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Based on observation, documentation review and staff interview the facility failed to ensure flammable antiseptic preparation applicators and soaked materials were removed from the operating room before the patient is draped or procedure is started in accordance with NFPA 101. (A709) The cumulative effects of this systemic practice resulted in the facility's inability to ensure the safety of all patients receiving surgical services at the facility. The hospital averaged 10,932 surgical cases for FY 2019. The active census was 133.

Findings include:

See A709

Based on observation, interview, and documentation review, the facility failed to meet the requirements for life safety, specifically Chapter 19 of the applicable provisions of the 2012 edition of the Life Safety Code of the National Fire Protection Association 101. This affected one (Patient #6) of one patient observed during a procedure. Record review for seven patients that had flammable antiseptics used for preparation, lacked documentation flammable antiseptic preparation applicators and soaked materials were removed from the operating room before the patient was draped or procedure started. (Patient #3, #4, #5, #6, #7, #8, and #9) This had the potential to affect all patients receiving surgical services at the facility.


Findings include:


Please refer to K933 for findings related to the facility's failure to ensure flammable antiseptic preparation applicators and soaked materials were removed from the operating room before the patient is draped or procedure is started.

Based on review of the infection control plan, record review, and staff interview it was determined the hospital failed to ensure surgical staff effectively monitored the biological/chemical indicators for surgical instruments prior to use. This plan was implemented following an incident in which unsterilized surgical equipment was used on a patient. This affected one patient and has the potential to affect all patients admitted for surgical services.(Patient #1) The hospital averaged 10,932 surgical cases for FY 2019. The active census was 133.

Findings include:

Review of the Infection Control Plan for FY 2020 states the goal of the infection control program is to allow for a systemic, coordinated, and continuous approach to performance improvement, focusing on surveillance, prevention, and control transmission of infections throughout the organization, and ensure the organization has a functioning, coordinated process in place to reduce the risks of healthcare associated infections in patients and exposure to healthcare workers.

Review of the medical record for Patient #1 revealed the patient was admitted on 10/22/19 for a right total hip replacement. It was determined another patient's unsterilized surgical instruments were used for the procedure. The medical record lacked evidence a biological/chemical indicator check was performed to ensure sterility of the surgical instruments prior to the procedure. The patient had no other surgical complications and was discharged to a skilled nursing facility on 10/25/19.

An interview was conducted with the Staff E on 02/03/2020 who reported being notified following the 10/22/19 incident. Patient #1 was notified on 10/22/19 of the operative exposure and potential for infection. The bloodborne exposure plan was followed and laboratory testing conducted. It was confirmed the source patient was negative for HIV, HepB surface AG and Hep C AB. Patient #1 was treated with prophylactic medications and will follow up with infectious disease in four and twelve weeks as per policy.

Staff K, operating room manager, stated in an interview on 02/03/2020 at 3:42 PM following the exposure incident surgery staff are required to complete a surgery check list daily for each surgical case which is monitored by the supervisor. This auditing tool ensures the biological/chemical indicator has been checked prior to a procedure. It was confirmed the surgical check list audits for monitoring did not begin until 01/06/2020. A request was made for the auditing tools to ensure effective monitoring was in place for the biological/chemical indicator checks.

The auditing tool revealed on 02/03/2020 there were 33 surgical cases and only 29 surgical check list audits were returned. Per the audit form, four surgical cases lacked evidence the biological/chemical indicators checks were completed prior to the procedure. It was reported the surgical check list are reviewed and discarded daily with no formal process for monitoring and/or ongoing auditing. Upon request, there were no evidence of the forms being monitored until the day of the survey.

An interview was conducted with the infection control officers on 02/03/20 at 11:00 AM who reported infection control audits are done monthly in surgery. A request was made for evidence of the audits and none were provided.

Based on record review and staff interview it was determined the hospital failed to ensure surgical instruments had proper sterilization prior to surgical procedures and failed to ensure an effective monitoring system was in place that prohibits vendors from having access to the central sterile area. (A951). The cumulative effect of these systemic practices resulted in the hospital's inability to ensure patient safety in the surgical environment. The hospital averaged 10,932 surgical cases for FY 2019. The active census was 133.

Based on record review and staff interview it was determined the hospital failed to ensure surgical instruments had proper sterilization prior to surgical procedures and failed to ensure a monitoring system was in place that prohibits vendors from having access to the central sterile area. This affected one patient and has the potential to affect all patients admitted for surgical services.(Patient #1) The hospital averaged 10,932 surgical cases for FY 2019. The active census was 133.

Findings include:

Review of Policy and Procedure POC-02-126 (Revised 09/30/19) for Instruments Care of and Decontamination for Surgical Services states the purpose of the policy is to promote patient safety by properly decontaminating and caring for all instrumentation. The care, handling, and decontamination of surgical instruments shall follow the recommendations of the manufacturer, FDA guidelines, Association of Perioperative Registered Nurses (AORN), the Association for the Advancement of Medical Instrumentation (AAMI) standards, and central sterile policies and work instructions. Instruments should be inspected prior to, during, and after surgery for alignment, proper function, and evidence of damage. After processing, all instruments are to be put on the appropriate shelving in a clean storage area to go back into rotation. Follow standard decontamination, assembly, and processing of instrumentation based on manufacturer guidelines and facility approved policies and work instructions. Sterilization logs will be maintained via the computerized instrument tracking system or the paper sterilization logs within the department.

Review of the medical record for Patient #1 revealed the patient was admitted on 10/22/19 for a right total hip replacement. It was determined unsterilized surgical instruments from another patient were used for the procedure. The patient had no other surgical complications and was discharged to a skilled nursing facility on 10/25/19.

An interview was conducted with Staff B and J on 02/03/2020 at 9:14 AM who reported on 10/22/19 it was discovered that two unsterilized instrument trays were used on a patient during the replacement of a right hip joint surgery. It was determined a vendor/supplier representative was allowed to gather the wrapped non-sterile trays from central sterile area the morning of the procedure. Following staff training and vendor notification a second "near miss" incident occurred on 01/06/2020 in which a vendor/supplier representative was again allowed to retrieve a non-sterile reconstruction drill from central sterile area contaminating the surgery set-up. During the survey it was determined the hospital lacked a monitoring system in place for vendor access to Central Sterile.

An interview was conducted with the Staff E on 02/03/2020 who reported being notified following the 10/22/19 incident. Patient #1 was notified on 10/22/19 of the operative exposure and potential for infection. The bloodborne exposure plan was followed and laboratory testing conducted. It was confirmed the source patient was negative for HIV, HepB surface AG and Hep C AB. The patient was treated with prophylactic medications and will follow up with infectious disease in four and twelve weeks as per policy.

Staff K, Operating Room manager, stated in an interview on 02/03/2020 at 3:42 PM following the exposure incident surgery staff are required to complete a surgery check list daily for each surgical case which is monitored by the supervisor. This auditing tool ensures the biological/chemical indicator has been checked prior to a procedure. It was confirmed the surgical check list audits for monitoring did not begin until 01/06/2020. A request was made for the auditing tool to ensure effective monitoring was in place for the biological/chemical indicator checks.

The auditing tool revealed on 02/03/2020 there were 33 surgical cases and only 29 surgical check lists were returned. Per the audit form, four surgical cases lacked evidence the biological/chemical indicators checks were completed prior to the procedure. It was reported the surgical check list are reviewed and discarded daily with no formal process for monitoring and/or ongoing auditing. Upon request, there were no evidence of the forms being monitored until the day of the survey.