HospitalInspections.org

Based on TEAMNET record review, work order review, administrative record review, asset snapshot review, policy and procedure review, observation, and staff interview the facility failed to have reliable safe equipment for 2 machines used in surgery, 1 operating room (OR) Anesthesia machine serial DRUL-0062 failed 5 times since 12/31/2023, and the nerve monitoring system (NIM) machine had failed twice during surgery. The facility failed to have a cleanable surface for OR 10 fixed table base. This failed practice caused patients preventable prolonged anesthesia time and has the potential to cause harm or death to all patients who present to the facility for surgery. The facility census was 340 on entrance.

The Standard cited A0951 also resulted in the Condition of Participation for Surgical Services to be not met.

The Condition is not met as evidenced by:

A. Review of TEAMNET (incident/equipment) request 570618 from 12/31/2023 revealed the Anesthesia machine (life sustaining equipment used in surgery) in OR 9, "not reading End Tidal Carbon Dioxide (ETCO2) and end tidal gas capabilities," (monitors gas exchange in the lungs while the patient is asleep in surgery) that required biomed (certified engineers) to call Drager [manufacturer] for machine malfunction assistance during the case while a patient was connected to the machine on 12/31/2023 at 11:53AM. See work order 61-1876894.

Review of TEAMNET request 571504 from 1/4/2024 revealed the Anesthesia machine in OR 9, "not reading ETCO2 and end tidal gas capabilities," that required biomed to call Drager [manufacturer] for assistance. See work order 61-18782297.

Review of TEAMNET request 577858 from 2/6/2024 at 8:00AM revealed the Anesthesia machine in OR 9, "The multi gas analyzer has been intermittently failing and gives no values but corrects itself ....but still needs to be inspected as it has failed critically and abruptly many times in the past." See work order 61-18967579.

Review of TEAMNET request 583282 from 3/4/2024 revealed the Anesthesia machine in OR 9, "The ventilator (life sustaining machine that provides breathing for the patient while they are asleep for surgery) will not pass a leak test. All disposables (circuits, soda lines, tan hose, etc.) were changed out several times and the machine passed the compliance and systems test, but not the ventilator." See work order 61-19029928.

B. Review of work order 61-18776894 from 12/31/2023 revealed the Scio four oxi plus (a part on the anesthesia machine that measures gas concentrations in the breathing circuit to help avoid under or overdosage of medicine used to put the patient to sleep during surgery) serial ASBA-0013 was replaced on the OR 9 Anesthesia machine on 12/31/2023.

Review of work order 61-18782297 from 1/5/2024 revealed the Anesthesia machine was pulled from OR 9 and put into storage on 2/14/2024 at 12:15PM [1 month and 9 days after submitted].

Review of work order 61-108059 from 1/18/2024 revealed the Vapor 2000 Sevoflurane (a part on the anesthesia machine that delivers an accurate, adjustable concentration of inhaled medicine used to put the patient to sleep during surgery) serial ASMA-0283 was not tested by Drager [manufacturer] until 3/1/2024 for Anesthesia machine in OR 9.

Review of work order 61-18967579 revealed on 2/9/2024 the data cable was replaced by Tech-A who noticed the network cable for the dock station was frayed in several places and taped, which was replaced for Anesthesia machine in OR 9.

Review of work order 61-19029928 revealed on 3/5/2024 Tech-B replaced a hose on the Anesthesia machine in OR 9 ventilator serial DRUL-0062, leak test on ventilator passed (test to determine if the machine is functioning properly).

C. Review of administrative record revealed OR 9 Anesthesia machine CO2 analyzer failed 2/5/2024 and 2/6/2024, removed from service 2/6/2024 after a meeting was held and determined the manufacturer Tech-C would evaluate anesthesia machines 1, 6, 9, 10, 11 and 12 for a second opinion. OR 9 Anesthesia machine was cleared for use by Tech-D and senior leadership and put back into service 3/1/2024 at 8:53AM.

D. Review of Asset Snapshot NIM machine (allows surgeons to identify, confirm and monitor motor nerve function to reduce the risk of nerve damage during surgery) Serial #1NN3-0392 revealed 1/10/2024 the NIM machine was not working, Tech-G called manufacturer about the issue, repaired. On 2/12/2024 the NIM machine monitor was not working. Tech-G set up the return to the manufacturer on 3/5/2024.

