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Based on observations, record reviews, and interviews, the hospital failed to meet the requirements of the Condition of Participation of Surgical Services as evidenced by:

1) failure to have an effective system in place to ensure contaminated surgical trays did not reach the operating room or were used in surgery for 4 (#1, #2, #4, #6) of 6 sampled patients (See findings at A-0951). ; and

2) failure to ensure staff wore personal protective equipment in restricted areas according to AORN standard and hospital policy as evidenced by multiple observations of hair and facial hair not contained within the bouffant hat, mask, and/or beard cover, masks worn hanging around necks, personal undershirts exposed outside of scrub suits, personal (laundered at home) cloth head covers were covered with a hospital supplied bouffant cap, and arms not covered with a jacket in the restricted areas (See findings at A-0951).

Findings:

Based on observations, interviews and record reviews, the hospital failed to ensure the policies governing surgical care designed to assure the achievement and maintenance of high standards of medical practice and patient care were implemented and enforced. This deficient practice is evidenced by not having an effective system to ensure contaminated surgical trays did not reach the operating room or were used in surgery. An Immediate Jeopardy situation was identified on 10/30/19 at 2:40 p.m. and presented to S47COO and S1CNO.

Review of medical records revealed on 10/16/19 Patient #2 had surgery for a fractured Tibia. A contaminated instrument was discovered in the surgical tray that was being used during the procedure and was not discovered until the surgery was in progress. As a result, Patient #2 had prolonged anesthesia as the contaminated tray and sterile field were removed and a new sterile field and tray were assembled. Three potentially contaminated screws were removed from the patient's Tibia and two new larger screws were inserted. The contaminated instrument had gone through 5 steps in the decontamination and sterilization processes including two steps at an offsite campus in Ascension Parish where the instrument was previously used. The contamination of the instrument was not discovered until during the surgical procedure.

Multiple cases were reviewed where contaminated surgical trays were not discovered until they reached the operating room.

Review of Patient #6's incident report dated 6/19/19 revealed that on 6/18/19 at 8:00 a.m. on 2 separate accounts a brown substance began leaking out of a Stryker Saber ear drill onto the patient and the sterile field.

Review of Patient #1's medical record revealed
she had been admitted on 7/16/19 to pre-op for Spinal Stenosis of her lumbar region. Further review revealed the surgery had been rescheduled to 7/25/19 due to instrument contamination.

Review of Patient #5's incident report dated 6/18/19 revealed that on 6/18/19 at 1:00 p.m. there was a 3 hour delay in surgery due to improper sterilization of operating equipment. Containers that arrived to the OR had been contaminated with hair, a mosquito and punctures in the wrapping.

Review of Patient #4's incident report dated 10/29/19 revealed that on 10/29/19 at 7:38 a.m. a contaminated instrument was found while checking pans in the OR.

Review of quality data revealed from 10/16/19 through 10/25/19 there were 29 surgical trays with contaminated debris. The hospital was unable to provide information on how many of the 29 trays reached the operating room. As recent as 10/29/19 a contaminated surgical tray reached the operating room.

The main campus does an average of 1,917 surgical cases per month. Surgeries and sterile processing are performed at the main campus and 3 offsite campuses.

On 10/31/19 at 9:15 a.m. S47COO presented the plan for lifting the immediacy of the Immediate Jeopardy situation, and the plan included the following:

1. Immediate Corrective Measures used to ensure there is an effective system to ensure contaminated surgical trays do not reach the operating room or used in surgery:
1.1 Created and implemented an instrument inspection reporting form to track and identify the root cause of the issue and to put in place measures to prevent the issue from reoccurring (Form provided)
1.2 Implement point of service process check in Sterile Processing-Sterilization Station selected for 2nd point-of-service process document using the Quality Assurance Checklist. (Checklist provided)
1.3 Created process to include Quality Assurance Checklist in the instrument set along with the surgical count sheet as a validation tool to the OR team of the second point of service process check.
1.4 SPD team education on newly implement point-of-service Quality Assurance process (Staff meeting minutes 10/30/19 and sign-in sheets provided)
1.5 SPD Leader or designee to audit Quality Assurance point-of-service. Audits will be performed weekly on 20 sets per sterile processing area.
1.6 The instrument inspection form and quality assurance data will be reviewed for compliance during the joint OR/SPD Huddle, including senior leaders. The expectation is that an Instrument Inspection form completed would also include the Quality Assurance Checklists for sets processed after midnight on 10/30/19.
1.7 Weekly compliance tracking data is reviewed by senior leaders as part of CEO Monday Senior Management Team meeting.
2: Immediate Corrective Measures used to ensure that the contaminated surgical trays do not reach the patient.
2.1 Instrument sets will continue to be opened and inspected prior to patient arrival to the
Operating room (EMR time out sample provided).
2.2 OR Staff assigned Point of Use and Accountability for Surgical Instruments/Sets
Education through online learning system (education content provided)
2.3 Any defect found with the instrument set will be documented on the OLOLRMC
Instrument Inspection sheet. This sheet will be attached to the Quality Assurance
Checklist and provided to the respective Operating Room Directors. Operating
Room
Directors to report at joint OR/SPD Huddle (meeting) regarding defects and
Non-compliance. (QA sheet provided)
2.4 Instrument sets with defect will be identified and data will be tracked through the
OLOL Instrument Inspection sheet. This data will be analyzed for trends and patterns
to include but not limited to personnel, defect type, service, and instrument type.
Data analyses will be aggregated weekly and monthly and reported to joint OR/SPD
Huddle.
2.5 Instrument sets with defects that make it to the sterile field during the procedure will
be entered into the Quantros System (electronic occurrence reporting system).
3: Surgical Attire for All Restricted and Semi-Restricted Areas. Immediate Corrective Measures used to ensure that team members, physicians, students, vendors, contract providers, and support staff adhere to surgical attire standards.
3.1 Using the AORN 2019 Guidelines for Peri-Operative Practice, the Senior Director of
Peri-Operative Services revised the existing SOS002Surgical Attire Policy (revised
policy provided.)
3.2 Compliance to the revised policy will be monitored by OR Supervisors or their
designee per shift. In addition, Infection Control and Quality specialists have been
assigned surveillance monitoring for PPE. Any non-compliance will be corrected
immediately. Operating Room Directors will report at the joint OR/SPD Huddle
regarding defects and non-compliance. Non-compliant individuals will be
documented and forwarded to respective leaders for further review and corrective and
progressive disciplinary actions.
3.3 PPE Audit Forms will be analyzed for trends and patterns. Data will be aggregated
Weekly and monthly and reported to joint OR/SPD Huddle.
4. Immediate Corrective Measures used to ensure that team members, physicians, students, vendors, contract providers, and support staff are educated on Sterile Processing Quality Assurance and Surgical Attire.
4.1 Developed and Implemented Computer Based Learning (CBL) modules that has been
Distributed to team members, physician, students, vendors, contract providers, and
staff. Completion of these CBLs will be done by their next scheduled shift with
100% compliance by 11/15/2019.
4.2 Medical Directors contacted each surgeon performing surgery on 10/13/19 to discuss
Implemented process changes in addition to the education and attestation.
4.3 COO and LPG President met with key physicians including but not limited to Trauma
Service, Surgeons Group of Baton Rouge, Cardiothoracic Surgeons, Colorectal
Surgeons, on 10/30/19 at 5:30 p.m. to discuss process changes, educational
requirements, and attestation.
4.4 CMO sent an electronic communication to all medical staff providers to discuss
Educational requirements, and attestation.
4.5 Contract services including but not limited to environmental services, biomedical
engineering, facilities management and LOPA were sent education and attestation.
4.6 Surgical Services Division huddle including clinical team members, Anesthesia and
Medical staff held to reinforce expectations regarding surgical attire, instrument
Inspection processes, quality assurance, safety event report, and point of use
cleaning.
4.7 Daily compliance with 4.1 is communicated by the Director, Clinical Education to
The respective surgical services and medical staff leaders. Compliance with quality
Improvement plan and PPE adherence will be reviewed at Surgical Services
Department meetings and huddles. Compliance with quality improvement plan and
PPE adherence will be reviewed at Surgical Chiefs.
4.8 Medical Staff Services will evaluate compliance for 4.1 for medical staff.
4.9 Expectations for Peri-operative will be integrated into new team member and medical
staff orientations.
Each planned action had the date started, the date of completion, and the Responsible person.


