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Based on observation, staff interview, facility document review, a focused review of the clinical records for seven (7) patients, and during the course of a complaint investigation, the facility staff failed to ensure the infection control program included the identification of all equipment which could be a potential source of infection, and that the equipment was being cleaned according to the manufacturers recommended guidelines to prevent potential transmission of disease/infection.

The findings include:

Staff interviews indicated the staff did not know, and policy and procedure did not address, the manufacturers's guidelines for the cleaning of the injector module of the iNOmax DS-ir Plus nitric oxide delivery system. It was during surveyor questions regarding the cleaning of this part of the equipment, and surveyor reference to the manufacturer's operation manual, that the facility staff acknowledged the equipment was not being properly cleaned after patient use.

Please refer to V749 for further information.

Based on observation, staff interview, facility document review, and focused clinical record review of seven (7) patients, the facility staff failed to ensure the manufacturers guidelines for the cleaning and disinfection of equipment was followed.

The facility failed to clean and disinfect the injector module per the manufacturer's guidelines for the iNOmax DS-ir Plus nitric oxide delivery system.

The findings included:

During a tour of the facility on 6/12/18 at at 10:10 a.m., the surveyor was unable to identify any patients currently receiving the "nitric" therapy. The surveyor requested a list of patients currently in the facility who were receiving treatment with the iNOMAX system, however, there were no patients currently receiving this treatment according to Staff Member #1 (Quality and regulatory Coordinator).

The iNOMAX DS is a delivery system used to deliver INOMAX (nitric oxide gas) by inhalation. Nitric oxide, the active substance in INOMAX, is a pulmonary vasodilator. INOMAX is a gaseous blend of nitric oxide and nitrogen (0.08% and 99.92%, respectively for 800 ppm).www.drugs.com/FDA prescribing information.

The facility Respiratory Care Policy and Procedure (facility review 2/12/18) "Inhaled Nitric Oxide", documented this drug (inhaled gas) is used with patients who have "demonstrable pulmonary hypertension (a condition in which high blood pressure affects the arteries of the lungs and the right side of the heart)". According to the FDA (Food and Drug Administration) prescribing information, this drug can also be used to "improve oxygenation in term and near-term neonates (newborns) with hypoxic (oxygen deficient) respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents."

On 6/12/18 at 11:15 a.m., the surveyor interviewed Staff Member #5 (Respiratory Care Director), Staff Member #6 (Respiratory Care Manager), and Staff Member #7 (Respiratory Care Education Coordinator) regarding the use and cleaning of the iNOMax delivery system. Staff Member #7, stated he/she is responsible for training the staff to operate and clean the equipment. Staff Member #5 stated, "The equipment vendor comes in and does the education for our staff on how to operate and maintain the equipment. The modules (iNoMax Delivery systems) we have currently are relatively new; we have had them about eighteen months. " The surveyor inquired as to the last time the vendor had been to the facility to provide education/training for staff. Staff Member #5 stated, "I will get that information for you, but I think it was about two years ago." The surveyor also requested a list of staff who had participated in this training as well as the full content of the training that was presented by the vendor. At that time, the surveyor requested the staff explain to the surveyor how the iNOMax was to be cleaned. Staff Member # 7 stated, "The equipment is wiped down on the unit (in the patient care area where it was used) at the bedside and then brought down here to the respiratory department and placed on the "dirty" side of the room, where we don PPE (Personal Protective Equipment) and clean it again. Once cleaned, the equipment is bagged and moved to the clean area where it is ready for use. The RT (Respiratory Therapist) that pulls the equipment is the one who brings it down and cleans it..." The surveyor inquired as to what was used to clean the equipment. Staff Member #5 stated, "The purple top cleaning wipes".

The surveyor inquired as to where the injector module was located on the module and how that specific part was to be cleaned. Staff Member #7 pointed out to the surveyor the injector module which was connected to the module by tubing and located on the side of the machine in a clear plastic bag. Staff Member #7 stated, "The injector module hooks on the "dry side" of the circuit where there is no heated or humidified air going through it. It is connected to the ventilator to deliver the nitric gas... It is wiped down with the purple top wipe for the wet time recommended . It is wiped down at the bedside and then wiped down again when it is brought down here." The surveyor requested a copy of the directions for use for the "purple top cleaning cloths" as well as a copy of the manufacture's directions for use and cleaning of the iNOMax and injector module and the operation manual.

The surveyor reviewed the "Safety Data Sheet" for the "Super Sani-Cloth Germicidal Wipe" (Purple Top cloths). According to this information the following was evidenced, in part: "...Recommended use: Use as a disinfectant on hard, non-porous surfaces..." According to the manufacturer of the wipe (PDI) the wipes are "effective against 30 (thirty) microorganisms in 2 (two) minutes)" (https://pdihc.com/all-products/super-sani-cloth).

