HospitalInspections.org

Based on a review of facility documentation, staff interview and a tour of the hospital's sterile processing area, the facility failed to ensure the reliability of equipment used for the sterilization of surgical instruments as the equipment was not maintained either according to the manufacturer's recommended maintenance schedule or according to an approved, evidence-based, documented alternative equipment maintenance program.

Findings were:

In an interview with Staff #12, Biomedical Manager, on the afternoon of 7/13/15 in the facility meeting room, he said the facility was currently using a preventive maintenance program for surgical instrument sterilization equipment that was an alternative equipment maintenance program (AEM). When asked if the program had ever been approved by the hospital's governing body, he said the alternative maintenance program, which had been in use for several years, had not been approved by the governing body or any other hospital committee. He stated the biomedical department was unable to provide documentation of factors and evidence it considered in developing the AEM, including the levels of risk to patient safety if the manufacturers' preventive maintenance instructions were not followed. He stated there was no documented evidence of consideration of the manufacturers' preventive maintenance instructions, although he did state, "We looked at the manuals, sure." He also stated there was no documented evidence of consideration of recommendations of nationally recognized expert associations regarding the maintenance of the equipment. In sum, he stated the facility could provide no documented evidence of any rationale used to develop or support the AEM in use. He also stated there had never been an analysis of the performance data of the sterilization equipment to determine whether modifications to the AEM might be justified or required. He stated, "We're still operating under the old [AEM] plan because the new plan is still in flux."

The University Medical Center of El Paso's Check Procedures, or "old maintenance plan" described by Staff #12 as the facility's alternative equipment maintenance program included no date and read as follows, in its entirety:
"General condition of equipment
Loose/missing hardware
Indicators/displays
Controls/Switches
Steam Press."

The minutes of the Environment of Care Committee on 6/10/15 included the following:
"1/15/15 meeting: [Staff #12] reported that he is working on implementing a new process based on Joint Commission standard EC.02.04.01. The Hospital manages medical equipment risks. EP 2 - The hospital maintains a written inventory of all medical equipment. Will be recategorizing each piece of equipment by priority. There are about (800) throughout the hospital. He will complete the matrix then create a policy. [Staff #12] will provide a timeline at the next meeting. Update 2/11/15:...presented [Staff #12's] report - he has added the following timeline:

· Estimated Inventory Complete date: Jan/Feb 2015
· Estimated Review and Scoring of Devices: March/Apr 2015
· New Policy on the AEM Program: Apr 2015
· Approval of New AEM Policy: May 2015
· Implementation: June 2015 ... "

In an interview with Staff #12, Biomedical Manager, on 7/15/15 at 2:30 PM he was asked about the Environment of Care meeting minutes of 6/10/15 which included the timeline for an Alternative Equipment Maintenance Program. He stated, "It's procedures we need to do for the program. The inventory of the equipment was completed. The rest has not been completed yet." He was asked if the revised Alternative Equipment Maintenance Program had been approved by the Environment of Care Committee. He replied, "No program, not yet. The plan was approved, my strategy to make a plan."

Staff #11, Facilities Management Director, added, "I talked to the technician that does PM (preventive maintenance) on the equipment. He said that checklist we gave you before was not accurate. He said he went to the Belimed manual and used - the preventive maintenance inspection sheet - but he doesn't have any documentation of it."

Staff #12, was asked about a "computer glitch" he mentioned which occurred "sometime between December 2013 to June 2014" which he stated affected the preventative maintenance database. He stated, "We contacted the software company to fix it...Some items got misplaced, some got lost, some records got jumbled."

Staff #11 added, "PMs got done but the records got lost." He confirmed there was no record to confirm when or if maitenance was done. He stated "The information came from the technicians who did it." Staff #12 added, "They ran Bowie Dick tests and everything else. But we lost things, so we don't have the documentation." He was asked whether preventive maintenance was completed or repeated on the sterilization equipment after they detected the database malfunction. He replied. "No we have so many hands on it all the time. We kept repairing them and inspecting them."

