HospitalInspections.org

.
Based on observation, interview and document review the hospital failed to ensure that (1) staff had proper training for decontaminating critical and (2) semi-critical devices, (3) failed to ensure that staff performed appropriate hand hygiene and (4)failed to ensure that staff followed the facility's policy for surgical attire in the operating room for 1 of 2 procedures observed.

Failure to ensure that staff are compliant with the hospital's policies and procedures for infection prevention puts patients at risk of harm from exposure to communicable diseases.

Findings included:

Item #1- Cleaning Critical Devices

1. On 06/06/19 at 10:00 AM, Investigator #4 observed a per diem staff member (Staff #401) in the sterile processing department as she decontaminated surgical instruments used in a previous robotic surgery case. The observation showed:

a. The staff member donned clean gloves over soiled gloves without removing the soiled gloves and performing hand hygiene.

b. The staff member rinsed the instruments with tap water instead of deionized water as indicated by the manufacturer's instructions, because she did not recognize the deionized water spigot adjacent to the sink's tap water spigot despite identified signage above the sink. At the time of the observation, the department's training consultant interrupted the staff member and directed her to re-rinse the items using the appropriate spigot.

2. Document review of the department staff meetings showed that during the June 2018 meeting, staff members received refresher training on cleaning the hospital's "Surgical Intuitive" robotic instruments. The sign-in sheet showed only 1 of 4 per diem staff members were present during the meeting.

Item #2- Cleaning Semi-Critical Devices

1. Document review of the hospital policy titled, "Endoscopes- Cleaning, Handling, Maintenance and Storage Procedure," (effective date 11/30/17), showed that the manufacturer's instructions for use (IFUs) are followed on each step of the pre-cleaning, cleaning and storage processes. The policy does not articulate step-by-step instructions for these steps.

Document review of the manufacturer's label for Medivator's Intercept Detergent shows that for best manual cleaning results, the detergent should be mixed with cool to warm water (68-95 degrees Fahrenheit).

2. On 06/06/19 at 3:00 PM, Investigator #4 observed a registered nurse (RN) (Staff #402) during the cleaning and disinfection of an Olympus endoscope. The observation showed that the staff member prepared the enzymatic cleaner, but failed to assess the water temperature prior to adding the enzymatic cleaner.

3. At the time of the observation, Investigator #4 asked the staff member if they tested the water temperature prior to adding the detergent. The staff member stated that they do not.

4. On 06/07/19 at 3:15 PM, Investigator #4 interviewed the hospital's Regulatory and Accreditation Consultant (Staff #403) about the policy and procedure documents available to staff. The staff member stated that none of the available information directed staff to assess the water temperature for the enzymatic cleaner.
.
Item #3- Hand Hygiene

1. Document review of the hospital's policy titled, "Infection Prevention: Surgical Services," document #WR.30.20, approved 07/16, showed that hand hygiene is performed before and after patient contact, before and after glove use, and any time hands have been soiled or thought to be soiled.

2. On 06/06/19 between 9:34 AM to 10:00 AM, Investigator #8 observed the surgical procedure for Patient #801. The observation showed:

a. A Registered Nurse (RN) (Staff #804), picked up an item from the floor and then returned to opening of sterile supplies to the sterile field without performing hand hygiene

b. A Surgical Technician (ST) (Staff #803) removed an item from the garbage and left the Operating Room (OR) without performing Hand Hygiene (HH).

c. The ST (Staff #803) entered the OR, retrieved the instrument cart, and exited out to the sterile core without performing HH.

d. An RN (Staff #807) entered the OR without performing HH prior to donning gloves.

e. Staff #803 left the OR three additional times without performing HH following removal or donning gloves.

f. Staff #804 removed her gloves to work on the computer and then donned gloves without performing HH.

g. The Accreditation Manager (Staff #808) confirmed the surgical staff were not following hospital policy for hand hygiene practice.

