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Based on observations and interviews, the Hospital's Infection Control program failed to identify, prevent, and control infection control issues and/or breeches. This deficient practice is evidenced by failure to ensure a sanitary environment was maintained in all surgical areas.

Findings:

On 12/23/19 from 9:30 a.m. to 12:00 p.m. an observation was conducted of the restricted/semi-restricted areas of the surgical department, the surgical area clean equipment storage room, and of the sterile processing department.
The following issues related to breaches in the sanitary environment were noted during the observations:

1. OR Room 2:
a. Tape noted on positioning belt, unable to be properly disinfected;
b. Cuts in the covering of the high backed stool (on the seat and on padded back support) with foam exposed- unable to be disinfected properly;
c. Cloth positioning belt noted on the floor under a metal stand;
d. OR table foot pad noted to have a puncture in the covering with foam exposed - unable to be disinfected properly.
e. The upper body pad of the OR table had a slice in it, approximately ¾ inch in length, with foam exposed - unable to be disinfected properly; and
f. Roll board noted to be propped up against the wall, contacting both the wall and the floor.

2. OR Room 5:
a. Roll board noted to be propped up against the wall, contacting both the wall and the floor.
b. cuts in the covering of the high backed stool (on the seat and on the padded back support) with foam exposed- unable to be disinfected properly;
c. OR surgery table wheels noted to have pits in surface and rust - unable to be disinfected properly;
d. Roll board noted to be propped up against the wall, contacting both the wall and the floor; and
e. A coating of dust noted on the wall vent located on the lower portion of the wall, near th floor.

3. Surgical area clean equipment storage room:
a. Equipment cart covered with a greyish-green cloth secured to the top of the cart with several layers of clear adhesive tape. S1ADSurg, present during the observation, indcated he had no idea when the cloth covered cart had last been cleaned and agreed the tape also prevented the cart from being properly disinfected.
b.Battery chargers with batteries being charged were noted to be stored on the above referenced cart and the charger base had a fine coating of dust;
c. A blue bin containing batteries was also observed on the cart and noted to have a covering of dust inside of the bin; and
d. 2 - Candy cane stirrup pads observed to have cloth sleeves on them. S1ADSurg was present and verified the cloth sleeves should not have been on the stirrup pads.

S1ADSurg confirmed all of the above referenced sanitary environment breaches during the observation.

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 ensure organization of the surgical services provided qualified personnel to furnish the surgical services offered by the hospital. This deficient practice was evidenced by failure to:
a. have a supervisor of the Central Sterilization department with experience and training in surgical sterile processing; and
b. ensure surgical staff skills competencies were assessed and documented annually, as set forth in the hospital competency assessment policy, for 8 (S1ADSurg, S6RN, S7ST, S8IT, S12ST, S15IT, S16IT, S17ORAsst) of 9 (S1ADSurg, S6RN, S7ST, S8IT, S12ST, S15IT, S16IT, S17ORAsst, S20IntDirSurg) total sampled personnel records reviewed;

2) failure to ensure established standards for inspection of surgical instruments was followed by staff in the CSD when assembling surgical trays as evidenced by an observation of sterile processing personnel's failure to inspect all instruments for rust/damage, complete cleaning, and failure to test the sharpness of surgical scissors during assembly of a surgical tray;

3) failure to ensure a system was in place to monitor/track/trend instruments, instrument sets, and equipment returned to CSD for actual or potential contamination and missing, damaged, or malfunctioning instruments and/or equipment returned to CSD for reprocessing;

4) failure to ensure staff followed AORN guidelines and hospital policy for attire in restricted and semi-restricted areas, as evidenced by multiple observations of:
a. hair not contained within the surgical head covering,
b. personal cloth head covers not laundered by the hospital's contracted laundry service, and not completely covered with a hospital supplied bouffant cap in the restricted areas,
c). masks worn hanging around necks,
d). a vendor of surgical supplies/equipment reentering the hospital with uncovered surgical scrubs and a mask hanging from his neck, and
e). personnel with nail polish while working in the OR;

5) failure to ensure safe injection practice policies and procedures were followed, as evidenced by 2 observations of, medications in ORs being set-up for surgical procedures, that were not properly labeled, empty syringes left unattended by anesthesia staff that had prepared them, and an observation of a nurse, in OR, drawing up an injectable medication without first cleaning the rubber septum on the vial with alcohol;

6) failure to ensure sterile surgical instruments set up for a pending surgical case had not been left in the OR suite unattended by hospital OR staff, prior to the patient arrival and starting the surgical procedure.
Findings:

1) Failure to ensure organization of the surgical services provided qualified personnel to furnish the surgical services offered by the hospital.

