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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the §482.42 Condition of Participation: Infection Control was out of compliance.

A-0749- Standard: The hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There must be an active program for the prevention, control, and investigation of infections and communicable diseases. Based on interviews and document review the facility failed to follow standards related to the reprocessing of surgical instruments to prevent the spread of infection. Specifically, the facility failed to prevent the routine use of immediate-use steam sterilization (IUSS) as a method for sterilizing surgical instruments. The failure was identified in 3 of 3 months of IUSS logs reviewed (May - July 2019). The facility further failed to perform standard precautions which consisted of hand hygiene and wearing hand protection in the surgical preoperative setting. The failure was identified in 2 of 3 observations of staff members completing iodine nasal swabbing during patient care in the outpatient surgical department.

Based on interviews and document review the facility failed to follow standards related to the reprocessing of surgical instruments to prevent the spread of infection. Specifically, the facility failed to prevent the routine use of immediate-use steam sterilization (IUSS) as a method for sterilizing surgical instruments. The failure was identified in 3 of 3 months of IUSS logs reviewed (May - July 2019). The facility further failed to perform standard precautions which consisted of hand hygiene and wearing hand protection in the surgical preoperative setting. The failure was identified in 2 of 3 observations of staff members completing iodine nasal swabbing during patient care in the outpatient surgical department.

Findings include:

Facility policy:

According to the "Perioperative Services/Sterile Processing Department Immediate Use Steam Sterilization Procedures", IUSS should be kept to a minimum. IUSS was a shortened sterilization process for certain instruments or devices needed for immediate use in a surgical procedure. IUSS described the process by which surgical instruments are sterilized for immediate use should an emergency situation arise during the surgery.

The Hand Hygiene-Outside the Surgical Setting protocol stated an indication for hand antisepsis was after touching a patient or patient's surroundings and /or exit from an occupied patient room.

1. The facility failed to prevent the routine use of immediate-use steam sterilization (IUSS) as a method for sterilizing surgical instruments.

a. On 7/30/19 at 1:30 p.m. an interview was conducted with the sterile process department (SPD) Supervisor (Supervisor #8). Supervisor #8 stated the SPD department was experiencing barriers which led to the routine utilization of IUSS cycles in order to have surgical instruments available for scheduled surgical cases. Supervisor #8 also reported delays from vendors providing "loaner instruments" for use in the operating room as a common barrier to completing full sterilization cycles. Supervisor #8 stated vendors were not consistently providing instruments at least 24 hours prior to scheduled cases in order for SPD staff to complete timely inspection and reprocessing (both the disinfecting, washing, and the sterilization of surgical instruments) of the loaner instruments. Supervisor #8 contributed vendor delays with loaner instruments as a common reason for the lack in surgical instrument availability. Supervisor #8 stated delayed vendor instruments contributed to the utilization of IUSS cycles in order to ensure the instruments were reprocessed and available for the scheduled cases that day.

b. A document review was conducted of the Immediate-Use Summary report provided for the months of May through July 2019. Review of the document found the facility completed IUSS cycles 567 instances during that time frame.

Of the 567 IUSS entries documented, 505 of the IUSS entries were documented as performed because there was "not enough inventory" which accounted for approximately 89% of the sample reviewed on the IUSS Summary Report.

Of the 567 IUSS entries documented, 42 entries were documented as performed because "loaner tray dropped off late" which accounted for approximately 7% of the sample reviewed on the IUSS Summary report.

The findings were not compliant with facility policy which read IUSS cycles should be kept to a minimum and used only in urgent clinical situations. The facility stated the national guidelines which they had adopted for sterilization were the AAMI guidelines which read "IUSS should not be used for purposes of convenience or as a substitute for sufficient instrumentation".

According to the Association for the Advancement of Medical Instrumentation (AAMI) ST79-2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities (pg. 63), "IUSS should not be used for purposes of convenience or as a substitute for sufficient instrumentation." Instrument inventories should be sufficient to meet the anticipated surgical volume and ensure that there is enough time to complete all critical elements of reprocessing. IUSS should be kept to a minimum and should only be used in urgent clinical situations.

c. On 8/1/19 at 12:10 p.m., an interview was conducted with the Manager of Infection Prevention (IP #4).

IP #4 stated the facility was actively trending IUSS rates and were currently above the goal target of approximately 3-5% which on review of the facility's IUSS Year Percentages found IUSS percentage rates increased approximately 4.6% from April 2019 to June 2019: April 2019 was documented as 3.83%, May 2019 was documented as 6.09%, and June 2019 was documented as 8.50%.

