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Based on observation, interview, and review of facility documents and policies, it was determined the facility failed to meet the Condition of Participation for Physical Plant and Environment when the facility failed to ensure the routine inspection and certification of the facility's medical gas system. The failure to ensure the routine inspection and certification of the medical gas system resulted in an Immediate Jeopardy situation for all currently admitted patients that required, or potentially required, the use of oxygen. The facility also failed to ensure medical equipment located in the surgical department of the hospital was inspected, and failed to ensure the proper disposal of facility trash.

Findings include:

1. Based on interview and review of facility documents, the facility failed to ensure the piped, medical gas system used throughout the facility was routinely inspected and certified by a medical technology inspector. This deficient practice, which resulted in an Immediate Jeopardy situation, identified on 08/07/18 at 3:50 PM by a Life Safety Code Inspector (LSCI) with the Kansas State Fire Marshal's Office. During an interview with a Medical Technology Inspector (MTI) and the LSCI on 08/08/18 at 4:00 PM, the MTI stated he had inspected and certified the medical gas system as safe for use, and the LSCI confirmed validation of the facility's corrective action and the removal of the immediate jeopardy. (Cross-reference C-0231.)

2. Based on observation, interview, and review of maintenance records, the facility failed to ensure an electrical machine located in the surgery/central sterilization room used to indicate a sterilization failure, was found to be in use and had no inspection sticker. (Cross-reference C-0222.)

3. Based on observation and interview, the facility failed to ensure the lids on outside trash dumpsters were closed, and failed to develop a policy and procedure related to the appropriate disposal of facility trash. (Cross-reference C-0223).

Based on observation, interview, and review of maintenance records, the facility failed to ensure all essential medical equipment was identified as currently inspected and tested for performance and safety prior to use, and during use, by staff. Specifically, staff used an electrical machine located in the surgery/central sterilization room, which indicates a sterilization failure, that had no inspection sticker.

Findings include:

An observation of the central sterilization room was conducted in the presence of the Operating Room Director (ORD) on 08/09/18 at 10:00 AM. The "Attest Rapid Readout Biological Indicator" (ATTEST-an electrical machine test system that provides a direct measure of surgical instruments decontamination), was observed in use and had no inspection sticker.

During the tour of the central sterilization room on 08/09/18 at 10:00 AM, the ORD looked for a sticker on the Attest machine. The ORD stated, "I don't see a sticker. I'm surprised it doesn't have one because our biomedical company inspected all the equipment this year. This is a replacement machine that I ordered a few years ago. It's at least two years old and we have been using it every day. It doesn't even have an old sticker on it. It must have been overlooked during the biomedical inspection. We have no cases until Monday and we can get it inspected before then. We can't use the machine until it is inspected."

On 08/09/18 at 10:30 AM, the ORD provided records of "Attest Rapid Readout Biological Indicator-process Monitor Documentation System" dated 6/16/15 through 08/08/18 indicating the facility monitored the Attest machine when the sterilizer was being used. The documentation indicated the test results were either "rejected or accepted". All results of testing were documented as "Accepted" verifying the machine had been calibrated and the result was acceptable.

On 08/09/18 at 11:30 AM, an interview with the Maintenance Supervisor (MS) revealed the facility could provide no record to verify the Attest machine had been inspected by the biomedical company. The MS provided an undated inventory list of all equipment used in the facility. The MS stated, "This list was used by the biomedical company on March 28th of this year when they conducted the first full inspection. The Attest machine is not on the list. I'll call the biomedical company and tell them to do an inspection as soon as they can."

On 08/09/18 at 3:15 PM, an interview with a technician with the biomedical company revealed he had been notified by the MS and had conducted an inspection of the Attest machine. The technician stated, "I received a call that an inspection was needed, and I got here around 2:40 PM. I looked at our records and we missed it on the March inspection. It wasn't on the initial inventory list that was provided by the facility. The purpose of the machine is to see that the sterilizer has done its job. The machine has been inspected and is functioning accurately. I placed a sticker on it with the month and the year according to NPA [National Products Guidelines]. I will send my report of the inspection to the facility tomorrow."

During an interview on 08/10/18 at 9:00 AM, the Materials Management Director (MMD), stated, "We should have had our fingers on it. We have a process problem. All equipment for the hospital comes to me and then it goes to maintenance before it is put into use. We have not had a good system for inventory, up to now we just count everything at the end of the year. From now on nothing leaves my department or sent to the floor until it has a sticker on it."

On 08/10/18 at 1:00 PM, the MS provided a copy of the biomedical technician's report. Review of the report, dated 08/09/18, indicated, "Inspection of device missed during implementation." The report included an inventory list titled, "All Client Inventory List, dated 08/09/18," that listed "3M Healthcare incubator ATTEST 390 surgery/recovery department."