3. On 06/06/19 at 10:25 AM, Investigator #8 observed the surgical procedure for Patient #802. The observation showed:

a. Staff #804 removed her gloves and applied new gloves with performing HH.

b. Staff #803 removed nonsterile gloves and exited the OR without performing HH.

c. Staff #808 confirmed the staff member failed to perform HH consistent with hospital policy.

4. On 06/06/19 at 3:15 PM, Investigator #4 observed a Registered Nurse (RN) (Staff #402) as he cleaned an Olympus endoscope. After decontaminating the endoscope, the staff member changed gloves prior entering required tracking information via keypad to the automated endoscope reprocessing unit. The observation showed the staff member failed to perform hand hygiene prior to donning clean gloves.

Item #4- Surgical Attire

1. Document review of the hospital's policy titled, "Dress Code in the Operating Room," document #WR.30.3 approved 9/17, showed that surgical attire includes head coverings (the covering of head and facial hair) and masks to cover the nose and mouth. The mask is to be secured to prevent venting.

2. On 06/06/19 at 9:34 AM, Investigator #8 observed the surgical procedure for Patient #801. The observation showed:

a. The Physician Assistant (PA) (Staff #801) was present in the OR while sterile instruments were open. The PA failed to secure his mask.

b. The Anesthesiologist (Staff #802) was present in the OR while sterile instruments were open. The Anesthesiologist failed to secure his mask.

c. The Surgeon (Staff #806) entered the operating room carrying his surgical mask in his hand.

d. The Accreditation Manager (Staff #808) confirmed the observation that the hospital staff were not following hospital policy for Surgical Attire.
.


35594

.

Based on observation, interview and document review, the hospital failed to deliver surgical services in a way that kept patients safe from serious harm from exposure to infection caused by improper sterilization of surgical instruments.

Failure to provide surgical services to patients in a way that ensures appropriate sterilization of surgical instruments puts patients at risk of serious harm from exposure to infectious organisms.

Findings included:

1. The surgical staff failed to complete all required elements of the pre-surgical Time Out for patient procedures including confirmation of appropriate sterilization of instruments for 3 of 3 patient discharged records reviewed (Patients #803, #804, and #805) and two observations of patient care (Patients #801 and #802).

2. Sterile processing staff failed to follow the manufacturer's instructions for decontamination of robotic surgical instruments.

Cross Reference: Tag 0749

Due to the scope and severity of deficiencies cited under §42 CFR §482.51 the Condition of Participation for Surgical Services was NOT MET.
.

.
Based on observation, interview, and review of policy and procedure, surgical staff failed to implement a consistent pre-surgical Time Out process. This was demonstrated by 2 of 2 surgical procedures observed (Patients #801, #802) and the review of 3 discharged patient records (Patients #803, #804, #805), including one patient (Patient #803) who was exposed to non-sterilized instruments during her surgical procedure.

Failure to have a consistent Time Out process prior to commencement of an invasive procedure creates opportunities for errors and patient harm.

Reference: Surgical Safety Checklist. World Health Organization; Patient Safety.
Before skin incision, the team is to verify the patient's name and the procedure/site where the incision will be made, review that the antibiotic prophylaxis has been ordered and given, discuss critical events anticipated by Surgeon including what are the critical and non-routine steps, how long with the case take, and if there will be any anticipated blood loss. The Anesthesiologist reports any patient specific concerns. The Nursing team reports any equipment issues or concerns and asks if the sterility (including indicator results) of the instruments has been confirmed.

Findings included:

1. Document review of the hospital's policy titled, "Site Marking, Briefing, Time Out and Debrief: Verification of Patient, Procedure and Procedure Site Procedure," procedure number 900.3.150, effective 1/19, showed the following:

a. Briefing (a check that the surgical/procedural team has performed prior to the Time Out). The purpose is to support the shared mental model and situational awareness for the patient and the procedure to be performed. The elements of the briefing are variable, based on the acuity of the patient and the complexity of the procedure.

b. A Time Out is completed immediately prior to the start of the invasive procedure. The responsibility for the Time Out is a coordinated effort involving the procedural team. The surgeon facilitates the Time Out. Staff stop all activity to actively participate in the Time Out process immediately prior to the start of the procedure. The following elements are verbally communicated in the Time Out and each member must agree to the following:
- Correct Patient
- Correct Procedure
- Surgeon verbally verifies the correct side.
- Each member of the Team must verbally agree prior to proceeding.

c. The circulating registered nurse (RN) documents the completion of the Time Out in the patient's medical record.

