equipment through inspections, testing and maintenance. Incorporating effective monitoring and follow-up on equipment hazard notices, recalls, and incidents involving equipment management problems, failures...Organizational Responsibility: Clinical Engineering (CE) is responsible Developing, reviewing, and maintaining the MEMP and supporting policies. Ensuring the MEMP is carried out at each Hospital, Medical Center, and accredited satellite location. Educating CE Managers on the MEMP and related policies... How to obtain repair services. Clinical users are informed during orientation how to obtain repair services from CE Departments. Clinical Department managers ensure that staff members are trained on procedures for requesting equipment repair services..."
During a review of the facility's policy and procedure (P&P) titled, "Work Order Processing Procedure," dated December 1999, the P&P indicated, "To ensure appropriate routing and response to emergency calls, routine repair, and corrective maintenance requiring schedule. Urgent Requests: Emergency requests shall be requested via the switchboard operator. These requests will be accepted only under the following conditions:
a. A condition exists with potential to adversely affect the safety of the environment of any patient, visitor, or staff member.
b. A condition exists that needs to be corrected within 5 minutes, e.g. flood situations, smoking, or burned electrical receptacle.
Work Request: Work order request forms shall be filled out for any request that does not require attention within 24 hours. These requests include but no limited to desk adjustments, hanging of pictures, bulletin boards and other repairs. Also use the work order request form for minor construction requests (projects less than $1000 in scope) such as; adding a shelf, adding an electric outlet..."
Tag No.: A0701
Based on observation, interview, and record review, the facility failed to ensure one of the two sampled emergency shut-off valves (Shut-Off Valve 1), an emergency oxygen and vacuum shut-off valve, was not blocked by a large cabinet, so in an emergency situation, the shut-off valve is visible and accessible.
This deficient practice prevented the door of the emergency shut-off valve from opening to access the shut-off valve in the event of an emergency situation, putting the safety of patients and employees in jeopardy.
Findings:
During a concurrent observation and interview on 5/22/24 at 11:35 a.m. with the Radiology technician (RT) 3 and Executive Director, Performance Excellence (EDPE) at the entrance to the CT room on the second floor, the outside wall on the right of the CT had damages. There was a large cabinet about six feet tall and about five feet wide placed against this wall leaving a gap about 12 inches between the cabinet and the wall. In this gap an emergency shut off valve (Shut-Off Valve 1) for oxygen and vacuum is located in the center of this wall. RT 3 stated he was unsure how long the cabinet was placed in front of the emergency shut off valve and was unsure of the reason of the cabinet being placed there.
During an interview on 5/23/24 at 10:15 a.m. with the Director of Facility (DF), DF stated the cabinet that was placed in front of the emergency shut off valve was an empty cabinet. DF stated the shut off valve is a shut off valve for oxygen and vacuum. DF further stated, "The cabinet should not have been placed there, there should be a clearance of 18 inches from the emergency shut off valve."
During a review of the facility's policy and procedure (P&P) titled, "Failure of Bulk Oxygen and Air," dated May 2024, the P&P indicated, "In the event of an unplanned shut down where the alarm system for oxygen and/or compressed air sounds, call engineering and immediately supply your patients on ventilators and oxygen with H or E tanks. The Shut off valves will be closed by the Respiratory Care Practitioners once they have back filled each area...For intensive care areas, pull the shut off valves for air and/or oxygen and plug in the H-Tank to the wall outlet at appropriate intervals depending on how many ventilators are being used."