Review of AORN Guidelines for Perioperative Practice (2018 Edition) revealed in part the following: under Instrument Cleaning, Recommendation XV, "Perioperative team members with responsibilities for cleaning and care of instruments used in surgery should receive initial and ongoing education and complete competency verification activities related to cleaning and care of surgical instruments.", and under Environment of Care, Part 1, Recommendation XI, " Perioperative personnel should receive initial and ongoing education and complete competency verification activities for establishing and maintaining a safe environment of care."

Review of the hospital policy titled, "Competency Assessment", Policy number: HR.LD.001, effective date: May 1, 2015, provided by S13QA as current, revealed in part:
Scope: Applies to all employees excluding Physicians Services Group. Employee groups listed as "At will" in the limitations of Employment Policy HRE.ER.019, employees with a written agreement, and volunteers. Contract staff will be held to the same standards as employees and the records must be maintained by the business.
Purpose: To define mechanisms used to assess and maintain competency of employees as required for the position and by regulatory agencies.
Definitions: 1. Competency refers to the skills, knowledge, abilities, and behaviors required to perform assigned duties and responsibilities safely and aptly. 2. Competency Assessment: Competency Assessment is conducted initially as part of orientation. Ongoing competency assessment occurs at a minimum annually.
Responsibilities: 1. Management is responsible for ensuring a mechanism exists to identify area specific competency requirements. 2. Employees are responsible for demonstrating competencies as required for each area or department.
Requirements: 3. Ongoing competency assessment is an essential process for verifying an individual's ability to perform their assigned job role by evaluating the ability to apply knowledge, perform skills and demonstrate critical thinking.

Review of the hospital's organizational chart, presented as current by S13QA, revealed the position of sterile processing supervisor was marked as vacant. Further review revealed S20IntDirSur was the interim Director of Surgical Services and the department of sterile processing fell under his line of authority.

Review of the personnel files for S1ADSurg and S20IntDirSur, provided by S19HR, revealed no documented evidence of training or experience in Sterile Processing.

Review of the personnel file for S15IT revealed the employee's last documented skills competencies for Sterile Processing and Decontamination were conducted on 6/21/17. Further review revealed no documented evidence S15IT had been deemed competent to perform competency evaluation of other CSD employees.

Review of the personnel file for S8IT revealed the employee's last documented skills competencies for Sterile Processing and Decontamination were conducted on 7/25/18. Further review revealed no documented evidence S8IT had been deemed competent to perform competency evaluation on other CSD employees.

Review of the personnel file for S16IT revealed the employee's last documented skills competencies for Sterile Processing and Decontamination were conducted on 12/26/19 (after surveyor request for skills competency assessments). There were no documented initial skills competency assessments. S13QA confirmed HR could not find any documented skills competency assessments in S16IT's personnel file prior to 12/26/19.

Review of the personnel file for S7ST revealed no documented evidence of observed competency evaluations that included demonstration of specialized skills.

Review of the personnel file for S12ST (date of hire: 7/11/06), revealed no documented evidence of observed competency evaluations that included demonstration of specialized skills.

Review of the personnel file for S6RN, (date of hire: 6/7/11), currently in the position of OR Circulator, revealed the last documented evidence of job specific skills performance competency evaluations was dated 4/13/15 and the competencies were not for OR skills. Further review of a competency evaluation, dated 6/26/19, revealed no documented evidence of observed competency evaluations that included demonstration of specialized skills related to aseptic and/or sterile technique and use of job performance related equipment.

Review of the personnel file for S17ORAsst, (date of hire: 2/13/06), placed in position of OR assistant 9/14/14, revealed no documented evidence of observed competency evaluations that included demonstration of specialized skills.

Review of the personnel file for S1ADSurg, (date of hire: 2/13/06), revealed no documented evidence of observed competency evaluations that included demonstration of specialized skills (OR) since 2016.

S13QA and S19HR, assisting with personnel file reviews on 12/26/19, verified the above referenced findings in the sampled personnel records reviewed.

In an interview, during an observation of the hospital's sterile processing department, on 12/26/19 at 11:50 a.m., S1ADSurg confirmed the hospital's previous central sterilization department supervisor had resigned approximately a week ago. He indicated S20IntDirSur was the interim Director of Surgical Services and the Sterile Processing Department (Central Sterilization Department) . He further indicated S20IntDirSur was currently on vacation and he (S1ADSurg) was covering for S20IntDirSur. S1ADSurg confirmed he was responsible for management of Surgical Services and the Central Sterilization Department in S20IntDirSur's absence. S1ADSurg confirmed he did not have training or experience in the sterile processing department.