Staff Member # 5 provided the surveyor with a copy of "Cleaning the INOmax DS-ir" pages 7-2 through 7-4, which evidenced the following, in part, "...External Surfaces and the Display Panel...Clean the outer surface of the INOmax DS-ir with a soft cloth dampened in a mild soap and water solution, isopropyl alcohol (70%) or with one of the following cleaning agents while following the manufacturers recommendations." Listed in the table of cleaning agents was the "PDI Super Sani Cloth- by PDI".

In this information, there was no reference to the cleaning of the injector module. The surveyor then referred to the operation manual (INOmax DS-ir Plus- Operation Manual [800 ppm (parts per million) INOMAX (nitric oxide) for inhalation] Series 3 software - part No. 20530 Rev-03 2014-07) on page 7-5 which documented "Injector Module Sterilizing and/or Disinfecting"- WARNING: If the injector module was used in the wet/humidified part of the breathing circuit, it should be sterilized between each patient use...If the injector module has been used in the dry part of the breathing circuit, the injector module should be sterilized and/or disinfected in 70% ethyl alcohol after each patient use..."

On 6/12/18 at 1:00 p.m., the surveyor interviewed Staff Member #5 regarding the information in the operation manual regarding the cleaning of the injector module. Staff Member #5 stated, "I had no idea we were supposed to do that...we have been wiping it off, but were not aware we were supposed to clean it that way. The vendor did our training and they did not tell us that...I will go back and look and see if it is in our on-line training modules." The surveyor also requested the information regarding staff training , as to when the training was done and staff participation as well as the content of the training.

On 6/12/18 at 3:00 p.m., Staff Member #18 (Director of Quality and Infection Control) stated, "When the education was done several years ago, the vendor did the teaching...the last training was two years ago and we do not have those records. When we received the new machines, the vendor never said anything about the autoclaving or disinfection of the injector module. We are reaching out to the vendor and the manufacturer..we went to the on-line education materials and they do not say anything about the cleaning at all...we have removed all the injector modules, we have six, and are sending them to be autoclaved. We will institute going forward, that no vendor can do education until Infection Prevention and the Department Head has reviewed the training to ensure it is correct and follows the appropriate infection control procedures and cleaning guidelines per the manufacturers recommendations. We will make sure we have a copy of whatever they are presenting with an attached sign-in sheet for our records..." At 3:40 p.m., Staff Member #5 stated, "They (vendor) stopped doing the injector module training in their education. They gave us computerized training which did not include the injector module cleaning. We had no idea we were to clean it like this until now...we do not have any copies of the training that was provided the last time they (vendor) was here...I am going to read every manual to make sure the vendor is giving us the correct training and not leaving anything out..."

During the complaint investigation, the survey team reviewed the facility Infection Control Plan as well as the charts of patients who had been ordered the use of the iNOmax "nitric" from December 2017 through current. Culture reports for the patients identified were reviewed and there was no evidence of any infections that could be attributed to the use of the iNoMax device.

The surveyor discussed the findings with Staff Members #18, #5, and #7 on 6/12/18 at at 3:00 p.m. and 3:40 p.m.

The findings were again discussed on 6/13/18 at 11:50 a.m. with Staff Member #18 who stated, "We need to revise our policy and procedures to include the manufacturer's recommended guidelines. We currently do not include that in the policy and procedure. We do have it in the policy and procedure for hospital approved disinfectants but need to do a better job at combining the two so it is covered and not so confusing."

On 6/13/18 at 12:55 p.m., the findings were again discussed with Staff Members # 1, #2, #4, #18 and #34 (CMO).

Based on observation, staff interview and facility document review, the facility staff failed to ensure the policies and procedures for respiratory services, particularly the cleaning of equipment was in accordance with Infection Prevention policies.

The Respiratory Care Services did not have a policy and procedure, nor were trained appropriately on how to clean and disinfect the injector module of the iNOMAX DS "nitric" delivery system.

The findings included:

The facility Respiratory Care Policy and Procedure (facility review 2/12/18) "Inhaled Nitric Oxide", documented this drug (inhaled gas) is used with patients who have "demonstrable pulmonary hypertension (a condition in which high blood pressure affects the arteries of the lungs and the right side of the heart)". According to the FDA (Food and Drug Administration) prescribing information, this drug can also be used to "improve oxygenation in term and near-term neonates (newborns) with hypoxic (oxygen deficient) respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents."

On 6/12/18 at 11:15 a.m., the surveyor interviewed Staff Member 5 (Respiratory Care Director), Staff Member #6 (Respiratory Care Manager), and Staff Member #7 (Respiratory Care Education Coordinator) regarding the use and cleaning of the iNOMax delivery system. Staff Member #7, stated he/she is responsible for training the staff to operate and clean the equipment. Staff Member #5 stated, "The equipment vendor comes in and does the education for our staff on how to operate and maintain the equipment. The modules (iNoMax Delivery systems) we have currently are relatively new; we have had them about eighteen months."

The surveyor inquired as to the last time the vendor had been to the facility to provide education/training for staff. Staff Member #5 stated, "I will get that information for you, but I think it was about two years ago." The surveyor also requested a list of staff who had participated in this training as well as the full content of the training that was presented by the vendor.