On 08/10/18 at 1:00 PM, the ORD provided a copy of the "Invoice" for the purchase order of the Attest. The "Invoice," dated 06/16/15, indicated, "Order date 06/12/15. . . shipped date 06/16/15 . . . Attest 390 Auto-reader for steam." The "Invoice" indicated the facility received the Attest machine in June 2015 and the machine had been used by staff for a period of three years and two months without inspection by the biomedical company.

During an interview on 08/10/18 at 1:15 PM, the Quality Assurance Compliance (QAC) nurse stated, "We have been talking about a system implementation to assure this never happens again. We are going to make sure there is a system management for every piece of equipment that is brought into the facility."

Review of the Attest "Product Description" indicated, "The 3M Attest is a biological indicator system specifically designed for rapid and reliable monitoring of steam sterilization processes . . . a fluorescence change indicates a steam sterilization failure."

Review of the "Biomedical Equipment Management" policy, dated June 2018, indicated: "All medical and electrical patient care equipment will be evaluated prior to use based on function, physical risks associated with clinical use maintenance requirements and equipment incidents. All incoming and existing equipment meeting the evaluation criteria are included in the Equipment Management Program. An inventory of equipment included in the program and equipment maintenance records documenting all maintenance on equipment is kept in the Engineering Department/Service office. All equipment is evaluated on function, risk, maintenance requirements and equipment history ...All equipment at this location will be inspected/serviced annually by biomedical personnel."

Review of the "Biological Testing for Steam Sterilization" policy, dated 03/2018, indicated: "Department: Central Service-approved by Director of Surgical Services. Policy: Evidence of effective steam sterilization processes will be documented . . . all steam sterilizers should be routinely tested using a biological indicator process device . . . biological indicators are test systems that provide a direct measure of the lethality of the steam sterilization process . . . a 3M Attest rapid readout biological indicator . . . is used to conduct daily routine efficacy."

Based on observation and interview, it was determined the facility failed to ensure the proper disposal of facility trash. This failure had the potential to affect all patients and staff at the facility.

Findings include:

Observation of the service area located outside the facility on 08/07/18 at 10:15 AM revealed two of three dumpsters, used for collecting facility trash, left with their lids open. Large bags of trash were visible inside the dumpsters.

During an interview on 08/07/18 at 10:30 AM, the Maintenance Supervisor (MS) stated trash taken out of the hospital is placed in the dumpsters located in the service area outside of the facility and the lids on the dumpsters should be closed. The MS stated the facility did not have a policy related to the proper disposal of facility trash.

Based on interview and review of facility documents, it was determined the facility failed to ensure Life Safety Code (LSC) requirements were met when the facility failed to ensure the piped, medical gas system used throughout the facility was routinely inspected and certified by a medical technology inspector. This deficient practice affected multiple care areas of the hospital including inpatient rooms, the emergency department, and the surgery department and resulted in an Immediate Jeopardy condition for all currently admitted patients that required, or potentially required the use of oxygen.

Findings include:

During the facility's health recertification survey from 08/07/18 through 08/10/18, a Life Safety Code Inspector (LSCI) with the Kansas State Fire Marshal's Office conducted an inspection of the facility.

During an interview on 08/07/18 at 4:15 PM, the LSCI stated an immediate jeopardy situation had been identified during the survey process on 08/07/18 due to the facility's failure to ensure the piped, medical gas system used throughout the hospital was routinely inspected and certified by a medical technology inspector. The LSCI further stated the facility's Chief Financial Officer (CFO) was notified of the Immediate Jeopardy on 08/07/18 at 3:50 PM.

During an interview on 08/07/18 at 6:00 PM, with the facility's CFO, Chief Nursing Officer (CNO), Quality Assurance (QA) Nurse, and Maintenance Supervisor (MS), the CFO stated the facility had taken measures to ensure a certified medical technology inspector would conduct an inspection of the medical gas system on 08/08/18. In addition, the CNO and QA stated two patients were identified that required oxygen. The CNO stated these patients were placed on portable oxygen concentrators and nurses were required to conduct respiratory assessments of the patient every two hours until the medical gas system of the hospital was certified. The QA further stated the surgical department cancelled all services until the medical gas system was inspected and the emergency department was diverting patient requiring respiratory care and services to other hospitals until the inspection was completed.

During an interview with the LSCI and the Medical Technology Inspector (MTI) on 08/08/18 at 4:00 PM, the MTI stated he conducted an inspection of the hospital's medical gas system and certified the gas system as safe to operate on 08/08/18. The LSCI confirmed the Immediate Jeopardy was removed upon the inspection and certification of the medical gas system.

A review of a facility document titled, "Acknowledgement of Services," dated 08/08/18, indicated the MTI had inspected and certified the facility's medical gas system as safe to operate.

*Cross-reference the facility's CMS-2567 (Statement of Deficiencies and Plan of Correction) for Life Safety Code (ASPEN #4HZX21).