STERILIZER MANUFACTURER MANUALS:

A review of the Operating Instructions for the BeliMed WD230/WD250 Washer, equipment used for high-level disinfection, revealed the following:
"9. Wash Chamber and Maintenance Chores
Only a machine that receives daily cleaning and preventive maintenance can operate properly. The wash chamber must be checked daily. The sieve system must be cleaned and potential foreign objects removed from wash chamber. The liquid level in the storage containers of applied additives must be checked daily, replenished if needed. The customer (normally the technical services of the hospital) is responsible for periodic maintenance work according to instructions received ... "

The Steris Amsco V-PRO maX Low Temperature Sterilization System is used for the sterilization of surgical instruments. The sterilizer manual included the following:
"The routine maintenance procedures described in this section of the manual should be performed whenever necessary and as outlined in Section 8.2, Routine Operator Maintenance ...regularly scheduled preventive maintenance is essential for safe and reliable operation of the equipment ...Maintain a record of all maintenance procedures performed on the Sterilization Unit ...
Routine Operator Maintenance: Perform the following routine maintenance procedures as indicated:
8.2.1 Daily: 1. If dirty, clean Sterilization Unit chamber ...
8.2.2 Weekly: 1. Complete instructions listed in Section 8.2.1 Daily; 2. Perform leak test on Sterilization Unit per instructions in Section 8.4, Leak Test ...
8.2.23 Monthly: Place a few drops of heavy machine oil (SAE 20 or 30 motor oil) on chamber door hinge pin. Work oil into hinge by operating and closing door several times.
8.2.4 Quarterly: Inspect door gasket. If gasket is brittle or has cracks, contact STERIS for replacement ... "
Table 8.1 of the manual included a preventive maintenance schedule that included required service to be performed at "min. frequency." A number of items were to be performed "2x per year" and "1x per year. "

The Belimed Steam Sterilizer TOP 5000 is a sterilizer used for surgical instruments. The User's Manual included a maintenance plan as follows:
"18.4.1 Daily Maintenance (before start sterilizing) ...Work to be performed ...
Clean: Sterilizer surface, if dirty ...
Printer paper: if red paper marking is visible on printout, replace the paper roll. If the printout is poor, replace printer ribbon ...
Leak Test ...Run a Warm-Up & Leak Test cycle. Any indication of a malfunction (leak rate > 1.3mbar/Min) must be reported to the supervisor, who will take appropriate action to determine the cause of the problem. Sterilizer should not be used during this time.
Steam penetration test. Run a Bowie-Dick Test ...
18.4.2 Weekly Maintenance ...Work to be performed ...
Clean:
o Chamber
o Chamber drain strainer
o Sterilizer surface
Examine the door seal:
o Door seal must be completely sucked back in the frame
o Door seal must not be mechanically damaged ...
Any indication of a malfunction must be reported to the supervisor, who will take appropriate action to determine the cause of the problem. Sterilizer should not be used during this time ...
o While closing the door you must be able to stop the movement by pressing down the door ...
Piping system: Open service doors and check for leaks ...
18.4.3 Maintenance level 1
Maintenance interval 650 hours (Quarterly) ...Work to be performed ... "
The above tasks were listed with the following additional tasks:
"Emergency Stop
o Check for proper operation. 2-door sterilizers: check function on operating and non-operating end.
Piping system
o Check for leaks: Reseal leaking points and replace seals or exchange parts if necessary.
Compressed air filter
o Drain filter: Drain off the condensate in the filter casing using the drain plug.
Sterile filter
o Unscrew sterile filter and sterilize filter with 134 [degree] C Fabric Packs cycle.
Control panel fan
o Check the air inlet fan for proper operation.
Leak Test
o Run a Warm-Up & Leak Test ...
Steam penetration test
o Run a Bowie Dick Test ... "

A number of additional work items were listed under maintenance to be performed every 2600 hours or yearly. In addition, there was the following:
"18.4.6 Yearly safety check. The Safety check is to log in a maintenance record ..." A 17-step safety check was listed.