In an interview 10/31/19 at 9:15 a.m. S1CNO reviewed the hospital's plan to remove the immediacy of the IJ with surveyors. The CNO reported the education had already touched 71% of the staff on the main campus (10/30/19 p.m. and 10/31/19 a.m.) and was being conducted on all surgical and SPD staff. She reported all vendors are currently being required to view the education and sign an attestation before they can sign into the vendor tracking system and enter hospital departments. The CNO reported emails had been sent to all credentialed staff and mid-level providers to include RNFAs, CRNAs, and SRNAs as well as students that would enter the surgical department and/or SPD.

Surveyors reviewed education content and sign-in sheets for surgical services staff, revised policies and procedures, and forms included in the plan of correction presented to remove the immediacy of the IJ.

Observations were made 10/31/19 from 9:45 a.m. to 10:45 a.m. in the main OR, tower OR, main SPD, and tower SPD departments accompanied by S4DirSurgSvc and S37ORDir. Observations were made of surgical instruments and cases being opened and inspected, staff attire in the restricted and semi-restricted areas of the surgical and SPD departments. Staff were interviewed and able to describe training provided earlier that morning. No problems were noted throughout the observations.

In an interview 10/31/19 at 11:30 a.m. S1CNO and S47COO were informed that the plan presented for lifting the immediacy of the IJ situation was accepted. S1CNO and S47COO were informed that, since there was not enough evidence to determine sustainability of the plan, the Condition of Participation of Surgical Services would remain at the condition level.




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Based on observations, interviews and record reviews, the hospital failed to ensure the policies governing surgical care designed to assure the achievement and maintenance of high standards of medical practice and patient care were implemented and enforced. This deficient practice is evidenced by:

1) failure to have an effective system in place to ensure contaminated surgical trays did not reach the operating room or were used in surgery for 4 (#1, #2, #4, #6) of 6 sampled patients;

2) failure to ensure staff wore personal protective equipment in restricted areas according to AORN standard and hospital policy as evidenced by multiple observations of hair and facial hair not contained within the bouffant hat, mask, and/or beard cover, masks worn hanging around necks, personal undershirts exposed outside of scrub suits, personal (laundered at home) cloth head covers were covered with a hospital supplied bouffant cap, and arms not covered with a jacket in the restricted areas; and

3)failure to enforce safe injection practices policies and procedures, as evidenced by 3 observations of medications in ORs being set-up for a surgical procedure that were not properly labeled and left unattended by anesthesia staff that had prepared them, and observation of an opened, unlabeld bag of IV fluid lying on a counter in an OR being set-up for a surgical procedure, where staff denied knowledge of the origin or purpose of the IV fluids, or if it had been left from a previous surgical case.

Findings:

1) Failure to have an effective system in place to ensure contaminated surgical trays did not reach the operating room or were used in surgery for 4 (#1, #2, #4, #6) of 6 sampled patients.

Review of the hospital's policy titled Decontamination, Cleaning of Surgical Instruments revealed in part:
Policy: All contaminated reusable surgical instruments will be decontaminated, rendering them safe for handling, according to the manufacture instructions for use.

Review of the hospital's policy titled Instruments, Inspection and Assembly revealed in part:
Policy: All instrument(s) will receive a final inspection before storage, packaging and sterilization.
Procedure:
1. All instruments will be inspected at the work station for functionality and cleanliness.
15. After inspection and assembly, instrument sets will be packaged according to procedure and sterilized.

