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Based on review of staff files and policies and procedures and interviews with staff, facility failed to provide a safe environment for patients.

The findings included:

a. Review of staff human resources files on 5/28/13 at approximately 1:30 pm in the administration conference room at Mission Trails Baptist Hospital, found that (S1-S4) human resources files all contained expired annual competencies, 3 of 4 files reviewed had last training as being completed in July of 2010 and 1 of 4 files had last training completed in March of 2010. The Infection Control and Sterile processing policy requires annual recertification on all competencies and staff had not completed required annual competencies in over 3 years.

b. Review of policies and procedures on 5/28/13 in the administration conference room, found that facility did not comply with all policies and proceudres.

- Review of policy titled "Infection Control in Sterile Processing" NURS-SS-SP-05, effective date January 2011, with last revision date November 2010, indicated the following information:

Policy Procedure / Guidelines -

- workflow should be designed in efforts to avoid cross-contamination between decontamination and sterilization areas. Facility failed to do this by allowing housekeeping staff to assist with the sterilization process without being trained. Housekeeping staff was involved by removing trays from the sterilizer and by opening sterilizer door when they entered the room, allowing for other staff to just come in and put away the trays on the shelf without documenting sterilizer temperature or indicator tape results in log book.

- Policy states that chemical indicators should be examined after sterilization and also before use of the item to verify that the item has been exposed to the sterilization process. Sterlizization department staff failed to examine chemical indicator tape due to finding trays outside of sterilizer, they assumed that those trays had been completed since housekeeping staff had pulled trays out of the sterilizer. Operating room technician who pulled trays for use from the shelf also failed to examine the indicator tape before use and failed to determine if the trays had been exposed to the sterilization process, allowing for unsterilized instruments to be used on a patient.

- Policy states that personnel working in sterile processing department will receive annual infection prevention education and training. After review of human resources files, found that all 4 files reviewed contained outdated information, all 4 personnel reviewed did not contain the required annual infection prevention prevention training as required by policy. Sterilization Technicians were not adequately trained and had not maintained their competencies as required by facility policy.

b. Review of policy titled "Biological and Performance Testing of the Sterilization Equipment" NURS-SS-SP-06, effective date January 2011, with last revision date November, 2010, indicated the following:

The purpose fo this policy is to provide a process and procedure that ensures the appropriate biological monitoring and performance testing of sterilization equipment. To ensure the effectiveness of the sterilization process.

Policy: sterilizer efficacy is monitored at daily basis each day sterilizer is used.

Procedure: biological indicator test results are read and interpreted by qualified personnel, recorded and then stored in the approved document envelope. Negative results indicate sterilizer is functioning properly, positive results indicate the sterilizer failed to kill the spores. Sterilizer that failed must meet sterilization parameters and taken out of service until fixed by Biomed department. In the event that items from the affected sterilizer have already been distributed, the recall procedure (see Recall Policy, NURS-SS-SP-04) is initiated immediately. The facility failed to comply with all aspects of this policy, housekeeping staff that were not trained or qualifed removed instrument trays from the sterilizer and did not interpret the biological indicator of trays and as a result instruments that were not sterilized were used on a patient. Sterilization Technicians failed to properly monitor the sterilization of equipment as required by policy.

c. Review of policy titled "Recall of In-hospital sterilized items" NURS-SS-SP-04, effective date January 2011, with a revision date of November 2010, indicated the following:

The purpose of this policy is to ensure patient safety, Baptist Health System has developed a process by which items of questionable sterility may be recalled from various units within the facility. This process will expedite the retrieval of processed items that are suspected to be non-sterile and to ensure adequate follow-up actions such as quarantine of sterilizer, notifications of physicians, affected department and surveillance of patients.

The policy also states that the recall procedure shall be followed anytime that a load of sterile instruments or supplies is in question. The recall procedure is initiated as soon as a potential problem is identified.

- The sterile processing technician or the individual who first becomes aware of the situation will immediately notify the Surgery director, Infection prevention and risk management. Staff failed to report as required by policy.

- Staff will complete form BHS 90420001CS Recall Notice, make a copy for sterile processing files, original sent to risk management, all recall notices should be kept in a recall log to show plan of action for correction. Staff failed to do a recall notice as required by policy, and staff also failed to maintain a recall log. The facility failed to follow their policy for recalling instruments that have been identified as not being sterile. During staff interviews, when asked if they were familiar with the process for recalling instruments, all staff were not aware of the required form that had to be completed and were not aware that they were to maintain a recall log.

c. Interview was conducted with the Regional Director of Risk Management on 5/28/13 at approximately 1:45 pm in the administration conference room, and she agreed facitliy failed to comply with policies and procedrues and also agreed that staff had not completed required annual competencies since 2010 and had not completed required annual training as required by facility policy.

Based on review of staff human resources files, policies and procedures and interviews with facility staff, Mission Trails Hospital failed to adhere to nationally recognized standards of practices in infection control aimed at reducing or eliminating bloodborne pathogens and healthcare acquired infections during the steriliztion of equipment.

