HospitalInspections.org

20914


Based on interview and document review, the hospital failed to ensure a document (Post-operative Anesthesia Evaluation form) in the medical record for one of nine sampled patients (Patient 9) was promptly completed and properly filed.

This deficient practice had the potential of resulting in post-operative complications due to anesthesia not being identified in a timely manner.

Findings:

On 4/26/16, at 2 PM, a review of Patient 9's electronic medical record with a member of the facility's Health Information Management department (HIM 1), indicated after admission to the facility Patient 9 had surgery under general anesthesia.

Review of a form titled, "Pre and Post Anesthesia Evaluation" indicated the post-operative section, located on the bottom of the form was blank and unsigned. This section included checkboxes and an area for comments regarding any adverse effects the patient had developed post-operatively.

During a concurrent interview, HIM 1 confirmed there was not any documentation of Patient 9's post-operative anesthesia status documented in the medical record. When questioned regarding the facility's process for auditing of electronic medical records, HIM 1 stated the HIM staff would have only checked the form to ensure content had been documented on the form, but not specifically whether each individual section had been completed.

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28020


Based on observation, interview and record review, the hospital failed to develop and implement measures to govern the identification, prevention, and control of infections and communicable diseases, when:

1. The hospital failed to ensure there was no presence of spotting and staining in two of two processed surgical trays (previously cleaned, disinfected, and sterilized surgical instruments), in Labor and Delivery (L&D).

2. The hospital failed to ensure there was no white fuzzy matter on a labor and delivery bed which had been previously cleaned and ready for patient use.

3. The hospital failed to ensure there was no presence of etching, spotting and staining on one of one processed surgical trays in the sterile processing department.

4. The hospital failed to ensure a Central Service Technician (CST 1) followed the hospital policy for cleaning and disinfecting of surgical instruments.

5. The hospital failed to ensure each step for high level disinfecting (complete elimination of all microorganisms in or on an instrument, except for small spores), was performed when a Licensed Vocational Nurse (LVN 1) in the GI (Gastro-Intestinal) Lab failed to thoroughly rinse endoscopes (a slender, tubular optical instrument used as a viewing system for examining an inner part of the body with an attached instrument for biopsy or surgery).

These failures had the potential to result in the hospital's inability to protect patients from potentially harmful infectious exposures or outbreaks and harm, in a universe of 157 patients.

Findings:

1. On 4/25/16 at 1:10 PM, a tour and observation of the Labor & Delivery (L&D) Unit was conducted with the hospital's Infection Control Manager (ICM), the L&D Manager and a L&D Technician (L&D Tech 1) were also present. Hospital staff were informed that surgical instruments which had already been processed, would need to be opened and inspected.

During the same observation, L&D Tech 1 was asked to open a C-section tray (Cesarean section, also known as a C-section is a surgical procedure used to deliver a baby through incisions in the mother's abdomen and uterus) and a vaginal tray, which were filled with various surgical instruments. Multiple instruments were observed to have brown staining and white spotting on the handles and hinges of the instruments.

During a concurrent interview on 4/25/16 at 1:25 PM, with L&D Tech. 1, she indicated that she was unsure what the staining was and she thought it could be from the water. She also stated the hospital's Central Sterile Department was responsible for cleaning all surgical instruments.

A record review was conducted on 4/26/16 at 2 PM of an un-dated hospital policy which referenced the Association for the Advancement of Medical Instrumentation (AAMI - a national organization for advancing the development, and safe and effective use of medical technology), titled, "Cleaning, and Decontamination & Inspection - Surgical Instrumentation & Power Instruments." The policy stipulated, "...Inspect surgical instruments to evaluate for cleanliness and correct working order after decontamination, and if soiled or defective, remove from service until cleaned or repaired..."

AAMI's Technology Information Report (TIR) 30: 2011 5.2.4 specifies:

"Rinsing
Adequate rinsing is necessary to remove all traces of enzymes, detergents, and residual soil. Water quality should be considered when developing and testing cleaning procedures. Water hardness, temperature, and the type of soil can have an impact on the effectiveness of cleaning products and rinsing and, consequently, the efficacy of the cleaning process. Water quality varies from one area to another and from season to season within the same area."

Additionally, AAMI TIR-34 2007 also specifies:

"Patient infection resulting from the use of contaminated devices (e.g., salt or organic deposits from the water used in reprocessing could inactivate the disinfectant or sterilant or could protect microorganisms from the disinfection or sterilization process; a disinfected or sterilized device could transmit an infection if rinsed with water containing unacceptable levels of microorganisms)."

2. On 4/25/16 at 2 PM, a tour of a C-Section Room in L&D was conducted with the Infection Control Manager, Environmental Services Manager (EVS Manager) and a Patient Transport Manager Assistant. An observation of a previously cleaned L & D bed was made and noted to have white fuzzy matter under the mattress railing.

During a concurrent interview with the Environmental Services Manager (EVS Manager), she stated the room had already been cleaned and was ready for patient use. The EVS Manager indicated the area where the white fuzzy matter was identified, was "non-reachable" by staff and she ordered supplies that would make it easier to access and clean the area. This surveyor reached under the bed and had no difficulty accessing the white fuzzy matter on the railing.