Review of the hospital's policy titled Sterilization Verification revealed in part:
Purpose: To ensure a process for identifying compromised sterile products/items and for load recall.
2. Any sterilized package that is torn, soiled or otherwise compromised prior to use is considered contaminated and will not be suitable for use.
4. The end user is responsible for ensuring quality control of processed goods.

Review of the hospital's policy titled Asepsis, Basic Surgical Principles revealed in part:
Purpose: To define aseptic practices to prevent contamination of the patient's wounds.
Policy: Principles of surgical asepsis should be practiced by all persons entering the Perioperative Services Department.
Procedure:
Basic principles of aseptic technique include but not limited to the following:
1. All materials in contact with the wound and in contact with the sterile field must be sterile. Sterile items must also be checked for package integrity, expiration date (if present), and the appropriate change in sterility process monitors if present.

Patient #2
Review of Patient #2's medical record revealed the patient arrived on 10/15/19 to the hospital's emergency department at 1:30 a.m. with the chief complaint of a fall prior to arrival. Documentation revealed Patient #2 was determined to have a closed fracture of the right tibial plateau.

Review of Patient #2's operative report revealed in part:
Procedure Performed:
1. Open treatment of right bicondylar tibial plateau fracture
2. Closed reduction with intramedullary rod placement right tibia.
Procedure in Detail:
Prior to using the opening reaming device it was identified that the previously used starting point wire was stuck within the opening reamer. This was present from the last patient this set was used on. At no point was this instrument placed inside the patient. Just because of this we considered the entire sterile field to be contaminated along with the wounds. The decision was made at this point to close his wounds remove all of the drapes remove the back table instrumentation and can perform a complete new set up.
The 5.0 cannulated screws were then removed along with the washers.
Due to the unavailability of a second 5.0 cannulated screw set, 6.5 screws were decided to be used. Only 2 screws were placed due to the increased size of the screw.

Review of an incident report involving Patient #2 dated 10/17/19 at 12:49 a.m. revealed the following occurrence from 10/16/19 at 8:00 p.m.: The procedure for Patient #2 was setup by myself (S13RN) and S33ST. All instrument pans were checked for sterility and gross contamination prior to bringing the patient in the room. The procedure progressed as intended until S7MD went to use the initial reaming instrument that is placed over a guidewire. It was noticed that a previously used guidewire was left inside the reaming instrument and therefore the instrument was to be considered contaminated. That set had been placed on the sterile field and it is our policy to consider the entire table contaminated in such an instance. And since incision had been made and screws implanted prior to noticing the contaminated instrument, we are to consider that the entire procedure has been contaminated. The contaminated setup was discarded and broken down and new instruments and setup were brought in, drapes were removed and the patient was re-prepped and draped. The procedure continued without further incident.

The medical record provided by the hospital for the last patient (Patient #3) that had the same surgery kit used previously to Patient #2 revealed he had been admitted to surgery at the hospital's offsite campus on 9/29/19 at 11:55 p.m. with wounds to the right lower leg. Two wounds were noted, right lateral and medial lower extremity, with mild bleeding. Tetanus not up to date, which was updated in the emergency room. During surgery Patient #3 had a right Tibia IM nailing and 3 screws placed.

In an interview on 10/28/19 at 4:00 p.m. with S8MD Infectious Disease, she said S7MD had done a surgery on Patient #2's Tibia on 10/16/19. She said S7MD said he did the tibial component and had to use a piece of equipment with a hollow bore and a guidewire fell out during the procedure. She said S7MD said it had to have come from the previous case because he had not yet put a guidewire in the piece of equipment. She said at that point he stopped the case and considered the equipment contaminated. She said the set was a vendor set used at another hospital. S8MD reported that the kit had been used at an offsite campus on September 30th and then had gone to the vendor's office. She said Patient #3 had no previous lab work because it was an emergency surgery.