Facility policy #K-7, entitled Steris Sterilization of Instruments in the Operating Room, last revised 01/15, included the following:
"The Steris Machine will be used for the safe, sterile processing of immersible surgical and endoscopic devices and instruments ...
A. Only trained Associates who have demonstrated competencies will use the Steris Machine ...
2. The diagnostic cycle will be run every morning to ensure proper functioning of the machine and filters ...
F. Maintenance of the Steris Machine and its filters will be performed by the Biomedical department on a regular basis according to the manufacturer's instructions and diagnostic cycle results ... "

In an interview on the afternoon of 7/15/15 at 12:30 p.m. in the hospital meeting room, the Biomedical Manager and the Facilities Management Director confirmed that the facility had not been following the manufacturers' instructions for equipment preventative maintenance or a facility-approved alternate equipment maintenance program on the equipment used to sterilize surgical instruments. In addition, the hospital, through a "computer glitch," lost documents necessary to demonstrate preventative maintenance performed on this equipment in 2014.

These finding were confirmed for a final time in an interview with the hospital Chief Executive Officer and other administrative staff on the afternoon of 7/15/15 in the facility meeting room.

Based on a review of documentation and interview, the facility failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases.

Findings included:


Facility policy #K-37.1, entitled Sterilization, Steam, Operating Room, last revised 01/15, included the following:
"The procedure indicated below will be followed to ensure the safe processing of surgical instruments for operative procedures using "Immediate Use" steam sterilization ...
Note: "Immediate Use" sterilization is to be used for emergency sterilization only. It should not be used as a substitute for the sterile processing of instruments in the Sterile Processing Department. All items processed using "Immediate Use" sterilization must be listed in the sterilization log ..."

Facility policy #IC-NC-K-111.1, entitled Immediate Use Sterilization of Implantable Items, last revised 01/15, stated in part:
"Immediate Use Sterilization of implantable items will be used only in emergency situations when there is insufficient time to sterilize an item by the preferred prepackaged method. However, when Immediate Use Sterilization is absolutely necessary, strict adherence to the procedure outlined in this policy must be followed ...
11. Record the following:
a. In the sterilizer log designated for that sterilizer, document patient name and medical record number, implant type, autoclave number, date, time and signature of the person performing the Immediate Use sterilization of the implant(s) ..."

Review of the Immediate Use Sterilizer Logs for the West Wing and North Tower for March 2015 through July 2015 revealed the following:
· In March,12 of 23 instances of immediate use sterilization (IUS) did not have a reason listed that was emergent.
· In May, 12 of 16 instances of IUS did not have a reason listed that was emergent.
· In June, 11 of 16 instances of IUS did not have a reason listed that was emergent.

In an interview on 07/14/15, staff member # 3 (Supervising Instrument Technician) was asked about the use of flash or immediate use sterilization at the facility. They replied, "This happens in the OR. I don't control this. This is when they have to do immediate use flash sterilization. They should put a reason why they had to flash it."

In an interview on 07/14/15, staff member # 18 (Nurse Manager Operating Area), confirmed that the IUS form requested a specific reason and that "not sterile" or "unsterile" was not a specific reason. This staff member also confirmed that some forms did not even list a reason for the IUS. They also stated, "Sometimes when they're add-ons - when they're not scheduled - that's the time when we have to do Immediate Use because we need it right away for the patient care. We're really getting away from using it, because we've said now it's not acceptable anymore. But when you look at the logs, our volume of flashing is actually going up. Those forms are filled out by the techs or nurses. The techs are the main ones doing the sterilizing ...We've done an in-service now to get people to fill out the form and to be more specific now. That was done on Friday."

Staff member # 18 (Nurse Manager Operating Area), was asked if IUS was ever used for implants. This staff member stated, "We're developing an implant log now. Immediate use sterilization was done on one implant. There should be a log if we have to do it. We won't be doing immediate use sterilization on implants, but we need to have a log if we do it. " This staff member confirmed the use of IUS on an implant without a log present. At the time of this survey, the facility was unable to identify the patient or date of the occurrence. Review of the the IUS logs from March-July 2015 did not reveal any identifiable incident of IUS used for an implant.