The findings included:

1. During review of staff human resources files on 28 May, 2013 in the administration conference room, found that 4 out of 4 staff files reviewed did not contain required annual competencies to include infection prevention training as required by hospital policy. The personnel files rvealed that the date of last training completed was June of 2010. One of the staff member is a regional staff member and her training had not been completed since, March of 2010. The annual training covers materials to include responsibilities for reading and documenting sterilizer temperatures and times that are critical to monitor proper sterilization cycle completion. All 4 staff files reveiwed did not contain updated training.

2. During review of facility policies on 28 May, 2013 in the administration conference room, found that the facility failed to comply with its own policies on the steriliztion process.

a. Review of policy titled "Infection Control in Sterile Processing" NURS-SS-SP-05, effective date January 2011, with last revision date November 2010, indicated the following information:

Policy Procedure / Guidelines -

- workflow should be designed in efforts to avoid cross-contamination between decontamination and sterilization areas.

Facility failed to do this by allowing housekeeping staff to assist with the sterilization process without being trained. Housekeeping staff was involved by removing trays from the sterilizer and by opening sterilizer door when they entered the room, allowing for other staff to just come in and put away the trays on the shelf without documenting sterilizer temperature or indicator tape results in log book.

- Policy states that chemical indicators should be examined after sterilization and also before use of the item to verify that the item has been exposed to the sterilization process.

Sterlization department staff failed to examine chemical indicator tape due to finding trays outside of sterilizer, they assumed that those trays had been completed since housekeeping staff had pulled trays out of the sterilizer. Operating room technician who pulled trays for use from the shelf also failed to examine the indicator tape before use and failed to determine if the trays had been exposed to the sterilization process, allowing for unsterilized instruments to be used on a patient.

- Policy states that personnel working in sterile processing department will receive annual infection prevention education and training.

After review of human resources files, found that all 4 files reviewed contained outdated information, all 4 personnel reviewed did not contain the required annual infection prevention prevention training as required by policy. Sterilization Technicians were not adequately trained and had not maintained their competencies as required by facility policy.

b. Review of policy titled "Biological and Performance Testing of the Sterilization Equipment" NURS-SS-SP-06, effective date January 2011, with last revision date November, 2010, indicated the following:

The purpose fo this policy is to provide a process and procedure that ensures the appropriate biological monitoring and performance testing of sterilization equipment. To ensure the effectiveness of the sterilization process.

Policy: sterilizer efficacy is monitored at daily basis each day sterilizer is used.

Procedure: biological indicator test results are read and interpreted by qualified personnel, recorded and then stored in the approved document envelope. Negative results indicate sterilizer is functioning properly, positive results indicate the sterilizer failed to kill the spores. Sterilizer that failed must meet sterilization parameters and taken out of service until fixed by Biomed department. In the event that items from the affected sterilizer have already been distributed, the recall procedure (see Recall Policy, NURS-SS-SP-04) is initiated immediately.

The facility failed to comply with all aspects of this policy in that housekeeping staff that were not trained or qualifed removed instrument trays from the sterilizer and did not interpret the biological indicator of trays and as a result instruments that were not sterilized were used on a patient. Sterilization Technicians failed to properly monitor the sterilization of equipment as required by policy.

c. Review of policy titled "Recall of In-hospital sterilized items" NURS-SS-SP-04, effective date January 2011, with a revision date of November 2010, indicated the following:

The purpose of this policy is to ensure patient safety, Baptist Health System has developed a process by which items of questionable sterility may be recalled from various units within the facility. This process will expedite the retrieval of processed items that are suspected to be non-sterile and to ensure adequate follow-up actions such as quarantine of sterilizer, notifications of physicians, affected department and surveillance of patients.

The policy also states that the recall procedure shall be followed anytime that a load of sterile instruments or supplies is in question. The recall procedure is initiated as soon as a potential problem is identified.

- The sterile processing technician or the individual who first becomes aware of the situation will immediately notify the Surgery director, Infection prevention and risk management. Staff failed to report as required by policy.

- Staff will complete form BHS 90420001CS Recall Notice, make a copy for sterile processing files, original sent to risk management, all recall notices should be kept in a recall log to show plan of action for correction.

Staff failed to do a recall notice as required by policy, and staff also failed to maintain a recall log. The facility failed to follow their policy for recalling instruments that have been identified as not being sterile. During staff interviews, when asked if they were familiar with the process for recalling instruments, all staff were not aware of the required form that had to be completed and were not aware that they were to maintain a recall log.

3. Facility staff were interviewed on 28 May, 2013 in the administration conference room. Quality assurance staff agreed that the sterilization process had not been completed as required by policy and standard operating procedures. All Sterlization department staff interviewed stated they failed to monitor the effectiveness of sterilization by not reading the indicator strip on the packages as they pulled them out of the autoclave. During interview with Staff #2, she stated she failed to record the temperature or other information from the sterilizer strip as required, she stated that she started the sterilizer late in the evening and walked out to go home and came back the next morning and assumed the sterilizing process was complete. She stated that housekeeping staff helped by pulling trays out of the sterilzer when they came in to do their cleaning duties and would set them aside and then the sterilizing department staff would put them away on the shelves.