E. Review of policy, "Environmental Cleaning in Operating Rooms, Sterile Processing Departments, and Procedural Areas (Last approved 4/2023)," revealed, "Clean: The absence of visible dust, soil, debris, blood, or other potentially infectious material."

F. During observation of Operating Room (OR) number 10 on 3/7/2024 at 10:23AM with RN-A revealed the fixed urology table base and lining was rusted and appeared to be painted over, not a cleanable surface. Confirmed by RN-A. Photograph obtained and attached.

G. During an interview with Tech-E and Tech-F 3/6/2024 at 2:45PM revealed Biomedical staff are certified engineers, and complete annual competencies by a manager who is credentialed in clinical engineering (CE). Only certified Drager CE techs work on Drager equipment. If equipment issues cannot be resolved by the CE tech assigned, the CE tech will reach out to other facility CE techs to service internal. If another CE tech cannot resolve the issue, then they call the manufacturer to service the equipment.

During an interview on 3/7/2024 at 12:59PM, the Chief Medical Officer (CMO) confirmed was aware of OR 10 fixed table requires replacement, on the list and the national team is completing an onsite equipment assessment next week.

During an interview on 3/7/2024 at 12:59PM RN-C could not recall if aware of OR 10 fixed table rust, and not a cleanable surface.

During an interview on 3/7/2024 at 1:21PM with RN-A and RN-B, both confirmed OR 9 Anesthesia machine serial DRUL-0062 Co2 analyzer had failed four times, and the ventilator once since December 2023. Surgical equipment issues are a daily occurrence that require perioperative staff to search for equipment that works to get them through the day. The NIM machine failed twice when doctors needed in surgery and required staff to go to the Ambulatory Surgical Center (ASC) to get a new NIM machine, plug it in and recalibrate prior to use for the patient, which caused the patient to be under anesthesia longer. The NIM machine was sent twice to manufacture, and the facility currently has a loaner. RN-A and RN-B revealed aware of OR 10 fixed urology table rust, not a cleanable surface and had quotes for construction and new table. RN-B was told must prioritize equipment replacement needs due to budget restraints.

Based on TEAMNET record review, work order review, administrative record review, asset snapshot review, policy and procedure review, observation, and staff interview the facility failed to have reliable safe equipment for 2 machines used in surgery, 1 operating room (OR) Anesthesia machine serial DRUL-0062 failed 5 times since 12/31/2023, and the nerve monitoring system (NIM) machine had failed twice during surgery. The facility failed to have a cleanable surface for OR 10 fixed table base. This failed practice caused patients preventable prolonged anesthesia time and has the potential to cause harm or death to all patients who present to the facility for surgery. The facility census was 340 on entrance.

The condition cited A0940 also resulted in the Condition of Participation for Surgical Services to be not met.

Findings Include:

A. Review of TEAMNET (incident/equipment) request 570618 from 12/31/2023 revealed the Anesthesia machine (life sustaining equipment used in surgery) in OR 9, "not reading End Tidal Carbon Dioxide (ETCO2) and end tidal gas capabilities," (monitors gas exchange in the lungs while the patient is asleep in surgery) that required biomed (certified engineers) to call Drager [manufacturer] for machine malfunction assistance during the case while a patient was connected to the machine on 12/31/2023 at 11:53AM. See work order 61-1876894.

Review of TEAMNET request 571504 from 1/4/2024 revealed the Anesthesia machine in OR 9, "not reading ETCO2 and end tidal gas capabilities," that required biomed to call Drager [manufacturer] for assistance. See work order 61-18782297.

Review of TEAMNET request 577858 from 2/6/2024 at 8:00AM revealed the Anesthesia machine in OR 9, "The multi gas analyzer has been intermittently failing and gives no values but corrects itself ....but still needs to be inspected as it has failed critically and abruptly many times in the past." See work order 61-18967579.

Review of TEAMNET request 583282 from 3/4/2024 revealed the Anesthesia machine in OR 9, "The ventilator (life sustaining machine that provides breathing for the patient while they are asleep for surgery) will not pass a leak test. All disposables (circuits, soda lines, tan hose, etc.) were changed out several times and the machine passed the compliance and systems test, but not the ventilator." See work order 61-19029928.

