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Based on observation, interview, and record review, the facility failed to ensure the infection control officer consistently implemented policies, procedures, and standards of practice for controlling infections as evidenced by:

1. Multiple previously processed surgical instruments were stiff (hard to open) in two (2) of two (2) inspected surgical trays;

2. There was no handwashing sink or eye wash station in the decontamination area of Sterile Processing Department (SPD) and the Gastrointestinal (GI) Laboratory;

3. There was no evidence of terminal cleaning in the decontamination area of the sterile processing department (SPD);

4. There was no evidence to indicate four of six autoclaves in SPD and in the perioperative area of the operating room (OR) were cleaned according to the manufacturer's instructions for use (IFUs);

5. There was no evidence of temperature and humidity monitoring in the sterile supply area (core area) of the OR;

6. The sink in the decontamination area of the GI lab was observed leaking enzymatic solution during cleaning of bronchoscopes;

7. Contact time was not being maintained during cleaning of one discharge room; and,

8. One dialysis nurse in isolation was observed not wearing appropriate personal protection equipment (PPE).

Findings:

On January 28, 2019, at 10:58 a.m., an interview was conducted with the Director of Infection Control (DIC) who stated they followed nationally recognized guidelines from:

a. APIC - Association for Professionals in Infection Control;

b. AORN - Association of periOperative Registered Nurses;

c. AAMI - Association for the Advancement of Medical Instrumentation; and,

d. CDC - Centers for Disease Control.


1. On January 28, 2019, at 11:00 a.m., two sterilization containers (a major and a minor) filled with multiple previously cleaned and sterilized surgical instruments were inspected, in the presence of the Director of Sterile Processing (DSP), the Lead Sterile Processing Technician (LSPT), and the DIC. The following was observed:

a. In the minor tray, 15 of 91 instruments contained the following:

- Two (2) instruments contained brown staining; and,

- Thirteen (13) hinged instruments were difficult to open.

In the major tray, 16 of 103 instruments contained the following:

- Sixteen (16) hinged instruments were difficult to open.

During the inspection of the two surgical trays, the DSP and the LSPT both were asked to wipe the stained instruments with a Sani- wipe. The stains were easily wiped off.

A review of the facility policy titled, "Cleaning Equipment: Instrument Cleaning/Processing," revised September 29, 2015, stipulated, "..Instruments that contain bone, tissue, dried blood or other difficult-to-remove debris should be presoaked in a warm detergent solution prior to processing in the washer sterilizer...All instruments with movable parts should be lubricated after every cleaning."

According to the AAMI, "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities", the CDC guidelines, and the AORN guidelines:

"Instruments should undergo an inspection for proper function and cleanliness.

1. Instruments should be inspected for a) cleanliness b) proper functioning and alignment, corrosion, pitting, burrs, nick, and cracks, sharpness of cutting edges c) any other defects; and,

2. Instruments in disrepair should be labeled and taken out of service until properly repaired or replaced ..."

A.A.M.I "Standards and Recommended Practice, Safe Handling and Biological Decontamination of Medical Devices in Heath Care Facilities and in Non-Clinical Settings, ANSI/AAMI ST35:2003, keeping in mind this process is in two steps: 1. Complete cleaning and 2. Washing and Sterilization".

2a. On January 28, 2019, at 2:48 p.m., a tour was conducted of the decontamination area of the SPD, in the presence of the Director of Sterile Processing (DSP), the Sterile Processing Technician (SPT), and the Director of Infection Control (DIC).

No handwashing sink or eye wash station was located in the decontamination area.

An interview was conducted with the SPT at 2:55 p.m. The SPT stated the handwashing sink and eye wash station were located in the pre pack area (clean area).

During a concurrent interview with the DSP, the DSP acknowledged the hand washing sink and the eye wash station were located in the pre pack area (clean area).

2b. On January 29, 2019, at 9:20 a.m., a tour was conducted of the GI lab in the presence of gastrointestinal technician (GIT), and the DIC. No handwashing sink and no eye wash station was located in the decontamination area.

An interview was conducted with the GIT at 9:26 a.m. The GIT stated the handwashing sink and eyewash station were located in the clean utility room which was located in the next room.