During another interview with the Patient Transport Manager Assistant, who was present for the above observation and interview, he stated that he could see the white fuzzy matter and told the EVS Manager, "Yeah, you can reach it." The EVS Manager stated that she would retrain the staff accordingly.

3. On 4/25/16 at 2:30 PM, a tour and observation of the hospital's Central Sterile Processing Department was conducted with the hospital's Infection Control Manager (ICM) who indicated that the hospital follows nationally recognized infection control guidelines which included guidelines from the Association of PeriOperative Registered Nurses (AORN - perioperative practices which are evidenced-based guidelines for perioperative RNs and the entire operating room team). The hospital's Sterile Processing Consultant was also present during the tour. Hospital staff were informed that surgical instruments which had already been processed, would need to be opened and inspected.

During the same tour at 2:37 PM, a Major tray (a tray which contained multiple sterile instruments) was opened and found to have three instruments, which were etched with physician names, and multiple instruments with brown staining. The Sterile Processing Consultant stated, "They were supposed to remove them from use, these must have got missed (referring to the instruments with the etching." The Sterile Processing Consultant also stated that the brown stains were from the hospital's hard water. She indicated that they identified the hard water problem some time ago. In addition, she stated that until they get the deionized water system, she didn't think they could remove the stains. The Sterile Processing Consultant said, "We have tried and are working on it." The Consultant attempted to scratch off the brown stains but was unsuccessful.

AORN (2016), "Guidelines for Cleaning and Care of Surgical Instruments," specifies, "When surfaces cannot be contacted by cleaning solution, thorough cleaning cannot be achieved; thus, these surfaces can retain organic material and debris. These retained materials can prevent contact of cleaning solutions and disinfecting or sterilizing agents with instrument surfaces, reduce the effectiveness of subsequent disinfection or sterilization processes..."

4. On 4/25/16 at 2:55 PM, a tour and observation was made of the hospital's decontamination room (a room where they clean dirty surgical instruments) with the Infection Control Manager (ICM) and the Sterile Processing Consultant. A Central Service Technician (CST) was present and was asked to demonstrate how she cleaned the dirty surgical instruments. The CST indicated that she had some dirty instruments that she was getting ready to process.

During the observation of the CST cleaning the dirty instruments, the following concerns were identified:

a) She placed approximately 20 surgical instruments into a basin filled with water, and a cleaner and pre-soak solution (Prolystica 2X Concentrate Enzymatic Pre-soak and Cleaner). Not all surgical instruments were submerged in the water and allowed them to soak for "3 to 5 minutes, per manufacturer recommendations."

b) She used a brush to scrub four instruments at one time while holding the instruments in the palm of her hand.

c) She scrubbed the instruments above the water.

The CST was asked why she did not fully submerge the instruments in the pre-soak solution and did not fill the sink with water and the solution. The CST stated because "There's no stoppers for the sink". The Sterile Processing Consultant stated that she would purchase stoppers.

On 4/26/16 at 11 AM, a record review of the hospital policy titled, "Instrument Care and Cleaning, revised 11/13", was conducted. The policy's purpose was to "Demonstrate proper procedure for care, cleaning and prepping of instruments for machine washing." The procedure for cleaning included, "...Cleanliness is essential for proper sterilization. All items shall be cleaned while being held under water to prevent aerosolization of contaminated fluids."

On 4/26/16 at 2 PM, a record review was conducted of a second policy titled, "Cleaning, Decontamination & Inspection - Surgical Instrumentation & Power Instruments, not dated." Under a section titled, "3. Surgical Instruments" the policy stipulated, "...Fill sink with warm water to the appropriate level to fully immerse surgical instruments ...Let the instruments soak for 1 - 5 minutes then proceed with brush cleaning the instruments one at a time under the water ... "

5. On 4/26/16 at 9:45 AM, a tour and observation were made of the hospital's Gastrointestinal Lab (GI Lab - an area where patients who require procedures of the digestive tract are performed). The tour was conducted in the presence of the Infection Control Manager and the Imaging Supervisor. They were asked to describe the hospital's process for performing high level disinfecting on endoscopes. The Imaging Supervisor
asked a Licensed Vocational Nurse (LVN 1) in the GI Lab to demonstrate the process.

At 9:50 AM, immediately after the tour was conducted, LVN 1 demonstrated and explained the hospital's process for performing high level disinfecting of endoscopes. The following concern was identified:

a). LVN 1 demonstrated and stated that they rinsed the scopes a total of one (1) time for "a couple of minutes", after they performed the cleaning and pre-soaking in the MetriCide OPA solution. She also indicated that they follow the manufacturer's recommendations and guidance.

On 4/26/16 at 2 PM, the manufacture's "How to Use MetriCide OPA Plus Solution," was provided by the Sterile Processing Consultant, and was reviewed. The document stipulated the following, "...Rinsing Instruments - after manual processing: After removing the instrument from the MetriCide OPA Plus Solution, thoroughly rinse the device by immersing it completely in a large volume (approx.. 9 liters) of fresh water ...Keep the instrument totally immersed for a minimum of one minute unless a longer time is specified by the instrument manufacturer. Manually flush all lumens with large volumes of water (not less than 100 ml {milliliters}) unless otherwise noted by the device manufacture. Repeat the procedure TWO additional times for a total of THREE rinses. THE VOLUME OF WATER USED IN EACH RINSE CYCLE SHOULD BE AT LEAST 9 LITERS..."