IP #4 stated the purpose for IUSS was to be utilized during emergent situations in the operating room, such as a specialized instrument dropped on the floor during a procedure and compromised the sterility. IP #4 stated routine utilization of IUSS for non-emergent situations was not consistent with infection prevention guidelines because those instruments may be reprocessed faster due to time constraints, and lacked a full sterilization cycle with completed dry time prior to use during a procedure. IP #4 stated a lack of instrument availability, such as vendors causing delays in instrument availability, were not considered emergent situations and should be avoided as a substitute for a full sterilization cycles in those instances.

IP #4 stated various reasons contributed to the lack of instrument availability, and the facility was still ongoing with their efforts to resolve those concerns and prevent staff from routinely utilizing IUSS for non-emergent reasons.

d. On 7/29/19 at approximately 3:47 p.m., an interview was conducted with an operating room (OR) registered nurse (RN #6) who stated staff routinely performed IUSS in order to make surgical instruments available for upcoming scheduled surgical cases.

RN #6 stated OR staff routinely needed contaminated surgical instrument for an upcoming scheduled surgical case, but because of lack of time in between cases staff utilized IUSS cycles instead of full sterilization cycles. RN #6 stated the process for IUSS involved returning contaminated instruments to the decontamination area of the Sterile Processing Department (SPD) with a "red tag" containing a "case number". RN #6 stated the purpose of the red tag was to indicate to SPD staff the surgical instruments contained were required for use immediately, therefore indicating the need for IUSS.

e. On 7/30/19 at 12:30 p.m., an interview was conducted with a SPD technician (SPD #7). SPD #7 confirmed the red tag IUSS process and stated IUSS cycles could only be performed on surgical instruments after receiving a supervisor's approval.

SPD #7 included a "lack of inventory", and "[lack of] enough time" as common reasons the SPD performed IUSS cycles to reprocess surgical instruments. Staff #7 stated surgical cases were scheduled too closely together and either there was not enough instruments, or not enough time in between cases, to complete full sterilization cycles (sterilization cycles which include a full drying-time according to manufacturer instructions) on the available contaminated instruments.


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2. The facility failed to ensure staff performed hand hygiene and wearing gloves according to facility infection control guidelines to prevent the spread of infection.

a. An observation of a patient nasal swab was performed on 7/30/19 at 10:00 a.m. in the pre-operative area of the outpatient surgical department. The observation revealed the pre-operative registered nurse (RN #1) did not apply gloves during the patient contact. This was in contrast to the facility adopted guidelines of infection control which read, part of routine infection control practices included standard precautions of wearing gloves for situations involving known or anticipated contact with blood, body fluids, tissue, mucous membranes, or nonintact skin.

b. On 8/1/19 at 10:00 a.m., outpatient pre-operative nurse (RN #2) was interviewed and stated hand hygiene should be performed prior to going into or coming out of a patient's room in order to prevent the spread of infection. RN#2 stated hand hygiene should be performed after gloves were removed and gloves should be worn during nasal swabbing to prevent possible cross-contamination from droplet secretions between patient and staff.

c. On 7/30/19 at 10:35 a.m., a second observation was conducted of a patient in Room 31 in the outpatient surgical department. The observation revealed advanced care partner (ACP #5) performed an Iodine nasal swabbing (antiseptic swab) of the patient. During the observation ACP #5 did not perform hand hygiene prior to patient contact. ACP #5 was then observed, without gloved hands, perform the nasal swab. ACP #5 discarded the supplies and was not observed performing any hand hygiene after the patient contact.

d. On 7/30/19 at 10:35 a.m., ACP #5 was interviewed and stated it was important to perform hand hygiene prior to and after patient contact. She stated she forgot to wear gloves while performing the Iodine nasal swab. ACP #5 also stated hand hygiene would reduce the risk of infection to both patients and staff.

e. On 8/1/19 at 12:11 p.m., the manager of infection control (IP #4) was interviewed and stated staff were to follow the adopted national standards which required hand hygiene and glove use during and after patient contact. IP #4 also stated gloves were to be used during any contact with body fluids, blood, or when touching contaminated supplies.

Lippincott Standard Precautions state "Part of routine infection control practices, standard precautions include wearing gloves for situations involving known or anticipated contact with blood, body fluids, tissue, mucous membranes, or nonintact skin."

The World Health Organization (WHO) lists five moments for Hand Hygiene as: before patient contact, before aseptic task, after body fluid exposure risk, after patient contact, and after contact with patient care surroundings.