During a concurrent interview with the DIC and GIT, both acknowledged the handwashing sink and eyewash station were located in the clean utility room with a door between the two areas (clean and dirty areas).

According to Occupational Safety and Health Administration (OSHA), CFR-2013-Title 29-Vol.5-Section 190-151, OSHA standards, stipulates, "An eyewash station be provided where chemicals that are hazardous to the eyes are located. Eyewash stations, either plumbed or self-contained, must be provided within the immediate area where chemicals such as instrument cleaning solutions or disinfectants that are hazardous to the eyes are located. Eyewash stations should be located so that travel time is no greater than 10 seconds from the location of chemical use or storage, or should be immediately available if the chemical is caustic or is a strong acid. Eyewash stations should be located on the same level as the hazard, with the path of travel free of obstructions (e.g., doors) that may inhibit immediate use of the eye-wash station. "

According to AORN standards, "The decontamination area must contain an eyewash station and a hand-washing sink. Instruments should not be cleaned or decontaminated in scrub or hand sinks."

3. On January 28, 2019, at 2:48 p.m., a tour was conducted of the decontamination area of the Sterile Processing Department (SPD), in the presence of the Director of Sterile Processing (DSP), the Sterile Processing Technician (SPT), and the Director of Infection Control (DIC). The following was observed:

a. A significant amount of green and white substance was on both the sink faucets and the pipes attached to the washer; and,

b. A large amount of dried white substance was on the floor in the corner between the counter and sink.

An interview was conducted with the Director of Environmental Services (DEVS) at 3:18 p.m. The DEVS stated the following:

- EVS was only responsible for cleaning the faucets above the sink and not the pipes below the counter;

- Terminal cleaning meant cleaning from top to bottom;

- EVS staff was not able to clean the flooring in the corner due to the location;

- EVS staff cleaned the faucets and they were unable to remove the green and white substance;

- She did not escalate this issue to anyone; and,

- They started a log for terminal cleaning January 2019.

During a concurrent interview with the DSP, he acknowledged the green and white substance on the faucets, the green substance on the pipes attached to the washer, and the white substance on the flooring in the corner between the counter and the sink. The DSP stated the green and white substance should have been removed with cleaning and terminal cleaning that was started in the decontamination area on January 7, 2019.

A review of the Environmental Services policy titled, " Surgical, procedure, and Sterile processing Areas-End of Day and Terminal Cleaning, " revised May 20, 2018, stipulated,"Terminal Cleaning procedure: The sterile processing department will be terminally cleaned daily when the area is being used, including weekends and holidays...3. Damp dust all horizontal work surfaces and high touch areas, including...c. sinks...4. Disinfect floors using wet vac or clean mop and hospital approved disinfectant. Inspect the room, report any needed repairs to appropriate staff. Complete cleaning log after each end of the day."

AORN, infection control standards the hospital followed, defines terminal cleaning as, "thorough environmental cleaning that is performed at the end of each day when the area is being used."

Both AORN and AAMI (Association for the Advancement of Medical Instrumentation) ST 79 recommend that sterile processing be terminally cleaned the same as the operating, delivery, and invasive procedure rooms. AAMI ST 79 (Section 3.4) states that the best practice is to provide separate housekeeping facilities for the decontamination and clean areas to avoid transferring contaminates from "dirty to clean" areas. AORN recommends that terminal cleaning and disinfection of the sterile processing areas "be performed daily when the areas are not being used."

AORN recommends (Recommendation V) a schedule for cleaning the following: Clean and soiled storage areas, storage cabinets, sterile storage area, aerators on faucets should be cleaned and disinfected on a routine basis ...

4a. On January 28, 2019, at 10:59 a.m., a tour was conducted of the, Sterile Processing Prep and Pack Area," in the presence of the Director of Sterile Processing (DSP), the Lead Sterile Processing Technician (LSPT), and the Director of Infection Control (DIC). The area contained four working sterilizers (machines used to sterilize surgical instruments). An observation was made of two of four sterilizers. The interior floors and walls of the holding chambers (an area where a cart holding surgical instruments is placed for sterilization) had large amounts of brown and rust color staining.