In an interview on 10/18/19 at 1:30 p.m. with S6OrthoNsgDir he said in the operating room before a procedure begins, the scrub technician and circulating nurse check the sterility of the surgical pack, that the wrap is intact, and the instruments are examined for contamination. He said the circulator will open items that are not sterile and the scrub technician will check the items for sterility. Once they are determined to be sterile, the instruments are placed onto the sterile field by the scrub technician. After surgery, prior to going down to processing, the instruments are wiped in the OR and placed back in the container they came in and transported to the dirty side of the sterile processing. He said there they are soaked in water for he thinks 5 minutes and then rinsed with high pressure water, then loaded into a tunnel washer. Before placing them into the tunnel washer, the person cleaning checks the instruments for debris as they go. He reported then once the tunnel washer cycle is complete, the clean and dry instruments are organized and inspected for cleanliness by the SPD technician. S6OrthoNsgDir said then the instrument kit is sterilized. Once sterilized, the clean instruments are placed on an elevator or dumbwaiter and sent to the next floor above which is open to the sterile core where the instruments are kept. He said the root cause analysis done by the hospital showed that the contaminated kit used on Patient #2 was human error and the contamination was missed at all three checks at the main campus. He verified there were 5 opportunities for the wire to be discovered prior to the Patient #2's surgery (2 in sterile processing at offsite campus, 2 in sterile processing at the main campus and the scrub technician in Patient #2's surgery).

In an interview on 10/29/19 at 9:48 a.m. with S14Vendor, he said he specialized in orthopedic trauma cases. He said in Patient #2's case, the set that was used is the only one like it in Baton Rouge. He said there are other kits for the same purpose but this was a new version. He said the reamer where the wire was discovered is the same as the others he has used for the past 6 years so there was nothing unusual about it. He said Patient #2's instrument kit was previously used at the offsite campus in Ascension. He said he was in Patient #2's case on 10/16/19. He said when S7MD was handed the reamer he saw the wire so they stopped everything and got a new kit. He said at the offsite before being sent here to the main campus, the kit would have been washed but not sterilized. He verified it should have been checked at the offsite by the person scrubbing on the dirty side and the person wrapping on the clean side. He said the diameter of the reamer and the diameter of the guide wire are almost identical so the bottle brush used to clean the bore would not have gone through because of the used wire so someone should have known there was a problem. He said they have scheduled a training for the staff to go over some instruments that are repeated cleaning problems to make sure they don't miss anything during the cleaning process but the training has not been done yet.

In an interview on 10/29/19 at 11:02 a.m. with S33ST, he said he was the scrub technician working in the OR when Patient #2 had his surgery on 10/16/19. He said when he checked the instruments. S14Vendor was in the operating room. He said he thought the reamer had a tip on it and he told S14Vendor but he told him it was a new set. S33ST said he should have investigated it further but did not. S33ST said when he handed S7MD the reamer the surgeon noticed the wire. He said he has been working at the hospital and found 2 contaminated surgery trays. He said today around 7:00 a.m. he opened a kit in the operating room and a piece of equipment had human tissue hanging off of it. S33ST said he did not document the contaminated kit or do an incident report, he just switched the kit out for a new sterile one.

Patient #6
Review of Patient #6's incident report dated 6/19/19 revealed that on 6/18/19 at 8:00 a.m. on 2 separate accounts a brown substance began leaking out of a Stryker Saber ear drill onto the patient and the sterile field.

Patient #1
Review of Patient #1's medical record revealed she had been admitted on 7/16/19 to pre-op for Spinal Stenosis of her lumbar region. Further review revealed the surgery had been rescheduled to 7/25/19 due to instrument contamination.

Review of Patient #5's incident report dated 6/18/19 revealed that on 6/18/19 at 1:00 p.m. there was a 3 hour delay in surgery due to improper sterilization of operating equipment. Containers that arrived to the OR had been contaminated with hair, a mosquito and punctures in the wrapping.

Review of Patient #4's incident report dated 10/29/19 revealed that on 10/29/19 at 7:38 a.m. a contaminated instrument was found while checking pans in the OR.