At that time, the surveyor requested the staff explain to the surveyor how the iNOMax was to be cleaned. Staff Member # 7 stated, "The equipment is wiped down on the unit (in the patient care area where it was used) at the bedside and then brought down here to the respiratory department and placed on the "dirty" side of the room, where we don PPE (Personal Protective Equipment) and clean it again. Once cleaned, the equipment is bagged and moved to the clean area where it is ready for use. The RT (Respiratory Therapist) that pulls the equipment is the one who brings it down and cleans it..." The surveyor inquired as to what was used to clean the equipment. Staff Member #5 stated, "The purple top cleaning wipes".

The surveyor inquired as to where the injector module was located on the module and how that specific part was to be cleaned. Staff Member #7 pointed out to the surveyor the injector module which was connected to the module by tubing and located on the side of the machine in a clear plastic bag. Staff Member #7 stated, "The injector module hooks on the "dry side" of the circuit where there is no heated or humidified air going through it. It is connected to the ventilator to deliver the nitric gas... It is wiped down with the purple top wipe for the wet time recommended . It is wiped down at the bedside and then wiped down again when it is brought down here." The surveyor requested a copy of the directions for use for the "purple top cleaning cloths" as well as a copy of the manufacture's directions for use and cleaning of the iNOMax and injector module and the operation manual.

Staff Member # 5 provided the surveyor with a copy of "Cleaning the INOmax DS-ir" pages 7-2 through 7-4, which evidenced the following, in part, "...External Surfaces and the Display Panel...Clean the outer surface of the INOmax DS-ir with a soft cloth dampened in a mild soap and water solution, isopropyl alcohol (70%) or with one of the following cleaning agents while following the manufacturers recommendations." Listed in the table of cleaning agents was the "PDI Super Sani Cloth- by PDI". In this information, there was no reference to the cleaning of the injector module. The surveyor then referred to the operation manual (INOmax DS-ir Plus- Operation Manual [800 ppm (parts per million) INOMAX (nitric oxide) for inhalation] Series 3 software - part No. 20530 Rev-03 2014-07) on page 7-5 which documented "Injector Module Sterilizing and/or Disinfecting"- WARNING: If the injector module was used in the wet/humidified part of the breathing circuit, it should be sterilized between each patient use...If the injector module has been used in the dry part of the breathing circuit, the injector module should be sterilized and/or disinfected in 70% ethyl alcohol after each patient use..."

On 6/12/18 at 1:00 p.m., the surveyor interviewed Staff Member #5 regarding the information in the operation manual regarding the cleaning of the injector module. Staff Member #5 stated, "I had no idea we were supposed to do that...we have been wiping it off, but were not aware we were supposed to clean it that way. The vendor did our training and they did not tell us that...I will go back and look and see if it is in out on-line training modules." The surveyor also requested the information regarding staff training , as to when the training was done and staff participation as well as the content of the training.

On 6/12/18 at 3:00 p.m., Staff Member #18 (Director of Quality and Infection Control) stated, "When the education was done several years ago, the vendor did the teaching...the last training was two years ago and we do not have those records. When we received the new machines, the vendor never said anything about the autoclaving or disinfection of the injector module. We are reaching out to the vendor and the manufacturer..we went to the on-line education materials and they do not say anything about the cleaning at all...we have removed all the injector modules, we have six, and are sending them to be autoclaved. We will institute going forward, that no vendor can do education until Infection Prevention and the Department Head has reviewed the training to ensure it is correct and follows the appropriate infection control procedures and cleaning guidelines per the manufacturers recommendations. We will make sure we have a copy of whatever they are presenting with an attached sign-in sheet for our rewords..." At 3:40 p.m., Staff Member #5 stated, "They (vendor) stopped doing the injector module training in their education. They gave us computerized training which did not include the injector module cleaning. We had no idea we were to clean it like this until now...we do not have any copies of the training that was provided the last time they (vendor) was here...I am going to read every manual to make sure the vendor is giving us the correct training and not leaving anything out..."

The hospital document "Policy Manual Infection Prevention - Hospital Approved Disinfectants" last reviewed by the Infection Prevention Committee on 3/26/18, was reviewed by the surveyor and evidenced, in part: "...POLICY STATEMENT: Disinfection and cleaning agents will be approved by Infection Prevention Committee to ensure correct agents are used per manufacturer's instructions and per recommended guidelines..."

The surveyor discussed the findings with Staff Members #18, #5, and #7 on 6/12/ at at 3:00 p.m. and 3:40 p.m.

The findings were again discussed on 6/13/18 at 11:50 a.m. with Staff Member #18 who stated, "We need to revise our policy and procedures to include the manufacturer's recommended guidelines. We currently do not include that in the policy and procedure (respiratory). We do have it in the policy and procedure for hospital approved disinfectants but need to do a better job at combining the two so it is covered and not so confusing."

On 6/13/18 at 12:55 p.m., the findings were again discussed with Staff Members # 1, #2, #4, #18 and #34 (CMO).