During a concurrent interview with the DSP and the LSPT, both acknowledged the large amounts of brown and rust color staining on the interior of the chambers. The DSP stated he was waiting for a brush he had ordered to arrive for cleaning the sterilizers. The DSP stated his staff only flushed the chamber drain.

The DSP was asked to provide documentation or logs to show the IFUs for routine cleaning and maintenance was done. The DSP stated they did not have any documentation to show the sterilizers were cleaned by the users of the machine, as recommended by the manufacturer.

A review of the manufacturer IFUs was conducted with the Director of Sterile Processing (DSP), and each step of the routine maintenance was discussed. The DSP stated they did not perform the following steps described in the manufacturer's IFUs for weekly cleaning:

"...Clean chamber whenever it becomes soiled, or as needed to maintain clean appearance...Chamber must be at room temperature, sterilizer off all night, before washing. 2. Wash the inside of the chamber and shelf assembly with a mild detergent solution such as Liquid-Jet 2 Instrument Detergent or current equivalent)...4. Professional cleaning of the chamber on a yearly basis (or as required due to local conditions) is suggested to maintain appearance of the chamber interior...Chamber Cleaning Procedure: 4. Liqui-Jet 2 detergent is an approved cleaning solution that is specifically formulated to remove many common chamber deposits. Use a dampened lint-free cloth, or soft brush attached to an extension handle to clean the chamber surface."


4b. On January 29, 2019, at 1:52 p.m., a tour was conducted of the Perioperative Department, in the presence of the Assistant Associate Perioperative Department (AAOR), the Perioperative Specialty Coordinator (ORSC), the Manager of perioperative services (MOR), and the Director of Infection Control (DIC). The area contained two working sterilizers. An observation was made of two of two sterilizers. The interior floors and walls of the holding chambers (an area where a cart holding surgical instruments is placed for sterilization) had large amount of brown, black, and rust color staining.

During a concurrent interview with the MOR and the ORSC, both acknowledged the large amounts of brown, black, and rust color staining on the interior of the chambers. The AAOR stated the sterile processing department was responsible for cleaning the sterilizers.

An interview was conducted with the DSP on January 28, 2019, at 3 p.m. The DSP was asked to provide documentation or logs to show the manufacturer's IFU for routine cleaning and maintenance were done for the sterilizers in the Perioperative department. The DSP stated they did not have any documentation to show the sterilizers were cleaned by the users of the machine, as recommended by the manufacturer. The DSP stated his staff would clean the sterilizers in the OR when they cleaned the sterilizers in SPD.

5. On January 29, 2019, at 9:39 a.m., a tour was conducted of the Perioperative Department Sterile Supply Area, in the presence of the Assistant Associate Perioperative Department (AAOR), the Perioperative Specialty Coordinator (ORSC), the Perioperative Manager (ORM), and the Director of Infection Control (DIC). There was no evidence of temperature and humidity monitoring of the sterile supply area, which was located in the core area of the Perioperative department.

During a concurrent interview with the ORM and ORSC, both acknowledged the temperature and humidity was not being monitored.

An interview was conducted with the AAOR on January 30, 2019, at 11:28 a.m. The AAOR stated she was not aware temperature and humidity was not being centrally monitored.

An interview was conducted with the Director of Facilities (DF) on January 30, 2019, at 11:32 a.m. The DF stated he was not aware the core area (where the sterile supplies were located) needed to be monitored.

A review of the facility policy titled, "High Level Disinfection," revised on October 23, 2018, stipulated, "...Storage of Medical devices after High-Level Disinfection: High-level disinfected items should be stored in a manner that will minimize potential for contamination. Room temperature should be approximately 24°C (75°F)...Maintain humidity at no greater than 70%."

6. On January 29, 2019, at 1:17 p.m., observations and concurrent interviews with the gastrointestinal technician (GIT) performing cleaning and disinfecting of a bronchoscope after a procedure were conducted in the decontamination room, in the presence of the DIC. The following was observed:

- The enzymatic solution level in the sink was decreasing;

- The GIT stated the enzymatic solution was leaking and needed to he continue to add more water;

- The GIT stated the IFU indicated he was to use two pumps of enzymatic solution for every two and one half gallons of water;

- The GIT stated he reported the leak in the sink some time ago; and,

- The GIT stated both compartments in the two compartment sink leaked.

