HospitalInspections.org

Based on review of facility documents, review of medical records and interview, the facility failed to ensure the use of restraint was in accordance with the order of a physician.

Findings were:

Facility policy entitled "Restraint Policy" stated in part "When clinically indicated, the RN who is trained in restraint technique upon a physician/LIP's order implements the restraint procedure."

5 medical records of restrained patients were reviewed. 1 of 5 restrained patients did not have a physician order for restraint. Patient # 12 was restrained on 5/17/19 without a physician order.

The above information was confirmed by the Director of Quality on June 19, 2019.

Based on observation and interview, the facility failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. The infection control officer failed to implement policies governing control of infections and communicable diseases.

Findings were:

"OSHA/Bloodborne Pathogen Regulations Policy #138-030-060" stated in part "The facility provides sufficient housekeeping and maintenance personnel to maintain the interior and exterior of the facility in a safe, clean, orderly, and attractive manner."

According to FDA Food Code 2009: Annex 3 - Public Health Reasons / Administrative Guidelines - Chapter 4, Equipment, Utensils, and Linens, "4-901.11 Equipment and Utensils, Air-Drying Required: Items must be allowed to drain and to air-dry before being stacked or stored. Stacking wet items such as pans prevents them from drying and may allow an environment where microorganisms can begin to grow. Cloth drying of equipment and utensils is prohibited to prevent the possible transfer of microorganisms to equipment or utensils."

During a tour of the surgical areas of the hospital on the morning of 6/18/19 with the Director of Infection Control and Director of Surgical Services, the following infection control issues were noted:

In the Stat Lab in the surgical suite:
o There was an area approximately 12" x 1" on a counter where the laminate had been broken off exposing the permeable wood surface beneath. A permeable surface makes effective cleaning impossible as contaminants can penetrate the surface.
o The floor was dirty.
o There were chips in the countertop, again making effective cleaning impossible.
o Clean linen ready for patient use was stored uncovered in the clean utility of the front hallway. Uncovered linen is left exposed to airborne contaminants, including such sources as sneezes and coughs among others, and potential spills.

In an interview with the Directors of Infection Control and Surgical Services during the tour, they confirmed the above findings.

During a tour of the nursing units and emergency department on the afternoon of 6/18/19 with the Director of Quality, the following infection control issues were noted:

o Outside sunlight could be seen under two sets of exterior doors in the hallway near the overflow care unit.
Openings to the exterior can serve as portals for pests and dust or debris.
o A chair on the Acute Care II unit adjacent to the nursing station had cracked vinyl which made thorough cleaning impossible.
o Small approximate 1" squares of old sticky hanging foam and Velcro were found throughout the facility, including in the pre-op nursing station and on the nursing units
o Beds were made after being sanitized. The mattresses were not allowed to air dry before linens were applied.
o Chipped paint on head boxes (behind patient beds) and on IV stands. This chipped paint makes through sanitizing impossible.

Tour of the kitchen on June 18, 2019 revealed the following:
o A soiled filter was noted above the ice machine
o Wet pans were stacked on top of one another and not allowed to air dry
o Review of the Café-Daily Cleaning Schedule revealed no documented cleaning of the flat grille, flame grill, deep fryer, pizza oven, microwave, tables/countertops, potato bar, salad bar, steam table, coffee/tea dispensers, toasters, or floors on 6/8/19. There is no documented cleaning of the Nourishment Room coffee pot on 6/4/19 and 6/5/19.

In an interview with the Director of Quality during the tour, she confirmed the above findings.


Based on a review of facility documentation and staff interview, the facility failed to equip the ORs with the appropriate quantity of surgical instruments for the daily procedure volume of the hospital as the facility was routinely using sterilization procedures intended for emergency use only as its standard method of sterilization between cases in order to reuse surgical instruments. This practice is contrary to current standards of practice. In addition, the hospital policy addressing immediate-use steam sterilization (IUSS) was not congruent with current regulatory standards. The use of immediate-use steam sterilization of surgical instruments on a routine basis, and the inadequate policy addressing this type of sterilization, placed any patient undergoing a surgical procedure at the hospital at risk for possible infection.