Review of a graph provided by the hospital revealed from October 2017 through September 2019, the documented surgical trays with defects included the following:
693 contaminated with debris
244 contaminated with a hole in the pack
118 missing instruments
92 incorrect labels
84 items unsterile
62 contained no filter
55 contained no indicator
26 with wrong instrument
23 wet set
14 extra item in set
9 non-functioning item
6 damaged instruments

Review of a graph provided by the hospital of quality events involving surgery trays with contaminated debris revealed:
10/16/19 - 4 trays
10/17/19 - 3 trays
10/18/19 - 6 trays
10/22/19 - 7 trays
10/23/19 - 5 trays
10/24/19 - 1 tray
10/25/19 - 1 tray
(27 trays total in 9 days)

In an interview on 10/29/19 at 1:22 p.m. with S1CNO, she said the contaminated debris data could be from any time after the instruments were washed. She said as of yet they have not narrowed down the particular events into specifics such as which staff was responsible for checking and cleaning the supplies. She said in the Interdisciplinary Quality Committee meeting held September 5th 2019 they spoke of SPD. She also said when they met with staff they said they have more of a problem cleaning vendor sets because they are all different. When asked if the hospital had isolated how many of the vendor kits had to be reprocessed as opposed to the hospital owned kits, she said they had not.

2) Failure to ensure staff wore personal protective equipment in restricted areas according to AORN standard and hospital policy.

Review of the 2018 edition of AORN Guidelines for Perioperative Practice revealed, in part, Recommendation III under Surgical Attire read, "Personnel entering the semi-restricted and restricted areas should cover the head, hair, ears, and facial hair ...The benefit of covering the head, ears, and hair is the reduction of the patient's exposure to potentially pathogenic microorganisms from the perioperative team member's head, hair, ears, and facial hair. A clean surgical head cover or hood that confines all hair and completely covers the ears, scalp skin, sideburns, and nape of the neck should be worn." Further review revealed, surgical masks should not be worn hanging around the neck (Surgical Attire, I.h.4), personal clothing that cannot be contained within the scrub attire either should not be worn or should be laundered in a health care-accredited laundry facility after each daily use ... (I.b.5), and when in restricted areas, all nonscrubbed personnel should completely cover their arms with a long-sleeved scrub top or jacket (I.c.)...and briefcases, backpacks, and other personal items that are taken into the semi-restricted or restricted areas should be cleaned with a low-level disinfectant and should not be placed on the floor (I.1).

Review of Hospital Policy #SOS002, titled "Attire, Surgical", last review: 07/29/19, provided as current revealed, in part, the following, "Procedure ...4. All persons who enter the semi-restricted areas of the surgical suite will change into freshly laundered surgical attire provided by OLOLRMC. All persons will be attired in a pant suit. In addition, a long sleeve warm-up jacket is required for all staff. It should be snapped closed during use ... 5. All possible head and facial hair (except for eyebrows and eyelashes) should be covered when in the semi-restricted and restricted areas of the surgical suite. This includes sideburns and neckline. a. Cloth hats are allowed, but must be completely covered with a bouffant cap. b. Staff with long hair may need to wear two bouffant hats to contain their hair.
7. All persons entering the restricted area of the surgical suite will wear a mask.
a. A surgical mask will be worn at all times in the operating room or core areas whenever sterile supplies or sterile instruments are open ...
c. Masks will cover both mouth and nose and be secured in a manner that prevents venting ...
8. Individuals involved in direct patient care will have all jewelry confined within the scrub attire or removed ... c. Earrings should be of small size or removed or covered by a bouffant hat."
References: AORN Guidelines for Perioperative Practice, 2015.