Document review of the hospital's Time Out Checklist titled "Briefing" -printed from the hospital's electronic documentation system showed that before the induction of anesthesia, the following questions were ascertained:

-Patient identified with 2+identifiers
-Procedure & site confirmed
-Consent verified
-White Board verified
-Sterility verified
-Team introduced
-Site marked
-Allergies reviewed
-Anesthesia/sedation plan of care reviewed
-All members of the team have discussed care plan and addressed concerns.

2. On 06/06/19 at 10:14 AM, Investigator #8 interviewed the Accreditation Manager (Staff #808) and the OR Charge Nurse (Staff #810) about the Time Out area of the EMR. Investigator #8 noted that the EMR allows each question to be individually clicked "Compliant" or "Not Compliant." Investigator #8 also observed that, above the "Compliant" button is another button titled "CONFIRM ALL" which allows staff to confirm all elements, even if the surgical team failed to ask the question. For example, "Have sterility of the instruments been confirmed?" Staff #808 and Staff #810 stated that they were not sure if staff answered all the questions before affirming the completion of the Time Out, prior to each surgical procedure.

3. Investigator #8 reviewed discharged medical records for 3 surgical patients (Patient #803, 804, 805). The document review showed:

a. Review of the discharged medical record for Patient #803, who received exposure to non-sterile instruments during her surgery on 05/02/19, resulting in post-exposure prophylaxis for Human Immunodeficiency Virus and testing for Hepatitis B, showed the EMR entry for "Have sterility of the instruments been confirmed?" marked as "Compliant".

b. Review of the discharged medical records for Patient #804 and #805 showed that the Time Out check boxes were all checked or confirmed.

4. On 06/06/19 at 9:34 AM, Investigator #8 and the OR Charge Nurse manager (Staff #810), observed the briefing and Time Out for Patient #801. The observation showed:

a. The Circulating RN (Staff #804), read aloud the procedure listed on the consent, then reported that the consent was signed, allergies verified, and intravenous antibiotic were received. Surgical Team members reported verbally in agreement. The staff failed to verify patient identification with 2+ identifiers, perform a white board verification, an instrument sterility verification, and the staff failed to discuss the care plan or address concerns prior to surgical incision.

b. On 06/06/19 at 10:14 AM, Investigator #8 interviewed the OR Charge Nurse Manager (Staff #810) about the observations. Staff #810 stated that the staff confirmation of the 2+ patient identifiers is completed as the patient enters the OR, not during the Time Out process.

5. On 06/06/19 at 10:44 AM, Investigator #8 and the OR Charge Nurse manager (Staff #810), observed the procedural briefing and Time Out for Patient #802. The observation showed:

a. The Circulating RN (Staff #807), read aloud the procedure listed on the consent, then reported that the consent was signed, allergies verified, and that intravenous antibiotic was not indicated. The Surgical Team members provided verbal agreement. The staff failed to verify patient identification with 2+ identifiers, perform a white board verification, an instrument sterility verification, and the staff failed to discuss the care plan or address concerns prior to surgical incision.

b. On 06/06/19 at 10:52 AM, Investigator #8 interviewed the OR nurse (Staff #807) about staff failure to verify patient's identification. Staff #807 stated that staff complete the patient identification as the patient enters the operating room.

6. On 06/06/19 at 3:30 PM, Surveyor #8 interviewed the Accreditation Manager (Staff #808) and the OR Charge Nurse Manager (Staff #810) about the observed non-compliance during the pre-surgical Time Out for Patients #801 and #802, and the use of the "CONFIRM ALL" toggle button for documentation of the Time Out responses in the patient EMR. The staff members confirmed this created a gap in the verification process for the surgical Time Out.