In a phone interview on 12/26/19 at 2:36 p.m. S20IntDirSur confirmed he was currently interim Director of Surgical Services and was also the interim Central Sterilization Department Director. S20IntDirSur reported he had 16 years of experience as Operating Room Director and his specialty in perioperative services was Recovery. He confirmed there was a current gap in having someone who is knowledgeable in Sterile Processing to serve as the CSD Director. S20IntDirSur confirmed sterile processing is a critical process and it is a position that requires a high level of knowledge and competence. He confirmed they don't currently have anyone competent in sterile processing to oversee the hospital's CSD. S20IntDirSur reported they also need to make sure they have an appropriate number of qualified staff to work in the sterile processing department. He confirmed the sterile processing department was short staffed at this time.

In an interview on 12/26/19 at 3:32 p.m. with S1ADSurg, he confirmed no one in current management/supervisory positions are knowledgeable enough about sterile processing to adequately supervise and evaluate whether processing is being done appropriately. S1ADSurg reported scrub techs had been sent to assist with coverage in sterile processing to work alongside other sterile processing employees. S1ADSurg confirmed the scrub techs had not had their decontamination and sterilization processing knowledge and skills competencies verified prior to them being sent to help out in sterile processing.

In an interview on 12/26/19 at 4:39 p.m. with S13QA, she confirmed the hospital did not currently have anyone in management positions in Surgical Services, on this campus, who possessed the knowledge and experience to provide oversight of the hospital's sterile processing department

In an interview on 12/26/19 at 10:00 a.m. with S8IT, she reported she was oriented by S15IT, another instrument tech who works in the sterile processing department. S8IT explained S15IT "had walked her through each step of how to do things in SPD". S8IT indicated she was not observed and checked off on performance of her duties. S8IT reported she has been employed for 3 years and they only did her skills competency checks on hire.She said they do an evaluation to show their improvements, but it is a verbal evaluation that does not include watching her perform her skills/job duties.

In an interview on 12/26/19 at 11:09 a.m., with S16IT, she reported she has worked at the hospital for 1 year. She reported S8IT had oriented her.

In an interview on 12/26/19 at 1:00 p.m. with S12ST, he confirmed his annual evaluations were verbal discussions. S12ST indicated there were no skills competency evaluations performed that involved anyone observing him perform his job duties. He indicated he thought once you were assessed as competent you were always considered competent.

In an interview on 12/26/19 at 1:47 p.m. with S7ST, she confirmed she did not have observed competency evaluations that included demonstration of specialized skills.

In an interview on 12/26/19 at 2:15 p.m. with S6RN, she indicated she had not had observed competency evaluations that included demonstration of specialized skills.

In an interview on 12/26/19 at 3:16 p.m. with S18ORSup, she confirmed OR staff evaluations did not include observation of demonstration of specialized skills. She reported all training is on Health-stream online.

In an interview on 12/26/19 at 3:32 p.m. with S1ADSurg, he confirmed skills competencies for OR staff and CSD staff had not been performed annually and any documented competency evaluations had not included observed demonstration of job skill performance, adherence to sterile technique, adherence to sterile processing procedures. He confirmed the hospital's surgical service and CSD practices were based on AORN standards.



2) Failure to ensure policies and procedures were established and implemented according to standards for inspection of surgical instruments was followed by staff in the CSD when assembling surgical trays as evidenced by an observation of sterile processing personnel's failure to check instruments for rust/damage and failure to test sharpness of surgical scissors during assembly of a surgical tray.

Review of AORN guidelines for Perioperative Practices, 2018, revealed the following, in part:
Under Instrument Cleaning, Recommendation X, "Surgical instruments should be inspected and evaluated for cleanliness and correct working order after decontamination and if soiled or defective, should be removed from services until they are cleaned or repaired: Items that are not clean or do not function can put a patient at risk for injury or SSI. Inspection and evaluation provide an opportunity to identify soiled or damaged instruments and to remove from service until clean or repaired. Xa. Items should be inspected and evaluated for: *cleanliness, *correct alignment, * corrosion, pitting, burns, nicks, cracks, *sharpness of cutting edges, *wear and chipping of inserts and plated surfaces; *missing parts; *...correct functioning; and *other defects."