B. Review of work order 61-18776894 from 12/31/2023 revealed the Scio four oxi plus (a part on the anesthesia machine that measures gas concentrations in the breathing circuit to help avoid under or overdosage of medicine used to put the patient to sleep during surgery) serial ASBA-0013 was replaced on the OR 9 Anesthesia machine on 12/31/2023.

Review of work order 61-18782297 from 1/5/2024 revealed the Anesthesia machine was pulled from OR 9 and put into storage on 2/14/2024 at 12:15PM [1 month and 9 days after submitted].

Review of work order 61-108059 from 1/18/2024 revealed the Vapor 2000 Sevoflurane (a part on the anesthesia machine that delivers an accurate, adjustable concentration of inhaled medicine used to put the patient to sleep during surgery) serial ASMA-0283 was not tested by Drager [manufacturer] until 3/1/2024 for Anesthesia machine in OR 9.

Review of work order 61-18967579 revealed on 2/9/2024 the data cable was replaced by Tech-A who noticed the network cable for the dock station was frayed in several places and taped, which was replaced for Anesthesia machine in OR 9.

Review of work order 61-19029928 revealed on 3/5/2024 Tech-B replaced a hose on the Anesthesia machine in OR 9 ventilator serial DRUL-0062, leak test on ventilator passed (test to determine if the machine is functioning properly).

C. Review of administrative record revealed OR 9 Anesthesia machine CO2 analyzer failed 2/5/2024 and 2/6/2024, removed from service 2/6/2024 after a meeting was held and determined the manufacturer Tech-C would evaluate anesthesia machines 1, 6, 9, 10, 11 and 12 for a second opinion. OR 9 Anesthesia machine was cleared for use by Tech-D and senior leadership and put back into service 3/1/2024 at 8:53AM.

D. Review of Asset Snapshot NIM machine (allows surgeons to identify, confirm and monitor motor nerve function to reduce the risk of nerve damage during surgery) Serial #1NN3-0392 revealed 1/10/2024 the NIM machine was not working, Tech-G called manufacturer about the issue, repaired. On 2/12/2024 the NIM machine monitor was not working. Tech-G set up the return to the manufacturer on 3/5/2024.

E. Review of policy, "Environmental Cleaning in Operating Rooms, Sterile Processing Departments, and Procedural Areas (Last approved 4/2023)," revealed, "Clean: The absence of visible dust, soil, debris, blood, or other potentially infectious material."

F. During observation of Operating Room (OR) number 10 on 3/7/2024 at 10:23AM with RN-A revealed the fixed urology table base and lining was rusted and appeared to be painted over, not a cleanable surface. Confirmed by RN-A. Photograph obtained and attached.

G. During an interview with Tech-E and Tech-F 3/6/2024 at 2:45PM revealed Biomedical staff are certified engineers, and complete annual competencies by a manager who is credentialed in clinical engineering (CE). Only certified Drager CE techs work on Drager equipment. If equipment issues cannot be resolved by the CE tech assigned, the CE tech will reach out to other facility CE techs to service internal. If another CE tech cannot resolve the issue, then they call the manufacturer to service the equipment.

During an interview on 3/7/2024 at 12:59PM, the Chief Medical Officer (CMO) confirmed was aware of OR 10 fixed table requires replacement, on the list and the national team is completing an onsite equipment assessment next week.

During an interview on 3/7/2024 at 12:59PM RN-C could not recall if aware of OR 10 fixed table rust, and not a cleanable surface.

During an interview on 3/7/2024 at 1:21PM with RN-A and RN-B, both confirmed OR 9 Anesthesia machine serial DRUL-0062 Co2 analyzer had failed four times, and the ventilator once since December 2023. Surgical equipment issues are a daily occurrence that require perioperative staff to search for equipment that works to get them through the day. The NIM machine failed twice when doctors needed in surgery and required staff to go to the Ambulatory Surgical Center (ASC) to get a new NIM machine, plug it in and recalibrate prior to use for the patient, which caused the patient to be under anesthesia longer. The NIM machine was sent twice to manufacture, and the facility currently has a loaner. RN-A and RN-B revealed aware of OR 10 fixed urology table rust, not a cleanable surface and had quotes for construction and new table. RN-B was told must prioritize equipment replacement needs due to budget restraints.