According to the Centers for Disease Control and Prevention (CDC) , due to the "potential for serious infections, flash sterilization is not recommended for implantable devices".See CDC reference below:

The Centers for Disease Control and Prevention (CC) website article, GUIDELINE FOR DISINFECTION AND STERILIZATION IN HEALTHCARE FACILITIES, 2008, by William A. Rutala, Ph.D., M.P.H., David J. Weber, M.D., M.P.H., and the Healthcare Infection Control Practices Advisory Committee (HICPAC), found at: , states on page 60 that "it [flash sterilization] is not recommended as a routine sterilization method because of the lack of timely biological indicators to monitor performance, absence of protective packaging following sterilization, possibility for contamination of processed items during transportation to the operating rooms, and the sterilization cycle parameters (i.e., time, temperature, pressure) are minimal...A few adverse events have been associated with flash sterilization. When evaluating an increased incidence of neurosurgical infections, the investigators noted that surgical instruments were flash sterilized between cases and 2 of 3 craniotomy infections involved plate implants that were flash sterilized849...Flash sterilization should not be used for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time817. Because of the potential for serious infections, flash sterilization is not recommended for implantable devices (i.e., devices placed into a surgically or naturally formed cavity of the human body); however, flash sterilization may be unavoidable for some devices (e.g., orthopedic screw, plates). If flash sterilization of an implantable device is unavoidable, recordkeeping (i.e., load identification, patient's name/hospital identifier, and biological indicator result) is essential for epidemiological tracking (e.g., of surgical site infection, tracing results of biological indicators to patients who received the item to document sterility), and for an assessment of the reliability of the sterilization process (e.g., evaluation of biological monitoring records and sterilization maintenance records noting preventive maintenance and repairs with dates)."

The facility was not performing biological indicator testing according to manufacturer's instructions, facility policy and current standards of practice. Cross refer 482.42(a)(1).

Based on a review of facility documentation and staff interviews, the facility was not ensuring sterilization of surgical instruments by performing biological indicator testing according to manufacturer's instructions, facility policy and current standards of practice.

Findings included:

A review of the 3 M Sterilization Recordkeeping books for the West Wing and North Tower revealed the following:
· The West Wing sterilizer (Belimed) did not have a daily biological test completed on the following dates:12-7-14, 12-20-14, 12-27-14, 12-28-14, 1-11-15, 1-17-15, 1-18-15, 2-1-15, 2-7-15, 2-8-15, and 04-16-15, 4-26-15, 5-2-15, and 5-3-15.
· The North Tower sterilizer (Sterrad) did not have a daily biological test completed on the following dates: 11-27-14, 12-7-14, 12-20-14, 12-27-14, 12-28-14, 1-4-15, 1-11-15, 1-17-15, 1-18-15, 2-1-15, 4-25-15, 4-26-15, 5-2-15, and 5-3-15.
· The West Wing sterilizer (Belimed) did not have the control fluorescence results indicated on the following dates: 11-9-14, 7-11-15, and 7-12-15.
· The North Tower sterilizer (Sterrad) did not have the control fluorescence results indicated on the following dates: 11-4-14, 11-6-14, 11-7-14, 11-9-14, 1-25-15, 1-26-15, 1-27-15, 2-2-15, and 2-10-25.
· The North Tower sterilizer (Sterrad) record keeping did not included "chemical indicator/Integrator", "Well No." or "Incubation" time in or out documented on 12-21-14.
· The North Tower sterilizer (Sterrad) record keeping did not included the incubation time out or the indicator results circled on 1-1-15.
· The North Tower sterilizer (Sterrad) record keeping on 2-28-15 did not included the well number for the test and control, on 6-27-15 the Rapid Fluorescence indicator results for the 1 hour tests were not circled.

In an interview with Staff #3, Supervising Instrument Technician, on 07/14/15 at 10:30 AM, she was asked if there were issues with running biological indicators on the sterilizers. She replied," We are doing biological indicators with each load. She (Joint Commission survey) wanted to see we were doing one every 24 hours at the same time. She wanted to see one prior to load each day. Our pack has the biological in each pack. Attest rapid have biologicals inside and chemical indicators inside ... A lot of our loads have an implant in each load. We do it (biological indicators) in every single load."