Review of Sterile Processing policies and procedures, provided in response to surveyor request for all policies and procedures related to the decontamination, processing, and sterilization of surgical instruments, revealed no policy and procedure was provided for the steps and processes related to decontamination, cleaning, inspection, packaging, and sterilization of surgical instruments and equipment in CSD.

An observation was conducted 12/26/19 at 11:06 a.m. in CSD, of S8IT assembling a Hand & Foot instrument set, to be sterilized. S8IT was observed to inspect only some of the instruments for residual contaminants, rust, alignment of teeth, or any burrs or damage to the 2nd half of the instruments. S8IT did not test the sharpness of any of the scissors in the instrument tray. S8IT confirmed she had not inspected all of the instruments and did not test the surgical scissors for sharpness. S8IT confirmed she should have inspected each instrument, and that all scissors should be tested for sharpness. S8IT reported that there are some times that instrument trays or sets are returned from the OR to be reprocessed because there was something found in the tray or the sterility was questioned, but could not provide an approximate number or frequency that this happened. She reported that OR staff did not notify them (CSD staff), but just put them in the decontamination room. S8IT reported no list or documentation of any surgical instruments or equipment that was returned for reprocessing. S8IT reported she and another IT were the only staff working today.


3) Failure to ensure a system was in place to monitor/track/trend for potential sterile processing issues related to contaminated/potentially contaminated surgical trays being returned to sterile processing for decontamination/reprocessing.

Review of policies and procedures provided for surgical services and sterile processing revealed no reference to a procedure for surgical instruments and equipment returned to the sterile processing department related to contamination or possible contamination. No procedure was provided for reporting and tracking these events.

Review of logs in CSD revealed no documentation of surgical instruments and equipment that were returned from the ORs for possible or actual contamination or equipment failure.

An observation 12/26/19 at 10:56 a.m. in CSD of a processed, sterile Ankle Distractor surgical instrument kit, opened by S1ADSurg for surveyor inspection revealed the kit had old adhesive stuck on the right corner, a small piece of silver metal flake sitting in the bottom of the tray and small area of rust-colored discoloration on a roll pin, an area approximately 3" x ½ " inches in the tray of dark brown substance/discoloration that was easily removed with an alcohol swab by S1ADSurg. S1ADSurg confirmed the observations and reported their process did not include documentation of which staff member assembled the instrument tray in preparation for sterilization. S1ADSurg confirmed the provider had no process in place for the documentation, tracking, or trending of instruments sets potentially contaminated or incorrectly processed.

In an interview 12/23/19 at 11:03 a.m. in CSD, S8IT reported that surgical instruments were sometimes returned from OR prior to surgery to be reprocessed. She reported she couldn't say how often, but maybe several times a month. S8IT reported that there is no log or documentation related to returned sets. She reported that the instruments/instrument sets were just brought to decontamination and dropped off.

In an interview 12/26/19 at 9:55 a.m. S12ST reported occasionally surgical instrument sets had to be returned to CSD for repossessing prior to a surgical procedure. He reported he guessed that happened a couple times a month. He reported the instruments were returned to CSD. He reported he was not aware of any specific process of notifying management or documenting the occurrence.

In an interview 12/26/19 at 9:44 a.m. S1ADSurg reported the hospital did not have a process in place to track potentially damaged or contaminated surgical instruments and equipment returned to CSD for reprocessing. S1ADSurg reported he did not know how frequently this occurred, as it was not reported, documented, and tracked. He reported there had been instances where instrument sets were returned because of bone fragments identified in the sets.

In an interview on 12/23/19 at 2:53p.m. S14ICO confirmed she was the IC Officer for the main campus and this offsite campus. She reported the hospital did not have a process in place to track potentially damaged, contaminated trays returned to central processing.


4) Failure to ensure staff followed AORN guidelines and hospital policy for surgical attire in restricted and semi-restricted areas, as evidenced by multiple observations of:
a. hair not contained within the surgical head covering,
b. personal cloth head covers not laundered by the hospital's contracted laundry service, and not completely covered with a hospital supplied bouffant cap in the restricted areas
c). masks worn hanging around necks, and,
d) a vendor of surgical supplies/equipment reentering the hospital with uncovered surgical scrubs and a mask hanging from his neck, with no staff aware that he had left the hospital with surgical attire and ensuring it was changed before reentering the restricted area(s); and
e). OR staff wearing nail polish while working in the OR.