Findings were:

Facility policy #6559672 entitled "Immediate-Use Steam Sterilization/Flash Sterilization," included the following:
"PURPOSE
To provide proper guidelines for immediate-use steam sterilization.
POLICY
1. IUSS (immediate-use steam sterilization)/flash sterilization will be used only when the particular instrument is not available otherwise.
2. Items that are flash sterilized must be used immediately.
3. The flash sterilizer is to be biologically monitored at the beginning of each day that cases are performed prior to start of the first case..."

A review of the hospital's and outpatient surgery center's IUSS log for 2018 and 2019 revealed multiple loads which were sterilized by immediate-use steam sterilization. For example in 2018, there were 98 listings documenting the use of IUSS which did not indicate emergency use. Only a few of the listings included reasons for this use. These reasons included: "Only have one set," "Quick Turnaround," "Needed a Extra," "We only have 2 sets," "Needed for case," "Only One Instrument," etc.

In an interview with the Director of Infection Control during a tour of the sterile processing area on the morning of 6/18/19, she stated, "We've bought a lot of instruments since last year. We've come way down on the use of IUSS now, and we're doing much better on that..."

All the above findings were confirmed with the hospital chief executive officer and other administrative staff on the afternoon of 6/19/19 in the hospital meeting room.

A statement by the American Society of Cataract & Refractive Surgery, prepared on February 16, 2007, and available at http://eo2.commpartners.com/users/apic/downloads/
RecPracticesCleaningSterilizingIntraocular.pdf included the following:
" c. Flash sterilization is designed to manage unanticipated, urgent needs for instruments. Flash sterilization should not be used to save time or as a substitute for sufficient instrument inventory ..."

Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008, published by the CDC, and available at http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf, includes the following: "Flash sterilization should not be used for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time ..."

A position statement on Immediate Use Steam Sterilization endorsed by the Association of perioperative Registered Nurses, Association of Professionals in Infection Control and Epidemiology, as well as a number of other surgical services professional organizations, and available at
http://www.apic.org/Resource_/TinyMceFileManager/
Position_Statements/Immediate_Use_Steam_Sterilization_022011.pdf, includes the following:

" "Immediate Use" is broadly defined as the shortest possible time between a sterilized item's removal from the sterilizer and its aseptic transfer to the sterile field ...A sterilized item intended for immediate use is not stored for future use, nor held from one case to another ...

It should be noted that IUSS is not equivalent to "short cycle" sterilization. Regardless of the cycle duration, correct use of a sterilization cycle for a wrapped/contained load that meets the device manufacturer's instructions for use (IFU) is the equivalent of terminal sterilization and is not IUSS if it includes use of a dry time and is packaged in a wrap or rigid sterilization container intended to be stored for later use ...

Professionally Accepted IUSS Standards of Practice

Consistent with standards of practice previously articulated by national associations with expertise in infection prevention, the availability of IUSS is not considered an appropriate substitute for maintaining a sufficient inventory of instruments ... While IUSS will accomplish sterilization if all of the steps before, during, and after the process are performed correctly, and used in compliance with specific device manufacturer's; sterilization manufacturer's; and, if applicable, container manufacturer's validated written instructions for use (IFU). Practices associated with the outmoded term "flash" sterilization have been implicated in surgical site infections and are considered to pose an increased risk of complications because of potential barriers to thorough completion of all necessary reprocessing steps ... IUSS also entails an increased risk of inadvertent contamination during transfer to the sterile field and damage to the instruments ... as well as risks related to wet instruments and the potential for burns ... Therefore use of IUSS, even when all steps are performed properly, should be limited to situations in which there is an urgent need and insufficient time to process an instrument by using terminal sterilization ..."

AORN (Association of perioperative Registered Nurses) 2015 Guidelines for Perioperative Practice includes the following:

"Immediate use steam sterilization (IUSS) should be kept to a minimum and should be used only in selected clinical situations and in a controlled manner ...Immediate use steam sterilization may be associated with increased risk of infection to patients ...

VII.a. Immediate use steam sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization. Immediate use steam sterilization should not be used as a substitute for sufficient instrument inventory ..."