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Based on observation, interview, and medical equipment inspection records, the facility failed to ensure that all essential medical equipment was identified as currently inspected and tested for performance. Specifically, an electrical machine located in the surgery/central supply room used to indicate a surgical instrument sterilization failure, (Attest) was found to be in use and had not been inspected by a biomedical technician. This deficient practice had the potential to cause serious wound infections for all surgical care patients.

Findings Include:

An observation on 01/22/19 at 10:00 AM of the central sterilization/supply room. Staff B, Director of Nursing was present and observed, the "Attest Rapid Readout Biological Indicator" (ATTEST-an electrical machine test system that provides a direct measurement of surgical instruments decontamination), had no inspection sticker. Staff B picked up the ATTEST machine and looked at the sides and bottom of the machine for an inspection sticker and could not find a sticker to indicate it had been inspected.

In a telephone interview on 01/22/19 at 10:15 AM, with Staff F, Operating Room Director revealed Staff F was present during the medical equipment inspection by a biomed technician on 09/26/18 and 09/27/18. (The biomed technician is contracted with the hospital to inspect the hospital's medical equipment bi-annually). Staff F stated, "I know I pointed it out to the technician when he was in the central supply room. I didn't check it after the inspection and I haven't seen a sticker on it. I should have made sure it was inspected."

In an interview on 01/22/19 at 12:00 PM, Staff B stated, "I looked at the hospital medical equipment inventory list and the Attest machine is not listed. I talked to Biomed and we will take the machine to them today and have it inspected. We don't have any surgeries scheduled this week because the OR Manager will not be here. We don't have another surgery scheduled until 02/13/19 and the machine will not be used until it has been inspected."

In an interview on 01/22/19 at 2:35 PM, Staff C, Central Supply Manager (CSM) stated, "I oversee the inventory of medical equipment. I wasn't aware that I was responsible for the equipment inventory. I thought each department manager was responsible for their own equipment. I didn't know we had that machine and it's not on the inventory list. We leave it up to each department manager to ensure their equipment is tested. There has been a lack of communication. If I had been informed I would have called the technician to come back and check the Attest machine. It didn't have an old sticker on it which means it has never been inspected."

Review of the manufacturer's instructions manual, undated, for the "Attest 290 Auto-Reader," indicated, Intended Use...is designed to incubate and automatically read...biological indicators...for a final negative fluorescence reading...A positive fluorescence reading, or a visual color change indicates a steam sterilization failure...a positive result (+) will automatically be shown as soon as it is detected...and means a sterilization process failure may have occurred. Act on any positive result immediately. Each facility must establish final readout time in its' policy and procedures...and the risk to the patient if the medical device is not sterile.

Review of the facility's policy, "Clinical Engineering Services Agreement-Exhibit B," indicated, Biomed Equipment Inspection and Preventive Maintenance-will provide a preventive maintenance program...including inspection, testing and calibration of the equipment in accordance with the manufacturer's instructions...all equipment will be tagged with a unique control number...Biomed will inspect new or leased equipment for the center prior to center placing such equipment into clinical use. The facility's staff did not follow the policy by having evidence the equipment was inspected.

Based on observation, policy review, and interview the facility failed to ensure that all essential medical equipment was identified, currently inspected, and were following manufacturer's instructions for monitoring the effectiveness of the sterilization of instruments in the autoclave. There was no evidence to show they were following the instructions and that the machine was functioning properly to prevent the contamination of biologicals that can potentially cause wound infections. This deficient practice had the potential to cause serious wound infections for surgical care patients.

Findings Include:

The manufacturer's instructions manual, undated, for the "Attest 290 Auto-Reader," included, Intended Use...is designed to incubate and automatically read...biological indicators...for a final negative fluorescence reading...A positive fluorescence reading, or a visual color change indicates a steam sterilization failure...a positive result (+) will automatically be shown as soon as it is detected...and means a sterilization process failure may have occurred. Act on any positive result immediately. Each facility must establish final readout time in its' policy and procedures...and the risk to the patient if the medical device is not sterile.