Review of AORN Guidelines for Perioperative Practice revealed the following under Surgical Attire, in part:
Clean surgical attire should be worn in the semi-restricted and restricted areas of the perioperative setting ...The collective body of evidence supports wearing clean surgical attire in the perioperative setting to reduce the number of microorganisms in the environment and the patient's risk for developing and SSI. Clean scrub attire has been laundered in a health care-accredited laundry facility and has not been previously worn ... (Recommendation I) and personal clothing that cannot be contained within the scrub attire either should not be worn or should be laundered in a healthcare-accredited laundry facility after each daily use ...(I.b.5) ... a fresh surgical mask should be donned before the health care worker performs or assists with each new procedure (1.h.3). Surgical masks should not be worn hanging around the neck (I.h.4). Further review revealed all individuals who enter the semi-restricted and restricted areas should wear scrub attire that has been laundered at a health care accredited laundry facility or disposable scrub attire provided by the facility and intended for use within the perioperative area (Recommendation II). Recommendation III documented personnel entering the semi-restricted and restricted areas should cover the head, hair, ears, and facial hair.

Review of the hospital policy and procedure # POP.GEN.008, titled "Uniform Policy for surgical services restricted areas", last reviewed 07/10/18 and provided by S13QA as current, revealed the following in part : Under definition of semi-restricted area: ...Personnel are required to wear surgical attire and cover all head and facial hair ....
Personnel: II.2 ...Fingernail polish is not to be worn ...5. After daily use, reusable surgical attire are placed in the appropriate receptacle for laundering ...8. Personnel should cover head and facial hair including sideburns and necklines. A single use head covering is to be worn over reusable head coverings ...12. Masks left dangling around the neck are not acceptable and should be removed ...17. Personal clothing should be covered by surgical attire. 18. Surgical attire should not be washed in the home. References: AORN Recommended Practices for Surgical Attire"

An observation on 12/23/19 at 9:20 a.m., made upon entering the hospital at the front entrance, revealed S4Vendor entering the hospital via the front entrance in Tulane surgical scrubs and attire with a surgical mask hanging from his neck. S4Vendor reported at that time he was a surgical vendor and had just run out to his car to get something. He verified he was wearing surgical scrubs.

In an interview 12/23/19 at 9:30 a.m. S1ADSurg identified the vendor, observed by surveyors, re-entering the hospital at the same time surveyor entered at the main/front entrance. S1ADSurg reported they were unaware the vendor had left the hospital in the surgical scrubs and could not confirm the surgical vendor had changed into clean scrubs upon his return. S1ADSurg confirmed the vendor should not have had his surgical mask on outside the OR, and not hanging from his neck.


Observations made in the restricted and semi-restricted of the surgery department 12/23/19 from 9:30 a.m. to 11:15 a.m. accompanied by S1ADSurg revealed the following:

-A person identified as a medical student, but S1ADSurg unable to identify his name, was observed in the restricted hallway wearing a disposable surgical skull cap with his head hair exposed from under the cap.

-S22ST in the restricted area/OR hallway with his hair uncovered from under a disposable skull cap;

-S6RN setting up OR 3 in preparation for a patient surgery, then walking out into the restricted hallway with hair exposed from under a disposable bouffant cap at the sides and back lower portion of her head;

-S7ST in hallway, exiting OR 3, which was being set up for a surgical procedure, with a cloth surgical hat, exposed approximately 1-1 ½ inches from under the front of her disposable bouffant surgical cap. S7ST reported that she keeps her cloth head covering in her locker. S7ST further reported her personal cloth head covering was not laundered by the health care-accredited contract laundry service, and that she did not launder it herself, but just continued to use it.

-S23MD exited an OR, after completing a surgical procedure, with his hair exposed from beneath his disposable skull cap.

Observations in the restricted and semi-restricted surgical areas, made 12/26/19 from 9:30 a.m. - 11:15 a.m., accompanied by S1ADSurg and S2CNO revealed the following, in part:

-S3Vendor exiting the restricted area into the public hallway with a surgical mask hanging from his neck;

-S10ST sitting in staff break room with a surgical mask hanging from her neck;

-S11MD with surgical mask hanging from his neck, exited OR and walked in to the lounge

S1ADSurg, present for the above noted observations confirmed all observed breeches in surgical attire.

An observation, made during an interview, 12/26/19 at 1:47 p.m. revealed S7ST was wearing nail polish. S7ST confirmed her position was as a surgical scrub technician, that she was working that day, scrubbing in on surgical cases, and was wearing nail polish. S7ST reported she wasn't sure what the hospital policy was regarding surgical staff wearing nail polish or artificial nails.