An Observation was conducted 10/28/19 from 9:30 a.m. to 11:00 a.m., of the tower OR restricted areas. The surveyor was accompanied by S4DirSurgSvc and S6OrthoNsgDir in the Tower OR department. S4DirSurgSvc and S37ORDir accompanied the surveyor in the main OR department and main SPD department. S4DirSurgSvc accompanied the surveyor during observations in the tower SPD department 10/28/19 from 1:50 p.m. to 2:56 p.m.
The following observations were made, with confirmation by S4DirSurgSvc:
Tower OR restricted areas:
-When entering the restricted area, S9RN and S19RN were observed to exit the surgical area with surgical masks hanging down from around their necks.
-At the surgery control desk area, S11SRNA and S12SRNA were both observed with masks hanging from their necks, as well as S34AT with a mask hanging from his neck.
-OR1:S16RNFA was observed wearing a surgical skull cap, with hair exposed and both ears uncovered, her undershirt was exposed at her neck and on both arms below the scrub top, and no jacket or garment to cover arms while instruments were open and being set up. S18ST was assisting with the setup of sterile instruments and OR, with no jacket leaving her arms exposed below the short sleeves of her scrub top.
-OR2: A clear plastic rectangular bag was observed on floor, by anesthesia machine, open and containing items that included a wallet, fabric pouch, and anesthesia notebook that were exposed with the top standing open. Staff identified this to belong to S36SRNA.
-Sterile corridor: SS19CRNA was observed wearing a skull cap with both ears exposed. S20RN was observed to have a fabric head cover, exposed on the top front from under her bouffant cap.
-OR3- Individual wearing a red bouffant cap, ears exposed, identified by S4DirSurgSvc as a vendor.
-OR hallway restricted area: A person, identified by S4DirSurgSvc as a Vendor, with no mask, leaving his beard, and sideburns exposed. S24RN was observed with a skull cap with hair exposed from under the cap. S21Vendor, separate from the first observed Vendor, with a beard not covered.
-OR4- S19CRNA wearing a skull cap with ears exposed. S20RN, also in OR4, which had open instruments and a patient in the room, was observed with a cloth head cover partially exposed under a bouffant cap, with her ears partially exposed and dangling earrings exposed.
-OR5- S25RN with ears uncovered and beard exposed outside of his mask;
-OR7: S23CRNA was observed to have facial hair exposed from under the sides of his mask, ears exposed, and hair exposed from under his surgical cap for almost ½ of the back of his head.
Main SPD department:
An observation was made 10/28/19 at 10:44 a.m. of S26SPD tech revealed he was inspecting, assembling, and packaging clean instruments to be sterilized with no mask and a full beard exposed. No staff inspecting and assembling instruments were observed to wear a mask.
Two males, identified as vendors by S4DirSurgSvc, and their red bouffant head covers, were observed to walk through SPD with beards exposed and no masks or beard covers. S4DirSurgSvc confirmed their beards should have been covered.

Main OR, restricted areas, accompanied by S4DirSurgSvc and S37ORDir:
-OR9- S31ST sitting on stool in OR, monitoring the OR with sterile tables set, with her ears and earrings uncovered.
-OR4- S40MD performing surgery with a skull cap leaving hair exposed in the back of his head, from under the cap.
-OR2- observation of S41MD and a resident performing surgery both wearing skull caps with hair exposed.

-OR15- during surgery, both S42CRNA and S43SRNA were observed to wear skull caps with head hair exposed below their caps.
-OR16- S44RN was observed to wear a skull cap with hair exposed below the cap and on the sides of his head. S45CRNA was observed to have a cloth head cover partially exposed from under her bouffant head cover.
- in OR06-S46MD was observed performing a surgical procedure with a large amount of hair exposed from her bouffant cap at the lower back of her head approximately 4 inches and the sides of her head.

Tower SPD department:
-An observation 10/28/19 at 2:50 p.m. in the tower SPD department accompanied by S4DirSurgSvc, revealed a male walk into the SPD department, wearing a ball cap of camouflage print, with sunglasses propped on the top of the ball cap, jeans, and work style boots. The male was observed to walk through the SPD department to the middle sink, of 3 sets of decontamination sinks, and while on a cellphone, looked under the sink. S4DirSurgSvc, present for the observation, reported he was a contracted plumber, here to assess and repair one of the decontamination sinks. S4DirSurgSvc reported he should not have been in the SPD department without full PPE, and should not have had his garments and gear on that he wore outside of the restricted area. S4DirSurgSvc confirmed that no one in the SPD department had approached the contracted plumber to stop him from entering or asking him to don appropriate PPE before reentering.

