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Based on observations, interviews and document review, the facility failed to ensure irrigation fluids placed in a warming cabinet were stored pursuant to manufacturer's instructions and safe for patient use.

This failure created the potential for patients to be at risk for health care acquired infections related to receiving irrigation fluids past the facility's instructed expiration date.

FINDINGS

POLICY

According to Warming of Parental and Irrigation Solutions, Irrigation solutions will be warmed to temperatures not exceeding 40 Celsius (104 Fahrenheit) for no longer than 72 hours.

REFERENCE

According to the Association of Operating Room Nurses (AORN), Guidelines for Perioperative Practice, 2015: Recommendation II.b.1 (page 530), Fluids kept in a warming cabinet should be labeled with an expiration date based on the manufacturer's recommendation for storage above room temperature.

1. The facility did not write expiration dates of fluids that were placed in a warming cabinet. In addition, the facility did not discard fluids in a warming cabinet that were past the facility's instructed date of use.

a) On 01/04/16 at 1:00 p.m., a tour of the clean utility room in the Preoperative (Preop) and Post Anesthesia (PACU) Units revealed the following irrigation solutions in a warming cabinet:

1 bottle of Sterile Water (1000 ml) with a written date of 11/05
1 bottle of 0.9% Normal Saline (1000 ml) with a written date of 12/1
3 bottles of 0.0% Normal Saline (1000 ml) with no written date noted
2 bottles of Sterile Water (1000 ml) with no written date noted

b) During the same tour, Registered Nurse #5 (RN) confirmed the dates written on the bottles corresponded to the date they were placed in the warmer. RN #5 stated s/he believed the bottles of fluid were able to be used within 3 months of placing them in the warmer. This was in contrast with the facility's policy. RN #5 further stated s/he was not aware of when the undated bottles had been placed in the warmer and therefore should not have been used for patient care.

c) On 01/06/16 at 10:04 a.m., an interview was conducted with the Infection Preventionist (Infection Preventionist #3) who revealed the facility followed infection control standards from multiple organizations including the Association of Operating Room Nurses (AORN). Infection Preventionist #3 stated the expectation was for staff to follow the facility policy regarding expiration dates of fluids in a warming cabinet due to an increased risk of bacterial infection if fluids were left longer than the expiration date.

Based on the nature of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation §485.635, PROVISION OF SERVICES, was out of compliance.

A-0278 - Standard: A system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel.

Based on observations, interviews and document review, the facility failed to maintain appropriate infection control processes in the areas of disinfection of surgical instruments and the storage of patient care supplies. This failure resulted in an increased risk of health care acquired infections for patients.

Based on observations, interviews and document review, the facility failed to maintain appropriate infection control processes in the areas of disinfection of surgical instruments and the storage of patient care supplies.

This failure resulted in an increased risk of health care acquired infections for patients.

FINDINGS

POLICY
According to Infection Prevention Plan, infection prevention and control allows for a systematic, coordinated and continuous approach by:
A. pertinent federal, state and local regulations pertaining to infection prevention and control are implemented and followed.
J. Coordination with all departments with the hospital regarding Infection Prevention and Control Policies to verify sound infection control practices are being followed.

According to Disinfecting of Surgical Items, items must be thoroughly rinsed with sterile water and dried in a manner which minimizes the risk of contamination.

According to Use of Liquid Chemical Disinfection, mix chemical disinfectant according to manufacturer's directions in a sterile soaking pan.

According to Instrument Decontamination, instruments should be rinsed thoroughly with fresh water.

According to Care of Instruments, Scopes and Powered Surgical Instruments, Scopes should be inspected, tested and processed according to manufacturer's instructions.
Powered surgical instruments should be inspected, tested and used according to manufacturer's instructions.

REFERENCE

According to Ellips FX Phaco Handpiece manufacturer's instructions, Cleaning: with the phaco infusion sleeve, and phaco needle still in place on the handpiece, inject 60 milliliters (ml) of distilled water through the infusion line and 60 ml of distilled water through the aspiration line of the phaco handpiece. Wipe the power cable of the handpiece with gauze soaked in distilled water. Improper/inadequate cleaning may result in particulate matter adhering to the instrument and exfoliation of particles into the surgical field. Do not use tap water for cleaning.

According to Bausch and Lomb Storz Ophthalmics Instruments manufacturer's instructions, if the instrument has lumens the lumens should be flushed using a syringe filled with 50 ml of warm distilled or deionized water.
According to Katalyst Surgical LLC Surgical Instrument Handling Instructions, flush thoroughly with distilled/deionized water, flush with alcohol, dry instruments completely and carefully with compressed air.

According to Katena Reusable Ophthalmic Instruments Sterilization Instructions, brushes and other cleaning implements should be cleaned and decontaminated after each use. However, it is best to use single-use brushes and other cleaning implements that can be discarded after use. After cleaning the instruments, thoroughly rinse them under running water. Then give them a final rinse using a clean bath of demineralized water. Thoroughly rinse and flush instruments with lumens using demineralized water. Visibly inspect each instrument for debris and damage, preferably under magnification.