An observation, during an interview 12/26/19 at 2:15 p.m. revealed S6RN wore nail polish on her fingernails. S6RN confirmed she worked in the OR as an RN Circulator, was working that day, and was wearing nail polish. S6RN reported she wasn't sure of the policy for OR staff wearing nail polish, but reported scrub techs should not wear it.


5) Failure to enforce safe injection practices policies and procedures, as evidenced by 2 observations of medications in ORs being set-up for a surgical procedure that were not properly labeled and opened empty syringes being left unattended by anesthesia, and observation of an RN in OR drawing up a medication without first cleaning the top of the vial with alcohol.

Review of AORN periOperative Guidelines (2018) revealed, under Medication Safety, V.k. "The rubber septum on all vials should be disinfected with alcohol and allowed to dry before each entry. The evidence supports disinfecting the rubber septum to remove any contaminant present on the stopper ...V.1.2, "The syringe should never be left unattended and should be discarded at the end of the procedure."

Review of a Nursing Practice and Skill document titled, "Administration of Medication: Withdrawing Medication from a Vial", provided by S13QA as the procedure following by nursing staff, revealed under "How to withdraw medication from a Vial", " Clean the rubber seal/stopper by wiping it vigorously with an alcohol swab ..."

An observation on 12/23/19 at 9:40 a.m., in OR 3 revealed 4 unwrapped hypodermic syringes lying on the top of the anesthesia cart with no labels. The OR was observed to be set up for a surgical procedure with opened surgical instruments on the surgical table. No OR staff were noted to be in the OR at the time of the observation. S1ADSurg, present for the observation verified the observation and the syringes should not have been opened and left on the cart.

In an interview on 12/23/19 at 9:50 a.m., in OR 3, S5CRNA reported he had opened the syringes in OR 3 and left them unattended. He confirmed the sterile syringes should not have been opened and left unattended.

An observation on 12/23/19 at 10:05 a.m. in OR 4 revealed on top of the unattended anesthesia cart were the following hypodermic syringes: a 5 ml syringe with 5 ml clear liquid with no label, a 10 ml syringe removed from the wrapper, and a 30 ml syringe removed from the wrapper. On top of the anesthesia drug machine were: an opened,empty 3 ml syringe with a label with only preprinted "Fentanyl" with no other labeling, an opened, empty 3 ml syringe, and an opened, empty 10 ml syringe with a white blank label on it. S1ADSurg, present for the observation confirmed the findings.

An observation on 12/26/19 at 10:45 a.m. in on OR revealed S21RN open a vial of Adrenalin 30mg/ml and withdraw medication for adding to irrigation fluid, in preparation for a surgical procedure. S21RN did not clean the rubber septum upon opening the vial, before puncturing the septum and withdrawing the medication. S21RN, at the time of the observation confirmed she did not clean the rubber septum of the new vial of medication because she thought it was already sterile, and was not aware that the rubber septum on injectable medication vials should be cleaned with alcohol prior to inserting the needle, whether they were previously opened or not.


6) Failure to ensure sterile surgical instruments set up for a pending surgical case had not been left in the OR suite unattended by hospital OR staff, prior to the patient arrival and starting the surgical procedure.

Review of AORN Guidelines for Perioperative Practice, (2018) revealed, in part under Sterile Technique, Recommendation VII, "Sterile fields should be constantly monitored. The sterile field is subject to unrecognized contamination by personnel, vectors (e.g. Insects), or breaks in sterile technique if left unobserved. VII.a.: Once created, a sterile field should not be left unattended until the operative or other invasive procedure is completed."

Review of hospital policy #POP.GEN.011, titled "Sterile Technique", provided by S13QA as current, revealed in part, the Surgery Department will adhere to the hospital's policies for infection prevention ... Procedure... F. A sterile field should be constantly monitored and maintained ....4. Unguarded sterile fields are considered contaminated.

An observation in OR3 on 12/23/19 at 9:40 a.m. revealed the room being set up for an orthopedic surgical procedure. During the time the surveyors were in the OR making observations, staff left the room unmonitored with the surgical table set with sterile instruments and supplies, uncovered. During this unoccupied room with sterile table set with uncovered surgical instruments.

In an interview 12/23/19 at 9:50 a.m. S1ADSurg confirmed the OR with opened instruments should not be left unmonitored by OR staff. S1ADSurg reported the hospital's surgical department followed AORN guidelines.



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