Staff #3 was asked how biological indicators are documented on the sterilizing records. "It shows biologicals on outside of the envelope and on inside index card. Back in May a consultant for Joint Commission came through and she told us we had documentation, having documentation inside. We had been documenting biological results on outside, but not filing out lot numbers and times. We changed that practice in May. It was already here (inside the envelope) now we put it on the outside too." Regarding the recent Joint Commission survey she stated, "She told us that's were we're not doing a control for each load, our practice is a biological for each load so we don't need to do a control for each load."

She was asked about documentation of the Rapid Fluorescence Indicator Results on the "3 M Steam Sterilizer Record Keeping log" and on the "3M Stream Sterilization Record Keeping Envelope". She replied, "It's not marked. I had a question. I was not sure what the fluorescence meant. On the controls, we do a control for each sterilizer, first thing in the morning we do a control for each sterilizer to compare."

She was asked about the use of flash or immediate use sterilization at the facility. She replied, "This happens in the OR. I don't control this. This is when they have to do immediate use flash sterilization. They should a put reason why they had to flash it." She stated that the sterile processing personnel perform the biological indicator tests on the 2 sterilizers located in the operating areas. She stated that some biological indicator tests were missed with these 2 sterilizers in the OR areas. "We're doing their biologicals. There were some missing, because some of the dates, I saw were on weekend. Sometimes someone filling in failed to do those. If not ones that come every morning to open the department, they could have forgotten."

Facility policy #K-37.1, entitled Sterilization, Steam, Operating Room, last revised 01/15, included the following:
"The procedure indicated below will be followed to ensure the safe processing of surgical instruments for operative procedures using "Immediate Use" steam sterilization ...
Note: "Immediate Use" sterilization is to be used for emergency sterilization only. It should not be used as a substitute for the sterile processing of instruments in the Sterile Processing Department. All items processed using "Immediate Use" sterilization must be listed in the sterilization log ...
4. Place a biological indicator inside the sterilizer pan if implants are being sterilized ... "

A manual from the website of the Centers for Diseases Control, http://www.cdc.gov/hicpac/Disinfection_Sterilization/13_11sterilizingPractices.html, entitled Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, included the following, in part:
"A rapid-readout biological indicator that detects the presence of enzymes of G. stearothermophilus by reading a fluorescent product produced by the enzymatic breakdown of a nonfluorescent substrate has been marketed for the more than 10 years. Studies demonstrate that the sensitivity of rapid-readout tests for steam sterilization (1 hour for 132oC gravity sterilizers, 3 hrs for 121oC gravity and 132oC vacuum sterilizers) parallels that of the conventional sterilization-specific biological indicators ...and the fluorescent rapid readout results reliably predict 24- and 48-hour and 7-day growth. The rapid-readout biological indicator is a dual indicator system as it also detects acid metabolites produced during growth of the G. stearothermophilus spores. This system is different from the indicator system consisting of an enzyme system of bacterial origin without spores..."

Product information provided by 3M at their website: http://multimedia.3m.com/mws/media/158079O/1292e-rapid-readout-product-profile.pdf
included the following brochure: 3M (Trademark)Attest (Trademark)1292ERapid Readout Biological Indicator Product Profile. The brochure included the following:
"Interpretation of Fluorescent versus Visual Color Change Readout ...The Attest auto-reader detects the presence of an active Bacillus stearothermophilus ATCC 7953 spore-associated enzyme by reading a fluorescent product that is produced when the Bacillus stearothermophilus ATCC 7953 spore-associated enzyme converts the non-fluorescent substrate, 4-methylumbelliferyl-alpha-D-glucoside, in the media vial. The fluorescence indicates the presence of active spore-associated enzyme and a sterilization process failure. Non-fluorescence indicates inactivation of the spore-associated enzyme and a correct sterilization process ...A fluorescent positive is detected within three hours of incubation, but no visual pH color change is detected. The fluorescent-positive should be regarded as a sterilization process failure and the appropriate action taken..."

The above findings were confirmed in an interview with the facility Chief Executive Officer and other administrative staff on the afternoon of 7/15/15 in the facility meeting room.