Review of the OR sterilization record, "Steam Sterilizer Record Keeping" listed May 16, 2018 as the last entry for monitoring the effectiveness of the sterilization machine.

Review of the facility's undated policy, "Central Sterile Duties," indicated, To provide sterile instruments to prevent the spread of infection during procedures...to destroy all forms of microbial life, including bacteria, virus, spores, and fungi...the first load of each week includes an Attest pack with a biological indicator. A control biological indicator is crushed and placed in the incubator for 24 hours. After autoclaving, the test vial is then crushed and placed in the incubator...the control vial should be yellow, and the test vial should remain the same color. This is then recorded on the sterilization record. If the test vial has changed colors, this is reported to infection control immediately. The facility's staff was not following the policy by recording all sterilizations.

Review of the facility's undated policy, "Quality Control of Loads," indicated, Each load processed in the flash sterilizers will have a record maintained. To ensure the probability that material sterilized was exposed to the appropriate parameters for sterilization...A daily log will be maintained for each sterilizer...biological testing will be done on steam sterilizers on every load. The facility's staff was not following the policy by not maintaining a daily log for all sterilizations.

In an interview on 01/23/19 at 4:30 PM, Staff F, Operating Room Manager stated, "I'm missing the last eight months of the autoclave sterilizer records. The Attest machine testing is included in those records. There was no evidence presented Staff F was following the manufacturer's instructions by having evidence to show they were monitoring the testing to prevent contamination.

Refer to C-0222 for the facility's failure to identify the need to inspect the sterilization equipment, Biomed to inspect biannually, and following manufacturer's instructions to test the machine was effective.

Based on document review, policy review, and interview the facility's Quality Assessment Performance Improvement program failed to ensure that essential sterilization equipment was being monitoring, collecting data, identifying potential problems, preventing contamination, and taking steps to prevent infections from potential contamination of the sterilization equipment. This practice had the potential to affect all surgical patients receiving surgery in this facility.

Findings Include:

Review of minutes from the "Medical Staff," meetings dated 01/01/18 through 01/15/19 revealed no documentation of hospital acquired surgical wound infections.

In an interview on 01/23/19 at 4:45 PM, Staff G, Quality Director stated, "The hospital had one hospital acquired infection in the last three years. There have been no surgical wound infections. Infection control reports to the medical staff every month. There are no reports of surgical wound infections."

Review of minutes from the "Medical Staff," meetings dated 01/01/18 through 01/15/19 revealed no documentation of hospital acquired surgical wound infections.

Review of the "Preventive Maintenance Check List," dated 01/01/18 to 05/01/18 and 09/01/18 to 12/31/18, (which was a bi-annual check for maintenance) revealed the Attest machine was not listed.

In an interview on 01/23/19 at 4:30 PM, Staff F, Operating Room Director stated, "I'm missing the last 8 months of the autoclave sterilizer records. The "Attest" machine testing was included in those records. I'll process all the surgical instruments now before any of them are used again."

In an interview on 01/23/19 at 5:00 PM, Staff B verified the hospital was unable to provide documentation of testing for the autoclave (steam sterilization) and the Attest machine.

Review of the facility's policy, "Central Sterile Duties," undated indicated, To provide sterile instruments to prevent the spread of infection during procedures...to destroy all forms of microbial life, including bacteria, virus, spores, and fungi...the first load of each week includes an Attest pack with a biological indicator. A control biological indicator is crushed and placed in the incubator for 24 hours. After autoclaving, the test vial is then crushed and placed in the incubator...the control vial should be yellow, and the test vial should remain the same color. This is then recorded on the sterilization record. If the test vial has changed colors, this is reported to infection control immediately. The facility's staff was not following the policy by recording all sterilizations and reporting to infection control.