An interview was conducted with the Manager of the GI (MGI) lab on January 29, 2019, at 1:40 p.m. The MGI stated she submitted a work order for evaluation and repair of the leak underneath the sink in the reprocessing area on December 14, 2018. The MGI stated she received an email from the facilities department stating the work order was completed on January 25, 2019.

A review of the facility policy titled, "Repair of Medical Equipment," revised April 28, 2015, stipulated, "...Purpose: Repairs are performed to correct equipment malfunctions in order to restore equipment to operational conditions. Procedure:...b. Complete and place the, "Caution Out of Order" tag on the equipment.



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7. An observation of Environmental Services (EVS) Staff 1 cleaning room 527 after a patient was discharged was conducted on January 29, 2019, at 9:15 a.m. EVS Staff 1 was observed wiping the mattress on the hospital bed with one Clorox Bleach Germicidal wipe. After completing the task, EVS Staff 1 proceeded to clean the rest of the room. After one and one half minutes, there were no visible wet areas remaining on the mattress.

An interview was conducted with EVS Staff 1 on January 29, 2019, at 9:40 a.m. EVS Staff 1 stated she let the bleach solution dry and when it was dry she did not re-wet the mattress with the Clorox Bleach Germicidal wipe.

An interview was conducted with the Director of EVS (DEVS) on January 29, 2019, at 2:45 p.m. The DEVS stated when a Clorox Bleach Germicidal wipe was used to clean a mattress, and the solution dried in one and one half minutes, the staff should not add more solution, but the staff should wait until three minutes had passed prior to making the bed.

A review of the technical information sheet for Clorox Healthcare Bleach Germicidal wipes (updated June 2017) was conducted. The technical information sheet indicated, "These EPA (environmental protection agency) registered disinfectant wipes contain sodium hypochloride and other ingredients to kill C.Difficile spores (a bacteria), and other healthcare relevant pathogens in 3 minutes on a variety of hard nonporous healthcare surfaces...To disinfect, all surfaces (are) to remain wet for the contact time."

An interview was conducted with the Infection Preventionist on January 29, 2019, at 3 p.m., who stated the three minute contact time when using Clorox Bleach Germicidal wipes must be maintained to ensure all bacteria were killed, and if the solution dried before the three minute contact time was achieved, the surface should be re-wet.



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8. During a tour of the fourth floor telemetry unit on January 29, 2019, at 1:35 p.m., accompanied by the Patient Experience Program Manager, Patient 8 was identified as having a dialysis treatment currently in progress.

Upon arrival to Patient 8's room, a, "Contact Precautions," sign was observed on the door of the room (indicating Patient 8 was infected with microorganisms that could be spread by direct or indirect contact with the patient. The dialysis registered nurse (DRN) was observed sitting next to the patient's bedside in a chair. The DRN was not wearing any personal protective equipment (PPE - gown, gloves, mask, or eye protection).

The record for Patient 8 was reviewed with the telemetry charge nurse (TCN). Patient 8, an 84 year old female, was admitted to the facility on January 26, 2019, with diagnoses that included chronic renal (kidney) failure and Extended Spectrum Beta Lactamase in the urine (ESBL - indicating the presence of drug resistant bacteria). The record indicated contact precautions were ordered due to ESBL in the urine on January 28, 2019.

The facility policy titled, "Isolation Precautions Protocols Transmission Based Precautions," was reviewed on January 29, 2019. The policy indicated the following:

a. Contact precautions were indicated for patients known or suspected to be infected with microorganisms that were transmitted by direct contact with the patients (hand to skin, skin to skin), or with indirect contact with the environmental surfaces or equipment in the patient's room;

b. Patients with ESBL, "shall," be placed on contact isolation upon diagnosis, until discharge;

c. Persons entering the room should wear PPE that included gloves and a gown.

During an interview with the TCN on January 29, 2019, at 1:55 p.m., the TCN stated the DRN should have been wearing PPE.