According to Ecolab Asepti-Zyme Enzymatic Instrument Presoak and Detergent manufacturer's instructions, add ½ fluid ounce (fl. oz.) per 1 gallon of water. For heavy organic load, 1 fl. oz. per gallon of water may be required.

According to the Association of Operating Room Nurses (AORN), Guidelines for Perioperative Practice, 2015:

Recommendation VII.a (page 624), the final rinse should be performed with treated (eg, distilled, reverse osmosis, filtered) water of a quality that will not stain or cause damage to instruments or contribute to recontamination of the instrument. Untreated water can contain contaminants, including endotoxins, which can be deposited on instruments during the final rinse.

Recommendation IX (page 626), Surgical instruments and equipment should be cleaned and decontaminated according to the manufacturer's validated, written instructions for use.

The Centers for Disease Control and Prevention Guideline for Disinfection and Sterilization in Healthcare facilities, 2008 (p.1-3), stated thorough cleaning of instruments is required before sterilization to remove inorganic and organic materials which would interfere with the effectiveness of the sterilization process.
Additionally, enzyme solutions should be used according to the manufacturer's instructions for proper dilution of the enzymatic detergent and contact with equipment for the specified amount of time.

1. The facility did not ensure the cleaning of surgical instruments was performed in accordance with manufacturer's instructions.

a) On 01/04/16 at 1:10 p.m., a tour of the decontamination room and sterile processing room was conducted with the Lead Instrument Tech (Tech #1), who demonstrated the process for pre cleaning and preparing surgical instruments for sterilization. Tech #1 stated s/he would soak and clean instruments in a disinfecting enzymatic solution, then rinse the instruments under running sink water. This was in contrast to the manufacturer's instructions which stated to use either deionized, distilled or demineralized water, depending on the instrument being cleaned.

Tech #1 further demonstrated the process of pre cleaning and preparing phacoemulsification handpieces (used during cataract eye surgeries) for sterilization. Tech #1 explained that the handpiece would be cleaned and scrubbed with a brush, flushed with water from the sink then wiped with an alcohol solution. This was in contrast with the manufacturer's instructions which stated to use distilled water when flushing and cleaning the instrument.

b) Additional interviews with Tech #1 were conducted on 01/05/16 at 8:57 a.m. and on 01/06/16 at 8:36 a.m. During these interviews, Tech #1 stated after eye instruments were pre cleaned they would be inspected for residual debris, however, s/he would not use any magnification to do so. This was in contrast with the manufacturer's instructions which stated to visibly inspect each instrument for debris and damage, preferably under magnification.

Tech #1 then stated s/he would reuse brushes to clean eye surgical instruments throughout the day. The brushes would be cleaned in the instrument washer daily and were discarded and changed approximately monthly. This was in contrast to the manufacturer's instructions which stated brushes and other cleaning implements should be cleaned and decontaminated after each use. However, it is best to use single-use brushes and other cleaning implements that can be discarded after use.

Tech #1 further explained that although each eye tray could have contained instruments from more than one manufacturer, s/he would use only the instructions from one manufacturer as guidance when pre cleaning and processing all of the surgical instruments in the eye tray.

c) On 01/05/16 at 8:57 a.m., an interview was conducted with the Director of Services (Director #2) from a company contracted through the facility that provided surgical instruments for ophthalmic (eye) surgeries. Director #2 stated the company loaned 6 surgical trays containing instruments used for eye surgeries to the facility. Director #2 then explained the instruments in the surgical trays could have been from more than one manufacturer although the differences in the instructions for use were minimal.

c) On 01/06/16 at 10:04 a.m. an interview with the Infection Preventionist (Infection Preventionist #3) revealed the facility followed infection control standards from organizations including the Centers for Disease Control and Prevention (CDC) and the Association of Operating Room Nurses (AORN). Infection Preventionist #3 stated s/he did not have an active role in the surgery and had never thought to observe surgeries performed in order to assess proper infection control practices. Infection Preventionist #3 explained his/her role in the Surgical Department of the facility involved being available in a consultative role to answer infection control related questions. Infection Preventionist #3 then stated s/he was unaware that surgical instruments were being processed and sterilized in contrast to manufacturer's instructions.

2. The facility did not follow manufacturer's instructions when disinfecting soiled scopes used for patient procedures.

a) On 01/04/16 at 12:45 p.m. a tour of the scope reprocessing room was conducted with the Endoscopy Technician (Tech #4), who revealed s/he was responsible for the cleaning and reprocessing of the scopes used for patient procedures. Tech #4 stated s/he would fill the sink with water and add one pump of enzymatic detergent to the water. Tech #4 then stated s/he was unaware of what the volume of the sink was but estimated about 3 gallons. Tech #4 further stated that one pump of enzymatic detergent equaled ½ oz. This was in contrast to the manufacturer's instructions which instructed to use 1 fl. oz. to 1 gallon of water.

b) On 01/06/16 at 10:04 a.m. an interview was conducted with the Infection Preventionist (Infection Preventionist #3), who stated s/he was unaware staff was unsure if the correct concentration of enzymatic solution was being used to clean scopes and that the expectation was for staff to follow manufacturer's instructions.