In an interview 10/28/19 at 11:00 p.m., after touring the ORs and main SPD unit at the hospital's main campus, S4DirSurgSvc reported the hospital's surgical services at all campuses followed AORN guidelines. S4DirSurgSvc reported she was not aware that AORN guidelines included ears be covered, but confirmed multiple observations were made with staff and authorized contract personnel not following hospital policy. The senior nursing director confirmed the observations made during observations of the surgical departments and SPDs at the main campus.

3) Failure to enforce safe injection practices policies and procedures.

Review of hospital policy #NOP-016 titled "Medication Labeling for Parenteral Administration, last reviewed and revised August 31, 2018, provided as current, revealed in part that parenteral medication included, but not limited to, IV infusion, IV Push, Intramuscular and subcutaneous injections. Further review revealed that Parenteral doses prepared outside of the pharmacy for immediate use would contain the following information: patient label with name/MRN number, drug name, and dose , base fluid and volume (where applicable), initials of preparer, Expiration date (which include the day, month, year, and time of day).

Review of the 2018 edition of the AORN Guidelines for perioperative Practice revealed, in part, under Medication Safety, (V.o.) "Unused, opened irrigation or IV solutions should be discarded at the end of the procedure", and (V.q.) "Intravenous solution containers should be punctured (eg, spiked) within 1 hour of the initiation of administration."

An observation10/28/19 at10:05 a.m. in tower OR6 revealed the room was being set (instruments opened, supplies in place) for a scheduled orthopedic case.
Observed on the anesthesia machine top, unattended, were the following:
-a syringe containing clear fluid labeled, "Phenylephrine 40 mg/ml", with no date, time, or initials
-A small bag of 0.9% normal saline labeled, "Phenylephrine 40 mg" with no date, time, or initials.
In an interview 10/28/19 at 10:10 a.m. S11SRNA verified he left the above medications unattended and did not include a date, time of preparation, or his initials on them.


An observation 10/28/19 at 12:55 p.m. in the main OR9 revealed the following:
- unattended medications on the anesthesia cart/machine which included:
-20mls white fluid in a syringe with no label;
-5ml clear fluid in a 10 ml syringe, with no label;
-5 ml clear fluid in a 5 ml syringe, with a label "Rocuronium" with no amount/strength, date, time, or initials;
-a 10 ml syringe with clear fluid in it, with a label preprinted with "Phenylephrine", with no amount/strength, date, time, or initials.
On top of a supply cabinet next to the anesthesia machine was a 1000ml bag of IV Normal Saline, with administration tubing spiked into the bag. No label was observed on the bag or the attached tubing to note the time and date it was spiked (opened), or initials of staff that prepared the bag of fluid.

In an interview 10/28/19 at 1:00 p.m. S29CRNA confirmed he had prepared the medication in the observed syringes, had not labeled them completely, and left them unattended on the anesthesia machine. He reported that he had not prepared the bag of IV fluids and was not aware of why it was there.

In an interview 10/28/19 at 12:58 p.m. S38ST and S3RN , in the process of setting up the OR for a surgical case, both reported they did not have any knowledge related to the bag of IV fluids with the attached tubing.
S4DirSurgSvc, present for the interview confirmed the observation, and that hospital policy at all campuses required medication pre-drawn be labeled with the medication, strength, the date and time it was drawn up, and the initials of the staff preparing the medication. She confirmed the medication should not be left unattended after being drawn up into the syringes. S4DirSurgSvc confirmed the IV fluids should have been labeled, and should have been discarded.

An observation 10/30/19 at 4:15 p.m. in the OR of the OLOL-Ascension offsite campus, during the preparation for a surgical procedure, revealed an unattended syringe of white liquid on top of the anesthesia machine with a preprinted label with Propofol with no date, time, or initials to indicate who withdrew the medication into the syringe, what date, or what time. S48SurgDir reported the CRNA on duty was S49CRNA, and verified it should not be unattended and should have included the date, time, and preparer's initials on the label.


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